The FDA voted not to approve Merck's NDA for Arcoxia for the symptomatic treatment of osteoarthritis (OA). Arcoxia has been under review by the FDA as an investigational selective COX-2 inhibitor since December 2003 for a 60 mg once-daily dose along with review of a separate related NDA for a 30 mg once-daily dose submitted in April 2004. The FDA's letter indicated that Merck would need to provide additional data in support of the benefit-to-risk profile for the proposed doses of the drug in order to gain approval.

"We are disappointed with today's decision," said Peter S. Kim, Ph.D., president, Merck Research Laboratories. "We pursued FDA approval of Arcoxia because we believe strongly that new medicines are needed for patients whose osteoarthritis pain is inadequately managed with currently available therapies. In addition, there is more long-term safety data from controlled clinical trials, in terms of patient-years on treatment, for Arcoxia than for any other NSAID, including traditional NSAIDs and Cox-2 selective inhibitors."

Arcoxia is available in 63 countries in Europe, Latin America, the Asia-Pacific region and Middle East/Northern Africa. Merck will continue to market Arcoxia outside the U.S., where it has been approved for a broad range of indications, including OA.

Three representatives from JLL Partners, Paul S. Levy, Ramsey A. Frank, and Thomas S. Taylor, have joined Patheon, Inc.'s board of directors, effective immediately. These appointments follow the approval by Patheon's shareholders on April 19, 2007 of a $150 million convertible preferred share investment in Patheon by JLL Partners.

"We are pleased to welcome Messrs Levy, Frank and Taylor to our board of directors," said Peter Green, chairman of Patheon. "They are highly experienced investors who have significant knowledge of the healthcare sector, having made a number of successful investments in this space. We look forward to working with them to drive strong growth in Patheon's revenues and earnings."

Paul Levy is a managing director of JLL Partners, which he founded in 1988. Prior to that, he served as a managing director of Drexel Burnham Lambert and as a chief executive officer of Yves Saint Laurent, Inc. He also served as vice president of administration and general counsel of Quality Care, Inc. and as an attorney at Stroock & Stroock & Lavan LLP.

Ramsey Frank is a managing director of JLL Partners. Prior to joining JLL in 1999, Mr. Frank served as a managing director of Donaldson, Lufkin & Jenrette Securities Corp. and as managing director of Smith Barney & Co.

Thomas Taylor joined JLL in 2005 after serving as president and chief executive officer of EPIX Holdings, a human resource outsourcer. Prior to that, he served as vice president and chief financial officer of Colorado Prime Corp. He has also worked at Kraft Foods as vice president of finance and strategy and at Central Soya as vice president and controller.

Almac Clinical Services has launched two new clinical trial supply systems that help to remove bottlenecks within the supply chain process with its new system of automated label verification. The Almac system was introduced following analysis of the current industry practice of 200% manual checking of both fixed and variable text on clinical trial study kit labels, and how lead time could be reduced.

According to the company, manual checking of study labels is no longer required with its new system, enhancing the speed of availability and providing a more robust audit trail. This label verification system is different in that variable content including randomization details are checked and verified by the system as well as industry standard fixed text checking.

The company has also introduced a fully automated modular over-encapsulation system for blinding of comparator products in clinical trials. With this system, individual tooling for each tablet shape/size is no longer required, resulting in improved timelines, according to the company.

Dr. Robert Dunlop, president, Almac Clinical Services, said, “We have identified bottlenecks that are common within the clinical supply chain and targeted our solutions to these two key areas. We are confident that our automated label verification system and new array of comparator blinding options will assist in ensuring trials are started on time and lead times are shortened to bring drug to market.”

James M. Cornelius has been appointed chief executive officer of Bristol-Myers Squibb with a term through 2009. Mr. Cornelius has served as interim chief executive for the past eight months, since the departure of Peter Dolan. He has also been a member of the company's board since January of 2005, previously serving as chairman and chief executive officer of Guidant Corp., chief financial officer of Eli Lilly and Co., and president and chief executive officer of IVAC Corp.

"As we conducted an extensive and thorough CEO search, it became increasingly clear that Jim was the ideal person to continue leading our company," said BMS chairman James D. Robinson III. "It was obvious to the board that his knowledge of the company and the dynamics facing the industry today were vital to our future progress. He has done a splendid job as CEO, and we couldn't be more pleased that he has agreed to stay in this role."

Since September, Mr. Cornelius has overseen the implementation of the company's strategic effort to reduce costs and mitigate risks while allowing the company to advance its pipeline and prepare for the next wave of new products. As part of this effort, BMS recently announced several partnerships including an agreement with AstraZeneca to co-develop and co-commercialize two late-stage diabetes compounds; an agreement with Pfizer to co-develop and co-commercialize apixaban, an anti-clotting agent; an agreement with Exelixis to discover and develop oncology compounds; a collaboration with Biocon and Accenture to expand the company's R&D presence in India; and a licensing agreement for diabetes compound saxagliptin in Japan.

Kenneth J. Martin, chief financial officer and vice chairman of Wyeth, has announced plans to leave the company at the end of June to pursue personal interests. Mr. Martin joined the company in 1984 and has served as chief financial officer since 2000. Wyeth plans to name a new CFO prior to Mr. Martin's departure.

