October 30, 2009
Posted on October 30, 2009 @ 10:13 am
Sanofi-Aventis 3Q09
3Q Revenues: $10.8 billion (+8%)
3Q Earnings:$3.3 billion (+16%)
YTD Revenues: $32.0 billion (+7%)
YTD Earnings: $6.7 billion (+20%)
Comments: Pharmaceutical sales were up 6% to $9.3 billion in the quarter and YTD sales rose 4% to $28.5 billion. Exchange rates favorably effected results by 2% and 3%, respectively. Lovenox and Lantus sales reached $1.1 billion, up 14% and 22%, respectively. Plavix sales were $968.9 million (+4%). Apidra sales were up 32% in the quarter to $49.6 million. Sales of Eloxatin were $281.6 million (-44%) due to generic competition. The company launched Multaq, an anti-arrhythmic, in the U.S. with sales of $19.0 million. Human Vaccines revenue rose 5% to $1.5 billion, driven by the performance of Pentacel, Pentaxim and Menactra, as well as the first H1N1 shipments.
Posted on October 30, 2009 @ 10:12 am
Eli Lilly and Co. has opened its new Biotechnology Center in San Diego, as part of its strategy to develop more biopharmaceuticals. The center will focus on discovering, engineering and conducting Phase I and II trials on potential biologic medicines, with an emphasis on cancer, diabetes and autoimmune diseases.
"We are moving full speed ahead toward building a biotechnology powerhouse," said John Lechleiter, Ph.D., Lilly chairman and chief executive officer. "The science, technology and talent at our new center in San Diego will help bring novel biotech medicines to patients faster and more efficiently, and reinforces Lilly's commitment and contributions to San Diego's burgeoning bioscience industry."
The facility is located within a life science hub near the University of California, San Diego and other biomedical research institutes. Lilly, as part of its FIPNet strategy, plans to leverage external resources in an effort to advance its pipeline.
Approximately 200 scientists are based at the center, more than half from Applied Molecular Evolution (AME), a wholly-owned Lilly subsidiary that discovers, engineers and develops biotechnology-based therapies from human proteins. The center is also the work base for scientists from discovery chemistry research and technology (DCRT), a division within Lilly that includes scientists from SGX Pharmaceuticals, which Lilly acquired in 2008.
"We are optimizing the synergies between AME and DCRT-San Diego by co-locating them," said Tom Bumol, Ph.D., vice president of biotechnology discovery research at Lilly and head of the new West Coast site. "We in the scientific community have only scratched the surface of what is possible for biologic drug design, and collaborations such as this taking place at our new center will help lead to the next generation of biotechnology-based treatments for patients."
Posted on October 30, 2009 @ 10:10 am
R. Todd Joyce has been named senior vice president and chief financial officer of
Watson Pharmaceuticals, effective immediately. Mr. Joyce succeeds Mark W. Durand, who left the company for personal reasons. Mr. Joyce has served as acting principal financial officer since July 27, 2009, when Mr. Durand took a leave of absence.
"I, the Board of Directors and the senior management team wish to thank Mark for his service to the Company. We appreciate this was a difficult decision for him, and wish him well in the future," said Paul Bisaro, Watson's president and chief executive officer. "We are fortunate that Todd has agreed to become our new CFO. Todd's financial expertise and his history within the organization will enable him to seamlessly perform these duties, and to continue the good work begun by Mark during his tenure. In addition, Todd's international experience will be important as we continue to expand globally, and particularly in the integration of Watson and Arrow Group following the anticipated close of the Arrow acquisition later this year."
Mr. Joyce joined the company in 1997 as corporate controller, and was named vice president, corporate controller and treasurer in 2001. Later, Mr. Joyce served as interim principal financial officer. Previously, he served as vice president of tax, and vice president of tax and finance at ICN Pharmaceuticals. Prior to ICN, Mr. Joyce served as a CPA for Coopers & Lybrand and Price Waterhouse.
October 29, 2009
Posted on October 29, 2009 @ 10:02 am
AstraZeneca 3Q09
3Q Revenues: $8.2 billion (+5%)
3Q Earnings: $2.1 billion (+27%)
YTD Revenues: $23.9 billion (+2%)
YTD Earnings: $6.0 billion (+27%)
Comments: Sales of Influenza A (H1N1) vaccine totaled $152 million in the quarter. Nexium sales were down 5% to $1.2 billion. Crestor sales were $1.1 billion (+24%). Seloken /Toprol-XL sales were $414 million (+103%). Symbicort sales were $562 million (+12%). Seroquel sales were $1.2 billion (+9%). Casodex sales in the U.S. were down 80% to $14 million following FDA approval of eight generic products. U.S. revenue was up 14%. Revenue in the Rest of World was up 7%. Revenue in Established Markets was up 4% and Emerging Markets was up 15%. In the quarter, diabetes treatment Onglyza was approved in the U.S. and EU.
Posted on October 29, 2009 @ 09:59 am
Novo Nordisk 3Q09
3Q Revenues: $2.5 billion (+11%)
3Q Earnings: $539.7 million (+3%)
YTD Revenues: $7.4 billion (+16%)
YTD Earnings: $1.7 million (+21%)
Comments: In the quarter, Diabetes care sales were $1.8 billion (+12%). Biopharmaceutical sales were $636.3 (+10%). NovoSeven sales were up 8%, Norditropin sales were up 14%, and Hormone replacement therapy sales were up 12%. North America sales were up 20%. Sales in Europe were up 2%. International Operations were up 10% and Japan and Oceania sales were up 20%.
Posted on October 29, 2009 @ 09:57 am
Allergan 3Q09
3Q Revenues: $1.1 billion (+4%)
3Q Earnings: $179.2 million (+8%)
YTD Revenues: $3.3 billion (-2%)
YTD Earnings: $401.1 million (-4%)
Comments: Specialty pharmaceuticals sales were up 8% in the quarter to $940.6 million, while medical devices sales were down 11% to $187.2 million. Botox/Neuromodulator sales were $327.8 million (+3%). Eye Care Pharmaceuticals revenue was $535.1 million (+5%). Skin Care revenue was $62.9 million (+136%). Urologics revenue was $14.8 million (-13%).
October 28, 2009
Posted on October 28, 2009 @ 09:47 am
PPD plans to spin off its compound partnering business from its core CRO business. The spin-off will result in two capitalized, highly focused, independent public companies, according to a PPD statement.
The CRO business will continue to operate under the PPD name and will be focused solely on its drug discovery and development services. The compound partnering business will focus on developing and commercializing its drug candidates and to access external capital, if needed, without any constraints associated with operating in combination with the CRO business.
Additionally, PPD has entered into an agreement to acquire Excel PharmaStudies, Inc., one of the largest CROs in China, providing PPD additional capacity and expertise in this market. The acquisition adds to PPD’s Phase II–IV clinical, data management, biostatistics, regulatory and quality assurance services. Excel will operate as a wholly owned subsidiary of PPD.
Excel’s 300 employees will join PPD, and Mark Engel, co-founder, will work exclusively with PPD as a strategic consultant. The acquisition, subject to various closing conditions, is expected to close in 4Q09.
Also, PPD has been awarded a contract by the FDA to evaluate the agency's Center for Drug Evaluation and Research (CDER) post-market spontaneous adverse event surveillance system. The company will evaluate the value of the spontaneous adverse event reports to support safety-related regulatory actions and report its findings to the FDA and the public.
The award of $2.7 million for the first year is part of a two-year project of FDA's Initiative for Maximizing the Benefit of Passive Adverse Event Collection throughout a Product's Life Cycle (IMPACT). The FDA will use these findings to develop an implementation strategy for ensuring optimal use of the system as part of its pharmacovigilance efforts to protect public health.
Posted on October 28, 2009 @ 09:45 am
PPD 3Q09
3Q Revenue: $341.1 million (-13%)
3Q Earnings: $37.7 million (-25%)
YTD Revenues: $1.1 billion (-11%)
YTD Earnings: $140.3 million (flat)
Comments: Development segment revenue for the quarter was $315.8 million (-12%), and income from operations was $52.2 million (-25%). Discovery sciences segment revenue for the quarter was $1.1 million (-68%). Discovery sciences segment loss from operations was $5.3 million, compared to income of $0.6 million in 3Q08, due to an increase in R&D expenses from the company’s dermatology business, which it acquired in 2Q09. Revenue in the quarter included a $3.0 million milestone payment from Takeda Pharmaceutical Co., triggered by the submission of a new drug application for alogliptin in Japan.
Posted on October 28, 2009 @ 09:44 am
AstraZeneca withdrew its regulatory submissions Zactima (vandetanib) 100mg in combination with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) from the FDA and the EMEA. The applications were submitted in June 2009.
The decision was based on updated analysis that demonstrated no overall survival advantage when vandetanib was added to chemotherapy, as well as preliminary feedback from regulatory agencies that the current package with progression-free survival (PFS) as the primary endpoint might not be sufficient for approval.
The company will complete its ongoing Phase III trial program to assess Zactima’s efficacy in different clinical settings.
Posted on October 28, 2009 @ 09:41 am
Morphotek, Inc. has entered into a license agreement with
Centocor Ortho Biotech for the development and commercialization of an antibody targeting solid tumors. Financial terms were not disclosed.
Morphotek has been granted an exclusive worldwide license for the development, manufacture and sale of the antibody. Preclinical studies conducted by Centocor have shown that the relevant antigen is over-expressed in many solid tumors.
