Sanofi-Aventis

3Q Revenues: $9.9 billion (-2%)

3Q Earnings: $1.9 billion  (-27%)

YTD Revenues: $29.6 billion (-3%)

YTD Earnings: $5.3 billion  (-18%)

Comments: Pharmaceutical sales in the quarter were up 5% to $8.5 billion, driven by the company's top 15 products. Lovenox sales were $917.5 million (+9%). Plavix sales were $910.3 million (+6%). Lantus sales were $884.3 million (+29%). Taxotere sales were up 17% to $261.5 million. Aprovel sales were up 15% to $430.6 million. Copaxone sales were $144.5 million (+19%). In the U.S., sales of Ambien CR and Ambien IR totaled $177 million and $28 million respectively. Vaccines revenue was $1.4 billion in the quarter (+9%). Flu vaccines were up 10% at $540.4 million. Polio/Pertussis/Hib Vaccines were up 43% to $280.3 million. R&D expenses were flat at $1.6 billion in the quarter (or +4.5% after excluding the effect of exchange rates). In the quarter, the company completed the acquisitions of Acambis (vaccines) and Symbion (nutraceuticals/OTC, Australia). 3Q and YTD results include the unfavorable effect of exchange rates.    

Rod Szarka has been appointed business development manager, QSV Biologics Ltd. He will be responsible for new business in California. Mr. Szarka has more than16 years of experience in drug research and development and four years of business development experience with pharmaceutical clinical trials. Prior to joining the company he was manager of business development at Global IQ. He spent several years with Cytovax Biotechnologies as laboratory research manager, where he was responsible for supervising, instructing and guiding research technicians in the microbiology, immunology and animal research unit. Mr. Szarka also spent time at ChemBioMed Ltd. and the Alberta Research Council.
   
Dr. Graeme Macaloney, QSV's president and chief executive officer, said, “Rod brings a strong ability to research potential companies and cultivate client relationships in the highly active California market for QSV. He couples this with a broad knowledge of protein, monoclonal antibody and vaccine drug development. Rod is a welcomed addition to the QSV Biologics team as he brings a professionalism and customer service ethic consistent with QSVs culture and reputation.”

GlaxoSmithKline will acquire Genelabs Technologies for approximately $57 million in cash. This acquisition is part of GSK’s effort to develop new therapies for hepatitis C virus (HCV). Genelabs will become part of GSK’s Drug Discovery organization and its HCV programs will be consolidated into GSK's therapeutic approaches already underway internally and through collaborations.
   
“Genelabs has demonstrated a strong track record in HCV drug discovery and identified numerous novel classes of inhibitors that target unprecedented mechanisms in the virus’s life cycle,” said Zhi Hong, senior vice president of the Infectious Diseases Centre for Excellence in Drug Discovery (ID CEDD) at GSK. “This arrangement, combined with our other collaborations, will give GSK a broad HCV drug discovery platform addressing novel targets and innovative therapeutic approaches.”
   
Fred Driscoll, president and chief executive officer of Genelabs, said, “This transaction provides our shareholders with certain value at a substantial premium to our stock price. Through the efforts of our experienced scientific staff and other employees, we have generated highly differentiated compounds with the potential to address unmet medical needs of people with the HCV infection. GSK’s world-class research and development organization will allow us to accelerate our strategic vision of providing novel treatments that deliver tremendous value for patients.”

Aryo Nikopour has been named vice president of scientific and technical services, and Greg McParland has been named chief operating officer at Irvine Pharmaceutical Services. These changes were made to accommodate the company’s growth, as well as the anticipated launch of its new subsidiary, Avrio Biopharmaceuticals, in January 2009.
   
Mr. Nikopour has spent five years at Irvine and has more than 20 years of experience in the pharmaceutical industry. His previous positions — at organizations such as PPD, Alpharma (Actavis), Solvay Pharmaceuticals and Solvay Animal Health — have helped develop his expertise in a range of areas, including chromatographic method development and validation, extractables/leachables studies, and implementation of new technologies and capabilities such as inhalation/nasal, biopharmaceutical and structural chemistry. He also has experience in scientific staff management, quality control, stability testing and regulatory requirements.
   
Mr. McParland has more than 30 years of experience in the pharmaceutical and chemical industries. Prior to joining the company, he was chief executive officer of Girindus America, Inc., a member of Solvay Organics, where he lead the company through the transition to become a commercial operation focused on small molecule and oligonucleotide APIs. His additional leadership experience includes working at Cambrex Corp., Altergy Systems, NextPharma and Aerojet Fine Chemicals in the areas of operations, sales and marketing, strategic planning, process optimization, and mergers and acquisitions.
   
“We are looking forward to continued growth under the leadership of Aryo Nikopour and Greg McParland,” said Assad J. Kazeminy, chief executive officer and founder of Irvine Pharmaceutical Services. “I am confident they will lead us to even greater success as we expand and work to provide ever improving services to our clients.”

Jubilant Organosys has strategically aligned its two entities, U.S.-based HollisterStier Laboratories and Canada-based Draxis Specialty Pharmaceuticals, and has assigned new leadership roles. The alignment is in an effort to leverage the strengths of these companies in the area of contract manufacturing of sterile injectables and non-sterile products and specialty pharmaceuticals. The unified operations will focus on R&D and product innovation for specialty pharmaceuticals, and will consolidate Jubilant’s sterile and non-sterile contract manufacturing with its multi-site capabilities.
   
Jean Pierre Robert has been appointed chief executive officer for the specialty pharmaceutical organization. He will be responsible for the radiopharmaceuticals business of Draxis as well as the allergy extracts business of HollisterStier. Marcelo Morales has been appointed chief executive officer for contract manufacturing. He will have responsibility for the sterile injectables manufacturing arm of HollisterStier and the sterile injectable, semisolids and solid dose manufacturing operations of Draxis.
   
“This strategic realignment will enable us to drive value for our customers through synergistic operations and will offer exciting opportunities for all of us,” said Jubilant Organosys co-chairmen Shyam and Hari Bhartia.

AMRI is expanding its multipurpose pilot plant facilities in Aurangabad, India for non-GMP manufacturing services to 1,000-liter scale capacity, which will allow the company to provide customized pilot scale materials. The new facility will serve as an extension to AMRI’s kilo lab capabilities in Hyderabad, which operates to 100 liters in scale. The plant's first production run is currently underway.
   
“We are pleased to offer another high value alternative to our customers seeking the cost benefit of doing business in Asia, but retaining the quality they expect from a U.S. based-organization. Separately, we look forward to realizing cost savings at our U.S. manufacturing operations by becoming our own provider for some raw materials, eliminating third party costs in both money and lead time. This expansion further demonstrates AMRI’s investment and focus in building a worldwide drug discovery and development platform,” said chairman, chief executive officer and president Thomas E. D’Ambra, Ph.D.
   
The company noted that certain plant production will be dedicated to making starting materials for the company’s U.S. manufacturing facilities, reducing the plant’s reliance on external resource providers.

Nicholas Moore, Ph.D. has been named director of development and pharmacology, discovery R&D, AMRI. Dr. Moore will be responsible for the company's internal R&D portfolio, including the progression of discovery phase programs and the guidance of emerging candidates toward clinical trials. Dr. Moore will report to Bruce Sargent, Ph.D., vice president of discovery R&D.  
   
Dr. Moore has more than 27 years of industrial experience in experimental pharmacology and drug development from early discovery through late clinical phases. Most recently, he was responsible for behavioral pharmacology at Lundbeck Research USA as an associate director in the neuroscience division. Prior to Lundbeck, Dr. Moore spent 23 years in neuroscience discovery research at the Lilly Research Center in roles of increasing responsibility. He has extensive knowledge of preclinical studies, product in-licensing, due diligence and laboratory animal science. While at Lilly he directed the preclinical studies required for the successful development and commercialization of schizophrenia  drug Zyprexa.
   
“Dr. Moore’s skills and experience strengthen our R&D capabilities, helping us build on our existing platform which has already delivered an AMRI oncology compound into Phase I, and in collaboration with BMS, the nomination of two clinical candidates, one of which is currently enrolled into Phase I studies by BMS,” said Dr. Sargent.

Wendy Shusko has been named chief operating officer of WellSpring Pharmaceutical. In her new role, Ms. Shusko will maintain financial responsibilities as well as broaden her oversight to operations with an initial focus on the newly acquired consumer brands product line.
       
Ms. Shusko joined the company in 2000 and most recently served as chief financial officer. She has more than 20 years of experience in finance and operations, with 16 of those years in the pharmaceutical industry. From 1992 until joining the company, Ms. Shusko worked in various management and financial positions for Roberts Pharmaceutical, an international pharmaceutical company, including director of finance and financial operations.
       
"WellSpring's success thus far can be attributed to driven efforts toward a common vision.  I am now asking Ms. Shusko to apply her experience and skills to operations with the anticipation that we will continue that trend in the years to come," said Dr. Robert A. Vukovich, WellSpring's chief executive officer and chairman.

