Pfizer

2Q Revenues: $12.1 billion (+9%)

2Q Earnings: $2.8 billion (+119%)

YTD Revenues: $24.0 billion (+2%)

YTD Earnings: $5.6 billion (+19%)

Comments: Pharmaceutical sales in the quarter were $11.1 billion (+9%) and $22.0 billion YTD (+1%), including exchange rate benefits of $800 million in 1Q08. Lipitor revenues in the quarter were $3.0 billion (+9%). Lyrica revenues in the quarter were $614 million (+52%). Celebrex revenues were $589 million (+23%). Sutent revenues were $211 million (+45%). Chantix (Champix outside the U.S.) revenues in the quarter were $207 million (+3%). U.S. sales were down 35% to $109 million, due to added safety information on the U.S. label, while international sales were $98 million (+197%). R&D expenses were $1.9 billion in the quarter (-8%), excluding $156 million of in-process R&D expenses associated with the acquisitions of Serenex, Inc. and Encysive Pharmaceuticals. Restructuring charges and acquisition-related costs were $569 million in the quarter (-46%). Results were impacted by the loss of U.S. exclusivity for Zyrtec, which Pfizer stopped selling in January 2008, and for Camptosar in February 2008. Zyrtec and Camptosar 2Q08 revenues decreased by $377 million and $104 million, respectively.

Wyeth 

2Q Revenues: $5.9 billion (+5%)
 
2Q Earnings: $1.1 billion (-6%)

YTD Revenues: $11.7 billion (+6%)

YTD Earnings: $2.3 billion (-5%)

Comments: Pharmaceutical sales were $5.0 billion (+5%), due to Effexor, Enbrel, Prevnar, and Zosyn sales, as well as the favorable foreign exchange, offset, in part, by lower sales of Protonix due to generic competition. Effexor sales in the quarter were $1.0 billion (+5%) and $2.0 billion YTD (+9%). Prevnar sales were $691 million (+9%) and $1.4 billion YTD (+12%). Enbrel revenues in the quarter were $976 million and $1.9 billion YTD, which includes sales outside U.S. and Canada (+36% 2Q and YTD) and alliance revenue in the U.S. and Canada (+6% 2Q and 23% YTD). Zosyn/Tazocin sales were $319 million (+14%) in the quarter and $661 million YTD (18%). R&D expenses (excluding impact of foreign exchange) were $836 million in the quarter (+1%) and $1.7 billion YTD (+6%).

Genzyme

2Q Revenues: $1.2 billion (+25%)

2Q Earnings: $69.6 million (-17%)

YTD Revenues: $2.3 billion (+25%)

YTD Earnings: $214.8 million (-11%)

Comments: Myozyme sales were up 65% in the quarter to $77.2 million. The company is still awaiting approval of its Myozyme 2000L-scale facility in the U.S.; the FDA is expected to discuss the BLA in October. Cerezyme sales were up 13% to $319.4 million. Sales of Fabrazyme were up 21% to $126.6 million. Sales of Aldurazyme were up 33% to $38.8 million. Thyrogen sales were $39.4 million (+34%). Renagel and Renvela sales were $168.6 million (+16%). Sales of Thymoglobulin and Lymphoglobuline were up 10% to $45.6 million. R&D expenses were up 92% in the quarter to $381 million and $644.7 million YTD (+77%). Earnings reflect a license fee of $175 million paid in the quarter for mipomersen, a cholesterol-lowering drug in late-stage development, and $70 million in 1Q08 for the purchase of Isis shares.

Bristol-Myers Squibb and AstraZeneca have submitted an NDA to the FDA and a MAA to the EMEA for Onglyza (saxagliptin) for the treatment of type 2 diabetes.  
   
The submissions are based on data from a clinical program conducted in addition to standard therapies, as well as in treatment naïve patients as a monotherapy. The program included studies that evaluated the drug at doses as high as 80 times therapeutic clinical doses. The six Phase III trials assessed the safety and efficacy of saxagliptin and involved more than 4,000 patients.
   
Onglyza, under joint development by BMS and AZ, is a DPP-4 inhibitor designed to be a selective, reversible inhibitor of the DPP-4 enzyme, with dual routes of clearance. Additional Phase III data for saxagliptin, including when added to a sulfonylurea, a thiazolidinedione and as initial combination therapy with metformin, are planned for disclosure later this year.

Merck

2Q Revenues: $6.1 billion (-1%)

2Q Earnings: $1.8 billion (+5%)

YTD Revenues: $11.9 billion (flat)

YTD Earnings: $5.1 billion (+50%)

Comments: Worldwide sales of Singulair were $1.1 billion in the quarter (-1%). Combined worldwide sales of Zetia and Vytorin, as reported by the Merck/Schering-Plough joint venture, were $1.2 billion (-9%). Worldwide sales of Zetia, marketed as Ezetrol outside the U.S., were $560 million (-3%). Worldwide sales of Vytorin, marketed outside the U.S. as Inegy, were $592 million (-14%). Cozaar and Hyzaar sales were $941 million (+11%). Sales of Fosamax and Fosamax Plus D, marketed as Fosavance in the EU, were $411 million (–48%) due to loss of U.S. marketing exclusivity. Sales Januvia, Janumet and Isentress were $2.0 billion in the quarter (+24%). Worldwide vaccine sales were $995 million (-5%). R&D expenses were $1.2 billion for the quarter (+13%). Restructuring costs, primarily representing employee separation costs associated with the company's global restructuring program, were $102 million in the quarter.

Biogen Idec

2Q Revenues: $993 million (+28%)

2Q Earnings: $207 million (+11%)

YTD Revenues: $1.9 billion (+30%)

YTD Earnings: $369.7 million (+16%)

Comments: Growth in the quarter was driven by Avonex sales up 14% to $527 million, Tysabri sales up 210% to $147 million, and Rituxan revenues from the unconsolidated joint business arrangement up 21% to $279 million. Tysabri revenue comprised $46 million related to product sold through Elan in the U.S. and $101 million related to product sold by Biogen Idec Internationally. Royalties in the quarter were $28 million (+22%). R&D expenses were $252.3 million in the quarter (+16%) and $510.5 million YTD (+25%)

Roche has entered into a definitive agreement  to acquire Mirus Bio Corp. for $125 million. Mirus Bio is a privately owned company based in Madison, WI, focused on the discovery and development of RNAi delivery technologies.
   
Under the terms of the agreement, Roche will maintain an RNAi research site in Madison. Mirus' transfection reagents business will be divested into a standalone business called Mirus Bio LLC. Employees will be offered a transition into their respective business unit. Closing of the transaction is expected during 2H08.
   
RNAi, a natural mechanism the body uses to 'silence' certain genes, represents a potential new class of therapeutics for difficult to treat diseases. The transport of RNAi molecules into the target cell has been the major challenge for this therapy. Mirus' delivery platform provides a new way of getting RNAi therapeutics to specific disease targets.
   
"The pioneering work in RNAi delivery by the scientists at Mirus, together with our Centre of Excellence for RNAi research in Kulmbach, puts Roche at the forefront of bringing this whole new class of treatment to patients who suffer from difficult to treat diseases," said Lee E. Babiss, global head of Roche Pharma Research. "Our global research team has made great strides in advancing RNAi therapeutics, and with our new colleagues in Madison we will now bolster those efforts. The technology brought by Mirus, together with additional technologies, will bring us closer to creating fully enabled RNAi therapeutics."

MeadWestvaco Corp. and Bilcare Ltd. have jointly acquired International Labs, a pharmaceutical packaging company based in St. Petersburg, FL. The acquisition will use the companies' capabilities for adherence-promoting pharmaceutical packaging in an effort to streamline the supply chain by eliminating several steps in the distribution channel, according to a Bilcare statement. The goal of the acquisition, which was completed on July 18th, is to make adherence packaging more widely available to consumers through growing low-cost generic and branded drug programs. Terms of the agreement were not disclosed.
    
The partnership combines MWV’s capabilities in healthcare packaging design (including compliance and injection molded packaging), Bilcare’s research and expertise in materials, products, processes and services for the integration of pharmaceuticals and packaging, and International Labs’ contract packaging services for retail pharmacies, and large generic and branded drug manufacturers.
   
“The combination of our turnkey capabilities has helped enable the creation of new, highly efficient, consumer-oriented supply chains that are changing the economics of global healthcare and improving patient outcomes,” said Bruce Thomas, senior vice president, global market strategy for MWV. “This acquisition is one component of our healthcare strategy in product innovation, capacity expansion, and other growth investments. We are continuing to work with retailers, including Wal-Mart, and generic and branded pharmaceutical companies to continue to bring our innovative healthcare compliance solutions to serve the fast-growing needs of the global healthcare market.”