"We are delighted to conclude this license agreement with Centocor Ortho Biotech as we are committed to bringing healthcare solutions to cancer patients, especially for areas of unmet medical need," said Philip Sass, Ph.D., chief operating officer of Morphotek. "Morphotek is well positioned to apply its technologies, knowledge and expertise in monoclonal antibody development for the development and commercialization of this antibody. The preclinical data package for this antibody have shown anti-cancer effects and we look forward to validating these in human trials."
October 27, 2009
Posted on October 27, 2009 @ 09:24 am
GSK and
Genmab have received approval of Arzerra (ofatumumab) from the FDA for use in patients with chronic lymphocytic leukemia (CLL) that do not respond to fludarabine and alemtuzumab. Arzerra is a monoclonal antibody that causes the body's immune response to fight against normal and cancerous B-cells.
The approval is based on results from a study in which 42% of patients with CLL, who did not respond to both fludarabine and alemtuzumab (two therapies used in treating CLL), responded to treatment with Arzerra. These patients had a median duration of response of 6.5 months. The most common adverse reactions were neutropenia, pneumonia, pyrexia, cough, diarrhea, anemia, fatigue, dyspnea, rash, nausea, bronchitis, and upper respiratory tract infections. The most common serious adverse reactions seen were infections (including pneumonia and sepsis), neutropenia, and pyrexia.
"The approval of Arzerra brings an important new treatment option to patients with refractory CLL," said Lisa N. Drakeman, Ph.D., chief executive officer of Genmab. "This approval also marks a key milestone for Genmab as it is our first antibody to reach the market. All of us involved in the development of Arzerra are pleased that we have been able to move the product so quickly through research and development and meet our goal of providing this innovative therapy to patients."
"Arzerra is a significant step forward in helping patients and physicians better manage the challenges of refractory CLL. Patients now have a new choice," said Kathy Rouan, Ph.D., vice president and medicines development leader at GlaxoSmithKline. "The Arzerra approval demonstrates the commitment of the GSK BioPharm and Oncology Units to developing new biopharmaceutical treatment options for cancer patients."
Posted on October 27, 2009 @ 09:22 am
Hospira 3Q09
3Q Revenues: $1.0 billion (+9%)
3Q Earnings: $116.2 million (+42%)
YTD Revenues: $2.8 billion (+4%)
YTD Earnings: $307.2 million (+42%)
Comments: In the quarter, Global Specialty Injectables revenue was $575.7 million (+24%). In the Americas, sales were $449.1 million (+32%). Asia Pacific sales were flat at $57.0 million. Revenue for Other Pharma (including contract manufacturing) was down 2% to $126.0 million in 3Q09. Global Specialty Injectables revenue YTD was $1.5 billion (+10%), with the Americas accounting for $1.2 billion (+17%) and Asia Pacific, $149.0 million (+4%).
Posted on October 27, 2009 @ 09:20 am
Scynexis, Inc. has received a payment from
Merck for achieving a preclinical milestone in the companies’ oncology drug discovery and development collaboration.
“We are pleased to celebrate success in reaching another milestone with our valued partner, Merck,” said Yves Ribeill, Ph.D., president and chief executive officer of Scynexis. “This milestone provides further validation of our long-term relationship with Merck in a number of therapeutic areas through discovery research and innovation.”
October 26, 2009
Posted on October 26, 2009 @ 09:12 am
HollisterStier Contract Manufacturing and sister organization,
Draxis Pharma, have appointed
Steven Rowan as vice president of business development, Jubilant Organosys Contract Manufacturing North America. Mr. Rowan will oversee a HollisterStier-Draxis corporate business development team.
The two companies have a partnership joining their capabilities and services under the ownership of Jubilant Organosys. Mr. Rowan will be responsible for global business development activities for HollisterStier and Draxis, as well as establishing strategic partnerships to strengthen the companies’ presence throughout Europe and Asia.
Mr. Rowan has more than 20 years of experience in the pharmaceutical and biopharmaceutical industries. His in-depth knowledge, extensive scientific background and experience implementing Six Sigma methodologies will benefit the organizations as they align their manufacturing services.
“I look forward to being a part of this team as we transition into having a more heightened global presence,” said Mr. Rowan. “Together, we offer a level of technical expertise, multiple dosage forms, and understanding of the entire life cycle that proves to be very competitive in the outsourcing industry ─ this is an exciting opportunity for me to help showcase our competitive advantages and strategically position HollisterStier and Draxis Pharma as leading industry players.”
Posted on October 26, 2009 @ 09:08 am
Cephalon, Inc. and
BioAssets Development Corp. (BDC) have signed an agreement that will provide Cephalon with an option to acquire BDC. Cephalon will pay $30 million upfront and an additional payment if it exercises its option. BDC stockholders could also receive additional future payments related to regulatory and sales milestones. The agreement is subject to customary closing conditions.
BDC, a privately held biopharmaceutical company, is currently conducting a Phase II placebo-controlled proof of concept study with the tumor necrosis factor (TNF) inhibitor, etanercept, epidurally administered to patients with sciatica. Sciatica is a neuropathic inflammatory pain condition that occurs when the sciatic nerve is compressed, injured or irritated. Results are expected to be available in 2H10. BDC has secured rights for use of TNF inhibitors for sciatic pain in patients with intervertebral disk herniation, as well as other spinal disorders.
"BioAssets offers an estate of intellectual property and scientific expertise that will allow us to evaluate our own domain antibody tumor necrosis factor inhibitor, CEP-37247 (formerly known as ART-621), for the treatment of sciatica," said Frank Baldino, Jr., Ph.D. chairman and chief executive officer of Cephalon. "Combining these two innovations helps fulfill our strategy to address unmet patient needs, while focusing on specialty physicians."
"Development of an improved non-surgical therapy for sciatica presents a pressing unmet medical need and a potentially significant commercial opportunity," commented James Gorman, M.D., Ph.D., chief executive officer of BioAssets. "Cephalon combines an innovative TNF inhibitor pipeline with a well established pain therapeutic franchise. I believe these capabilities uniquely position Cephalon to develop and commercialize a novel biologic therapy for these patients."
Posted on October 26, 2009 @ 09:05 am
Exelixis and
Bristol-Myers Squibb achieved positive Phase II data showing that XL184 demonstrated activity in patients with glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer. The study evaluated the safety, tolerability, and clinical activity of XL184 at daily doses of 175 mg or 125 mg in 46 patients with previously treated GBM, including some patients who had received prior antiangiogenic therapy.
The overall rate of confirmed partial response in the patients treated at 175 mg was 17%. Among patients without prior antiangiogenic therapy, 21% achieved confirmed responses. In patients who had received prior antiangiogenic therapy, 8% progressed on vandetinib and achieved a confirmed partial response. Of the 46 patients treated at the 175 mg dose level, 21% attained 6-month progression-free survival (PFS) rate with 35% of patients censored for PFS at the time of analysis. The median duration of response was 5.9 months. The median PFS interval was 3.7 months.
“The updated data from patients treated with the 175 mg dose of XL184 is consistent with what we have reported previously and continue to demonstrate that the compound is clinically active,” said Michael M. Morrissey, Ph.D. president of R&D at Exelixis. “While the data from the 125 mg dose cohort are still early, they are encouraging and we will continue to evaluate the suitability of this dose and potentially others for future clinical studies. This trial in its totality is providing important information that will enable future decision making with respect to designing and implementing trials of XL184 in this patient population.”
October 23, 2009
Posted on October 23, 2009 @ 08:41 am
Novartis 3Q
3Q Revenues: $11.1 billion (+3%)
3Q Earnings: $2.1 billion (+1%)
YTD Revenues: $31.3 billion (flat)
YTD Earnings: $6.1 billion (-8%)
Comments: Pharmaceutical sales in the quarter were $7.2 billion (+8%). Diovan sales were $4.4 billion (+5% in local currencies), driven by expansion in Japan, which accounts for approximately 20% of sales. Exforge sales were $475 million (+81% lc). Tekturna/Rasilez sales were $202 million (+114% lc). Gleevec/Glivec sales were $2.9 billion (+12% lc). Zometa sales were $1.1 billion(+9% lc). Femara sales were $925 million (+16% lc). Exjade sales were $469 million (+30% lc). Sandoz revenue was $1.9 billion (-3%). Vaccines and Diagnostics sales were down 18% to $543 million, due to lower sales of H5N1 (avian flu) pandemic vaccines in 2009.
Posted on October 23, 2009 @ 08:39 am
BioStorage Technologies, Inc. expanded its European operations with the opening of a new 16,140 sq.-ft., full-service biorepository in Frankfurt, Germany. The new facility will offer worldwide, industry-compliant logistics and supply chain management that meets all international customs and transportation regulations, as well as documentation requirements.
“We are pleased to see such rapid global growth since opening our initial Germany-based facility in 2007,” said F. John Mills, M.D., Ph.D., chief executive officer and chairman of the board at BioStorage Technologies. “Frankfurt has been an ideal location for us to create additional alliances and partnerships with companies conducting pharmaceutical research and development in Europe.”
The company also recently expanded U.S. operations, adding a 40,000 sq.-ft. cold-storage facility and creating 125 new jobs at its global headquarters in Indianapolis.
Posted on October 23, 2009 @ 08:36 am
John L. Workman has been appointed executive vice president and chief financial officer,
Omnicare, Inc., effective November 18th. Mr. Workman will oversee all of the company’s financial operations as well as its information technology function. He will report to Joel F. Gemunder, Omnicare’s president and chief executive officer.