Laureate Pharma has entered into a cGMP contract manufacturing agreement with Tolera Therapeutics, a biotechnology company that develops targeted therapies and safer solutions for immune modulation and related medical needs. Under the agreement, Laureate will produce Tolera's TOL101 monoclonal antibody under cGMP conditions to be used in clinical trials. Terms of the agreement were not disclosed.
   
"We are pleased to work closely with Tolera to accelerate their antibody therapeutics program to clinic," said Robert J. Broeze, Ph. D., president and chief executive officer of Laureate. "We are committed to providing Tolera with superior services to help them achieve their manufacturing objectives."
   
"We are excited to work with Laureate, a company with demonstrated expertise in biopharmaceutical manufacturing. Their capabilities in both clinical and commercial-grade materials can support our aggressive development and commercial plans," said John J. Puisis, president and chief executive officer of Tolera. "We look forward to our partnership with Laureate in utilizing their specialized experience in the manufacture of monoclonal antibodies."

QSV Biologics Ltd. has formed an Australian subsidiary, QSV Biologics Australia Pty Ltd., and has appointed Dr. Neville McCarthy to its board of directors.
    
Dr. Graeme Macaloney, founder and chief executive officer, said, “The formation of our Australian subsidiary demonstrates the commitment QSV has for the biopharmaceutical industry in Australasia. The addition of Dr. McCarthy, a founding statesman of the Australian biotech industry, including 17 years at the helm of CSL, brings tremendous experience of — and connectivity to — the Australian and regional industry. I am very pleased and excited to be working with such a gentleman and scholar.”
   
Dr. McCarthy is a medical scientist and an officer of the Order of Australia. His career encompasses the founding and operation of his own medical practice, serving as director with ER Squibb, managing director of Commonwealth Serum Laboratories (CSL), managing director and chairman of Chiron Mimotopes (Australia), chairman of Mabtech Ltd, chairman of Monash IVF Group, and director of Southern Medical Diagnostics Pty. Ltd.

Avid Bioservices, Inc. has signed a manufacturing supply agreement with Catalyst Biosciences to produce clinical-grade material for Catalyst's drug candidate, CB 813, a new version of factor VIIa for the treatment of acute bleeding in hemophilia patients.
   
Under the terms of the agreement, Avid will begin manufacturing drug supply under cGMP regulations and provide cell bank preparation, process development, and preparation of the manufacturing portion of the NDA.  Further details were not disclosed.
   
“This agreement with Catalyst Biosciences for their lead clinical candidate is the most recent example of the traction we are gaining as a trusted provider of cGMP manufacturing services, as well as our broad capabilities as a provider of valuable ancillary services," said Steven W. King, president of Avid.  "We are delighted to be working with the talented Catalyst team and their promising engineered protease technology.”
   
"Avid's expertise in the scale-up and manufacture of clinical-grade biotechnology therapeutics and their strong customer orientation made them a good choice for Catalyst,” said Nassim Usman, Ph.D., chief executive officer of Catalyst Biosciences.

Bilcare Global Clinical Supplies has expanded its global distribution and warehousing capabilities for clinical trial supplies. The company has signed a service agreement with World Courier to use depots in Argentina, Brazil, Colombia, Chile, Mexico, Peru, and Russia. The new locations add to Bilcare's existing locations in India, UK, Singapore and the U.S. The company plans to add more global depot locations in the near future.
   
As a result of working with World Courier, Bilcare will be able to enhance its capabilities globally, to receive, control, verify and store client materials in temperature-controlled facilities providing specialty storage conditions, pick-and-pack handling, and certified delivery to client-designated locations, according to a company statement.
   
"With the drug discovery program leading to potential new drugs becoming more complex, the need to clinically test drug efficacy and safety in diverse population groups across multiple geographic regions is becoming a crucial necessity. This necessity is driving clinical trials to be conducted at multiple locations across the globe," said Mohan Bhandari, chairman and managing director of Bilcare Ltd.

Cipher Pharmaceuticals has appointed John MacInnis as vice president, portfolio development and licensing. Mr. MacInnis will be responsible for identifying and evaluating pipeline products and technologies, and pursuing strategic alliances and partnerships for the company's drugs in targeted markets.
   
Mr. MacInnis has experience in the life sciences industry with expertise in large global pharmaceutical, private equity and portfolio management consulting. Most recently, he was vice president, business development at Kromite, a consulting firm that offers strategic support to life science companies, including technical risk assessment and benchmarking, forecasting, licensing support, portfolio and resource optimization and strategic planning. He held the position of executive vice president, business development at DRI Capital, where he was responsible for the identification and evaluation of life science royalty financing opportunities. Previously, he served as director, disease area strategy within Novartis Global Marketing (Basel), and executive director, CNS Franchise within the strategic marketing group at Johnson and Johnson.
   
"We are very pleased to welcome John to the team," said Larry Andrews, president and chief executive officer of Cipher Pharmaceuticals. "His global new product and business development knowledge, private equity experience and complementary skill set will be highly beneficial in our pursuit of new product opportunities and additional partnerships for our current late-stage portfolio."

Celgene has terminated its licensing agreement with MethylGene for oncology histone deacetylase (HDAC) inhibitors, including MGCD0103. As a result, MethylGene will reacquire the rights to these programs. MethylGene also announced plans to implement a strategic initiative to focus its resources on the clinical development of its pipeline.
   
As part of the termination, Celgene will continue to support MGCD0103 for 90 days to help with the transition. Celgene acquired the rights to MGCD0103 through its March 2008 acquisition of Pharmion Corp. MethylGene now owns the worldwide rights to MGCD0103 (with the exception of certain Asian territories), MGCD265 and MGCD290, all of which are at various stages of clinical development.
   
"We believe regaining exclusive rights to MGCD0103 will allow MethylGene to accelerate submissions to the FDA aimed at lifting the partial clinical hold for MGCD0103," said Donald F. Corcoran, president and chief executive officer of MethylGene. "We believe that MGCD0103 represents a promising opportunity for the treatment of cancer and has demonstrated clinical activity in a number of tumor types evaluated to date. With MGCD0103 back in MethylGene's hands, upon successful lifting of the partial clinical hold, we will evaluate the funding requirements, development pathway, partnerships and alternative arrangements needed to potentially move the program forward."
   
MethylGene also announced it will discontinue its discovery research activities. The first phase of the reduction will occur during the next two months with additional reductions planned during 2009 as funded discovery research with Celgene and Otsuka Pharmaceutical are concluded. It is expected that approximately half of the company's staff of 109 full-time employees will be affected by the transition.
   
"We are aligning the organization toward our development opportunities in order to better realize the value of our proprietary clinical pipeline. By streamlining the organization to focus on development, we expect to extend our current cash resources and progress our clinical pipeline toward nearer term value enhancing milestones," said Mr. Corcoran. "Decisions such as this are difficult. We are a company that has grown due to the talent, hard work and expertise of our employees and we greatly appreciate their contributions. We owe it to our colleagues and to our shareholders to seek success in the clinical development and ultimate commercialization of our lead compounds.”

GlaxoSmithKline Biologicals (a GSK unit) and AFFiRiS GmbH have entered a collaboration agreement granting GSK exclusive rights to AFFiRiS's Alzheimer's disease vaccine programs that target beta-amyloid. GSK is acquiring exclusive rights to develop and commercialize two vaccine candidates currently in Phase I development that are based on AFFiRiS AFFiTOPE technology. GSK also has an exclusive option to develop and commercialize alternative Alzheimer's vaccine candidates in preclinical development.
   
Under the terms of the agreement, AFFiRiS will receive an up-front payment of $28.8 million and is eligible for future milestone payments and royalties. The total potential value of the agreement could reach $551.3 million in the event of full commercial success of the candidate vaccines. This agreement is subject to government approval.
   
AFFiRiS AFFiTOPE technology allows the design of proteins with very specific binding characteristics that are ideally suited for the development of vaccines against disease-causing "rogue" human proteins such as beta-amyloid, which is central to the pathology of Alzheimer's disease.
   
Walter Schmidt, co-founder and chief executive officer of AFFiRiS, said, "We are pleased that we could secure GSK Biologicals, one of the world's leading vaccine companies, in collaborating on the development our Alzheimer's disease vaccine programs. This deal brings together two companies with strong innovation, vaccine development and commercialization capabilities and experience."

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) has submitted a NDA to the FDA for carisbamate, an investigational compound for the adjunctive treatment of partial onset seizures in patients 16 years of age and older.
   
The filing is supported by data from three placebo-controlled trials in patients with epilepsy. Results from the first study were presented at the Ninth EILAT Conference on Antiepileptic Drugs in June and results from two additional studies will be presented at the annual meeting of the American Epilepsy Society later this year.
   
In 1999, J&JPRD and SK Holdings Co. entered into a license agreement to develop and commercialize carisbamate under which J&JPRD received global marketing rights. If approved, carisbamate will be marketed by Ortho-McNeil Neurologics under the brand name Comfyde.

