Laureate Pharma, Inc. has entered into a cGMP contract manufacturing agreement with Enobia Pharma, a biotechnology company developing an enzyme replacement therapy for the treatment of hypophosphatasia. Under the agreement, Laureate will produce Enobia's fusion protein for treatment of hypophosphatasia, a rare, and potentially fatal metabolic bone disease characterized by skeletal hypomineralization. Terms of the agreement were not disclosed.

"We are delighted by the confidence Enobia has shown by continuing to utilize our specialized experience in the manufacture of fusion proteins," said Robert J. Broeze, president and chief executive officer of Laureate. "We have a successful relationship with Enobia and will work with them closely to help them achieve their manufacturing objectives."

"Our partnership with Laureate is an important component of our manufacturing strategy. We look forward to our partnership with Laureate and advancing our hypophosphatasia program into the clinic," said Robert Heft, president and chief executive officer of Enobia.

Robert M. Haggerty has been appointed to the newly created position of vice president of quality, Hyaluron Contract Manufacturing (HCM). Mr. Haggerty will be responsible for overseeing quality and regulatory compliance at the company’s Burlington, MA facility.

“Mr. Haggerty’s extensive experience will enhance our ability to provide our clients with the best possible products and services,” Shawn Kinney, president of HCM explained. “We are especially pleased with his knowledge of global quality practices as our business continues to grow both in the U.S. and abroad.”

Mr. Haggerty has more than thirty years of experience in quality and regulatory compliance in the pharmaceutical/biopharmaceutical industries. Most recently, he was the director of quality assurance at Alexion Pharmaceuticals where he was responsible for all quality assurance start-up activities at its new biotech facility. Prior to that, he held positions of increasing responsibility at Ben Venue, Dupont Merck, and Transkaryotic Therapies (now Shire). Throughout his career, Mr. Haggerty has been involved in the successful launch of multiple drug products and has achieved numerous NDA and sNDA approvals.

As vice president of quality, Mr. Haggerty will oversee the quality of products and services, as well as on-time delivery and courteous, professional communication. He will also be responsible for overseeing compliance with FDA and ISO regulations, as well as facilities and engineering validations.

PPD, Inc. plans to expand its operations in Bellshill, Lanarkshire, in an effort to meet the increasing demand for its drug development services. The company expects to invest as much as $30 million to expand its offices in this location during the next three years.

The expansion will create approximately 390 additional jobs in biostatistics, data management, pharmacovigilance, product development, and clinical trial management and monitoring. PPD currently employs more than 350 professionals in Scotland at its Strathclyde Business Park.

This investment will include the construction of a new 34,000-sq.-ft facility to be built next to the company's existing Fleming House offices, which were opened earlier this year and also comprise 34,000 sq.-ft. PPD will continue to retain space at Avondale House in Strathclyde Business Park until the new facility is completed.

"With the biopharmaceutical industry increasingly relying on global outsourcing to speed drug development and reduce costs, demand for our services continues to grow," said Fred Eshelman, chief executive officer of PPD. "Scotland offers both intellectual and technical resources that make it an important hub for our global clinical research operations."

OSG Norwich Pharmaceuticals, a CMO based in Norwich, NY, has been acquired by AFI Partners, a NYC-based private equity group. The company, which was owned by Outsourcing Services Group, will now be known as Norwich Pharmaceuticals, Inc., and operations at the Norwich facility will continue uninterrupted, according to a company statement. In addition, the current leadership team will remain in place, and continue to manage the business. OSG Norwich launched in 2001 and its workforce has grown from 250 people to 425; all current employees will also remain with the new company.

"We are excited to begin the next chapter of our company's history with AFI Partners," remarked Christopher R. Calhoun, president of OSG Norwich. "Our focus will remain on providing best-in-class services to our valued customers in the pharmaceutical business. We have demonstrated that we have highly competent people who can provide the quality and service demanded by the industry, with a high level of regulatory expertise, at a value level that our customers expect. With the support of AFI, we will be able to continue to make the necessary investments in the operation to remain at the forefront of our industry."

E. J. Antonio, managing partner at AFI, stated, "AFI brings considerable manufacturing expertise to Norwich, in addition to a shared vision for long-term growth. We are fully prepared to make the necessary investments that will expand Norwich's capacity and capabilities. We look forward to working with the Norwich team, as we build a strategy that will maximize the company's potential."

ImClone Systems and Bristol-Myers Squibb have amended the terms of their Erbitux agreement regarding the development and promotion in North America. Under this amendment, the companies have expanded the investment in the ongoing clinical development program for Erbitux by as much as several hundred million dollars. BMS will be responsible for development costs up to a threshold value. The companies will share costs beyond this threshold.

The companies added Phase II and Phase III trials to further explore the activity of Erbitux in a variety of therapeutic settings. The results of these studies will be used to support new registrational opportunities for the drug. The clinical program will supplement the existing data for Erbitux in colorectal and head and neck cancers and explore the use of Erbitux in additional tumor types including brain, breast, bladder, gastric, lung, pancreas and prostate.

"By broadening the Erbitux development program with ImClone Systems and utilizing pharmacogenomic markers and other screening technologies, we intend to enhance cancer patient outcomes which may further differentiate Erbitux from other commercially available antibodies," said Elliott Sigal, M.D., Ph.D., executive vice president, chief scientific officer and president, R&D, BMS. "This plan further demonstrates BMS's focus on the development of innovative compounds, like Erbitux, and highlights our company's dedication to partnerships that can maximize the potential of products in our portfolio."

"This new commitment to Erbitux represents one of the largest and broadest cancer-focused development programs for any antibody. The agreement aligns the development and commercialization of Erbitux at ImClone Systems and BMS to benefit both companies' shareholders, and most importantly, cancer patients," stated Alexander J. Denner, Ph.D., chairman, executive committee of ImClone Systems. "We are very pleased by this agreement and look forward to the two companies working in harmony."

Akorn, Inc. and Hyaluron Contract Manufacturing (HCM) have signed a development and supply agreement for two ANDA injectable suspension products.

One of the products is an injectable sustained release pharmaceutical, which will be available in both prefilled syringe and vial configurations. The second ANDA product is an anti-inflammatory and will be available in multiple packaging configurations. Hyaluron will manufacture both drug products for Akorn, which will be responsible for marketing and distributing them within the U.S. Akorn will own both ANDAs, coordinate the bioequivalency clinical trials and prepare the ANDA regulatory filings. Financial terms of the agreement were not disclosed. The products are expected to launch in 2010.

Arthur S. Przybyl, Akorn's president and chief executive officer stated "We are excited to be working with Hyaluron on these two opportunities. Both products will be key growth drivers for our company, similar to our upcoming Vancomycin capsule, Tetanus Diphtheria Vaccine and Akten product launches. The addition of injectable suspensions to Akorn's portfolio complements our line of injectable drug products that includes both proprietary and generic drugs."

Shawn Kinney, Hyaluron's president stated, "Our decision to partner with Akorn is reflective of our commitment to provide our clients with innovative solutions to all their formulation and filling needs. We look forward to working with Akorn, and to the opportunities this collaboration presents to make a lasting contribution to the market for sterile injectable products."

Crucell N.V. has entered into a co-exclusive PER.C6 and Advac technology license agreement with Wyeth. Under the terms of the agreement, Crucell will receive an upfront payment, milestone payments, annual maintenance fees, and royalties on product sales. Financial details were not disclosed.

AdVac technology is a recombinant vector technology used to develop adenoviral-based products. PER.C6 technology is based on a human cell line developed for the large-scale manufacture of biological products including vaccines.

Kenneth C. Frazier, Merck's executive vice president and general counsel, has been named executive vice president and president, global human health, Merck & Co.

