Wyeth and Catalyst Biosciences, Inc. have formed an exclusive worldwide collaboration for the discovery, development and commercialization of Factor VIIa products to treat hemophilia and other bleeding conditions. Total payments under the collaboration could exceed $500 million and include an upfront payment of $21 million, research funding and milestone payments.

Wyeth will fund the discovery, research and preclinical development by Catalyst of Factor VIIa products, including Catalyst's CB 813 for the treatment and prophylaxis of acute bleeding in patients with hemophilia. The term of the research agreement is two years, which Wyeth may extend for as many as three additional years. Wyeth will be responsible for the development, manufacturing and worldwide commercialization of products resulting from the collaboration. Wyeth will also have the right of first negotiation for any additional clotting factors discovered by Catalyst.

Catalyst may earn as much as $40 million during the next two years, including the upfront payment, research funding and preclinical and clinical milestone payments. Catalyst will be eligible to receive development and commercialization milestones, plus royalties on sales of products resulting from the collaboration.

"This collaboration serves as an excellent fit with our recombinant Factor VIII and Factor IX hemophilia products and provides us with an opportunity to expand Wyeth's hemophilia franchise," said Mikael Dolsten, president, Wyeth Research. "We have been impressed by the caliber of Catalyst's therapeutic protein engineering skills used in the Factor VIIa program and the lead candidate CB 813. We look forward to a highly productive collaboration."

"We are thrilled to join forces with Wyeth, a biopharmaceutical company at the forefront of both hemophilia treatment and the development and commercialization of biologic therapies," said Nassim Usman, Ph.D., chief executive officer of Catalyst Biosciences. "This collaboration highlights the value Catalyst has created in our Factor VIIa portfolio of products. Revenues generated from research collaborations such as this one allow us to continually expand and support existing discovery efforts around bleeding disorder product candidates and the engineering of new Alterase therapeutic products."

Sanofi-Aventis is restructuring its R&D operation and plans to close eight of its 27 R&D sites. The new R&D model, which is expected to be in place by 2013, aims to group researchers in more productive structures, working more closely with academics and hospitals to help drive innovation. The company will focus on diabetes, cancer and age-related diseases as well as anti-inflammatory and anti-infectious diseases, according to Christian Lajoux, head of Sanofi-Aventis France.

Under the reorganization, four sites in France and sites in Britain, Japan, Spain and the U.S. will close. According to the company, there will be no layoffs at this time but a plan for voluntary departures is being considered. The company employs 13,000 people in R&D and administrative positions.

“The objective of this new R&D model is to propose innovative solutions that respond to specific, unmet needs of patients and continue our success in a very competitive international environment,” said Christopher A. Viehbacher, chief executive officer of Sanofi-Aventis. “It is centered on the real needs of patients, the development of scientific networks and openness toward outside entities to strengthen creativity, and a flexible and entrepreneurial approach to research.”

Covance, Inc. is expanding its analytical and stability services facility in Madison, WI, doubling capacity for large-scale, long-term stability and release programs for preclinical, clinical, and chemistry, manufacturing, and control (CMC) development of pharmaceutical and animal health products.

The expanded facility includes upgraded stability chambers equipped with high-density tracked shelving to help increase pharmaceutical analysis service capacity and utilization, and will have as many as ten walk-in chambers and several reach-in chambers. The facility will also provide space for further expansion.

"Covance is committed to providing world-class CMC analytical services for our clients to provide the highest quality data and reduce developments timelines," said Henry Hummel, vice president and general manager, Madison sites, Covance. "Together with our integrated discovery, preclinical, and clinical service offerings and dedicated program management team, we can now offer CMC analytical services as part of an entire molecule development program."

Pharmaceutical Development Services Ltd. (PDS) has opened an office in South Carolina to support expansion efforts in the U.S. Dr. Jeff Rudolph will guide U.S. pharmaceutical companies with drug development in Europe, covering regulation, quality management, European legal framework and the sourcing of local contractors.

Dr. Michael Gamlen, managing director of PDS, said, "Having established expert knowledge in European pharmaceutical development, we have built up a bank of expertise in our team that can considerably shorten the timescales and reduce the costs for American companies of introducing pharmaceutical products into Europe. Our business from U.S. companies has steadily increased and by opening a U.S. office with Dr. Rudolph as our main contact point, we are ensuring that we can effectively manage our expansion in the U.S."

Dr. Rudolph is an experienced pharmaceutical scientist with more than 30 years of experience with domestic and international development and management of branded, generic and OTC products. He held senior pharmaceutical development positions at McNeil Laboratories (J&J) and spent 23 years at AstraZeneca and its predecessor companies, where his responsibilities included vice president, international pharmaceutical development/R&D operations. Dr. Rudolph most recently provided consulting services to the healthcare industry in the areas of CMC, process optimization, production troubleshooting, device design, organizational and business development as well as serving as an expert witness on formulation/drug delivery patent cases.

MorphoSys AG will receive a milestone payment from Centocor Ortho Biotech, Inc. for the initiation of a Phase I trial using a HuCAL-derived, fully human antibody in the therapeutic area of inflammation.

"The advancement of a new HuCAL antibody into human clinical trials is an important step forward for MorphoSys," commented Dr. Simon Moroney, chief executive officer of MorphoSys. "Progress in the development of innovative biopharmaceutical agents by our partners is a key driver of our company's growth."

This is the second HuCAL antibody program derived from the companies' collaboration to enter clinical trials. With the new study, Centocor Ortho Biotech will be running three clinical trials of HuCAL antibodies.

Mylan Inc. and Biocon Ltd. have entered a definitive agreement to collaborate on the development, manufacture, supply and commercialization of multiple, generic biologic compounds.

Mylan's chairman and chief executive officer Robert J. Coury commented, "This unique collaboration combines Biocon's scientific expertise, excellent product development track record, appreciation of complex regulatory requirements, and state-of-the-art, cost-efficient and scalable biologics manufacturing with Mylan's one-of-a-kind global commercial footprint and our regulatory expertise around the world. Biocon also has a unique corporate culture that is very similar to Mylan's. All of these attributes will provide a critical synergy and create a strong and effective long-term partnership."

Biocon chairman and managing director Dr. Kiran Mazumdar-Shaw commented, "Biocon is extremely pleased to have found a partner as strong as Mylan to accelerate our work in generic biologics, especially with monoclonal antibodies, and take it to the next level around the world, especially in regulated markets. Monoclonal antibodies are emerging as the most dominant class in biologics. Through this partnership we hope to deliver high quality, affordable biogeneric antibodies and biologics, thereby addressing a critical need to lower spiraling healthcare costs in both the developed and emerging economies."

The two companies will share development, capital and certain other costs. Mylan will have exclusive commercialization rights in the U.S., Canada, Japan, Australia, New Zealand and in the EU through a profit sharing arrangement with Biocon. Mylan will have co-exclusive commercialization rights with Biocon in all other markets around the world. Financial terms and product details were not disclosed.

Icon Central Laboratories has moved its Singapore central laboratory to a new, larger facility located at Loyang Way, Eastern Singapore. The new laboratory meets the growth in demand for Icon's services in Singapore, which has increased by 149% over the past six months. The larger facility also enables the company to expand its test menu offerings in the region to include increased esoteric testing as well as flow cytometry, molecular diagnostics and biomarkers, to complement the services of Icon's other wholly-owned central laboratories in Europe, India and the U.S.

"As ICON celebrates its 10th year of operation in Singapore, our move to a larger laboratory signals our continued commitment to the region," commented Bob Scott-Edwards, president, Icon Central Laboratories. "Singapore has become a regional hub for drug development in Asia-Pacific and we now have the capacity, the range of testing services and, above all, a highly experienced team of lab professionals to support the growth of clinical trials in the region."

Icon Central Laboratories Singapore supports all major therapeutic areas, including cardiovascular, oncology, endocrinology and metabolism, and virology. The laboratory serves as a regional hub for test samples from Australia, New Zealand, South Korea, Malaysia, Singapore, Taiwan, Japan, Thailand, Hong Kong, China and Indonesia. The unit received CAP (College of American Pathologists) accreditation in March 2009.

Teva Pharmaceutical Industries and Active Biotech have completed patient enrollment for the second pivotal Phase III clinical trial, BRAVO, evaluating the novel, oral once-daily immunomodulating compound, laquinimod, for the treatment of relapsing-remitting multiple sclerosis (RRMS). BRAVO is a global clinical trial designed to evaluate the efficacy, safety and tolerability of laquinimod versus placebo, and to provide risk-benefit data for laquinimod versus a currently available injectable treatment, Avonex.

“Teva and Active Biotech are encouraged by the potential of laquinimod to address patients' unmet need for an oral immunomodulating MS therapy that provides efficacy while maintaining safety,” said Moshe Manor, Teva’s group vice president, Global Branded Products. “We look forward to continuing our clinical Phase III program of laquinimod, and hope it will offer enhanced quality of health for RRMS patients.”

The companies recruited more than 1,200 patients at 156 sites in the U.S., Europe, Israel and South Africa for this trial. The first global Phase III trial of laquinimod completed enrollment in November 2008, after recruiting more than 1,000 patients at 152 sites. The trial is currently ongoing. In February 2009, laquinimod received Fast Track designation from the U.S. Food and Drug Administration (FDA).