Mohan Bhandari, chairman and managing director of Bilcare, commented, “We are excited about the acquisition of International Labs; our partnership with MWV will allow us to combine our global experience, primary and secondary packaging expertise, and research and development capabilities to bring compliance packaging solutions to customers throughout the world.”   

Roche has proposed to acquire the outstanding interest in Genentech for a total of approximately $43.7 billion. Roche acquired a majority in Genentech in 1990 and currently owns 55.9% of the company.
   
Under the plan, Genentech will operate as an independent research and early development center within Roche from its existing campus in South San Francisco, retaining its employees and approach to discovering and progressing new molecules. Roche's Palo Alto Virology R&D activities will relocate to South San Francisco, while its Palo Alto Inflammation group will become part of Roche's Nutley, NJ R&D organization. Nutley will host two global Disease Biology Areas (Oncology and Inflammation) as well as key functions in Metabolism. Genentech's site in South San Francisco and Roche's NJ campus will represent the biggest R&D centers in the U.S. within the Roche Group.
   
Roche's Pharma commercial operations in Nutley will be moved to Genentech's site in South San Francisco. The combined company's U.S. commercial operations in pharmaceuticals will use the Genentech name. The existing U.S. sales organizations of both companies will be maintained. Genentech's late stage development and manufacturing operations will be combined with the global operations of Roche. Roche's manufacturing in Nutley will be closed and support functions, such as informatics and finance, will be consolidated.
   
Severin Schwan, chief executive officer of Roche, said, "We are looking forward to working more closely with our colleagues from Genentech. We have great respect for their achievements and we will take the necessary steps to nurture Genentech's innovative and unique science-driven culture. The Genentech Founders Research Center will operate as an independent unit within the Roche Group to safeguard a diversity of different approaches and to foster the long term flow of novel breakthrough medicines. At the same time, we will be better able to share technologies and expertise in pharmaceuticals and diagnostics across the Group and broaden the mutual access to the external innovation networks of both companies. As Genentech has grown from a research-focused biotech venture into an integrated pharmaceutical organization, the transaction will also unlock synergies by leveraging the scale of the combined operations in the U.S. and improving operational efficiency."
   
The terms and conditions of the transaction will be determined through negotiations with the independent directors. Roche expects to complete the transaction as soon as possible following negotiation of a definitive merger agreement.

Roche

1H08 Revenues: $21.5 billion (+4%)

1H08 Earnings: $5.6 billion  (-2%)

Comments: Pharmaceutical sales were $16.8 billion (+3%). Oncology sales increased 15%, driven by Avastin (+36% to $2.3 billion), MabThera/Rituxan (+17% to $2.8 billion), Herceptin (+11% to $2.4 billion), Tarceva, (+28% to $574.2 million) and Xeloda (+14% to $560.5 million), which offset lower Tamiflu sales. Tamiflu sales declined $1.1 billion compared to 1H07 due to reduced pandemic stockpiling orders. R&D expenses were $4.0 billion (+12%).  

AMRI opened its first in vitro biology lab in Singapore and completed a 10,000-sq.- ft. lab expansion for medicinal chemistry discovery services, doubling the capacity of its Science Park III facility.
   
The in vitro biology group will test compounds synthesized by AMRI’s Singapore-based medicinal chemistry teams to deliver potency data using cell-based or biochemical assays. AMRI anticipates hiring an additional 70 or more chemists and biologists to staff the facility during the next three years.
   
“This expansion continues AMRI’s investment in building out a worldwide drug discovery and development platform. Along with parallel investments in the U.S., India and Hungary, AMRI’s global footprint is gaining a critical mass and customers’ acceptance due to our focus on quality, highest standards and a strong brand of excellence. This latest investment in Singapore continues our plan to provide customers a broad range of services, capabilities and geographic choices,” said chairman, chief executive officer and president Thomas E. D’Ambra, Ph.D.

Quentin Roach has been named senior vice president and chief procurement officer, Bristol-Myers Squibb. Mr. Roach will be responsible for global leadership for supplier relationship management, company-wide sourcing strategies, and procurement of all materials and services.
   
“As we transition Bristol-Myers Squibb to a next-generation BioPharma model, Quentin will play a key role in continuing to maximize the strategic value that procurement can deliver to the company,” said Carlo de Notaristefani, president of Technical Operations. “He brings extensive procurement and supply chain experience that will serve him well in his new position,” said Mr. de Notaristefani.
   
Prior to joining the company, Mr. Roach was vice president of Global Customer Strategy & Process Management at Bausch & Lomb Inc., where he also led the company’s Global Customer Strategy Steering Committee. While at Bausch & Lomb, he held a number of leadership roles in sourcing and procurement, supply chain, and packaging engineering. Earlier, he was chief purchasing officer and director of Auxiliary Operations at the University of Rochester/Strong Health System. He held a number of procurement and operations roles at other companies including Delphi Automotive Systems and General Motors Corp.

Teva Pharmaceutical Industries and Barr Pharmaceuticals have signed a definitive agreement under which Teva will acquire Barr for $7.5 billion plus the assumption of approximately $1.5 billion of debt. The acquisition will expand Israel-based Teva's presence in the U.S. and Eastern European generics markets as well as add to Teva’s specialty pharmaceutical platform through the addition of Barr’s substantial women’s health portfolio.
   
Shlomo Yanai, president and chief executive officer of Teva, said, “The acquisition of Barr will elevate Teva’s market leadership to a new level. The combination of our two companies provides an outstanding opportunity strategically and economically: It will enhance our market share and leadership position in the U.S. and key global markets, further strengthen our portfolio and pipeline, and provide upside to our strategic plan, by allowing us to exceed our 20/20 goals for 2012.”
   
Bruce Downey, chairman and chief executive officer of Barr, said, “This transaction will enable Teva to capitalize on Barr's portfolio of unique generic and proprietary products, benefit from our capabilities in biologics, and expand its presence in important Central and Eastern European markets. This agreement has the full support of Barr's board of directors and senior management, and will benefit the shareholders, customers and employees of Barr.”
   
The combined global company will operate directly in more than 60 countries and employ approximately 37,000 people worldwide. The transaction is expected to close in late 2008.

Gilead Sciences 

2Q Revenues: $1.3 billion, (+22%)

2Q Earnings: $442.8 million (+9%)*

YTD Revenues: $2.5 billion (+22%)

YTD Earnings: $939.0 million (+15%)

Comments: Product sales were a record $1.2 billion in the quarter driven by the antiviral franchise ($1.1 billion, up 34%), including the strong growth of Atripla and continued growth of Truvada. Atripla sales were $355.1 million (+67%) and Truvada sales were $516.1 million (+34%). R&D expenses in the quarter were $176.5 million (+30%)

*Earnings in the quarter include an after-tax stock-based compensation expense of $26.4 million and an in-process research and development expense of $7.8 million.

The FDA has completed an inspection of Synomics Pharmaceutical Services' facilities and operations in Wareham, MA. The inspection included both PAI and general regulatory compliance, as Synomics Pharma had been named in three NDAs. No 483's were issued.
   
John Pirro, vice president and chief operating officer of Synomics Pharma, said, "The positive inspection of our facilities and operations by the FDA attests to the strength of our comprehensive quality management system. Our highly trained scientists and industry experts, led by Dr. Kirk Smith, director Quality Systems, have worked together to develop a fully integrated GLP and cGMP quality system that assures reduced regulatory risk without adding inefficiencies or costs. Further, this system integrates the principles from recent FDA and AAPS initiatives for bioanalysis for clinical trials, bridging the regulatory requirements from preclinical to commercial development."

Novartis

2Q Revenues: $10.7 billion (+14%)

2Q Earnings: $2.3 billion (+17%)

YTD Revenues: $20.6 billion (+11%)

YTD Earnings: $4.6 billion (+13%)

Comments: Pharmaceutical sales were $6.9 billion (+14%) in the quarter and $13.2 billion (+10%) in 1H08, driven by Diovan sales along with contributions from recently launched products, which offset an 11% decline in the U.S. due to generic versions of Lotrel, Lamisil, Trileptal and Famvir, along with the Zelnorm withdrawal. Oncology sales in 1H08 were $4.0 billion, driven by Gleevec/Glivec sales of $1.8 billion (+17%), as well as strong contributions from Zometa, Sandostatin and Femara. Cardiovascular product sales in that period were $3.3 billion, which benefited from gains for Diovan ($2.9 billion in 1H08). Galvus gained European approval for type 2 diabetes in 1Q08 and has been launched, but the company announced that it does not plan to resubmit Galvus in the U.S. after delays and additional testing that would be required. The Sandoz generic unit had $3.8 billion in sales (+13%) in 1H08; sales at the Vaccines and Diagnostics unit were $602 million (+25%).