Mr. Frazier will oversee more than 30,000 employees and have responsibility for the company's marketing and sales organizations worldwide, including the global pharmaceutical and vaccine franchises. Mr. Frazier will lead the global human health organization in the preparation, launch and marketing of new products and will work with his successor, Bruce N. Kuhlik, on Vioxx-related issues. Mr. Frazier will continue to report to Richard T. Clark, Merck's chairman, president and chief executive officer, and serve on the company's executive committee.

"In Ken, we are fortunate to have an exceptional leader who knows the company, its business and the industry intimately and who has a demonstrated ability to drive the transformation necessary to achieve our long-term objectives," said Mr. Clark.

Mr. Frazier served as Merck's general counsel since 1999, first as senior vice president, and then promoted to executive vice president in 2006. Prior to that, he held positions of increasing responsibility as vice president and deputy general counsel (1999), assistant general counsel for corporate staff (1997), and vice president of public affairs (1994). Mr. Frazier joined the company in 1992 as vice president, general counsel and secretary of the Astra Merck Group.

Bruce N. Kuhlik, who is being promoted to senior vice president, will succeed Mr. Frazier as general counsel with responsibility for Merck's legal and public affairs functions. He will report directly to Mr. Clark and serve as a member of the executive committee.

"The depth and breadth of Bruce's knowledge of the law, the pharmaceutical business and the regulatory regimes under which our company operates enable him to make valuable contributions across a broad range of legal, business and policy matters, but especially leading our Vioxx litigation strategy," said Mr. Clark.

Mr. Kuhlik joined the company in 2005 as vice president and associate general counsel, responsible for the company's Vioxx litigation defense. Prior to that, he was senior vice president and general counsel for the Pharmaceutical Research and Manufacturers of America (PhRMA).

Amgen

2Q Revenues: $3.7 billion (+3%)

2Q Earnings: $1 billion (earnings were $14 million in 2Q2006)

YTD Revenues: $7.4 billion (+9%)

YTD Earnings: $2.1 billion (+110%)

Comments: Worldwide sales of Aranesp were down 10% to $949 million, driven by a decline in U.S. demand. Sales of Epogen increased 2% to $624 million in the quarter. Combined worldwide sales of Neulasta and Neupogen increased 4% to $1 billion. Sales of Enbrel were up 14% to $823 million. R&D expenses increased 7% to $777 million in the quarter due to the advancement of Denosumab, Vectibix, and Motesanib Diphosphate, into Phase III trials. YTD and 2Q earnings in 2006 were impacted by acquired in-process R&D of $1.1 billion related to the acquisition of Abgenix.

Mark T. Crane has been appointed vice president, business development and marketing, Ricerca Biosciences, LLC. Mr. Crane joins the company from Bridge Pharmaceutical, Inc. (formerly Gene Logic) and has held similar positions at Quest Pharmaceutical Services and MDS Pharma Services. In his new position, Mr. Crane is responsible for business development and marketing of all services to pharmaceutical and biotechnology companies.

"Ricerca is pleased to recruit Mark Crane, a proven leader with a long and consistent track record of performance," said Ian Lennox, Ricerca's executive chairman. "Mark is very knowledgeable of the preclinical market and has excellent client relationship skills.”

AstraZeneca plans to expand its restructuring program and will eliminate 10% of its 2006 workforce, or approximately 7,600 jobs, as part of an effort to reduce costs and save $900 million by 2010. According to chief executive officer, David Brennan, the job losses will affect its European sales and marketing team as well as employees working in R&D and other areas in Britain, Sweden, Germany, France, the U.S. and Canada. The cost of the restructuring will be $1.6 billion.

The company has been investing through acquisitions to rebuild its pipeline as well as restructuring manufacturing to save costs. In February, the company announced the acquisition of Arrow Therapeutics, adding to its portfolio of anti-infective treatments. At the time the company planned to cut 3,000 jobs. In April, the company announced the acquisition of MedImmune for $15.6 billion, adding biological medicines and vaccines.

Also, chief financial officer Jon Symonds, plans to leave the company at the end of the month to join Goldman Sachs. According to Mr. Brennan, a search for his replacement is underway and the company's financial controller, Paul Kenyon, will act as interim finance head.

Bristol-Myers Squibb 

2Q Revenues: $4.9 billion (+1%)

2Q Earnings: $706 million (+6%)

YTD Revenues: $9.4 billion (-1%)

YTD Earnings: $1.4 billion (flat)

Comments: Worldwide pharmaceutical sales were flat at $3.9 billion. U.S. pharmaceutical sales increased 2% to $2.2 billion due to growth of key products and sales of newer products Baraclude, (increased to $59 million, up from $14 million 2Q2006) Orencia (increased to $55 million, up from $18 million) and Sprycel ($35 million, up from $21 million), partially offset by the impact of increased generic competition for Pravachol (down 59% to $132 million). Sales of Plavix and Avapro/Avalide, part of the company's alliance with sanofi-aventis, increased 4% to $1.2 billion and increased 6% to $297 million, respectively. R&D expenses increased 5% to $778 million. In the quarter, the company's NDA for ixabepilone was accepted by the FDA and Orencia was approved by the EMEA.

Thermo Fisher Scientific, Inc. has entered into an agreement to acquire Qualigens Fine Chemicals, a division of GlaxoSmithKline Pharmaceuticals (GSK India) based in Mumbai. Qualigens is a chemical manufacturer and supplier serving a variety of industries, including pharmaceutical, petrochemical, and food and beverage.

"The well-established and extensive channel network of Qualigens will make Thermo Fisher the leading supplier to India's research market, allowing us to accelerate our growth in a country where science and industry are moving forward at an exciting pace," said Marijn E. Dekkers, president and chief executive officer of Thermo Fisher Scientific. "In addition to greatly augmenting our customer channel, Qualigens is an ideal complement to our bioscience reagents and research chemicals business, enabling us to offer a wider range of products to a broader customer base. We also expect to benefit from greater access to local products, raw materials and manufacturing capabilities, as we expand in India and throughout Asia."

Qualigens also markets and sells a range of diagnostic kits under license. The business had sales of approximately $24 million in 2006 and has approximately 150 employees across the country. The acquisition is expected to close early in 4Q2007, subject to GSK India shareholder approval and other customary closing conditions.

Merck will acquire NovaCardia, Inc., a privately held clinical-stage pharmaceutical company focused on cardiovascular diseases, for $350 million. NovaCardia's lead product candidate KW-3902, an adenosine A1 receptor antagonist, is currently in Phase III trials in patients with acute congestive heart failure (CHF). The drug works by blocking adenosine-mediated constriction of blood flow to the kidneys and inhibiting reabsorption of salt and water by the kidney, increasing urine volume and maintaining renal function in patients with CHF.

"This acquisition continues to deliver on our strategy of targeted acquisitions in areas of unmet medical need in the therapeutic areas of strategic importance for Merck such as cardiovascular diseases," said Richard Kender, vice president of business development and corporate licensing at Merck.

"We are excited to see our lead product become part of the superb scientific environment of Merck," said Randall E. Woods, president and chief executive officer at NovaCardia. "NovaCardia demonstrated the potential of KW-3902 in clinical trials, and we believe that Merck can expedite the development of this novel agent."

Wyeth received an approvable letter from the FDA for Pristiq, a serotonin-norepinephrine reuptake inhibitor (SNRI), currently under review for moderate-to-severe vasomotor symptoms (hot flashes and night sweats) associated with menopause. However, the company needs to provide additional data regarding the potential adverse cardiovascular and hepatic effects associated with the use of Pristiq in this indication. The Agency requested a one-year clinical trial conducted in postmenopausal women. The FDA also requested that Wyeth address certain CMC (Chemistry, Manufacturing and Controls) deficiencies prior to approval.