"Ken Martin has played key roles at Wyeth for many years and has been an important contributor to our success," says Robert Essner, chairman and chief executive officer, Wyeth.

Crucell N.V. and Novartis Vaccines and Diagnostics, Inc. have extended a non-exclusive research license agreement for PER.C6. The agreement allows Novartis to use Crucell's cell technology in manufacturing alphavirus vectors for its vaccine research programs. Financial details were not disclosed.

The PER.C6 technology is a cell line for the development and large-scale manufacture of biopharma products including vaccines.

Roche Carolina Inc. (RCI) has announced plans to expand its Florence, SC pharmaceutical manufacturing facility. The $60 million investment will involve the construction of a new multi-purpose production unit in an existing manufacturing building. The expansion will help enable Roche to meet production needs for current and future life-saving medications, according to a company statement. As a result of this investment, 25 to 30 new positions are expected to be created at the facility.

Construction is scheduled to begin in mid-2007 with completion by the end of 2008. An estimated 200 construction-related jobs, many to be provided through local contractors, will be required for the project.

"The decision to invest in Florence is a reflection of our past success and the willingness of Florence and South Carolina to encourage the growth of existing industry," said Dr. Frank Cox, president and general manager of Roche Carolina Inc. "We are grateful to the community for its support and recognition of the underlying importance of our business to improving human health."

Roche Carolina Inc., a pharmaceutical process development and bulk active ingredient manufacturing company, is an affiliate of the multinational group of companies headed by Roche Holding Ltd. of Basel, Switzerland.

SAFC, a member of the Sigma-Aldrich Group has completed construction of two new protein API facilities at its St. Louis, MO manufacturing campus. The new Biologics manufacturing facility consists of a 25,000-sq.-ft. cGMP purification and manufacturing suite for transgenic plant and other non-animal derived protein APIs and a 6,000-sq.-ft. facility for purification of animal-derived protein APIs. Validation for commercial operation of this $16 million expansion at the 400,000 sq. ft. St Louis manufacturing campus is expected by mid-year 2007.

"This expansion for SAFC Pharma further reflects our recognized market leadership in cGMP purification of therapeutic proteins from natural sourced material," said SAFC President Frank Wicks. "The expanded capacity responds to the increased demand for large-scale supply and will meet late-stage clinical trial and commercial manufacturing needs for both transgenic and naturally-sourced APIs."

The Biologics facility features some of the largest extraction and purification suites of their kind in the industry, according to SAFC. The Class 100,000 (ISO 8) and Class 10,000 (ISO 7) clean rooms will accommodate multiple one-meter chromatography columns and ultrafiltration operations, with API target quantities in the five-kilogram range. Also featured is a Class 10,000 (ISO 7) lyophilization suite.

Completely separated to prevent potential cross-contamination, the facility for animal-derived API purification also features Class 100,000 (ISO 8) and Class 10,000 (ISO 7) clean rooms. These will also include multiple one-meter chromatography columns and ultrafiltration operations to give API quantities in the five-kilogram range.

Bristol-Myers Squibb and Pfizer have announced a worldwide collaboration to develop and commercialize apixaban, an anticoagulant discovered by BMS being studied for the prevention and treatment of a broad range of venous and arterial thrombotic conditions. In a separate agreement, the companies will also collaborate on the R&D and commercialization of a Pfizer discovery program that includes advanced preclinical compounds with "potential applications for the treatment of metabolic disorders, including obesity and diabetes," according to a Pfizer statement.

Apixaban is currently in Phase III trials investigating its potential in the prevention of venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), and the prevention of stroke in patients with atrial fibrillation (AF). Phase II trials are studying apixaban in the treatment of acute symptomatic DVT and for the secondary prevention of cardiovascular events in patients with acute coronary syndrome.

Terms of the apixaban agreement include an upfront payment of $250 million by Pfizer to BMS. Pfizer will fund 60% of all planned development costs effective January 1, 2007, and BMS will fund the remainder. BMS may also receive additional payments of as much as $750 million based on development and regulatory milestones. The companies will jointly develop the clinical and marketing strategy of apixaban, and will share commercialization expenses and profits/losses equally on a global basis.

In the other program, Pfizer will be responsible for all research and early-stage development activities for the metabolic disorders program, and the companies will jointly conduct Phase III development and commercialization activities. BMS will make an upfront payment of $50 million to Pfizer as part of this agreement. The companies will share all development and commercialization expenses along with profits/losses on a 60%-40% basis, with Pfizer assuming the larger share of both expenses and profit/losses.

"By combining our company's long-standing strengths in cardiovascular drug development and commercialization with Pfizer's global scale and expertise in this field, we can maximize the potential benefits of apixaban for patients. In addition, the metabolic disorders program complements existing research efforts in another area of significant unmet medical need where BMS is quite active," said Jim Cornelius, interim chief executive officer, BMS. "This collaboration supports our strategy to focus on serious diseases, maintain commercial emphasis on specialists and high-prescribing primary care physicians, and work with partners to offset the risks inherent with developing certain medicines."