“We are delighted to welcome John to our executive management team,” said Mr. Gemunder. “John has demonstrated strong financial leadership and an operational focus throughout his career, and we believe he will be an invaluable asset in building upon our financial strength and operational efficiency across the organization to support our objective of generating long-term profitable growth.”
Mr. Workman currently serves as executive vice president and chief financial officer of HealthSouth Corp., the nation's largest provider of inpatient rehabilitative healthcare services. At HealthSouth, he was responsible for all financial activities as well as the company’s information technology function. Prior to joining HealthSouth, Mr. Workman was chief executive officer of U.S. Can Corp., where he also served as chief operating officer and chief financial officer during his six-year tenure. Previously, he spent more than 14 years with Montgomery Ward & Co., Inc.
Posted on October 23, 2009 @ 08:33 am
Hovione has acquired an aseptic spray-drying production line, vial filling and back up utilities from
Acusphere, providing access to equipment and knowledge for the production of sterile drug substance and sterile drug product. The equipment includes sterile filtration, aseptic spray drying, secondary drying and vial filling, as well as terminal sterilization systems, lyophilization, WFI and clean steam production utilities.
"This is a very exciting move for Hovione, we are adding aseptic production -a tough new area of pharmaceutical manufacturing- to our offering. We have been considering aseptic production for some time and today we took the first step," said Dave Hoffman, head of Hovione's Exclusives and Particle Design Business Units.
The acquisition adds to Hovione's cGMP spray-drying facilities, which includes lab, pilot and various commercial scale production installations in Portugal, U.S. and in Ireland.
October 22, 2009
Posted on October 22, 2009 @ 10:02 am
Merck 3Q
3Q Revenues: $6.0 billion (+2%)
3Q Earnings: $3.5 billion (earnings were $1.1 billion in 3Q08)
YTD Revenues: $17.3 billion (-3%)
YTD Earnings: $6.5 billion (+4%)
Comments: Singulair sales were $1.1 billion in the quarter (+5%). Combined global sales of Zetia and Vytorin, as reported by the Merck/Schering-Plough partnership, were $1.0 billion (-7%). Global sales Cozaar and Hyzaar were $861 million in the quarter (-3%). Januvia sales were up 30% to $491 million. Gardasil sales were $311 million (-22%). R&D expenses were $1.3 billion for the quarter (+7). Restructuring costs, primarily related to employee separations, were $42 million for the quarter compared to $757 million in 3Q08.
Posted on October 22, 2009 @ 09:59 am
Bristol-Myers Squibb 3Q
3Q Revenues: $5.5 billion (+4%)
3Q Earnings: $1.3 billion (-54%)
YTD Revenues: $15.9 billion (+4%)
YTD Earnings: $3.5 billion (-26%)
Comments: Biopharmaceutical sales were $4.8 billion (+6%). Plavix sales were $1.6 billion (+8%). Sales of Abilify were $653 million (+16%). Reyataz sales were $360 million (+5%). Sustiva Franchise revenue was $315 million (+7%). Erbitux sales were down 3% to $179 million. Sprycel sales were up 30% to $107 million. R&D expenses were $820 million in the quarter (+5%). BMS’ share of Mead Johnson’s earnings was $127 million in the quarter (-20%).
Posted on October 22, 2009 @ 09:56 am
Schering-Plough 3Q
3Q Revenues: $4.5 billion (-2%)
3Q Earnings: $515 million (-16%)
YTD Revenues: $13.5 billion (-4%)
YTD Earnings: $2.0 billion (+43%)
Comments: Pharmaceutical sales in the quarter were $3.5 billion (+6%). Sales of Remicade were up 8% to $608 million. Sales of Temodar were $278 million (+2%). Nasonex sales were up 3% to $266 million. Pegintron sales were down 16% to $198 million. Global sales of Clarinex were $164 million (-7%). Prescription Claritin sales were $95 million. Net sales of the cholesterol franchise, which include sales of the cholesterol joint venture plus sales recorded by S-P in non-joint venture territories (such as Japan and Latin America), were $1.1 billion (-5%). R&D expenses were $913 million in the quarter (+2%). For the quarter and YTD, results include $160 million gain on sales of certain divested animal health products associated with the OBS acquisition.
Posted on October 22, 2009 @ 09:53 am
Dr. Hui Cai has been appointed as vice president of business development,
WuXi PharmaTech. Dr. Cai will report directly to Dr. Richard Soll, senior vice president of Integrated Services.
Prior to joining the company, Dr. Cai was president of Inflexion BioPartners and vice president of corporate development at HUYA Bioscience. Previously, Dr. Cai spent ten years at Johnson & Johnson Pharmaceutical R&D on multiple small molecule drug discovery programs.
"I am very pleased to welcome Hui on board as we continue to enhance our business development," commented Dr. Ge Li, chairman and chief executive officer of WuXi PharmaTech. "Hui brings us a broad portfolio of expertise and experience in strategic planning, business development, and portfolio management, with which we are confident that our discovery business will grow rapidly."
Posted on October 22, 2009 @ 08:02 am
Covance 3Q09
3Q Revenues: $475 million (+8%)
3Q Earnings: $51 million (flat)
YTD Revenues: $1.4 billion (+7%)
YTD Earnings: $134 million (-11%)
Comments: Late-Stage Development accounted for 59% of 3Q revenues and was up 24% to $279 million. Early Development was down 9% to $196 million. For YTD, Late-Stage is up 21% to $794 million and Early is down 7% to $631 million. 3Q09 net income got a $9 million boost from the save of IV/WRSand $2 million from a favorable tax settlement.
Posted on October 22, 2009 @ 07:58 am
Amgen 3Q09
3Q Revenues: $3.8 billion (flat)
3Q Earnings: $1.4 billion (+23%)
YTD Revenues: $10.8 billion (-4%)
YTD Earnings: $3.7 billion (+17%)
Comments: Product sales fell 1% in 3Q09 to $3.7 billion; U.S. sales were flat at $2.9 billion. Enbrel sales climbed 3% to $924 million, with a price increase offsetting a drop in unit sales in dermatology. Aranesp sales fell 19% to $685 million in the quarter, while Epogen rose 5% to $663 million. Neulasta and Neupogen sales grew 2% to $1.2 billion. For YTD, Enbrel sales are -4% at $2.6 billion.
Read Amgen's profile in this year's Top 10 Biopharmas Report!
October 21, 2009
Posted on October 21, 2009 @ 09:44 am
Laureate Pharma has signed a biopharmaceutical development and manufacturing agreement with an undisclosed client. Laureate will develop the process to manufacture a unique Fc Fusion Protein and produce it under cGMP conditions for use in clinical trials. Terms of the agreement were not disclosed.
"This project is a great fit with the experience that we have developed over the past few years working with fusion proteins," said Robert J. Broeze, Ph. D., president and chief executive officer of Laureate Pharma. "We have had great success working with these unique protein products and are delighted to have the opportunity to help advance this product into the clinic."
"We are seeing a strong trend in the biopharmaceutical industry to develop fusion protein products with unique properties," commented Dan Leone, Laureate's vice president, business development. "Along with monoclonal antibodies, manufacturing fusion proteins has become one of Laureate's core competencies."
Posted on October 21, 2009 @ 07:52 am
ICON 3Q09
3Q Revenues: $220 million (-2%)
3Q Earnings: $24 million (+12%)
YTD Revenues: $660 million (+2%)
YTD Earnings: $63 million (+11%)
Comments: Chief executive officer Peter Gray remarked, "While higher than normal cancellations held back net business awards, the levels of business opportunity continue to be strong and we remain optimistic for the future.”
Posted on October 21, 2009 @ 07:44 am
Lilly 3Q09
3Q Revenues: $5.6 billion (+7%)
3Q Earnings: $942 million (loss of $466 million in 3Q08)
YTD Revenues: $15.9 billion (+5%)
YTD Earnings: $3.4 billion (+119%)
Comments: Earnings comparisons were affected by Lilly's 3Q08 charge of $1.5 billion to settle federal and state investigations into Zyprexa marketing practices. U.S. revenues rose 14% to $3.1 billion, while ex-U.S. figures fell 1% to $2.4 billion. In 3Q09, Zyprexa revenues rose 3% to $1.2 billion, Cymbalta rose 10% to $790 million, Humalog rose 16% to $500 million, and Almita sales grew 47% to $462 million. For the YTD, Zyprexa is flat at $3.5 billion, Cymalta is up 14% to $2.2 billion, Humalog is up 12% to $1.4 billion and Alimta is up 41% to $1.2 billion. Beseiged by generic competition, Gemzar sales fell 25% to $332 million in 3Q09 and 19% to $1.1 billion YTD. The company recognized sales and collaboration revenues of $102 million for Erbitux, which it acquired when it bought ImClone.
Read our Lilly profile in this year's Top Companies Report!
Posted on October 21, 2009 @ 07:34 am
Novavax and
Xcellerex have entered into a strategic collaboration to accelerate the development of Novavax's vaccine manufacturing process to commercial scale and begin immediate production of a novel 2009 H1N1 flu vaccine. The two companies will utilize Novavax's unique virus-like particle (VLP) vaccine technology to produce initial commercial quantities of H1N1 vaccine with Xcellerex's FlexFactory biomanufacturing platform. Xcellerex will provide development expertise and product manufacturing in exchange for manufacturing supply fees from Novavax. Novavax recently launched a two-stage, 4,000-patient trial of its H1N1 flu vaccine in Mexico to support registration in that country.