Elan

3Q Revenues: $270.1 million (+53%) 

3Q Loss: $83.5 million  (loss of $87.4 million in 3Q07) 

YTD Revenues: $730.4 million (+35%)

YTD Loss: $240.5 million (loss of $321.5 million in YTD07)

Comments: Biopharmaceuticals business grew by 85% driven by a strong performance from Tysabri, with Elan’s recorded sales up 159% to $164.5 million. Total in-market sales of Tysabri were $237.0 million in the quarter (+154%). Azactam sales were $24.2 million (+17%). Maxipime sales were $5.7 million down from $19.2 million in 3Q07. R&D expenses were $90.0 million in the quarter (+53%) primarily related to the advancement of the company’s Alzheimer’s disease programs in the clinic. Revenue from the Elan Drug Technologies (EDT) business was up 3% to $71.2 million. Manufacturing revenue and royalties totaled $67.5 million and total contract revenue was  $3.7 million in the quarter. Due to uncertainty in the financial and credit markets, Elan has decided to hold onto the EDT business and allow it to develop and grow as an independent, wholly-owned subsidiary. Potential generic competition looms for several of the products from which Elan earns manufacturing revenue and royalties.

Patheon has opened a new Pharmaceutical Development Services (PDS) suite at its Whitby Development Center in Canada for the small-scale development and manufacturing of solid dosage forms for early clinical studies.
   
The 2,500-sq.-ft. suite, as well as the facility, are GMP-compliant for manufacturing products for Phase I and II clinical studies. The suite will contribute to Patheon's Quick To Clinic offering for First Time in Human (Phase I) studies. The new facility will also add early-phase pharmaceutical development and manufacturing capacity, with a manufacturing scale of 1kg to 10kg. The suite has multiple labs with the capability for small-scale dosage form development, as well as the manufacture of powder-in-bottle, tablets (immediate and modified release), capsules, oral liquids, and nasal sprays.
   
Colin Minchom, Ph.D., vice president, PDS, Canada, said, "We're very excited about the rapid response capabilities of the new Whitby suite. This new facility will significantly strengthen Patheon's competitiveness in the pharmaceutical and biotechnology early development arena."
   
Terry Novak, president, North America and chief marketing officer, added, "Patheon is committed to investing in its development services business and with this new capacity in Whitby; we can now offer rapid early phase development to our North American customers."

Amgen

3Q Revenues: $3.9 billion (+7%)

3Q Earnings: $1.2 billion (earnings were $201 million in 3Q07)

YTD Revenues: $11.3 billion (+3%)

YTD Earnings: $3.2 billion (+39%)

Comments: Sales of Aranesp were up 3% to $845 million. Sales of Epogen increased 5% to $634 million. Combined sales of Neulasta and Neupogen were up 8% to $1.2 billion. Sales of Enbrel were $893 million (+9%). Sales of Sensipar increased 32% to $161 million. R&D expenses were $729 million in the quarter (-6%). Earnings in 3Q07 were negatively impacted by $590 million of acquired in-process R&D related to the acquisitions of Alantos Pharmaceutical Holdings and Ilypsa, Inc., as well as $293 million of restructuring charges.

Lilly

3Q Revenues: $5.2 billion (+14%)

3Q Loss: $465.6 million (earnings were $926.3 million in 3Q07)

YTD Revenues: $15.2 billion (+13%)

YTD Earnings: $1.6 billion (-26%)

Comments: Zyprexa sales were $1.2 billion in the quarter (+2%). Cymbalta sales were $716.4 million (+40%). Gemzar sales were $440.2 million (+12%). Humalog sales were up 19% to $432.6 million. Cialis sales were $376.6 million (+21%). Alimta sales were $313.9 million (46%). Strattera sales were $149.5 million (+15%). Byetta sales were $201.2 million (+22%). R&D expenses were $953.0 million in the quarter (+13%). The 3Q08 loss was due to charges totaling $1.5 billion related to pending and resolved Zyprexa investigations. In the quarter, the company completed the $64.0 million acquisition of SGX Pharmaceuticals, a San Diego-based biotechnology company.

Bristol-Myers Squibb

3Q Revenues: $5.3 billion (+14%)

3Q Earnings: $2.6 billion (earnings were $858 million in 3Q07)

YTD Revenues: $15.3 billion (+17%)

YTD Earnings: $4.0 billion (+74%)

Comments: Pharmaceutical sales were up 15% to $4.5 billion in the quarter. Growth was driven by strong performance from Plavix, Abilify, the HIV and hepatitis portfolio, as well as Orencia. Plavix sales were $1.4 billion in the quarter (+15%). Abilify sales were $564 million (+34%). Sustiva Franchise sales were $294 million (+24%). Reyataz sales were $342 million (+25%). Orencia sales were up 98% to $119 million. Avapro/Avalide sales were $334 million (+8%). Baraclude sales were up 100% to $144 million. Earnings include a $2.0 billion after-tax gain attributed to the sale of the company’s ConvaTec business. R&D expenses were up 4% to $834 million in the quarter.

Merck plans to eliminate 7,200 jobs by the end of 2011 as part of a new restructuring program aimed at lowering overhead and becoming more competitive. As part of the program, Merck will streamline management layers by eliminating about 25% of senior and mid-level executives. The company currently employs about 56,700 people. The new job cuts are in addition to the 2005 restructuring program that eliminated 10,400 jobs.
   
According to a company statement, the new job cuts are expected to produce savings of $3.8 billion to $4.2 billion from 2008 to 2013 and will cost between $1.6 billion and $2.0 billion through the end of 2011, when the program is expected to be complete.

Merck

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

3Q Earnings: $1.1 billion (-28%)

YTD Revenues: $17.8 billion (-1%)

YTD Earnings: $6.2 billion (+26%)

Comments: Januvia sales were $379 million in the quarter (+105%). Sales of Isentress were $107 million. Worldwide sales of Singulair were $1.0 billion (+1%). Cozaar and Hyzaar sales were $888 million (+9%). Combined worldwide sales of Zetia and Vytorin, as reported by the Merck/Schering-Plough joint venture, were $1.1 billion in the quarter (-15%). Worldwide sales of the Gardasil were $401 million (-4%). R&D expenses were $1.2 billion in the quarter (-19%). Restructuring costs, primarily related to employee separation costs associated with the company's global restructuring programs, were $757 million in the quarter and $49 million in 3Q07.

Wyeth

3Q Revenues: $5.8 billion (+5%)

3Q Earnings: $1.1 billion (flat)

YTD Revenues: $17.5 billion (+5%)

YTD Earnings: $3.5 billion (-4%)

Comments: Pharmaceutical sales in the quarter were $4.9 billion (+5%) driven by Enbrel, Prevnar and Nutritional products, as well as the favorable impact of foreign exchange. This was partially offset by lower sales of Protonix. Also contributing to revenue growth were new products, Tygacil, Torisel and Pristiq. Enbrel sales (outside U.S. and Canada) were $697 million (+32%). Enbrel alliance revenue (U.S. and Canada) was $294 million (+23%). Prevnar sales were $717 million (+13%). Sales of Protonix products were $234 million (-45%). R&D expenses in the quarter were flat at $793 million.

Amylin Pharmaceuticals and Lilly have entered into a product supply agreement for exenatide once weekly, a compound under development to treat type 2 diabetes. Under terms of the agreement, Amylin will receive an initial cash payment of $125 million and Amylin will supply product for sales in the U.S. and to Lilly for sales outside of the U.S. Lilly will also reimburse Amylin for its share of the $500-plus million capital investment in the West Chester, OH facility through the cost of goods sold for exenatide.
   
As part of the overall supply pact, Lilly will make available to Amylin a $165 million line of credit that Amylin can draw upon beginning in 4Q09 through 2Q11.
   
"Amylin and Lilly continue to strengthen our exenatide alliance, building on the success of Byetta, our first-in-class medicine that has been used by approximately 1 million patients worldwide," said John C. Lechleiter, Ph.D., Lilly's president and chief executive officer. "With this agreement, we acknowledge Amylin's commitment in making this important investment to build critical manufacturing capacity."
   
"The state-of-the art manufacturing facility in Ohio is readying for full-scale commercial manufacturing of exenatide once weekly," said Daniel M. Bradbury, president and chief executive officer of Amylin Pharmaceuticals. "This agreement strengthens our balance sheet and provides us with financial flexibility in the future, while moving us closer to our goal of bringing exenatide once weekly to patients as quickly as possible."

Pfizer

3Q Revenues: $12.0 billion (flat)

3Q Earnings: $2.3 billion (earnings were $761 million in 3Q07)

YTD Revenues: $36.0 billion (+1%)

YTD Earnings: $7.8 billion (+45%)

Comments: Pharmaceutical revenues in the quarter were $11.0 billion (-1%). Lipitor revenues in the quarter dropped 1% to $3.1 billion. Zyrtec and Camptosar revenues decreased by $549 million to $428 million and $121 million, respectively, impacted by the loss of U.S. exclusivity. Lyrica revenues were $675 million (+45%). Celebrex revenues were $625 million (+8%). Sutent revenues were $226 million (+49%). Chantix revenues were down 24% to $182 million. R&D expenses in the quarter were $1.9 billion (-6%). Results for 3Q07 and YTD07 include charges associated with the impairment of Exubera assets and the decision to exit Exubera, including $1.1 billion of intangible asset impairments, $661 million of inventory write-offs, $454 million of fixed asset impairments, and $584 million of other exit costs.