HollisterStier Contract Manufacturing received its certificate of GMP compliance by the Medicines and Healthcare Products Regulatory Agency (MHRA). This certification was issued following an inspection of the company's facilities, quality systems and processes and includes the manufacture of Investigational Medicinal Products for clinical trials, as well as the a terminally sterilized diluent on its new Small Volume Parenterals Line (SVP II).   
   
The new SVP II line at the company's 172,000-sq.-ft. facility is available to aseptically fill liquid and lyophilized pharmaceutical products in vials ranging from 2mL through 200 mL in batch sizes from 20 to 3,000 liters.  A recent routine GMP inspection also concluded with no inspection observations being issued for the new SVP II line.
   
“HollisterStier is pleased that our facility has received MHRA certification and a positive inspection from the FDA,” said Rick Lapointe, president of HollisterStier Contract Manufacturing Business Unit.  “We dedicate ourselves to ensuring our manufacturing processes operate at an exemplary level — this level of acknowledgement is something in which we’re all very proud.”

Genzyme and PTC Therapeutics have entered an exclusive global collaboration to develop and commercialize PTC124, PTC's late-stage oral therapy for the treatment of genetic disorders due to nonsense mutations.
   
Under the terms of the agreement, PTC will commercialize the drug in the U.S. and Canada, and Genzyme will commercialize the treatment in all other countries. Genzyme will make an up-front payment of $100 million, plus potential milestone and royalty payments. PTC will be financially responsible for one ongoing and three additional trials of PTC124, which may potentially be applicable to hundreds of genetic diseases. PTC124 is currently being evaluated in a Phase IIb trial for Duchenne muscular dystrophy (DMD), and a Phase IIb trial in cystic fibrosis (CF) is expected to begin by the end of this year.
   
In the U.S., there are an estimated 10,000 DMD patients, approximately 13% of which have nonsense mutations. Of the more than 30,000 U.S. patients with CF, about 10% have nonsense mutations. The companies also plan to explore PTC124's potential to make a difference for patients with other types of severe and debilitating genetic diseases.

Abbott

2Q Revenues: $7.3 billion (+15%)

2Q Earnings: $1.3 billion (+34%)

YTD Revenues: $14.1 billion (+14%)

YTD Earnings: $2.3 billion (+34%)

Comments: Worldwide pharmaceutical sales increased 17% percent in the quarter to $4.1 billion, driven by Humira, Niaspan and Kaletra. Humira sales were $1.1 billion in the quarter (+48%), Niaspan sales were $194 million  (+14%) and Kaletra sales were $355 million (+13%). R&D expenses grew 13% to $657 million in the quarter. Pharmaceutical sales were $8.0 billion for the first half of the year (+16%). Humira sales reached nearly $2.0 billion in 1H08 (+51%).

3M Drug Delivery Systems has designed a proof-of-concept device using a solid microstructured transdermal system (sMTS) for the systemic delivery of high potency pharmaceuticals. The technology was showcased this week at the annual meeting of the Controlled Release Society in New York, where John K. Simons, Ph.D., microstructured transdermal project manager at the company, explained the in vivo data, including depth of penetration, timed release, and demonstration of systemic delivery.

The research findings showed that the delivery of naloxone via an sMTS patch was comparable to a subcutaneous injection with regard to bioavailability and pharmacokinetic (PK) profile. Time-release data showed that the dosage was delivered quickly after the patch was placed on the skin, with the majority of the initial array content delivered within 30 seconds. This data along with the systemic delivery studies, confirmed that efficient systemic delivery is possible with coated microstructures. 3M's sMTS technology was previously used for vaccine delivery and this new application expands the range of APIs that can be delivered transdermally.
   
"This technology will help pharmaceutical providers differentiate their products with a minimally invasive and more comfortable self-administration method," said Dr. Simons.

Novartis has extended its RNAi therapeutics collaboration with Alnylam Pharmaceuticals through October 2009. The alliance was initiated in October 2005 and is focused on the discovery, development, and commercialization of RNAi therapeutics toward a defined number of Novartis-selected disease gene targets.
   
“Our efforts with Novartis have been very productive over the past three years, and we are delighted that Novartis has elected to extend our alliance for another year,” said John Maraganore, Ph.D., chief executive officer of Alnylam. “Novartis was a pioneer in recognizing the potential of RNAi therapeutics as a new class of medicines, and we look forward to continuing our work with them as we advance this innovation to patients.”
   
Under the agreement, both companies are responsible for RNAi discovery activities and Novartis is responsible for development and commercialization of RNAi therapeutic products. With the extension of the alliance term, Novartis will continue to fund R&D efforts conducted by Alnylam. Novartis also retains its right to exercise a non-exclusive platform license from Alnylam in exchange for an undisclosed payment and future milestones and royalties. In addition, Novartis has the option to extend the collaboration for an additional one-year term through 2010. Novartis retains certain rights to purchase Alnylam equity up to 19.9%; current Novartis ownership is approximately 13.4%.

Victor Dixon has been appointed vice president and general manager for the printed components business of Catalent Pharma Solutions' Packaging Services segment. Mr. Dixon will be located at the company’s facility in Philadelphia, PA.

Mr. Dixon has in-depth experience and a strong track record of success in packaging and printing. He joins the company from Cortegra Group, a packaging manufacturer, where he was president and chief executive officer. Prior to that, he spent 10 years at Alcoa, Inc. in positions of increasing responsibility, serving as general manager, vice president and general manager and vice president global sales for the Flexible Packaging business.

“Catalent has been fortunate to recruit Victor Dixon. His extensive knowledge of the industry and strong commercial planning skills will enable him to contribute significantly to our success,” said Tracy Tsuetaki, group president, Packaging Services for Catalent.

Johnson & Johnson

2Q Revenues: $16.5 billion (+9%)
2Q Earnings: $3.3 billion (+8%)
YTD Revenues: $32.6 billion (+8%)
YTD Earnings: $6.9 billion (+23%)

Comments: Pharmaceutical sales were $6.3 billion (+3%), driven by Topamax sales ($677 million up 17%), Velcade sales ($205 million up 63%), Risperdal Consta sales ($343 million up 23%), and Remicade sales ($886 million up 2%). Growth was negatively impacted by lower sales of anemia drug Procrit, down 14% to $652 million, due to a decline in the market, and Risperdal Oral sales, down 16% to $712 million, due to generic competition outside the U.S. Companywide international sales were $8.2 billion (+16%), while U.S. sales were $8.2 billion (+2%). Medical devices and diagnostics sales were up 12% to $6.1 billion and consumer sales were up 13% to $4.0 billion. In the quarter, Evolence was FDA-approved for the correction of moderate to deep facial wrinkles and folds and Concerta was approved for the treatment of ADHD in adults.

Genentech
2Q Revenues: $3.2 billion (+7%)
2Q Earnings: $782 million (+5%)
YTD Revenues: $6.3 billion (+7%)
YTD Earnings: $1.8 billion (+21%)
Comments: Rituxan sales were $651 million in the quarter (+12%). Avastin sales were $650 million (+15%). Herceptin sales were $338 million (+3%). Tarceva sales were $119 million (+17%). Sales in the market reached $2.4 billion (+9%). Royalty revenue in the quarter was up 30% to $629 million primarily due to growth in ex-U.S. sales of the company's products by collaborators and foreign exchange benefits of the weak dollar. R&D expenses in the quarter were $649 million (+8%), or 20% of operating revenue.

Roche plans to suspend its HIV research because pending medicines fail to show significant improvement over existing therapies, according to a company statement. The company also claimed it will "refocus resources within virology on diseases in which the company can deliver substantial improvements over existing medications." Research scientists currently working in HIV will be reassigned to other activities, according to Linda Dyson, a spokeswoman in Roche's U.S. office in NJ.
   
The company plans to continue to support its molecular diagnostic tests and drugs already on the market, including the fusion-inhibitor Fuzeon. Roche has partnered with Trimeris, Inc., a NC-based biotech company, to sell Fuzeon, which had sales of $266.8 million last year. The drug has experienced some difficulty in the past because of its high cost, which is approximately $25,000 for a year's supply.

Actelion has signed an agreement with GSK valued at as much as $3.3 billion to jointly develop and market Actelion's experimental sleeping pill candidate, almorexant. Actelion will receive an upfront payment of $148 million and $409 million upon registration of the drug. Actelion is also eligible to receive as much as $2.7 billion in success-based milestones, as well as royalties. Under the agreement, GSK will receive exclusive worldwide rights, excluding Japan, to co-develop and co-commercialize the drug.
   
Results from a late stage-trial investigating almorexant's safety and efficacy in insomnia patients are expected in 2009. Current data suggests the drug helps insomniacs fall and stay asleep in a nonsedative fashion.
   