"We're very pleased to collaborate with Bristol-Myers Squibb on the worldwide commercialization of apixaban, which has the potential to be a best-in-class product and would represent an excellent strategic fit with our global cardiovascular franchise," said Jeffrey B. Kindler, chairman and chief executive officer, Pfizer. "We see significant opportunities for an orally active anticoagulant with the clinical profile apixaban has demonstrated to date, particularly because of the clear need for new treatments to combat thrombosis and stroke. This agreement demonstrates our commitment to pursue revenue opportunities both through our business development and external alliances as well as our internal research and development pipeline."

In a surprise announcement during the first morning of INTERPHEX2007, Jubllant Organosys acquired Hollister-Stier Laboratories (HS), a Spokane, WA-based contract manufacturer of sterile Injectable vials and lyophilization products, for $122.5 million, plus $16 million in capital commitments.

In a joint statement, Shyam S. Bhartia and Hari S. Bhartia, co-chairmen and managing directors of Jubilant Organosys, said, "We are excited that we have found the right fit in Hollister, with an opportunity to leverage a common and new customer base. It gives us a ready entry into contract manufacturing of injectables and presents a compelling business opportunity, especially in the U.S. market. Additionally, it also brings with it a high-quality, steady cash flow business in allergy extracts and products. Hollister is profitable and, given its strong financials, the acquisition will augment our financial performance from day one and create incremental value for all our stakeholders."

According to a Jubilant statement, the privately held Hollister-Stier posted 2006 revenues of $55 million, with a strong outlook for 2007. In the past four years, the company posted a 40% CAGR in revenues from this business. Hollister also brings with it a stable and steady cash flow Allergy Extracts and Products Business, in which it has an established presence for the last 85 years. HS was majority-owned by Windward Capital Partners since 1999, a lengthy period for a private equity firm to hold onto a company.

Jubilant intends to retain the company's current management. Anthony D. Bonanzino, president and chief executive officer of HS, remarked, "The management of Hollister-Stier is extremely excited by this acquisition, which further strengthens our position in the CMO industry. This allows us to continue our high rate of growth in our CMO business and maintain our presence as one of the largest producers of allergenic extracts. Most importantly, Hollister-Stier will continue to provide the same level of quality and service that our contract and allergy clients have come to expect of us."

The acquisition is expected to close by June 2007.

Charles River Laboratories International has named Cheri Walker, Ph.D. to the role of corporate senior vice president, corporate development. Dr. Walker will be responsible for CRL's global corporate development function, directing all aspects of its merger, acquisition and strategic joint venture activities. She will also participate  in the strategic planning process of the company.

Prior to joining CRL, Dr. Walker was vice president, M&A for Qiagen Sciences where she oversaw the corporate development of Qiagen's North American life sciences tools and molecular diagnostics businesses. Previously, she held senior corporate development and operational positions at Invitrogen, where she successfully executed acquisition and licensing transactions.

James C. Foster, Chairman, president and chief executive officer of CRL, noted, "We are delighted to have Cheri join the Charles River team. Her depth of experience in life science transactions adds greater strength to our management team."

Amgen

1Q Revenues: $3.7 billion (+15%)

1Q Earnings: $1.1 billion (+10%)

Comments: Aranesp sales grew 14% to $1 billion; Enbrel sales (Amgen only) rose 11% to $730 million, Neulasta sales were up 17% to $714 million, while Epogen and Neupogen grew modestly, between 3 and 4% to $625 million and $299 million respectively. New product Vectibix posted $51 million it its first 1Q. Sensipar sales were up 72% to $105 million.

David J. Brown has been appointed director, project services, Integrated Project Services (IPS). In this role, Mr. Brown will lead the project services and project controls teams to develop strategies for solutions to support client projects and business objectives. He will also oversee the implementation of a wide range of project controls functions such as estimating, planning, cost control, change management, progress measurement, risk management and cash flow projections for the benefit of key pharmaceutical and biopharmaceutical clients.

"Dave brings a keen understanding of all phases of project work including conceptual design, detailed design and engineering, specifications, energy studies, construction support and validation," said Dave Goswami, PE, principal and president, IPS. "Our clients will benefit from Dave's extensive experience in project controls which provide real-time access to critical daily events and information that impact the progress, budget and overall cost of projects. We are delighted that Dave has joined IPS and look forward to his many contributions."

Mr. Brown's 23 years of experience includes project controls and mechanical engineering serving clients in the commercial, institutional, healthcare, government, manufacturing and life sciences industries. He was responsible for overseeing mechanical systems for bulk pharmaceuticals including oral solid dosage, biotech facilities including cell culture, purification and aseptic fill/finish, biological and chemical labs, pilot plants, warm and cold rooms, central plants and utilities. Most recently, Mr. Brown was northeast regional director, project services with CH2M Hill Lockwood Greene.

Stiefel Laboratories, Inc. has made several staff promotions and organizational changes as part of its integration of operations into one global company following its 2006 acquisition of Connetics Corp.

The company has combined its U.S. sales and marketing teams; created a new global marketing team responsible for marketing the company's product portfolio and launching the former Connetics products; and strengthened its global medical affairs function, which facilitates collaboration and partnership between marketers and medical professionals at the company.

