The FDA informed Genzyme that it will re-inspect the company’s Allston Landing, MA manufacturing facility. The re-inspection is a follow-up to an inspection the agency conducted in May 2009 and is intended to verify that all CAPA identified in a February warning letter have been implemented.

In a letter to Genzyme, the agency indicated that all promised actions had not been either fully or adequately implemented at the time of the May inspection.During the re-inspection, the FDA will also review Genzyme’s remediation efforts related to the recent identification of a virus at the Allston plant that required the company to temporarily halt production. The sanitization of the facility is complete and production of Fabrazyme and Cerezyme has resumed. Genzyme will schedule the re-inspection as soon as possible.

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Craig C. Phillips has been appointed as vice president and general manager of the Oncology Business Unit of Cephalon. In this role, Mr. Phillips will have responsibility for managing all aspects of the U.S. oncology business including sales, marketing and medical affairs.

"Since joining Cephalon two years ago, Craig has clearly demonstrated an ability to exceed expectations and bring value to our organization through his leadership," said Robert Roche, Cephalon's executive vice president, Worldwide Pharmaceutical Operations. "I am confident that Craig's leadership and vision will support the dynamic growth of the Cephalon Oncology business and allow us to continue to bring medicines that matter to the healthcare professionals and patients battling cancer."

Mr. Phillips joined Cephalon in 2007 as senior group director of sales, national accounts and sales training for the Oncology Business Unit. Under his leadership, the sales team was instrumental in 2008 for the successful U.S. introduction of two indications for Treanda for Injection, the most recent addition to the company's Oncology portfolio. Prior to joining Cephalon, he spent 15 years at Johnson & Johnson and has more than 22 years of pharmaceutical industry experience.

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Jeffrey Davidson, Ph.D. has been named senior director, Clinical Statistics. In this new position, Dr. Davidson will oversee all statistical activities and staff, as well as provide strategic direction and leadership for all statistical functions.

Dr. Davidson comes to Octagon with extensive experience in statistics and biometrics, totaling more than 20 years in industry. Prior to joining the company, he worked as senior vice president, Statistical Consulting at a global CRO, where he developed and led the business unit responsible for providing statistical consultancy to clients in the life sciences industry. Previously, he served as senior vice president, Biometrics at the same company, where he directed all Biometrics and Medical Writing.During his career, Dr. Davidson also served as vice president, Global Biometrics at Shire Development.

Dr. Davidson also led statistical efforts at Purdue Pharma, led Medical Affairs Statistics at Hoffmann-La Roche, and held a leadership role at Knoll. He further served as Therapeutic Area Statistical Lead at Wyeth.

"Dr. Davidson's extensive experience in the industry will be an asset to Octagon," commented Matt Stroschien, vice president, Operations, Octagon. "We're looking forward to the positive and innovative impact he will have on Octagon's Clinical Statistics initiatives."

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Covance will acquire Merck's Seattle-based Gene Expression Laboratory in exchange for a $145 million, five-year supply agreement with Merck for genomic analysis services. The lab performs genomics services such as genotyping, gene sequencing and gene expression profiling.

"The acquisition of this laboratory brings world-class talent and technologies to Covance and further expands our capabilities in genomics testing and personalized medicine," said Joe Herring, chairman and chief executive officer of Covance. "We recognized the need to expand our footprint in the important and growing genomics testing market and this transaction provided both a superior and quicker entry point than the build or buy options we considered. The overall size of the genomics market is estimated at several hundred million dollars per year, including services for discovery/preclinical and clinical trials support."

"We believe this acquisition establishes Covance as the largest genomics service provider in the world," said Deborah Tanner, corporate senior vice president, and president, Central Laboratory Services at Covance. "This agreement will broaden our participation in projects and partnerships with clients in the drug discovery process."

Covance expects to offer employment to the majority of current employees and is scheduled to assume occupancy of the site and operation of the Gene Expression Laboratory on August 17, 2009.

"The Gene Expression Laboratory has established a strong reputation for consistent delivery of high quality experimental data in support of Merck's external collaborations and internal research projects," said Dr. Rupert Vessey, vice president, Merck Research Laboratories. "This agreement assures continued access to these services for our researchers while securing a future for the facility as an integral part of a world leading drug development service provider."

See Merck's profile in this year's Top 20 Pharma Report!

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AstraZeneca has submitted an NDA to the FDA for vandetanib 100 mg for use in combination with chemotherapy for the treatment of advanced non-small cell lung cancer in patients previously treated with one prior anti-cancer therapy. The company also submitted an MAA to the EMEA for the drug. If approved, the treatment will be marketed as Zactima.

Evaluation of vandetanib is ongoing as a monotherapy or in combination with other anti-cancer therapies in a range of tumor types, including thyroid cancer. Results from the ZEPHYR (300mg monotherapy study in EGFR failures in advanced NSCLC, Phase III) and ZETA (300 mg monotherapy in advanced medullary thyroid cancer, Phase III) studies will be presented in the first half of 2010.

According to AZ, Vandetanib has a unique profile that fights cancer through two clinically proven mechanisms: by blocking the development of tumor blood supply (anti-angiogenesis or anti-VEGFR), and by blocking the growth and survival of the tumour itself (anti-EGFR). Vandetanib also inhibits RET-tyrosine kinase activity, an important growth driver in certain types of thyroid cancer.

Howard Hutchinson, M.D., AZ's chief medical officer, commented, "Lung cancer is an area of high unmet need and these submissions are an important step toward potentially broadening the treatment options available for patients."

See AZ's profile in this year's Top 20 Pharma Report!

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Covance 2Q09

2Q Revenues: $466 million (+7%)

2Q Earnings: $43 million (-16%)

YTD Revenues: $907 million (+7%)

YTD Earnings: $83 million (-17%)

Comments: Early Development revenues dropped 6% in the quarter to $200 million, reflecting lower demand in toxicology services. Demand grew for clinical pharmacology, analytical chemistry and research services. Late-Stage Development revenues grew 19% to $266 million, driven by increases in demand for central lab services, as well as clinical development and commercialization services.

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Sanofi-Aventis will buy Merck's 50% interest in the companies' animal health joint venture, Merial Limited, for $4 billion in cash. The price values Merial at 3 times its 2008 sales and 10.2 times itsearnings before interest and taxes (EBIT).

In addition to the Merial agreement, Merck, SA and Schering-Plough announced the signing of a call option agreement. Following the closing of the Merck/Schering-Plough merger, SA will have the option to combine the Intervet/Schering-Plough Animal Health business with Merial to form an animal health joint venture that would be owned equally by the new Merck and SA.

"These agreements should enable us to proceed expeditiously with the closing of our merger with Schering-Plough in the fourth quarter as planned, and also gain an outstanding animal health business through Intervet/Schering-Plough Animal Health," said Richard T. Clark, Merck's chairman, president and chief executive officer. "We are pleased that our long-time partner Sanofi-Aventis will purchase Merck's interest in Merial, the successful joint venture we built together," he added. "We look forward to the potential opportunity to bring together the strong animal health businesses of sanofi-aventis and the new Merck."

Christopher A. Viehbacher, chief executive officer of SA, remarked, “We are pleased with the acquisition of Merial, a major global player in animal heath, and the possibility of combining Merial and Intervet/Schering-Plough's complementary businesses. The combination would create a new leader in this $19 billion global animal health market, supporting our vision of a global diversified healthcare leader. In an environment of increasing complexity, I am convinced that alliances have an important place and I look forward to the prospect of further partnering with the new Merck in animal health to build on our longstanding relationship."

The sale of Merck's interest in the Merial joint venture is subject to clearance by the European antitrust authorities.

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AstraZeneca 2Q09

2Q Revenues: $8.0 billion (flat)

2Q Earnings: $2.4 billion (+70%)

YTD Revenues: $15.7 billion (flat)

YTD Earnings: $4.0 billion (+21%)

Comments: Two generic marketers of Toprol-XL withdrew from the U.S. market,and the introduction of generic Casodex was delayed, giving AZ a boost. Nexium posted a 6% drop in sales in 2Q09 to $1.2 billion, while Crestor posted a 23% rise to $1.1 billion. Nexium sales rose 12% to $1.2 billion. Seloken/Toprol-XL sales doubled to $417 million. Symbicort sales were up 6% to $551 million.

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Valeant Pharmaceuticals International will acquire Tecnofarma S.A. de C.V., a privately held company located in Mexico for approximately $33 million. Tecnofarma is a producer of generic pharmaceuticals, with $33 million in annual sales primarily to the government and private label markets. Valeant's subsidiary in Mexico works in the branded generics field and does not currently serve either of those two markets.

The deal will allow Valeant Latin America to reduce its dependence upon third party manufacturers, since Tecnofarma has several manufacturing sites, including a new 160,000 sq. ft. manufacturing plant. Technofarma has 80 registered products that Valeant can bring into its branded generics marketing efforts.

"The acquisition of Tecnofarma is consistent with our business plan strategy," stated J. Michael Pearson, Valeant's chairman and chief executive officer. "The government and private label markets in Mexico are large and growing components of the overall pharmaceutical industry in the region and are complementary to Valeant Mexico's current market focus on the commercial branded generic market. Adding two well-established businesses to our current branded generic portfolio mix, a new pipeline of products for our branded generic business, as well as a manufacturing infrastructure capable of expanding to meet future demand, we believe we are well positioned to reach our growth objectives in Latin America."

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Sanofi-Aventis 2Q

2Q Revenues: $10.4 billion (+11%)

2Q Earnings: $3.2 billion (+29%)

YTD Revenues: $20.4 billion (+7%)

YTD Earnings: $6.2 billion (+22%)

Comments: Pharmaceutical sales were up 7% to $9.4 billion. Lantus sales were up 26% to $1.1 billion. Lovenox sales were up 13% to $1.1 billion. Taxotere sales were $820 million (+11%). Plavix sales were up 5% to $989 million. Eloxatin sales were down 4% to $496 million. Sales in the U.S. and Europe were up 5%, and 20% in emerging markets. Human vaccine sales were down 1% to $1.0 billion. This includes $32.5 million of H5N1 vaccine sales in the U.S., compared to $192.5 million in 2Q08. Excluding H5N1 vaccine sales, 2Q sales were up 18%. *Earnings in the quarter and YTD reflect adjusted income and exclude selected items.