Schering-Plough

3Q Revenues: $4.6 billion (+63%)
 
3Q Earnings: $589.0 million (-21%)

YTD Revenues: $14.2 billion (+58%)

YTD Earnings: $1.3 billion (-29%)

Comments: Pharmaceutical sales were $3.5 billion in the quarter (+54%) driven by Remicade sales, up 32% to $564 million, and Temodar sales, up 27% to $273 million. Nasonex sales were up 6% to $258 million. Sales of Pegintron were $235 million (+6%). Revenues for the quarter also benefited from the inclusion of $896 million of OBS product sales and a favorable impact from foreign exchange. Sales of the global cholesterol joint venture with Merck, which include Vytorin and Zetia, totaled $1.1 billion in the quarter (-15%). Schering-Plough does not record these sales in its revenues; sales from the JV are accounted for under the equity method, impacting earnings directly. R&D expenses were $893 million in the quarter (+33%), which includes a $20 million upfront R&D payment. Earnings exclude purchase accounting adjustments, special and acquisition-related items, a $160 million pre-tax gain from the divestitures of certain animal health products and $19 million of income from the termination of the respiratory joint venture with Merck.

Biogen Idec

3Q Revenues: $1.1 billion (+38%)

3Q Earnings: $207 million (+74%)

YTD Revenues: $3.0 billion (+33%)

YTD Earnings: $576.5 million (+32%)

Comments: Tysabri sales recorded by Biogen, based on its collaboration with Elan, were $171 million (+172%) in the quarter. This consisted of $56 million related to product sold through Elan in the U.S. (based on $122 million of in-market sales); and $115 million related to product sold by Biogen internationally. Avonex sales were up 26% to $573 million. Rituxan sales were up 27% to $299 million (co-marketed in the U.S. with Genentech). R&D expenses were $269 million in the quarter (-6%).

Azopharma Product Development Group has entered the microdosing market and will provide services to synthesize material open to microdose studies as well as formulate and administer microdoses in a clinical setting, and analyze samples.
   
Microdosing involves the use of radiolabeled materials at very low levels where patients are dosed at 1/100 of the anticipated therapeutic dose. Samples are then analyzed with an Accelerate Mass Spectrometer (AMS), which is capable of detecting the labeled compound at 10-21 mole levels. The extremely low dose levels minimize potential toxic effects in humans while providing pharmacological data, which may not be found in animal research. Microdosing is important among pharmaceutical and regulatory agencies and enables the industry to save time and money on development processes by receiving early PK and ADME data in humans.
   
Phil Meeks, chief executive officer of Azopharma Product Development Group said, “This new service is a natural extension of our current business model. We are already a leader in the formulation and clinical trial fields. This gives our clients a new option in their development process. Due to the improved safety and potential gains in development timelines, we foresee this technology becoming a key part of the drug development process.”

Laureate Pharma has entered into a cGMP contract manufacturing agreement with Tolerx, Inc. to produce Tolerx's humanized anti-GITR antibody known as TRX518, which is currently in development for cancer and chronic viral indications. Details of the agreement were not disclosed.
   
"The partnership with Tolerx validates the progress we have made in biomanufacturing and our commitment in helping our clients bring novel therapies to the market," said Robert J. Broeze, Ph.D., president and chief executive officer of Laureate. "With our well-established monoclonal antibody experience, we will partner closely with the Tolerx team to help them achieve their manufacturing objectives."
   
"Laureate Pharma has a proven track record in biopharmaceutical manufacturing, including capabilities in both clinical and commercial-grade materials," said Dr. Douglas J. Ringler, president and chief executive officer of Tolerx. "This agreement enables us to operationally leverage Laureate's expertise and infrastructure while we seek to establish new treatment paradigms in the immunology space."

Shabbir Anik, Ph.D. will join Althea Technologies as president and chief executive officer. Dr. Anik will lead the company's expansion of its product development, clinical trial and commercial manufacturing services.
      
"We are delighted to welcome Dr. Anik to Althea and feel that his background and expertise is a wonderful match for the company," said Dr. Magda Marquet, co-chair of Althea Technologies. "He is a rare blend of scientist, manager and leader, and we are excited about Althea's continued success with Shabbir at the helm. . . As we continue to grow to serve our clients, Shabbir's experience in manufacturing, his understanding of the critical interplay of services in bringing a product to commercial success, and his ability to manage these activities across the globe will be invaluable to Althea."
      
Dr. Anik previously served as president of Pharmaceutical Development Services (PDS) at Patheon, Inc., where he was responsible for building and managing the company's global PDS business. He also served as senior director of Pharmaceutical Development and Operations for the biotechnology company Neurex. Dr. Anik began his career at Syntex, serving in positions of increasing responsibility, including serving as vice president and program director.

Pfizer and UCB have formed a new technology company, Cyclofluidic, established with the goal of accelerating the drug discovery process by allowing researchers to test a broader range of potential new drug in less time. The UK Government’s Technology Strategy Board helped to facilitate this arrangement between the two companies and will continue to support Cyclofluidic by co-funding its R&D. The new company will be jointly owned by Pfizer and UCB.

Cyclofluidic’s goal is to develop technologies that automate and integrate processes known as flow chemistry and flow biology to help pharmaceutical companies shorten timelines within the drug development process. Through extensive collaboration with key academics and component manufacturers, Cyclofluidic plans to develop a microfluidic closed loop lead optimization platform that will enable researchers to access expertise in flow chemistry, flow screening and microfluidic engineering. Cyclofluidic will also provide training for both flow chemistry and biology scientists at its facility located in the South of England.

Iain Gray, chief executive officer of Technology Strategy Board, said, “Our role is to stimulate the development and deployment of technologies which, as well as benefiting society, also provide global business opportunities for the UK. Cyclofluidic is an excellent example of the private and public sectors working together to develop world-leading technologies which have the potential to bring enormous benefit to patients in the and around the world. We are delighted to offer our support and investment."

“Cyclofluidic’s entry into the rapidly evolving microfluidic technology area has the potential to radically transform the medicinal chemistry and biology interface,” said Dr. Neil Weir, senior vice president of research at UCB. “It’s an exciting opportunity for UCB and Pfizer to collaborate and offers real potential for improved productivity, underlining our commitment to innovation for patients.”

Novartis AG is restructuring the management of three of four business units, with plans to cut 550 marketing jobs in an effort to save $80 million annually starting in 2010, according to Joerg Reinhardt, head of the vaccines unit and chief operating officer. The restructuring is part of chief executive officer Daniel Vasella's plan to thwart losses of its best-selling drug Diovan due to generic competition.

 

Thomas Ebeling, head of the consumer health unit, is leaving the company and will be replaced by George Gunn, currently head of the animal health division. Mr. Reinhardt's position will be filled by Andrin Oswald, chief executive of Speedel AG, which was acquired by Novartis earlier this year. Andreas Rummelt, head of the Sandoz generic drugs division, will be replaced by Jeff George, who leads emerging markets. Mr. Rummelt will head quality assurance. David Epstein, head of the oncology division, will also oversee a new unit focusing on molecular diagnostics. Mr. Vasella has reached an agreement with the board to extend his contract, according to a Novartis statement.

 

The company also plans to cut its sales force and concentrate on marketing drugs to managed care organizations instead of selling to general practitioners.

Novartis

3Q Revenues: $10.7 billion (+12%)

3Q Earnings: $2.1 billion (+32%)

YTD Revenues: $31.4 billion (+12%)

YTD Earnings: $6.7 billion (+19%)

Comments: Pharmaceutical sales were $6.7 billion in the quarter, up 14% (9% in local currencies). Growth was driven by the oncology and cardiovascular franchises as well as $800 million in sales from recently launched products, Lucentis, Aclasta/Reclast, Exforge, Tekturna/Rasilez, Exjade and Exelon Patch. Oncology sales were $2.1 billion (+15% lc) driven by Gleevec/Glivec with $950 million in sales (+15% lc), Zometa with $360 million in sales (+9% lc) and Femara with $289 million in sales (+16% lc). Cardiovascular sales were $1.7 billion (+20% lc), driven by the new high blood pressure medicines Tekturna/Rasilez and Exforge as well as Diovan ($1.4 billion, +9% lc). Vaccines and diagnostics sales were up 16% to $666 million (+14% lc). Sandoz revenues were $1.9 billion, up 7% (flat in local currencies). 2007 results included an incremental environmental provision charge of $590 million to cover worldwide remediation plans.

 

Gilead Sciences

3Q Revenues: $1.4 billion (+30%)

3Q Earnings: $504 million (+27%)

YTD Revenues: $3.9 billion (+25%)
 
YTD Earnings: $1.4 billion (+19%)

Comments: The company achieved record revenues in the quarter. Growth was driven by the company’s antiviral franchise, with sales up 39% to $1.2 billion, including strong performances by Atripla and Truvada, with sales up 77% to $427.6 million and 34% to $549.1 million, respectively. Viread sales were $156.0 million in the quarter (+5%). Sales of Hepsera increased 15% to $91.2 million, driven primarily by a favorable foreign exchange impact and sales growth in North America and certain European markets. Sales of AmBisome were up 6% to $72.9 million. Royalty, contract and other revenues were $32.8 million, down 66% due to lower Tamiflu royalties from Roche ($8.6 million in 3Q08 compared to $77.4 million in 3Q07). R&D expenses were $188.1 million in the quarter (+34%).