Charles Stiefel, chief executive officer and chairman of the board of Stiefel Labs, commented, "This is an exciting time for Stiefel Laboratories. The products, technology, and the expertise of employees in Palo Alto at the former Connetics Corp. expand our product portfolio. Our product development pipeline is complemented with potential products that will add depth to our offerings. This new structure and the proven team we have assembled will allow us to leverage global efficiencies, unify sales and marketing strategies, and strengthen the Stiefel Laboratories brand globally."

To lead this new team, the company has promoted Bill Humphries to the newly created position of chief commercial officer. Mr. Humphries will be responsible for all Stiefel sales, marketing, strategic communications, public relations, and other commercial aspects of the company's global business.

Richard J. MacKay has been appointed to vice chairman of the board of directors. In his new role, Mr. MacKay will assess the most important issues that face the company in a global context and assist the board and chief executive officer on key projects and relationships. Mr. MacKay, who has been associated with Stiefel Labs and its products for more than 40 years, will retain the title of president, Stiefel Canada, Inc.

Also, Pierre Boucher was promoted to executive vice president, responsible for day-to-day operations and strategic planning for Stiefel Canada; Jim Hartman has been promoted to senior vice president, Stiefel U.S. Rx, where he will be responsible for the day-to-day commercial operations of the U.S. Rx business; Bresly Jaramillo has been promoted to senior vice president for Latin America and the Caribbean (LATAC); Gabriel McGlynn will serve as senior vice president of Eurasia, which now includes the combined EMEA (Europe, the Middle East and Africa) and APAC (Asia Pacific) regions; Dr. Larry Staubach, vice president for global medical affairs, and his team will facilitate the collaboration and partnership between the company's marketers and medical professionals; Alfonso Ugarte, vice president of global marketing, will lead the team responsible for the globalization of the combined product portfolio; Luis Pena, vice president for global portfolio planning, will be responsible for overseeing and leading the planning of the global new products pipeline; Karen Cavanaugh, vice president of the global steroid responsive dermatoses franchise and new product planning, will lead the development and marketing of the company's combined steroid responsive dermatoses portfolio and the commercial operations group in the development of new products.

AstraZeneca has entered into a definitive agreement to acquire MedImmune, Inc. for $15.6 billion in cash, approximately 11 times MedImmune's 2006 revenues. The acquisition adds to AZ's presence in the growing biological medicines and vaccines areas of drug research. The acquisition is expected to close this June.

The combination of MedImmune with AZ’s subsidiary, Cambridge Antibody Technology (CAT), will create a fully integrated biologics and vaccines business within the AZ Group with additional R&D, regulatory, manufacturing and global sales and marketing reach. The acquisition will allow AZ to address drug targets through three key technological approaches: small molecules, biologics and vaccines.

In 2006, MedImmune had revenues of $1.3 billion. The company's products include FluMist nasal spray flu vaccine, Synagis for infectious respiratory disease and Ethyol for reducing chemotherapy side effects. MedImmune also has two late-stage products in development: the next-generation Synagis and a refrigerated formulation of FluMist. With the acquisition, AZ's portion of biologics in the pipeline will increase from 7% to 27%, according to an AZ statement. MedImmune's chief executive officer, David Mott, and its head of research, James Young, will remain after the acquisition is complete.

AstraZeneca

1Q Revenues: $7 billion (+13%)

1Q Earnings: $1.6 billion (+10%)

Comments: Growth in the quarter was driven by combined sales of five key products: Nexium, Seroquel, Crestor, Arimidex and Symbicort, up 17% to $3.6 billion. R&D expenses were $1.2 billion in the quarter, up 36%. In the quarter, the company decided to terminate its licensing and collaboration agreement with AtheroGenics Inc., resulting in charges totaling $83 million.

Rentschler Biotechnologie GmbH has opened a U.S.-based sales office in New Providence, NJ. Rentschler, a full-service biopharmaceutical CMO, is expanding its sales activities in an effort to improve the support for its North American clients. Its manufacturing and fill/finish services are carried out at the company's facilities in Laupheim, Germany, in accordance with international GxP standards.

Rentschler is currently expanding the capacities of its technological and operative plants, allowing the production of material for supplying both clinical studies and the market. Also, setting up additional fermenter suites has strengthened the company's biotechnology business of custom manufacturing services from cell line development to large-scale cGMP production, registration of drugs and fill/finish, according to a company statement.

Dr. Nikolaus F. Rentschler, chief executive officer at Rentschler Biotechnologie, commented, "We have completed a number of successful projects with clients in the U.S. With the U.S. sales office we want to further develop our North American business."

Abbott submitted a NDA to the FDA for a fixed-dose combination of Niaspan (extended-release niacin) and simvastatin (the generic version of Zocor). The combination targets multiple lipid parameters in a single pill.

Niaspan and simvastatin are two widely prescribed medications for treating cholesterol. Niaspan is used to raise HDL "good" cholesterol levels, and simvastatin is effective in reducing LDL "bad" cholesterol levels. This combination addresses LDL, HDL and triglycerides in a single pill, which may lead to improved patient convenience and outcomes.

The application includes data from two large clinical studies composed of more than 1,150 randomized patients, which evaluated safety and efficacy of the combination of Niaspan and simvastatin in patients with mixed dyslipidemia. These studies measured the additional impact of combining Niaspan and simvastatin on key lipid parameters.