Actelion will continue to lead the development program and potential registration for almorexant in the first indication, primary insomnia, with GSK contributing 40% of the costs. Almorexant will also be studied in other orexin-related disorders and all costs and profits related to these programs will be shared equally.

Michael P. Bailey, senior vice president of commercial operations at ImClone Systems, has resigned effective August 1, 2008. Mr. Bailey has accepted a senior level commercial position with Synta Pharmaceuticals, a New England-based biopharmaceutical company.
   
ImClone has appointed Joseph I. DePinto as vice president of commercial operations, effective July 14, 2008. He will assume responsibility for the company's commercial operations department upon Mr. Bailey’s departure. Mr. DePinto has 20 years of experience in pharmaceutical sales, marketing and commercial business strategy for oncology products.
   
“Joe has a solid track record of delivering impressive results for the oncology therapeutic franchises he championed. His proven leadership in sales and marketing will be of significant value as we aggressively seek to maximize the global potential of Erbitux and our robust pipeline of novel antibodies in the future,” said John H. Johnson, chief executive officer of ImClone. “Through Michael’s leadership of ImClone’s commercial efforts over the past two years, we are well positioned to extend the growth of Erbitux in the years to come. We thank Michael and wish him continued success as he pursues the next phase of his career.”
  
Mr. DePinto joins the company from Johnson & Johnson Pharmaceutical Services, where he served as global marketing leader, Oncology Therapeutics since 2006. In this role, he was responsible for leading the development and execution of worldwide commercial strategies, market analyses and forecasts. Previously, Mr. DePinto was with Ortho Biotech Products for 12 years where he held management positions of increasing responsibility in oncology sales and marketing and most recently served as vice president, oncology sales. Prior to joining Ortho Biotech, he held field sales positions at Upjohn Pharmaceuticals from 1990 to 1994.  

Dr. Derek Winstanly has been appointed chair-elect of The Association of Clinical Research Organizations (ACRO). Dr. Winstanly, executive vice president of strategic business partnerships for Quintiles Transnational, was appointed the 2008 chair-elect in June. He is a respected leader of the CRO industry, having held various global leadership positions within Quintiles since joining the company in 1999.  In his current role, he works with senior biopharmaceutical executives to provide long-term strategic solutions, and is responsible for the office of the chief medical officer as well as the ethics and quality assurance functions of the company.
    
“I congratulate Dr. Winstanly on his appointment as chair-elect of ACRO,” said David Spaight, ACRO chair and president of MDS Pharma Services.  “His experience and insight will enhance the association’s efforts to demonstrate the important contributions that CROs make to the clinical research enterprise.”
    
“I am pleased to join the leadership of ACRO at a time of extraordinary growth for our industry,” added Dr. Winstanly.  “I look forward to driving the association’s efforts to increase public understanding about the vital role CROs play in the conduct of safe and high-quality clinical studies to accelerate the development of new medical treatments.”

John H. Albright has been appointed head of regulatory affairs and compliance for Celsis Rapid Detection, Celsis International. In his new role, Mr. Albright will be the liaison to key regulatory bodies and industry associations influencing the pharmaceutical, home care, cosmetics and personal care and beverage markets served by Celsis. He will also serve as a regulatory adviser and consultant to companies either using or evaluating Celsis technology to streamline their manufacturing and testing processes.  
    
Prior to joining Celsis, Mr. Albright spent 13 years in both the Diagnostic and Pharmaceutical Operations divisions of Abbott Laboratories. He served in a variety of project management positions including quality systems validation manager, product technical support and R&D. During his tenure, he drove the successful development, launch and production of global immunoassay products.
    
“John Albright adds an important customer focus to our regulatory services,” said Jay LeCoque, chief executive officer of Celsis. “His experience in quality assurance testing and validations, coupled with his track record for global regulatory approvals, makes him uniquely qualified to counsel companies looking at rapid methods to streamline their manufacturing process without sacrificing quality or control.”

Merck, Lilly, and Pfizer have joined forces to create new drug discovery and development methods aimed at saving time and money by reducing the failure rate of clinical trials. The three companies and PureTech Ventures LLC have invested $39 million to launch Enlight Biosciences LLC. Enlight will represent the first for-profit venture in which Merck, Lilly or Pfizer collaborates with its competitors.
   
"Merck, Lilly and Pfizer don't see competitive conflicts because they view the technologies Enlight seeks to develop, including advanced body-imaging methods, as 'pre-competitive,'" said David Steinberg, Enlight's chief executive officer.
   
"Today, drug discovery is tremendously tech-dependent, and many of the pharmaceutical companies are falling behind," said Enlight co-founder Raju Kucherlapati, a genetics professor at Harvard Medical School.
   
"If you can find the winners earlier, and lose faster with the failures, you can really improve R&D productivity," said Steven Paul, executive vice president for science and technology at Lilly. He said that 70% of industry trials fail at the Phase II stage, the level just before final human trials. That is "just too high," he said, "and that's where these technologies come into play."
   
Enlight will establish new companies that aim to exploit any new technologies created, where members have the chance to license the technology and buy shares in it. The first of these, Endra Inc., uses sound and light imaging to examine the effects of drugs on internal organs.  

Novartis AG plans to acquire the remaining shares of Speedel Holding AG for approximately $881 million, according to a company statement. Novartis currently holds 61.4% of the company. The acquisition would give Novartis full control over the promising blood-pressure drug Tekturna that Speedel helped develop, and Novartis would no longer have to pay Speedel licensing fees.
   
Tekturna was launched in the U.S. last year and Novartis expects that it will eventually replace its blockbuster blood-pressure drug Diovan, which faces generic competition by 2012.
   
Speedel was reportedly reluctant to sell and in a statement, chief executive officer Alice Huxley said, "In light of the currently very challenging environment for Speedel, i.e. the upcoming financing needs and the depressed market sentiment, I have agreed to a solution which promises a solid fundament for the future of Speedel."
   
Dr. Huxley bought the rights to Tekturna in the mid-1990s after Novartis opted out of further development. She offered Speedel's board her resignation and, according to a Speedel spokesman, the board will decide whether to accept it and whether to support the acquisition in the next 10 days.  

Dr. Debra Yu has been appointed vice president of strategy, WuXi PharmaTech. Dr. Yu will be responsible for leading the company's strategic planning and initiatives. She will report to Dr. Ge Li, chairman and chief executive officer of WuXi PharmaTech.
   
Prior to joining the company, Dr. Yu co-led Pfizer's venture capital group and was instrumental in working in areas such as diagnostics, asset monetization and creative finance structures and Pfizer's innovation agenda. Earlier she was a general partner at Delphi Ventures and a managing director at Bay City Capital, two Bay area venture firms focused on the life sciences. Dr. Yu has also held senior positions at many leading companies and organizations like McKinsey & Co., the FDA, the Wilkerson Group, Morgan Stanley & Co., Genentech and the Permanente Co.  
   
"I am very pleased to welcome Debra on board to further increase the depth of our senior management," commented Dr. Ge Li. "With 19 years of experience in venture capital and life sciences, Debra will provide strategic guidance as we continue building a global drug and medical device R&D service platform through organic growth, partnership and M&A."

Lilly has signed a definitive merger agreement to acquire SGX Pharmaceuticals, Inc. for approximately $64 million in cash. SGX, based in San Diego, CA, is a biotechnology company focused on oncology drug discovery and development.
   
The acquisition gives Lilly access to FAST, SGX's fragment-based, protein structure guided drug discovery technology, and to its portfolio of preclinical oncology compounds focused on a number of high-value kinase targets.
   
The two companies began collaborating in 2003 to determine 3-D structures of key Lilly drug targets using SGX's x-ray crystallography technology. The ongoing collaboration also provides Lilly with access to SGX's state-of-the-art synchrotron beamline facility at the Advanced Photon Source (APS) located at the Department of Energy's Argonne National Lab in Chicago, IL.
   
"After a successful collaboration over the past several years, we are excited to bring the scientific and technological expertise of SGX into Lilly's research organization, while at the same time expanding our presence in the San Diego area," commented Steven M. Paul, M.D., executive vice president, science and technology for Lilly. "We will leverage the combined resources of both companies to strengthen our structural biology capabilities and seek out innovative therapies for patients."
   
"We believe that this merger provides an excellent opportunity for the potential of SGX's platform and pipeline to be realized, while simultaneously providing our shareholders with attractive financial terms," said Mike Grey, chief executive officer of SGX Pharmaceuticals. "As we have evolved from a platform technology organization to a drug discovery company, we believe that this transaction represents a timely opportunity to place our programs and technology assets in the hands of a world-class company with the experience and resources to advance innovative treatments for patients."
   
The transaction, subject to certain closing conditions, is expected to close in the second half of 2008.