Pfizer released results from a Phase III trial of Sutent in patients with advanced pancreatic islet cell tumors, also known as pancreatic neuroendocrine tumors, which is a different type of cancer than the more common pancreatic adenocarcinoma. Study findings demonstrated that median progression-free survival (PFS) was 11.1 months in patients treated with Sutent compared to 5.5 months in patients treated with placebo. Researcherspresented the data at the 11th World Congress on Gastrointestinal Cancer in Barcelona, Spain. The independent Data Monitoring Committee (DMC) recommended halting the trial earlier this year because Sutent showed significant benefit and the study had met its primary endpoint. Full analysis of the data is ongoing.

“In this study, Sutent demonstrated an impressive improvement in progression-free survival for patients with pancreatic islet cell tumors,” said Dr. Eric Raymond, M.D., Ph.D., professor of Medical Oncology and head of University Department of Medical Oncology (Service Inter Hospitalier de Cancerologie) Bichat-Beaujon, Clichy, France, and lead investigator on this study. “This is encouraging news for patients, especially given that there are limited treatment options for this type of advanced cancer.”

“The observation of substantial improvement in progression-free survival in Sutent-treated patients was the basis for the independent Data Monitoring Committee’s recommendation to halt accrual to the study early,” said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs for Pfizer’s Oncology Business Unit. “This is welcome news, as there is currently no standard of care for patients with pancreatic islet cell tumors who progress on prior therapy.”

GlaxoSmithKline and Chroma Therapeutics have formed a collaboration to develop macrophage-targeted compounds using Chroma’s proprietary esterase-sensitive motif (ESM) technology, which adds amino acid esters to compounds with the aim of targeting the compounds to specific cells in the inflammatory disease process.

Chroma will undertake four discovery and development programs to identify small molecule therapeutics, including its macrophage-targeted HDAC inhibitor programme for inflammatory disorders such as rheumatoid arthritis. Chroma will receive an up-front cash payment and, in addition, GSK will invest in Chroma’s Series D equity financing.

Chroma is eligible to receive as much as $1 billion in milestones, option fees and tiered royalties based on compounds arising from the collaboration, if all four programs are successful. For each program, Chroma will have responsibility for R&D activities through completion of clinical proof of concept studies. After the completion of such studies for each program, or earlier if it so chooses, GSK may elect to obtain an exclusive, worldwide license to product candidates within the program. At such time GSK will assume full responsibility for development and commercialisation. Chroma will retain full rights to further develop and commercialize its product candidates in any programme GSK chooses not to license.

"This agreement marks GSK's continued efforts to access the best science and technology platforms worldwide" said Shelagh Wilson, vice president and head of the European Center of Excellence for External Drug Discovery. "We believe Chroma's ESM platform has tremendous potential, and look forward to working with Chroma to accelerate the discovery and development of innovative new medicines for patients"

Nick Green has been named to the newly created position of president, Dishman Contract Research and Manufacturing Services (CRAMS) at the Dishman Group. Mr. Green will report to Jay Vyas, managing director of the global pharmaceutical services provider, and will assume responsibility for management and operations of all contract research, contract development and contract manufacturing activities within the Dishman Group, which encompasses both the CRAMS services offered under the Dishman name and under the CARBOGEN AMCIS name (the wholly owned Switzerland-based subsidiary of Dishman).

Mr. Green previously served as president of Codexis Pharmaceuticals. Prior to Codexis, he served as chief executive officer and managing director of Shasun Pharma Solutions, and prior to that, as president and chief executive officer of Rhodia Pharma Solutions. He has also held operating management positions with chemical and life science companies, including Clariant Life Sciences, Nipa Biocides and Hodgson Chemicals.

“We are delighted to add an experienced executive from the pharmaceutical industry to our senior management team,” said Vyas. “With his strong background and extensive experience of more than 20 years in contract service operations, Nick will play a key leadership role in driving, managing and accelerating Dishman’s growth in this area."

Syntagon has successfully renewed its GMP certification for the manufacture of clinical APIs following an audit by the Swedish Medical Products Agency. The two-day audit scrutinized Syntagon’s facilities, documentation, QA and QC departments.

The Swedish agency, known as Läkemedelsverket, carries out GMP audits every three years. Syntagon first gained accreditation from the Agency in 2003. The certification allows Syntagon to continue to make clinical APIs for clinical trials throughout Europe and North America.

“We are delighted to be successfully re-audited by the [Swedish Medical Products] Agency. It demonstrates our continued commitment to quality and our full compliance with GMP,” said Paul Alhadeff, Syntagon's QA officer.

With operations in Sweden, Latvia, and China, Syntagon specializes in synthetic preparation of small molecules under GMP manufacture.

OctoPlus N.V. has started pharmaceutical production in its new GMP manufacturing facility in Leiden, The Netherlands. The facility has received a license from the Dutch authorities to manufacture pharmaceutical products according to international GMPs and the first production has taken place successfully.

The expansion of OctoPlus' headquarters started in November 2006. The new building includes offices, laboratories and a GMP manufacturing plant that produces final drug product for OctoPlus' clients. Expansion of the manufacturing capacity was necessary to facilitate the growing client demand. With the expansion, OctoPlus' manufacturing capacity more than doubled and the company can now produce clinical scale Phase I, II, III and small-scale commercial supplies of injectable pharmaceutical products and other complex formulations.

Simon Sturge, chief executive officer of OctoPlus, commented, "We are very proud to report that the expansion of the production facility in our headquarters in Leiden has obtained official approval from the Dutch authorities and we have now started producing pharmaceutical products as a fully licensed facility."

Biogen Idec has enrolled the first patient in a Phase III, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of PEGylated interferon beta-1a (BIIB017) in patients with relapsing multiple sclerosis (RMS). The trial, called ADVANCE, will determine the efficacy of PEGylated interferon beta-1a in reducing relapse rates in patients with RMS.

“A major issue with patient adherence to injectable therapies for MS is the frequency of injections,” said Peter Calabresi, M.D., principal investigator of the ADVANCE trial and professor of neurology and director of The Johns Hopkins Multiple Sclerosis Center. “Examined in Phase I studies, PEGylated interferon beta-1a was shown to be much longer acting than intramuscular interferon beta-1a and thus offers the possibility of every two or four week dosing without compromising efficacy. This could greatly increase the convenience of this first line class of therapy."

Interferon beta-1a has been successfully used to treat patients with relapsing-remitting multiple sclerosis for more than 10 years. PEGylation protects the interferon beta-1a molecule from being degraded, extending the amount of time the drug remains in a patient's system. The process has been used in other therapeutic areas, and Biogen Idec is studying this innovation in interferon therapy for MS. Administered via subcutaneous injection, PEGylated interferon beta-1a is being studied to evaluate its potential to reduce the frequency of treatment injections and provide patients with an effective and more convenient dosing option.

“Bringing PEGylation to the interferon-class of MS treatments would be an innovation welcomed by the MS community,” said Michael Panzara, M.D., M.P.H., vice president, chief medical officer of neurology, Biogen Idec.

Felix Hsu has been appointed senior vice president of WuXi AppTec U.S. In his new role, Mr. Hsu will be responsible for WuXi's U.S. business. He will report to Edward Hu, chief operating officer, acting chief financial officer, and current head of U.S. operations.

Prior to joining WuXi, Mr. Hsu worked at Medtronic for 14 years in positions of increasing responsibility. He has broad experience as a product manager and business leader, serving as director of Heart Valve Worldwide Marketing; vice president of Business Excellence; vice president of Cardiac Surgery for Asia Pacific, based in Hong Kong; and vice president of Supply Chain Integration based in Minneapolis. Prior to working at Medtronic, he served in product management, sales management, and strategic planning roles at Abbott Laboratories and as a business manager at Sabratek.

"I am very pleased to welcome Felix on board as we continue to strengthen our U.S. management team," commented Dr. Ge Li, chairman and chief executive officer of WuXi PharmaTech. "Our U.S. operations offer a range of testing services critical to the successful development and regulatory approval of new biologics and medical devices. We expect our U.S. business will grow under Felix's leadership."

Wei-Min Chang has been appointed vice president of operations and general manager of the company's SynTheAll (STA) manufacturing facility, located in the Jinshan chemical industry zone of Shanghai. Mr. Chang will report to Dr. Li. Dr. Eric Gu, who previously held those roles, has been appointed vice president of business development for Manufacturing Services, reporting to Dr. Suhan Tang, chief manufacturing officer.

The SynTheAll facility manufactures APIs and advanced intermediates for use in preclinical and clinical trials. The company recently completed construction of an expanded facility, known as SynTheAll Phase 2, to produce advanced intermediates and APIs for late-stage clinical trials and commercial supplies. This new facility is expected to open in stages, beginning in late 2009.