According to the American Heart Association (AHA), more than 38 million Americans have complex lipid disease. Combination therapy makes up 15% of the more than $17 billion U.S. cholesterol management market and represents the fastest-growing segment.

Johnson & Johnson Pharmaceutical Research & Development, LLC (J&JPRD) began construction of a new building on its Spring House, PA campus that will add approximately 150,000 sq. ft. in new lab, clinical development and office space to its existing facilities. Once completed in 2009, the site will be the company's East Coast hub for discovery research and early clinical development. J&JPRD will retain 680 existing jobs at the site, and plans to add another 120 jobs during the next three years.

"This expansion demonstrates our commitment to ongoing R&D as a key driver of our future success," said Joseph C. Scodari, worldwide chairman pharmaceuticals, Johnson & Johnson. "J&J is proud of its long heritage of pioneering research on this site. More than 15 major products were discovered or developed here, including several of our company's major prescription medicines, such as Topamax, Ultram and Ultracet. We intend to continue building on that tradition for many more years to come."

"This investment is a key component of our long term strategy to continue the sustained flow of innovative, high-quality compounds from our internal research," said Paul Stoffels, M.D., company group chairman, pharmaceutical R&D, J&J. "The new facility will provide our East Coast team with state-of-the-art capabilities to accelerate drug discovery and early development programs, and continue our tradition of delivering new medicines and driving value for our patients."

Pfizer

1Q Revenues: $12.5 billion (+6%)

1Q Earnings: $3.4 billion (-16%)

Comments: Worldwide pharmaceutical revenues grew 5% in the quarter to $11.6 billion. Revenue growth was driven by Lipitor, up 8% to $3.4 billion, Celebrex, up 22% to $598 million, and Lyrica, up 106% to $395 million, as well as Geodon, up 18%, Caduet, up 89%, Detrol, up 17%, Zyvox, up 39%, Vfend, up 26%, Viagra, up 11%, Zyrtec, up 10%, and Aromasin, up 33%. Also, revenues for two new products, Chantix/Champix and Sutent reached $162 million and $102 million, respectively. Earnings were impacted by revenue reductions for products that recently lost U.S. exclusivity: Norvasc, down $115 million, Zoloft, down $615 million, and Zithromax, down $112 million. R&D expenses were $1.7 billion in the quarter, up 8%.

Nabi Biopharmaceuticals has executed a definitive agreement to sell its Aloprim for Injection product to Bioniche Teoranta for $3.7 million. Bioniche Teoranta is based in Ireland and is part of Bioniche Pharma Group. The transaction, subject to customary closing conditions, is expected to close during the second quarter.

"When we recently announced our intent to form two strategic business units, Nabi Biologics and Nabi Pharmaceuticals, we determined Aloprim was no longer a strategic component of our product portfolio," said Dr. Leslie Hudson, interim president and chief executive officer of Nabi. "This sale marks another step for Nabi toward the realization of our strategic plan."

BioConvergence LLC is expanding its Bloomington, IN headquarters in an effort to better serve its pharma/biopharmaceutical clients. BioConvergence will add approximately 20,000 sq. ft. to its existing 50,000-sq.-ft. facility to accommodate its growing cGMP materials management business unit. The expansion also adds approximately 15 new employees to its existing 21 employees and includes a multi-million dollar investment in facilities and equipment.

“BioConvergence began with a goal to serve growing life sciences businesses in need of an experienced partner for the development of new molecules heading to the clinic and market and to provide unsurpassed materials and supply chain management capabilities that are increasingly in demand across the world. Our clients have shown confidence in our ability to deliver valuable results with speed and quality. We have been audited by the FDA and have earned preferred provider status with multiple clients,” said Alisa Wright, chief executive officer of BioConvergence.

"The new expansion of our facility and our employment growth projections keep BioConvergence on track to fulfill commitments for incentives from the State of Indiana and Monroe County, and we thank our government, economic development, community and business partners for their past support, which have allowed us to get our business up to speed in our first year of operations. We look forward to many years of growth to come,” Ms. Wright added.

Lexicon Genetics released data highlighting potential therapeutic targets related to its collaboration with Genentech. These target discoveries were made through the collaboration between the two companies that was initiated in December 2002 and expanded in November 2005 to advance the R&D and commercialization of new biologic drugs. Lexicon has developed antibodies for one of these targets, designated LG842, which it is now advancing through preclinical research.

The data revealed that the neutralization of LG842, a circulating protein expressed predominantly in adipose tissue, placenta, pancreas and liver, resulted in lower triglycerides and cholesterol in in vivo models. In preclinical studies, LG842 was shown to decrease plasma triglycerides and cholesterol. Lexicon has the option to choose six targets from the collaboration to advance into biotherapeutics drug discovery efforts. LG842 was one of the first two targets selected by Lexicon for internal development.

"Our in vivo studies, recently corroborated by human genetic data, have defined an important new pathway for potential treatments of dyslipidemia and metabolic disorders related to cardiovascular disease," commented Brian P. Zambrowicz, Ph.D., Lexicon's chief scientific officer. "We believe that our collaboration with Genentech has been enormously fruitful. We have been able to elucidate the function of a number of genes that have shown promise in important areas of medicine."