"Our technology offers Novavax a cost-effective and flexible manufacturing solution for this public health crisis by achieving full commercial-scale production of VLP-based vaccines much more rapidly than traditional vaccine production methods," stated Joseph Zakrzewski, Xcellerex's president and chief executive officer.
"This strategic partnership represents a major step forward for Novavax and will allow us to increase the scale of our VLP vaccine manufacturing process and expand capacity to satisfy potential demand for our H1N1 VLP vaccine in Mexico. This alliance will also enable us to establish commercial-scale production capabilities for our VLP-based seasonal influenza vaccine program and significantly advance our timeline for full scale manufacturing," said Rahul Singhvi, Novavax's President and Chief Executive Officer.
October 20, 2009
Posted on October 20, 2009 @ 09:06 am
Pfizer 3Q
3Q Revenues: $11.6 billion (-3%)
3Q Earnings: $2.9 billion (+26%)
YTD Revenues: $33.5 billion (-7%)
YTD Earnings: $7.9 billion (flat)
Comments: Total pharmaceutical sales in the quarter were $10.7 billion (-3%). Primary Care sales were down 4% to $5.5 billion. Specialty Care sales were up 3% to $1.6 billion. Oncology revenue was $371 million (-5%). Established Products revenue was $1.6 billion (-12%) and Emerging Markets revenue was $1.6 billion (-4%). U.S. revenues were $4.8 billion (-2%) in the quarter and international revenues were $6.8 billion (-4%). YTD U.S. revenues were $14.3 billion (-6%) and international revenues were $19.2 billion (-8%). Revenues in the quarter and YTD were unfavorably impacted by 5% and 6% respectively, due to foreign exchange. R&D expenses were down 13% to $1.6 billion in the quarter and down 11% to 5.0 billion YTD.
Posted on October 20, 2009 @ 09:03 am
Biogen Idec 3Q
3Q Revenues: $1.1 billion (+3%)
3Q Earnings:$279.6 million (+35%)
YTD Revenues: $3.3 billion (+7%)
YTD Earnings: $671.1 million (+15%)
Comments: Growth in the quarter was driven primarily by Tysabri sales, up 21% to $207 million. Avonex sales were $580 million (+1%). Revenues for the quarter included $284 million from Biogen Idec’s co-promotion arrangement with Genentech for Rituxan. Revenues from other products in the quarter were $15 million, compared to $14 million in 3Q08. Royalty revenues in the quarter were flat at $35 million.
Posted on October 20, 2009 @ 05:31 am
Lonza has withdrawn its offer to acquire
Patheon. Patheon's Special Committee of Independent Directors and Lonza also mutually agreed to terminate discussions regarding other possible strategic transactions between Lonza and Patheon.
When Lonza's proposal was made public in August, JLL Patheon Holdings LLC, which holds 57% of the Patheon's outstanding restricted voting shares, announced that it rejected the proposal and would not support any transaction involving a sale of its shares of Patheon. Lonza offered $3.55 for each share of Patheon, a premium over JLL's earlier $2.00/share bid to take the company private.
October 19, 2009
Posted on October 19, 2009 @ 09:00 am
Charles River Laboratories has laid off 115 workers from its CTBR Bio-Research unit near Montreal. The company laid off 140 employees from CTBR in May 2006. After this round of layoffs, CTBR will have approximately 1,480 employees.
In an e-mail to
The Montreal Gazette, CRL spokeswoman Amy Cianciaruso remarked, "Like others in our industry, Charles River has been affected by this slowdown and we are taking the difficult but necessary steps to align our workforce with the current demand."
Posted on October 19, 2009 @ 08:37 am
Dr. Robert Garnick has joined
Peregrine Pharmaceuticals as the head of regulatory affairs. Dr. Garnick was formerly the senior vice president of regulatory, quality and compliance at Genentech. During his 24-year career at that company, he was responsible for 17 new product approvals, including most of the company's top selling monoclonal antibody therapeutics such as Rituxan, Herceptin, Avastin and Lucentis. Dr. Garnick will be responsible for overseeing Peregrine's interactions with the FDA and regulatory agencies around the world, and will lead the development of the company's regulatory strategies for advancing its novel MAb-based treatments for cancer and infectious diseases.
"Rob has an unparalleled track record in the biotechnology and pharmaceutical industry, having led the regulatory, quality and compliance strategy for developing many of the most successful monoclonal antibody therapeutics currently on the market representing multiple disease areas," said Steven W. King, president and chief executive officer of Peregrine. "His profound understanding of every aspect of the regulatory process and how it impacts clinical design and drug development is already proving invaluable as we prepare for the next stage of clinical development for our innovative drug candidates bavituximab and Cotara. We have made considerable progress over the past few years in our clinical programs and bringing Rob's expertise and experience on board at this critical time is a significant development for the company."
Dr. Garnick has over 30 years of experience in drug and biologic pharmaceutical development. He joined Genentech in 1984 and after a series of promotions, he became vice president of quality in 1994 and was later promoted to senior vice president of regulatory, quality and compliance in 2001. In this role, Dr. Garnick was responsible for all the regulated aspects of Genentech's business including drug development, commercial production and promotional and labeling compliance. After leaving Genentech in 2008, Dr. Garnick founded Lone Mountain Biotechnology and Medical Devices Inc., a successful company specializing in drug and device consulting where he remains as president and chief executive officer.
Posted on October 19, 2009 @ 08:29 am
Amgen received a Complete Response Letter from the FDA for the BLA for Prolia (denosumab) in the treatment and prevention of postmenopausal osteoporosis. The letter requested several items, including further information on the design of Amgen's previously submitted post-marketing surveillance program.
The letter did not require additional pre-marketing clinical trials to complete the review of the treatment indication, but the FDA has requested a new clinical program to support approval of Prolia for the prevention of postmenopausal osteoporosis indication.
The FDA has determined that a Risk Evaluation and Mitigation Strategy (REMS) is necessary for Prolia and must include a medication guide, a communication plan, and a timetable for submission of assessments of the REMS. The agency acknowledged receipt of Amgen's previously submitted proposed REMS materials. The FDA has also requested all updated safety data related to Prolia.
Amgen is reviewing the Complete Response Letter and will work with the FDA to determine the appropriate next steps regarding these applications.
Amgen expects to receive a separate response for its application for Prolia in the treatment and prevention of bone loss due to hormone ablation in breast and prostate cancer patients.
"We are confident that we can quickly respond to the FDA's requests for the treatment of postmenopausal osteoporosis indication and plan to do so in the near term," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of R&D at Amgen. "Amgen is fully committed to working with the FDA to make Prolia available to patients in the near future."
Amgen also has submitted Prolia for approval in postmenopausal osteoporosis and bone loss in breast and prostate cancer patients due to hormone ablation therapy in the European Union, Switzerland, Australia and Canada. Amgen is working closely with regulatory agencies in each of these regions to make Prolia available to patients around the world.
Read our Top Companies report on Amgen!
October 16, 2009
Posted on October 16, 2009 @ 08:38 am
Pfizer has completed its acquisition of Wyeth following the regulatory approval from all government authorities required by the merger agreement and approval by Wyeth shareholders. Under the terms of the transaction, each outstanding share of Wyeth common stock has been converted into the right to receive $33 in cash and 0.985 of a share of Pfizer common stock.
Pfizer and Wyeth will begin joint operations today. The integration of local Pfizer and Wyeth entities is subject to completion of various local legal and regulatory obligations.
Posted on October 16, 2009 @ 08:22 am
GlaxoSmithKline gained approval for Cervarix in Japan, becoming the first cervical cancer vaccine to be approved by the Japanese Ministry of Health, Labour and Welfare (MHLW).
The vaccine, which is formulated with GSK’s AS04 adjuvant system, has been licensed for the prevention of pre-cancerous lesions (cervical intraepithelial neoplasia – CIN 2 and 3) and cervical cancer (squamous-cell carcinoma and adenocarcinoma) caused by human papillomavirus (HPV) types 16 and 18, in girls and women aged 10 and above.
The approval was based on data supporting the efficacy and safety profile of the vaccine, which included analysis of the largest efficacy trial of a cervical cancer vaccine, involving nearly 19,000 women. These data demonstrated that the vaccine was highly effective at protecting against the two most common cervical cancer-causing HPV types, 16 and 18. The study also showed that rates of serious adverse events and medically significant conditions in the group vaccinated with Cervarix were similar to the control group.
Marc Dunoyer, president of GSK Japan, commented, “We are extremely pleased with the approval of Cervarix, which is designed to protect women from cervical cancer – a disease that is responsible for the death of 10 Japanese women every day. Experts believe that vaccination in conjunction with regular screening will significantly reduce the burden of cervical cancer, and GSK is committed to working alongside the Japanese government to help ensure that women and girls are educated about the role that vaccination can play in protecting them against it.”
The vaccine is currently approved in the 27 member states of the EU, Australia, Brazil, South Korea, Mexico and Taiwan.
October 15, 2009
Posted on October 15, 2009 @ 08:51 am
SCHOTT’s Pharmaceutical Packaging business began production of ready-to-fill glass syringes at its manufacturing facility in Lebanon, PA. The company has invested more than $14 million in the new production capability, and will add 40 new jobs during the next year.
Syringe production capability at the 170,000-sq.-ft. plant will be 270,000 units per day. The company will move to 24-hour production within the next two years. With the addition of ready-to-fill syringes, all of SCHOTT’s pharmaceutical packaging products, which include vials, ampoules and cartridges, will now be produced in North America. SCHOTT will be the second company to produce ready-to-fill syringes in the U.S.