Prior to joining WuXi, Mr. Chang worked at Eastbound Synopharma (HK) Holding Co. as vice president of Chemical Development, responsible for research and development, small-scale manufacturing, quality control/quality assurance, regulatory affairs and other general administrative functions at Eastbound Shanghai Institute. From 1999 to 2006, he worked for Taiwan Biotech as the company's head of U.S. operations and as vice president of R&D/Quality/Regulatory Affairs/API Operations. From 1989 to 1998, he was senior process engineer/chemical engineer at Eli Lilly, where he was responsible for designing and developing manufacturing processes for advanced intermediates, APIs, and bulk pharmaceuticals at both laboratory and pilot plant scale.

"We are delighted to have someone with Mr. Chang's extensive manufacturing experience to manage our Jinshan facility," said Dr. Li. "Wei-Min's knowledge of cGMP manufacturing operations within the pharmaceutical, biotechnology, and chemical industries will help WuXi manage its manufacturing facilities efficiently and effectively."

AMRI has finished the construction of a new state-of-the-art chemistry R&D facility in Budapest, Hungary. The successful completion and move into 32,300 sq. ft. of laboratory and administrative space is part of the company’s plan, initiated in 2008, to transform its European hub into a higher value discovery services business through consolidation of multiple locations, equipment and operating costs.

The new site provides capacity for the anticipated expansion of synthetic chemistry services, currently projected to double over the next five years.The facility also includes a scale-up laboratory for non-GMP synthesis for batch sizes as large as 25 liters. AMRI also contends it will offer "significant improvements in operational efficiencies and enhanced technology transfer."

“The successful completion of this expansion increases the ability of AMRI to execute on its strategy to accelerate growth and expand its presence in the European marketplace,” said chairman, chief executive officer and president Thomas E. D’Ambra, Ph.D. “Critical to the decision to undertake this project was the company’s drive to cultivate a customer base relatively untapped. We believe this latest investment, along with our parallel investments in the US, India and Singapore, will further strengthen AMRI’s presence as a premier provider of a broad range of scientific services, capabilities and geographic choices around the globe.”

The U.S. District Court for the District of New Jersey has ruled against Sanofi-Aventis in its U.S. Eloxatin patent litigation, granting judgment in favor of several generic companies. SA plans to appeal this decision, which if upheld could result in an earlier-than-expected launch of generic Eloxatin in the U.S.

Under the judgment, Hospira's version of the chemotherapy medication does not infringe on the original. Hospira is anticipating FDA approval shortly for its generic version of Eloxatin. Teva Pharmaceutical Industries also has a version of the drug, which is awaiting FDA approval.

Eloxatin, known generically as oxaliplatin, had more than $1.8 billion in sales in 2008 for Sanofi.

Synteract will open a Central Eastern European office in Prague, Czech Republic, this summer. The office will offer regulatory, site management/monitoring, pharmacovigilence and project management services, including data management, biostats (including CDISC) and medical writing are available to clients globally.

The separate business unit will be headed by Kristi Clark, currently the senior director of Project Management and Global Business Operations at the headquarters office in Carlsbad, CA. Ms. Clark has been with the company for almost four years and has more than 19 years of industry experience, which includes 12 years of global trial experience in the biopharma industry.

Chief executive officer Ellen Morgan said, “Our goal is to provide our clients with the same flexibility, guidance and responsive service for their multinational trials that they have become accustomed to when working with us domestically. We decided that this year is the right time to move forward to provide the one-stop shop and broader services they need. Having Kristi on the ground in Europe will also help us to evaluate additional potential partners who fit our model.”

“We will maintain the same level of service in our Central Eastern European office that we now offer in our U.S.-based offices, yet still retain our corporate culture overseas,” said Ms. Clark. “Having key Synteract employees transferred from the U.S. to the Prague office confirms our commitment to quality and will help our clients have more confidence that their international trials will meet the standards they expect from our company, to support them with continuity from phase one to four trials.”

Vetter Secondary Packaging (VSP) has completed the installation of six automatic packaging lines at the company’s new packaging services facility based in Ravensburg, Germany. The facility allows the company to double its production capacity and provides a variety of packaging options for clients from one location, including hand-packing, pen assembly, auto-injectors, safety devices, automatic setting of plungers, labeling, and blistering.

Vetter managing director Thomas Otto said, “Due to increasing economic and regulatory pressures, secondary packaging is becoming a critical issue for our customers. Vetter’s new facility increases available capacity and enhances the range of services we can provide. In addition, it gives us the ability to perform all processes, from support in the early development phase to commercial manufacturing and even secondary packaging, at the highest quality and safety levels.”

Novartis received approval from the FDA for Ilaris (canakinumab) for the treatment of children and adults with cryopyrin-associated periodic syndrome (CAPS), which includes a number of rare but life-long auto-inflammatory disorders with debilitating symptoms and limited treatment options. The drug was granted priority review based on its potential to meet an important clinical need for CAPS patients.

Ilaris is the first approved treatment for patients as young as four years old suffering from two forms of CAPS: familial cold auto-inflammatory syndrome (FCAS) and Muckle-Wells syndrome. CAPS is caused by a single gene mutation that leads to overproduction of interleukin-1 beta (IL-1ß), which causes sustained inflammation and tissue damage including long-term consequences such as deafness, bone and joint deformities, central nervous system damage leading to visual loss, and amyloidosis resulting in renal failure and early death.

Ilaris, previously known as ACZ885, is a fully human monoclonal antibody that rapidly and selectively blocks IL-1ß. The dosing schedule for Ilaris is once every eight weeks, which is less frequent than the current approved therapy.

Clinical trials for Ilaris are also underway in systemic juvenile idiopathic arthritis (SJIA), gout, chronic obstructive pulmonary disorder (COPD) and type 2 diabetes.

Eden Biodesign Ltd. and Selexis have expended their collaboration via a joint marketing partnership, which will provide global biopharma companies access to their services for the development of monoclonal antibodies and recombinant proteins derived from mammalian cell culture.

“We are very happy to be able to formally announce our relationship with Selexis and their extremely powerful approach to the development of high-productivity cell lines, which we are able to offer to our clients,” said Dr. Roger Lias, president of Eden Biodesign’s U.S. subsidiary and group commercial director. “We recognize the vital importance of speed-of-development and of attractive final cost-of-goods for biopharmaceuticals. Working with our colleagues at Selexis provides the opportunity for our mutual clients to achieve both.”

“The relationship with Eden has enabled a number of mutual clients the ability to progress rapidly from DNA to cGMP manufacturing with a cost effective manufacturing platform, without sacrificing performance or quality,” said Andrew Sandford, vice president of business development for Selexis’ U.S. subsidiary. “At Selexis we appreciate the efforts associated with cGMP manufacturing and are pleased to recommend Eden to our clients as an ideal option for cGMP manufacturing.”

Eden Biodesign provides biopharma, vaccine process development, and cGMP manufacturing services. The company also offers clients consultant services. Selexis offers technologies and services for the rapid development of high-performance, stable mammalian cell lines. Its SURE Cell Line Development Platform generates high producing cell lines in five weeks, according to the company.

Quintiles opened a new office in Accra, Ghana to improve efficiency and expand capacity to monitor clinical studies in Western Sub-Saharan Africa. The new office will provide access to the surrounding West African countries, and will begin to facilitate monitoring of a large malaria vaccine study currently under way.

The Ghana office is based at the grounds of the University of Ghana at the Noguchi Memorial Institute for Medical Research. Quintiles has entered a partner-site agreement and will work with professor Alex Nyarko, Ph.D., director of the institute and professor David Ofori-Adjei, a specialist physician with more than 30 years’ experience studying infectious diseases. As part of the agreement with the institute, Quintiles will provide training for new investigators across a range of therapeutic areas, as well as training for clinical research associates (CRAs).

“This expansion offers huge potential to reach patients in Sub-Saharan Africa, which has an estimated population of 760 million people,” said Gillian Corken, chief executive officer, Quintiles Africa. “Initially the focus will be on diseases such as malaria, TB and HIV. However, we anticipate that as the infrastructure and economies in Africa develop, like many other non-traditional regions before, it will play an increasingly important role in recruiting patients for many other therapeutic areas, such as oncology and cardiovascular.

Crucell N.V. is acquiring Xcellerex, Inc.'s FlexFactory bioproduction line and multiple XDR single-use bioreactors as part of its effort to expand capacity and flexibility of its manufacturing capabilities. The project will deliver new, validated clinical manufacturing capacity at Crucell’s operations in Leiden, The Netherlands during 1Q10. Financial terms were not disclosed.

“The FlexFactory purchase is an important part of our product development strategy as we build capacity to support our growing pipeline of vaccines and therapeutic antibodies for infectious diseases,” commented Dr. Cees de Jong, chief operating officer at Crucell. “In addition to coming on line rapidly, the FlexFactory platform has great potential to increase our operational efficiency based on its flexibility for multi-drug production, use of disposables, and reduced operating expenses.”

Xcellerex president and chief executive officer Joseph Zakrzewski commented, “Crucell is the world’s largest independent vaccine manufacturer and a growing infectious disease company. The company’s FlexFactory purchase is a major endorsement of our manufacturing and development platform.”

