AstraZeneca 2Q08

2Q Revenues: $8.0 billion (+9%, +2% at Constant Exchange Rate)

2Q Earnings: $1.6 billion (+13%, +6% CER)

YTD Revenues: $15.6 billion (+10%, +3% CER)

YTD Earnings: $3.1 billion (+4%, -3% CER)

Comments: Sales were buoyed by 35%/27% growth in Crestor, which reached $916 million in 2Q08. Toprol sales plummeted 55%/58% in the quarter, while Nexium sales plateaued at $1.3 billion. Symbicort sales rose 25%/12% to $518 million and Pulmicort was up 20%/14% to $383 million. AZ took a charge of $131 million for restructuring in the quarter; the current restructuring program has now amounted to $1.2 billion in charges.

Javelin Pharmaceuticals and Baxter Healthcare have expanded their commercial supply relationship for Dyloject, Javelin’s proprietary injectable diclofenac product. The drug is currently marketed in the UK and is in Phase III trials in the U.S. for acute post-operative pain. The expanded relationship provides additional manufacturing capacity for Dyloject, principally for distribution in the EU, and builds on the existing manufacturing agreement executed between Javelin and Baxter for the United States.

"We are pleased to strengthen our relationship with Baxter. This expanded commercial supply agreement will provide increased capacity for Dyloject in Europe as we grow sales of the product in the U.K. and prepare for the anticipated launch of the product in multiple European countries in the near future.” said Martin Driscoll, Javelin's chief executive officer.

Sanofi-Aventis 2Q08

NOTE: All amounts in Euros

2Q Revenues: EUR 6.7 billion (-4%)

2Q Earnings: EUR 1.0 billion*

YTD Revenues: EUR 13.6 billion (-4%)

YTD Earnings: EUR 2.3 billion*

Comments: Pharmaceutical revenues were up 4% for the quarter to EUR 6,032, and up 2% for HY08 to EUR 12,421. Lantus sales grew 27% in 2Q08 to EUR 576, while Lovenox sales only increased 5% to EU 637. Overall Ambien sales continued to crater, dropping 22% in 2Q08 to EUR 191. Ambien group sales are down 50% for HY08. Vaccine sales were up 17% to EUR 657, driven by 78% growth in influenza vaccines and 18% growth in adult booster vacines. For HY08, vaccine sales rose 10% to EUR 1,205. Overall sales in 2Q08 grew 12% in non-U.S./non-Europe regions; those areas were up 7% and 1%, respectively.

* Announcement did not include figures for consolidated earnings for 2Q07 or HY07, instead releasing figures that excluded certain costs.

Bristol-Myers Squibb has offered approximately $4.5 billion to buy ImClone, its development partner in cancer treatment Erbitux. BMS already owns 17% of ImClone shares through its development deal, so the all-cash offer puts a 30% premium on ImClone's share price.

Said BMS chairman and chief executive officer James M. Cornelius, “Our proposed acquisition of ImClone represents an evolutionary development in our companies’ seven-year-long relationship, and is in the best interests of Bristol-Myers Squibb and ImClone shareholders and employees, and the patients we serve together. Bristol-Myers Squibb is the natural partner for ImClone as we possess the knowledge base and resources to advance the company’s growth over the long-term, not only with respect to Erbitux, the important cancer therapy we jointly commercialize, but also in terms of developing ImClone’s pipeline assets. Our current contractual relationship with ImClone . . . has been very successful, and we believe that, by applying Bristol-Myers Squibb’s financial, R&D and marketing capabilities to support the product, we will be able to reach an even broader patient population.”

He added that the acquisition would create financial growth by 2012-13 and help drive growth in the years beyond. The companies' development and commercialization agreement for Erbitux expires in 2018. Under the agreement, ImClone receives a distribution fee based on a flat rate of 39% of net sales in North America. Both companies are also in a pact with Merck KgA to market Erbitux in Japan. Merck KgA sells Erbitux in other non-North American markets.

Paul F. Skultety, Ph.D. has been named director of pharmaceutical services at Xcelience, Inc. He will oversee the company's preformulation, analytical and formulation services.

Dr. Skultety has more than 26 years experience in pharmaceutical research and formulation development. He has held senior executive positions, including vice president of scientific development at Aptuit Inc., vice president of pharmaceutics at Quintiles, and director of solids formulations development at Hoechst Marion Roussel (formerly Marion Merrill Dow and Marion Labs). He began his career in 1982 as a research pharmacist for Abbott Laboratories.

"Paul brings a wealth of experience and leadership to Xcelience. He is focused and realizes what it takes to work in the demanding customer services arena that we face everyday and he still enjoys it," stated Derek G. Hennecke, president and chief executive officer of Xcelience.

