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.