The FlexFactory is based on the application of single-use technologies, controlled environmental modules (CEMs), and process automation including electronic batch records. Xcellerex will provide support and training services as well as contract manufacturing services to help accelerate Crucell’s deployment efforts. The FlexFactory line will be assembled, tested, and operated at Xcellerex for protocol development and simultaneous operator training. Xcellerex may also complete engineering and/or GMP manufacturing runs for Crucell before transplanting the modular FlexFactory line to the Leiden facility for site validation and start-up.

H. Michael Shepard, Ph.D., has joined Halozyme Therapeutics as vice president, discovery research. Dr. Shepard is a recipient of numerous biotechnology patents and scientific awards for his contributions to the development of innovative therapies. He has more than 25 years of experience in the biotechnology industry. At Genentech, Dr. Shepard led the team that discovered the breast cancer drug, Herceptin, which was designed to attack HER2 positive breast cancers. In 2007, Dr. Shepard shared the Warren Alpert Prize from Harvard Medical School in recognition of this achievement.

Dr. Shepard also built successful programs at various biotechnology companies in areas including antibiotics, cancer gene therapy and receptor fusion proteins. He served as chief scientific officer of Canji, Inc. and, most recently, founder and president of Receptor BioLogix, Inc.

“We are delighted to have Dr. Shepard’s discovery research leadership at Halozyme,” said Gregory Frost, Ph.D., Halozyme’s chief scientific officer. “Mike’s ability to translate his broad scientific understanding into innovative biologics complements the research and development team at Halozyme as we build a world class biopharmaceutical organization.”

Genzyme Corp. has detected a virus that impairs cell growth in one of six bioreactors at its Allston Landing manufacturing facility. The company has temporarily interrupted bulk production to sanitize the facility and is collaborating with regulatory agencies to resume production. The company expects the plant to be fully operational by the end of July.

The virus strain, vesivirus 2117, has not been shown to cause human infection but interferes with the growth of CHO cells used to produce biologic drugs. It was likely introduced through a nutrient used in the manufacturing process. According to the company, this virus caused declines in cell productivity at its Allston and Geel facilities in two previous instances in 2008, which were subsequently addressed.

The company declared that its current inventories for Cerezyme and Fabrazyme are not sufficient to meet projected global demand. The timing and extent of the Cerezyme supply constraint is being clarified and will be communicated as soon as possible. The company expects Fabrazyme supply constraints to occur for a limited period beginning in September. The company will work with physicians, patients and regulators to help minimize the impact on patients.

“The patients who need these therapies are our priority,” said Henri A. Termeer, Genzyme’s chairman and chief executive officer. “We are confident in the quality of the products produced in Allston and in our ability to resolve the issue affecting the plant. The impact will be temporary.”

MorphoSys AG and Schering-Plough have extended their antibody collaboration for another year. The partnership, initiated in May 2006, may be extended by Schering-Plough annually until 2011.

The agreement grants SP continued access to MorphoSys's antibody library HuCAL GOLD at SP's research site in Palo Alto, CA, with options for therapeutic licenses. MorphoSys is eligible to receive license fees, plus milestone payments for antibody projects undertaken by SP that advance to clinical development, and royalties on HuCAL antibodies developed under the agreement. Under the extended agreement, MorphoSys continues to receive annual user fees for access to its HuCAL platform.

"We are pleased with Schering-Plough's decision to extend the current collaboration," commented Dr. Simon Moroney, chief executive officer of MorphoSys. "This demonstrates once more the continued commitment of leading pharmaceutical companies worldwide to our HuCAL technology for their antibody-based drug development programs."

AMRI has made a series of changes to its India operations and leadership team, supporting the establishment of an integrated offering of chemical development and manufacturing services as part of an effort to increase efficiencies of the company's global operations and to reduce costs.

Rajesh Shenoy, Ph.D. has been named managing director, India operations. Previously director for the company’s site in Hyderabad, India, Dr. Shenoy’s role has expanded to include large scale commercial manufacturing operations in Aurangabad, India. He assumed leadership for Hyderabad operations in 2005 as part of the AMRI team that established one of the company’s first sites outside of the U.S., and its first in India. Dr. Shenoy will report to Steven R. Hagen, Ph.D., AMRI vice president of pharmaceutical development and manufacturing.

Sivakumar Sivasubramanian has been named director, general operations to assume oversight for all general plant operations and engineering services for AMRI in India. Mr. Sivasubramanian joined AMRI in Hyderabad in 2005 as general manager, operations.

Sridhar Vaddeboina, Ph.D. has been named director of analytical services, India Operations. Dr. Vaddeboina most recently served as manager, analytical quality services for India operations, and will now lead all analytical and quality functions in India.

“We are pleased to announce the promotions of Drs. Shenoy and Vaddeboina and Mr. Sivasubramanian into these expanded leadership roles,” said AMRI Chairman, CEO and President Thomas E. D’Ambra, Ph.D. “Besides benefiting from their ability to achieve positive results as demonstrated by their efforts in establishing and growing our Hyderabad site, we believe that there will be significant synergies and collaborative benefits gained by combining leadership of the entire AMRI India footprint under one helm.”

James M. Frincke, Ph.D. has been named president and chief executive officer of Hollis-Eden Pharmaceuticals, Inc. Dr. Frincke was also elected to the company's board of directors.

Dr. Frincke joined Hollis-Eden in 1997 as vice president, R&D, was promoted to executive vice president in 1999, and to chief scientific officer in 2001. He joined Hollis-Eden from Prolinx, Inc., where he served as vice president, Therapeutics R&D, from 1995 to 1997. During his 28 years in the biotechnology industry, Dr. Frincke has managed major development programs including drugs, biologicals, and cellular and gene therapy products aimed at the treatment of cancer, infectious diseases and organ transplantation.

Dr. Frincke has held vice president, R&D positions in top-tier biotechnology companies including Hybritech/Eli Lilly and SyStemix Inc. (acquired by Novartis). In various capacities, he has been responsible for all aspects of pharmaceutical development including early stage research programs, product evaluation, pharmacology, manufacturing, and the management of regulatory and clinical matters for lead product opportunities.

GlaxoSmithKline and Synta Pharmaceuticals will end their collaborative agreement for the clinical development and commercialization of elesclomol, a chemotherapy adjuvant, by September 10, 2009. Worldwide rights to elesclomol will revert to Synta and Synta may pay GSK a low single-digit royalty on any potential future sales of elesclomol.

“We appreciate GSK’s contributions to this program and understand their decision,” said Safi R. Bahcall, Ph.D., president and chief executive officer of Synta. “We will be meeting with medical and scientific advisors to review the data from the SYMMETRY trial and additional results later this year, and will use this guidance to inform our choices for a path forward for the program. We expect to report more on additional data and plans for the program later this year.”

Dr. Bahcall added that Synta is continuing to evaluate the potential of elesclomol, while also focusing its resources on other programs in its portfolio, particularly the Hsp90 program. He remarked, “With a strong cash position, a portfolio of first-in-class and best-in-class programs, and a productive discovery engine, we are excited about the potential of our pipeline and are committed to realizing the potential of these programs to benefit patients.”

Isogen LLC, a sterile manufacturer based in Wilmington, DE, has made several appointments to its management team.

Mark Koscinski, CPA, has been appointed chief financial officer and treasurer of Isogen, and is responsible for the overall financial strength and stability of the Company. Mr. Koscinski serves as the principal financial and accounting officer of the company, with oversight of the treasury and controllership functions. Mr. Koscinski has more than 25 years of experience in finance, with more than 15 years in executive leadership. Prior to joining Isogen, Mr. Koscinski was Senior vice president and chief financial officer of Butler International, a $350 million technical services business. Mr. Koscinski was also manager at KPMG and has significant SEC experience.

Rosemarie Fisher, CPA, has been appointed controller. Ms. Fisher's responsibilities include improving Isogen's profitability by accessing a wide range of areas from budgets and performance measurements to accounting and reporting systems. Currently, Ms. Fisher is president of Real Possibilities, a management and technology firm, and serves Isogen through this company. Prior to founding Real Possibilities, she held the positions of executive vice president and chief financial officer at Pyramid Consulting, general accounting manager at The Hibbert Group and corporate accounting officer at Tingley Rubber Corporation.

Diane Wood has been appointed director, Quality Assurance and Regulatory Affairs. In her role, She is responsible for the planned and systematic compliance activities necessary to ensure all products and services Isogen provides to its customers meet the given requirements. A senior quality executive, Ms. Wood has more than 25 years' experience in developing quality and documentation systems and authoring multiple CMC filings and biologic applications. Prior to joining Isogen, Ms. Wood was a quality leader at Beecham Laboratories, Hoechst-Roussel Pharmaceuticals, Ortho Pharmaceuticals / Advanced Care Products, Novo Nordisk Pharmaceuticals and Serono Laboratories.

Malcolm Montgomery, Ph.D., has been appointed director, Lab Services. He will lead Isogen's Lab Services team in analytical method development/validation and the testing/release of pharmaceutical products. Dr. Montgomery is an analytical chemist with more than 15 years of experience in small molecule and biological drug products. Prior to joining Isogen, Dr. Montgomery held director and senior level positions at Microbac Laboratories, Centocor Research and Development, Merck, Apollon and Wyeth-Ayerst.