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Stephen Cutler, Ph.D. has been appointed senior vice president and chief operating officer, Kendle. Dr. Cutler has more than 20 years of senior management and operations leadership experience in the CRO and biopharmaceutical industries. He will provide global leadership for the company's worldwide late-stage operations, leveraging Phase II-IV capabilities to maximize integrated service offerings for customers. He replaces Chris Bergen, who has been appointed executive vice president and chief administrative officer. Dr. Cutler will report directly to chairman and chief executive officer, Candace Kendle, Pharm.D.

Dr. Cutler joins the company following 14 years with Quintiles, where he most recently served as senior vice president, global project management, responsible for more than 600 people and 500 active projects spanning all therapeutic areas. Previously, he was senior vice president, clinical, medical and regulatory, leading more than 1,200 associates based in North America with responsibility for approximately 200 projects. Dr. Cutler also served as senior vice president, project management, Europe, and vice president, oncology, Europe, and held regional leadership positions in South Africa and Australia.

Mr. Bergen will provide dedicated executive leadership for strategic technology and infrastructure enhancement initiatives with a focus on innovation, productivity and global connectivity.

Other recent executive moves include the appointment of Simon Higginbotham as senior vice president and chief marketing officer, adding to his leadership role in the company's early-stage business, and the appointments of Jarrod Pontius as vice president, chief legal officer and secretary, and Keith Cheesman as senior vice president and chief financial officer.

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Daniel E. Leone has been appointed vice president of business development, Laureate Pharma, Inc. Mr. Leone will be responsible for the company’s worldwide business development activities, including sales and marketing. He will also support the contract development, manufacturing, and bioprocessing businesses.

Most recently, Mr. Leone served as executive director of contract manufacturing at Ben Venue Laboratories, where he was responsible for sales, marketing and new business development for its parenteral contract manufacturing services business. Prior to Ben Venue, he was vice president of business operations at Boehringer Ingelheim Chemicals where he was responsible for sales, marketing, new business development and supply chain management for its API business. Prior to that he held positions of increasing responsibility at Hoechst Corp.

"We are pleased to welcome Dan to Laureate's leadership team," said Robert J. Broeze, Ph.D., president and chief executive officer of Laureate. "Dan is a seasoned executive with more than 20 years of experience in business development and he brings an impressive background that includes broad international business development and management experience in contract manufacturing, pharmaceuticals and specialty chemicals. His capabilities include strong leadership, and strategic and organizational skills that have produced positive results in early stage and mature businesses."

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Alliance Medical Products, Inc. (AMP) has opened its East Coast sales office located in Howell, NJ, and appointed Thomas J. Puskar as associate director and East Coast account executive. He will be responsible for staffing the new sales office. AMP provides contract manufacturing of sterile drugs, drug delivery devices and lab services at its Irvine, CA manufacturing facility.

Juan Valdes, president and chief executive officer of AMP, said, “We are pleased to offer this expanded service to our growing number of clients on the East Coast. Tom’s experience in parenteral fill and finish will enable us to immediately provide the level of service our clients expect from us.”

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Amgen and GlaxoSmithKline entered into a collaboration under which the companies will share commercialization of Amgen's monoclonal antibody denosumab for postmenopausal osteoporosis (PMO) in Europe, Australia, New Zealand and Mexico, once approved in these countries. Amgen will commercialize the drug for PMO and oncology in the U.S. and Canada and for all oncology indications in Europe and specified markets.

GSK will register and commercialize denosumab for all indications in China, Brazil, India and South Korea. Under the collaboration, Amgen has the option to expand its role in commercialization in both Europe and certain emerging markets in the future. Amgen will receive an initial payment and near-term commercial milestones totaling $120 million, and ongoing royalties. In Europe, the two companies will share profits and in emerging markets. GSK will be responsible for commercialization expenses and will purchase denosumab from Amgen to meet demand.

"Our collaboration with GlaxoSmithKline will help Amgen bring the promise of denosumab to patients in Europe and other parts of the world more effectively than if we commercialized the drug globally on our own," said Amgen chief executive officer, Kevin Sharer. "Amgen and GlaxoSmithKline together are uniquely positioned to help medical providers and patients understand the clinical promise and economic value of denosumab."

"This pioneering treatment that Amgen has developed will be a strong addition to our biopharmaceuticals portfolio," commented Andrew Witty, chief executive officer of GlaxoSmithKline. "The data for denosumab is very encouraging and we believe it will provide significant benefit and value to patients with postmenopausal osteoporosis and other bone disease conditions. Together with Amgen we are committed to increasing worldwide access to this medicine."

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Amgen 2Q

2Q Revenue: $3.7 billion (-1%)

2Q Earnings: $1.3 billion (+40%)

YTD Revenues: $7.0 billion (-5%)

YTD Earnings: $2.3 billion (+14%)

Comments: Product sales in the quarter were down 2% to $3.6 billion. Sales in the U.S. were flat at $2.8 billion, while international sales were down 6% to $801 million. The decline reflects the unfavorable impact of foreign exchange, which totaled approximately $103 million. Worldwide sales of Aranesp were down 16% to $693 million. Epogen sales were $638 million (+3%). Combined sales of Neulasta and Neupogen were $1.2 billion (-4%). Sales of Enbrel were up 7% to $899 million. Sensipar sales were up 11% to $167 million. Earnings in the quarter were positively impacted by a $115 million income tax benefit. Earnings for 2Q08 were negatively impacted by $263 million in losses for settlements of certain commercial legal proceedings.

View Amgen in Contract Pharma's Top Companies Report:
http://contractpharma.com/articles/2009/07/amgen

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Covance has increased global capacity to conduct metabolite identification supporting preclinical development and early human studies. The company’s metabolite identification services now include14 senior scientists located in Madison, WI and Harrogate, UK, and an instrumentation total of five mass spectrometers, six QTrap mass spectrometers and access to nuclear magnetic resonance (NMR) analysis for unequivocal structural identification.

The additions at the Madison facility were designed accommodate increased client demand resulting from the FDA’s recent Guidance for Industry on Safety Testing of Drug Metabolites.

“These additions build upon our track record of excellence in metabolite identification for preclinical development and early human studies conducted at Covance,” said Jon Denissen, vice president of Global DMPK, Covance. “This shows our commitment to provide clients faster results and with the highest level of expertise and quality.”

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Teva 2Q

2Q Revenue: $3.4 billion (+20%)

2Q Earnings: $521 million (-2%)

Comments: Pharmaceutical sales in the quarter in North America were $2.1 billion (+36%). Sales in Europe were down 4% to $732 million. International sales were $481 million (+20%). Sales of Copaxone were up 21% in the quarter to $682 million. Sales of Azilect were $55 million (+31%). Sales in the women's-health business, acquired from Barr, were $80 million (+4%). The increase reflected higher sales of the Plan B contraceptive. Sales of respiratory products were up 13% to $189 million. R&D expenses in the quarter were $169 million, or 5% of sales, compared to $198 million in 2Q08.

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Sanofi-Aventis will buy Shantha Biotechnics, a Hyderabad, India-based vaccine company. According to an SA statement, "Sanofi Pasteur, the vaccines division of the Sanofi-Aventis Group, will support Shantha’s ongoing development as a platform to address the need for high quality affordable vaccination in international markets."

The transaction values Shantha at $780 million; the unit's Shantha's sales this fiscal year are projected to be $90 million. Shantha, founded in 1993, develops, manufactures and markets several vaccines. Dr Varaprasad Reddy, the founder of Shantha Biotechnics, will continue to lead the company as managing director.

Christopher A. Viehbacher, SA's chief executive officer, commented, “Shantha provides Sanofi Pasteur with a portfolio of new vaccines in development which complement Sanofi Pasteur’s current vaccines, positioning the company to accelerate its growth in strategically important emerging markets.The state-of-the-art manufacturing facilities allow Sanofi Pasteur to gain high quality capacity in order to enable us to provide important vaccines at affordable prices to many people around the world.Our commitment to this objective is highlighted by the creation of a new Strategic Committee which I am delighted to announce will be chaired by Alain Mérieux.”

Shantha works with supranational organizations like UNICEF and PAHO to supply major international markets including Asia-Pacific, Africa and Latin America. In 1997, Shantha launched SHANVAC-B, the first recombinant Hepatitis B vaccine produced in India. SHANVAC-B, SHANTETRA (combination vaccine of Diphteria, Pertussis, Tetanus and Hepatitis B), SHAN5 (combination vaccine of Diphteria, Pertussis, Tetanus, Haemophilus influenza B and Hepatitis B) and SHANTT (Tetanus toxoid vaccine) are prequalified by the World Health Organization for supplying to United Nation agencies globally.Shantha also has an important portfolio of vaccines in development.

Isogen LLC’s Science Center, a new 20,000 sq.-ft. aseptic filling and manufacturing facility located in Newark, DE, has successfully completed its media fills and has begun fulfilling customer orders to pharmaceutical and biopharmaceutical companies. The mandatory three-step process evaluates equipment, processes and procedures to ensure quality standards.

“We’re excited to have completed our media fills and to be filling product for our customers!We are providing something very unique to our industry – the ability to develop life-saving therapeutics more effectively and affordably within an environment that utilizes the latest technology and adheres to the highest global manufacturing standards,” said Les Edwards, Isogen chief executive officer.

The center meets U.S., EU and Japan regulatory needs, and was designed by the Isogen Engineering Team, along with Precis Engineering and in collaboration with Cyma Builders and AES Clean Technologies.


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Jonathan Leff, M.D. has been appointed vice president and chief medical officer, Halozyme Therapeutics. Dr. Leff was previously the vice president and global head of inflammation clinical development at Roche. He has experience in pharmaceutical product development from early stage molecules to global regulatory filing, approval and launch.

“Dr. Leff is a highly accomplished leader with a proven track record of successfully developing and commercializing large and small molecules across a broad range of therapeutic areas. I am delighted to welcome such a talented executive to Halozyme,” said Jonathan Lim, M.D., Halozyme’s president and chief executive officer. “This latest addition to the leadership team is indicative of Halozyme’s strong commitment and ability to attract some of the best and brightest talent in the biopharmaceutical industry.”