“We hope to increase the market share of domestically produced ready-to-fills, once we are fully operational here in Lebanon,” said Renard Jackson, Vice President of SCHOTT North America, Inc. and General Manager of its Pharmaceutical Packaging Division. “We’re delivering the same high quality standards our customers have come to expect.”
The company plans to further invest $30 million in the Lebanon facility in the future, and potentially employ 80 additional people.
Posted on October 15, 2009 @ 08:49 am
Evotec AG has extended its research collaboration with
Ono Pharmaceutical Co., Ltd. and initiated a new discovery alliance. Evotec will provide drug discovery activities, including high throughput screening, medicinal chemistry and in vitro pharmacology to discover small molecular weight compounds against an ion channel target selected by Ono. Ono will use Evotec's ion channel drug discovery platform and expertise and in return, Evotec will receive research funding and milestone payments.
The two companies have been collaborating on novel inhibitors for a protease target since March 2008. Within this collaboration Evotec provides protein crystallography, medicinal chemistry, biology and ADMET services to Ono with the goal of advancing a compound to clinical development.
"Since we have a high regard for Evotec's wide range of drug discovery technologies, and the existing collaboration with Evotec targeting a protease has progressed as planned, we are now pleased to enter into a new drug discovery agreement on an ion channel with Evotec utilizing their proprietary drug discovery platform. We anticipate the collaboration will result in identifying a novel drug candidate with a high potential," said Kazuhito Kawabata, Ph.D., managing director, Research Headquarters at Ono.
Dr. Mario Polywka, chief operating officer of Evotec, commented, "We are delighted to be expanding our collaboration and initiating a new discovery collaboration with Ono, a partner with whom we enjoy a close relationship. This expansion clearly demonstrates the value we bring to our alliance partners in the area of drug discovery. We look forward to continuing working closely with our colleagues at Ono."
Posted on October 15, 2009 @ 08:46 am
Lonza Group and the special committee of independent directors at
Patheon have extended the exclusivity period granted to Lonza, which was scheduled to expire today. The extension allows for continued discussions regarding possible strategic transactions between the two companies. The period of exclusivity will continue until terminated by either party. Other terms of the exclusivity arrangements will remain.
Because JLL Patheon Holdings LLC has announced it’s not prepared to sell its shares of Patheon at this time, discussions between Lonza and the committee include potential transactions that do not require the sale of JLL's shares.
Posted on October 15, 2009 @ 08:10 am
Azopharma Product Development Group and
PharmaNet Development Group have formed a business development and co-promotion alliance to leverage complementary services, develop business opportunities, and jointly manage projects for certain services provided by the two companies.
Phil Meeks, Azopharma's chief executive officer, commented, "This agreement is an exciting opportunity for both of our organizations. Both companies will be introduced to new sets of clients and the clients will be exposed to new compelling solutions for their early phase development."
Jeffrey P. McMullen, PharmaNet's president and chief executive officer, added, "PharmaNet's and Azopharma's services complement each other. Azopharma is an established provider of in vivo services with preclinical and toxicology capabilities and our bioanalytical capabilities are ideally positioned to support these studies."
October 14, 2009
Posted on October 14, 2009 @ 09:49 am
Lilly has sold its Tippecanoe Laboratories manufacturing facility to
Evonik Industries AG. The manufacturing site, located in Lafayette, IN, will remain in operation with a focus on producing high-quality APIs and specialty chemical and animal health products.
The two companies will also enter into a nine-year supply and services agreement, in which Evonik will manufacture final and intermediate step APIs for certain Lilly human and animal health products. Approximately 700 current Lilly employees, representing all full-time non-contracted workers dedicated to the site, will be offered employment with Evonik. Financial terms of the deal were not disclosed.
The decision to sell the site is based upon a projected decline in utilization of the site due to several factors, including upcoming patent expirations on certain medicines made at the site, Lilly's strategic decision to purchase, rather than manufacture, many late-stage chemical intermediates, and the evolution of the Lilly pipeline toward more biotechnology medicines, according to a Lilly statement.
"Today's announcement represents a positive outcome for employees at the site, the Lafayette community and Lilly," said John Lechleiter, Ph.D., Lilly's chairman and chief executive officer. "We are confident in our decision to sell Tippe Labs to Evonik, as it is a well-established multinational company that will continue to operate the site and more fully utilize its capabilities."
"The acquisition of Tippecanoe Laboratories enables us to meet the growing demand for intermediates and active pharmaceutical ingredients in the pharmaceutical industry and substantially boosts our global exclusive synthesis business," said Dr. Klaus Engel, chief executive officer of Evonik Industries. "The pharmaceutical market is attractive, economically stable, and produces growth rates near the double-digit range every year."
"Tippecanoe Laboratories has maintained a longstanding presence in the Lafayette community and has produced lifesaving medicines for patients and leading animal health products for more than a half-century," commented Frank Deane, Ph.D., president of Lilly manufacturing operations. "We are pleased to reach an attractive outcome that allows the site to remain in operation, maintains employment opportunities for almost 700 affected employees and allows both Lilly and the state of Indiana to continue to benefit from the site's capacity and technical capabilities."
The transaction will close by the end of 2009.
Posted on October 14, 2009 @ 07:43 am
Galapagos NV has expanded its global strategic alliance in metabolic diseases with an affiliate of
Merck to incorporate the development of new therapies for atherosclerosis. Galapagos will be responsible for the discovery and preclinical development of new small molecule candidate drugs based on novel Galapagos targets.
The alliance will make use of Galapagos' proprietary target discovery platform for identification of novel targets in atherosclerosis, as well as in obesity and diabetes. After validation, targets will be selected by a joint steering committee and entered into screening and chemistry by Galapagos. Merck will have an exclusive option to license in each candidate for clinical development and commercialization on a worldwide basis. Upon exercise of such option, Merck will be responsible for the development and commercialization of the candidate drug. Galapagos may execute Phase I clinical studies and will have the right to further develop and commercialize certain compounds for which Merck does not exercise its exclusive option.
In January 2009, Galapagos formed an alliance with Merck in diabetes and obesity. Under the terms of this expanded agreement, Galapagos is eligible to receive research, regulatory and sales milestone payments that may total in excess of $645 million. Galapagos is also eligible to receive royalties upon commercialization of any products covered under the agreement.
This expansion is separate from Galapagos' alliance with Merck in inflammatory diseases, which was formed in April 2009.
Posted on October 14, 2009 @ 07:39 am
Susan Kramer, Dr. P.H., has been named vice president, Project and Alliance Management at
XOMA Ltd. Dr. Kramer has 25 years of industry experience at Genentech and two biotechnology companies and a strong focus on product development and alliance management. She will lead and direct the program management activities for XOMA 052, both strategic and operational, from clinical development through approval. She also will provide leadership to the company's project and alliance management group.
Prior to joining XOMA, Dr. Kramer served as the vice president of development at Anesiva, Inc. where she led the development of Adlea, a non-opioid analgesic. Prior to Anesiva, Susan co-founded Corthera, Inc., and led the development of Relaxin for use in congestive heart failure, orthodontics and preeclampsia. During her 18 years at Genentech, Dr. Kramer served in a number of management positions including senior director of bioanalytical technology, where she supervised a group of more than 100 scientists. She was the project champion and manager of a number of key Genentech projects with partners like Boehringer Ingelheim, Toray Industries, Daiichi Seiyaku and Fujisawa Pharmaceuticals.
Posted on October 14, 2009 @ 07:36 am
Abbott 3Q09
3Q Revenues: $7.8 billion (+4%)
3Q Earnings: $1.5 billion (+37%)
YTD Revenues: $22.0 billion (+2%)
YTD Earnings: $4.2 billion (+26%)
Comments: Pharma revenues for 3Q09 were $4.1 billion, a 2% drop from last year. Currency fluctuation accounted for a 6% shortfall. Pharma sales for YTD were $11.6 billion, down 4% (with a 7% hit from currency). Pharma sales were led by Humira, which posted sales of $1.5 billion (+24%) in 3Q09 and $3.8 billion (+21%) YTD. Depakote sales plummeted due to generic competition, falling 71% to $92 million in 3Q09 and $324 million YTD. Earnings this quarter got a boost from a favorable patent settlement for a stent.
October 13, 2009
Posted on October 13, 2009 @ 08:32 am
Bruce J. Seeley has been named executive vice president, commercial at
Seattle Genetics. Mr. Seeley brings more than 18 years of experience in oncology drug marketing and sales to the company, most recently from Genentech BioOncology. The company also promoted
Kirk D. Schumacher to vice president, legal affairs and compliance, and general counsel.
“Bruce will lead our efforts to build Seattle Genetics’ marketing and sales functions as we position the company for commercial operations, including the planned 2011 product launch of brentuximab vedotin (SGN-35),” said Clay B. Siegall, Ph.D., president and chief executive officer. “His depth of experience in the commercialization of oncology drugs, including two of the most important therapies for the treatment of cancer, Herceptin and Taxotere, will be a tremendous asset to the company.”
Dr. Siegall added, “Kirk Schumacher has been instrumental at Seattle Genetics, including his contributions to several strategic collaborations and equity financings, and his oversight of our legal affairs. Bruce and Kirk will play key leadership roles as Seattle Genetics continues to execute on its corporate goals.”