"Wyeth remains committed to the development of Pristiq as a potential treatment for moderate-to-severe vasomotor symptoms associated with menopause," says Gary L. Stiles, M.D., executive vice president and chief medical officer, Wyeth Pharmaceuticals. "We will work with the Agency to satisfy its requests for additional data and move the medicine forward in the FDA review process."

On January 22, 2007, the company received an approvable letter for Pristiq for the treatment of Major Depressive Disorder (MDD), which did not require additional clinical studies prior to approval for this indication. The company plans to submit its complete response to the MDD approvable letter at the end of August, and the Agency is expected to render a decision in 1Q2008.

Galapagos achieved the second milestone under the antibody collaboration with Novartis for bone-related diseases, triggering a payment of $1 million to Galapagos. Galapagos will pay $750,000 of this amount to ProStrakan as part of their December 2006 agreement.

The Novartis/ProSkelia SASU (formerly a subsidiary of ProStrakan) collaboration was formed in September 2006. Under the terms of the original agreement with Novartis, total milestones could exceed $100 million plus royalties. The first milestone, announced in December 2006, was related to intellectual property. The collaboration was then transferred to Galapagos as part of its acquisition of ProSkelia from ProStrakan on December 22, 2006. Under the terms of Galapagos' acquisition of ProSkelia, Galapagos and ProStrakan split milestone and royalty income from existing agreements—25% for Galapagos and 75% for ProStrakan, while Galapagos is responsible for R&D costs.

"We are pleased with the smooth integration of ProSkelia R&D under Galapagos management," said Onno van Stolpe, chief executive officer of Galapagos. "This milestone demonstrates the progress our research team has made since the acquisition in December."

Dr. Wilson Totten, chief executive of ProStrakan added, "The terms and conditions of the sale of ProSkelia enabled us to retain an interest in future up-side from existing agreements. We are now beginning to see the cashflow from those programs come through and we expect this revenue stream to continue to develop and add value over the coming years."

Eli Lilly & Co.

2Q Revenues: $4.6 billion (+14%)

2Q Earnings: $664 million (-19%)

YTD Revenues: $8.9 billion (+13%)

YTD Earnings: $1.2 billion (-29%)

Comments: Net income was impaired by the purchases of Hypnion and Ivy Animal Health. Cymbalta was the top gainer, with 2Q sales rising 67% to $520 million. Zyprexa sales grew 9% to $1.2 billion while #3 seller Gemzar posted sales of $396 million (+15%). R&D expenses rose 10% to $854 million.

MPI Research recently added new toxicology capacity as part of an expansion project. Completed July 20th, the 79,000-sq.-ft. expansion includes the addition of 84 animal rooms, new surgical suites and accommodations for specialized infusion work.

The project is part of a multi-phased expansion plan fueled by the growing R&D needs of the pharmaceutical and biotechnology industries. In 2006, the company completed toxicology expansion projects totaling $65 million, including 95 animal rooms plus significant laboratory and office space.

"Our expansion projects are driven by our customers' need for timely, cost effective research and development services," said Bill Parfet, chairman and chief executive officer of MPI Research. "Our ongoing investments in capacity, service expansions and infrastructure will further assure our customers of timely study starts, quality services, and on-time reporting to keep their drug development programs moving forward."

Biogen Idec

2Q Revenues: $773 million (+17%)

2Q Earnings: $186 million (net loss of $171 million in 2Q2006)

YTD Revenues: $1.5 billion (+17%)

YTD Earnings: $318 million (net loss of $48 million in 2Q2006)

Comments: Avonex sales rose 8% to $462 million, Rituxan was up 12% to $231 million and Tysabri brought in $48 million in sales to BI ($72 million in total sales, with the remainder going to partner Elan). The company announced that there are 14,000 MS patients using Tysabri.

Xceleron, a provider of analytical strategies for drug development, will expand its U.S. business by signing of a lease on a facility in Germantown, MD. The facility, opening in November 2007, will house a new accelerator mass spectrometer (AMS) and employ at least 20 people in scientific, commercial and administrative roles.

Professor Colin Garner, Xceleron's chief executive officer, commented, "This is a major strategic development in the evolution of our company. We will invest as much as $7.5 million on the purchase of a new AMS and associated equipment to carry out analysis on pharmaceutical drug candidates. Our new facility will allow us to substantially increase our development capacity to better serve our customers worldwide." The company began U.S. operations in 2005.
 

Schering-Plough

2Q Revenues: $3.2 billion (+13%)

2Q Earnings: $539 million (+108%)

YTD Revenues: $6.2 billion (+15%)

YTD Earnings: $1.1 billion (+75%)

Comments: SP's Remicade sales were up 28% to $394 million. Nasonex sales grew 22% to $295 million. Combined Vytorin/Zetia sales were $1.3 billion (shared with Merck). R&D expenses rose $160 million to $696 million, including a $60 million upfront payment for a licensing deal with Novacea.

Merck

2Q Revenues: $6.1 billion (+12%)

2Q Earnings: $1.7 billion (+6%)

YTD Revenues: $11.9 billion (+6%)

YTD Earnings: $3.4 billion (+12%)

Comments: Led by Gardasil, vaccine sales reached $1.0 billion in 2Q, up from $349 million. Singular sales rose 15% to $1.1 billion. Combined Vytorin/Zetia sales were $1.3 billion. R&D costs dropped 12% to $1.0 billion for the quarter. Higher costs in 2Q2006 reflected R&D costs from the GlycoFi acquisition. FY2007 restructuring costs are projected to reach $500-$700 million.

Wyeth achieved positive preliminary results from a Phase I trial of a new oral formulation of methylnaltrexone, an investigational drug being developed with Progenics for the treatment of opioid-induced constipation (OIC). The latest data showed that a substantial majority of patients receiving the higher of the two doses tested, responded to treatment.

The Phase I trial, conducted by Wyeth, was a double-blind, randomized, single-dose, crossover pharmacokinetic/pharmacodynamic study in subjects receiving methadone, an opioid used to treat addiction. The new oral formulation was generally well tolerated. Based on these findings, the companies will soon initiate an additional Phase I trial to optimize the new oral formulation.

Draxis Health, Inc. has made senior level organization changes in an effort to streamline its core operating businesses in Montreal. Effective immediately, Mr. Jean-Pierre Robert assumes the role of president of Draxis Specialty Pharmaceuticals, Inc. (DSP), which provides sterile products, non-sterile products and radiopharmaceutical products.

Mr. Robert was previously president of Draximage, the division of DSP that produces and markets radiopharmaceutical products. Mr. Robert will also have responsibility for Draxis Pharma, the contract manufacturing division of DSP.

Also, the office of the president has been established at the corporate level and will include Dr. Martin Barkin, president and chief executive officer of Draxis Health Inc., and Dan Brazier, chief operating officer. Dr. Barkin and Mr. Brazier will retain their current responsibilities. Mr. Robert will report to Mr. Brazier.

"This revised organizational structure reflects our desire to further streamline our Montreal operations while recognizing that future growth will come from three specialized functional areas," said Dr. Barkin. "The appointment of Jean-Pierre to this new position means that we will continue to benefit from efficiencies that we have already seen through the integration of a number of functions such as finance, information technology, logistics and human resources."

Prior to joining Draxis in April 2005, Mr. Robert spent several years with Tyco Healthcare (Canada), most recently as vice president and general manager, where he oversaw domestic and export operations, including marketing, sales, finance and contract manufacturing operations. Most recently, he was president and chief executive officer of an emerging Canadian biotechnology company. Mr. Robert has 27 years experience in the pharmaceutical industry.