Akorn, Inc. has entered into a 10-year exclusive contract manufacturing supply agreement with an undisclosed pharmaceutical firm. Under the terms of the agreement, Akorn will be responsible for the manufacturing and supply of several injectable drug products. Akorn anticipates annual contract revenue from these products to be between $4 million and $5 million for the duration of the supply agreement.
   
Arthur S. Przybyl, Akorn’s president and chief executive officer stated, “This agreement reflects Akorn’s commitment to providing high quality contract manufacturing services to the pharmaceutical industry. We look forward to supplying these important drug products from our Decatur, IL facility.”

AAIPharma received certification from Sweden’s Medical Products Agency (MPA) for EU Good Manufacturing Practice (GMP) compliance of its Wilmington, NC operations. The company's tablet, capsule and other solid dose drug manufacturing and testing operations are now certified as meeting EU GMPs, allowing the Wilmington plant to produce these products for shipment to countries in Europe.  
    
AAIPharma’s sterile manufacturing operations in Charleston, SC also passed an FDA inspection and gained EU GMP certification.
    
“Certification of our Wilmington operations in addition to the approval of our Charleston manufacturing plant by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in January, is a testament to AAIPharma’s goal to provide high quality pharmaceutical contract manufacturing services to the global market,” stated Lee Karras, senior vice president of Global Pharmaceutical Services at AAIPharma.
 

Patheon has been selected by SK Life Science, Inc., the US-based subsidiary of Korean SK Holdings, as its development services partner for two Central Nervous System (CNS) drug candidates. Patheon will provide formulation and analytical development services as well as clinical supplies for one of the CNS candidates in advanced clinical studies. Patheon will also provide development and clinical materials manufacturing services for another CNS candidate in Phase I trials.
   
"We are very pleased to have been selected by SK Life Science to develop these important new drug candidates, and we look forward to continuing to provide them with exceptional service on their development projects," said Wes Wheeler, president and chief executive officer of Patheon. "This agreement to develop SK Life Science's two innovative candidates for the treatment of CNS disorders expands upon our existing relationship with the company, having recently completed Phase I development and clinical materials manufacturing for their next generation pain drug candidate."
   
"Patheon produced quality clinical materials for the pain drug project within our timelines. As a result we were very comfortable with awarding Patheon these two additional key projects," said Dr. S. James Lee, vice president pharmaceutical development of SK Life Science.

The pending sale of Pfizer's Little Island and Loughbeg plants in Cork, Ireland did not go through, according to a company statement, leaving 480 jobs at risk. The potential buyer withdrew its offer, citing that the facility does not meet its requirements. The sale of the plants, which made APIs for Pfizer drugs, was announced in February 2007 after the cholesterol drug torcetrapib failed in clinical trials. The Cork plants were slated to produce almost 40% of torcetrapib’s active ingredients. If the plants are not sold by the end of 2009, the facility will close.
   
“This is very disappointing as we were hopeful we could reach a positive conclusion,” a Pfizer spokesperson said. According to a report in the Irish Examiner, one “multinational” CMO entered due diligence and examined the plant and its accounts.
   
Pfizer is currently recruiting as many as 100 staff for its biologics facility at Shanbally in Ringaskiddy, where some of the staff at the Little Island and Loughbeg plants may be able to relocate.

Fresenius SE has agreed to acquire APP Pharmaceuticals, a provider of hospital-based injectable pharmaceutical products for $3.7 billion. The agreement also includes a contingent value right ("CVR") that could deliver as much as $970 million more by 2011, depending on APP's success. In addition, Fresenius will assume all of APP's outstanding debt, a net of $940 million; the total value of the acquisition could reach $5.6 billion.

APP will join Fresenius as part of its Fresenius Kabi division. Through the acquisition of APP, Fresenius Kabi enters the U.S. pharmaceutical market and achieves a strong position in the U.S. injectable generics market.

Dr. Ulf Mark Schneider, chairman of the board of Fresenius SE, remarked, "APP is a fast-growing, highly profitable company with a strong management team that has an excellent market position in the U.S. Our firm very much shares APP's dedication to quality and medical excellence for the benefit of patients. The acquisition provides significant growth opportunities for Fresenius Kabi. With the APP platform, Fresenius Kabi will be able to market its product range in the U.S. Fresenius Kabi's international marketing and sales network will allow us to sell APP's products globally. We welcome APP employees to our team and very much look forward to serving the North American healthcare community."

Headquartered in Schaumburg, IL, APP is a hospital-based injectable pharmaceutical company, focusing on oncology, anti-infective, anesthetic/analgesic and critical care markets. The company develops, produces and markets a portfolio of more than 100 hospital-based injectable products and operates three manufacturing facilities producing a range of dosage formulations, including lyophilization.

Althea Technologies, has signed a Letter of Intent to establish a complementary commercialization partnership with Protein'eXpert of Grenoble, France. The agreement provides access to Protein'eXpert's advanced protein engineering, process development and optimization expertise, along with the Althea's cGMP manufacturing resources for production and fill/finish services from Phase I clinical to commercial manufacturing.

"The partnership with Althea Technologies is a great opportunity for us. Their very strong position in the U.S. market and their outstanding production facilities shall perfectly complement our expertise and set of services based on Recombinant protein engineering, development and small scale cGMP production," says Dr. Tristan Rousselle, chief executive officer of Protein'eXpert.

"We are very pleased to enter this agreement with Protein'eXpert. Their highly regarded science and service standards are a wonderful complement to Althea's manufacturing services. We are confident that this will strengthen Althea's presence in Europe and provide Althea clients valuable early stage process development capabilities," stated Dr. Magda Marquet, president and co-chief executive officer of Althea Technologies.

Gianfranco Ferrari, chairman and president of Fabbrica Italiana Sintetici S.p.A. (FIS) died on on March 9 at the age of 84. With his father and two brothers, Mr. Ferrari founded what has become the largest cGMP manufacturer in Italy in 1957 and created a solid portfolio of generic APIs. FIS focused on contract manufacturing services and has grown into one of the larger players in Europe, maintaining its API portfolio. The privately held company posted 2007 sales of near $180 million and has approximately 600 employees working at two sites in Italy.

Relistor subcutaneous injection, a treatment for opioid-induced constipation (OIC), has been approved by the European Commission. The drug, developed by Wyeth and Progenics, is now approved in the 27 member states of the European Union as well as Iceland, Norway, and Liechtenstein. Relistor is the first approved treatment for OIC in the European Union.

"The approval of Relistor by the European Commission is another major milestone for this innovative therapy, the first medicine approved for the treatment of opioid-induced constipation in advanced illness patients," said Paul J. Maddon, M.D., Ph.D., founder, chief executive officer and chief science officer of Progenics.

Joseph M. Mahady, president, Wyeth Pharmaceuticals, added, "We are proud to be able to offer this new innovation to physicians and health care providers caring for palliative care patients with advanced illness. We are pleased to have received regulatory approvals for Relistor from Canada, the U.S., and Europe in quick succession, as they represent significantly developed markets for opioid use in palliative care patients."

Commercial launch of Relistor in Europe will be rolled out on a country-by-country basis, with the first launch anticipated to occur later this month.

Patheon has entered a sales and marketing agreement with Italy's BSP Pharmaceuticals, a developer and manufacturer of cytotoxic pharmaceutical products. Patheon will promote BSP's cytotoxic manufacturing capacity and development services and Aldo Braca, president, Patheon Europe, will serve as president and chief executive officer of BSP Pharmaceuticals until a successor is named. For a transitional period, Mr. Braca will fill both roles.
   
"Cytotoxic manufacturing represents a major market opportunity, and a capability that Patheon does not have in its network. With these agreements in place, Patheon can now offer its clients a complete suite of services — which now includes cytotoxics — in contract manufacturing and formulation development," said Wes Wheeler, chief executive officer and president.
   
Cytotoxic products play a significant role in the oncology market, which is estimated to be approximately $9.6 billion and is expected to reach $12.8 billion by 2009.

Bayer HealthCare will acquire Maxygen’s hemophilia program assets, including next-generation recombinant Factor VIIa protein MAXY-VII, the company's lead candidate, which is expected to enter Phase I trials in 3Q08. The total transaction is valued at $90 million with a potential milestone payment of $30 million. This agreement includes a license to use Maxygen’s MolecularBreeding technology, a research platform for exploiting gene targets. Bayer also receives exclusive rights to use this technology for 30 specified gene targets.
   
“MAXY-VII has the potential to be an important expansion of therapeutic options for people living with hemophilia and we are pleased to add this to our global development portfolio. The agreement fits into our growth strategy for our specialty pharmaceutical business and builds on our expertise in the commercialization and manufacturing of protein therapeutics,” said Dr. Gunnar Riemann, member of the executive committee of Bayer HealthCare. “Our scientists are actively collaborating with researchers in academia and biotechnology firms to leverage novel research platforms. Access to Maxygen’s MolecularBreeding technology provides us with another tool to expand our product pipeline.”
   