Merck
1Q Revenues: $5.8 billion (+7%)
1Q Earnings: $1.7 billion (+12%)
Comments: Gardasil sales reached $365 million in the quarter. Key products -- including Singulair, Zetia, Vytorin and Januvia -- drove results in the quarter. Combined global sales of Zetia and Vytorin, as reported by the Merck/Schering-Plough partnership (recognized as equity from a joint venture and not as revenues), reached $1.2 billion, up 47%. Singulair sales reached $1 billion, up 25%. Worldwide sales for Januvia (launched in October) reached $87 million in the quarter. R&D expenses were $1 billion for the quarter, up 9%.

Wyeth
1Q Revenues: $5.4 billion (+11%)
1Q Earnings: $1.3 billion (+12%)
Comments: Worldwide pharmaceuticals revenue was up 11% to $4.5 billion in the quarter, driven by Prevnar, Enbrel, Nutrition products and Zosyn sales. Prevnar sales were $617 million, up 43%. Enbrel sales (outside of the U.S. and Canada) were $445 million, up 33%. Zosyn sales were $281 million, up 18%. Alliance revenue increased 20% to $304 million in the quarter due to higher Enbrel sales in the U.S. and Canada. R&D expenses were $750.7 million, up 10%. Results for the quarter included net charges of $42.6 million related to the company's productivity initiatives.

Schering-Plough
1Q Revenues: $3 billion (+17%)
1Q Earnings: $565 million (+52%)
Comments: Sales of Remicade increased 34% to $373 million in the quarter. Nasonex sales rose 24% to $284 million. Sales of Pegintron increased 10% to $217 million. Clarinex sales were $204 million, up 28%. Sales of Temodar grew 20% to $196 million. Global cholesterol joint venture sales, which include Vytorin and Zetia (which are shared with Merck and are not recognized as product revenues), totaled $1.2 billion in the quarter, up 48%. R&D expenses were $707 million, up 47%.

Gilead
1Q Revenues: $1 billion (+48%)
1Q Earnings: $407.4 million (+55%)
Comments: Product sales were a record $840.2 million in the quarter, up 50%. HIV product sales were $705.1 million, up 56%. Truvada sales were $345.9 million, up 39%. Atripla sales were $190.2 million, up 38%. Hepsera sales were $71.3 million, up 35%. Royalty, contract and other revenues totaled $188.2 million, an increase of $54.7 million from 1Q2006. This increase was driven by Tamiflu royalties from Roche of $167.9 million, up 46%. R&D expenses in the quarter were $130.1 million, up 47%.

Avanir Pharmaceuticals achieved positive results from its Phase III trial evaluating Zenvia, an NMDA antagonist and sigma-1 agonist, in diabetic neuropathic pain.

The primary endpoint of the trial was based on the daily diary entries for the Pain Rating Scale as defined in the FDA's SPA. In the trial, two doses of Zenvia, 45/30 mg DMQ and 30/30 mg DMQ dosed twice daily, were compared to placebo based on patient diary entries for the Pain Rating Scale. Both Zenvia treatment groups had lower pain ratings than placebo patients. In the DMQ 45 and DMQ 30 patient groups, average reductions were significantly greater than placebo patients at Days 30, 60, and 90. Zenvia also demonstrated statistically significant improvements in a number of key secondary endpoints including the Pain Relief Ratings Scale and the Pain Intensity Ratings Scale.

Abbott

1Q Revenues: $5.3 billion (15.5%)

1Q Earnings: $697.5 million (-19%)

Comments: Worldwide pharmaceutical sales were $3.4 billion, up 16.6%. Humira grew to $289 million in sales, up $32.4. Earnings in the quarter excludes after-tax charges of $57 million for acquisition integration, $75 million related to fair value adjustments of Abbott's investment in Boston Scientific, and $55 million for cost reduction initiatives.

The FDA has licensed Sanofi Pasteur's H5N1 vaccine, the first avian flu vaccine for humans. Sanofi Pasteur, in collaboration with the National Institutes of Health, submitted a BLA to the FDA for the vaccine. The licensure is the first step in achieving the government's goal of stockpiling vaccine to protect those who are at increased risk of exposure to the H5N1 flu virus contained in the vaccine during the early stages of a pandemic.

"The licensure of the nation's first vaccine is a significant milestone in pandemic preparedness," said David Williams, president, chairman and chief executive officer of Sanofi Pasteur. "As the leading manufacturer of influenza vaccine in the world and a longstanding, responsible member of the immunization community, we will play a key role in helping safeguard human health if an influenza pandemic strikes. We look forward to continuing to work with the U.S. government and others, to prepare for this crisis."

The licensure was based on a successful trial conducted by the National Institute of Allergy and Infectious Diseases evaluating the safety and ability to generate an immune response when administered in two doses in healthy adults 18 through 64 years.

GE Healthcare, a unit of General Electric Co., has acquired Wave Biotech LLC, a supplier of disposable manufacturing technologies for the biopharmaceutical industry. The acquisition of Wave Biotech LLC, including its subsidiary Wave Europe Pvt. Ltd., expands GE Healthcare's products and services for the manufacture of biopharmaceuticals such as antibodies and vaccines. Financial terms were not disclosed.