Gilead Sciences

2Q Revenues: $1 billion (+53%)

2Q Earnings: $407.9 million (+54%)

YTD Revenues: $2.1 billion (+51%)

YTD Earnings: $815.3 million (+54%)

Comments: Growth in the quarter was driven by HIV product sales, up 60% to $762.2 million. Atripla, launched in July 2006 in the U.S., achieved $212.4 million in sales. Truvada sales were $385.4 million, up 29%. Also contributing to growth in the quarter were Hepsera sales, up 32% to $75.2 million, and AmBisome sales, up 16% to $64.8 million. Royalty, contract and other revenues from collaborations were $143 million, up 51% in the quarter. R&D expenses in the quarter were $135.9 million, up 50%.

Severin Schwan, currently chief executive officer of Roche Diagnostics, will succeed Franz B. Humer as chief executive officer of the Roche Group effective March 2008. Dr. Humer will focus on his role as chairman of Roche Holdings.

Franz B. Humer said, “In view of the increasing complexity of the tasks involved, the board has decided to separate the chairman and CEO roles. I am delighted that we are appointing Severin Schwan, a 40 year-old executive with an outstanding track record and broad international experience at both corporate and divisional level, as the new CEO. As Chairman I will continue to work with the board and executive committee to continue building Roche into a leading global healthcare corporation.”

Franz Humer joined Roche in 1995 as head of the Pharmaceuticals Division. He was appointed chief operating officer in 1996, chief executive officer of the Roche Group in 1998, and chairman of Roche Holding in 2001. He is a member of the boards of Allianz AG and Diageo Plc and of the JPMorgan International Council.

Mr. Schwan began his career in 1993 at Roche Basel as a finance officer. Following management positions in Germany and Belgium, he became head of Roche Diagnostics’ global finance organization before being named head of the division’s Asia–Pacific organization. In January 2006 Mr. Schwan was appointed chief executive officer of Roche Diagnostics.

Wyeth

2Q Revenues: $5.6 billion (+10%)

2Q Earnings: $1.2 billion (+13%)

YTD Revenues: $11 billion (+10%)

YTD Earnings: $2.5 billion (+12%)

Comments: Pharmaceutical sales were $4.7 billion in the quarter, up 11%, driven by higher sales of Prevnar (+22%), Protonix (+25%), Enbrel (+37%), Nutrition products (+19%), and Zosyn (+17%). This increase was offset by lower sales of Zoton and Inderal LA due to generic competition. In the quarter, Lybrel and Torisel received FDA approval. 2Q results include charges of $49.8 million related to the company's productivity initiatives.

Roche

MYTD Revenues: $18.6 billion (+15%)

MYTD Earnings: $4.1 billion (+29%)

Comments: Pharmaceutical sales increased 18% to $9.3 billion for the half-year. Growth was driven by key oncology drugs (MabThera/Rituxan, Herceptin, Avastin, Xeloda and Tarceva), up 22%, as well as metabolism, (Bonviva/Boniva up 127% to $304 million) transplantation and virology drugs, including increased Tamiflu sales for pandemic stockpiling. Lucentis, Genentech’s recently launched medicine for age-related blindness, was also a contributor to growth. Herceptin, Avastin and Xeloda approved for additional cancer indications in the EU and Japan.

Vincent Santa Maria has been appointed president of Bilcare, Inc. Mr. Santa Maria has more than 25 years of experience primarily in pharmaceutical operations and pharmaceutical services, most recently serving as a consultant to the industry.

"Vincent is highly regarded throughout the clinical services industry and brings a wealth of knowledge and experience to Bilcare," said Mohan Bhandari, chairman and managing director of Bilcare Ltd. "Given his expertise and drive, we are confident that Vincent will be a great asset for business development and provide the necessary leadership as we continue to set new standards of product quality and customer service in what is becoming an increasingly competitive marketplace."

Prior to serving as a consultant to the pharmaceutical industry, Mr. Santa Maria was president and managing director of Almedica Service Corp. where he oversaw daily operations including manufacturing, business development, project management, quality assurance, finance, risk management, human resources and IT.

Mr. Santa Maria succeeds Steve Jacobs who served as Bilcare president and global chief operating officer for the past two years.

Pfizer

2Q Revenues: $11.1 billion (-6%)

2Q Earnings: $1.3 billion (-48%)

YTD Revenues: $23.6 billion (flat)

YTD Earnings: $4.7 billion (-29%)

Comments: Worldwide pharmaceutical revenues for the quarter were $10.1 billion, down 7%. The following drugs performed well in the quarter and YTD respectively: Celebrex, 1% and 12%; Lyrica, 49% and 73%; Detrol/Detrol LA, 5% and 11%; Zyvox, 21% and 30%; Geodon/Zeldox, 8% and 14%; Caduet, 50% and 69%; Vfend, 23% and 25%; and Aromasin, 22% and 27%. 2Q revenues were hit hard by generic Zocor's competition against Lipitor and the loss of U.S. exclusivity for Zoloft and Norvasc. Earnings were impacted by the company's payments to Bristol-Myers Squibb regarding the apixaban collaboration.

Crucell N.V. has established two business units for vaccines and proteins in an effort to enhance its focus on specific opportunities for both product units. Mr. Björn Sjöstrand has been appointed to head the Vaccines Business Unit and Mr. Arthur Lahr has been appointed to head the Protein Business Unit.

Mr. Sjöstrand was chief executive officer of SBL Vaccines, which was acquired by Crucell in November 2006. Mr. Lahr was Crucell's chief strategy officer and executive vice president sales and business development. Both Mr. Sjöstrand and Mr. Lahr will remain members of Crucell's management committee.

The company has made additional appointments to support its growth strategy. Ms. Oya Yavuz has been named director of investor relations. Ms. Yavuz was previously vice president for investor relations at Wolters Kluwer N.V.

Dr. Herbert Heyneker joined the company's Protein Business Unit as senior vice president R&D. Dr. Heyneker was formerly chief technical officer of Eos Biotechnology, a functional genomics company he co-founded in 1996. He was involved in founding several life science companies including ProtoGene, GlycoGen and GenPharm International. From 1984 till 1990, he served as vice president, research at Genencor International, and in the early 90s he was a visiting scholar in the Department of Genetics at Stanford University's Medical School.

The company also announced that chief business officer Kuno Sommer will leave the company in September 2007.

Dr. Ronald H.P. Brus, Crucell's chief executive officer, remarked, "Crucell has become a global player in the vaccine industry and has established a significant technology presence in the $40 billion protein drug industry. We have now set up dedicated business units with strong leadership to tailor our approach to grow aggressively in these two different but complimentary markets. Additionally, increased transparency in financial results will allow shareholders to follow and value our progress more accurately."

JHP Pharmaceuticals has signed an asset purchase agreement to acquire King Pharmaceuticals' Rochester, MI sterile manufacturing facility, as well as legacy products manufactured there and a contract manufacturing business. The companies also entered into a manufacturing and supply agreement under which JHP will provide certain fill and finish support for King’s hemostatic product, Thrombin-JMI (thrombin, topical, bovine, USP).

Eric J. Bruce, King's chief technical operations officer, said, "This transaction represents the continued successful execution of our strategy for long-term growth, particularly with respect to the realization of greater operating efficiency for our company. This transaction will enable us to redeploy our current investments in these assets to our ongoing R&D and business development initiatives."

Peter Jenkins, co-founder of JHP, said, “JHP is delighted to secure these cornerstone assets for our planned business in the U.S. The acquired products will provide immediate critical mass in our target hospitals and clinic market and we are confident in the opportunity to build the contract manufacturing business at Rochester.”

Under the terms of the asset purchase agreement, JHP will pay King approximately $90 million, subject to final inventory adjustments. The agreement is subject to customary regulatory approvals and is expected to close in 3Q2007.