“This agreement allows Maxygen to capture significant value from this preclinical asset, and puts MAXY-VII in the hands of the hemophilia leader,” said Russell Howard, chief executive officer of Maxygen. “MAXY-VII has the potential to become the world’s first approved shuffled protein therapeutic, a milestone that is likely to open up many more opportunities for Maxygen’s technology. Bayer is the ideal company to move the MAXY-VII program toward that goal.”

Akorn, Inc. and Bioniche Pharma have entered into a five-year commercial manufacturing and supply agreement for two undisclosed pharmaceutical products. Under the terms of the agreement, Akorn will be responsible for the manufacturing and supply of the two injectable products. The two products are expected to launch in the second half of this year.
   
Arthur S. Przybyl, Akorn’s president and chief executive officer, stated, “We are very pleased to have been selected as the contract manufacturer for these important hospital injectable products. We continue to seek contract pharmaceutical manufacturing opportunities in hospital injectables, ophthalmics and lyophilized products in order to expand this business.”

Catalent Pharma Solutions has entered into a joint marketing and collaboration agreement with One World Design and Manufacturing Group. Under the terms of the agreement, both companies will market One World's NextBottleT unit-dose compliance bottle to pharmaceutical manufacturers. One World will produce the injection-molded device and Catalent will provide filling and packaging services. The two companies will also collaborate on developing new packaging solutions, focusing on patient compliance.
    
Tracy Tsuetaki, group president of Catalent's Packaging Services, said, "Helping manufacturers improve patient outcomes and address patient compliance is a key focus for Catalent. Early on we recognized the uniqueness of One World's NextBottle in addressing this need. Additionally, we realized that pharmaceutical manufacturers would require a robust, cost-effective solution in order to adopt this approach. We are pleased to partner with One World and look forward to working with them."
   
Matt Coe, One World's chief operating officer, remarked, "Patient non-compliance is a huge issue in the pharmaceutical industry. When we designed the NextBottle, we wanted to make sure that we designed a package that would improve compliance, have a familiar look and feel, and be able to be filled very easily. We are excited to collaborate with Catalent and leverage their extensive contract packaging capabilities in order to make the NextBottle a success."

Altea Therapeutics has entered into a partnership with Hospira for the development and commercialization of an undisclosed product using its PassPort Transdermal Delivery System. Under the terms of the agreement, Hospira has exclusive worldwide rights to develop and commercialize the product. Altea will fund certain Phase I studies and Hospira will fund all further product development, manufacturing, and commercialization. Altea will receive an upfront payment, which includes an equity investment. Altea could receive milestone payments of as much as $109 million and royalties on sales of the product over the term of the agreement.
   
“This agreement further validates the development of the Altea Therapeutics transdermal patch technology for drugs that previously were administered by needle injection or infusion, including water-soluble proteins, carbohydrates, and small drugs," said Dr. Eric Tomlinson, president and chief executive officer of Altea. “Based on our existing relationship with Hospira, we believe they are the ideal partner with the technological and scientific expertise, and the global commercial reach necessary to develop and commercialize this product.”

Symbio LLC has opened a new Phase I clinical unit in Michigan City, IN. Symbio provides clinical trial management, biometrics, consulting, product development and topical formulation development. With the addition of the Phase I Unit, the company can provide Phase I through Phase IV development. The Phase I unit has 62 beds and is located within Saint Anthony Memorial Hospital.

Bioanalytical Systems, Inc. (BASi) has sold its Baltimore Clinical Pharmacology Research Unit to a subsidiary of Algorithme Pharma Holdings, Inc. for $850,000 in cash, exiting the Phase I market.
   
Algorithme, based in Montreal, is a CRO providing human clinical trials for Phase I and bioequivalence studies, as well as bioanalytical services.  

AstraZeneca and Palatin have amended their January 2007 global licensing and research agreement to discover, develop and commercialize compounds targeting melanocortin receptors.
   
Under the amendment, Palatin has agreed to license additional compounds and associated intellectual property to AZ. Palatin will receive development and regulatory milestone payments if any additional compound advances into human clinical trials, as well as sales milestone payments and royalties if any additional compound is commercialized. AZ is responsible for product commercialization, discovery and development costs.
   
"The collaboration between AstraZeneca and Palatin is very productive and has resulted in valuable scientific and technical advances," stated Dr. Trevor Hallam, Palatin's executive vice president for R&D. "We look forward to initiating human clinical trials for obesity."

Genmab has reached a development milestone for ofatumumab (HuMax-CD20) under the terms of its collaboration with GlaxoSmithKline. The milestone triggers a $6 million payment to Genmab as a result of the first patient treated in the Phase II study of ofatumumab in relapsing remitting multiple sclerosis (RRMS).
   
"Our collaboration with GSK continues to progress as both companies work towards providing new treatment options for patients," said Lisa N. Drakeman, Ph.D., chief executive officer of Genmab. "We are pleased to begin treating patients in the first study of ofatumumab in RRMS, an unpredictable and debilitating disease."
   
Ofatumumab is a fully human, next generation monoclonal antibody that targets a distinct small loop epitope on the CD20 receptor on the surface of B-cells.

Galapagos NV's service division, BioFocus DPI, will provide compound management and related services to Sepracor for a total contract value of $1.5 million. Under the terms of the agreement, BioFocus DPI will receive, register, and store selected compounds from Sepracor's compound library, and plate and replicate these compounds for three years. Services will be provided by BioFocus DPI's compound management facility in San Francisco, CA.
   
"We welcome Sepracor as a new client to BioFocus DPI," said Onno van de Stolpe, chief executive officer of Galapagos. "Our compound management site has been able to broaden its customer base over the last year, and with this agreement we further expand our list of pharma companies."

Michael J. Giuliani, M.D. has been appointed vice president of R&D for Covidien's Pharmaceutical Products and Imaging Solutions. He will lead the R&D organization's efforts to identify and deliver advancements to the pharmaceutical and imaging markets. Dr. Giuliani reports to Timothy R. Wright, president, Pharmaceutical Products and Imaging Solutions.
   
Dr. Giuliani has more than 25 years of medical experience and is a clinical neurology specialist who has served as a professor in the Department of Clinical Neurology at the University of Pittsburgh. Dr. Giuliani was also the co-director of the National Institutes of Health-sponsored Clinical Research Training Program and a member of the University of Pittsburgh Internal Review Board.
   
Dr. Giuliani joins the company from Xanodyne Pharmaceuticals, where he was chief medical officer and executive vice president of product development. Prior to that, he was the senior director of clinical neuroscience/ophthalmology at Merck and director of CNS Research at Wyeth.  
   
James L. Young, Ph.D. has joined the company as vice president of R&D operations for Pharmaceutical Products and Imaging Solutions. Dr. Young will guide all planning, operation and monitoring activities for the Pharmaceutical and Imaging R&D organizations. He will manage all R&D support activities for proprietary products, including pharmaceutical development operations and clinical development programs.
   
Dr. Young also joins the company from Xanodyne Pharmaceuticals, where he was vice president of product development. He has 20 years of experience in the pharmaceutical industry, having served in management, strategic development, sales and scientific roles at companies such as Nexeon, AstraZeneca and Merck.  
   
Ralph A. Heasley, Ph.D. has been appointed vice president of global R&D technology, Pharmaceutical Products. Dr. Heasley will be responsible for overseeing and directing pharmaceutical R&D activities, with a focus on creating better technical products and processes.
   
Dr. Heasley has more than 30 years of experience in pharmaceutical R&D, having held executive-level and other key positions at Xanodyne, Quintiles, and 3M Pharmaceuticals.
   
Randel Frazier will continue as vice president, global R&D, Imaging Solutions. He will lead all aspects of imaging development efforts, with an additional focus on exploring new uses for existing imaging capabilities and on developing new products using the company's competencies in radiology, nuclear imaging and contrast delivery systems.
   
Mr. Frazier has more than 25 years of experience in medical device and pharmaceutical R&D. He joined Tyco Healthcare in 1994 and became vice president, Imaging R&D in 2002. He has also served in R&D, manufacturing, sales and marketing roles for several other companies, including Colorado Medtech, , Gambro and 3M.

GlaxoSmithKline has submitted its response to questions raised by the FDA regarding its application for approval of Cervarix, its vaccine to prevent cervical cancer.
   
GSK will also submit Phase III efficacy study data from HPV-008, which is expected to be available later this year. GSK has decided to augment its application for approval with these data to ensure they are included in the U.S. label. The company anticipates submitting these data in the first half of 2009 and FDA action is expected within six months following this submission. Interim data from this study were filed in the original application for the vaccine in March 2007. The company does not expect that new clinical studies will be required for approval.
   