Valeant Pharmaceuticals International has concluded its exclusive worldwide collaboration agreement with GlaxoSmithKline for retigabine, an investigational drug for the treatment of adult epilepsy patients with refractory partial onset seizures. Under the terms of the agreement, Valeant received an upfront payment of $125 million from GSK.

Catalent Pharma Solutions received notice that the FDA has approved the sale of a prescription product manufactured at its recently opened pre-filled syringe facility in Brussels, Belgium. Syringes from the Brussels facility will likely be dispensed to patients in the U.S. during the next few months.
   
Richard Yarwood, group president of Catalent’s Sterile Technologies segment, said, “We are very pleased to have reached this important milestone in the evolution of our Brussels facility, and to further extend our strategic partnership with this customer. With this first FDA product approval, we are even more strongly positioned to help our customers satisfy the fast growing U.S. market demand for drugs and biologics in the prefilled syringe format.”

Abbott

3Q Revenues: $7.5 billion (+18%)

3Q Earnings: $1.1 billion (+51%)

YTD Revenues: $22.0 billion (+15%)

YTD Earnings: $3.3 billion (+39%)

Comments: Worldwide pharmaceutical sales were $4.1 billion in the quarter (+17%), driven by growth in Humira, Kaletra, TriCor, and Niaspan. U.S. sales were $3.7 billion (+18%). International sales were $2.0 billion (+22%) with a positive impact of exchange of 10%. Humira sales reached $1.2 billion in the quarter (+50%). Kaletra sales were $387 million (+14%). TriCor sales were up 11% to $334 million. Niaspan sales were up 16% to $194 million. Depakote sales were down 17% to $317 million due to generic competition. Worldwide vascular sales were $636 million in the quarter (+58%). Coronary stents accounted for $383 million (+135%).

WuXi PharmaTech, Inc. has reached an agreement with Johnson & Johnson Pharmaceutical R&D, Division of Janssen Pharmaceutica, N.V. (J&JPRD) to expand its pharmaceutical R&D services collaboration. In addition to providing discovery chemistry services WuXi, will now also provide research services in the area of discovery biology, chemical and analytical development services, formulation, and preclinical and bioanalytical services, under the new agreement.
   
Dr. Ge Li, chairman and chief executive officer of WuXi PharmaTech, said, "We are very pleased to expand our partnership with J&JPRD. This agreement leverages WuXi's strong R&D capabilities from early stage discovery to commercial production to deliver reliable, high quality and cost-efficient services to J&JPRD. Our partnership demonstrates the strength of our innovation driven and fully integrated R&D service platform."

Charles River Laboratories International opened its 60,000-sq.-ft. preclinical facility in Shanghai. The new facility is aimed at fostering growth in that emerging market by assisting global and local biopharmaceutical companies with their drug development programs. The new facility is expected to provide Good Laboratory Practice (GLP) services in the first quarter of 2009.
   
The China facility will provide a range of services that are compliant with regulatory agencies including: Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), Canadian Council on Animal Care (CCAC), China’s State Food and Drug Administration (SFDA), Organization for Economic Cooperation and Development (OECD), and the FDA.
   
“As our clients make their initial forays into China, we are creating a center of excellence that embodies global best practices alongside them,” said James C. Foster, president, chairman and chief executive officer of Charles River. “Our clients have come to appreciate and rely on the expertise Charles River brings to their drug development efforts, and the convenience of our facilities in close proximity. The same high standards of research, safety, humane care and good laboratory practices that globally distinguish Charles River are replicated in our Shanghai facility.”

Catalent Pharma Solutions has opened a new temperature controlled warehouse in Bolton, UK to meet increased demand for clinical supply services, particularly cold-chain storage and distribution. “The opening of the warehouse further enhances Catalent’s ability to support the global clinical trial requirements of our customers,” said Frank Lis, vice president and general manager of Global Clinical Supplies for Catalent.
   
The new 11,800-sq.-ft. warehouse is an extension of the existing facility and is fully operational. The temperature controlled warehouse has 2,000 controlled ambient storage locations and a 320-pallet refrigerator.  

Genentech

3Q Revenues: $3.4 billion (+17%)

3Q Earnings: $731 million (+7%)

YTD Revenues: $9.7 billion (+11%)

YTD Earnings: $2.5 billion (+17%)

Comments: U.S. product sales were $2.5 million in the quarter (+14%). Avastin sales were $704 million (+18%). Rituxan and Herceptin sales were both up 15% in the quarter to $655 million and $368 million, respectively. Lucentis sales were $225 million (+14%) and Xolair sales were $136 million (+12%). R&D expenses were $777 million in the quarter (+26%). Royalty revenue was $687 million (+31%) due to growth in royalties from sales outside the U.S. by licensees. Results in the quarter were impacted by a $44 million expense related to employee retention programs in response to the Roche proposal to acquire outstanding Genentech shares; a $105 million expense related to a collaboration agreement with GlycArt and Roche; and a $67 million expense related to the “impairment of certain assets in the company’s investment portfolio.”

Tegrant Corp. created a new joint venture to market its ThermoSafe products in the Asia Pacific region. ThermoSafe Brands Asia will operate as a JV between Tegrant and FEC Corp., a Hong Kong-based investment company focused on the Asian packaging market. FEC operates nine factories across China and Malaysia through its subsidiary Kingpak Packaging Group. The venture will manufacture and distribute temperature assurance products across the Southeast Asian region. ThermoSafe Brands Asia will be headquartered in Singapore.
   
"We are pleased to have formed our joint venture with such an esteemed company as FEC, whose expertise in packaging is well-known in Asia. Southeast Asia has been identified as a high growth priority for ThermoSafe Brands, and we have an immediate need to supply Temperature Assurance Products to current customers in the region,” said Ron Leach, president and chief executive officer of Tegrant Corp.
   
Colleen Bohn, president of ThermoSafe Brands, said, “I am excited about what this new venture means for ThermoSafe and its customers. We will now be able to produce common products for our customers in the U.S. and Asia and ensure that they are manufactured with the same quality standards and specifications. Additionally, we will serve our customers with a local sales and support team in Asia that has full access to our state-of-the-art design and testing capabilities.”

Johnson & Johnson

3Q Revenues: $15.9 billion (+3%)

3Q Earnings: $3.3 billion (+30%)

YTD Revenues: $48.6 billion (+8%)

YTD Earnings: $10.2 billion (+25%)

Comments: Worldwide Pharmaceutical sales were flat at $6.1 billion in the quarter, with an operational decline of 2.5% and a positive impact from currency of 2.7%. Domestic sales were down 6%, while international sales increased 10% (3% from operations and 7% from currency). Velcade, Remicade, Topamax and Risperdal Consta performed well in the quarter. Velcade sales were $190 million (+46%); Remicade sales were $978 million (+19%); Topamax sales were $728 million (+19%); Risperdal Consta sales were $338 million (+15%). Sales of Risperdal were down 63% to $320 million due to generic competition. Worldwide Consumer sales were $4.1 billion in the quarter (+13%). Worldwide Medical Devices and Diagnostics sales were $5.7 billion (+9%). 3Q07 included an after-tax restructuring charge of $528 million associated with a cost improvement program.

Akorn, Inc. has entered into a five-year supply agreement with an undisclosed ophthalmic company. Under the terms of the agreement, Akorn will be responsible for the manufacturing and supply of the ophthalmic product, for which it holds the ANDA. Revenues from this agreement are expected to begin in early 2009.
   
Arthur S. Przybyl, Akorn’s president and chief executive officer, stated, “We continue to grow our contract manufacturing services and are pleased to announce this new long-term partnership. During 2008, Akorn’s contract manufacturing business has expanded to include four new ophthalmic and two new injectable partnerships. To date, two ophthalmic partnerships are generating revenue, one injectable partnership is expected to launch in October 2008, and the remaining partnerships will begin generating revenue in 2009.”

Schwarz Pharma Manufacturing, Inc., a unit of Schwarz Pharma AG of Monheim, Germany, announced a $12 million expansion of its Seymour, IN manufacturing plant and distribution center. As a result of this expansion, the company expects to add 150 employees for a total of 516 by 2011. The company plans to begin hiring managers, business associates and production staff later this month.
   
The 280,000-sq.-ft. facility handles manufacturing for all of the company's products sold in the U.S., including blood pressure medication Univasc.

Genmab has reached the sixth milestone in its collaboration with GlaxoSmithKline for ofatumumab (HuMax-CD20), as the first patient received treatment in the Phase I study of ofatumumab in relapsed/refractory follicular non-Hodgkin's lymphoma and chronic lymphocytic leukemia in Japan. The milestone payment was approximately $5.6 million.

Ofatumumab is an investigational, new generation, human MAb that targets a distinct membrane proximal, small loop epitope of the CD20 molecule on the surface of B-cells. Ofatumumab is being developed to treat chronic lymphocytic leukemia, follicular non-Hodgkin's lymphoma, diffuse large B-cell lymphoma, rheumatoid arthritis and relapsing remitting multiple sclerosis.