King’s 2006 sales for the legacy products included in the agreement totaled approximately $51 million. Revenue from contract manufacturing at the facility totaled approximately $14 million in 2006. The agreement includes the following legacy branded pharmaceutical products: Adrenalin, Aplisol, Brevital, Delestrogen, Ketelar, Pitocin, Pitressin, Tigan, Triostat, Coly-Mycin, Cortisporin. JHP plans to offer employment to all current employees at the Rochester manufacturing facility.

Xcellerex, Inc. received two Phase I contracts awarded by the Defense Advanced Research Projects Agency (DARPA) for the Accelerated Manufacture of Pharmaceuticals (AMP) program. The total funding for the two Phase I contracts is more than $13 million. The AMP program is focused on technologies for producing emergency therapeutics and vaccines, rapidly and cost effectively in order to respond to a range of biological threats. Phase I of the AMP program is focused on optimizing host strains that will express a model vaccine and antibody, and demonstrating small-scale production. Subsequent phases will focus on rapid process optimization, scale up and cost-effective production.

Xcellerex will serve as the prime contractor on the first grant, in which the company is collaborating with Dowpharma, Biopharm Services, and DeltaDOT, Ltd. The team combines Xcellerex's PDMax process development and FlexFactory manufacturing technologies with Dowpharma's Pfenex Expression Technology, a Pseudomonas based expression system. DeltaDOT's Peregrine and Osprey high throughput technology platforms provide critical analytical capabilities required to track product quality, and BioPharm Services will provide advanced modeling capabilities for biopharmaceutical manufacturing.

Dr. Michael Callahan, program manager for DARPA's AMP program, stated, "The AMP program will develop radically-enhanced high-throughput manufacturing technologies to direct novel protein expression platforms to produce vaccines and antibodies at unprecedented rates, in huge quantities and at extraordinary low cost per dose."

Parrish Galliher, Xcellerex's founder, president, and chief technology officer, said, "The DARPA grants recognize the potential of Xcellerex's PDMax and FlexFactory systems to establish biomanufacturing capacity and produce vaccines and therapeutic proteins rapidly and cost-effectively. Current production methods can take many months to optimize for large-scale production, while a large-scale manufacturing process and facility could require years to prepare. While there have been significant efforts directed at the discovery of new vaccines and therapeutics, less attention has been focused on developing novel manufacturing technology."

Xcellerex is collaborating with Neugenesis (prime contractor), SRI International and BioPharm Services on the second contract. The grant is based on the use of PDMax and FlexFactory to show the potential of Neugenesis's NeuBIOS protein production platform. Neugenesis and SRI will provide project management and integration systems for the team.

Johnson & Johnson

2Q Revenues: $15.1 billion (+13%)

2Q Earnings: $3.1 billion (+9%)

YTD Revenues: $30.2 billion (+15%)

YTD Earnings: $5.7 billion (-8%)

Comments: Worldwide Pharmaceutical sales were $6.1 billion in the quarter, up 5.8%. Topamax, Remicade, Risperdal, Risperdal Consta, Invega and Concerta contributed to this growth. In the quarter, the European Commission granted marketing authorization for Invega for the treatment of schizophrenia and the FDA approved an additional indication for Invega for long-term maintenance of schizophrenia. Worldwide consumer segment sales were $3.6 billion in the quarter, up 48.6%. YTD earnings reflect an IPR&D of $807 million.

Integrated Project Services (IPS) broke ground for a new Biopol Laboratory facility in Post Falls, ID. Biopol Lab is a subsidiary of ALK-Abello, a producer of allergy immunotherapy pharmaceuticals. Biopol is ALK-Abello's main source material supplier of allergen materials.

The new 12.5-acre site combines Biopol's five facilities into a new main building. The first phase will be approximately 68,000 sq. ft. Biopol is relocating its lab, offices, manufacturing facilities, and associated in-process and finished product warehouses from its present Spokane, WA location.

IPS is providing design, product development and process engineering services and ensuring validation in accordance with latest cGMP and cGLP requirements. The new facility will increase Biopol's capacities and scale up for its allergen source materials products. The site also includes new pollen and mites processing buildings, as well as energy efficiency for process and utility systems, odors/dust control systems, and waste treatment.

"IPS is the perfect partner for Biopol. They have a high level of competency and the experience required for the detailed design of this bulk pharmaceutical facility," stated Miles Guralnick, president/managing director, Biopol Laboratory, Inc. "The Post Falls facility offers the additional space and increased capacity to enable us to continue to provide an uninterrupted supply of quality allergenic biological source materials. We look forward to a good collaboration and to a very successful project."

BioCryst Pharmaceuticals, Inc. and Roche initiated the first Phase II study to evaluate BCX-4208/R3421 in patients with moderate to severe plaque psoriasis. BCX-4208 is an inhibitor of purine nucleoside phosphorylase (PNP), an enzyme essential for the proliferation of activated T cells. With its mechanism of action, BCX-4208 has the potential to address a range of autoimmune diseases as well as transplant rejection.

The Phase II double-blind, placebo-controlled trial is comprised of three arms, each enrolling 20 patients with moderate to severe psoriasis. Two arms will receive active drug in different dosage strengths, while patients in the third arm will receive placebo. Patients in all three arms will be dosed once daily for six weeks.

"We are excited that BCX-4208 is advancing into Phase II testing," said Jon P. Stonehouse, chief executive officer of BioCryst. "The potential for a new oral therapy that is convenient, safe and effective would be an important addition to currently available treatment options for the many millions of patients who suffer from serious autoimmune conditions around the world. BCX-4208 is the lead compound in our second-generation PNP inhibitor program and the initiation of this trial represents a significant step towards demonstrating proof-of-concept with this promising approach in important disease areas."

Solvay Chemicals has appointed Marcie Peters, Cameron Berry and Gary Waller to top positions at the company's Houston, TX headquarters. Ms. Peters has been named vice president, supply chain, responsible for customer services and logistics. She joined the company in 1995 as marketing analyst for Solvay Polymers, Inc. and most recently served as business director, Soda Ash for Solvay Chemicals.

Mr. Berry has been named business director, Soda Ash, where he is responsible for sales and marketing. Mr. Berry joined Solvay Minerals in 1995 as logistics analyst, and he most recently served as vice president, logistics for Solvay Chemicals. Mr. Waller has been appointed to the position of director, customer services and imported products.

Mr. Waller joined Solvay Polymers in 1987 as shipping and distribution superintendent, and most recently served as director, order to cash, for Solvay Chemicals.

Amgen and Daiichi Sankyo Co., entered a collaboration and license agreement for the development and commercialization of denosumab in Japan. Denosumab is a fully human monoclonal antibody that targets RANK Ligand (an essential mediator of cells that break down bone) and is being investigated in a broad range of bone loss conditions including osteoporosis and bone metastases.

Daiichi Sankyo will have exclusive rights to develop and commercialize denosumab in Japan in post-menopausal osteoporosis, oncology and potentially additional indications. As part of the agreement, Amgen will receive exclusive worldwide rights to certain Daiichi Sankyo intellectual property as applicable to denosumab.

Amgen will receive an upfront payment of $20 million. Daiichi Sankyo will be responsible for development costs for denosumab in Japan and will pay approximately $150 million of the expected worldwide development costs through 2009. Daiichi Sankyo is eligible to receive milestone payments based on the approval of denosumab in the EU or Japan in two indications. Daiichi Sankyo will pay royalties on annual sales of denosumab in Japan.

"Daiichi Sankyo is an ideal partner for denosumab," said Kevin Sharer, chairman and chief executive officer of Amgen. "Daiichi Sankyo is uniquely positioned to bring this potential therapy to patients with a wide spectrum of bone-related diseases in Japan."