Mr. Seeley previously worked at Genentech, most recently as senior director for Herceptin and T-DM1 marketing. His responsibilities included development and implementation of marketing and launch strategies, including product differentiation, pricing, distribution, medical education and promotion. Before that, he spent four years at Aventis Pharma in increasing roles of responsibility, including head of new product commercialization and licensing, global marketing, oncology. While at Aventis, he managed the global marketing activities for Taxotere. Mr. Seeley also held various marketing and sales positions at Rhone-Poulenc Rorer and Bristol-Myers Squibb. He received a Bachelor of Arts in Sociology from the University of California at Los Angeles.
Posted on October 13, 2009 @ 07:12 am
J&J 3Q09
3Q Revenues: $15.1 billion (-5%)
3Q Earnings: $3.3 billion (+1%)
YTD Revenues: $45.3 billion (-7%)
YTD Earnings: $10.0 billion (-2%)
Comments: Worldwide pharmaceutical revenues dropped 14% to $5.2 billion in 3Q09, with currency fluctuation accounting for 2% of that. U.S. pharma revenues dropped 19% to $2.9 billion. For the YTD, worldwide pharma revenues dropped 13% to $16.5 billion (4% from currency), with U.S. drug revenues falling 15% to $9.7 billion. During the quarter, U.S. sales of Topamax fell from $606 million to $72 million. The only major pharmaceutical products to show growth in the quarter were Remicade (+6% to $1.0 billion), Risperdal Consta (+4% to $353 million), and Velcade (+22% to $231 million). New drugs Prezista and Invega were up worldwide 91% to $151 million and 9% to $97 million, respectively.
Posted on October 13, 2009 @ 07:00 am
SAFC Pharma, part of the Sigma-Aldrich Group, has completed an addition to its Carlsbad, CA, facility, expanding its contract manufacturing services for its late phase and commercial clients. The $12 million project includes the addition of two fully segregated state-of-the-art viral product manufacturing suites, built to employ disposable bioreactor technologies, expanding SAFC Pharma's biologics, viral vaccines and gene therapy manufacturing to commercial-scale quantities.
The Carlsbad site specializes in the process development and manufacturing of viral vaccines and viral therapeutics, including support services, from preclinical process and analytical development to final fill/finish and commercial bulk drug supplies. The new expansion, designed for multi-lot campaigns, includes dedicated cell expansion, bioreactor production, purification and cleanroom suites. Adding 8,000 sq. ft. of manufacturing space to the existing 44,000-sq.-ft. site, the addition enables both 100-liter batch production in stirred tank bioreactors and 1,000-liter batch manufacturing in disposable bioreactors, and is Biosafety Level 2 compliant, allowing manipulation of human pathogens. Designed from the outset as a containment facility, the expansion space allows clients to secure a dedicated suite of cleanrooms for larger scale manufacturing.
"We are delighted to announce this expansion of our capabilities at our Carlsbad facility, particularly when the economic environment has been so challenging," commented David Feldker, Vice President SAFC Pharma. "We expect to see a great deal of value in the biologics and viral manufacturing marketplace in the next three to five years generated by two main customer types - those with late clinical phase opportunities but without any in-house manufacturing capability and those with late clinical phase opportunities that have some manufacturing capabilities but may be seeking an additional 'safety net' or wish to avoid additional capital expansion until their technology and drug has proven itself. By adding and extending our capabilities at Carlsbad, we are providing customers with an attractive, clear pathway that adds value and supports secure, successful product launches."
Facility validation studies are currently underway, with an expected start of cGMP manufacturing operations by the end of December 2009. The site added numerous utility support systems to allow for continuous operation and will now utilize its new Water For Injection (WFI) system. The expansion in Carlsbad follows the acquisition in 2007 of Molecular Medicine BioServices, Inc.
October 12, 2009
Posted on October 12, 2009 @ 08:41 am
QRxPharma has signed a contract with
Patheon to manufacture clinical supplies of QRxPharma's controlled release Dual-Opioid formulation, MoxDuoCR. MoxDuoCR is designed to provide 12 hours of pain relief in patients suffering from moderate to severe chronic pain (including cancer, lower back, osteoarthritis and neuropathic).
"The Patheon relationship represents a major step forward for QRxPharma that rounds out our platform of MoxDuo products," said Dr. John Holaday, QRxPharma's managing director and chief executive officer. "Our goal is to provide physicians and patients with a variety of complementary Dual Opioids for managing moderate to severe pain. MoxDuoCR is expected to deliver clinical benefits similar to those clinically demonstrated with MoxDuoIR (immediate release formulation) - fewer side effects and superior pain relief."
The new formulation includes tamper resistant features and is designed to provide 12 hours of pain relief. "We are targeting a twice daily dosage with MoxDuoCR, and we anticipate our initial Phase I studies will begin this year to evaluate the pharmacokinetic profile of this patented formulation," said Dr. Holaday. MoxDuoIR is in Phase III trials and scheduled for an NDA in 2010. MoxDuoCR is anticipated to complete clinical trials in 2012.
Posted on October 12, 2009 @ 08:19 am
David Wolton has been named vice president manufacturing at
CMC Biologics. Mr. Wolton has held positions with Elan, Wyeth and Lonza during his 23-year biotech career.
“We are delighted to add David’s tremendous experience to CMC Biologics.He has a proven track record in managing successful manufacturing teams and will bring new opportunities for production efficiencies,” said Peter Vilby, CMC's chief operating officer.
“CMC Biologics continues to attract the highest caliber people in our industry, and David Wolton’s appointment will ensure continued delivery of products to our customers,in the highly demanding regulatory environment of biologicals,” said Mads Laustsen, the company's chief executive officer.
Posted on October 12, 2009 @ 08:17 am
Onyx Pharmaceuticals has signed an agreement to acquire
Proteolix, Inc., a privately held biopharmaceutical company focused on discovering and developing novel therapies that target the proteasome for the treatment of hematological malignancies and solid tumors. Proteolix's lead compound, carfilzomib, is a proteasome inhibitor currently in multiple clinical trials, including a Phase IIb trial for patients with relapsed and refractory multiple myeloma.
"Carfilzomib is a next-generation product candidate with a proven and well-validated mechanism of action, strong efficacy signals, demonstrated tolerability and a potential accelerated approval pathway," said N. Anthony Coles, M.D., president and chief executive officer of Onyx. "This acquisition leverages Onyx's proven expertise in developing and commercializing Nexavar and provides strategic expansion into the $16 billion hematological malignancies market. The transaction structure reflects our approach to growing our business in a disciplined fashion, including earnout payments contingent on specific approval-based events. In addition, our development plan is designed to maintain our ability to continue to grow operating cash flow in 2010 and beyond."
Onyx will make a $276 million cash payment upon closing of the transaction. Additional payments include $40 million payable in 2010 based on the achievement of a development milestone and as much as $535 million contingent upon the achievement of certain regulatory approvals for carfilzomib in the U.S. and Europe. A payment of $170 million (of the potential $535 million) is based upon the achievement of accelerated FDA approval. The transaction is expected to close in 4Q09, subject to the receipt of clearance under the Hart-Scott-Rodino Act and customary closing conditions.
October 9, 2009
Posted on October 9, 2009 @ 09:45 am
Hospira has signed a business cooperation agreement with South Korea-based
Celltrion for future distribution of biogeneric products in the U.S., Europe, Australia, New Zealand and Canada. Celltrion is currently developing eight biogeneric products, five of which relate to Hospira's pipeline.
The companies will collaborate on manufacturing and supply of the products. Following regulatory approval, Hospira and Celltrion will co-market the drugs, with the products independently commercialized under each company's brand name. Financial terms were not disclosed.
"Celltrion brings a history of expertise in the manufacturing of protein-based therapeutics," said Christopher B. Begley, chairman and chief executive officer, Hospira. "This partnership gives Hospira access to Celltrion's large biogenerics portfolio, and is an excellent example of Hospira's commitment to organic and inorganic growth. We're excited to work with Celltrion, and we look forward to expanding Hospira's presence in these significant biogenerics markets."
"Hospira is the world leader in generic injectable pharmaceuticals and has the capabilities and experience to successfully sell biogenerics in these important markets," said Jung-Sin Seo, chief executive officer and chairman, Celltrion. "We believe this partnership will benefit both companies by combining Hospira's broad outreach with Celltrion's advanced biologic manufacturing capabilities."
Posted on October 9, 2009 @ 09:43 am
Paul S. Changelian, Ph.D. and
Peter L. Toogood, Ph.D. have been appointed to
Lycera Corp.'s drug development team. Dr. Changelian, previously director of inflammation biology at Pfizer, will serve as vice president of biology. Dr. Toogood, who was an associate director and research fellow at Parke-Davis and Pfizer, will be Lycera's vice president of chemistry and chemical biology. Both will play important roles in Lycera's efforts to develop novel small molecule treatments for patients with autoimmune diseases including psoriasis, rheumatoid arthritis, lupus erythematosis, inflammatory bowel disease and transplant rejection.
Together Drs. Changelian and Toogood have more than 30 years of drug discovery and development experience. Dr. Changelian's research focuses on autoimmune diseases, organ transplantation and kinase biology. Dr. Toogood's research is in immunology, inflammation, infectious diseases and cancer.
"Paul and Peter bring a wealth of experience in autoimmune drug discovery and development that will be essential to Lycera's success," said Dr. Gary Glick, the company's co-founder and chief scientific officer. "Their track records of successfully developing promising compounds in this area will be crucial as we continue to advance our development initiatives for small-molecule immunomodulators."
October 8, 2009
Posted on October 8, 2009 @ 09:14 am
3M Drug Delivery Systems is expanding its capabilities with a new lab site at its Singapore facility in Yishun. The Singapore lab will develop products in both the inhalation and transdermal drug delivery categories for pharmaceutical customers in the Asia Pacific region. The facility houses both a feasibility lab and two process development labs.
