PharmaNet Development Group, Inc. has opened a new Phase I clinic in Toronto, Canada and new offices in Brussels, Belgium and Milan, Italy. The company has also relocated its Zurich, Switzerland office to allow for future growth of its staff.

"In support of the continued growth in demand for clinical development services and the trend towards more large, global studies, we are opening additional office locations and clinics to intensify our presence in the region and meet the needs of our clients around the world," commented Jeffrey P. McMullen, president and chief executive officer, PharmaNet Development Group, Inc. "We believe this continued expansion will allow us to serve our clients better."

The new facility in Toronto is approximately 40,000 sq. ft. and has four clinical units with 160 beds. The new offices in Brussels, Milan and Zurich will support late stage clinical development programs in these regions. Each office includes room for future expansion. The Brussels office, which opened last month, houses a staff of five. The Milan office, which opened earlier this month, currently accommodates nine employees and supports several field-based regional staff. The new location in Zurich currently accommodates 26 employees.

The European Commission granted marketing authorization for Invega, an atypical antipsychotic medication for the treatment of schizophrenia. This once-daily medication is specifically designed to deliver paliperidone—the drug's active ingredient—through the osmotic delivery system (OROS). In clinical trials, Invega demonstrated significant efficacy controlling the symptoms of schizophrenia compared to placebo and was generally well tolerated. Invega is the first treatment for schizophrenia approved in the EU that uses the OROS delivery system.

Invega will be marketed in Europe by Janssen-Cilag and in the U.S., the product is marketed by Janssen, L.P. as Invega Extended-Release Tablets. Both are subsidiaries of Johnson & Johnson.

The marketing authorization was granted based on efficacy and safety results of an extensive clinical development program that included: three six-week, placebo controlled clinical studies involving more than 1,600 patients with acute schizophrenia in 23 countries, a 40-week double blind, placebo controlled study in 207 patients examining time to relapse, and another study assessing safety and tolerability in 114 elderly patients suffering from schizophrenia.

Greg Norden has been named senior vice president and chief financial officer, Wyeth. Mr. Norden previously served as executive vice president and chief financial officer at Wyeth Pharmaceuticals and has been with the company since 1989. He has held positions of increasing responsibility, including senior vice president, finance and chief financial officer, American Home Food Products, and senior vice president and chief financial officer, Wyeth Labs. He also served as executive vice president and chief financial officer, Wyeth Pharmaceuticals since 2000. Mr. Norden succeeds Kenneth J. Martin, who plans to leave the company effective June 30, 2007.

SGS India Ltd.'s Chennai facility has passed an FDA inspection conducted in February 2007. It was both a pre-approval and a GMP inspection. The facility is classified as "acceptable." This was the first FDA inspection of the SGS QC testing laboratory in Chennai.

"Providing high quality analytical services in all of our QC Testing laboratories is the prime commitment to our worldwide pharmaceutical clients," said Manfred Weiler, global business manager at SGS Life Science Services. "Passing the FDA inspection is a great achievement for our Indian QC testing laboratory. It is also a result of our continuous efforts to improve and harmonize quality systems and processes throughout our network of 14 QC laboratories in North America, Europe and Asia."

The SGS Chennai site began pharmaceutical testing in 1995, and received local GMP government approval at that time. In 1997, the facility obtained ISO 17025 certification for chemical, mechanical, and biological fields. In February 2005, the Life Science Services operations moved to Ticel Biopark, a purpose-built lab facility dedicated to R&D and drug development services. SGS occupies approximately 2400 square meters of state-of-the-art lab space for chemical, microbiological and toxicological testing. The current QC testing staff consists of more than 40 employees.

The Chennai facility provides testing services in the GMP and GLP areas: raw material and finished product testing, microbiological testing, stability testing, toxicology, biotechnology and medical device testing.

Pfizer initiated a Phase III trial to evaluate the safety and efficacy of sunitinib malate, in combination with a standard chemotherapy regimen, in patients with metastatic colorectal cancer (mCRC). Also, new data from a Phase I study showed that sunitinib malate is active and generally well-tolerated in combination with a standard chemotherapy regimen, FOLFIRI, in previously untreated patients with mCRC. These data support further evaluation of sunitinib malate in mCRC in a Phase III program.

The Phase III study is currently enrolling in Europe, Canada, Asia and South America and will include more than 700 patients to evaluate the safety and efficacy of sunitinib malate combined with FOLFIRI, a standard chemotherapy regimen used in mCRC comprised of fluorouracil (5-FU), folinic acid (leucovorin), and irinotecan, compared with FOLFIRI plus placebo, in the first-line treatment of patients with mCRC.

Progenics Pharmaceuticals and Wyeth achieved positive results from a three-month open-label extension study of subcutaneous methylnaltrexone for the treatment of opioid-induced constipation (OIC) in patients with advanced illness.

Eighty-two OIC patients completed a placebo-controlled Phase III study (MNTX 302) and participated in the three-month open-label extension study of subcutaneous methylnaltrexone. The goal of the extension study was to obtain efficacy and safety data on subcutaneous methylnaltrexone, administered as needed, for as long as three months.

Forty-two OIC patients received subcutaneous methylnaltrexone previously in MNTX 302, and then entered the open-label extension study. The mean laxation response rates were 45.5% during the first month, 57.7% in the second month, and 57.3% in the third and final month. For the remaining 40 patients who had first received placebo in the MNTX 302 study prior to this open-label extension study, laxation response rates were 48.3% during the first month, 47.6% in the second month, and 52.1% in the third and final month. Consistent with previous studies, subcutaneous methylnaltrexone was generally well-tolerated in the three-month open-label study, and the most common adverse event reported was abdominal pain which was typically mild-to-moderate in severity.

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. have submitted a sNDA to the FDA for Nexavar for the treatment of patients with hepatocellular carcinoma (HCC), the most common form of liver cancer. Nexavar is currently approved for the treatment of advanced kidney cancer. The companies are also planning a Phase III study of Nexavar in the adjuvant treatment of HCC following the complete removal of early stage liver cancer.

The sNDA is based on positive data from the international, Phase III, placebo-controlled Sorafenib HCC Assessment Randomized Protocol (SHARP) trial, which demonstrated that Nexavar extended overall survival by 44% in patients with HCC versus placebo. There were no significant differences in serious adverse event rates between the Nexavar and placebo-treated groups. Currently, there are no FDA-approved drug therapies that significantly extend survival of patients with liver cancer.

Merck's NDA for Isentress has been accepted by the FDA. Data in the NDA support the proposed use of Isentress in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.

The priority review status is a designation for investigational products that address unmet medical needs. The FDA is expected to review and act on the NDA within six months of submission. Merck anticipates FDA action by mid-October and is moving forward with regulatory filings in other countries.

If approved, Isentress would be the first in a new class of antiretroviral agents called integrase inhibitors that inhibit the insertion of HIV DNA into human DNA, blocking the ability of the virus to replicate and infect new cells.

ViroPharma, Inc.'s HCV-796 for hepatitis C virus infection has been granted fast track designation by the FDA. HCV-796, an orally dosed non-nucleoside hepatitis C viral polymerase inhibitor that interferes with the replication of hepatitis C virus (HCV), is currently in Phase II trials and is being co-developed with Wyeth Pharmaceuticals.

"The receipt of fast track designation for HCV-796 is an important regulatory step forward as we continue to work closely with the FDA and our Wyeth colleagues throughout the development process," commented Robert Pietrusko, Pharm.D., ViroPharma's vice president of global regulatory affairs and quality.

Fast track designation may potentially expedite the review of a drug that demonstrates the potential to address an unmet medical need for a serious life-threatening condition. It allows the FDA to accept, on a rolling basis, portions of a marketing application for review prior to the completion of the final registration package.

Abbott and Genentech have formed a collaboration for the global research, development and commercialization of two of Abbott's investigational anti-cancer compounds, ABT-263 and ABT-869. The companies will share further development and commercialization of the compounds. They will co-promote any resulting products in the U.S., while Abbott will promote any resulting products outside the U.S. Financial terms were not disclosed.

These compounds represent promising scientific approaches to treating cancer. ABT-263, a Bcl-2 family protein antagonist, restores apoptosis -- a natural process by which damaged or unwanted cells die and are cleared from the body -- in a variety of cancer cells. ABT-869, a VEGFR-based multi-targeted kinase inhibitor, suppresses tumor growth by preventing the growth of new blood vessels that supply the tumor with oxygen and nutrients and by inhibiting key angiogenic signaling pathways. Both compounds are currently in Phase I trials in several tumor types. Phase II trials for ABT-869 will begin this year.

"We hope that the combination of Abbott's scientific discoveries and Genentech's proven experience in the oncology arena can help bring these promising anti-cancer compounds to patients," said John Leonard, M.D., vice president, global pharmaceutical R&D, Abbott. "It takes significant resources to discover and develop new medicines. We believe that our collaboration with Genentech, in addition to our pipeline of other cutting-edge scientific approaches to fighting cancer, will allow Abbott to build a world-class oncology franchise."