"We believe that denosumab has the potential to be a first-in-class, leading product in Japan for multiple indications within Daiichi Sankyo's therapeutic areas of focus. Denosumab's potential applicability in oncology makes it an important part of the foundation for our growing oncology business," said Takashi Shoda, president and chief executive officer of Daiichi Sankyo.

Pharming Group's facilities for the manufacture of Rhucin have passed all EMEA inspections, establishing GMP compliance for pharmaceutical production. The EMEA has confirmed that all facilities and processes involved in the manufacture of Rhucin, Pharming's lead product, operate according to GMP standards. These include facilities for transgenic rabbits, the external facilities where milk and product are processed, and the company's headquarters in Leiden, in relation with quality aspects of Rhucin.

Dr. Bruno Giannetti, chief operations officer at Pharming, said, "Obtaining GMP status for our facilities and processes is a major achievement for our company. It is a critical step in the review and approval process of Rhucin and it is difficult to overestimate the importance of achieving this milestone. It is testimony to the hard and excellent work that our team has put in to convert a research idea of 'turning milk into medicine' into a well-developed and GMP-approved manufacturing process. Our transgenic rabbit facility is the first of its kind in the world to obtain this status."

Pharming has filed a marketing authorization application for Rhucin in Europe and expects to hear from the scientific committee of the EMEA in the second half of 2007. In the U.S., Pharming plans to finalize its clinical trial in the second half of 2007. The company will present results from the clinical trials of Rhucin for the treatment of HAE in 3Q2007.

DSM and Crucell entered a non-exclusive PER.C6 research licensing agreement with Russia-based Masterclone. Masterclone will use Crucell’s technology to develop an undisclosed antibody. Financial details were not disclosed.

The PER.C6 technology platform has been developed for the large-scale manufacture of biopharmaceutical products such as vaccines and proteins.

Icon has acquired DOCS International, a European clinical research staffing organization, for approximately $40 million in cash. DOCS operates in eight countries and focuses on the training and supply of contract and permanent clinical research personnel to the pharma/biopharma industries.

"The acquisition of DOCS International gives Icon a significant presence in the European clinical research staffing market and creates a strong platform which we can leverage for future expansion. Their experienced management team will bring a wealth of experience in the European market to Icon," said Icon's chief executive officer, Peter Gray.

DOCS will be integrated with Icon's existing U.S. staffing business, Icon Contracting Solutions, to form a global business unit. "This will enable Icon to meet the requirements of sponsors for more flexibility when they run clinical projects internally, and give them access to a global pool of talent through one vendor," noted Sean Leech, newly appointed president of the expanded business unit.

Pim van de Riet, DOCS' chief executive officer, remarked, "We are delighted to be joining forces with Icon. Our combined knowledge and commitment to the clinical research staffing market will allow us to continue to attract, assess and place talented individuals and teams at all levels of experience on a global basis".

Genentech

2Q Revenues: $3.0 billion (+37%)

2Q Earnings: $747 million (+41%)

YTD Revenues: $5.8 billion (+40%)

YTD Earnings: $1.5 billion (+53%)

Comments: U.S. product sales were $2.1 billion in the quarter, up 25%. Rituxan sales were $582 million, up 11% and Avastin sales were $564 million, up 33%. Royalty revenues were $484 million in the quarter and included approximately $65 million in one-time revenues from a new collaboration agreement, which included three years' worth of royalty revenues. R&D expenses increased 55% to $603 million in the quarter. The company submitted two sBLAs for Herceptin in adjuvant breast cancer.

QSV Biologics and Alseres Pharmaceuticals have signed a contract for the process development and cGMP manufacture of Cethrin for spinal cord injury. QSV will be responsible for technology transfer, process development and cGMP manufacture of Phase IIb/III clinical trial material. Alseres licensed the drug from BioAxone Therapeutics. Cethrin is a Rho inhibitor that stimulates axon regeneration.

Dr. Graeme Macaloney, QSV president and chief executive officer said, "This first-in-field therapy for acute spinal cord injury is an exciting breakthrough, given that there are no approved alternatives. We are proud to be providing the manufacture of this important spinal cord therapeutic for Alseres, which has received orphan drug designation from the FDA."

"As Alseres prepares to initiate its Phase IIb/III clinical trials in acute spinal cord injury later this year, we believe that QSV provides technical know-how and value to this program-critical process," said Mark Pykett, president and chief operating officer of Alseres.

Alpharma Pharmaceutical Co. has completed its agreement with Zhejiang Hisun Pharmaceutical Co. (Hisun), doubling its capacity to manufacture one of Hisun's major APIs, vancomycin, subject to FDA and European regulatory approvals. Vancomycin is for severe gram-positive hospital infections. Alpharma currently manufactures vancomycin at its sites in Copenhagen, Denmark and Budapest, Hungary.

"Our partnership with Hisun has been highly productive," said Carl Aake Carlsson, president of Alpharma's Active Pharmaceuticals division. "Progress at the new Chinese facility has been excellent, and we look forward to continuing to collaborate with Hisun as we significantly expand Alpharma's capacity of its largest active pharmaceutical ingredient, Vancomycin, to meet the growing demand for this product."

Alpharma purchased vancomycin from Hisun in 2006 pending the completion of the construction and regulatory approval process of a new Vancomycin manufacturing plant at the Hisun facility in China. The new facility will be owned and operated by Alpharma, incorporating technology purchased from Hisun, as well as Alpharma technology. The new facility is expected to be complete in early 2008.

Tercica, Inc. has entered an agreement with Genentech for the development, manufacture and commercialization of two products containing Genentech's recombinant human growth hormone Nutropin AQ and Tercica's recombinant insulin-like growth factor-1 Increlex for the treatment of short stature, adult growth hormone deficiency (AGHD), and potentially other metabolic disorders. Nutropin AQ and Increlex were originally designed and formulated so that the therapies could be combined and given as a single, daily injection.

Pending FDA guidance and IND acceptance, Tercica plans to initiate Phase II development in 2008 of one combination product for patients with low IGF-1 levels and short stature not associated with growth hormone deficiency; and a second combination product for patients with AGHD.

Under the terms of the collaboration, Tercica may be eligible to receive a total of $53 million in equity payments, opt-in payments, R&D cost reimbursement, and milestone payments. In connection with the transaction, Genentech will purchase $4 million in Tercica's common stock. Tercica will fund and lead initial development efforts for both combination products. Genentech has certain rights to opt-in to the development programs for both products.

Azopharma has reached an agreement to purchase Kos Pharmaceuticals' R&D facility along with assets in Hollywood, FL. Azopharma chief executive officer Phil Meeks said, "We are pleased about the addition of our new facility in Hollywood, FL, and our expanded capacity to manufacture cGMP clinical trial material. This acquisition will significantly increase our ability to support our customers and our Phase I Express process, which enables our customers to move quickly and efficiently toward clinical trials. Phase I Express includes preclinical, preformulation, formulation development, analytical R&D, QC release, stability, manufacturing, packaging and labeling of clinical supplies for Phase I, studies."

The FL facilities are cGMP compliant and FDA registered and inspected, as well as DEA approved for testing all schedules of controlled drugs and for manufacture on an as-requested basis.

Noven Pharmaceuticals, Inc. has agreed to acquire JDS Pharmaceuticals, LLC for approximately $125 million in cash and take on approximately $10 million in liabilities. JDS is a privately-held specialty pharmaceutical company that currently markets two branded prescription psychiatry products and has in its pipeline potential products in psychiatry and women's health.

The acquisition provides Noven with two marketed products, a next-gen psychiatric pipeline that includes one pending NDA and one product in Phase III trials, and a product entering Phase III for vasomotor symptoms associated with menopause.