"Study 008 is a key study that will be completing later this year, and we expect the final results will strengthen the U.S. label for Cervarix," said Barbara Howe, M.D., vice president and director, North American Vaccine Development, GSK. "We continue to have positive and productive discussions with the FDA and remain confident in the vaccine's safety and efficacy profile. We look forward to bringing this important new cervical cancer vaccine to girls and women in the U.S."
   
The vaccine is currently approved in 67 countries including the EU, Mexico, Australia, Singapore and the Philippines. Licensing applications have been submitted in more than 35 additional countries including Japan.

Schering-Plough and Merck withdrew the NDA for the Claritin (loratadine)/Singulair (montelukast) combination tablet. The companies also terminated the their respiratory joint venture formed in May 2000. The FDA issued a not-approvable letter in April for the proposed fixed-dose combination of the two drugs. This decision does not impact the companies' cholesterol joint venture.    
   
As a result of the termination, Schering-Plough expects to receive payments totaling $105 million from Merck per the joint venture agreements, which Schering-Plough will recognize over the remaining three quarters of 2008.

Exelixis and GlaxoSmithKline will end their six-year collaboration based on its success, on October 27, 2008, as scheduled. Under the terms of the collaboration, GSK has the right to select two compounds for further development and commercialization. Exelixis will have the right to develop and commercialize compounds not selected by GSK. Exelixis' exclusivity obligations will now be limited to the compounds selected by GSK. Exelixis will have the right to develop and commercialize any collaboration target or compound that does not infringe upon the intellectual property associated with compounds selected by GSK for further development and commercialization.
   
"This collaboration represents a successful alliance that has truly benefited both companies. With the selection of GSK089 (formerly XL880) and potentially one other compound, GSK has been able to strengthen its oncology pipeline. I am enthusiastic about the compounds remaining in the collaboration, and continue to be impressed by Exelixis' quality of science and productivity," said Paolo Poletti, M.D., senior vice president of the Oncology Medicines Development Center at GSK.
   
To date, Exelixis has received approximately $235 million from GSK, which includes upfront, milestone, and R&D support payments. If GSK selects a second compound, Exelixis will be entitled to receive an additional milestone payment of either $55 million or $27.5 million. Exelixis is eligible for development milestones and royalties on compounds selected for development and commercialization by GSK. Exelixis will pay GSK a small royalty on certain candidates not selected by GSK.

Centocor's BLA has been submitted to the FDA requesting approval of golimumab (CNTO 148) as a monthly subcutaneous treatment for adults with active forms of rheumatoid arthritis (RA), psoriatic arthritis and ankylosing spondylitis. Golimumab is the company's next-generation human anti-TNF-alpha monoclonal antibody. It's being studied as an every four-week subcutaneous injection and as an intravenous (IV) infusion therapy. In February 2008, the company submitted a MAA to the EMEA for golimumab as a monthly subcutaneous treatment for the same indications.
   
The submission is based on five Phase III trials: golimumab as the first-line option in the treatment of early onset RA before methotrexate; golimumab for patients with active RA despite methotrexate use; and golimumab administered subcutaneously in patients with active RA and previously treated with biologic anti-TNF-alpha agent.

Dave Mott, president and chief executive officer of AstraZeneca's biologics business unit, MedImmune, has decided to leave the company at the end of July for personal reasons. Tony Zook, chief executive officer of AstraZeneca’s North American business and executive vice president of global marketing, has been appointed head of MedImmune on an interim basis until a permanent successor is named.
   
David Brennan, chief executive officer of AstraZeneca, said, “Under Dave Mott’s leadership, the team at MedImmune has built a unique capability to discover, develop and deliver innovative biologic treatments — an important element of AstraZeneca’s future strategy. We will continue to build on that strong platform, maximizing the potential of products in the MedImmune portfolio while delivering innovative new biological medicines and vaccines that treat and prevent disease.”



Sanofi Pasteur, the vaccines unit of Sanofi-Aventis, has established a new automated vaccine production facility in Val de Reuil, France to respond to increased vaccine demand worldwide. This new $156 million facility incorporates the latest technology and is part of the $935 million that the company has invested in France between 2005 and 2008.
   
"Sanofi Pasteur's commitment to global health is exemplified by significant investments in vaccine production infrastructures. These efforts are aimed at meeting a world demand for vaccines expected to double by 2016," said Wayne Pisano, president and chief executive officer of Sanofi Pasteur, who inaugurated the new production unit. "The new facility will provide high-end production work environment for dedicated people who produce vaccines for the world."
   
The new facility can produce vaccines against 20 diseases and is designed to respond to pandemic flu, once the flu strain is identified by the World Health Organization. Construction of the 7,800-square-meter building began in 2006 and is projected to be operational by the end of this year. The facility is scaled to fill 200 million syringes and vials per year, twice the current capacity at this site.

Dr. Lori McDonald has been named vice president, quality and compliance at MDS Pharma Services. Dr. McDonald will lead the company's ongoing program to build and manage quality and regulatory compliance systems across its global business platforms.
   
"I'm delighted that Dr. McDonald has joined our leadership team," said president David Spaight. "By enabling process improvements and compliance with regulatory requirements, she and her staff will be instrumental in helping MDS Pharma Services deliver high-quality, on-time services. This will help our clients expedite their drug discovery and development programs."
   
Dr. McDonald previously served as vice president, regulatory affairs with Alder Biopharmaceuticals. From 2001 to 2006, Dr. McDonald held a series of leadership roles with Cardinal Health, most recently having served as executive director, regulatory affairs. Prior to that, she worked at Ligand Pharmaceuticals and Abbott Laboratories.

DSM Biologics and Crucell have entered into an agreement with Avid Bioservices to bring Avid into their Vendor Network. Under the terms of the agreement, Avid will be a pre-approved CMO for licensees of the PER.C6 cell line in the western U.S. Avid is the first U.S.-based CMO to be awarded this status. Other terms of the agreement were not disclosed.

Karen King, president of DSM Biologics, noted, "We are confident that Avid's excellent reputation and service level will be instrumental in making the PER.C6 technology available to licensees on the west coast, bringing our technology to a wider regional base as we continue to grow globally."

Steven W. King, president of Avid Bioservices, added, "We are honored to achieve the distinction of being the first pre-approved U.S.-based CMO to manufacture proteins and antibodies using the PER.C6 cell line. This technology is recognized throughout our industry as providing important advantages compared to other platforms, including serum-free medium, scalability and high productivity levels, making the system an ideal fit for Avid."

The PER.C6 technology platform has been developed for the large-scale manufacture of biopharmaceutical products such as recombinant proteins, including monoclonal antibodies.

WuXi PharmaTech and Covance have entered into a Memorandum of Understanding to create a 50/50 joint venture to provide preclinical contract research services in China. Operations of the proposed joint venture will be located in a 323,450-sq.-ft., purpose-built facility in Suzhou, China, which is currently being built by WuXi. This facility, expected to be completed in 2009 and designed to meet the FDA and worldwide regulatory standards, will provide GLP toxicology, drug metabolism and bioanalytical chemistry services. In addition to the facility, which will be provided by WuXi, Covance plans to make an initial investment of approximately $30 million. Financial and structural details of the joint venture are expected to be disclosed once definitive terms are agreed and the entity is officially formed later this year.

Said Joe Herring, Covance chairman and chief executive officer, "Covance and WuXi share a common commitment to quality, people, and building client relationships based on trust and performance. Covance's market-leading and high-quality preclinical operations, combined with WuXi's track record of delivering world-class drug discovery and development services, will enable us to provide superior drug development solutions to our global pharmaceutical and biotech clients in the region."

Dr. Ge Li, chairman and chief executive officer of WuXi PharmaTech, added, "We will be able to immediately leverage Covance's world-class expertise and global network. This will allow us to accelerate bringing a full-range of preclinical services and GLP toxicology capabilities to this facility. The partnership is important to our mission of building a global R&D outsourcing service platform that will ultimately help our partners to improve the success of discovery and shorten the time of development."

The FDA has extended by three months its review of the NDA for Effient, which was previously known by its generic name of prasugrel. The drug's application was accepted in February 2008 and its deadline for action was this week. The new action date is September 26, 2008.

The proposed indication for Effient is for the treatment of patients with acute coronary syndromes (ACS) being managed with an artery-opening procedure known as percutaneous coronary intervention (PCI).

The three-month extension is intended to give FDA more time to complete its review of the drug, which demonstrated greater efficacy that market-leader Plavix, but also a possibility of greater side effects. The agency did not request additional trials from co-developers Daiichi Sankyo and Lilly as part of the NDA, but the companies do plan to begin a large Phase III trial to compare Effient and Plavix in medically managed ACS patients.