Robin Uhl has been appointed director of Business Development. Working closely with the chief executive officer, Ms. Uhl is responsible for generating revenue, building a strong sales pipeline, creating awareness of Isogen in the marketplace and developing partnerships that will propel Isogen's growth. Ms. Uhl has more than 20 years of experience in leading marketing, communications and sales for professional services firms. Prior to joining Isogen, Ms. Uhl served as vice president of marketing for Butler International. In addition, Ms. Uhl has held key positions at Arthur Andersen and Dun and Bradstreet.

"We're very excited about the management team we have in place at Isogen. All of our directors -- those added recently, as well as those who have been with us from the start -- are sought-after leaders who are at the top of their game. We truly have a winning team," commented Austin McDonald, Isogen's chief operating officer.

Patheon 2Q

2Q Revenues: $167.4 million (-10%)

2Q Earnings: $0.5 million (loss of $8.0 million in 2Q08)

YTD Revenues: $314.6 million (-10%)

YTD Loss: $5.3 million (loss of $22.6 million YTD08)

Comments: Exchange rate fluctuation affected most results for the quarter. Commercial manufacturing revenues were down 11% to $135.2 million, but gross profit rose by $2.0 million from 2Q08. North American commercial revenues were $67.0 million (-7%), primarily due to reduced customer demand for some products. European commercial revenues were $68.2 million (-14%). Pharmaceutical Development Services revenues for quarter were down 8% to $32.2 million. Operating income for the quarter was $13.4 million or 8% of revenues, up from $3.3 million or 2% of revenues in 2Q08. Income from continuing operations was $1.8 million, compared with a loss of $6.0 million in 2Q08. Earnings in the quarter reflect $2.9 million in expenses associated with the JLL Offer.

Dr. Yujing Yang has assumed the position of director of Purification Technologies, North America, at Sartorius Stedim Biotech. He has experience in all areas of biopharmaceutical downstream processing and knowledge of biotech-related technologies, such as Xflow filtration and membrane chromatography. Dr. Yang reports to Dr. Uwe Gottschalk, vice president of marketing, Purification Technologies.

Prior to joining the company, Dr. Yang was industrial commercial leader for life sciences in Greater China at GE Healthcare, where he was responsible for marketing, sales and support teams. Prior to this position, he was technical marketing director for Asia, and held various positions in business development, product management, application and technical support. Dr. Yang has also held various management and research positions at Pall Corp., the U.S. National Research Council and the Boston Biomedical Research Institute.

Xenon has entered into a strategic alliance with Merck to discover and develop small molecule candidates for the potential treatment of cardiovascular disease.

Xenon will perform validation studies using its clinical genetics platform, as well as drug discovery and select preclinical development of small molecule compounds for targets selected by a joint steering committee. Merck has the option to exclusively license targets and compounds from Xenon for development and commercialization. Xenon will receive research funding and is eligible for option exercise fees, research, development and regulatory milestone payments of as much as $94.5 million for the first target and $89.5 million for each subsequent target selected for drug discovery. Xenon will also receive royalties on sales of any products resulting from the collaboration. Xenon retains the development and commercialization rights for compounds that Merck does not select.

"We are very excited to be collaborating with Merck to define new therapeutics in the area of cardiovascular diseases," said Simon Pimstone, president and chief executive officer of Xenon. "With this deal, Xenon is continuing its strategy of risk mitigation by select partnering, while retaining ownership of other programs."

Jubilant Biosys, a Bangalore-based subsidiary of Jubilant Organosys Ltd., has entered into a discovery and development collaboration with Endo Pharmaceuticals to develop a portfolio of oncology targets with a focus on delivering preclinical candidates for joint clinical development.

Endo will own any compounds developed under the collaboration and will be responsible for worldwide commercialization. In the initial three-year agreement, Jubilant will receive research funding and success-based development milestones, as well as royalties on the successful commercialization of the compounds developed.

Mr. Shyam Bhartia, chairman and managing director, and Mr. Hari S Bhartia, co-chairman and managing director, Jubilant Organosys, said, "We are pleased to announce this collaboration with Endo Pharmaceuticals, and look forward to the prospect of contributing to Endo's expanding discovery pipeline. We anticipate significant rewards on successful development of compounds and its subsequent commercialization. This partnership continues to demonstrate Jubilant's mission to be India's largest provider of innovative solutions for accelerating global drug development and enabling affordable patient care."

Dr. Ivan Gergel, M.D., executive vice president of R&D at Endo Pharmaceuticals commented, "We are excited about this opportunity with Jubilant. We look forward to our collaboration with the goal of bringing new therapies and healthcare solutions to patients."

Lars-Olof Eriksson, Ph.D., MS.c. has been appointed vice president of PAREXEL’s Start-up and Accelerated Recruitment Team (START). Dr. Eriksson will lead a global team that provides strategic, comprehensive approach to accelerate study initiation and achieve last patient in (LPI) milestones for regional and international trials conducted for clients.

"Approximately 45% of study delays are due to patient recruitment and enrollment issues. To help biopharmaceutical companies overcome these costly delays, PAREXEL has expanded our study start-up and recruitment capabilities under the leadership of Dr. Eriksson," said Mark A. Goldberg, M.D., chief operating officer, PAREXEL. "As the number, size, and complexity of trials increase, we expect our clients to benefit significantly from the additional depth of Dr. Eriksson's expertise in achieving faster timelines and superior clinical program performance."

Dr. Eriksson has more than 30 years of experience in patient recruitment, site implementation, project management, and global drug development and has expertise in implementing programs across Europe, North America, and Latin America. Dr. Eriksson previously served as senior director of clinical research operations, specializing in patient recruitment, at Merck. While at Merck, he also had responsibility for worldwide site implementation.

Dr. Peter Carberry has been appointed senior vice president and head of global development operations, Astellas Pharma Global Development (APGD). Dr. Carberry is responsible for enhancing the effectiveness and efficiency of the integrated global operational platform including the data sciences and clinical operations organizations.

"We are pleased that Peter has joined Astellas and we know that he will contribute significantly to the development of innovative products," said Dr. Steven Ryder, president of APGD. Peter is one of several key hires at APGD that were brought on to strengthen and accelerate our research and development function.

Prior to joining the company, Dr. Carberry was the vice president of clinical operations, development planning and performance analysis and the office of international development at Genentech. In that role, he developed a global platform for the execution of non-clinical and clinical activities and established key relationships with company stakeholders. Previously, he was the senior vice president of global clinical operations at Johnson & Johnson Pharmaceutical R&D. Dr. Carberry began his industry career with Pharmacia at the Kalamazoo Research site.

Velesco Pharmaceutical Services opened a manufacturing facility and office in Kalamazoo, MI and has moved its Ann Arbor, MI labs to the Michigan Life Science and Innovation Center (MLSIC) in Plymouth, MI.

The company's new 10,000-sq.-ft. office and manufacturing facility in Kalamazoo will manufacture non-sterile cGMP clinical trial supplies for pharma companies and will focus on providing clinical supplies for early phase trials. Product offerings include powder-in-capsule, powder-in-bottle, ointments/creams, oral and topical liquids, over-encapsulation for blinded studies and packaging.

"Velesco's addition of clinical trial material manufacturing capabilities allows us to provide a full service offering to our clients as they move from pre-clinical drug development into the clinic," said Velesco chief executive officer and co-founder David Barnes, Ph.D.

"The life science talent in Michigan compelled us to stay and grow here," said Velesco chief operating officer and co-founder Gerry Cox. "There's a uniquely high concentration of the experienced pharmaceutical researchers Velesco needs to be successful in its aggressive growth plans."

Raj Rai has been appointed interim chief executive officer of Akorn, Inc., while the board of directors looks for a permanent replacement. Mr. Rai replaces Jeffery A. Whitnell, who is leaving the company to pursue other interests.

Mr. Rai has been a strategic consultant to the company for the past three months and has 15 years of healthcare services experience. Most recently, he was the president and chief executive officer of Option Care, Inc., a pharmacy services provider of home infusion therapies and specialty pharmaceuticals. Mr. Rai currently serves on the board of directors of SeQual Technologies, a manufacturer of portable oxygen concentrators.

The company also announced the appointment of Timothy A. Dick as chief financial officer. Mr. Dick joins the company from Walgreens-Option Care, Inc., where he served as vice president, operations improvement and analysis with responsibility for finance, pricing and process improvement. Mr. Dick has previously held various leadership positions in the areas of financial planning, analysis, and acquisitions at Option Care. Prior to joining Option Care, he held various management positions in finance and acquisitions with both Johnson & Johnson and Peace Health, a Seattle-based regional health care system.

Joseph Bonaccorsi has been appointed senior vice president, general counsel and secretary. Mr. Bonaccorsi previously served in this position for Option Care from 2002 through 2007. Following Walgreen’s acquisition of Option Care, he served as senior vice president mergers and acquisitions and counsel for the Walgreen’s-Option Care Home Care division.

Dr. John N. Kapoor, Akorn’s chairman of the board, stated, “I am pleased with the progress the company has made in the last few months. With the addition of the new management team, we believe the company is on the path to capitalize on the opportunities that exist in the fast growing generic pharmaceutical industry.”