Paul K. Wotton, Ph.D., has been named president and chief executive officer of Antares Pharma. Dr. Wotton previously served as president and chief operating officer, the titles he held upon joining the company in July 2008. Concurrently, Jack E. Stover has resigned as both chief executive officer and vice chairman of the board.

Dr. Wotton previously served as chief executive officer of Topigen Pharmaceuticals, following a stint as head of global business development at SkyePharma, as well as senior level positions at Eurand, Penwest Pharmaceuticals, Abbott, Merck, Sharp and Dohme.

Commenting on his new responsibilities, Dr. Wotton said, “I look forward to building shareholder value at Antares. The depth of our product pipelines in both our pharma and parenteral device divisions as well as our key partnership activities provide near and long-term growth opportunities for our business and share price.”

Abbott opened its new development labs and a pilot plant facility based in Ludwigshafen, Germany. The facility will research technologies and test large-scale production of newly developed drug formulations. The expansion is part of the company's global drug delivery business, SOLIQS.
   
"Abbott is committed to advancing scientific innovation and bringing new medicines to patients," said John M. Leonard, M.D., senior vice president, Pharmaceuticals, Research and Development, Abbott. "Innovative drug formulation is critical to the development of effective new treatments that make a difference for patients."
   
"Nearly 40% of pharmaceutical compounds never reach the clinical study phase because they cannot be absorbed in the human body," said Jorg Breitenbach, Ph.D., senior director of drug product development and head of SOLIQS. "The SOLIQS expansion builds on Abbott's expertise in drug delivery technology and addresses the rising demand for innovative, patient-focused formulations."
   
The facility will evaluate new processes for its current technologies, Meltrex, Xellex, NanoMorph and smartCrystals that target the formulation of soluble complex pharmaceutical substances. Using the Meltrex technology for example, Abbott developed a new tablet formulation of its drug Kaletra that does not require refrigeration and can be taken with or without food. This tablet formulation also offers the convenience of fewer pills.

Takeda Pharmaceutical Co. Ltd. received notification that the FDA will not be able to complete its review of the alogliptin NDA by the Prescription Drug User Fee Act (PDUFA) date of October 27, 2008.
   
The agency indicated that due to internal resource constraints it would not be able to complete the alogliptin review by the PDUFA date. According to a Takeda statement, the FDA did not provide guidance as to when the review might be completed. If the FDA does not complete its review of the NDA by the end of the year, development partner PDD will not receive the $25 million alogliptin approval milestone in 4Q08. The NDA was submitted in December 2007 for the treatment of type 2 diabetes.

CEL-SCI Corp. has taken delivery of the new manufacturing facility for its lead drug candidate Multikine. This facility, located in the Baltimore area, will produce Multikine for use in CEL-SCI's Phase III trial for first-line therapy of previously untreated head and neck cancer, and for manufacturing the drug upon approval. The facility cost about $22 million to build and will soon be commercially ready. Currently the facility can produce about $600 million worth of drug per year and can be built out to produce nearly $2 billion worth of drug product per year.
    
Geert Kersten, CEL-SCI's chief executive officer, said, "Having our own Multikine dedicated manufacturing facility gives us control and eliminates a great deal of risk from our product development. Our next step is to completely validate the facility and to bring it on line for manufacturing."
   
CEL-SCI's upcoming Phase III trial is an 800-patient study designed to demonstrate that administration of Multikine to head and neck cancer patients before they receive any conventional cancer treatment will increase their survival. Head and neck cancer affects about 650,000 people per year.

Patheon has completed its expansion of services using a new Intermediate Scale Processing Suite (ISPS) at its Cincinnati, OH facility. The ISPS provides increased manufacturing capacity, bridging the company's development and commercial scale facilities.
   
The ISPS equipment includes an intermediate scale Diosna-P300 high shear granulator coupled with Niro-MP4 fluid bed dryer with solvent and high potency compound handling capabilities. This suite will allow the production of batch sizes ranging from 35-115 kg. The ISPS will allow the company to provide development, clinical, registration, scale-up, validation and commercial services to customers. The ISPS provides greater flexibility in scheduling experiments on a larger scale, using less active pharmaceutical ingredients (API) compared to commercial scale, according to the company.

Terry Novak, Patheon's president, North America and chief marketing officer, stated, "The ISPS provides us with another valuable service to address the unique needs of our customers. By adding this equipment we will be able to reduce time and resources it takes to moving a new product though development."

Dr. Christophe Berthoux has been named executive vice president, global sales and marketing and chief commercial officer, Charles River Laboratories. In this newly created position, Dr. Berthoux will lead the global realignment of the company's sales and marketing organization, with the goal of enhancing the company's interface with its customers.

"Given Dr. Berthoux's scientific and business training, his in-depth customer knowledge, as well as his considerable sales and marketing experience, I am confident that he will provide extraordinary levels of leadership in driving this newly created global organization," said James C. Foster, chairman, president and chief executive officer of Charles River.

Muhammad Asif, Ph.D. has been named director of analytical development, and Paul Maffuid, Ph.D. has been named senior vice president of operations, Irvine Pharmaceutical Services.

Dr. Asif has more than 17 years of experience including supporting the development of pharmaceutical products through his various roles at MannKind Corp., DEY, L.P. (an associate of Merck KGaA), Wyeth, and Fujisawa, USA. His expertise ranges from analytical method development and validation to extractables/leachables, product characterization studies and preparation of analytical portions of the CMC sections of INDs, NDAs and ANDAs.

Dr. Maffuid has 20 years of experience in the pharmaceutical industry having worked at various companies, including Arena Pharmaceuticals, Inc., Magellan Laboratories, Inc., Cabrillo Laboratories, Amylin Pharmaceuticals, Inc., Glaxo research, California Biotechnology and Syntex, Inc. He is a member of the American Association of Pharmaceutical Scientists and the American Chemical Society, and has authored several publications.

Irvine Pharmaceutical Services welcomes Dr. Maffuid and Dr. Asif as part of the company's ongoing efforts to continually improve its client services through employment of unparalleled professionals. "I am proud to have Dr. Maffuid and Dr. Asif join our staff," said Assad J. Kazeminy, chief executive officer and founder of Irvine Pharmaceutical Services. "Each brings an impressive depth of knowledge and experience, which I am confident will prove invaluable to our current and future clients."

Pfizer, as part of its strategy to improve growth, plans to reorganize its business units in an effort to better coordinate drug development and commercialization. These changes are part of chief executive officer Jeffrey Kindler's plan to "establish smaller operating units that can enhance innovation and accountability, but will draw upon the advantages of scale and resources Pfizer offers," said Raymond Kerins, a spokesman for Pfizer. The changes will take effect in January.
   
The reorganization will create three new units: primary care, specialty care and emerging markets. The primary-care unit will handle the drugs often prescribed by first-line doctors, such as the cholesterol treatment Lipitor. Specialty care will include drugs marketed to specialist doctors, such as anti-HIV drug Selzentry. The emerging-markets unit will handle the marketing of Pfizer drugs in emerging markets. The divisions will be responsible for drug development through sales and marketing. Research focused on the discovery of potential new drugs will continue to be handled by Pfizer's R&D arm, which is led by Martin MacKay.
   
Each unit will be led by a general manager who will report to Ian Read, president of worldwide pharmaceutical operations. Pedro Lichtinger, previously Pfizer's area president for European pharmaceuticals, will lead the new primary-care unit. Olivier Brandicourt will lead the specialty-care division. He was previously senior vice president of a unit focused on cardiovascular drugs. Jean-Michel Halfon will lead the new emerging-markets unit.
   
The reorganization plans do not include job cuts or changes to senior management, according to Mr. Kerins. The company previously created business units for oncology and established products. It also has an animal-health unit.

Bridge Laboratories has been awarded a follow-on contract by the National Institute on Drug Abuse (NIDA). The five-year contract has an estimated value of $4.1 million if all options are exercised. Under the new contract, Bridge will provide toxicological evaluations for potential medications used to treat drug abuse.
   
“We appreciate the confidence NIDA has shown in Bridge Laboratories over the past five years and look forward to collaborating with them to find ways to significantly improve prevention, treatment, and policy as it relates to drug abuse and addiction,” said Tom Oakley, president and chief executive officer, Bridge Laboratories.

Millipore Corp. opened a new membrane casting manufacturing facility in Carrigtwohill, County Cork, Ireland. The 30,000-sq.-ft. facility nearly doubles the company’s membrane production capabilities in Ireland.
   
“Millipore is celebrating 20 years in Cork. By opening this new facility, we are illustrating our strong commitment to continue our work in Ireland,” said Millipore's chairman, president, and chief executive officer, Martin Madaus. “Since 1988, our Cork operation has grown from the ground up into a Millipore Manufacturing Center of Excellence employing more than 580 people. We are very proud of our strong track record in process manufacturing.”
   
The new $83 million membrane casting facility is expected to produce a majority of the company’s membrane. These membranes are used in a range of Millipore products requiring filtration and purification. The company’s products are used to sterilize drug solutions, test beverages for purity, filter IV fluids in patient care and to support other applications in the medical device, pharmaceutical and biotechnology industries.