Dr. Leff managed the worldwide clinical development and registration for MabThera/Rituxan, ocrelizumab, and Actemra while at Roche. From 2002 to 2007, he was vice president, North American medical affairs, at Amgen, where he led a department of 500 professionals, and oversaw five therapeutic areas. From 1994 to 2002, Dr. Leff was at Merck, where he performed Phase I-IV research studies for Singulair.

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Tranzyme Pharma’s oral gastrointestinal (GI) prokinetic drug candidate TZP-102, for the treatment of gastroparesis in diabetic patients, was granted Fast Track designation from the FDA. Gastroparesis is a serious complication of diabetes mellitus that affects approximately 30-60% of diabetic patients.

Fast track designation is designed to facilitate the development and expedite the review of a drug candidate that treats a serious or life-threatening condition and addresses an unmet medical need. Tranzyme is currently enrolling patients in a multi-national Phase II, randomized, double-blind, placebo-controlled study of TZP-102. The trial will evaluate the safety and efficacy of TZP-102 in accelerating gastric emptying and improving symptoms of gastroparesis in diabetic patients.

“We are extremely pleased that TZP-102 has received the FDA’s designation as a Fast Track product,” said Gordana Kosutic, M.D., Tranzyme’s vice president of Clinical and Regulatory Affairs. “We routinely hear from patients suffering from gastroparesis who are excited about the progress of our clinical programs and hopeful that a safe and effective therapy is forthcoming. Being granted Fast Track status is another milestone in helping to meet that need.”

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Phil DiGiacomo has been promoted to vice president, sales and marketing at Anderson Packaging. Mr. DiGiacomo assumes the role previously held by Peter Belden. Mr. Belden is now executive vice president and managing director for Brecon Pharmaceuticals in Wales, a business unit of AmerisourceBergen Packaging Group. Mr. DiGiacomo has more than 30 years of experience in the contract pharmaceutical packaging industry, most recently holding the title of director of East coast sales at Anderson.

“We are very excited to have Phil’s leadership as the vice president of sales and marketing,” said Shawn Reilley, president of Anderson. “Since joining Anderson, Phil has made a substantial impact on our overall business. He brings a wealth of knowledge and experience in the industry, which we have certainly benefited from. Phil’s insights will be critical in driving our future opportunities as we expand our service offerings and target growth markets.”

Also, Matt Dawes has been promoted to director of sales. Mr. Dawes joined the company seven years ago and most recently served as director of customer project planning. In his new role, Mr. Dawes reports to Mr. DiGiacomo.

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Juan Venceslao has been appointed to the newly created position of director, Dishman Generic API Business. Mr. Venceslao will report to Jay Vyas, managing director. He will be responsible for the company’s existing generic API portfolio, and will also have a leadership role in driving and managing growth in this area.

“We are delighted to add someone with Juan’s caliber and experience to our senior team” said Mr. Vyas. “With his background in bulk APIs, Juan will bring substantial market knowledge and will play a key role in helping Dishman to build and maintain a strong technology offering to both the ethical and generic pharmaceutical industries.”

Previously, Mr. Venceslao served as marketing and commercial manager Europe, Asia, Australia, and Middle East for Uquifa S.A., a pharmaceutical API supply company.


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Compass Pharma Services has completed a capital investment project to upgrade its production capabilities to include ISO Class 8 (ISO 14644) specifications in order to provide packaging services for certain high-potency pharmaceutical products.

“These capital improvements now allow us to provide cGMP contract packaging services for select potent pharmaceutical compounds such as enzymes, antibiotics, antifolates, antimetabolites and some hormones,” said Tony Fenno, chief operating officer. “Compass Pharma investments continue to position the company as a responsive contract pharmaceutical packaging partner for sophisticated, high-demand contract packaging services for the pharmaceutical industry.”

The improvements for ISO-Class 8 certification include a fully integrated production suite where the primary packaging area has negative differential air pressure relative to surrounding gowning and secondary packaging areas. High-Efficiency Particulate Air (HEPA) filters are used in the primary packaging area.

Manufacturing Automation Corp. of Princeton, NJ assisted with the engineering/design and validation of the new ISO Class 8 area. Also, Whitehouse Analytical Laboratories, Inc. has been retained to provide the company with ongoing analytical services.

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Bristol-Myers Squibb has signed an agreement to acquire Medarex, Inc. for $2.1 billion in cash (net of Medarex’s $300 million in cash holdings). The transaction has been approved by the boards of directors of both companies, and Medarex has agreed not to solicit any other acquisition partners. BMS will finance the deal with its existing cash.

BMS will gain Medarex’s UltiMAb Human Antibody Development System and next-gen Antibody-Drug Conjugate (ADC) technology for use in immunology and oncology therapeutic areas. BMS will receive royalties on sales of currently marketed therapies: Simponi, Stelara and Ilaris. BMS will have rights to seven antibodies in clinical trials and rights to preclinical assets, as well as rights to ipilimumab, currently in Phase III development for metastatic melanoma and Phase II trials in lung cancer.

“Medarex’s technology platform, people and pipeline provide a strong complement to our company’s biologics strategy, specifically in immuno-oncology,” said James M. Cornelius, chairman and chief executive officer, BMS. “With its productive and proven antibody discovery capabilities, ability to generate interesting therapeutic programs and unique set of preclinical and clinical assets in development, Medarex represents what we’re looking for in terms of our String of Pearls strategy. This acquisition is another important step in our BioPharma transformation.”

Said Howard H. Pien, Medarex’s chairman and chief executive officer, “We believe this transaction represents a great opportunity to place our clinical programs and technology assets in the hands of one of the world’s premier biopharmaceutical companies with the expertise and resources to bring innovative cancer treatment options to patients in need.”

View BMS in Contract Pharma's Top Companies Report:
http://contractpharma.com/articles/2009/07/bristolmyers-squibb

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Bristol-Myers Squibb 2Q

2Q Revenues: $5.4 billion (+3%)

2Q Earnings: $1.3 billion (+29%)

YTD Revenues: $10.4 million (+3%)

YTD Earnings: $2.2 billion (+17%)

Comments: Revenues were up 8% excluding foreign exchange impact. Biopharmaceutical sales were $4.7 billion in the quarter (+4%). Plavix sales were $1.5 billion (+11%). Abilify sales were $643 million (+22%). Baraclude sales were $179 million (+32%). Sustiva franchise sales were $312 million (+11%). Reyataz sales were $331 million (+2%). Orencia and Sprycel sales were up 40% and 41% to $148 million and $107 million, respectively. Erbitux sales were down 12% to $173 million. R&D expenses were flat at $781 million in the quarter.

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http://contractpharma.com/articles/2009/07/bristolmyers-squibb

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Wyeth 2Q

2Q Revenues: $5.7 billion (-4%)

2Q Earnings: $1.3 billion (+13%)

YTD Revenues: $11.1 billion (-5%)

YTD Earnings: $2.5 billion (+7%)

Comments: Excluding the unfavorable impact of foreign exchange, earnings were up 2% for the quarter and first half. Effexor sales were down 25% to $772 million in the quarter. Prevnar sales rose 24% to $783 million. Enbrel alliance revenue was $304 million (+7%), while Wyeth’s sales of Enbrel outside the U.S. and Canada were $736 million (+6%). Premarin product sales were down 5% to $257 million. Hemophilia product sales were $248 million (-1%). Protonix product sales were $237 million (+4%). Results in the quarter include charges of $66.1 million related to productivity initiatives and costs associated with the proposed merger with Pfizer. R&D expenses in the quarter were up 7% to $885.3 million.

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Genzyme 2Q

2Q Revenues: $1.2 billion (+5%)

2Q Earnings: $192.2 million (earnings were $69.6 million in 2Q08)

Comments: Myozyme revenue was $79.3 million, up from $67.4 million in 1Q09, reflecting the E.U. approval of production at the 4000 L scale. Cerezyme revenue was down 7% to $298.1 million, impacted by the temporary Allston shutdown and unfavorable currency exchange rates. Sales of Fabrazyme were $134.3 million (+6%). Sales of Thyrogen were $42.9 million (+9%). Hematologic oncology revenue doubled in the quarter to $55.9 million, driven by new revenue from Leukine and Fludara, acquired from Bayer at the end of May. Results include $13 million in lost revenue due to the interruption of Cerezyme shipments associated with the temporary shutdown of the Allston manufacturing facility in June. Earnings in 2Q08 reflect a $175 million licensing fee associated with mipomersen.

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GlaxoSmithKline 2Q

2Q Revenues: $10.5 billion (-10%)

2Q Earnings: $2.3 billion (-12%)

YTD Revenues: $20.3 billion (-12%)

YTD Earnings: $3.9 billion (-25%)

Comments: Pharmaceutical sales were $8.7 billion in the quarter (-11%). Seretide/Advair sales were flat at $1.9 billion. Valtrex sales were $590 million (+7%). Combivir sales were down 23% to $160 million. Epzicom/Kivexa sales were $202 million (-2%). Seroxat/Paxil sales were $215 million (-15%). Avodart sales were up 14% to $208 million. Avandia product sales were $309 million (-20%). Augmentin sales were $230 million (-11%). Vaccine revenues in the quarter were up 9% to $1.2 billion, with Rotarix sales up 59% to $110 million and Cervarix sales of $113 million, up from $30 million in 2Q08. R&D expenses were down 6% to $1.5 billion.

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Pfizer 2Q

2Q Revenues: $11.0 billion (-9%)

2Q Earnings: $2.3 billion (-19%)

YTD Revenues: $21.9 billion (-9%)

YTD Earnings: $5.0 billion (-10%)

Comments: Pharmaceutical sales were down 9% to $10.1 billion. The negative impact of foreign exchange accounted for a drop of $1.1 billion, or approximately 9%. U.S. revenues in 2Q09 were $4.5 billion (-5%). International revenues were $6.5 billion (-12%) and reflected operational growth of 2%, offset by a 14% unfavorable foreign exchange rate. Lipitor sales were down 10% to $2.7 billion. Norvasc sales were down 18% to $518 million. Chantix sales were $192 million (-7%). Lyrica sales were $629 million (+2%). Geodon sales were flat at $231 million. Celebrex sales were $548 million (-7%). Sutent sales were $223 million (+5%). Camptosar sales were down 38% to $85 million. The decline in 1H09 revenues included the loss of U.S. exclusivity for Zyrtec in January 2008 and Camptosar in February 2008, the loss of exclusivity in Japan for Norvasc in July 2008, as well as the revenue declines for Lipitor and Chantix/Champix. Results include restructuring charges and acquisition-related costs of $459 million in the quarter and $1.0 billion YTD.