"We are very pleased to be entering into this collaboration with Abbott for the development of therapies that may offer new options to treat patients with cancer," said Hal Barron, M.D., senior vice president, development and chief medical officer for Genentech. "We believe that these molecules are strong complements to our existing anti-angiogenesis and apoptosis research and development programs and have the potential to broaden our pipeline with important, innovative compounds."

Wyeth has exercised its right to license three bone anabolic drug targets from a 2003 osteoporosis research agreement with Galapagos, resulting in a $1.4 million milestone payment to Galapagos.

This is the second milestone reached in the osteoporosis collaboration. Galapagos has applied its osteoporosis disease expertise to discover and validate novel drug targets for Wyeth. In November 2004, Wyeth selected a set of these targets for internal validation.

Under the terms of the 2003 agreement, Galapagos could receive milestone payments of as much as $40.4 million from the collaboration. The targets involved in the Wyeth collaboration are unrelated to the validated targets in Galapagos' osteoporosis program.

"Wyeth licensing targets identified by Galapagos speaks to the strengths and uniqueness of our target discovery approach," said Onno van de Stolpe, chief executive officer of Galapagos. "The expertise which led to this milestone with Wyeth also forms the basis for our own portfolio of novel targets in osteoporosis."

John H. Stewart has been named acting president of Purdue Pharma L.P. Mr. Stewart succeeds Michael Friedman who retired as president and chief executive officer after 22 years with the company. Mr. Stewart will focus on leading Purdue Pharma in the U.S. while continuing to serve as president of Purdue Pharma, Canada.

Throughout his 33-year career with Purdue Pharma, Canada, Mr. Stewart has held positions in clinical research, business development, product development, regulatory affairs and sales. He joined the company as a sales representative in 1974 and moved into clinical research two years later, holding positions of increasing responsibility in scientific affairs before being appointed executive vice president and general manager in 1989 and president in 2006.

"As a highly respected and seasoned professional, John is a welcomed addition to our executive team. His industry experience, management abilities and focus on actions that improve healthcare outcomes make him the ideal choice for Purdue, and we are confident that the company will be in excellent hands under his leadership," said the Purdue Pharma board of directors.

Roche and Toyama Chemical Co. have entered into a licensing agreement for the research, development and commercialization of Toyama's oral rheumatoid arthritis agent T-5224. By inhibiting a specific inflammatory process, T-5224 has the potential to block signs and symptoms of rheumatoid arthritis and the progressive destruction of joint and bone. The compound is currently in Phase I.

Under the terms of the agreement, Roche has been granted exclusive rights to research, develop, and market T-5224 worldwide excluding Japan where Toyama Chemical will retain exclusive rights. The agreement also includes the joint R&D of back-up candidates to T-5224. Toyama Chemical will receive upfront payments and milestone payments totaling as much as $370 million, based on certain development and commercial milestones. If approved, Toyama Chemical will receive royalties on sales of T-5224.

"This novel oral compound complements Roche's developing portfolio of drug candidates in inflammation and rheumatoid arthritis. The agent T-5224 has the potential to inhibit a key trigger of rheumatoid arthritis and has already shown promising pharmacological efficacy and safety in early clinical studies," said Jean-Jacques Garaud, head of Roche Pharma Development. "Our new collaboration is good news for all patients with rheumatoid arthritis as well as for our two companies. We are looking forward to collaborating with our new colleagues in Japan to develop T-5224."

"By entering into a R&D collaboration with Roche, one of the world's leading R&D companies, we are able to increase Toyama's potential for novel drug development in the anti-inflammatory field, which is a field of concentration for Toyama Chemical," said Masuji Sugata, president of Toyama Chemical.

Under legislation to be introduced in the U.S. Senate, makers of generic drugs would gain the right to market generic versions of biopharmaceutical medicines. The legislation would create a pathway for the FDA to approve generic treatments made through biotechnology.

According to analysts, competition from lower-cost generics may cut biopharmaceutical drug prices by a third. Generic companies are targeting drugs whose patents have already expired or are set to expire. Companies such as Barr Pharmaceuticals and Teva Pharmaceutical Industries have already made significant investments in acquisitions and facilities outside the U.S. for the technology to make generic versions of biopharmaceuticals.

The Senate proposal would require generic companies to conduct animal studies and at least one clinical trial in humans unless the FDA determines that these steps aren't necessary. The FDA also would have leeway to decide if a generic product could be substituted by a pharmacist for a prescribed brand-name drug.

European regulators allow approval of generic versions they refer to as biosimilars, however, these products are not recognized as identical to the original drugs. Novartis AG recently received support from a European panel to sell biogeneric versions of Johnson & Johnson's Eprex, an anemia drug sold in the U.S. as Procrit and as Amgen's Epogen.

The Senate health committee is expected to address the legislation on June 27.

James M. Saponaro has joined BioStorage Technologies, Inc. (BST) as executive vice president. In this new role, Mr. Saponaro will oversee the company’s sales and marketing, operations, information technology and business development functions.

Mr. Saponaro has more than 20 years of executive experience driving the operations of businesses within healthcare markets including pharmaceutical distribution, retail pharmacy franchising, capital equipment, surgical instruments, surgical implants, pharmaceuticals and nutritionals. He spent the last 14 years in multiple executive positions in pharmacy distribution and retail pharmacy franchising and services for Cardinal Health, where he most recently served as chief operating officer of its retail franchise pharmacy division.

“Jim’s experience in delivering on aggressive strategic plans and leading profitable, high-growth operations for various healthcare and life science organizations is a tremendous addition to the strong BioStorage Technologies team,” said F. John Mills, M.D., Ph.D., BST’s chairman and chief executive officer. “In addition, his entrepreneurial background and metrics-based methodologies uniquely positions him to help us maximize our global reach while ensuring we remain nimble enough to react to the ever-changing pharmaceutical and biotech marketplace.”

Pfizer received approval for Lyrica capsules for the management of fibromyalgia, a chronic, widespread pain condition affecting more than six million Americans. Characterized by relentless chronic pain, fibromyalgia is usually accompanied by poor sleep, stiffness and fatigue, deep tenderness, soreness and flu-like aching.

Fibromyalgia is thought to result from neurological changes in how patients perceive pain, specifically a heightened sensitivity to stimuli that are not normally painful. Lyrica binds to a specific protein within overexcited nerve cells and works to calm damaged nerves. This is thought to reduce the level of pain in patients suffering from fibromyalgia, although the exact mechanism of how Lyrica acts in fibromyalgia is not known.

In the clinical trials, Lyrica demonstrated rapid and sustained improvements in pain compared with placebo. In addition, patients taking Lyrica reported feeling better and improvements in physical function.

Novartis received approval from the FDA for Exforge, a once-daily tablet combination of two high blood pressure medicines: Diovan, an angiotensin receptor blocker, and Norvasc, a calcium channel blocker.

The approval was supported by an extensive clinical program involving more than 5,000 patients. In two placebo-controlled trials, Exforge helped nine out of 10 patients reach their treatment goal of diastolic blood pressure under 90 mmHg, or more than a 10 mmHg reduction in diastolic blood pressure from baseline levels.

Exforge was approved in January 2007 in the EU and is currently available in nine EU countries, including Germany and the UK. Exforge is also available in Switzerland.

Akorn, Inc. and Cipla, Ltd., a pharmaceutical company located in Mumbai, India, have signed an exclusive development and supply agreement for an oral ANDA drug product for the prevention of organ transplant rejection.

Under the terms of the 10-year agreement, Cipla will be responsible for the development, manufacturing and supply of the drug product. Akorn will be responsible for the bioequivalency clinical trial, ANDA submission and marketing and distribution in the U.S. and PR. Cipla will receive milestone fees for the ANDA development and Akorn will own the ANDA. Akorn expects to launch the product in late 2009. Under the agreement, Akorn and Cipla will share revenues on a 60/40 basis.

Arthur S. Przybyl, Akorn's president and chief executive officer, stated, "This exclusive drug development and supply agreement reinforces our commitment to expanding our business relationship with Cipla." According to 2006 IMS data, the total market size for this drug is approximately $750 million for all indications.

Microtest Laboratories and Texcel Medical have formed a strategic alliance to assist pharmaceutical manufacturers and biotechnology companies in the development of combination products.

Combo products, consisting of medical devices embedded with pharmaceutical or biologics components, comprise approximately 30% of new products under development, according to a joint statement from the companies, and are growing at a 10% compound annual growth rate, with a market expected to reach $9.5 billion in 2009.

"The combination products market is booming. Yet many pharmaceutical companies are struggling to manage the convergence of devices and drugs or biologics and the host of unique FDA testing guidelines, practices and regulations that such products require," according to Steven Richter, Ph.D., president, Microtest. "For such firms, outsourcing is the solution, provided that the arrangement is struck with the right partner."

Microtest provides testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Texcel provides manufacturing infrastructure and engineering expertise for surgical, interventional, and implantable medical devices.

"Together, we offer a unique, seamless synergy of expertise in the design, prototyping, development, testing, approval, and manufacturing of combination products," said Larry Derose, president, Texcel.

Pfizer has discontinued a development program for PF-3512676, an investigational compound, in combination with cytotoxic chemotherapy in lung cancer. The program includes two Phase III trials and two Phase II trials. Pfizer licensed the compound from Coley Pharmaceutical Group in 2005. Rights to the drug have reverted to Coley.