Alnylam Pharmaceuticals has earned a $20 million technology transfer milestone from Takeda Pharmaceutical Co. Ltd. as part of the companies' strategic alliance formed in May 2008. The payment is related to the transfer of Alnylam’s platform technology, including documents, materials, and intellectual property, to Takeda for the development of RNAi therapeutics. Alnylam also received a $100 million upfront payment when the deal was executed. Alnylam is eligible to receive an additional $30 million in technology transfer milestone payments.
   
“We are excited about the progress we have already made in enabling Takeda with Alnylam RNAi drug discovery capabilities and intellectual property,” said Barry Greene, president and chief operating officer at Alnylam. “We look forward to continuing our efforts in this strategic collaboration which is focused on advancing the development of RNAi therapeutics on a global basis, including Alnylam’s right to co-develop and co-commercialize certain Takeda RNAi therapeutic products in the U.S. market.”
   
The agreement provides Takeda with worldwide, non-exclusive access to and enablement with Alnylam’s RNAi therapeutics platform technology and intellectual property in the fields of oncology and metabolic disease, with the right to expand the number of therapeutic fields in the future. It also includes a collaboration and cross-license of delivery technologies between the two companies, and a drug discovery collaboration on certain RNAi targets. Alnylam has opt-in rights to co-develop and co-commercialize Takeda RNAi therapeutic programs in the U.S.

Genentech and Biogen Idec's Phase III study of Rituxan in combination with fludarabine and cyclophosphamide chemotherapy met its primary endpoint of improving progression-free survival (PFS), as assessed by investigators, in patients with previously treated CD20-positive chronic lymphocytic leukemia (CLL), compared to chemotherapy alone. There were no new or unexpected safety signals reported in the study.  
   
An independent review of the primary endpoint is being conducted for U.S. regulatory purposes. Data from the study, REACH, will be submitted for presentation at a future medical meeting.  
   
"REACH, the largest relapsed CLL trial ever conducted, is the first Phase III study of this treatment combination to show an improvement in progression-free survival for patients," said Hal Barron, M.D., Genentech's senior vice president, development and chief medical officer. “We look forward to collaborating with Biogen Idec to discuss these data with the FDA in the future.”
   
"Patients with CLL currently have few approved treatment options after the disease progresses following initial chemotherapy," said Cecil Pickett, Ph.D., Biogen Idec's president of R&D. "The REACH results are promising, and pending confirmation of the results by independent review, we look forward to submitting an application to the FDA for Rituxan’s potential approval in this indication."

Pharmatech Associates has been chosen by Pacific Biopharma Group (PBG) to provide the design for the first FDA- and EMEA-approved biomanufacturing facility to be built in China, which will represent the first reference document reviewed by the FDA as part of any licensure activity in China.
   
The new 181,000-sq.-ft. facility is a cGMP lab that uses single-use technology throughout the biomanufacturing process. The facility will be located in Taizhou, Jiangsu Province, in the emerging biomedical science park known as China Medical City (CMC). The project is a joint venture between PBG and CMC. In addition to manufacturing biotechnology products for late-stage clinical supplies, the facility will be used for development projects from the California Institute for Quantitative Biosciences (QB3).   
   
“Pharmatech Associates understands every phase of the drug development lifecycle, not just pharmaceutical construction,” said Dr. S. Chang, vice president manufacturing, Pacific Biopharma Group. “Their ability to integrate the critical considerations necessary for international biological market approval is essential to the success of our program in China.”
   
“We are delighted that PBG chose Pharmatech for this endeavor. The project caters directly to our deep understanding of product development, technology and international compliance,” said Bikash Chatterjee, president and chief technology officer, Pharmatech Associates.

Eli Lilly and Co. and ImClone Systems have entered a definitive merger agreement under which Lilly will acquire ImClone for approximately $6.5 billion in cash. The acquisition of ImClone supports the Lilly's strategy to increase its focus on biopharmaceuticals and adds oncology therapies Gemzar, Alimta and Erbitux to its biologics pipeline.
   
The combined companies creates a biopharmaceutical oncology franchise offering targeted therapies and oncolytic agents along with a pipeline spanning all phases of clinical development. The combined oncology portfolio will target various solid tumor types including lung, breast, ovarian, colorectal, head and neck, and pancreatic. The acquisition also expands Lilly's biotechnology capabilities with ImClone's development and commercial manufacturing facility, which will provide flexibility to develop and manufacture complex biomolecules.
   
"We think very highly of ImClone's ground-breaking work in oncology, particularly its success with Erbitux, a blockbuster targeted cancer therapy, and its ability to advance promising biotech molecules in its pipeline," said John C. Lechleiter, Ph.D., Lilly's president and chief executive officer. "We are excited about the possibilities of improving outcomes for individual patients and building value for shareholders. This transaction will broaden our portfolio of marketed cancer therapies and boost Lilly's oncology pipeline with three promising targeted therapies in Phase III in 2009. By bringing together ImClone's and Lilly's marketed oncology products, pipelines, and biotech capabilities, we are taking a very important step forward in addressing the challenges of patent expirations we will face early in the next decade. We look forward to working with the ImClone team and their partners to ensure a smooth transition."
   
John H. Johnson, ImClone's chief executive officer, said, "We believe this is an important step forward in ImClone's and Lilly's shared goal of addressing the medical needs of cancer patients around the world. The significant progress ImClone has made over the last few years is a direct result of the important contributions of our employees, and joining forces at this stage of our growth will allow us to leverage Lilly's global capabilities and make even greater advancements in our proprietary pipeline."
   
Erbitux is marketed by ImClone's two partners, Merck KGaA and Bristol-Myers Squibb. ImClone co-promotes Erbitux in North America with BMS. In 2007, worldwide sales of Erbitux were approximately $1.3 billion.

Perrigo Co. has acquired Laboratorios Diba, S.A. for approximately $25 million in cash. Based in Guadalajara, Mexico, Laboratorios Diba is a store brand manufacturer of OTC and prescription pharmaceuticals, including antibiotics, hormonals and opthalmics. The acquisition is expected to add nearly $15 million of annual sales.
   
Perrigo's chairman and chief executive officer, Joseph C. Papa stated, "Perrigo has been in the Mexican market for more than 65 years and is the leading supplier of prescription and OTC store brand products there. The acquisition of Laboratorios Diba will enable us to market an additional 150 formulas and 50 trademarks into the rapidly growing Mexican store brand market, saving consumers money on their healthcare options. This further exemplifies Perrigo's commitment to meeting the growing need for quality, affordable healthcare around the world."

Alcan Global Pharmaceutical Packaging has acquired the Chakan flexible packaging plant from Associated Capsules Ltd. in India.
The acquisition expands Alcan's presence in the Indian pharmaceutical market. The Chakan facility has annual sales of $3.6 million and employs approximately 100 people. The integration into the Alcan Packaging group is expected to be completed in early 2009.

"The acquisition of this facility advances our leadership position in pharmaceutical flexibles through growth in emerging markets," said Ilene Gordon, president and chief executive officer, Alcan Packaging.
   
"Chakan is a well equipped plant with dynamic people and an asset base that will complement our current product portfolio," said Michael Schmitt, president of Alcan Global Pharmaceutical Packaging division. "The expertise with local pharmaceutical companies will be an excellent addition to our organization, increasing our ability to service global and regional customers while maintaining the high quality standards they have come to expect from us."
   
 

Genentech, Roche, and GlycArt (a company wholly-owned by Roche) have entered into a collaboration that includes a license from GlycArt to Genentech for the joint development and commercialization of GlycArt’s GA101 molecule. The companies will develop GA101, a humanized anti-CD20 monoclonal antibody engineered to increase both direct- and immune-mediated target cell death, for the potential treatment of hematological malignancies and other oncology-related B-cell disorders such as non-Hodgkin’s lymphoma.
   
Under the agreement, the three companies will share certain development costs and Genentech will record $105 million in R&D expenses in 3Q08. Genentech will receive commercialization rights in the U.S. GA101 is currently in Phase I/II trials for CD20-positive B-cell malignancies, such as non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL). GlycArt and Roche plan to provide Phase I data at the American Society of Hematology meeting in December 2008.
   
Pablo Umaña, chief scientific officer and co-founder of GlycArt, said, “With its unique mode of action, we believe GA101 has the potential to extend the therapeutic benefit over current standards of care, including treatment for patients who do not respond to current therapies.”
  
“This collaboration with GlycArt and Roche for the GA101 molecule complements our existing research program and our focus on innovative compounds,” said Hal Barron, M.D., Genentech's senior vice president, development and chief medical officer. “We are pleased that through this program we may have the potential to offer a new option to treat patients with hematological malignancies.”
   
“Our early investment in pioneering technologies continues to provide new hope for patients,” said William M. Burns, chief executive officer, Roche Pharmaceuticals. “The exciting work in antibody engineering carried out by our scientists at GlycArt can now be taken to the next stage in developing clinically differentiated treatments.”

A federal court granted Amgen a permanent injunction prohibiting Roche Holding AG from selling its Mircera anemia treatment in the U.S., as well as upheld a jury verdict regarding certain patent-infringement claims.
   