Millipore Corp. has opened its expanded single-use biomanufacturing facility in Danvers, MA. The 33,000-sq.-ft. expansion concentrates on producing a wide range of the company's Mobius single-use technologies, and allows for scale-up when additional manufacturing capacity is needed.

"We’re pleased to mark the completion of this facility because single-use technologies are becoming such an integral part of the biopharmaceutical landscape and our customers’ processes,” said Jean-Paul Mangeolle, president, Bioprocess Division, Millipore. “This expansion demonstrates our ability to stay at the forefront of the industry and our commitment to single-use technologies."

The bioprocess facility will employ approximately 120 people and contains 12,500 sq. ft. of Class 10,000 cleanroom space, which is in the process of becoming LEED Gold certified.

“Operational flexibility is key as companies turn more and more to single-use technologies. This facility allows us to meet this increasing demand and helps us meet our customers’ needs,” said Paul Chapman, vice president, Downstream Processing, Millipore.

CSL Ltd. and Talecris Biotherapeutics, Inc. have terminated the merger agreement announced on August 12, 2008, under which CSL agreed to acquire Talecris for $3.1 billion in cash. As part of terminating the agreement, CSL will pay Talecris a $75 million breakup fee. The plasma supply contract the parties entered into in connection with the merger agreement will remain in effect.

Dr. Brian McNamee, chief executive officer and managing director of CSL, said, "We are disappointed that the U.S. Federal Trade Commission (FTC) resolved to block the transaction. As we have previously stated, we fundamentally disagree with the FTC case and matters included in their complaint. Although we continue to believe in the many customer benefits and significant financial synergies that supported the transaction, CSL’s board of directors did not believe that entering into a protracted litigation process with the FTC, with its inherent risks, substantial costs, and lengthy distraction of CSL management and staff from planning and running our businesses, would be in the best interests of our stakeholders.”

Lawrence D. Stern, Talecris' chairman and chief executive officer, said, "After discussions with CSL, we have mutually agreed that litigation regarding the antitrust issue was not the path forward. Based on a careful analysis of the situation and all alternatives available, we believe that termination of the merger agreement is in the best interest of all parties. We are disappointed that patients will not benefit from the efficiencies we saw in the proposed combination. Through the process, we developed an even greater appreciation for CSL's competencies, professionalism and integrity, and we wish Brian and his team well in their future endeavors."

ICON has signed a strategic partnership with Lilly to manage the company's clinical trial site setup and monitoring in Europe for managed studies. The agreement extends the companies' November 2008 partnership, under which ICON was selected to manage Lilly's clinical data management business outside of the U.S.

"Today's announcement marks another milestone in the successful partnership between ICON and Lilly," commented Peter Gray, chief executive officer at ICON. "We have worked together to create a truly flexible model that better meets Lilly's patient and portfolio needs and will also drive productivity within Lilly's clinical operations in Europe. We look forward to continuing to assist Lilly with its transformation initiatives and to delivering the quality services that will expedite their drug development pipelines."

"We are constantly evaluating how we can do things better to increase our flexibility and focus our internal efforts on our core capabilities," commented Jeff Kasher, vice president and chief operating officer of Global Clinical Development at Lilly. "This strategic agreement enables us to leverage ICON's significant expertise in clinical trial monitoring and site management in Europe and will increase our ability to speed innovative medicines to patients."

GlaxoSmithKline and Shenzhen Neptunus Interlong Bio-Technique Co. Ltd. have entered into a definitive agreement to form a joint venture focused on developing and manufacturing flu vaccines for the Chinese market.

Jean Stéphenne, president and general manager of GlaxoSmithKline Biologicals, said, “This new alliance enables GSK to build new vaccines capability in a critical emerging market such as China. The new joint venture will combine the potential of GSK’s adjuvant technology and expertise in vaccine development together with the extensive experience of Shenzhen Neptunus in the Chinese vaccines market. Together we will gain access to specific local influenza antigens and make available new vaccines to benefit public health in China and neighboring territories.”

The alliance will develop and manufacture influenza vaccines for China, Hong Kong and Macau that will include vaccines for seasonal, pre-pandemic and pandemic influenza. These vaccines are expected to become available during the next few years. GSK will provide access to its adjuvant system, which helps to improve efficiency and optimize production by increasing the number of vaccine doses that can be produced using a smaller amount of antigen. Shenzhen will provide additional local manufacturing capacity and R&D expertise. Both companies will provide further investment in manufacturing.

GSK will take a 40% stake in the joint venture, contributing $33.5 million in cash and assets. Shenzhen Neptunus will take a 60% stake equivalent to $49.4 million. Under the terms of the agreement, GSK is expected to purchase additional shares and obtain a majority equity interest in the joint venture within the next two years.

Patheon's Swindon, UK facility has extended its aseptic vial-filling capabilities to include the commercial supply of small-scale specialty products. The facility recently received FDA approval at Swindon, allowing the company to provide clients with a seamless service, where development batches and commercial product can be supplied from the same filling line. This new capability is now operating at the Swindon site for vial sizes ranging from 2mL to 30mL, and allows for the use of disposable components.

Wes Wheeler, president and chief executive officer of Patheon, stated, "We can now produce commercial product from the same production line that is used for Phase II and Phase III clinical batches. This allows clients to commercialize their drugs much faster than would normally be expected."

GlaxoSmithKline, Novartis, Roche, and Eli Lilly have joined forces to invest venture capital into Aileron Therapeutics, a biotech company based in Cambridge, MA that is using novel chemical structures to make a new class of medicines. GSK, Novartis, Roche and Lilly are all investing in a $40 million fundraising by the company.

Aileron’s synthetically locked (or "stapled") peptides, in theory, will be able to target biochemical pathways involved in cell function and disease that conventional drugs cannot reach. Aileron plans to use the funding to pay for advancing the first experimental products towards clinical trials in 2010. Potential treatment areas include cancer, and immune, metabolic and infectious diseases.

"We believe that stapled peptides could represent a 'fourth estate' in therapeutics, emerging as a major class akin to small molecules, antibodies and vaccines," said Michael Diem, partner at SR One, GSK's venture arm.

Other investors in the latest funding round include Excel Medical Ventures and Apple Tree Partners. In previous financings, Aileron has raised $20 million in funding.

MDS Pharma Services is renovating and expanding its discovery pharmacology operation in Taiwan. The expansion, which will be completed in 2010, is part of the company's new strategic focus on early stage operations, discovery through Phase IIa proof-of-concept services.

The Taiwan facility supports molecular screening and profiling, as well as in vivo safety and efficacy testing. The renovation plan significantly expands and upgrades each area. In vivo capacity has been doubled and will include dedicated space to meet individual client needs. The site's automated molecular screening and profiling capability and efficiency will be improved with additional robotic high-throughput screening capacity and analytical support.

"This new and expanded facility will cement our position as the global leader in the discovery pharmacology space, where we are one of the top two providers of molecular screening, and a key supplier of in vivo efficacy and safety testing," said MDS Pharma Services president David Spaight. "This investment builds on a 40-year track record of success in this service area, and supports our recently announced strategic focus on the Discovery through Phase IIa Proof-of-Concept segment of the outsourcing market."

The Taiwan site is part of the company's pharmacology/DMPK line of service, which offers molecular, cellular, ADME/DMPK and in vivo assays for use in identifying lead drug candidates, profiling for selectivity, determining potential for adverse events, evaluating efficacy and establishing proof of concept.

Ortho Biotech Oncology R&D, a unit of Centocor R&D, Inc., has entered into a five-year Cooperative R&D Agreement (CRADA) with the National Cancer Institute (NCI) to research and develop new cell therapy technologies as potential cancer treatments. Steven A. Rosenberg, M.D., Ph.D., chief, Surgery Branch, will serve as the NCI principal investigator. These adoptive immunotherapy technologies are designed to help the immune system fight cancer by seeking out and destroying cancerous tumor cells using a patient's own immune system T cells. Adoptive immunotherapies have the potential to spare healthy tissue from standard cancer treatments such as radiation and chemotherapy.

Positive responses to this therapy have been observed in patients with malignant melanoma, a type of skin cancer that ranks sixth among U.S. men and seventh in U.S. women for the most commonly diagnosed cancer, according to the NCI. In recent years, Dr. Rosenberg's team pioneered a new technology in which T cells obtained from a patient's blood are genetically engineered to express receptors that give them specific immunity against cancer cells and then re-administered.

Researchers at Ortho Biotech Oncology R&D independently developed an adoptive immunotherapeutic approach that uses tumor antigens and other materials to stimulate T cells from a patient's blood to become Cytotoxic T Lymphocytes (CTLs), which recognize and attack tumor cells. Early clinical results show that this technology holds promise in melanoma patients and also has the potential to work in other types of cancers.

Under the CRADA, Dr. Rosenberg's lab will conduct a clinical trial in melanoma patients using Ortho Biotech's technology with the hope that the technology will be effective in other types of cancer as well. The other part of the CRADA will focus on a collaborative effort on a T-Cell Receptor (TCR) research program.