The transaction closing, subject to customary closing conditions, is expected by early August.

"This is a transformational acquisition that expands our business model," said Robert C. Strauss, Noven's president, chief executive officer and chairman. "The transaction advances Noven from a leading drug delivery company to a broader-based, fully-integrated specialty pharmaceutical company. We believe it will increase Noven's growth rate over the longer term, as well as greatly improve the visibility of our pipeline and financial goals."

Phillip M. Satow, chief executive officer and co-founder of JDS, said, "At JDS, we have assembled a highly-experienced management team, a solid sales force with two marketed products, and a valuable new product pipeline. By joining with the expertise and resources of Noven, we believe we can accelerate development of our psychiatry business, independently develop Mesafem in women's health, and more rapidly achieve the vision that we have been working toward at JDS."

Following closing, Mr. Satow is expected to join Noven's board of directors. After 15 years with Pfizer and three years as vice president and general manager of the Carter Wallace pharmaceutical business, Mr. Satow served as executive vice president of Forest Laboratories and president of its pharmaceuticals subsidiary. JDS was founded in August 2004 by Mr. Satow and his son, Michael Satow, JDS president and chief operating officer.

Roche's Phase III Actemra RADIATE (RheumAtoiD ArthritIs Study in Anti-TNF FailurEs) trial met its primary endpoint in patients with moderate to severe rheumatoid arthritis (RA) who failed to respond to anti-tumor necrosis factor treatments (anti-TNFs).

The third multinational Phase III study of Actemra showed that more patients treated with Actemra plus methotrexate achieved a significant reduction in the signs and symptoms of RA as evaluated by ACR20 following 24 weeks of treatment, compared to those who were treated with placebo plus methotrexate.

Actemra was generally well tolerated. The most common adverse events reported more frequently in the Actemra arms of the trial were nausea, headache, nasopharyngitis, diarrhea and upper respiratory tract infection.

Additional Phase III trials exploring Actemra in RA are ongoing with another study scheduled to report in 2007.

Vincent Lagrotteria has been appointed vice president, global sales and marketing, Bilcare. Mr. Lagrotteria has more than 20 years of healthcare industry experience in global sales, marketing, business, process improvement and corporate development.

Prior to joining the company, Mr. Lagrotteria was vice president, global business development for Charles River Laboratories. He previously served as senior vice president, sales, marketing and strategic initiatives for Medifacts International, a global CRO. The firm grew from $7 million to $30 million during his tenure. Before joining Medifacts, he was executive director, business development at Quintiles.

“We are pleased to welcome Vinny to the Bilcare family,” said Steve Jacobs, Bilcare president and global chief operating officer. “With the tremendous depth and breadth of experience that he brings to us, combined with his leading a highly talented and enthusiastic Sales and Marketing team, the obvious outcome will be tremendous growth and success for our company.”

Roche and Alnylam Pharmaceuticals have entered into a major alliance in which Roche will obtain a non-exclusive license to Alnylam's RNAi technology platform. The alliance will initially cover four therapeutic areas: oncology, respiratory diseases, metabolic diseases and certain liver diseases. The two companies will collaborate on RNAi drug discovery for one or more disease targets in these areas. Also, Roche will acquire Alnylam's European research site in Kulmbach, Germany, which will become Roche's Center of Excellence for RNAi drug discovery.

RNAi is a natural mechanism that the body uses to inhibit expression of certain genes. Using RNAi creates a direct opportunity to develop specific and potent drugs for hard to treat diseases.

"Alnylam has made significant advances in RNAi therapeutics, one of the most promising approaches to tomorrow's healthcare technology. Working together with Alnylam provides us with new capabilities to target complex diseases within our focus areas," said Lee E. Babiss, head of Roche Global Pharma Research. "Our mission is to find novel solutions for patients who suffer from difficult to treat diseases and we will be fully committed to this goal, together with our new colleagues located at the acquired site in Kulmbach."

The alliance has a potential value in excess of $1 billion, including upfront payments, potential milestone payments for multiple products and field expansion payments, but excluding potential royalties on future sales of commercial products. Under the terms of the agreement, Roche will pay Alnylam $331 million in upfront cash payments and equity investment, including 1.9 million shares of Alnylam common stock, representing approximately 5% of Alnylam's outstanding common stock.

Novavax, Inc. signed a non-exclusive, worldwide license agreement with Wyeth for the rights to a patent application covering virus-like particle (VLP) technology for vaccines. The agreement includes an upfront payment, annual license fees, milestone payments and royalties on any product sales. Payments to Wyeth could total $5 million through 2008.

Novavax is developing pandemic and seasonal flu vaccines based on the VLP technology. VLPs mimic the three-dimensional structure of a virus but do not contain genetic material, thus they cannot replicate and cause infection or disease. VLPs have been shown to activate multiple responses in the immune system.

"We are delighted to have completed this license agreement with Wyeth and see this license as another important step in building a strong intellectual property position for our influenza vaccine programs," stated Rahul Singhvi, president and chief executive officer of Novavax.

InterMune, Inc. has entered into a new supply agreement with Boehringer Ingelheim Austria GmbH for Actimmune, eliminating InterMune's $91.6 million in future purchase commitments that existed under the previous supply agreement. InterMune will pay BI Austria approximately $5.5 million. Under the terms of the new supply agreement, InterMune is not required to make any minimum annual purchase commitments and BI Austria is not required to commit to reserving any minimum annual capacity for the manufacture of Actimmune.

Dan Welch, chief executive officer of InterMune, said, "We are very pleased to have eliminated the significant purchase commitments of the previous supply agreement and established a new supply agreement for Actimmune on terms that are attractive to InterMune. Our new supply agreement provides for a steady supply of Actimmune at the same cost as our previous supply agreement and allows flexibility to adapt supply to future demand for Actimmune."

Quintiles Transnational Corp. has announced plans to expand and consolidate its Global Central Laboratories (GCL) in Smyrna, GA, and its Clinical Development Services (CDS) office in Atlanta within a single structure in nearby Marietta, GA.

The 201,366-square-foot, three-story structure in Marietta will more than double the combined space now occupied by GCL and CDS, allowing for the addition of about 400 jobs through 2011. Renovation of the structure is expected to begin the third quarter of 2007, with the first groups of employees scheduled to move during the second quarter of 2008.

"For our Global Central Laboratories, this is another expansion to accommodate the growth of our business, following the additions of labs in China and India and expansion of our lab in Scotland," said Dennis Gillings, CBE, chairman and chief executive officer of Quintiles Transnational. "The increasing demand for our CDS and laboratory services is driving the need to expand, and we're taking this opportunity to bring our Atlanta units together to improve coordination and efficiency for our customers."

The project is being managed by Solution Property Group and renovation is being done by Purdum Construction of Kansas City, MO. Quintiles is investing $19 million in the project, along with an $11 million incentive package developed by Cobb County, the Georgia Cancer Coalition, the Georgia Research Alliance and the Georgia Department of Economic Development.

AstraZeneca has entered an R&D pact with Silence Therapeutics in the respiratory field. Silence will receive initial access fees, clinical development and commercial milestone payments as much as $400 million, plus royalties on product sales.

The three-year collaboration is designed to discover and develop proprietary siRNA molecules against as many as five specific targets provided by AZ. The companies will collaborate in the early phase of identification and optimisation of novel siRNA molecules, while AZ will retain full responsibility for clinical development and commercialization. The agreement is primarily in the respiratory field but includes an option to allow for targets that extend the collaboration into other disease areas of interest to AZ.

Silence will provide a license to its proprietary siRNA technology in return for an initial access fee of $15 million, which includes an equity investment of $10 million. AstraZeneca will hold nearly 3% of the voting rights of Silence Therapeutics.