Interim analysis of the Phase III trials by an independent Data Safety Monitoring Committee (DSMC) showed that PF-3512676 did not produce additional clinical efficacy over the standard cytotoxic chemotherapy regimen alone. The DSMC concluded that the risk-benefit profile did not justify continuation of the trials. Pfizer agrees with the findings of the DSMC and is discontinuing the related trials.

"We are communicating these results to patients and the scientific and medical community," said Dr. Charles Baum, vice president of Pfizer's R&D. "While these results show the challenge of bringing new therapies to patients with cancer, Pfizer remains committed to advancing our broad and diverse oncology programs which include over two hundred clinical trials of sixteen new medicines in clinical studies in immunotherapy, signal transduction inhibition and angiogenesis inhibition."

Howard Moody has been named vice president of Information Technology. Mr. Moody will be responsible for implementing IT applications to improve processes, increase operational efficiencies and fuel business growth. He will report to David Spaight (president) and Tom Gernon (chief information officer).

Mr. Moody has clinical laboratory and CRO experience and more than 30 years in diverse IT roles. Prior to joining the company, Mr. Moody was chief information officer at Medifacts International, a CRO in Rockville, MD, where he was responsible for global information technology and services. Prior to that, he worked for Churchill & Harriman, a pharmaceutical company in Princeton, NJ, as a senior management consultant. He spent five years at Covance in Princeton, NJ, as chief information officer and senior vice president. His experience also includes IT leadership roles at Quest Diagnostics, SmithKline Beecham, and Deluxe Data Systems.

"As a leading contract research organization, our business relies upon having innovative IT applications to meet our customers' needs on a global scale," said Mr. Spaight. "Mr. Moody's vast experience will enhance our ability to offer our customers innovative IT solutions that support their drug discovery and development initiatives."

Catalent Pharma Solutions, formerly Cardinal Health Pharmaceutical Technologies and Services, has officially launched as an independent company. The Blackstone Group acquired the business from Cardinal Health in April 2007. Within the contract services industry, speculation has run rampant as to what the new entity would be named. According to a statement to the press, Catalent "was created to combine the ideas embodied by the words 'catalyst' and 'talent.'"

The statement also pointed out that Catalent has a long heritage of dose form innovation, having commercialized softgel capsule technology and Liqui-Gel formulations, created the "fast dissolve" oral tablet category with Zydis, and introduced the vegetable-based capsule VegiCaps Soft. The company is also known for its child-resistant, senior-friendly and compliance-enhancing packaging designs.

"Catalent intimately understands the global challenges our customers face while developing and commercializing life-enhancing and life-saving drugs or innovative consumer health products," said John Lowry, president and chief executive officers of Catalent Pharma Solutions. "By consistently providing our customers with the technologies, services and reliable solutions they have come to expect from us, we enable them to focus on their own core competencies."

The U.S. District Court for the Southern District of New York has upheld the patent for the API of Plavix, allowing Bristol-Myers Squibb and Sanofi-Aventis to retain exclusivity of the antiplatelet drug through November 2011. The companies were battling in court with Apotex, a generic manufacturer based in Toronto.

An ill-conceived "exclusive generic" agreement between BMS and Apotex opened  a loophole that allowed Apotex to sell enormous amounts of generic Plavix to wholesalers. As part of the agreement, BMS could not pursue an injunction for the first five days of Apotex's sales. This may have cost BMS nearly $2 billion in sales. Another side-agreement limits the amount of damages that BMS and SA can request, but that may be overturned in court, permitting the "innovator" companies to seek triple-damages.

Apotex plans to appeal the ruling. The company contends that the case is very similar to the one it conducted regarding Pfizer's Norvasc,  which Apotex lost at the circuit court level but won on appeal.

CuraGen Corp. will close its pilot manufacturing plant, effective July 27, 2007. As a result, the company will reduce its workforce by approximately 40 employees, primarily composed of preclinical and manufacturing researchers, and additional support staff from within the organization. CuraGen previously announced that it would make reductions in early-stage and preclinical drug discovery and decreased emphasis on internal manufacturing capabilities.

The pilot facility, also known as the Biopharmaceutical Sciences Process (BPS) facility, is a 29,000-sq.-ft. leased facility that was used by CuraGen for pilot scale production of proteins and antibodies. The BPS facility primarily supported early-stage pipeline development and non-GMP manufacturing.

Affected employees will be eligible for a severance package that includes severance pay, continuation of benefits and outplacement services. Charges relating to this move, the majority of which will be accrued during the second quarter of 2007, are estimated to be approximately $8 million, including non-cash charges of approximately $6 million in writeoffs.

"The contribution made by all members of the CuraGen team is sincerely and deeply appreciated. This strategic decision was difficult but necessary to ensure that CuraGen focuses its resources and invests appropriately into velafermin, belinostat and CR011-vcMMAE which represent the most significant value to CuraGen, its employees and its shareholders," stated Frank Armstrong, M.D., president and chief executive officer of CuraGen.

MedImmune founder Wayne T. Hockmeyer, Ph.D. is retiring as president of MedImmune Ventures, Inc. Dr. Hockmeyer has also stepped down as the company's chairman upon AstraZeneca's completion of its tender offer to acquire all outstanding shares of MedImmune common stock.

Dr. Hockmeyer commented, "I am honored to have been a part of building one of the most successful biotechnology companies in the world. The last 19 years at MedImmune have been exciting, professionally stimulating and remarkably productive. I believe the company, now as a part of AstraZeneca, will continue to be successful in developing new and promising therapies that improve healthcare. I also expect MedImmune to continue to grow as one of the premier biotech companies, adding new jobs, playing an important leadership role in the scientific community, and continuing its involvement as a dedicated corporate citizen."

Althea Technologies has been contracted by GeoVax Labs to manufacture its HIV-1 DNA (AIDS) vaccine. This vaccine will be utilized in GeoVax's Phase II trials, which are planned to start in early 2008. GeoVax chose Althea as the contract manufacturer for its DNA vaccine based on Althea's "extensive experience in the field of DNA vaccine manufacture and its regulatory compliance history," according to a press statement.

GeoVax AIDS vaccines are designed to prevent development of AIDS caused by the virus known as HIV-1 by vaccinating individuals prior to infection with the AIDS virus. The GeoVax vaccine regimen employs a "prime-boost strategy." Trial participants are administered the GeoVax HIV-1 DNA vaccine which "primes" the immune system followed by the GeoVax HIV-1 MVA (Modified Vaccinia Virus) boost. Both vaccines deliver over 50% of the AIDS virus components but cannot cause AIDS. Safety and immunological results from earlier as well as ongoing human trials have been very encouraging thus supporting planned acceleration of large scale Phase II studies, said a GeoVax statement.

Parexel International has opened a new location in Hyderabad, India. Through this new location, PAREXEL "offers its clients a wide range of clinical research and data management services while deepening its long-term commitment in India," according to a company statement.

"We are especially excited to be breaking ground in India's 6th largest metropolis, which is quickly becoming an important biotechnology hub," said Josef von Rickenbach, Parexel's chairman and chief executive officer.

The office is staffed by locally-based key management, and a team of experts with extensive knowledge of India's regulatory process. "Last year, Parexel entered into a joint venture arrangement with Synchron, an India-based clinical research organization, to form Parexel International Synchron Private Limited, to provide a broad range of Phase II- IV clinical research services," said Mark A. Goldberg, M.D., president of Clinical Research Services and Perceptive Informatics, Parexel International. "The opening of our Hyderabad location was a natural next step to meet client demand in India for our services."

The FDA has granted fast track status to Bristol-Myers Squibb's ixabepilone, an epothilone B analog. Ixabepilone has been submitted as a monotherapy to treat patients with metastatic or locally advanced breast cancer after failure of an anthracycline, a taxane, and capecitabine and in combination with capecitabine to treat patients with metastatic or locally advanced breast cancer after failure of an anthracycline and a taxane.

The company remarked that there are few proven treatment options available to patients with breast cancer whose disease has rapidly progressed through or whose disease is not responding to prior treatment with chemotherapies (anthracycline and taxane).

Cook Pharmica, the contract biopharmaceutical manufacturing division of Cook Medical, has named two vice presidents to its corporate leadership. Connie Degen has been named vice president of operations and Tedd Green has been named vice president of business operations and chief financial Officer.

Ms. Degen has worked extensively in Quality and Manufacturing operations in both the food and pharmaceutical industries. Prior to joining Cook Pharmica, she served as the quality director for Baxter Pharmaceutical Solutions, a sterile parenteral contract manufacturer. She became Cook Pharmica's director of quality in 2004 and then assumed responsibilities for manufacturing group as director of operations. In her new role, Ms. Degen is responsible for directing and overseeing all activities of manufacturing, maintenance, manufacturing sciences and engineering.

Mr. Green joined Cook Pharmica in 2005 after serving as a senior business analyst for Eli Lilly & Co. He was responsible for providing strategic financial and general business support to Lilly's Business-to-Business operations and was involved in pricing and discounting strategies, economic impact modeling and establishing a new distribution services model in the U.S. marketplace. Mr, Green's responsibilities as vice president of business operations and CFO include providing overall strategic leadership by overseeing the fiscal, human resource, project management, business development and marketing programs, policies and services.