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Lilly 2Q

2Q Revenues: $5.3 billion (+3%)

2Q Earnings: $1.2 billion (+21%)

YTD Revenues: $10.3 billion (+2%)

YTD Earnings: $2.5 billion (+28%)

Comments: Product sales were up 2% to $5.1 billion, while alliance revenue rose 54% to $179.5 million, primarily due to Erbitux revenues through the ImClone acquisition. Zyprexa sales were $1.2 billion (-3%). Cymbalta sales were $744.4 million(+14%). Humalog sales were $477.5 million (+9%). Cialis sales were flat at $363.6 million. Gemzar sales were down 20% to $353.2 million. Alimta sales were $385.3 million (+40%). R&D expenses were $1.0 billion, or 20% of total revenue, up 9% in part because of the ImClone acquisition and increased late-stage trial and discovery research costs. In 2Q08, results included a charge of $35.0 million for acquired in-process R&D associated with the in-licensing transaction with TransPharma Medical and a charge of $88.9 million for restructuring and other charges associated with exiting manufacturing operations. In the quarter, the company received FDA approval of Effient (prasugrel) tablets for the reduction of thrombotic cardiovascular events and an expanded indication for Alimta in non-small cell lung cancer (NSCLC).

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Gilead Sciences 2Q

2Q Revenues: $1.7 billion (+29%)

2Q Earnings: $571.4 million (+31%)

YTD Revenues:$3.2 billion (+28%)

YTD Earnings: $1.2 billion(+26%)

Comments: Product sales were up 29% to a record $1.6 billion, driven primarily by the antiviral franchise with product sales up 26% to $1.4 billion. Truvada sales were up 18% to $608.1 million. Atripla sales were up 60% to $569.1 million. Other antiviral product sales, including Viread, Hepsera and Emtriva, were down 6% to $233.1 million. Sales of Letairis increased 79% to $44.1 million. Sales of Ranexa, gained through the acquisition of CV Therapeutics, were $36.1 million from April 15, 2009. R&D expenses were $241.6 million, compared to $176.5 million in 2Q08. This increase was primarily a result of higher headcount from the acquisition of CV Therapeutics. Royalty, contract and other revenues resulting primarily from collaborations were $78.8 million in the quarter (+ 29%), driven primarily by Tamiflu royalties from Roche of $51.9 million.

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ICON 2Q

2Q Revenues: $220 million (+1%)

2Q Earnings: $22.8 million (+21%)

YTD Revenues: $439.8 million (+5%)

YTD Earnings: $43.7 million (+22%)

Comments: New business awards in the quarter were $266 million, representing a book-to-bill ratio of 1.2. Results in the quarter include one-time restructuring costs of $13.4 million.

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Merck 2Q

2Q Revenues: $5.9 billion (-3%)

2Q Earnings: $1.6 billion (-12%)

YTD revenues: $11.3 billion (-5%)

YTD Earnings: $3.0 billion (-41%)

Comments: Worldwide sales of Singulair were $1.3 billion in the quarter (+ 16%). Combined sales of Zetia and Vytorin, as reported by the Merck/Schering-Plough partnership, were $1.0 billion (-10%). Cozaar and Hyzaar sales were $906 million (-4%). Gardasil sales were $268 million (-18%). Rotateq sales were $126 million (-29%). Januvia sales were up 38% to $462 million. Isentress sales were $172 million (+123%). Revenue from the AstraZeneca alliance for certain products including Nexium, was $386 million in the quarter. Restructuring costs in the quarter, primarily related to employee separations, were $37 million. R&D expenses were $1.4 billion for the quarter (+19%), reflecting an increase in the company's external licensing activity.

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Schering-Plough 2Q

2Q Revenues: $4.6 billion (-6%)

2Q Earnings: $671 million (+45%)

YTD Revenues: $9.0 billion (-6%)

YTD Earnings: $1.5 billion (+90%)

Comments: Pharmaceutical sales were down 3% in the quarter to $3.6 billion, reflecting 7% operational growth and an unfavorable impact from foreign exchange of 10%. Remicade sales were $565 million (+2%). Nasonex sales were up 3% to $321 million. Sales of Temodar were $256 million (+2%). Sales of Pegintron were down 6% to $215 million. Clarinex sales were $226 million (-6%). Sales of Claritin were $96 million (-13%). Combined sales of Zetia and Vytorin in the cholesterol joint venture with Merck, were $1.0 billion (-10%). R&D expenses were $863 million in the quarter (-5%). Earnings exclude purchase accounting adjustments related to the Organon acquisition and special, merger- and acquisition-related items.

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Spectrum Pharmaceuticals received Fast Track designation from the FDA for apaziquone in bladder cancer. Fast Track is designed to facilitate drug development and expedite the review of drugs intended to treat serious conditions and demonstrate the potential to address unmet medical needs.

“We are pleased that the FDA has accepted apaziquone for bladder cancer under its Fast Track program,” said Rajesh C. Shrotriya, M.D., chairman, president, and chief executive officer of Spectrum. “In a marker lesion study, where patients had previously failed multiple therapies, apaziquone produced a 67% complete response and was well-tolerated. We look forward to continuing with Phase III studies evaluating the efficacy and safety of apaziquone, while working with the FDA to expedite the drug’s development, review and approval process so we can help address the substantial unmet needs of patients suffering from non-muscle invasive bladder cancer.”

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Orexigen Therapeutics reported that all three remaining Phase III trials of Contrave, a combo of bupropion SR (a.k.a. Wellbutrin) and naltrexone SR, met their co-primary endpoints for the treatment of obesity. The results from the successfully completed Contrave Obesity Research, or COR, program of more than 4,500 patients exceed the FDA categorical efficacy benchmark for clinically significant weight loss, supporting the company's plan to file an NDA with the FDA in the first half of 2010.

"The successful completion of the COR Phase III program is a major milestone for Orexigen, and the results demonstrate the potential for Contrave to help patients in their battle against obesity," said Mike Narachi, president and chief executive officer of Orexigen. "These results highlight the benefits of Contrave, a novel combination that was specifically designed to address the behavior and reward pathways in the brain that impact one's ability to initiate and sustain weight loss."

All Phase III trials in the COR program were 56 week, randomized, double-blind, placebo-controlled trials. The co-primary endpoints were the proportion of patients achieving at least 5% weight loss and percent change in body weight compared to placebo.

Raoul Fisser was named a Qualified Person (QP) to the Quality Affairs team of SynCo Bio Partners. Mr. Fisser joined the Netherlands-based company from Astellas Pharma where he worked in Pharmaceutical Development, having previously gained experience in the QA Department of the largest manufacturing site of Yamanouchi in Japan. He will now support SynCo’s existing QP, Rob Sprenkels, in the release of GMP batches of recombinant protein, polysaccharide and live-microbial-based bulk drug substances and final product. This addition reflects SynCo’s growing client base and the solid business it has established, according to a company statement.

"Raoul is an excellent addition to SynCo’s Quality Affairs team and this expansion demonstrates the continuous growth in both client base and batch production at SynCo since our inception in 2000.Going forward, we look to supporting our clients in GMP production of an even wider range of novel biopharmaceuticals." commented Pierre Warffemius, the company's chief executive officer.

SynCo recently expanded the number of clinical and commercial biopharmaceutical batches it is capable of releasing annually. Theexpansion in batch release capabilities will allow SynCo to continue to grow revenues and to increase the number of GMP biopharmaceutical batches it can release each year, the company reported.

John LaHaye has been appointed to the position of vice president of business development for Catalent Pharma Solutions commercial packaging business. Mr. LaHaye has responsibility for the U.S. commercial packaging sales force and is based at Catalent’s Philadelphia, PA facility.

Mr. LaHaye joins the company from Sentrx, where he was executive vice president of business development for the past seven years. Prior to that, Mr. LaHaye was president of Innaphase and president of the SalesPlus Division for Dendrite International.

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Novartis has extended its RNAi therapeutics collaboration with Alnylam Pharmaceuticals for a fifth and final year, through October 2010. The alliance, initiated in 2005, is focused on the discovery, development, and commercialization of RNAi therapeutics toward Novartis-selected disease gene targets.

Both companies are responsible for RNAi discovery activities and Novartis is responsible for development and commercialization of RNAi therapeutic products. Novartis will continue to fund R&D efforts. Novartis retains the right to exercise a non-exclusive platform from Alnylam in exchange for certain license payments, as well as an undisclosed payment and future milestones and royalties. Also, Novartis retains certain rights to purchase Alnylam equity up to its current ownership level, which is approximately 13%.

“We are thrilled that Novartis has once again elected to extend our alliance, this time for a fifth and final planned year,” said John Maraganore, Ph.D., chief executive officer of Alnylam. “This is the second extension that Novartis has elected to make, which we believe reflects the success of our collaborative efforts as well as the scientific progress we have made in advancing our innovative technology to patients. Novartis has been an industry pioneer in recognizing the potential of RNAi therapeutics as a new class of medicines, and we look forward to continuing our work with them.”

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Gilead Sciences and Tibotec Pharmaceuticals, a unit of Johnson & Johnson, have entered an agreement to develop and commercialize a new fixed-dose combination of Truvada and TMC278 (rilpivirine).

Gilead will assume the lead role in the manufacturing, registration, distribution and commercialization of the fixed-dose combination drug worldwide, excluding the developing world and Japan. Tibotec will be responsible for the commercialization of rilpivirine as a stand-alone product and will hold rights to co-promote the fixed-dose combination in these territories. The companies will also work to make the combination drug available in the developing world.