“Expanding our presence in Singapore will help us provide Asia Pacific customers with a product development service that has both local and global capabilities,” said Jim Vaughan, vice president and general manager, 3M Drug Delivery Systems Division. “Our team in Singapore understands the region’s regulatory requirements, and is able to quickly respond to customer needs. Additionally, our global laboratory network helps us deliver the outstanding quality the 3M brand is known for.”
The lab is 3M Drug Delivery Systems’ first contract R&D facility in the Asia Pacific region dedicated to pharmaceutical product development. Products developed by the Singapore lab will be suitable for manufacture in 3M’s global network of manufacturing sites in St. Paul, MN, and Loughborough, U.K, and will be developed to conform to global standards.
Posted on October 8, 2009 @ 09:11 am
Creapharm Europe has established a U.S. subsidiary, Creapharm-MP5, Inc. Through its subsidiaries Creapharm and MP5, Creapharm Europe manufacturers cytotoxic and other high-potency drugs as well as clinical supply services.
As part of the launch, Matthew Maupin has been appointed vice president of business development, North America. Mr. Maupin’s efforts will focus on promoting MP5’s services in the U.S. and Canada with particular focus on the oncology market. He will also promote Creapharm’s clinical supply offerings.
Most recently, Mr. Maupin was the vice president of business development for a U.S. CMO. Previously held leadership positions in quality and operations in addition to owning a research reagent business focused on RNAi (RNA interference).
Posted on October 8, 2009 @ 09:02 am
NextPharma has expanded its capabilities with the addition of clinical trial services at its San Diego, CA facility. The company’s clinical services include: randomization double-blinding, generation of emergency letters, packaging, kitting, labeling (Phase I – Phase IV studies), cold-chain storage, distribution, return accountability and destruction.
Bill Wedlake, NextPharma’s chief executive officer, added, “We are excited by the addition of this new Clinical Trials Service facility in San Diego. Our Clinical Trials Services personnel have proven expertise in supporting global clinical trials for pharmaceutical, biotechnology academic and research organizations. This new service will leverage our growing presence in pharmaceutical development and contract manufacturing in the U.S.”
NextPharma’s North American operation based in San Diego, CA, serves small to large companies in the biotechnology, pharmaceutical, diagnostic, and medical device markets. Its aseptic area has cleanroom suites offering Class 10,000 (Class 7 or Class C) formulation rooms and Class 100 (Class 5 or Class A) filling hoods or rooms. This facility is FDA licensed for drugs and medical devices and ISO 13485:2003 certified for medical device manufacturing.
NextPharma also has a clinical trials services facility Göttingen, Germany with packaging suites for primary and secondary packaging, a cold storage area, a packaging suite for secondary packaging of high potency drugs, and the capability to perform primary packaging under inert gas conditions, as well as a suite for packaging humidity-sensitive products. The facility operates under cGMP guidelines, meets European compliance regulations and is in the process of being validated to meet FDA regulatory requirements.
October 7, 2009
Posted on October 7, 2009 @ 09:08 am
Baxter International, Inc. has been granted marketing authorization for Celvapan H1N1 pandemic vaccine from the European Commission. Celvapan H1N1 is the first cell culture-based and non-adjuvanted pandemic flu vaccine to receive marketing authorization in the EU.
Baxter continues to deliver vaccine to national health authorities that have agreements with the company. Initial quantities of vaccine have already been received by a number of countries, including the UK and Ireland.
Baxter is confirming the safety and immunogenicity of Celvapan H1N1 in clinical trials and will supplement the licensure post-approval with data from its ongoing clinical program. Preliminary safety data indicates the vaccine is well tolerated. The current dosing schedule calls for two 7.5 µg doses of vaccine to be given 21 days apart. The company expects the data from the trial of healthy adults to indicate whether a single dose may be possible for Celvapan H1N1. This study will also determine whether a lower dose is sufficient to induce the necessary immune response.
Posted on October 7, 2009 @ 09:06 am
Catalent Pharma Solutions’ dose form development, manufacturing and packaging facility in Schorndorf, Germany, has successfully completed an FDA inspection. The inspection, triggered by pre-approval inspection requirements for two separate products, resulted in three minor observations on FDA Form 483.
Sharon Johnson, Catalent’s executive vice president of Quality, said, “The success of this inspection again demonstrates Catalent’s operational performance, depth of regulatory expertise, track record of quality and commitment to excellence. We are pleased to offer our customers added flexibility in their supply chain options for products coming to the U.S.”
Catalent’s Schorndorf business provides formulation and development services, clinical and commercial manufacturing for oral tablet and capsules, powders and other dose forms. The business also provides clinical and commercial packaging, clinical supply chain management services, and product development and commercial supply chain solutions for products in these dosage forms.
Posted on October 7, 2009 @ 09:04 am
Charles River Laboratories’ new Shanghai facility received accreditation from the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), the Canadian Council on Animal Care (CCAC) and the Shanghai Laboratory Animal Commission (SLAC). The AAALAC recognizes humane care of research models, CCAC acknowledges veterinary services, and SLAC acknowledges animal welfare policies.
“These three accreditations are a milestone in Charles River’s strategy to create a Center of Excellence in China,” said James C. Foster, president, chairman and chief executive officer of Charles River. “As the leading international CRO with GLP capabilities in China, we are replicating the Company’s high standards of research, safety, humane care and laboratory best practices that globally distinguish Charles River.”
October 6, 2009
Posted on October 6, 2009 @ 08:58 am
Dr. Ganesh Iyer has been appointed president and chief executive officer,
OctAlgos Therapeutics Inc., effective immediately.
"We were incredibly fortunate to have attracted such a uniquely qualified executive as Dr. Iyer to lead Algos," said Gary Smaby, Algos board chair and managing partner for Quatris Fund, the company's lead investor. "Dr. Iyer possesses the rare combination of scientific expertise and business acumen needed to lead Algos in the deployment of the Company's new service-based CRO model focused on assisting leading pharmaceutical companies in bringing their technological breakthroughs to the marketplace," adds Mr. Smaby.
Dr. Iyer was previously director of strategic analysis and business operations at MDS Pharma Services. Dr. Iyer has more than 16 years of strategic and business development experience with prominent companies, including ZymoGenetics/Novo Nordisk, Xcyte Therapies, SkeleTech, MDS Pharma Services and Microsoft.
"I am very excited about joining Algos and look forward to working with an excellent team to achieving our mission and goal to become the premier preclinical in vivo pain research services company," commented Dr. Iyer.
Posted on October 6, 2009 @ 08:55 am
Bristol-Myers Squibb and
AstraZeneca were granted marketing authorization for Onglyza from the European Commission. Onglyza is indicated as a once-daily 5 mg tablet in adult patients with type 2 diabetes to improve glycaemic control in combination with metformin, sulphonylurea or thiazolidinedione, when these drugs alone, with diet and exercise, do not provide adequate glycaemic control.
The marketing authorization is based on data from six Phase III registrational trials and a Phase IIIb study comparing saxagliptin plus metformin with sitagliptin plus metformin. The trials assessed the safety and efficacy of Onglyza and involved 4,148 patients with type 2 diabetes, including 3,021 patients treated with Onglyza.
Onglyza is the first drug to be launched in Europe through BMS and AZ’s worldwide R&D collaboration. Onglyza will be launched in 4Q09.
Béatrice Cazala, BMS president, Europe, and president, global commercialization, said, “The European Commission decision marks an important milestone in the alliance between Bristol-Myers Squibb and AstraZeneca. Our legacy in treating type 2 diabetes and cardiovascular disease, together with our knowledge and expertise, enables us to deliver to patients a medicine that will offer further choice for the treatment of this serious condition.”
Ulf Sather, AstraZeneca’s regional vice president for Europe, said, “Diabetes is a growing epidemic currently affecting some 53 million people in Europe with the number of cases expected to increase. Today’s announcement is good news for those affected by type 2 diabetes and further demonstrates the commitment of AstraZeneca and Bristol-Myers Squibb to bring much needed options for the treatment of type 2 diabetes.”
Posted on October 6, 2009 @ 08:51 am
OncoGenex Pharmaceuticals, Inc. received an additional Fast Track Designation from the FDA for OGX-011 (custirsen sodium) for progressive metastatic prostate cancer in combination with first-line docetaxel treatment. OGX-011 previously received Fast Track for second-line docetaxel treatment for progressive metastatic prostate cancer following docetaxel.
Fast Track Designation is granted to products that may provide a significant improvement in the safety or effectiveness of the treatment for a serious or life-threatening disease. It was based on data from a randomized, Phase II study that suggested OGX-011 in combination with first-line docetaxel treatment may improve survival in patients with castrate resistant prostate cancer (CRPC).
"An expansion of the current Fast Track Designation to include OGX-011 in combination with first-line docetaxel treatment is consistent with our current development plans in prostate cancer," said Scott Cormack, chief executive officer of OncoGenex. "We intend to execute Phase III trials, which now have completed Special Protocol Assessments for first-line and second-line chemotherapy treatment, and these Fast Track Designations along with the SPA's should help us move expeditiously toward commercialization of OGX-011 in prostate cancer."