"Connie and Tedd both have demonstrated excellent leadership and performance and have been very valuable to our progress to date," said Cook Pharmica president Jerry Arthur. "These roles will assist in positioning Cook Pharmica for expected workforce growth and capacity expansion."

Aptuit, Inc. and Laurus Labs Ltd. have formed a new contract drug development company, Aptuit Laurus, which will combine Aptuit's global offerings in drug development with Laurus' R&D and manufacturing expertise and new state-of-the-art facilities in India. The combined company will provide pharmaceutical companies with integrated services, technologies and manufacturing capabilities across the entire drug development cycle.

The new company will be based at Laurus' new 160,000-sq.-ft. R&D facility in Hyderabad, which employs more than 200 scientific personnel, and additional facilities in Vishakhapatnam and Bangalore. Aptuit Laurus will initially provide services to clients in early-stage drug discovery, medicinal chemistry, lead optimization, process development, scale-up and process optimization, safety and hazard assessment, formulation development and analytical chemistry. These services will be provided through Laurus' large-scale manufacturing plant, which is currently under construction in Vishakhapatnam and Aptuit's existing informatics development and support group of 100 employees in Bangalore.

Aptuit will invest approximately $100 million during the next four years to expand Aptuit Laurus' development, manufacturing and informatics capabilities with the addition of a complete suite of development services including: medicinal chemistry, preclinical, solid-state chemistry, consulting, clinical packaging and logistics, Phase I/IIa research and large-scale dosage form manufacturing.

"Laurus Labs shares our strategic vision to build an end-to-end drug development services partner with high service levels and an emphasis on technology, and their offerings align neatly with ours," said Michael A. Griffith, founder and chief executive officer of Aptuit. "It's an excellent cultural fit, and provides a new set of choices for our 600 pharmaceutical company clients. We are committed to integrating all of our major systems including sales, contracts, IT, quality, project management and finance to present one face to our global customer base."

"Aptuit is the ideal strategic partner for Laurus," said Dr. Satyanarayana Chava, founder and chief executive officer of Laurus Labs. "Our strengths are complementary, and we are very focused on the value and efficiencies to be gained for our customers in having access to a full range of research, development and manufacturing capabilities and services on a truly global scale. " Dr. Satyanarayana will serve as chief executive officer of Aptuit Laurus. He brings more than 20 years of industry experience to the partnership, including his most recent role as chief operating officer of Matrix Laboratories Ltd., where he played a key role in transforming that company into one of the major pharmaceutical companies in India. Dr. Satyanarayana founded Laurus with two colleagues in 2005.

Paul Roney, Ph.D., DABT, and Lisa Jenkins, Ph.D., have been appointed senior regulatory consultants, Kendle. These appointments were made to help drive continued growth in the company's regulatory business worldwide by providing strengthened regulatory consulting expertise to advise customers on their regulatory strategies from early stage through registration, according to the company.

Dr. Roney will provide strategic advice and expertise regarding nonclinical toxicology, including strategic planning, preparation of the nonclinical section of INDs and NDAs, helping customers to prepare and meet with the FDA and construction of expert reports and other regulatory documents. He will be based at the company's office in Rockville, MD.

Dr. Jenkins, who will be based out of the company's Cincinnati office, will be responsible for regulatory submission projects, including INDs and NDAs. She will provide guidance to the company's biopharmaceutical customers for Prescription Drug User Fee Act milestone meetings and related briefing documents, as well as strategic advice on clinical and regulatory development plans.

Prior to joining the company, Dr. Roney was a toxicology reviewer in the Division of Neurology Products at the FDA. In this position, he wrote the primary review of the nonclinical sections of INDs and NDAs for drugs in development to treat neurological and psychiatric diseases. He worked closely with other members of the review team to produce integrated assessments of the risks associated with these drugs and frequently met with industry representatives to offer guidance on the nonclinical issues associated with all phases of drug development.

Dr. Jenkins joins the company from Wyeth Pharmaceuticals, Inc. where she served most recently as senior manager, worldwide regulatory affairs, responsible for providing strategic and functional regulatory support for several global eCTD, IND and NDA filings. Dr. Jenkins also served as a principal statistician at Wyeth and was actively involved in the planning, execution and reporting of Phase I-III CNS trials.

Cephalon, Inc. received approval from the FDA to market Nuvigil Tablets, a non-amphetamine wake-promoting agent for the treatment of excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy, and shift work sleep disorder (SWSD). In OSAHS, Nuvigil is indicated as an adjunct to standard treatment(s) for the underlying obstruction. Nuvigil is the single-isomer formulation of modafinil, the API contained in Provigil Tablets, which was approved by FDA in 1998 to improve wakefulness.

Cephalon's clinical program will evaluate the use of Nuvigil as a treatment for medical conditions such as bipolar depression, cognition associated with schizophrenia, excessive sleepiness in medical conditions such as Parkinson's disease, and fatigue in patients who are being treated for cancer. The company currently plans a commercial launch of Nuvigil pending additional clinical data.

Novo Nordisk has initiated a Phase I clinical trial of GlycoPEGylated Factor VIIa, a long-acting version of NovoSeven Coagulation Factor VIIa, triggering an undisclosed milestone payment to Neose Technologies, Inc. under the companies' license agreement. The trial will assess the safety and pharmacokinetics of GlycoPEGylated Factor VIIa in healthy volunteers.

"Novo Nordisk is committed to developing therapies to prevent or reduce bleeding episodes and to improve the quality of life in patients with hemophilia. We are pleased that our collaboration with Neose has resulted in a long-acting Factor VIIa clinical development candidate that has the potential to contribute to this goal," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.

"We are pleased that GlycoPEGylated Factor VIIa has entered clinical development, making it the third GlycoPEGylated therapeutic protein to reach this milestone. Novo Nordisk has proved to be an ideal partner for this development candidate, and we are confident that their clinical expertise will continue to add value to this program," said George J. Vergis, Ph.D., Neose president and chief executive officer.

MedImmune, Inc. has been awarded a contract from the U.S. Department of Health and Human Services (HHS) to modify its U.S. vaccine manufacturing facilities to produce pandemic influenza vaccines using its live, attenuated, needle-free technology. The total value of the fully funded base contract is approximately $55.1 million. MedImmune will contribute approximately $14 million to the retrofitting of its U.S. vaccine manufacturing facilities.

MedImmune's marketed flu vaccine, FluMist, is currently manufactured, blended, filled, packaged, stored and distributed through a series of procedures at the company's operations in CA, the UK, PA, and KY. MedImmune will modify and expand its equipment and processes at its U.S. facilities and provide manufacturing operations to help the government rapidly respond to vaccine manufacturing needs in the event of a pandemic.

Sanofi Pasteur has been awarded a $77.4 million contract by the HHS to modify its flu manufacturing facility. Sanofi Pasteur will contribute approximately $25 million to the project. The contract covers costs for design, modification and maintenance of the facilities at a state of readiness to respond to pandemic flu vaccine requests by the HHS.

The design phase will begin immediately and modifications will begin when the company's new flu vaccine manufacturing facility is licensed by the FDA and operational. The existing facility will be phased out and decommissioned. The company's capacity will nearly triple from its current capacity, which has been approximately 50 million doses of vaccine for the U.S. market during the past several flu seasons.

Thermo Fisher Scientific, Inc. has entered a strategic partnership with Megaware, a life science technology organization, to deliver a new bioanalysis/equivalence solution and joint support services for pharma, biopharma and CROs.

Under the terms of the collaboration, the two companies will market a new end-to-end software solution that provides bioequivalence functionality on a single platform in an effort to hasten and manage clinical trials. Market growth in generic drug production has created the need for fast efficient bioequivalence studies to meet FDA ANDA guidelines.

"The market for bioequivalence studies in India and the Far East is growing rapidly, and the Thermo Scientific Watson LIMS is seen as the de facto standard for bioanalysis/equivalence. Thermo Fisher’s unparalleled strength in this field complements Megaware's in-depth experience with the CRO industry in the market," said Dave Champagne, vice president and general manager of informatics for Thermo Fisher. "Our collaboration with Megaware will lead to the first total solution for this market, eliminating time and administrative burden from the bioequivalence challenge."

The two companies will target the market for bioanalysis/equivalence studies, initially in India, due to its lower cost and rapid growth of clinical trials, and then across the Far East and other markets. The consultancy firm McKinsey estimates that U.S. and European pharmaceutical companies will spend $1.5 billion per year on trials in India by 2010.

"We have an established customer base in contract research and pharmaceutical companies in India, who are encouraged by the development of robust enterprise automation solution to enable them to gain FDA approval quicker," said Ajit Nagral, president of Megaware. "We believe that Thermo Fisher, and Megaware, together deliver the best-in-breed solution for this market."

Dr. Matthias Maase has been appointed director for BASF's new business development operation in the company’s North American Intermediates Regional Business Unit based in Florham Park, NJ. He replaces Dr. Frank Stein, who is returning to BASF’s Ludwigshafen site to a new assignment as Group Leader for Alkylamines and Alkylalkanolamines in the BASF Intermediates division.