Johnson & Johnson has submitted an NDA for rivaroxaban to the FDA. The drug, an investigational, oral, once-daily anticoagulant for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip or knee replacement surgery, was co-developed with Bayer HealthCare AG.

Ortho-McNeil, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., will market the drug in the U.S., if it's approved. Bayer holds marketing rights in countries outside the U.S.

Venous blood clots, also known as venous thromboembolism (VTE), include DVT — a blood clot in a large vein, usually in the legs — and PE — a blood clot that has traveled to the lungs — both of which are life-threatening but often preventable complications following major orthopedic surgery.

The filing was supported by data from the global RECORD (REgulation of Coagulation in major Orthopedic surgery reducing the Risk of DVT and PE) clinical trial program. The RECORD program involved more than 12,500 patients in four studies and compared rivaroxaban to injected enoxaparin, for the prevention of total VTE in patients undergoing either total knee or hip replacement surgery.

Bridge Laboratories has reached an agreement to build its second preclinical facility in China. This purpose-built, 150,000-sq.-ft. facility will be adjacent to the company's existing laboratory in the Zhongguancun Life Science Park located in Beijing. Construction will begin in 4Q08 and is expected to be complete by 4Q09.

The facility is designed to meet FDA and worldwide regulatory standards, and will provide GLP toxicology, immunology, vaccine, and bioanalytical services, according to the company. This new facility will quadruple Bridge’s available laboratory space in Beijing.

“Bridge is committed to providing quality preclinical services to our customers, and this new facility will enable us to expand our ability to deliver U.S.-level regulatory compliant outsourced discovery and development services in a cost effective manner,” said Tom Oakley, president and chief executive officer of Bridge Laboratories.

Amgen 2Q

2Q Revenues: $3.8 billion (+1%)

2Q Earnings: $941 million (-8%)

YTD Revenues: $7.4 billion (-1%)

YTD Earnings: $2.0 billion (-2%)

Comments: U.S. sales dropped 1% in 2Q08 to $2.8 billion while international sales rose 17%. Aranesp sales fell 13% in the quarter due to regulatory and reimbursement changes, while Epogen sales were flat. Neulasta and Neupogen combined sales rose 15% to $1.2 billion, driven primarily by Neulasta. Enbrel sales increased 2% to $841 million, as competition curtailed sales growth. Sensipar sales grew 39% to $150 million. R&D expenses were flat, partly as a result of licensing out several R&D programs to Daiichi Sankyo and Takeda.

Matthew T. Mullarkey has been named chief operating officer of West Pharmaceutical Services. Mr. Mullarkey was previously chief executive officer and president of Impact Materials Group of Cleveland, OH, a privately owned engineered materials business. He succeeds Steve Ellers, who will remain President of the company through a transition period and until his planned retirement in 2010. The transfer of management responsibilities will commence immediately.

"I am very pleased to find an executive of Matt's caliber for this critical position and to be able to afford him the opportunity to benefit from Steve's extensive experience during the transition period," said Donald E. Morel, Jr., Ph.D., West's chairman and chief executive officer. "His management of multi-national operations in different industries, including healthcare and rubber manufacturing, and incorporating new product, process and information technologies should fit in very well with our global operations and strategic objectives."

Prior to joining Impact Materials Group, Mr. Mullarkey worked in senior executive and consulting capacities, including most recently as group vice president, global operations at Invacare Corporation, a multi-national manufacturer and distributor of home medical equipment and disposables, and at Delco Remy International, Cambridge Management Consulting and Michelin Tire Group.

Sanofi-Aventis has offered $550 million to buy out UK-based vaccine maker Acambis. Acambis' board has agreed to the acquisition. Sanofi's vaccine division, Sanofi Pasteur, has worked with Acambis for more than a decade and is currently partnered with it for three projects.

Sanofi Pasteur president and chief executive officer Wayne Pisano remarked, “We are delighted that the board of Acambis has unanimously agreed to recommend our proposed acquisition. This mutually beneficial acquisition is a logical step building upon Sanofi Pasteur and Acambis’ decade long partnership on key projects to develop and market vaccines of the future. Acambis’ skilled workforce made of individuals who share our passion for vaccines and prevention of diseases will contribute to our future success. We look forward to welcoming them into Sanofi Pasteur’s innovation driven organization.”
 
Acambis markets a smallpox vaccine to the U.S. government and has several other late-stage programs in place, targeting Japanese encephalitis, dengue and West Nile virus, along with several other early-stage programs.

Cobra Biomanufacturing has extended its recent manufacturing agreement with South Korea-based ViroMed Co. and the two companies plan to form a joint venture. The extended collaboration includes a long term-research, development and technical consultancy agreement for all ViroMed products. The agreement will provide ViroMed with guaranteed process development and manufacturing resources.