Wave Biotech develops and manufactures bioreactors designed to replace traditional and more expensive stainless steel tanks and piping. Wave Biotech's single use bioreactors are also increasingly being used to enable the manufacture of patient-specific cell and gene therapy products.

Ann O'Hara, general manager of GE Healthcare's BioProcess business, said, "Wave Biotech is an excellent company with a strong track record of innovation and a product range that is highly complementary with our existing BioProcess business. The combination of GE Healthcare and Wave Biotech will allow us to expand into new applications and to create a broad offering of added value tools and services for biopharmaceutical manufacture."

"We are very excited to be part of GE Healthcare, who already offer a broad range of technologies and services to the biopharmaceutical manufacturing industry," said Dr. Vijay Singh, president and founder of Wave Biotech. "Our customers will benefit greatly from the global presence and the R&D resources that GE Healthcare brings to the table. The integration of single-use cell culture with GE Healthcare's existing filtration and downstream operations will provide a host of new disposable solutions to this growing industry."

Patheon plans to restructure its network of six pharmaceutical manufacturing facilities in southern ON, Canada as part of its strategy to focus on developing and manufacturing prescription pharmaceutical products and to improve profitability.

The company plans to divest its Niagara-Burlington Operations business, which is focused on the manufacturing of over-the-counter (OTC) products, with facilities in Fort Erie and Burlington Gateway and the commercial operations at Burlington Century. The sale will include the assets, including equipment, facilities and land. Third-party contracts will be assigned to the purchaser, subject to client approval. It is anticipated that the purchaser will assume responsibility for the commercial manufacturing staff at all three locations. The company plans keep its leased Burlington Century facility where its central quality control lab is based.

To improve capacity and profitability of the remaining Canadian sites, Patheon plans to transfer all commercial production and development services at its York Mills site in Toronto to its site in Whitby, Ontario, and some production to its Mississauga and Cincinnati sites. Following completion of this process, expected to take approximately two years, the company plans to close its York Mills facility and sell the land and building at this location.

"This initiative represents a significant step forward in our strategy to improve the profitability of our business," said Riccardo Trecroce, chief executive officer, Patheon. "Our objective is to focus our resources and capital on the development and manufacture of prescription pharmaceutical products which represent higher-margin revenues, while also improving capacity utilization and operational effectiveness at our sites."

Johnson & Johnson

1Q Revenues: $15 billion (+16%)

1Q Earnings: $2.6 billion (-22%)

Comments: Worldwide Pharmaceutical sales were $6.2 billion in the quarter, up 11%. Sales growth reflects the strong performance of Topamax, Levaquin, and antipsychotic franchise, which includes Risperdal, Risperdal Consta and Invega. Earnings in the quarter reflect an in-process R&D charge of $807 million associated with the acquisition of Conor Medsystems, Inc.

Merck has submitted a sBLA for Gardasil to the FDA to update the labeling to include efficacy data showing protection against additional cervical cancer causing HPV types responsible for more than 10% of cervical cancers, vaginal and vulvar, and data on immune memory.

Gardasil is approved for use in girls and women ages 9 to 26 for the prevention of HPV types 16- and 18-related cervical cancer, cervical pre-cancers (CIN 2/3 and AIS), vulvar pre-cancers (VIN 2/3) and vaginal pre-cancers (VaIN 2/3) and for the prevention of genital warts and low-grade cervical lesions (CIN 1) caused by HPV types 6, 11, 16 and 18.

Under the Prescription Drug User Fee Act (PDUFA), for standard supplemental BLAs filed in 2007, the FDA's goal is to review and act on 90% of BLAs within 10 months of receipt.

Millipore Corp. is the first company to integrate Radio Frequency Identification (RFID) technology with filtration products used to manufacture biopharmaceutical drugs. The new RFID capability will be branded as SMART Technology and will be introduced at the INTERPHEX 2007 Conference in New York.

According to the company, using RFID technology in filtration products allows customers to increase speed by quickly and reliably retrieving critical information, such as when and how the product was manufactured. RFID can also deliver real-time information about product performance and identify which fluids are present during the manufacturing process. This can help customers with regulatory compliance and improve recording and conveying manufacturing data. Other benefits of the technology include: improved readability and non-linear access to information, rewritable and encryptable, greater security, mechanically and thermally stable gamma irradiatable.

The company recently entered into an exclusive license with Tack Smart Filter Technology BV to embed the RFID technology in its filters and filtration equipment for biopharmaceutical applications. Millipore has also formed relationships with Tagsys RFID for tags and reader components; the Tech Group for injection molding and fabrication and Northern Apex-RFID for RFID integration services and instrument development.

“Using RFID technology to record and convey valuable product and process information allows our customers to more efficiently develop and validate key process steps,” said Roland Heinrich, Ph.D., vice president, R&D of Millipore’s Bioprocess Division. “In an industry where time-to-market and compliance are crucial, RFID improves the speed and confidence with which critical data is exchanged for these steps.”