Iain Ross, chairman of Silence, said, "This transaction provides further validation of the potential application of our proprietary AtuRNAi molecules and our leading position in the fast-developing field of RNAi therapeutics."

Jan M. Lundberg, AZ's executive vice president, discovery research, said, "SiRNA technology will enable AstraZeneca to target disease mechanisms intractable to small molecules and other approaches."

Bristol-Myers Squibb has cancelled development of Medivir's preclinical HIV compound MIV-170. The compound did not meet the BMS's desired profile, according to a Medivir statement. MIV-170 belongs to the group of polymerase inhibitors that Medivir already discontinued the development of and that are administered by the subsidiary Medivir HIV Franchise AB.

"Everyone is aware of the obvious risks in early pharmaceutical development. MIV-170 has not yet reached clinical development and statistically half of all pharmaceutical projects fail in this early pre clinical development phase. However, the license agreement with BMS has already provided Medivir with payments that by far exceed Medivir's investments in the project" said professor Bo Oberg, chief executive officer of Medivir HIV Franchise AB.

DSM subsidiary DSM Nutritional Products Ltd. has acquired privately owned Pentapharm Holding Ltd. Pentapharm is a developer and producer of active ingredients and system solutions for the cosmetics industry but also has a presence in pharmaceutical and diagnostics markets, offering specialized products for niche applications in the context of human blood coagulation disorders. The company posted sales of approximately $50 million last year. Financial terms were not disclosed.

"We are very pleased with this acquisition, as it further enriches our existing Personal Care portfolio of vitamins and sun-filters with highly specialized actives based on innovative technologies," said Krijn Rietveld, senior vice president and head of new business development, DSM Nutritional Products.

Novartis and Intercell AG have formed a strategic alliance for the development of vaccines. The alliance combines Novartis' research, development, manufacturing and commercialization capabilities with Intercell's research skills and pipeline.

Intercell's portfolio includes more than 10 projects for which Novartis may choose for further development, including the IC43 vaccine candidate for hospital-acquired pseudomonas infections, currently in Phase II trials, and the preclinical IC47 vaccine for pneumonia infections in the elderly and infants. The alliance will focus on the development of vaccines derived from Intercell's Antigen Identification Program (AIP), including IC31 adjuvant technology in selected areas, which complements Novartis' reverse vaccinology system of selecting vaccine candidates based on highly conserved antigen sequences. Novartis also has opt-in rights to all future vaccine candidates discovered by Intercell during the collaboration.

"This novel alliance will further leverage the potential of various Intercell vaccine candidates with the research, development, manufacturing and commercialization expertise of Novartis," said Jörg Reinhardt, chief executive officer of Novartis Vaccines and Diagnostics. "We are pleased to have reached this alliance with Intercell, which shares our vision of science in vaccines and is widely regarded as having one of the most innovative pipelines."

Intercell is responsible for all costs through Phase II trials and Novartis is responsible for Phase III development, manufacturing and commercialization. Novartis has exclusive rights to further develop the next-generation IC31 adjuvant for use in enhancing the effectiveness of flu vaccines. Novartis will make an upfront payment of $366.5 million to Intercell for exclusive opt-in rights for any existing un-partnered vaccine project or any future projects. This upfront payment includes the purchase of 4.8 million new Intercell shares, which will increase Novartis' equity stake in Intercell to 16% from 6%. The agreement is subject to customary regulatory approvals.

Roche received approval from the FDA for its sNDA to market Tamiflu capsules in 30 mg and 45 mg doses. The lower dose capsules provide an alternative for the treatment and prevention of influenza types A and B in patients one year and older. The capsules also have a longer shelf life than the liquid suspension formulation, offering an improved option for pandemic stockpiling.

The sNDA was filed in March based on data already available for the 75 mg capsule. The method of manufacturing will remain the same. The 30 mg and 45 mg capsules will be available in pharmacies nationwide for the 2007-2008 flu season.

Novartis Vaccines will increase the supply of its Fluvirin vaccine 30% for distribution in the U.S. during the 2007-2008 flu season and plans to produce approximately 40 million doses. Based on accelerated production plans, half of these doses are planned for September delivery, with all doses expected to be delivered by the end of October, depending on the release of doses by the FDA.  
   
"Providing a reliable and timely supply of flu vaccines is a top priority for Novartis in supporting U.S. public health goals of increasing vaccination rates among the growing number of people at risk and recommended for vaccination," said Rajiv De Silva, president of Novartis Vaccines in the U.S.

Biogen Idec and Cardiokine, Inc. have signed an agreement to jointly develop lixivaptan, an oral compound expected to enter a Phase III trial this year for the treatment of hyponatremia in patients with congestive heart failure (CHF).

Lixivaptan is a selective V2 vasopressin receptor antagonist that has demonstrated promising activity in treating hyponatremia, an imbalance of sodium and water in the body. Lixivaptan works by causing water to be excreted from the kidney, without affecting sodium or other electrolytes. In heart failure patients, hyponatremia is associated with volume overload, a key symptom leading to hospitalization. Hyponatremia is an important feature of other disorders including liver cirrhosis and syndrome of inappropriate antidiuretic hormone (SIADH), and can contribute to morbidity and negative outcomes.

Under terms of the agreement, Cardiokine will receive a $50 million upfront payment and as much as $170 million in additional milestone payments for successful development and commercialization of lixivaptan, as well as royalties on commercial sales. Biogen will be responsible for commercialization of lixivaptan and Cardiokine will have an option for co-promotion in the U.S.

"With this late-stage oral compound, we continue to leverage our global development and specialty market expertise to grow our business and broaden our therapeutic focus. An effective treatment for hyponatremia could be beneficial to patients with a variety of diseases, including heart failure," said James C. Mullen, Biogen Idec's president and chief executive officer. "This program will expand our efforts in cardiovascular care and we look forward to working with Cardiokine to deliver this promising new product for patients."

Abraxis BioScience, Inc. has plans to split its hospital-based product business, Abraxis Pharmaceutical Products (APP) and Abraxis Oncology and Abraxis Research (the new Abraxis BioScience), into two independent, public companies. According to the company, the transaction would enable each company to compete more effectively in their respective markets.

Abraxis will have $1.45 billion of senior credit facilities comprised of a funded $1.3 billion term loan and an unfunded $150 million revolving credit facility. APP will be responsible for the debt following the separation. A portion of the proceeds raised through the debt financing will be used to repay existing debt and approximately $1 billion will be transferred to the new Abraxis BioScience just prior to the separation.

Patrick Soon-Shiong, M.D., chairman and chief executive officer of Abraxis BioScience, stated, "Strategic initiatives executed over the past few years, including the acquisition of global rights to Abraxane and the nab technology platform, the acquisition of the AstraZeneca anesthesia/analgesic portfolio and the acquisition of the Pfizer manufacturing facility in PR, have accelerated the growth of two robust businesses with more than 1,900 employees and combined revenues that are expected to approach $1 billion by the end of 2007.

The transaction is expected to be complete in 4Q2007, subject to customary closing conditions.

Sanofi-Aventis is withdrawing its application for rimonabant for the treatment of obesity in the U.S. A U.S. advisory panel recently said that the drug should not be approved because it may increase suicidal thoughts and depression.

The company said it is working to resubmit the drug, known as Acomplia and Zimulti, at a future date and would undertake necessary discussions with the FDA on required modifications to its file. SA may still file for approval based on the success of a large trial currently underway regarding its safety and efficacy. In the EU, regulators are still reviewing the latest safety data on the drug and a final decision is expected next month.

Acomplia is currently approved in 42 countries and marketed in 20 to treat obesity and overweight patients with associated cardiovascular risk factors.

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