"This public-private partnership represents an extraordinary opportunity to bring together complementary and substantial expertise and resources from two groups with the common goal of advancing a highly promising new modality of therapy for patients with cancer," says Jay P. Siegel, M.D., chief biotechnology officer of Johnson & Johnson's Pharmaceuticals and Medical Devices & Diagnostics businesses.

"Dr. Rosenberg and NCI have extensive experience in the development of immunotherapies for melanoma and other cancers, as well as a strong track record in conducting early phase clinical studies. We look forward to collaborating with NCI to optimize technologies and to begin testing of our immunotherapy technology in melanoma patients by the end of 2009, with the possibility of additional studies for other types of cancer and other technologies in years to come," adds William N. Hait, M.D., Ph.D., senior vice president and worldwide head of oncology research and development, who with Dr. Siegel will direct the Ortho Biotech Oncology Research & Development team under the collaboration.

Bart Peterson has been appointed senior vice president of corporate affairs and communications, Eli Lilly and Co. Mr. Peterson will report to chairman, president and chief executive officer, John C. Lechleiter, Ph.D. He will also serve on the company's executive and the operations committees.

Mr. Peterson will lead an organization that is responsible for international, federal, and state government relations; advocacy and professional relations; public policy planning and development; external and internal communications; pricing, reimbursement, and access; corporate social responsibility; branding; anti-counterfeiting; health information technology coordination; and community and public relations. As part of his new role, he will lead the company's interactions with the public health sector and other payers worldwide. This includes leading Lilly's effort to support reform of the U.S. health care system.

"Bart is a proven leader with a strong list of achievements. His strategic approach, intellect, and political acumen will make him a valuable addition to Lilly's leadership team," said Dr. Lechleiter. "Bart's unique public service and private sector perspectives and experiences will enrich our thinking across a broad range of business issues. He joins Lilly's top leadership at an important moment in time when Lilly and the pharmaceutical industry face significant challenges both in the U.S. and abroad."

Mr. Peterson has a distinguished record of leadership and achievement in both the public and private sectors. He served two terms as mayor of Indianapolis (1999 - 2007), where he championed the formation of charter schools. He was also instrumental in the effort that led to the creation of BioCrossroads to promote the development of life sciences businesses in the region. Mr. Peterson also served as chief of staff for then Governor of Indiana, Evan Bayh.

Merck's preliminary results for the Phase III study of rolofylline (MK-7418), an investigational medicine for the treatment of acute heart failure, shows that the drug did not meet the primary or secondary efficacy endpoints. The company will continue to analyze the data with outside experts, however it will not file applications for regulatory approval this year. Results from this study will be presented at a medical meeting later this year.

The 2,033-patient Phase III study, PROTECT, was designed to show that rolofylline 30 mg would improve symptoms of acute heart failure compared to placebo. The secondary endpoints were that rolofylline 30 mg would reduce the risk of death or cardiovascular or renal re-hospitalization 60 days after treatment, and that rolofylline 30 mg would reduce the incidence of persistent kidney impairment.

"Advances to help patients with acute heart failure, a disease that is the leading cause of hospitalization for patients over age 65 and that is associated with a high rate of mortality, have long been elusive," said Dan Bloomfield, M.D., executive director, cardiovascular research, Merck Research Laboratories. "These results are disappointing because we had been hopeful that blocking the adenosine A1 receptor with rolofylline would prove to be a useful new approach for these patients.

Abbott and AstraZeneca have entered into an agreement under which the two companies will co-promote Abbott's cholesterol drug Trilipix (fenofibric acid) in the U.S. Financial terms were not disclosed.

"Abbott's portfolio of lipid therapies is designed to help physicians manage a patient's total lipid profile," said Jeffrey Stewart, divisional vice president, Primary Care, Abbott. "With AstraZeneca's established presence in the cardiovascular space, this agreement allows Abbott to expand visibility and education of Trilipix among physicians whose patients may benefit from this medication."

"Part of AstraZeneca's corporate strategy is to establish successful external collaborations. AstraZeneca has a long-standing commitment to cardiovascular health and has an established presence in the cholesterol market. This agreement allows us to further strengthen our presence with physicians by including Trilipix as an offering to physicians for patients with dyslipidemia," said Jim Helm, vice president, cardiovascular, AstraZeneca U.S. "With clinical data to support its use in helping certain patients with mixed dyslipidemia to manage all three key lipids, Trilipix is another important therapeutic option we can now offer physicians."

The two companies have also submitted a NDA to the FDA for an investigational compound for the treatment of mixed dyslipidemia—a combination of two or more lipid abnormalities including high LDL-cholesterol, high triglycerides and low HDL-cholesterol. The drug contains the active ingredients of Crestor (rosuvastatin calcium) and Trilipix (fenofibric acid). The NDA submission is supported by data from multiple studies, including efficacy and safety studies with the 5mg, 10mg and 20mg doses of the combined drug. Pending approval, the drug will be marketed as Certriad.

"The NDA submission is an important milestone in the development of CERTRIAD and demonstrates our commitment to developing treatments for dyslipidemia," said Howard Hutchinson, chief medical officer, AstraZeneca. "We look forward to continued discussions with the FDA about this potential new medicine."

"Patients with mixed dyslipidemia are an underserved segment of the dyslipidemic population," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott. "If approved, Certriad could become an important treatment option for physicians looking to provide comprehensive management of mixed dyslipidemia to their patients."

Dr. Betsy Garofalo has been named as the global therapy area leader for CNS, Astellas Pharma Global Development. Dr. Garofalo is a pediatric neurologist and epileptologist and has more than 17 years of drug development experience.

"Betsy's charge as head of the global therapy area is to provide strategic direction and leadership for the development of all Astellas CNS compounds," said Dr. Steven Ryder, president of APGD. Betsy's deep experience in CNS disorders and past successes make her an excellent choice to help us develop new medications for the many patients with unmet medical needs.

In addition to her work at Astellas, Dr. Garofalo is an adjunct associate professor of pediatrics at the University of Michigan. In 2007, she formed the Michigan Technology and Research Institute, where she provided consulting services to the pharmaceutical industry. Dr. Garofalo previously held numerous positions of leadership at Parke-Davis and Pfizer R&D.

OctoPlus N.V. has signed a new drug delivery technology evaluation contract for two compounds with a European biotech company. Under the contract, OctoPlus will evaluate the feasibility of two controlled release formulations that combine the active ingredients of the client's compounds with OctoPlus' drug delivery technology. If the evaluations are successful, the contract may progress to a full process development, manufacturing and licensing agreement.

Dan Dunham has been named vice president of compliance at Astellas Pharma US, Inc. Mr. Dunham will be responsible for governance of the compliance program to ensure the company’s adherence to federal and state healthcare program requirements and regulations.

"We are very pleased to add Dan to our senior management team to provide strategic direction and leadership for the compliance department," said Seigo Kashii, president and chief executive officer of Astellas. "He brings with him 30 years of legal, compliance and extensive pharmaceutical experience, which will accelerate Astellas toward our company goals."

Prior to joining Astellas, Mr. Dunham held legal positions at Pfizer, Pharmacia and Warner-Lambert. He managed civil and criminal investigations into manufacturing, laboratory, marketing and promotion and pricing practices, and supervised a docket of domestic and international commercial and products liability lawsuits. While at Warner-Lambert, he created and implemented the company's worldwide corporate compliance program and office.

Sartorius Stedim Biotech (SSB) received several large orders for consumables used in biopharmaceutical production from leading global vaccine manufacturers. These items include specialty filters, aseptic single-use bags and other disposables for sterile filtration of pharmaceutical liquids and for storage and transport of intermediate serum products.

The orders are related to A(H1N1) flu vaccine testing and the expected startup of production operations. Governments from many countries have been requesting significant quantities of the vaccine from these producers in an effort to stockpile a sufficient supply. SSB supplies products both for classic, egg-based vaccine production and innovative cell culture-based processes using bioreactors.

"We are carefully tracking the situation and are in close contact with our global customers so we are well prepared," said Dr. Joachim Kreuzburg, chief executive officer of SSB. "Apart from the current situation we are facing with the outbreak of swine flu, we have long understood the growing importance of the vaccine market and have been developing appropriate products, especially for flexible single-use."

Sentry Logistic Solutions, Inc. has changed its name to Sentry BioPharma Services, Inc. The change is intended to represent the company’s enhanced service offerings and market focus.

“As our company has matured over the past four years, we decided this is an ideal time to improve our branding to better represent the organization” said Jennifer Marcum, chief executive officer of Sentry BioPharma Services. “We believe our new name better reflects our evolution into a contract biopharmaceutical service provider addressing labeling and packaging, supply chain management, coordinated global distribution and fulfillment services supporting high value and stringently regulated legend drug products and materials.”

Genzyme Corp. has completed the transaction with Bayer HealthCare to acquire the worldwide rights to Campath/MabCampath (alemtuzumab). Genzyme is now responsible for the development and commercialization of the drug and is conducting two Phase III studies of alemtuzumab in relapsing-remitting multiple sclerosis (MS) patients.