Dr. Maase joined the company in 1999 in the Chemicals Research & Engineering department in Ludwigshafen, Germany. His team developed and established the company's BASIL technology, the first commercial process utilizing ionic liquids. He then served in a management position where he was responsible for the marketing of ionic liquids and ionic liquid based technologies. As recognition for their work in this field, Dr. Maase and his team were awarded the BASF Group Innovation Award in 2004, the ECN Innovation for Growth Award in 2004 and the IChemE (Institution of Chemical Engineers) Award in 2005.

ProNAi Therapeutics, Inc. has signed a supply agreement with Polymun Scientific GmbH, an Austrian contract biopharmaceutical developer, to manufacture the company's PNT2258 DNAi-based cancer therapeutic.

Under the terms of the agreement, Polymun will use its cross-flow injector technology to manufacture ProNAi's liposome-formulated lead drug candidate, which is in the final stages of preclinical toxicology testing. ProNAi plans to submit an IND for PNT2258 later this year.

Dr. Richard D. Gill, president and chief executive officer of ProNAi, said, "Polymun has proven, successful experience in manufacturing drug product for U.S. clinical trials, and we are very happy to be working with them as we advance PNT2258 into the clinic. ProNAi is confident that Polymun's manufacturing processes and technology are state-of-the-art and up to the task of formulating our oncology drug candidate, which features our novel oligo delivery method for the safe and effective administration of nucleic acid-based therapies."

Dr. Dietmar Katinger, vice president of business development of Polymun, said, "Polymun is delighted to have the opportunity to work with ProNAi in making this innovative drug candidate. Among our specialties, our company has considerable experience in working with liposomal formulations, and we look forward to this fruitful collaboration to help realize the potential of treating patients with these promising therapeutic nucleotides."

The FDA Endocrinologic and Metabolic Drugs Advisory Committee did not recommend approval of Sanofi-Aventis' rimonabant (Zimulti / Acomplia) to the FDA for use in obese and overweight patients with associated risks factors. The company will continue to work closely with the FDA regarding the committee's recommendations. The FDA will take action by July 26, 2007 for rimonabant.

Rimonabant is the first member of a new therapeutic class of drugs that selectively block the CB1 receptors of the endocannabinoid system (ECS). When working normally, this system of receptors in the brain and throughout the body helps regulate food intake and how the body uses and stores fats and sugars. Rimonabant is currently approved in 37 countries and is marketed in 18 as Acomplia.

Additional safety data from ongoing clinical studies with rimonabant show the most common adverse events were consistent across studies and included gastrointestinal (nausea, vomiting, diarrhea), nervous system (headache, dizziness, paresthesia/hypoesthesia/dysesthesia) and psychiatric disorders (anxiety, insomnia, depressed mood and depression). These adverse events generally occurred within the first two to three months, and were often mild to moderate.

Pharmacopeia will receive $5 million payment from GlaxoSmithKline in connection with two companies' product development and commercialization agreement from March 2006. This is the second $5 million payment Pharmacopeia has received.

This payment was triggered by Pharmacopeia's completion of early discovery activities. Pharmacopeia is eligible to receive a third $5 million payment based on additional early discovery activities. Pharmacopeia is also entitled to milestone payments totaling as much as $83 million per program for any drug development program pursued through the alliance, along with royalties from the sales of any products commercialized by GSK. Pharmacopeia may pursue development of any programs GSK declines to complete.

Hugh Cowley, senior vice president and head of the Center of Excellence for External Drug Discovery (CEEDD) at GSK, said, "The alliance between the CEEDD and Pharmacopeia is off to a tremendous start, and the CEEDD is very pleased with the progress to date on the several programs underway. We expect the alliance to contribute to GSK's development pipeline in the future, validating the collaboration model we sought to establish under the CEEDD umbrella at GSK."

"The alliance with GSK has proven to be very valuable to Pharmacopeia," said Les Browne, Ph.D., president and chief executive officer of Pharmacopeia. "Allying our scientific expertise and platform with the insights we obtain from the CEEDD scientists provides an excellent opportunity to develop novel therapeutics and approaches that we believe may one day address some of the most significant unmet medical needs."

The global pharmaceutical market will more than double in value to $1.3 trillion by 2020, according a PricewaterhouseCoopers report, entitled Pharma 2020: The Vision - Which Path Will You Take? The factors influencing this estimate include increasing worldwide demand for medicines as the population grows, ages and becomes more obese, and as chronic conditions and infectious diseases tied to global warming rise. However, the industry's current business model is unsustainable and fundamental change in the way it operates is required in order to capitalize on future growth opportunities, according to the report.

By 2020, the report contends, Brazil, China, India, Indonesia, Mexico, Russia and Turkey could account for as much as one-fifth of global pharmaceutical sales, up by 60% from 2004. Also, chronic conditions in the developing world will increasingly resemble those of the developed world, with a significant rise in hypertension and diabetes. In addition, many scientists are predicting global warming and a rise in greenhouse gases to have a major effect on the world's health, resulting in the spread of diseases such as malaria, cholera and higher prevalence of respiratory illnesses such as asthma and bronchitis.

"The pharma industry will not be in a strong position to capitalize on opportunities unless R&D productivity improves,'' said Dr. Steve Arlington, global pharmaceutical research and development advisory leader, PricewaterhouseCoopers and principal author of the report. "The core challenge is a lack of innovation. The industry is investing twice as much in R&D as it was a decade ago to produce two-fifths of the new medicines it then produced.

"Over the next decade, the industry must shift its investment focus more toward research and less on sales and marketing. Pharma's traditional strategy of placing big bets on a few small molecules, marketing them heavily into primary care with the aspiration of achieving blockbuster sales, will no longer suffice,'' added Dr. Arlington. "It must focus on the development of medicines that prevent, treat or cure. These must demonstrate tangible benefits and tackle unmet medical needs. Governments and payers must play their part and ensure the industry is rewarded for these efforts."

Some of the major changes the report forecasts are:

The blockbuster sales model will disappear and the emphasis will be based on therapeutic benefit and outcomes that can add the most value.

Companies will be financially rewarded for developing new therapies versus me-too medicines. Risk-sharing agreements will become more mainstream, with drug manufacturers adjusting prices according to the results of outcomes analysis data that demonstrates drug efficacy.

Focus will shift from treatment to preventive healthcare. There will be a significant increase in the production of vaccinations, with the market estimated to grow to $42 billion by 2015.

New technologies will drive R&D and will reshape the business strategies of pharma companies.

The current R&D model, involving Phases of clinical trials and regulatory submissions, will be replaced by collaborative in vivo testing and "live license" issued contingent on the ongoing performance of the drug over its lifecycle. The industry will conduct smaller, more focused clinical trials, continuously sharing results with regulators.

There will be greater international regulatory collaboration by sharing safety and efficacy data. There may well be one global regulatory system by 2020, administered by national or federal agencies.

Supply chain functions will become revenue generating and will be responsible not only for distribution but creating new channels to market products. Furthermore, 2020 will likely give rise to "made to order" therapies rather than "made to forecast" using just-in-time manufacturing and delivery techniques learned from other industries such as the automotive sector.

More sophisticated direct-to-consumer distribution channels will diminish the role of wholesalers.

Dale M. Edgar, Ph.D. has been appointed executive director and chief scientific leader of Eli Lilly and Co.'s discovery sleep research program. Dr. Edgar has more than 25 years of experience in the field of sleep research. He will report to David Bredt, M.D., vice president of integrated biology.

"We are delighted that Dale has decided to bring his considerable expertise to Lilly," said Dr. Bredt. "He brings a wealth of experience in sleep research as well as innovative insights into preclinical and clinical drug discovery. We look forward to having him join the team here at Lilly, and to adding renewed emphasis to our sleep disorder research program."

Dr. Edgar was formerly chief science and technology officer at Hypnion, Inc., a Lexington, MA-based biopharmaceutical company focused on treatments for sleep disorders. He co-founded Hypnion with three other sleep and biological rhythms experts in 2000; Lilly subsequently acquired Hypnion in January of this year. Prior to founding Hypnion, he was Associate Professor of Psychiatry & Behavioral Sciences at Stanford University, and faculty investigator at the Stanford University Sleep Disorders Research Center in California.

Jacobs Engineering Group, Inc. received a contract from Wyeth Medica Ireland to provide design and construction management services for a new pilot scale lab facility at the Grange Castle site, Clondalkin, Ireland. The development includes expanding and consolidating all development activities on site to support manufacturing and finishing operations. The project cost is estimated at $40 million.

Jacobs group vice president Phil Stassi commented, "We are excited about helping Wyeth with this important project at their Grange Castle site and continuing our long established relationship. By applying the right blend of technical expertise and local knowledge to this important project, we help develop world-class facilities."

Laura Kragie, M.D., has been appointed vice president of clinical development and chief medical officer, Emisphere Technologies, Inc. Dr. Kragie was previously president and chief scientific officer of Kragie BioMedWorks, a strategic regulatory consulting group. Dr. Kragie will report to Michael V. Novinski, president and chief executive officer of Emisphere Technologies, Inc.