"We remain confident in our prasugrel submission package," said Jennifer Stotka, M.D., vice president for Global Regulatory Affairs at Lilly. "The TRITON trial encompassed a large amount of data from over 13,000 patients. We will continue to work closely with the FDA throughout the review process and continue discussions to determine if any requirements under the new FDA Amendment Act (FDAAA) legislation will apply."

Diana Wood has been named vice president, business development for Stason Pharmaceuticals, where she will be responsible for all business development functions, including guiding the company's global business development activities. Ms. Wood is a senior executive with extensive experience in sales, marketing, business and strategic planning, product development and general management on a worldwide basis. She will report directly to chief executive officer Harry T. Fan.

Most recently, she served as the executive vice president, business development at Chiltern International, where she oversaw the company's global business development and marketing functions, and advised clients on their product development platforms. Prior to joining Chiltern, she served as the director, product development for oncology at Chugai Pharma USA.

"We are pleased to welcome Diana to Stason," said Mr. Fan. "As a seasoned business development executive, she has built a highly respected track record and earned the trust of the pharmaceutical community. Diana will be a strategically important asset to our company."

Penn Pharmaceutical Services U.S. Inc, asubsidiary of UK-based Penn Pharmaceutical Services Ltd., has expanded its clinical trial supplies distribution capabilities with the opening of a 75,000-sq.-ft., temperature-controlled storage and distribution facility in South Wales, UK.
 
The new facility has 2,400 pallet locations, making it one of the EU's largest facilities with regulatory approval for the storage and distribution of investigational medicinal products (IMPs), according to the company. Paul Wituschek, U.S.-based director of business development, remarked, "The opening of our new storage and distribution facility in the UK means that we have increased our offering to non-EU pharma companies who are looking to break into the EU marketplace."

Mr. Wituschek added that Penn's storage and distribution services act as a 'portal' into Europe and beyond for U.S. companies, enabling them to import and distribute pharma products, including IMPs, for use in clinical trials programs.
 
Penn has global reach through an international sales force and strategic alliances for its services offered from its single site operation in South Wales. It is a Welsh company that provides a range of fully integrated and cost effective pharmaceutical development, clinical trial supply and custom manufacturing services to the international health care industry.

Dr. Patrice Hugo has been named vice president of scientific affairs for the global central lab network of MDS Pharma Services. In this role, he will lead the development of innovative biomarkers and esoteric assays to enhance clinical development productivity from Phases I through IV.

"We're delighted to offer our clients access to Dr. Hugo's experience and expertise in the development and application of biomarkers," said MDS Pharma Services' president David Spaight. "The importance of biomarkers has grown as the industry shifts toward personalized medicine and seeks to expedite drug discovery and development while controlling costs. Dr. Hugo's appointment reflects our intention to remain a key player in this important arena."

Dr. Hugo has more than 15 years of relevant experience in discovery, preclinical, clinical development, diagnostics and biotechnology, with a focus on biomarker evaluation and development. His biomarker experience crosses various therapeutic areas including oncology, infectious disease, inflammation, metabolic disease, and women's health. He comes to MDS Pharma Services from Caprion Proteomics, where he was executive vice president, R&D. From 1997 to 2003, he was with PROCREA BioSciences, first as the vice president of scientific research and then as chief scientific officer.

Stiefel Laboratories will acquire Barrier Therapeutics for approximately $148 million. The parties expect the transaction to close by the end of the third quarter of 2008.

"This acquisition demonstrates our continued commitment to advancing the field of therapeutic dermatology," said Charles W. Stiefel, chairman and chief executive officer of Stiefel Laboratories. "We are very impressed with Barrier Therapeutics' innovative products and pipeline. This strategic move will further expand our oral and topical product portfolio in development and increase our sales of novel treatments for skin conditions."

"We are very proud of the accomplishments of the entire Barrier Therapeutics team since we were founded in 2002, and we are pleased that Stiefel Laboratories recognizes the value that we have created," said Al Altomari, chief executive officer of Barrier Therapeutics. "We believe this transaction provides substantial value to our stockholders. We believe Barrier Therapeutics' product portfolio and innovative R&D pipeline candidates are among the greatest assets in dermatology and will strengthen Stiefel Laboratories' position in the global dermatology market."

Barrier's board has approved the merger agreement and will recommend that company stockholders tender their shares in connection with Stiefel's tender offer.

Rentschler Biotechnologie has started operation of a 2,500 L multi-process production suite for its bio-CMO operations. The company now has nine stand-alone GMP suites with volumes of 30, 250, 500 and 2,500 liters, allowing the production of material for clinical trials as well as commercial supply.

The new bioreactor is designed such that batch, fed-batch, or perfusion cell culture processes can be run. Protein purification is performed in two suites for pre- and post-virus inactivation, respectively.

The global market for biopharmaceutical products is growing constantly and rapidly. As a consequence, since 2002, Rentschler Biotechnologie has invested more than 70 million Euros to enhance its production capacities, while tripling its workforce since 2001 to 350.

Sigma-Aldrich has entered into a five-year collaboration to develop optimal cell lines for the production of monoclonal antibodies. Scientists at the University of California, San Francisco will lead the research into antibodies for a variety of cancer targets, autoimmune diseases, stem cell characteristics and commonly neglected disease targets, according to a company statement.

Under the terms of the agreement, research targets will be determined by a steering committee composed of leading scientists at UCSF, including Lewis Lanier, Ph.D. Professor and Vice Chair, Department of Microbiology & Immunology; Jeffrey Bluestone, Ph.D. Director, UCSF Diabetes Center; and Susan Fisher, Ph.D. Professor, Department of Cell & Tissue Biology. The committee will direct research into antibodies for cancer targets, stem cell surface markers and autoimmune disease targets. The University will have free access to the antibodies resulting from the partnership for its ongoing immunology and disease research.

"Sigma-Aldrich is committed to developing the most comprehensive and highly validated collection of monoclonal antibodies available for the cell biology research community," said Dr. David Smoller, President of Sigma-Aldrich's Research Biotech Business Unit. "By partnering with the highly regarded UCSF research team, Sigma-Aldrich is helping to further promote the study of a number of important cancer targets, regenerative medicine applications and neglected diseases."

Sigma-Aldrich is expanding its antibody content offering as part of its plan to become a leading developer and manufacturer of the next generation of monoclonal antibody products for life science researchers. Earlier this year, the company announced a partnership to distribute the highly-validated Prestige antibodies powered by Atlas Antibodies, the commercial arm of the Human Proteome Resource. The company is also collaborating with AbD Serotec, a Division of MorphoSys, to design, produce and distribute unique recombinant research antibodies using MorphoSys's proprietary HuCAL GOLD technology.

India-based Intas Biopharmaceuticals Ltd. has acquired Biologics Process Development, based in Poway, CA. With the acquisition process underway, both Intas Biopharma and BPD are actively pursuing plans to work closely toward fulfillment of common business objectives in the area of biologics Contract Research and Manufacturing Services (CRAMS), according to an Intas statement.

This acquisition is intended to facilitate Intas Biopharma’s foray into the U.S. market especially to expand its CRAMS business. Dr. Scott M. Brown, founder, president and chief scientific officer of BPD, will continue as president and chief scientific officer.

Intas Biopharma’s venture into the CRAMS business has opened up new vistas for R&D in the area of biopharmaceuticals and biosimilars, according to the company. Dr. Dhananjay Patankar, Intas' chief technology officer, commented, "IBPL has taken up the CRAMS opportunity in the biotechnology space as a focus area with tremendous potential and is preparing to scale up its facilities. IBPL offers a unique business model for offshore clients, providing competitive advantages in terms of developing new biotech products, technology transfer and contract manufacturing in a seamless manner and at committed costs, quality, and time."

Millie Tan has been named senior vice president, Global Marketing and chief marketing officer, and David Coman has been named senior vice president, Communications and Patient Recruitment at Quintiles Transnational.

"Both Dave and Millie bring a wealth of experience and impressive records of success in marketing and communication," said Mike Mortimer, chief administrative officer. "I am excited to have them join our senior management team to play key roles in our efforts to strengthen our presence in the marketplace."

Ms. Tan joins Quintiles from Monster Worldwide. Most recently, she was chief marketing officer of its European business, prior to which she led core marketing in the US. Previously, she held increasingly senior positions in consumer marketing with Polaroid and Gillette, including overseas assignments in Hong Kong and Tokyo.

Mr. Coman joined Quintiles from Dendrite International where he was the vice president of Global Marketing and led both marketing and corporate communications. Previously, he held executive leadership positions in telecommunications companies where he initiated direct-to-consumer strategies. He began his career with Young & Rubicam, a market-leading global advertising agency.