“Gilead and Tibotec share a strong focus on bringing safe and effective treatment options to people living with HIV/AIDS,” said John C. Martin, Ph.D., chairman and chief executive officer, Gilead Sciences. “Fixed-dose regimens have become the standard of care as HIV treatment has evolved toward more simplified regimens for patients. We are very pleased to collaborate with Tibotec and look forward to advancing this new fixed-dose product.”

Tibotec is currently studying the combination of Truvada and rilpivirine in Phase III trials. If approved, it will be second complete antiretroviral treatment regimen for HIV available in a single tablet taken once daily.

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Novartis 2Q

2Q Revenues: $10.5 billion (-2%)

2Q Earnings: $2.0 billion (-10%)

YTD Revenues: $20.3 billion (-2%)

YTD Earnings: $4.0 billion (-12%)

Comments: Sales in the quarter and YTD were up 8% in local currencies (lc), but were impaired by fluctuations in exchange rates. YTD Pharmaceutical sales were up 3% to $13.5 billion (+11% lc). New products, Lucentis, Exforge, Exjade, Exelon Patch, Reclast/Aclasta and Tekturna/Rasilez, contributed $2.0 billion in sales YTD. This represented 15% of division sales compared to 9% in YTD08. Sandoz sales were down 9% to $3.5 billion (+4% lc). Consumer Health sales were $2.7 billion, down 9% (+2% lc). Vaccines and Diagnostics sales were $494 million, down 18% (-15% lc). YTD08 results included deliveries of H5N1 pandemic flu vaccines. Financing costs for the 25% Alcon stake also impacted earnings.

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Biogen Idec 2Q

2Q Revenues: $1.1 billion (+10%)

2Q Earnings: $144.9 million (-30%)

YTD Revenues: $2.1 billion (+11%)

YTD Earnings: $391.5 million (+5%)

Comments: Growth in the quarter was driven by Tysabri sales, up 27% to $188 million, and Avonex sales, up 12% to $591 million. Revenues include $276 million from Biogen’s joint business arrangement with Genentech for the co-promotion of Rituxan in the U.S. and a payment of $110 million related to the collaboration and license agreement with Acorda Therapeutics. R&D expenses in the quarter were up 65% to $416.5 million. Royalties were $25 million in the quarter compared to $28 million in 2Q08.

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Peter Green has resigned as chairman of the board and director of Patheon, Inc., effective immediately. Mr. Green joined the board as chairman in 1996.

The board has appointed Claudio F. Bussandri as the new chairman. Mr. Bussandri is the retired president and chief executive officer of McKesson Canada, where he served from 1995 to 2007. Prior to that, Mr. Bussandri was president and chief executive officer of Lantic Sugar Ltd., from 1987 to 1995. He also served as executive chairman of Lantic's U.S. subsidiary, Refined Sugar Inc. (RSI), and executive chairman of Lantic's Barbados sugar trading company. Mr. Bussandri has also held senior positions at Nabisco Brands Ltd. of Canada and held management positions with Gillette of Canada.

Currently, Mr. Bussandri is vice chairman of the board of the McGill University Health Centre (MUHC), and is chairman of MUHC's Human Resource Committee.

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Covance Inc. has signed an agreement to sell its Interactive Voice & Web Response Services (IVRS/IWRS) business to Phase Forward. The two companies have also entered into a multi-year marketing agreement to provide Phase Forward's EDC solutions and IVR/IWR services to Covance clients for five years. The sale, subject to certain closing conditions, is expected to close by the end of August.

Covance will also collaborate with Phase Forward on EDC technology used in the management of trials, including bedside data capture, electronic diaries, and other technologies used to help improve the efficiency of the drug development process.

"Covance remains fully committed to providing our clients with integrated drug development solutions, including advanced technology for supporting clinical trials," said Joe Herring, chairman and chief executive officer of Covance. "We are delighted to broaden our relationship with Phase Forward to include market leading IVRS/IWRS technology for clinical trials. The transaction also allows Covance's management team to focus more attention and investments on growing our service offerings in the larger markets we serve."

"Covance and Phase Forward are committed to working together to deliver best-of-class solutions to our clinical trial customers," said Bob Weiler, chairman, president and chief executive officer of Phase Forward. "Covance has been a pioneering leader in the IVRS/IWRS market and we look forward to building upon their success. We are also delighted to solidify our long-term strategic relationship with one of the world's leading and most successful CROs."

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Water Street Healthcare Partners, a private equity firm focused exclusively on the health care industry, has acquired the Pharmaceutical Development division from AAIPharma Inc. for an undisclosed sum.

The firm said that it will commit as much as $75 million in equity financing to expand the unit's capabilities, "with the goal of building it into the leading provider of pharmaceutical development services." The new company is named AAIPharma Services Corp.

The company, which will retain its headquarters in Wilmington, NC, serves more than 300 large pharmaceutical and biotechnology companies throughout North America. Its team of 450 scientists and professionals specialize in services that encompass the entire process of pharmaceutical drug development from discovery through commercialization. Its primary areas of expertise include analytical chemistry, formulation development, clinical packaging, oral drug delivery and contract manufacturing.

"We are thrilled to partner with Water Street to establish ourselves as an independent company," said L. Lee Karras, who has led the business for the past three years and has been appointed the company's chief executive officer. "In addition to providing significant capital resources, Water Street offers extensive pharmaceutical expertise that will benefit our company, employees and customers as we embark on a new strategic course. Together with Water Street, we will build on our core strengths to provide our customers with unparalleled knowledge and capabilities that will enable them to successfully navigate the complex drug development process."

"The rising complexity of drug development and the costs related to maintaining those capabilities in-house are leading global pharmaceutical and biotech companies to increasingly turn to outside resources for assistance," said Al Heller, an operating partner with Water Street. "AAIPharma Services goes beyond traditional levels of support to provide customers with unique expertise and capabilities that creatively address challenges that arise during drug development and manufacturing. The company is highly regarded for collaborating with customers to ensure they consistently achieve high-quality results. This is the unique value proposition that we intend to build on."

AAIPharma Services is Water Street's second platform investment in 2009 and first investment in the life sciences sector, according to a company statement. AAIPharma's Early Clinical and Clinical Development businesses were not part of the acquisition and will remain with AAI.

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Sartorius Stedim Biotech (SSB) and SAFC Biosciences have signed a global partnership agreement aimed at providing more comprehensive solutions to biopharmaceutical manufacturers. The alliance combines SSB’s filtration and liquid handling systems expertise with SAFC’s development and manufacturing of cell culture media and downstream purification products.

The companies will combine their experience with generating application data on filter and mixing performance with critical purification buffers and cell culture media. Extractable and leachable data will also be generated with buffers and media, and filters and biobag combinations.

In addition, SAFC expects to use SSB technology for storage and mixing of cell culture media to optimize its fluid/powder handling systems. Each company will offer its products with the assistance and support of its partner, to serve customers in solution creation, validation support, process improvement, technical support and problem solving.

Reinhard Vogt, executive vice president and board member of Sartorius Stedim Biotech, said, “This additional capability is instrumental for offering fully integrated cell culture media storage and mixing solutions. For customers, this partnership will yield a powerful combination of fluid management and liquid/powder systems and help them to enhance the efficiency of their cell culture processes. With this agreement, we are moving one step closer to the reality of a “totally disposable factory” with integrated technologies and control systems.”

Archie Cullen, SAFC vice president global sales, commented, “Sartorius Stedim Biotech offers SAFC Biosciences the opportunity to partner with a market leader in process and single-use technologies development, and will enable us to provide integrated, single-use systems to the global biopharmaceutical cell culture community. This agreement enhances our position as the cell culture partner with the widest range of highly customized products and services.”


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Abbott 2Q

2Q Revenues: $7.5 billion (+3%)

2Q Earnings: $1.3 billion (-3%)

YTD Revenues: $14.2 billion (+1%)

YTD Earnings: $2.7 billion (+21%)

Comments: Worldwide pharmaceutical sales were $3.9 billion (-4%).
Depakote sales were down 75% to $102 million due to generic competition. Humira sales were $1.3 billion (+20%). Kaletra sales were $343 million (-4%). TriCor/Trilipix sales were $336 million (+9%). Lupron sales were up 28% to $197 million. Worldwide vascular sales were $658 million (+34%), with U.S. vascular sales up 81% to $395 million. Earnings include a $505 million after-tax gain and ongoing contractual payments from Takeda associated with the conclusion of the TAP joint venture.

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BASi has expanded its business development team in the U.S. and Canada. Don Hawker will represent BASi in Canada and the western U.S. covering CA, OR, WA, ID, NV, UT, MT, AZ and WY. Mr. Hawker will use his sales and marketing background to help expand BASi’s contract research services (preclinical, bioanalytical, large molecule bioanalysis, method development, pharmaceutical analysis) and specialized instrumentation and accessories for electrochemistry and in vivo sampling products.

Mr. Hawker has an extensive background in sales and marketing in the life sciences industry, including GLP large and small molecule bioanalysis, proteomics, bioinformatics, GMP bioanalytical and more. He previously held positions at Tandem Labs, Solvias and Aspectrics.

“Don’s unique blend of business development, sales and marketing experiences gives BASi a definite advantage,” stated Jon Brewer, BASi’s vice president of sales and marketing.“Don maintains excellent relationships with key scientists, technology assessment and outsourcing professionals in large pharma and biotech organizations — that will give him a head start on his work for BASi.”


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Johnson & Johnson 2Q

2Q Revenues: $15.2 billion (-7%)

2Q Earnings: $3.2 billion (-4%)

YTD Revenues: $30.3 billion (-7%)

YTD Earnings: $6.7 billion (-3%)

Comments: Worldwide pharmaceutical sales were $5.5 billion in the quarter (-13%), including a 5% negative impact from currency. Domestic sales were down 16% and international sales were down 9%, the latter of which reflected an operational increase of 3% but a negative currency impact of 12%. Remicade sales were $1.1 billion (+24%). Sales of Prezista were $140 million (+59%). Velcade sales were $229 million (+12%) and Concerta sales were $317 million (+14%). Sales of Topamax and Risperdal were down 73% and 66%, respectively, due to generic competition.