"Dr. Kragie's rich experience as a Medical Officer with the FDA and the Center for Drug Evaluation and Research (CDER) working on regulatory review on a wide array of drug products, along with her deep knowledge of the many facets of biotech, are among the many skills Dr. Kragie brings to Emisphere," said Mr. Novinski. "Dr. Kragie also brings a real sense of business management, deep clinical trial experience and varied pharmaceutical development skills. We are very excited to have her bring this wealth of experience to Emisphere."

At BioMedWorks, Dr. Kragie specialized in pipeline and drug development strategies, efficacy and safety determination, biomarker/surrogate endpoints, intellectual property portfolio development, and regulatory strategies. She guided clients at all stages of their regulatory processes, from pre-IND through to launch and post-approval phases. Dr. Kragie also investigated unmet clinical needs and new indications for approved drugs. Dr. Kragie's research and nonprofit efforts worked to generate and communicate knowledge regarding food, drug and environmental interactions with endocrine systems and their impact on health and disease.

Eurand Pharmaceuticals Ltd. initiated the rolling submission of its NDA with the FDA for Zentase for the treatment of Exocrine Pancreatic Insufficiency (EPI), a deficiency of digestive enzymes normally produced by the pancreas that can result from a number of diseases, including cystic fibrosis, chronic pancreatitis, and pancreatic cancer. Zentase, the company's lead product candidate, has been granted fast-track designation by the FDA.

Zentase is a pancreatic enzyme product (PEP) designed to meet FDA guidelines for PEPs. In April 2004, the FDA mandated that all manufacturers of EPI drug products file a NDA and receive approval for their products by April 2008 or be subject to regulatory action.

Pancreatic enzyme products are inherently unstable and in order to compensate for enzyme degradation over time, all manufacturers currently include an overfill of enzymes in the finished product. As a result, patients receive PEPs with variable and uncertain levels of potency, resulting in inconsistent therapeutic effect. In April 2006, the FDA issued 'Guidance for Industry' addressing the elimination of product overfill allowed under current regulations. As a highly stable product, Zentase does not require overfill and is filled at 100% of label claim.

The Zentase NDA filing includes the results of two Phase III studies that show a clinically relevant increase in the absorption of fat, protein and other nutrients, which is maintained over time. The studies also show that Zentase led to fewer symptoms associated with impaired nutrient absorption and was well tolerated.

A compound under development by Albany Molecular Research, Inc. and Bristol-Myers Squibb will proceed into preclinical development, triggering a $1.5 million payment to AMRI. This is the first milestone in the companies' research collaboration to develop improved treatments for depression and diseases of the central nervous system (CNS).

Under the 2005 licensing agreement, BMS received an exclusive license to develop and commercialize a series of biogenic amine reuptake inhibitors from AMRI's research program. The payment is a result of the selection of a clinical candidate and advancement into preclinical toxicity and safety testing by BMS. If the compound moves into Phase I testing, additional milestone payments would be triggered.

The compound may represent a new class of therapeutic agents that could lead to an improved treatment for depression or other CNS disease indications. The two companies will continue to evaluate additional compounds for development, as the nominated compound progresses further along the development pipeline.

Under the original agreement, AMRI is eligible to receive as much as $66 million per compound in development and regulatory milestone payments for the first two compounds and additional payments of as much as $22 million per compound on subsequent compounds. AMRI will also receive royalties on worldwide sales of commercialized compounds.

Archemix Corp. and Merck Serono, a division of Merck KGaA, have formed a multi-year strategic alliance to discover, develop and commercialize aptamer therapeutics with a focus on cancer treatments. The alliance combines Archemix' SELEX technology to discover and generate aptamer candidates with Merck's oncology drug development and commercialization capabilities. In addition, Archemix and Takeda have signed a multi-year, three-target agreement that also focuses on the discovery, development and commercialization of aptamer-based therapeutics.

Under the terms of the first agreement, Merck KGaA will invest $29.8 million in Archemix and will have the option to acquire additional stock upon an initial public offering. This is the second research agreement between the two companies this year.

Merck Serono has the option to obtain product licenses to some of Archemix's lead stage aptamer programs in oncology and to select and develop aptamers against six additional targets in oncology and other indications, including autoimmune and inflammation disorders. Merck Serono can also use Archemix's SELEX technology for internal target validation. Archemix has the option to co-develop and co-promote any of the products being developed in the U.S.

"The collaboration with Merck Serono represents a key strategic initiative for Archemix and the development of our pipeline, especially in the area of cancer," said Errol De Souza, Ph.D., president and chief executive officer, Archemix. "We will be working with a recognized leader in drug development to discover, develop and commercialize first-in-class aptamer-based therapeutics. With our co-development and co-promote options we can participate in the development and commercialization of certain of the products that come out of the collaboration while simultaneously generating cash flows to fund our proprietary aptamer pipeline."

Under the agreement with Takeda, Archemix will receive a $6 million upfront payment to discover and generate product candidates to three disease-associated targets identified by Takeda. Takeda will be granted exclusive, worldwide rights for research, development, manufacturing and commercialization for any aptamer-based products resulting from the collaboration. Archemix will also receive research funding and clinical development milestone payments for each target selected for development. Archemix will also earn royalties and milestones on worldwide sales of the developed aptamers commercialized by Takeda.

"Our alliance with Takeda is the sixth major partnership we have formed within the past year and is a major step in the continued validation of aptamer therapeutics," said Dr. De Souza of Archemix. "Takeda is an excellent partner for Archemix and this collaboration is a key component of successfully implementing our strategy of forming collaborations with multi-national pharmaceutical companies to rapidly advance aptamer programs into clinical development."

Altus Pharmaceuticals has reacquired development and commercialization rights to ALTU-135 from Dr. Falk Pharma, terminating their development and commercialization collaboration in Europe and countries of the former Soviet Union, Israel and Egypt. Altus' enzyme combination, ALTU-135, is designed to improve fat, protein and carbohydrate absorption in pancreatic insufficient individuals, including cystic fibrosis patients.

Under the agreement, Altus regains control of all of the assets resulting from the collaboration. Dr. Falk Pharma has agreed to transfer the orphan designation they received from the EMEA in July 2004. In exchange, Altus will pay Dr. Falk Pharma $16 million during the next three years.

"We believe that this agreement with Dr. Falk Pharma is in the best interest of our company," stated Sheldon Berkle, president and chief executive officer of Altus. "Altus now has the freedom to evaluate multiple strategic options for worldwide commercialization, including retaining full commercial rights worldwide or seeking a new commercial collaboration, with the ultimate goal of maximizing the value of our ALTU-135 assets."

The two companies had entered into a development, commercialization and marketing agreement for ALTU-135 in December 2002, under which, Altus granted Dr. Falk exclusive development and commercialization rights to ALTU-135 for the treatment of symptoms caused by exocrine pancreatic insufficiency. Under the agreement, Altus has received upfront and milestone payments from Dr. Falk totaling $14.7 million.

Patheon

2Q Revenues: $181 million (-5%)

2Q Loss: $22 million (earnings were $3 million in 2Q2006)

YTD Revenues: $352.7 million (+1%)

YTD Loss: $24 million (loss of $8.5 million YTD2006)

Comments: Rx manufacturing services revenues were down $6.3 million, or 4%, due to volume declines for two major products manufactured at Caguas, PR: Zocor, which lost patent protection in June 2006, and Levothyroxine sodium, which experienced loss of market share. These declines were partially offset by gains in commercial Rx volumes at the company's operations in Italy and France. OTC manufacturing services declined by $8.8 million, or 32%, primarily due to lower volumes at Whitby and Cincinnati due to clients sending back products to their own manufacturing networks. Revenues from pharmaceutical development services (PDS) increased by $6.2 million, or 28%, due to growth at the Toronto Region, Cincinnati and Swindon PDS operations. In the quarter, repositioning expenses were $4 million and YTD expenses were $7.7 million. The company completed its financial restructuring process in the quarter with the purchase of $150 million shares by JLL Partners, and the refinancing of its North American and UK debt. Earnings in the quarter were impacted by one-time expenses of $13.5 million in connection with these refinancing activities.

Akorn, Inc. has added two injectable drug products to its API Supply and Margin Sharing Agreement with Natco Pharma Ltd. One of the ANDA drug products is for the prevention of nausea and vomiting associated with cancer chemotherapy, and the other product is for the reduction of renal toxicity and xerostomia in cancer patients undergoing chemotherapy and radiation. According to 2006 IMS data, the market size for the two finished products is approximately $433 million.

Under the agreement, Natco will be responsible for the supply of the API for both drug products. Akorn will be responsible for the manufacturing, regulatory submissions, marketing and distribution in the U.S. and Canada.

Arthur S. Przybyl, Akorn's president and chief executive officer stated, "We are excited to expand our business partnership with Natco Pharma. These two products will continue to build upon our anti-cancer drug product franchise."

Rejeev Nannapaneni, Natco Pharma's chief operating officer stated, "We are happy to continue this fruitful partnership with Akorn."

Abbott received marketing authorization from the European Commission for the use of Humira as a treatment for severe Crohn's disease. Humira is the first self-administered biologic for the treatment of Crohn's disease, offering a convenient treatment option that can help patients control of their disease. This is the fourth indication for Humira in the U.S. and the EU.