October 5, 2009
Posted on October 5, 2009 @ 09:36 am
GlaxoSmithKline and
XenoPort, Inc. achieved positive results from a Phase II trial evaluating GSK1838262/XP13512 (gabapentin enacarbil) in patients with neuropathic pain associated with post-herpetic neuralgia (PHN), who have had an inadequate response to gabapentin. In this double-blind, two-period cross-over study, 3600 mg/day of GSK1838262 demonstrated a statistically significant improvement over 1200 mg/day of GSK1838262 on the primary endpoint, which was the change from baseline to the end of the treatment period in the 24-hour average pain intensity score.
This study enrolled 138 subjects with PHN who had been experiencing pain for at least three months following healing of the herpes zoster skin rash. Subjects with a history of inadequate response to gabapentin received a dose of 1800 mg/day of gabapentin for two weeks. Subjects who had a 24-hour average pain score of at least four on the 11-point pain intensity rating scale were then randomized to receive either 1200 mg/day of GSK1838262 for the first treatment period followed by 3600 mg/day for the second treatment period, or 3600 mg/day followed by 1200 mg/day. Subjects received 2400 mg/day of GSK1838262 for four days in between the two treatment periods.
“These results from another positive study of GSK1838262 in the treatment of PHN will be important as we evaluate our next steps in the development program for neuropathic pain,” said Atul Pande, M.D., senior vice president, GlaxoSmithKline Neurosciences Medicines Development Center.
“Clinical trial experience has shown that there are PHN patients who do not experience adequate pain relief,” said Ronald W. Barrett, Ph.D., chief executive officer of XenoPort. “We are encouraged by these Phase II results and plan to share further details about the study at a future medical meeting.”
Posted on October 5, 2009 @ 09:35 am
Pharmatek Laboratories, Inc. has acquired the Xcelodose 600S system, adding to its preclinical and early phase clinical GMP supply capabilities. The company will install the unit in its solid dose manufacturing facility in San Diego, CA and it’s expected to be validated by mid-October. The company is currently scheduling Xcelodose manufacturing productions for November and December.
"Pharmatek is always looking for ways to move our customers' drug candidates into the clinic more efficiently without compromising quality," said Jeffrey Bibbs, Ph.D., chief scientific officer of Pharmatek. "For powder-in-capsule (PIC) applications, the Xcelodose can drastically decrease time to clinic while also lowering the cost of drug product for first-in-human trials."
The Xcelodose, manufactured by Capsugel, a division of Pfizer, is a precision powder micro-doser and automated encapsulator that has the ability to fill formulations or API directly into capsules. The Xcelodose can measure to levels as low as 100 micrograms and can dispense into capsules from size 00 to 4. According to the company, dosing directly into capsules can reduce the amount of API required and the unit reduces overall development time by simplifying analytical and stability protocols.
Posted on October 5, 2009 @ 09:33 am
OctoPlus N.V. plans to reduce its work force by approximately 25% across all areas of the company. This past year, the company announced a change in strategy to become a drug delivery service-based business in an effort to lead to ongoing short-term revenues and long-term potential royalties.
Simon Sturge, chief executive officer of OctoPlus, said, "These efficiency measures will enable us to operate more competitively and will help to broaden our client base, which will diversify our revenue sources in both drug delivery and pharmaceutical services, aside from our current revenue stream from Locteron. These steps will enhance our ability to build a profitable service organization although these reorganizational changes will prevent us from being operationally cash flow positive in the second half of the year. The measures taken today will streamline the company going forward."
October 2, 2009
Posted on October 2, 2009 @ 09:19 am
Xcellerex and
Itero Biopharmaceuticals have entered into a strategic collaboration for the production of Itero’s lead product, an undisclosed therapeutic protein. Xcellerex will provide development and product manufacturing for global clinical and commercialization supplies. The two companies anticipate that this will be a multi-product collaboration. For the first product, Xcellerex will manufacture Itero’s Phase III clinical materials in 2010/2011.
“Xcellerex is enabling Itero’s rapid drug development through Phase III utilizing its state-of-the-art PDMax process development platform and its FlexFactory technology, which should provide Itero and its future partners with a cost-effective and flexible manufacturing alternative at full commercial scale,” stated Joseph Zakrzewski, Xcellerex’s president and chief executive officer.
“We believe Xcellerex is the right choice for Itero given their innovative, portable technology and their extensive manufacturing experience, which includes nearly 20 products for clinical trial development,” said Bryan Lawlis, Ph.D., Itero’s president and chief executive officer. “With the equity component of our collaboration, we are confident in their commitment to fully support our manufacturing needs as we make significant strides in building our product portfolio.”
Financial terms were not disclosed. Xcellerex, as part of the payment structure, will become an equity holder in Itero. The collaboration also anticipates Itero’s future purchase of a portable FlexFactory.
Posted on October 2, 2009 @ 09:18 am
The Kansas City District Office of the FDA submitted a recommendation of approval to the Center for Drug Evaluation and Research for
The University of Iowa Pharmaceuticals (UIP) to manufacture an aseptically filled sterile, prescription drug product for a client. The drug product contains a new chemical entity and is a sterile solution that is aseptically filled into a vial.
The FDA recommendation followed a Pre-Approval Inspection (PAI) of UIP’s facilities and procedures and review of the product’s manufacturing and testing procedures based on the client’s NDA. The inspection covered cGMPs as well as specific information related to the manufacture and analytical testing of the product.
"This accomplishment validates the significant upgrades UIP has made in its sterile products manufacturing area and quality systems to support our goal of providing contract services for new pharmaceutical products from inception through commercial launch and beyond,” said Mickey L. Wells, Ph.D., director of UI Pharmaceuticals.
Posted on October 2, 2009 @ 09:13 am
Haupt Pharma has added a new department and separate area for the production and handling of sex hormone-containing solids, such as oral contraceptives, that will go into operation at its Münster plant.
Haupt Pharma will use the new production facilities to manufacture film- and sugar-coated tablets that will be packed in blisters. The new facility follows the closed and high-containment principle to prevent substances from contaminating machinery and the surrounding area, using a dispensing isolator, one-pot dry mixer and wet-granulating equipment, high-containment tablet presses, as well as a film- and sugar-coater. Critical transfer processes will be carried out using containers that allow dust-free loading of the equipment using special valve systems and lifting columns.
The new production facility complies with FDA requirements. Construction of the separate production area for sex hormone-containing solids began in October 2008 and will be handed over to the production department in November 2009.
October 1, 2009
Posted on October 1, 2009 @ 09:22 am
Merrimack Pharmaceuticals, Inc. and
Sanofi-Aventis signed an exclusive worldwide licensing agreement for the development and commercialization of MM-121, a fully human monoclonal antibody designed to block signaling of the ErbB3 receptor. MM-121 is currently in Phase I testing as a potential treatment for cancer.
SA will make an upfront payment of $60 million and will be responsible for all development costs. Merrimack is eligible for an additional $470 million in milestone payments as well as royalties on sales. Merrimack will develop MM-121 through Phase II for each indication and SA will be responsible for further development. Merrimack retains the right to co-promote the therapy in the U.S.
The ErbB3 receptor is a novel target known to be a key mediator of a signaling network that impacts a broad array of cancers. By targeting ErbB3, MM-121 is believed to have a broad application across cancer as both a monotherapy and in combination with other therapeutics.
"Merrimack's expertise along with their knowledge of biologics development has allowed them to successfully identify ErbB3 as a promising target and rapidly bring MM-121 into clinical development," said Marc Cluzel, senior vice president R&D, SA. "MM-121 is a pioneering monoclonal antibody which brings a new innovative approach to Sanofi-Aventis' oncology portfolio. We are very excited to collaborate with Merrimack on the development of MM-121, which we believe is a very promising compound that will address a significant gap in treating cancer patients."
Posted on October 1, 2009 @ 09:21 am
Troy W. McCall, Ph.D. has been promoted from chief operating officer to chief executive officer at
Premier Research Group, effective immediately. He replaces Dr. Simon Yaxley, who will transition to an advisory role with the company’s board of directors as deputy chairman.
Michael Barry, non-executive chairman of the board, said, “On behalf of the board, I would like to thank Dr. Yaxley for his efforts, commitment to excellence, and vision as CEO and co-founder of Premier Research. Dr. McCall’s commitment, drive, and deep understanding of the business make him the ideal successor to ensure that Premier Research maintains its outstanding track record of growth and customer service.”
Dr. McCall led the successful integration of four acquisitions, established a global organization, and achieved year-on-year growth in excess of 20%.During Dr. McCall’s tenure, the company also initiated support of medical device trials in the U.S., launched a Functional Sourcing group, expanded clinical research sites, and completed its first NDA submission on behalf a sponsor.
Dr. Yaxley commented, “It is exciting and rewarding to have Troy stepping into the CEO role.This is what we have been working together towards and he deserves the recognition.I can think of no one more suited to continue to grow this successful company we, and many others, have worked hard to create.I also look forward to my continued involvement in the business as we continue to grow both organically as well as through acquisition.”
Posted on October 1, 2009 @ 09:19 am
Dr. John Nash has been named senior director of ADME/PK for
BioFocus. Dr. Nash has 30 years of industrial experience with both service and major pharmaceutical companies. Most recently, he worked for Charles River Laboratories in Quebec, Canada, where he was responsible for strengthening the DMPK service business. John also worked with Anserve and AstraZeneca/Syngenta in the UK in metabolism and pharmacokinetics.
“John Nash’s appointment is a major win for BioFocus in the UK,” commented Dr. Chris Newton, senior vice president, BioFocus.“With this hire, BioFocus continues to elevate its 175-scientist facility at Chesterford Research Park into a leading integrated discovery research center for pharma, biotech and not-for-profit organizations worldwide.”
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