Hisamitsu Pharmaceutical Co., based in Japan, plans to acquire Noven Pharmaceuticals, Inc. for $428 million in cash. Noven is a provider of transdermal patch-based treatments for attention deficit hyperactivity disorder and hormone therapy.

The companies expect that Noven will continue as a standalone business unit, operating at its current locations in Miami and New York with its employees. The agreement was approved by the boards of directors of both companies and a tender offer is expected to start July 28.

Wyeth received approval from the Chilean Ministry of Health, MINSAL (Ministerio de Salud), for Prevenar 13 Valent, (Pneumococcal Conjugate Vaccine 13 Valent (Diphtheria CRM(197) Protein)) for infants and young children. MINSAL is the first government agency to approve the vaccine.

The vaccine is approved for active immunization of children aged 6 weeks through 5 years for the prevention of invasive pneumococcal disease, as well as pneumonia and otitis media (middle ear infection) caused by 13 pneumococcal serotypes. Pneumococcal disease (PD) is the leading cause of vaccine-preventable death worldwide in children younger than 5.

"The approval of Prevenar 13 in Chile is the first of many regulatory decisions we anticipate receiving around the world this year," says Emilio Emini, Ph.D., executive vice president, Vaccines R&D, Wyeth. "We believe that Prevenar 13 is an important milestone in Wyeth's ongoing commitment to public health in the fight against serious pneumococcal disease worldwide."

The company has submitted regulatory applications for Prevenar 13 in more than 50 countries and has been granted priority review in the U.S., Canada, Australia and South Africa. Prevenar 13 is also being studied in global Phase III trials in adults, with regulatory submissions expected in 2010.

InNexus Biotechnology and Genhelix Biopharmaceutical Co. have signed a Letter of Intent to set the stage for a planned strategic collaboration to focus on developing novel antibodies engineered with InNexus' DXL technology.

The research and licensing agreement between the collaborators is expected to be completed later this year. InNexus will conduct preclinical development for a DXL therapeutic against an undisclosed target, with Genhelix providing GMP production and commercial manufacturing. DXL antibodies are biologics engineered with the novel ability to link with one another (self-binding) upon reaching their target, exhibiting marked enhancements for ADCC and CDC functions over the source antibody, according to an InNexus statement.

The planned alliance follows InNexus' recent successful meeting with the FDA, where the agency expressed support for the company's product development plans, following a comprehensive review of the proposed clinical pathway for its lead preclinical candidate, DXL625 (CD20) for the prospective treatment of Non-Hodgkin's Lymphoma and/or Chronic Lymphocytic Leukemia. The agency also provided a Manufacturing Exception Approval, allowing InNexus to manufacture all clinical material needed for DXL625's Phase l trial in its facilities located on the campus of Mayo Clinic in Scottsdale, AZ.

Jeff Morhet, chief executive officer of InNexus, commented, "Our organizations are poised to strategically collaborate as partners focused on the development of new products, while maintaining our respective business competencies. This collaboration provides significant opportunities for both companies, and represents a creative approach to partnering that brings resources and capabilities together while the partners stay focused."

David Marcos Martinez, chief executive officer of Genhelix, remarked, "The antibody industry is growing at an unprecedented rate. Today, it is estimated to have over $30 billion in worldwide sales, and antibodies are expected to be the pharmaceutical industry's leading choice for the development of new therapeutic compounds. We are excited to be working with Mr. Morhet, his team and the partnership, as both organizations have enormous potential."

Mary Lynne Hedley, Ph.D. has been appointed executive vice president of operations and chief scientific officer of Abraxis BioScience. Dr. Hedley most recently served as executive vice president of Eisai Corp. of North America following Eisai’s acquisition of MGI Pharma, where she had served as executive vice president and chief scientific officer since 2005. She joined MGI in 2004 as senior vice president and general manager. Previously, Dr. Hedley co-founded Zycos, Inc., a biotechnology company, and held roles of progressively greater responsibility ultimately leading to her serving as the company’s president and chief executive officer.

“Mary Lynne is an exemplary leader with a strong track record of driving the growth of biotechnology companies,” said Lonnie Moulder, president and chief executive officer of Abraxis. “Her general management and R&D leadership experience, coupled with a deep scientific background, make her an ideal addition to our executive team. We are very pleased to have this experienced executive join Abraxis as we advance our mission to enhance the lives of cancer patients throughout the world.”

The FDA has approved the NDA by Daiichi Sankyo and Eli Lilly and Co. for Effient (prasugrel) tablets for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndromes who are managed with an artery-opening procedure known as percutaneous coronary intervention (PCI). PCI usually includes the placement of a stent to help keep the artery open.

Effient helps keep blood platelets from sticking together to form clots, which can block an artery. Taking Effient with aspirin after PCI has been shown to reduce the chances of having a cardiac event (such as a heart attack) and stent-related blood clots (known as stent thrombosis) among patients with acute coronary syndromes (ACS), a common cardiovascular condition, according to a Daiichi statement.

"After more than a decade of research and testing, we are proud to provide this new treatment option to patients with ACS who are managed with PCI," said Takashi Shoda, president and chief executive officer, Daiichi Sankyo Company, Limited. "Our Daiichi Sankyo and Lilly alliance will launch Effient in the U.S. in the coming weeks."

"The FDA approval of Effient is a major step forward in the treatment of acute coronary syndromes," said John Lechleiter, Ph.D., chairman and chief executive officer of Lilly. "The Daiichi Sankyo/Lilly alliance has provided doctors with an important new option that provides greater protection against thrombotic cardiovascular events to help those suffering with ACS who are being managed with PCI."

In trials, Effient demonstrated a risk "significant, sometimes fatal bleeding," according to the FDA, so the drug will contain a "black box" warning.

The risk of bleeding was highest in patients who were either 75 years of age or older, weighed less than 132 pounds, or who had a prior history of transient ischemic attacks (TIA) or stroke. Effient is contraindicated in patients with a history of prior TIA/stroke. It is generally not recommended in patients 75 years of age or older, except for patients in high-risk situations, such as those with diabetes or a history of prior heart attack.

The approval came 18 months after submission, and involved some controversy around the FDA's advisory panel. The drug is expected to compete with Plavix, the blockbuster marketed in the U.S. by Bristol-Myers Squibb.

Endo Pharmaceuticals has licensed the exclusive rights to develop and market Bioniche Life Sciences' Urocidin in the U.S., with an option for global rights. Urocidin is a formulation of Mycobacterial Cell Wall-DNA Complex (MCC) developed by Bioniche for the treatment of non-muscle-invasive bladder cancer that is currently in Phase III testing.

Under the agreement, Bioniche will receive an up-front cash payment of $20 million and the potential for as much as $110 million in additional payments based on future clinical, regulatory, and commercial milestones. Bioniche will manufacture the product and receive a transfer price for supply.

"We are excited about the opportunity to expand our portfolio in bladder cancer treatment and enhance our late stage development pipeline," said David Holveck, president and chief executive officer of Endo Pharmaceuticals. "In August Endo plans to launch Valstar, for the treatment of bladder cancer. If successful in clinical development, Urocidin has the potential to extend and enhance our recent therapeutic expansion and strengthen the Valstar franchise."

Graeme McRae, chairman, president and chief executive officer of Bioniche, added, "Endo Pharmaceuticals represents the optimal development and commercialization partner for Bioniche, given its understanding of the bladder cancer market and breadth of pharmaceutical industry experience. We look forward to advancing the Urocidin development and commercialization program in collaboration with the Endo team."

AstraZeneca has terminated its license agreement with MAP Pharmaceuticals, Inc. related to the company's Unit Dose Budesonide (UDB) product candidate. All rights to the drug revert to MAP, who plans to suspend development of UDB, which did not meet primary endpoints in a Phase III trial in children 12-months to eight years of age with mild asthma.

"Physicians and parents continue to express a need for improved therapies for pediatric asthma that offer faster nebulization times, lower doses of steroid exposure, improved treatment compliance and reduced side effects when compared to currently available therapies. MAP Pharmaceuticals is considering options for its pediatric asthma program moving forward, including the development of a next generation therapy with budesonide," said Timothy S. Nelson, president and chief executive officer of MAP Pharmaceuticals.

Jonathan Lieber has been appointed chief financial officer, Xcellerex, Inc. Mr. Lieber joins the company from Altus Pharmaceuticals, where he was senior vice president, chief financial officer, and treasurer. During his tenure, he was instrumental in raising approximately $250 million in three financings, including a $110 million initial public offering. Previously, he served as a vice president in SG Cowen’s Healthcare Investment Banking Group.

“Jon brings a wealth of expertise in finance, raising capital, and management,” said Joseph Zakrzewski, president and chief executive officer of Xcellerex. “We look forward to many contributions from Jon as we accelerate the growth of our three businesses, including single-use component bioreactors/mixing systems and the FlexFactory, contract development & manufacturing services, and proprietary biomolecule development.”

Addex Pharmaceuticals reached the second preclinical milestone in an exclusive collaboration and license agreement with Merck, focused on developing allosteric modulators for treatment of Parkinson's disease and other undisclosed indications. Addex will receive $500,000 for the second milestone.

Using allosteric modulators, this collaboration is focused on developing drugs that specifically activate the metabotropic glutamate receptor 4 (mGluR4). The preclinical study showed the desired non-dopaminergic activity profile after oral administration of mGluR4 positive allosteric modulator (PAM) in an animal model of Parkinson's disease.

Under the terms of the agreement, Addex is eligible to receive as much as $106.5 million in research, development and regulatory milestones for the first product developed for multiple indications. Additional milestones of as much as $61 million would be payable if a second and third product is developed. Addex is also eligible to receive royalties on sales of any products resulting from this collaboration. Merck is responsible for clinical development.

Lonza and Medarex, Inc. have signed a collaboration agreement under which Lonza will provide manufacturing services to support the development and commercialization of Medarex’s pipeline of therapeutic proteins and antibody drug conjugates (ADCs). As part of the agreement, Lonza may provide process development services for certain Medarex programs and may reserve manufacturing capacity for antibody and ADC programs at its biopharmaceutical facilities around the world. Further details were not disclosed.