Crohn's disease is a chronic, inflammatory disease of the gastrointestinal (GI) tract that affects more than one million people in North America and Europe. Common symptoms of Crohn's disease include diarrhea, cramping, abdominal pain, weight loss, fever, and in some cases, rectal bleeding. Complications include intestinal obstruction, ulcers that form tunnels to surrounding tissues, and malnutrition.  

Genzyme Corp. plans to build a new biomanufacturing plant in Lyon, France, for the production of Thymoglobulin, a treatment used in transplantation, in order to meet the anticipated long-term demand for the drugs current and potential new indications.

The company is making additional investments in its global manufacturing infrastructure to support the growth of existing products and future products from its late-stage pipeline. Genzyme is completing the development of a new plant in Belgium for the production of monoclonal antibodies and proteins and expanding other facilities, including its Allston Landing protein manufacturing plant in Boston. The company recently received regulatory approvals for a new filling and packaging facility at its manufacturing site in Ireland, the company's European center for the final production and distribution of a range of products, including Thymoglobulin.

Thymoglobulin's sales last year were up 17%. The product is currently approved in more than 50 countries for various indications, including the treatment and the prevention of acute rejection of solid organ transplants. Thymoglobulin also has potential in hematological disorders and autoimmune diseases such as diabetes.

The new 140,000-sq.-ft. facility in Lyon will replace the company's smaller plant in nearby Marcy l'Etoile and will provide more than twice the manufacturing capacity. Approximately 165 people are currently employed at this plant, and Genzyme plans to add 50 jobs once the new facility is operating at full capacity. The project is expected to cost $142 million and construction is expected to begin later this year. Regulatory approvals are expected starting in 2010 and manufacturing is expected to begin in 2011.

"As with our other new facilities, we intend the Lyon plant to serve as a highly visible expression of Genzyme's purpose, which is to innovate and set new standards in both the products that we develop for patients and in the way that we operate as a company," said Mark Bamforth, senior vice president for corporate operations.

Amgen will acquire Alantos, a private company developing drugs for diabetes and inflammatory diseases, for $300 million in cash. Alantos' lead drug candidate, ALS 2-0426, is a DPP-IV inhibitor in Phase IIa development for the treatment of type II diabetes.

Under terms of the agreement, Alantos will become a wholly-owned subsidiary of Amgen. The acquisition has been approved by the boards of directors of each company and the shareholders of Alantos. Subject to customary closing conditions, the transaction is expected to close in 3Q2007.

ALS 2-0426 is an orally administered inhibitor of DPP-IV, which inactivates glucagon-like peptide-1 (GLP-1), a mediator of blood glucose levels following meals. Phase IIa studies were initiated in May in collaboration with Servier, the development and commercialization partner outside the U.S.

"We are pleased to add this clinical stage DPP-IV inhibitor to our growing portfolio of therapeutics for the treatment of metabolic diseases," said Roger M. Perlmutter, M.D., Ph.D., Amgen's executive vice president for R&D. "We also intend to pursue the MMP program with the hope of bringing a novel, disease modifying therapy into the clinic for osteoarthritis."

"We are happy to have reached an agreement with Amgen that will build on the important R&D accomplished to date and will help to advance promising compounds to patients with serious and life-threatening illnesses," said Alantos's chief executive officer, Keith E. Dionne, Ph.D.

Centocor, Inc. and Schering-Plough received approval from the European Commission for a new indication for Remicade for the treatment of severe, active Crohn's disease (CD) in pediatric patients, aged 6 to 17 years, who have not responded to conventional therapy. Remicade has been studied only in combination with conventional immunosuppressive therapy.

Remicade is the first biologic therapy approved in the EU for the treatment of pediatric CD, a condition that causes inflammation of the gastrointestinal tract, resulting in symptoms such as diarrhea, fever, abdominal pain, weight loss and in some patients, delayed development and stunted growth.

In May 2006, the FDA approved Remicade for pediatric patients with moderately to severely active CD who have had an inadequate response to conventional therapy. Remicade was first approved in the U.S. for adult Crohn's disease in 1998 and in 2005 for adult ulcerative colitis.

Intertek Group has acquired Quantitative Technologies Inc. (QTI), a contract analytical research and development laboratory. QTI has served the North American market for more than 15 years, specializing in the pre-market launch stages of the drug and product development life cycle. QTI is located in Whitehouse, NJ with approximately 60 employees and a cGMP lab.

The acquisition is intended to advance Intertek's strategic growth in expert support services to the global pharmaceutical, medical device and drug delivery industry. QTI will operate in the Intertek OCA Division (Caleb Brett) Pharmaceutical Services group. That group's chief executive officer, Mark Loughead, commented, "QTI has an outstanding reputation in the industry and will further expand our ability to support the pharmaceutical and related sectors for outsourced R&D and testing expertise."

John Conti-Ramsden, Ph.D., global director for Intertek Pharmaceutical Services, added, "The acquisition of QTI further develops Intertek's USA offering and global platform in the area of pharmaceutical services. Intertek already provides a wide range of testing services to pharmaceutical clients from its laboratories in Europe and GLP bioanalytical services from the Alta laboratories in California."

Quintiles Transnational Corp. plans to build a new office near Edinburgh for its product development business in Scotland, including Quintiles Laboratories, and its NovaQuest group. The company will add 150 jobs in Scotland during the next four years and is investing $13 million in the new building.

The new 112,000-sq.-ft. facility will be built in Livingston, West Lothian, near the company's existing 36,500-sq.-ft. lab in Bathgate. Approximately 80,000 square feet will be used for the laboratory business and the product development and NovaQuest personnel will move into the new building and will occupy about 25,000 square feet. Quintiles will have 390 employees at the two locations.

"Our lab business is expanding globally and in Europe because of our proximity to clinical trial sites and our tight quality control," said Thomas Wollman, senior vice president, Global Central Laboratories. "This new facility will enhance our level of customer service in the UK and Europe, just as our new central lab in Mumbai has improved service in India. We will continue to look for opportunities to strengthen our global central lab network."

Quintiles will sign a 15-year lease for the facility and is receiving a $2.4 million Regional Selective Assistance Grant from the Scottish Executive. Under terms of the grant agreement, Quintiles has agreed to add 150 jobs.

AstraZeneca's chief financial officer, Jon Symonds, is resigning from the company at the end of July. He will join investment bank Goldman Sachs as a managing director in mid-September, according to a company statement. The company has begun an external search to replace Mr. Symonds, who joined the company -- then Zeneca -- from KPMG in 1997 and was involved in the merger negotiations with Sweden's Astra. He was key in the company's financial turnaround when share prices had dropped and when the company faced a series of problems with its products.

Mr. Symonds was a potential candidate to replace Tom McKillop as AstraZeneca's chief executive in 2005, however, David Brennan, then head of the company's U.S. operations, was appointed to the position. In a statement, the company said that Mr Symonds' legacy at AstraZeneca included "a record of consistent strong financial performance and a mature, well structured global finance leadership team."

"Jon has played a critical role in driving AstraZeneca to become one of the leading, most focused and most successful pharmaceutical companies in the world," said Mr. Brennan.

inVentiv Health, Inc.'s Clinical Solutions division has signed a new agreement with ClinPhone for a full suite of software and services to help accelerate clinical trials in the biopharmaceutical industry.

Under the terms of the agreement, inVentiv Clinical Solutions will complete a technology and knowledge transfer of the clinical data capture software, ClinPhone EDC. inVentiv Clinical will then be able offer clients a range of EDC and management services to help address the need for speed and accuracy throughout the clinical trial process.

Mike Hlinak, president and chief executive officer of inVentiv Clinical Solutions, said, "This agreement with ClinPhone allows us to further broaden our service offering by adding our own EDC system which will no doubt better service the increasing needs of our clients for speed and accuracy of clinical trial data. The addition of our own EDC platform also solidifies our position in the market as the clear leader in providing flexible, cost effective clinical outsourcing solutions."

Jim Langford, head of North American sales for ClinPhone stated, "ClinPhone's market leading position in clinical technologies teamed with inVentiv's position as premier provider of clinical outsourcing solutions will benefit sponsors by taking this leading EDC technology and blending it with the outstanding services provided by inVentiv. The decision by inVentiv to utilize our technology as the platform for their data management services further solidifies our position of having the most flexible applications and business model for the clinical outsourcing industry."

Amgen has plans to acquire Ilypsa, a private biotechnology company developing non-absorbed drugs for renal disorders, for $420 million in cash. Ilypsa's lead drug candidate, ILY101, is a phosphate binder for the treatment of hyperphosphatemia in chronic kidney disease (CKD) patients on hemodialysis. Under terms of the agreement, Ilypsa will become a wholly-owned subsidiary of Amgen. The acquisition has been approved by the boards of directors of each company and the shareholders of Ilypsa. Subject to customary closing conditions, the transaction is expected to close in 3Q2007.

"Ilypsa and ILY101 are a strategic fit for Amgen's nephrology portfolio and further demonstrate our commitment to explore, develop and commercialize promising therapies that help in the fight against kidney disease and its complications," said George J. Morrow, Amgen's executive vice president of Global Commercial Operations.