Genzyme has also acquired the worldwide marketing and distribution rights to oncology drugs Fludara (fludarabine phosphate) and Leukine (sargramostim). Genzyme now has full responsibility for developing and marketing the acquired products and will record sales revenue in the U.S. and more than 90 other countries. The two companies will continue to work together during a transition period following the closing to ensure continued product supply to patients or support services to providers.

“With our broad portfolio of new and existing innovative therapies, combined with a large array of genetic testing services, Genzyme is positioned to offer patients and physicians a comprehensive set of treatment options across the continuum of care for hematologic malignancies,” said Mark Enyedy, president of Genzyme Oncology and Multiple Sclerosis. “In addition, alemtuzumab for multiple sclerosis is a potential significant therapeutic advance for patients, and we are pleased to be leading this program that we expect will provide an important catalyst for the company’s long-term growth.”

In exchange for the rights to alemtuzumab, Genzyme will make payments to Bayer following product approval under an earn-out arrangement based on product revenue. Similarly, in exchange for the rights to Campath, Fludara and Leukine, Genzyme will make future payments based on revenue. Also, Genzyme will acquire a new Leukine manufacturing facility upon FDA approval of the plant, which is expected in 2010.

Daniel Cammarata, CPA has joined the company as its chief financial officer. Mr. Cammarata will report to Phil Meeks, chief executive officer and will be responsible for overseeing all financial operations for Azopharma Product Development Group and its subsidiaries. Daniel Cammarata comes to Azopharma with a healthcare services background and was chief financial officer for both AllianceCare and Interim Healthcare.

“We are very excited to have a professional of Dan’s caliber join our organization. He brings years of experience as CFO for growing companies such as ours and will provide leadership to continue managing that growth,” commented Mr. Meeks. “Additionally, Dan has a strong track record of decreasing costs and streamlining business systems. In light of the current economic environment these talents are invaluable.”

Mr. Cammarata said, “I am very excited about joining Azopharma. This company has a strong track record for growth and customer service. I am looking forward to being a part of such a strong team.” Prior to entering the healthcare industry, Mr. Cammarata worked with several leading telecommunication, retail and financial services firms.

IDT Biologika has opened new offices outside Washington, DC in Herndon, VA in response to increased demand for the company’s services in the U.S. market. In Europe, IDT operates pharmaceutical and biological development and manufacturing facilities to supply world markets. Peter Linzmeyer, executive vice president of IDT Biologika Corp., will run the new office. IDT’s expansion into the U.S. market coincides with the recent opening of new filling and packaging facilities in Germany this past January.

According to Dr. Ralf Pfirmann, chief executive officer of IDT Biologika, the establishment of operations in the U.S. will allow the company to support its customers’ operations in the U.S. drug market and to develop closer working relationships with firms in the region. Said Dr. Pfirmann, “IDT Biologika has had an excellent reputation in Europe as one of the premiere outsourcing partners for pharmaceutical companies for over two decades, particularly in the area of biologics. During this time, we have continually improved our facilities through investment and have developed the personnel and business processes commensurate with a global supplier of these services to the industry. The opening of a U.S. location is a logical next step in our growth to become a global supplier of sterile liquid dosage forms.”

Sparta Systems, Inc. has opened Hong Kong operations to expand its global footprint and to help drive quality and compliance standards in the Asia-Pacific region. To lead this initiative, the company has appointed Critz Chan to serve as the managing director of APAC and set the business strategy, drive overall sales and support customer deployments for the region. Mr. Chan has begun building his team of quality and regulatory compliance experts to run the sales support department.

Mr. Chan has 25 years of experience supporting U.S. companies with establishing, operating and continuing expansion in the Asia-Pacific region. Prior to joining the company, he served as the vice president of sales and general manager for APAC at NMS Communications and held a number of key positions at General DataComm, Prime Computer, McKeown Software and Paxus Finance Software.

"The APAC region is a critical center for global manufacturers in regulated industries, and Sparta Systems sees a great opportunity to drive quality efforts in this market while expanding our global presence," said James E. McGowan, chief executive officer of Sparta Systems. "We recognize that suppliers, manufacturers and distributors require of our expertise for enabling enterprise quality management and global compliance best practices.We plan to support these organizations while helping improve product supply quality for companies on a global scale."

MDS, Inc. is divesting its Phase II-IV operations to INC Research for $50 million. MDS plans to focus on early stage discovery through Phase IIa CRO services.

"We are taking action to enhance shareholder value by focusing our business portfolio on areas where we believe we can expand market leadership," said Stephen P. DeFalco, president and chief executive officer, MDS Inc. "While our investments in MDS Pharma Services' Late Stage have significantly strengthened the business, further success requires greater scale. By divesting our Phase II-IV operations, we will be better able to take advantage of our core competencies in Early Stage. We believe this will prove beneficial to the success of the business, to customers and to shareholders."

Under the terms of the agreement, INC Research will acquire MDS Pharma Services' Phase II-IV operations, which includes approximately 800 employees who conduct large, multi-site clinical trials in more than 25 countries. The acquisition of MDS Pharma Services Phase II-IV operation is expected to enhance INC Research’s therapeutic expertise in vaccine, respiratory, cardiovascular and endocrinology clinical research, and extend its global presence in emerging markets including South America, Asia Pacific and Africa.

“We see the MDS Pharma Services Phase II-IV operations as an exceptional fit with our services and culture at INC Research. With this acquisition we will unite two respected players with specialized international capability to form a new global leader with a full range of CRO services,” said James Ogle, chief executive officer of INC Research. “Furthermore, these synergies will provide customers with a more robust service offering and enhance an unyielding commitment to execute on projects with the highest standard of quality in the industry.”

As a result of its strategic focus on early-stage CRO services, the company intends to sell its Central Labs. This operation has more than 600 employees at six sites in Europe, North America and Asia. The transaction is expected to close in the third quarter of the MDS 2009 fiscal year.

Steve Leonard has been appointed senior vice president of Global Operations, Catalent Pharma Solutions. Mr. Leonard will be located at the company’s corporate headquarters in Somerset, NJ.

Mr. Leonard joins the company from GE Healthcare’s Medical Diagnostics business, where he served as general manager of Global Operations, responsible for more than 10 sites in Europe, Asia and the Americas. He spent 22 years at GE and held a variety of leadership roles, with responsibility for areas such as plant management, global sourcing and supply chain, global product quality, and global operations.

John Chiminski, president and chief executive officer of Catalent, said, “Steve is a proven leader who brings to Catalent not only operational expertise, but a strong focus on customers. I am pleased to welcome Steve to the Catalent executive team and am confident that he can take Catalent’s operational excellence to the next level.”

SAFC and Cherokee Pharmaceuticals have entered an exclusive strategic partnership that includes the sourcing, analytical testing, warehousing, packaging and distribution of large-scale raw materials for pharmaceutical manufacturing meeting cGMP quality standards.

The collaboration to co-market and co-sell raw materials for pharmaceutical customers combines SAFC's global sourcing and production capabilities with Cherokee's analytical labs, large-scale cGMP manufacturing, warehousing and distribution facilities. SAFC will be responsible for all product sourcing including processing reagents and excipients from its network of suppliers, and Cherokee will conduct analytical testing, storage, packaging and distribution services.

Cherokee Pharmaceuticals, located in Riverside, PA, has significant storage and expansion capabilities and has a dedicated rail link to potentially serve the Northeast U.S. SAFC will use Cherokee's cGMP validated site, which can house cooled, frozen and hazardous substances, warehousing and distribution hub for large-scale raw materials for the pharmaceutical industry.

SAFC president Gilles Cottier said, "This agreement is a win-win situation, not only for SAFC and Cherokee Pharmaceuticals, but also for our respective customers. In marrying SAFC's sourcing capabilities, which bring significant cost and quality benefits to the table, with Cherokee Pharmaceuticals expertise in analytical testing and cGMP manufacture and storage, we are providing top level, high-quality resourcing that will support our U.S. customers throughout their respective supply chains, enabling them to both streamline and improve their risk mitigation strategies."

Murvin Lackey, president of distribution for Cherokee Pharmaceuticals, added, "The core competencies of both companies present a competitive advantage for us and our customers. This strategic partnership allows us to provide an integrated sourcing, distribution process to our customers who seek a secure supply chain."

SAFC Pharma has also received certification of its highly potent active pharmaceutical ingredient (HPAPI) conjugation suite at its St. Louis, MO campus, by SafeBridge Consultants, Inc. for the safe handling of potent drug substances. The 600-sq.-ft. suite was designed to support the entire drug development pipeline, from early-stage clinical supplies to kilogram quantities, and expandable to commercial-scale.

"Gaining SafeBridge certification status for our HPAPI conjugation suite provides our customers with complete confidence in our ability to handle their potent compound projects safely and efficiently," commented David Feldker, SAFC Pharma vice president. "This adds to our already significant experience in the production of HPAPIs, an area in which we continue to see rapid growth as targeted oncology evolves. The suite builds upon 15 years of HPAPI manufacturing experience at SAFC's Madison, WI site, which is also SafeBridge certified, and upon more than 30 years of experience in conjugation technology at the St. Louis facility."

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