Mircera is currently available in Europe and the FDA has approved the drug, but the legal dispute prevented its sale. The drug, if released in the U.S., would compete directly with Amgen's anemia drugs Aranesp and Epogen, which accounted for more than 40% of its revenue in 2007.  
   
In March, a Massachusetts district county judge pushed back his decision on whether to grant Amgen the permanent injunction, asking a third party to compare dosing and pricing of the companies' products. A jury had found last October that Roche's Mircera infringes 11 of Amgen's patents protecting Epogen.
   
"Amgen is pleased with today's ruling, which recognizes that Amgen is entitled to a permanent injunction against Roche and reaffirms the infringement and validity of our patents," general counsel David Scott said in a statement.

Alba Therapeutics Corp. has made several promotions. Linda Arterburn, Ph.D., has been promoted to vice president of preclinical development and program management. Francisco Leon, M.D., Ph.D., has been promoted to vice president, clinical development and medical affairs. Roberto Allen has been promoted to vice president, legal affairs and intellectual property. Mark Ginski, Ph.D., has been promoted to senior director of product and analytical development and Kate Huber has been promoted to director of clinical operations.
   
Prior to joining the company, Dr. Arterburn was executive director of discovery research at Market Biosciences where she initiated an inflammation research program and was lead inventor on two patents involving novel anti-inflammatory lipids. Previously she led clinical research and scientific affairs at Market Biosciences. Dr. Arterburn also spent seven years at W.R. Grace & Co., where she led an in vitro toxicology research program, and then served as manager of technology and planning.
   
Dr. Leon is an immunologist with training in basic and clinical immunology and a clinical development in the field of mucosal immunology. Prior to joining the company, Dr. Leon was a director of clinical development, inflammatory and respiratory diseases at MedImmune, where he worked on asthma and mucosal vaccination. He was a director of clinical discovery, oncology / immunology at Bristol-Myers Squibb, where he worked on Crohn's disease, rheumatoid arthritis, and transplantation.
   
Prior to joining the company, Mr. Allen was president of Respire Medical, Inc., a respiratory and home health care provider serving the Mid-Atlantic region. He was also counsel at Kollman & Saucier, P.A., where he practiced general corporate and labor and employment law. Previously, he was a senior associate in the business department at Saul Ewing LLP.
   
Dr. Ginski's has experience with lead candidate selection, preformulation and formulation development, development, transfer and validation of analytical and bioanalytical methods, and packaging, labeling and distribution of clinical trial supplies. Prior to joining the company, Dr. Ginski served as associate director of preformulation sciences at Shire, where he played an integral role in developing and implementing Shire's Proscreen and Optiscreen programs designed to facilitate lead candidate selection and product development. Additionally, he worked at Guilford Pharmaceuticals, where he was responsible for leading exploratory pharmaceutics and CMC programs for various development programs. He has published numerous R&D articles and is an inventor for numerous global patents.
   
Ms. Huber has more than 25 years of experience in the health care industry and has been involved in all aspects of the conduct of Phase I - III clinical trials. She has worked in managing complex projects in the areas of celiac disease, oncology, CNS, vaccines, and diagnostics for HIV, HbsAg, and tuberculosis. Ms. Huber joins the company from Nabi Biopharmaceutical and Guilford Pharmaceuticals, where she had increasing responsibilities in the vaccine, oncology and CNS arenas. She has extensive experience in the diagnostic business and previously worked for Ortho Diagnostic Systems, Inc. and Pharmacia, where she helped develop diagnostic tools for pregnancy, HIV, Hepatitis B, and blood banking reagents.

Merck has decided not to seek regulatory approval for taranabant, an investigational drug to treat obesity, and is discontinuing its Phase III development program for taranabant in obesity. The drug is similar to Acomplia, the Sanofi-Aventis obesity drug that was rejected by the FDA because of adverse events.
   
"Available Phase III data showed that both efficacy and adverse events were dose related, with greater efficacy and more adverse events in the higher doses. Therefore, after careful consideration, we determined that the overall profile of taranabant does not support further development for obesity," said John Amatruda, M.D., senior vice president and research head, diabetes and obesity, Merck Research Labs. "We thank the patients and investigators around the world who collaborated with us on the research program for taranabant and look forward to developing new medicines for obesity to address the significant medical need posed by this disease."

Christopher Perley has been named vice president and general manager of Bristol-Myers Squibb's Devens biologics manufacturing facility. Mr. Perley will be responsible for continuing the supervision of the project to build the Devens facility and will have overall management responsibility for the site when it becomes operational in 2011.
    
“With an approved capital expenditure of $750 million, the Devens facility represents the largest capital investment in the history of Bristol-Myers Squibb,” said Carlo de Notaristefani, president of technical operations, BMS. “As the company evolves toward a next-generation biopharma model, combining the best of biotech with the best of a traditional pharmaceutical company, biologics will play an increasingly important role in driving our company’s future growth and success, and will be key in helping patients prevail over serious disease. Chris brings extensive biopharmaceutical experience that will support the company in this transition.”
   
Prior to joining the company, Mr. Perley was vice president of network strategy at Wyeth Biotech, where he gained experience in biopharmaceutical process development, production, supply chain management, and operations. Previously, he held manufacturing and biotechnology process development roles at the Genetics Institute in Andover, MA, and at Hoffmann-La Roche in Nutley, NJ.

Biologic Safety Research, Inc. (BSR) is joining PreLabs, LLC to expand their contract laboratory operations. The existing BSR management team will integrate into the PreLabs organization and continue to guide the expanded group. PreLabs appointed Boris Predovich to serve as president and chief executive officer and Philippe Baneux, DVM to serve as chief scientific officer for the newly expanded company. PreLabs/BSR will provide discovery, preclinical and GLP testing.
   
“Market demand has created an exciting opportunity for us to expand our business,” said Robert Locke, BSR president. “Transitioning BSR into PreLabs will leverage our existing scientific and operational expertise while adding the CRO and pharmaceutical management expertise that Boris Predovich and Philippe Baneux bring with their 20 plus years at Covance and Pfizer, respectively.”

GlaxoSmithKline plans to eliminate as many as 850 jobs in R&D in the U.S. and Britain, which represents 6% of the company's total R&D staff. According to a company statement, the cuts were necessary "to ensure that we can invest in key areas of future growth and evolve our business to compete effectively in what is a rapidly changing and challenging environment for pharmaceutical companies."
   
Earlier this year, the company had announced plans to cut 350 R&D positions. According to Claire Brough, a spokeswoman for the Brentford, U.K. office. The exact number of job cuts will be determined after consultations with employees and unions.
   
Andrew Witty, GSK's chief executive officer has pledged to increase the company's investment in outside research. According to Mr. Witty, half of GSK's drugs in development eventually could come from partnerships with outside firms. To support his plan, Mr. Witty has set up a board that includes venture capitalists to review R&D projects and decide which to fund. He has eliminated some areas of research in order to focus the company on eight disease areas. GSK has Centres of Excellence for Drug Discovery (CEDDs) dedicated to each disease area. These changes impact at least three CEDDs.

Gergely Makara, Ph.D. has been named director of chemistry for European operations, AMRI. Dr. Makara has responsibility for all European chemistry products and services including custom synthesis, medicinal chemistry, analytical services, library design and production. He will report to Philip Small, Ph.D., managing director of AMRI’s European operations.
   
Dr. Makara has more than 10 years of industrial experience focused on the development of compound libraries and lead optimization at leading drug discovery companies in the U.S. Most recently, he served as the head of Merck’s Target Validation Chemistry group where he was involved in setting up infrastructure for parallel chemistry synthesis and associated chemoinformatics. Prior to Merck, Dr. Makara was director, hit-to-lead optimization and chemical library development for Neogenesis Pharmaceuticals.
   
“Dr. Makara brings critical scientific and leadership experience to our European operations. His proven ability to form and lead innovative teams is particularly relevant in helping us to execute against our plan to expand services and operations offered to customers worldwide, and more specifically, to further relationships within the European marketplace,” said Dr. Small.
   
AMRI chairman, president and chief executive officer Thomas E. D'Ambra said, “The addition of Dr. Makara further demonstrates AMRI’s commitment to the restructuring plan initiated in May to provide a strong foundation for future expansion through realignment of customer offerings, with an emphasis on the expansion of medicinal chemistry and drug discovery services in Europe.”

Tara Webb has been appointed senior director of business development, Accelerated Community Oncology Research Network (ACORN). Ms. Webb will focus exclusively in the field of oncology, working closely with a select group of sponsors.  
   
“Tara Webb has an exceptional background in the CRO field and is widely respected for her industry knowledge, capabilities and integrity,” said Edward J. Stepanski, Ph.D., chief operations officer of ACORN. “Her responsibilities at ACORN CRO will include presenting ACORN’s capabilities to pharmaceutical companies and emerging biotechs, forging alliances with key accounts and providing customer service oversight on behalf of clients.”  
   
Ms. Webb brings a successful record of establishing and cultivating CRO relationships. Most recently, she served as senior director, business development for i3 Statprobe, where she was responsible for developing new business opportunities and strengthening current client relationships both nationally and internationally.  

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