“We are pleased to be working with such a successful mid-size biotech company to advance and strengthen their robust portfolio of innovative therapies,” said Dr. Stephan Kutzer, head of Lonza Biopharmaceuticals. “Supporting Medarex’s immediate and long-term needs with our expertise in mammalian cell culture and antibody drug conjugates is both exciting and rewarding.”

Medarex’s biologics portfolio is focused on treating oncology and immunology therapeutic indications with ten antibody programs in Phase III to Phase I development. Under the terms of the agreement, Lonza may be supporting a portion of the Medarex product pipeline.

ICON has acquired Veeda Laboratories Ltd., a provider of biomarker laboratory services to pharmaceutical and biotechnology companies. The acquisition adds to ICON's bioanalytical and immunoassay capabilities provided at its lab in Manchester, UK, and through Prevalere Life Sciences in the U.S.

“Biomarkers of disease are assuming an ever increasing role in the discovery and development of drugs,” commented Thomas Frey, president, ICON Development Solutions. “In Veeda Laboratories, we have acquired a company that has a very strong reputation for biomarker development and has well-established relationships with top-tier pharmaceutical and biotechnology companies. Veeda’s team of scientists will also greatly enhance ICON’s existing team of biomarker experts.”

“We are excited to be joining ICON,” commented John Allinson, head of Veeda Laboratories, Oxford. “This deal will enable us to enhance and expand our biomarker, pharmacokinetic and immunogenicity services and to offer our clients a broader suite of drug development services. We look forward to working closely with ICON’s global network of laboratories to develop innovative biomarker solutions that improve clients’ drug development and therapeutic decision making.”

Merck and Portola Pharmaceuticals, Inc. have signed an exclusive global collaboration and license agreement for the development and commercialization of betrixaban, an investigational oral Factor Xa inhibitor anticoagulant currently in Phase II development for the prevention of stroke in patients with atrial fibrillation (SPAF).

Portola will receive an initial payment of $50 million and is eligible to receive additional payments totaling as much as $420 million based on development, regulatory and commercialization milestones, as well as royalties on sales of betrixaban. Merck will assume all development and commercialization costs. Portola has retained an option to co-fund Phase III trials in return for additional royalties and co-promotion of the drug in the U.S.

"Betrixaban represents an important addition to our late-stage portfolio with the potential to be a significant medicine in the Factor Xa inhibitor class," said Luciano Rossetti M.D., senior vice president and franchise head, Atherosclerosis and Cardiovascular, Merck Research Laboratories. "This agreement reinforces Merck's focus on developing an innovative portfolio of products for the treatment and management of multiple aspects of cardiovascular disease."

Charles Homcy, M.D., president and chief executive officer of Portola, commented, “This is the second major collaboration we have announced this year validating the high quality of our drug candidates and the expertise of our R&D team. This represents a significant milestone for the company and we now have over $175 million in cash to further advance the rest of our valuable proprietary pipeline.”

AstraZeneca plans to further develop AZD3480 (TC-1734) for attention deficit/hyperactivity disorder (ADHD) and will make a $10 million milestone payment to Targacept. AZ will also continue development of AZD1446 (TC-6683) in Alzheimer’s disease. The drug is currently in Phase I and was discovered through the parties’ ongoing research collaboration.

Targacept is also eligible to receive a milestone payment for AZD3480 if ADHD is the only target indication for which AZD3480 is developed further. Targacept remains eligible to receive more than $100 million if development, regulatory and commercial sale milestones are achieved for AZD3480 in ADHD, as well as royalties on any future sales of AZD3480 in any indication. Targacept may also receive future success based milestones for AZD1446 and royalties on any future sales.

“We continue to be enthusiastic about neuronal nicotinic receptors as a promising new mechanism in the treatment of multiple cognitive disorders,” said Bob Holland, vice president and head of the Neuroscience Therapy Area, AstraZeneca. “We believe the therapeutic profile of AZD3480, a non-stimulant, may be an important advance for treating patients with ADHD and we also remain positive about the potential of NNR agonists to treat Alzheimer’s disease.”

“We appreciate the efforts and dedication of our colleagues at AstraZeneca as we work together to develop and deliver the promise of NNR Therapeutics to patients affected by cognitive disorders like ADHD and Alzheimer’s disease,” said J. Donald deBethizy, Ph.D., president and chief executive officer of Targacept. “In addition to AZD3480 and AZD1446, we remain enthusiastic about the breadth and pharmacological diversity of our portfolio. With our pipeline, strong alliances and a cash runway that we expect to fund our operations for at least the next two years, we are well positioned to execute our business plan.”

Absorption Systems has acquired Perry Scientific, Inc., an in vivo toxicology and pharmacokinetics testing company located in San Diego, CA. Perry’s research services include testing for toxicology, medical devices, preclinical models and CNS pharmacology.

In addition to routine preclinical pharmacokinetics testing, Absorption Systems will now conduct GLP studies in the San Diego testing facility, which is accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International.

“The acquisition of Perry Scientific furthers our mission to efficiently move clients from the early stages of drug discovery testing for ADME and pharmacokinetics through the definitive safety and toxicology testing necessary for new drug and device submissions,” commented Patrick M. Dentinger, president and chief executive officer of Absorption Systems. “By offering a full range of tests, we will be able to design and perform studies that will get clients to the point of submission to the FDA as quickly as possible.”

“Joining forces with Absorption Systems is a natural step in our growth because our respective businesses are entirely complementary,” said Andrew Perry M.D., Ph.D., founder of Perry Scientific. Now we can offer our customers the convenience and accuracy of having an entire preclinical testing package performed at a single facility—the combined company offers all the services needed to move a new drug from the benchtop to the clinic.”

Biogen Idec's PEGylated interferon beta-1a (BIIB017) for relapsing multiple sclerosis (RMS) was granted Fast Track designation by the FDA. Biogen plans to enroll more than 1,200 patients in a Phase III, randomized, double-blind, placebo-controlled trial that will evaluate the efficacy and safety of the drug in patients with RMS.

The FDA's Fast Track program is designed to expedite the review of new drugs that are intended to treat serious or life-threatening conditions and have the potential to address unmet medical needs.

“Early-stage clinical trials suggest that PEGylated interferon beta-1a has the potential to offer less frequent dosing without compromising efficacy, which would be a significant development for people living with multiple sclerosis,” said Michael Panzara, M.D., M.P.H., vice president and chief medical officer of neurology at Biogen Idec. “We look forward to working closely with the FDA to expedite the compound’s development and review process.”

Norwich Pharmaceuticals, Inc. has formed a strategic alliance with Emerson Resources, Inc. focused on bringing together the capabilities of the two companies in order to provide a broader range of services to the industry.

Norwich recently completed an expansion of its capabilities and services focused on full product lifecycle support, with a concentration in the area of new product development. Chris Calhoun, president of Norwich Pharmaceuticals, commented, “This alliance builds on our long-standing relationship with Emerson, and on our new full-service capabilities at Norwich, offering a clear path to commercialization for the clients of both our companies.”

Adolfo Gomez, president of Emerson Resources, said, “Our two companies were formed at about the same time, we’ve grown together, and we’ve been working together for years. Being relatively close to one another, we have been able to quickly access and share each other’s resources. By leveraging our collective experience and combined production capacity, both companies can bring faster, more flexible full-service capabilities to our customers, without the burdens of added bureaucracy that often hamper our competitors.”

Emerson will provide early stage development and clinical trial material manufacturing, as well as analytical services, and support of formulation development, method qualification for pilot clinical trials and analytical method transfer. Phase III and commercial batches will be manufactured exclusively at the Norwich facility, with full regulatory support for compiling INDs/NDA’s/ANDA’s and marketing applications for selected projects.

A joint governance team will oversee the alliance and will be responsible for overall performance management and individual project teams executing separate initiatives. Joint projects will be managed through a single point of contact.

Galapagos NV has successfully identified a second preclinical candidate compound in its osteoarthritis alliance with GlaxoSmithKline (GSK) and reached a milestone on another compound, triggering payments to Galapagos totaling $7.3 million.

This small molecule candidate meets all of the chemical and biological criteria set by GSK and is now ready for scale up chemistry and safety studies. Phase I trials are expected to begin in 2010.

“Six months after announcing our first pre-clinical candidate in this alliance, we are pleased to announce the delivery of a second candidate drug,” said Onno van de Stolpe, chief executive officer of Galapagos. “This achievement illustrates that Galapagos is successfully progressing multiple programs across each alliance, thereby increasing the likelihood of producing novel, disease-modifying therapeutics.”

The two companies entered the alliance 
in June 2006 to discover and develop disease-modifying medicines for GSK’s global R&D organization. To date, Galapagos has earned approximately $42 million in payments from GSK under this alliance.

The European Commission has granted marketing authorization for Novo Nordisk's Victoza for the treatment of type 2 diabetes in adults. The authorization covers all 27 European Union member states.

Victoza is the brand name approved in Europe for liraglutide, the first once-daily human Glucagon-Like Peptide-1 (GLP-1) analogue developed for the treatment of type 2 diabetes. The authorization covers:

1. combination treatment with metformin or a sulphonylurea in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin or sulphonylurea, and
2. combination treatment with metformin and a sulphonylurea or metformin and a thiazolidinedione in patients with insufficient glycaemic control despite dual therapy.

"This is an important milestone for Novo Nordisk and for the treatment of type 2 diabetes," says Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "In clinical studies involving more than 6,500 people with type 2 diabetes, Victoza has been shown to have a significant blood glucose-lowering effect and lead to weight loss, while having a low risk of hypoglycaemia. On this background, we are convinced that Victoza is a valuable new treatment option for people with type 2 diabetes."

Novo Nordisk will launch Victoza in the UK, Germany and Denmark during the summer and in other European markets during the second half of 2009 and throughout 2010.

Novartis has committed to a 10-year term of the strategic alliance with MorphoSys. The companies began their alliance in December 2007. The decision to extend to the full term of the agreement was based on the successful achievement by MorphoSys of certain predefined improvements in its proprietary technologies, according to a MorphoSys statement. The collaboration will now run until 2017 and may be extended by Novartis for an additional two years beyond that time under the same financial terms and conditions. The option for Novartis to terminate the alliance after seven years has been removed.