Additionally, the companies have signed a memorandum of understanding to explore the potential of establishing a joint venture commercial scale biomanufacturing company that would enable the JV Company to manufacture ViroMed products for commercial supply, at the JV's new facilities.

These agreements extend the manufacturing collaboration announced in June 2008, under which Cobrabio will manufacture ViroMed’s plasmid DNA therapeutic, VM206RY, for the treatment of tumours expressing Her2/neu.

Simon Saxby, chief executive officer of Cobra, remarked, “The further development of our partnership with ViroMed is a very positive step forward for Cobrabio, providing a strong medium- to long-term business forecast. Having worked closely with ViroMed to develop a successful manufacturing process for its plasmid DNA product we are delighted to enter into a long-term agreement, with a broad scope that will bring significant benefits to both parties.”

Millennium, a division of Takeda, has begun two Phase I trials of MLN4924, a first-in-class, small molecule inhibitor of the Nedd 8 Activating Enzyme (NAE), a target discovered by the company. MLN4924 advanced to the clinic with the first patient dosed in April 2008. The two Phase I dose escalation studies aim to assess safety, tolerability, pharmacokinetic and pharmacodynamic effects in patients with advanced solid tumors or with hematological malignancies.

Millennium also began a Phase I hematologic trial of MLN8237, a first-in-class, specific Aurora A kinase inhibitor, based on preclinical data on the role of Aurora A in lymphomas and other hematologic tumors. Preclinical results also showed substantial activity in pediatric neuroblastoma and acute lymphocytic leukemia (ALL). Millennium plans to expand the program into Phase II trials in late 2008/early 2009.

"The progress of these two Millennium-discovered oncology drugs is important to our goal of bringing innovative medicines to cancer patients," said Nancy Simonian, M.D., Millennium's chief medical officer. "The emerging data associated with MLN4924 and MLN8237 support our vision of solidifying Takeda as a leader in oncology discovery and development by 2020."

Azopharma Product Development Group, Inc. has added new equipment at its formulation and manufacturing division, ApiCross Drug Delivery Technologies in Hollywood, FL. The company added the MG Futura Capsule Filler and Bausch & Strobel Aseptic Filling Isolator, new in the powder filling process. These additions support the company's Xcelodose powder micro-dosing system. The new equipment is part of Azopharma’s recent manufacturing expansion, which includes 17 new manufacturing suites for GMP, cytotoxic and aseptic products.
   
The MG Futura, equipped with a standard powder-dosing unit, has the ability to dose two different pellets into a single capsule and is capable of production levels of 6,000/12,000/24,000 and 48,000 capsules per hour. The machine can also perform overencapsulation for use in blinded clinical studies. The B&S Aseptic Filling Isolator provides containment and aseptic isolation during the powder filling operation as well as low humidity conditions. The isolator will also be a key component of Azopharma’s cytotoxic and potent compound production activities, according to the company.
   
Phil Meeks, chief executive officer of Azopharma, said, “The addition of these two pieces of equipment compliment our comprehensive formulation capabilities for all dosage forms and expands our ability to manufacture tablets, capsules and powders.”

Symyx Technologies, Inc. launched its new client-directed and collaborative research services for Life Sciences. These services allow clients to access Symyx’s installed base of parallel experimentation and testing capabilities through packaged offerings for solubility studies, polymorph screening, salt selection, co-crystallization, API stability in liquid and solid formulations, excipient compatibility, organic synthesis and process optimization.
    
Symyx recently signed a one-year agreement with Bristol-Myers Squibb for the use of Symyx Research Services for solubility studies. Under terms of the agreement, Symyx will perform solubility studies for BMS through May 2009.
    
“Symyx Research is continuing to transform its offerings into packaged, smaller scope and easily accessible solutions,” said Richard Boehner, president of Symyx Research. “We are pleased to enter this agreement with Bristol-Myers Squibb to provide solubility research services which will help them achieve a greater level of R&D efficiency.”

Ortho-McNeil Neurologics, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., itself a division of Johnson & Johnson, received approval from the FDA for pediatric exclusivity for Topamax for use in patients aged 1 to 24 months with partial onset seizures.
   
The FDA is continuing its review of the application to determine the safety and efficacy of Topamax in this patient population. Based on the data submitted, no indication is sought for this age group.
   
A recent court decision extended the drug's period of exclusivity through March 2009. The drug was set to expire in September 2008. Topamax was not approved for use in pediatric patients aged 1 to 24 months.
   
Topamax is indicated as initial monotherapy in patients 10 years of age and older with partial onset seizures or generalized tonic-clonic seizures, as well as adjunctive therapy for adults and children (aged two and above) with partial onset seizures or generalized tonic-clonic seizures, and in adults and children as adjunctive therapy for the treatment of seizures associated with Lennox-Gastaut syndrome. Topamax is indicated in adults for theprophylaxis of migraine headache.