"We are delighted to reach an agreement with Amgen that will help drive Ilypsa's most promising therapeutic program closer to commercialization as an important new option for patients," said Jay Shepard, president and chief executive officer of Ilypsa. "I am proud of the talented team at Ilypsa and believe Amgen offers a promising future for our extraordinary drug candidates."

ILY101, an oral agent that works by preventing the absorption of ingested phosphate, has completed Phase II trials in patients with CKD who are on hemodialysis.

Xceleron has signed a master services agreement with Sanofi-Aventis to assess the human metabolism of novel compounds in early clinical development. Prof. Colin Garner, Xceleron's chief executive officer, said, "Xceleron is delighted to be working with Sanofi-Aventis to optimize their radiolabelled clinical studies. Increasingly, leading pharmaceutical companies are adopting Xceleron’s new drug development strategies to maximize data on compounds in the exploratory clinical development phase. This powerful new knowledge enables our partners to make much more informed decisions about the future clinical development of each new drug."

Dr. G. Ulrich Kuerzel, deputy head, GMPK Frankfurt and head of Metabolism / In Vitro Systems for Sanofi-Aventis Deutschland GmbH, commented, "Initial data we are receiving from these studies confirm our interest in using Xceleron’s ultra-sensitive analytical technology. We are gaining important information that has not been available to us previously."

Xceleron's approach enables human drug-metabolite profiling to be performed earlier in the clinical development process, such as Phase I. This analysis helps drug developers to detect and measure ultra-low levels of both known and unknown metabolites producing data that isn’t available using other analytical techniques, according to the company. Early human profiling also helps identify the most suitable species for use in long term toxicology and pharmacology studies.

Abbott has entered into a commercial license agreement with Dowpharma for its Pfenex Expression Technology, a Pseudomonas-based technology for biologic production. Abbott's product is a proprietary protein for which the company has already developed a high-yield production strain and a fully scalable process. Dow will transfer the production strain to Abbott and support its regulatory filing. Under the agreement, Abbott will have a non-exclusive license to use Pfenex for the development and manufacture of the drug.

"This agreement with Abbott is yet another validation in a long line of agreements by the pharmaceutical industry that our technologies continue to deliver valued solutions. We are pleased to be working with Abbott to help fulfill its future protein production needs as part of this commercial license agreement," said Nick Hyde, global business director for Dowpharma. "Proteins produced by Pfenex Expression Technology are now in human clinical trials and the system consistently delivers high quality protein faster than traditional expression systems."

Valeant Pharmaceuticals International has signed an agreement to sell its manufacturing facilities in Humacao, PR and Basel, Switzerland to Legacy Pharmaceuticals International. The sale includes the company's Reptilase product. Terms of the transaction were not disclosed.
     
Timothy C. Tyson, Valeant's president and chief executive officer, said, "The sale of the two manufacturing sites in Basel and Humacao represents the final step in our restructuring initiative, most of which was completed last year. We continue to make excellent progress toward the achievement of our metric goals."

AstraZeneca has acquired DSM Biologics' manufacturing facility in Montreal, Canada. The 66,000-sq.-ft. facility will be used to manufacture antibody drug candidates for AZ's clinical trials. The facility will be re-commissioned and AZ plans to begin full-scale production in 2009.

Leendert Staal, president and chief executive officer of DSM Pharmaceutical Products, commented, "We are very pleased with this transaction, hereby completing an important step in our Biologics strategy. We have a strong focus on technology development, and jointly with our partner Crucell have recently established Percivia, a new company in Cambridge, MA, for the sole purpose of developing the PER.C6 platform. We are developing our manufacturing facility in Groningen, Netherlands as a center of excellence for the scale-up and use of new PER.C6 technologies. The Montreal facility did not fit in this strategy."

In December 2005, DSM stopped using the Montreal facility as part of its strategy for DSM Biologics, which is to develop and out-license a new manufacturing technology platform based on the PER.C6 human cell line, in a joint venture with Crucell N.V. The two companies recently achieved production yields of 10g/L in the fermentation of monoclonal antibodies using the PER.C6 technology.

Parexel has extended its alliance with Phase Forward, allowing Parexel to continue to offer Phase Forward's InForm electronic data capture (EDC) product as part of its solution set. The two companies first partnered in 1999. Parexel also uses Phase Forward's Clintrial product, a clinical data management and analysis system which integrates electronic and paper-based study data, as well as Clintrace software, an adverse event tracking and reporting system.

"We are pleased to continue our alliance with Phase Forward and to be able to provide our clients with a premier EDC solution that integrates with our overall technology platform for their global clinical development programs," said Mark A. Goldberg, M.D., president of Clinical Research Services and Perceptive Informatics at Parexel.

"As EDC continues to gain traction, we believe we can help biopharmaceutical and medical device companies realize the full benefits of EDC, and we look forward to working with Parexel in pursuing this goal," said Bob Weiler, chief executive officer and president, Phase Forward.

Millennium Pharmaceuticals, Inc. has made two significant advancements in its Aurora A kinase program. The company achieved positive preliminary results from a Phase I study of MLN8054, a first-in-class small molecule to the Aurora A kinase. Also, the company has initiated a new Phase I program for MLN8237, a second-generation Aurora A kinase inhibitor.

Aurora A kinases are required for cancer cells to divide and create tumors. In preclinical models, the inhibition of Aurora A kinases has been shown to stop the proliferation of the cells and reduce tumor growth. Aurora A kinases have been shown to be over-expressed in a variety of cancers.

"The preliminary results from the MLN8054 Phase I study validate the potential of our product candidates in this exciting area," said Nancy Simonian, M.D., chief medical officer, Millennium. "Building on our early experience with MLN8054 and our enhanced understanding of the biology and chemistry of the Aurora A kinase, we have engineered MLN8237, with expectations for even better efficacy and tolerability."

Millennium Pharmaceuticals has appointed three members to its executive management team: chief scientific officer Joseph Bolen, Ph.D., chief medical officer Nancy Simonian, M.D., and senior vice president of non-clinical development sciences Peter Smith, Ph.D. Together they will lead the company's R&D efforts.

"The skill, experience and passion that Joe, Nancy and Pete bring to their jobs are unequaled in the industry. Together, they will continue to drive our efforts of bringing new medicines to patients," says Deborah Dunsire, M.D., president and chief executive officer of Millennium.

Dr. Bolen joined the company in 1999 to lead oncology discovery efforts. In 2002 he was appointed senior vice president of discovery, and named chief scientific officer in 2006. Prior to joining the company, he held positions with Hoechst Marion Roussel, DNAX Research Institute of Molecular and Cellular Biology, Bristol-Myers Squibb Pharmaceutical Research Institute and the National Institutes of Health.

Dr. Simonian joined the company in 2001 to lead clinical development efforts, and in 2006 was named chief medical officer. She is responsible for all clinical, regulatory, pharmacovigilance and development project management functions at the company. Prior to joining the company, she held a clinical research position at Biogen. She was previously an assistant clinical professor of neurology at Massachusetts General Hospital and Harvard Medical School.

Dr. Smith joined the company in 2001 as senior vice president of preclinical development and was named senior vice president of non-clinical development sciences in 2006. He oversees preclinical development for all discovery and development programs. Prior to joining the company, he held positions at Smithkline, Merck, Pharmacia and Searle/Monsanto.

Immunicon Corp. has entered into a research services agreement with Bristol-Myers Squibb (BMS) involving protein and molecular targets associated with circulating tumor cells (CTCs).

Leon Terstappen, M.D., Ph.D., chief scientific officer of Immunicon said, "The list of pharmaceutical partners and biomarkers continues to expand. Our collaborations span across protein biomarkers, phosphoproteins and a variety of FISH assays to study gene amplification in a number of different carcinomas. We believe that our development work will advance the understanding of cancer biology as well as accelerate the time to market for promising new drugs."

Roberto J. Bitton, M.D. has been appointed project leader, Latin America, Kendle. In this role, he will provide medical and therapeutic expertise for Phase I-IV clinical development projects for the company's biopharmaceutical customers, with an emphasis on oncology therapeutics. Dr. Bitton is a board-certified medical oncologist and has more than 20 years of academic, CRO and pharmaceutical industry experience. He has led clinical teams in every phase of the oncology drug development process.

"Oncology now ranks as the most researched therapeutic area worldwide in terms of drug development," said Martha Feller, Ph.D., senior vice president, global clinical development, Kendle. "Dr. Bitton's extensive oncology expertise will further strengthen our therapeutic experience in this significant and growing area of global clinical development."

Dr. Bitton most recently served as medical manager, South Latin America Sub-Region for Novartis Oncology, where he was responsible for late phase and medical marketing. Prior to that, he served as associate medical director, leading the efforts for various cancer vaccines from R&D through Phase II trials for an independent pharmaceutical company in Argentina, and as a program leader in the clinical oncology department for Pharmacia-Upjohn in Milan, Italy.

"Dr. Bitton's full-spectrum background in oncology is critically important as the focus in drug development continues to shift beyond simply bringing a new compound to market toward effectively managing the entire life cycle of each drug," added Dr. Feller.

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