"Our alliance with Novartis is developing well and we are therefore delighted to be able to exploit its full potential", commented Dr. Simon Moroney, chief executive officer of MorphoSys. "The latest technological advances in our core antibody platform contributed significantly to achieving this extension."

In December 2007, MorphoSys and Novartis forged a comprehensive strategic alliance in the discovery and development of biopharmaceuticals. Financial terms include committed payments in excess of $600 million over the 10-year lifetime of the agreement. Within the collaboration, two antibody programs are currently in clinical development.

Johnson & Johnson and Elan Corp. entered a definitive agreement under which J&J will acquire all of the assets and rights to Elan's Alzheimer's Immunotherapy Program (AIP), through a newly formed company. J&J, through its affiliate, will invest $1 billion in Elan in exchange for newly issued American Depositary Receipts (ADRs) of Elan, which represents 18% of the company's outstanding shares.

The AIP Program is the result of Elan's collaboration with Wyeth to research, develop and commercialize selective products for the treatment and/or prevention of neurodegenerative conditions, including Alzheimer's disease.

Elan will receive a 49.9% equity interest in the newly formed J&J company and will be entitled to a 49.9% share of the profits and certain royalty payments upon the commercialization of products under the collaboration with Wyeth.

J&J will assume and continue Elan's activities with Wyeth under the AIP Program and will initially commit as much as $500 million for the development and commercialization of bapineuzumab, currently in Phase III trials evaluating slowing the progression of Alzheimer's disease, as well as other compounds. The agreement provides for additional funding as needed.

"Alzheimer's disease is a significant unmet need in aging populations globally," said Sheri McCoy, J&J’s worldwide chairman, Pharmaceuticals. "Johnson & Johnson's development capabilities, commercial experience and global reach will provide the foundation to accelerate the AIP Program development, and increase its potential availability for patients globally."

Elan chief executive officer Kelly Martin contends that this transaction positively impacts Elan and patients globally, remarking, "This transaction will leverage Elan's unique scientific and clinical work and leadership in bringing treatments to market that potentially slow the progression of Alzheimer's disease. The Elan commitment to scientific innovation and patients remains absolute and we will continue to build upon and expand our leadership in the fields of neuroscience and immunology."

The FDA has mandated that Pfizer update the U.S. product labeling for Chantix, a smoking cessation treatment, with safety information in a black box warning as well as revised warnings and precautions.

The updated label, based on post-marketing reports, highlights safety information about reports of neuropsychiatric events and updates the warning about reports of neuropsychiatric symptoms and suicidality. It also adds warnings about reports of allergic reactions and serious skin reactions, and updates precautionary information about driving or operating machinery to include details about reports of accidental injury.

“The labeling update underscores the important role of health care providers in treating smokers attempting to quit and provides specific information about Chantix and instructions that physicians and patients should follow closely,” said Dr. Briggs W. Morrison, senior vice president, Primary Care Development Group at Pfizer. “Quitting smoking is one of the best things people can do for their health, but the quitting process is both difficult and complex.”

GlaxoSmithKline’s smoking cessation drug, Zyban, will also put a black box warning on its label.

The FDA has approved Sanofi-Aventis's Multaq (dronedarone) 400 mg tablets. Multaq, an anti-arrhythmic, is the first drug approved in the U.S. to show a clinical benefit to reduce cardiovascular hospitalization in patients with atrial fibrillation (AF) or atrial flutter (AFL), according to SA. The FDA's approval is based on five international, multi-center, randomized clinical trials involving nearly 6,300 patients.

“The FDA approval of Multaq is an important milestone in the management of atrial fibrillation or atrial flutter that demonstrates the commitment of Sanofi-Aventis to provide patients and physicians with important new medicines in therapeutic areas with significant healthcare needs,” said Christopher A. Viehbacher, chief executive officer of SA. “Sanofi-Aventis is proud of its ability to bring innovative therapies to market and contribute to reducing the public health burden of atrial fibrillation.”

To ensure the use of Multaq in the appropriate patient population, Sanofi-Aventis U.S. LLC has launched mPACT — Multaq Partnership for Appropriate Care and Treatment — the Risk Evaluation and Mitigation Strategy (REMS) developed by sanofi-aventis U.S. LLC. The mPACT Partnership was developed to assist healthcare professionals (HCPs) with the identification of appropriate patients and to ensure the safe use of Multaq while minimizing risk. The risk mitigation program consists of a Communication Plan for HCPs, a medication guide for patients and post-marketing surveillance.

“We are pleased that the FDA has granted approval of Multaq for patients in a therapeutic area that has seen few new treatment options in the last 20 years,” said Marc Cluzel, M.D., SA's senior vice president, R&D.

The incidence of atrial fibrillation is growing worldwide in relation to aging populations. It is emerging as a public health concern and affects about 2.5 million people in the U.S. and 4.5 million people in the EU. Atrial fibrillation is a potentially life-threatening condition, with significant burden on patients, health care providers and payers.

Multaq® is under regulatory review by the European Medicines Agency (EMEA).

Pfizer is discontinuing the SUN 1122 Phase III trial evaluating Sutent plus FOLFIRI (irinotecan plus infusional 5-fluorouracil and leucovorin) versus FOLFIRI alone for the first-line treatment of metastatic colorectal cancer (CRC). An independent Data Monitoring Committee found that the addition of Sutent to the chemotherapy regimen would be unable to demonstrate a statistically significant improvement in the primary endpoint of progression-free survival (PFS) compared to FOLFIRI alone. No new safety issues were identified.

“We are disappointed with this result, but trial successes and failures are an integral part of cancer drug development and contribute to a growing body of knowledge on improving patient care,” said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs for Pfizer’s Oncology Business Unit. “Pfizer remains committed to developing new agents for colorectal and other GI cancers with ongoing clinical studies evaluating other agents in its pipeline. Investigators will be consulted about the status of sunitinib colorectal studies other than the SUN 1122 trial. Pfizer also continues to study sunitinib in late-stage trials as a potential treatment for various other types of cancer.”

Sutent is currently approved for both gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate, and advanced/metastatic renal cell carcinoma (RCC).

Astellas Pharma and Maxygen will establish a joint venture focused on the discovery, research and development of multiple protein pharmaceutical programs, including Maxygen’s MAXY-4 program and other early stage programs. As part of the arrangement, Astellas will have an option to acquire all of Maxygen’s ownership interest in the joint venture within three years of the joint venture. The arrangement expands the two companies existing MAXY-4 collaboration in autoimmune diseases and transplant rejection.

Maxygen will contribute all of its programs and technology assets in protein pharmaceuticals, as well as $10 million in cash for the new JV. Maxygen's ownership interest will be approximately 83%. Astellas will also invest $10 million and will have a 17% ownership interest. Should Astellas acquire Maxygen’s ownership interest at specified exercise prices, the increase each quarter will go from $53 million to $123 million during the three-year term of the option. Grant Yonehiro, Maxygen’s chief business officer, is expected to serve as chief executive officer of the venture.

Under a separate collaboration agreement, Astellas will fund all of the costs, as much as $30 million over the three-year option term, for the discovery, research and development of multiple protein therapeutics (other than MAXY-4) by the JV. Astellas will be granted an option to obtain a license to one product developed by the venture under this collaboration, if Astellas does not exercise its buy-out option during the option term. Development costs for the MAXY-4 program will be shared by the JV under the terms of the existing MAXY-4 collaboration agreement.

In the event Astellas does not exercise its buy-out option, all rights to the protein therapeutics developed through the JV will be retained by the JV, and Astellas will provide as much as 18 months of transition funding to it.

Charles River Laboratories has made changes within its Research Models and Services (RMS) and Preclinical Services (PCS) and Sales organizations. Real H. Renaud, corporate executive vice president and president, Global RMS, announced he will retire by the end of 2010. As part of the transition of Mr. Renaud’s responsibilities, Davide Molho, D.V.M. has been promoted to corporate senior vice president, North American and European RMS.

James C. Foster, chairman, president and chief executive officer, said, “Real Renaud has had a stellar career at Charles River, beginning 45 years ago and rising through the ranks to head our global RMS business. Under his leadership, we have become the premier provider of research models and scientific support services to the drug development industry, recognized worldwide for our quality, biosecurity and scientific expertise. Real has developed a world-class management team, including his successor, Davide Molho, which positions us extremely well to maintain our market leadership.”

Dr. Molho joined Charles River Italy in 1999, and was promoted to director of operations for RMS Italy in 2002. In 2005, his role was expanded to include all French RMS operations and in 2007, he became corporate vice president, European RMS.

Through the restructure of the PCS business, the company created a dual-accountability structure with both global functional teams and site-level management, in an effort to increase harmonization and integration of all services across the PCS organization.

Under the new global operations structure, Brian Bathgate, Ph.D., corporate senior vice president, will assume responsibility for Global Laboratory Sciences in addition to his current responsibility for Global Biopharmaceutical Services. Dr. Bathgate will maintain oversight of PCS, Europe. Christopher J. Perkin, D.A.B.T., corporate senior vice president, will oversee site operations in North America and China. He will have responsibility for harmonizing technical operations and site infrastructure. Stephen K. Durham, D.V.M., Ph.D., D.A.C.V.P., corporate vice president, will assume responsibility for global toxicology and pathology. Dr. Durham will set global standards for and ensure effective delivery of these services across all PCS sites. Joseph C. Siglin, Ph.D., D.A.B.T., divisional vice president, will continue to focus on implementation of the company’s Lean Six Sigma program and other global process improvement initiatives.

Charles River is also realigning its sales organization, switching from a sales approach focused on its portfolio of products and services, to one focused on value-based solutions by customer segment. The company is establishing a three-part sales organization for global biopharmaceutical companies, small and mid-size pharmaceutical and biotechnology companies, and the academic and government sector.

Dr. Christophe Berthoux, corporate executive vice president, Global Sales and Marketing, and chief commercial officer, said, “This is the next step in the evolution of our Sales organization from locally to globally focused. Consistent with the PCS restructuring, we believe the realigned sales force will more effectively address our clients’ needs, and be able to access resources throughout the organization to support each client’s specific requirements.”

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