Galapagos' BioFocus DPI service division has signed two new collaborations with Ono Pharmaceutical Co. Ltd., building on the successful relationship between Ono and DPI, which began in 2004. Under the first collaboration, BioFocus DPI will use selected compounds from its SoftFocus and other synthetic small molecule collections to perform high throughput screening for Ono's drug discovery program. In the second collaboration, BioFocus DPI will apply its medicinal and computational chemistry and ADME profiling expertise in multiple medicinal chemistry projects for Ono.

"We are pleased with the new contracts with Ono that build on the longstanding relationship between Ono and DPI. The new contracts show the benefit of building a global drug discovery service business. We combine expertise from our acquired companies Discovery Partners International, BioFocus as well as Inpharmatica, realizing the synergy in bringing these activities together," added Onno van de Stolpe, chief executive officer of Galapagos.

"We are dedicated to creating innovative medicines," said Dr. Daikichi Fukushima, managing director, Ono. "Accordingly, we are enthusiastic about extending the relationship with BioFocus DPI, a leading company in drug discovery, so that we can continue creating novel drug candidates."

Lilly

1Q Revenues: $4.2 billion (+14%)

1Q Earnings: $508.7 million (-39%)

Comments: Alimta, Byetta, Cialis, Cymbalta, Forteo, Strattera, Symbyax, Xigris and Yentreve, collectively grew 57% to $1.3 billion, and accounted for 30% of total sales, compared with 22% of in 1Q2006. Earnings for the quarter were affected by in-process R&D charges associated with the ICOS acquisition and OSI in-licensing agreement and restructuring charges associated with "manufacturing decisions"; Lilly recently decided to close some European locations and halt construction of a plant in Virginia.

CDISC (Clinical Data Interchange Standards Consortium, Inc.) has added two directors to its board, Dr. Christopher Chute of the Mayo Clinical College of Medicine and Paula Brown Stafford of Quintiles Transnational Corp. Dr. Chute and Ms. Stafford bring a wealth of relevant experience to the CDISC board from their respective roles as professor and chair for the biomedical informatics department at the Mayo Clinical College of Medicine, and as executive vice president of global data management at Quintiles.

Ms. Stafford brings a global perspective and broad experience from her varied roles within a large CRO. Her current role is heading the globalization of the Quintiles Data Management function, where she leads a team of 1,200 people, representing $100 million investment in revenue.

"Paula's expertise and perspective will be most valuable at this critical point in CDISC's growth and adoption," states Rebecca Kush, president of CDISC.

Ms. Stafford added, "To date, Quintiles has delivered nearly 200 CDISC-compliant databases on behalf of Pharma. My belief is that the key to the industry's future is to deliver a CDISC-compliant data structure before the first patient enters a trial. The FDA supports this view and believes that CDISC is the natural leader to make this happen. I am keenly interested in bringing my expertise to the CDISC table and to help lead the vision for the pharmaceutical industry." Ms. Stafford has accepted the position of chair of the board's Financial Oversight Committee. She will serve the term through 2007.

Dr. Chute has authored numerous peer-reviewed publications regarding standards work in the specific areas of vocabulary and health concept representation in Health Informatics. Dr. Chute has also chaired efforts such as the Joint HL7 and SNOMED Meeting: The Boundary between Vocabulary and Information Models, NASA Vocabulary Summit (2004); ANSI Health Informatics Standards Board (HISB) (2004-2005); NIH Biomedical Computing and Health Informatics: Special Emphasis Panel (2005). Dr. Chute is currently the chair of the U.S. Delegation to the ISO Informatics Technical Committee (2007-2009). Dr. Chute will serve on the board from 2007 through 2009.

"CDISC will most certainly benefit from Dr. Chute's invaluable expertise in the areas of terminology, information technology and standards development," stated Ms. Kush.

The CDISC board has a total of ten directors. Two others were re-elected to serve a second three-year term for 2007-2009. Dr. Pierre-Yves Lastic, senior director, standards management and data privacy at Sanofi-Aventis, and William Rosen, executive director, external affairs, standards and support with Pfizer.

The FDA Arthritis Advisory Committee voted 20-to-1 against recommending approval of Merck's Arcoxia for the symptomatic treatment of osteoarthritis. The drug has been under review by the FDA as an investigational selective COX-2 inhibitor since the NDA was submitted in December 2003 and is currently available in 63 countries in Europe, Latin America, the Asia-Pacific region and Middle East/Northern Africa.

Merck presented data from a comprehensive clinical program that included efficacy and safety findings for Arcoxia 30 mg and 60 mg once daily from 11 studies in patients with osteoarthritis; safety findings from seven additional studies in other patient populations; and data from a 34,000-patient, long-term MEDAL (Multinational Etoricoxib and Diclofenac Arthritis Long-Term) Program. Merck believes the overall benefit to risk profile is favorable to support approval of Arcoxia for treating the signs and symptoms of osteoarthritis.

The Committee's recommendation will be considered by the FDA as part of its review of the NDA (for a 60 mg once daily dose) along with review of a separate related NDA for a 30 mg once daily dose of Arcoxia submitted in April 2004. Merck anticipates action by the FDA on April 27th.

The company will continue to market Arcoxia outside the U.S., where it has been approved for a broad range of indications, including osteoarthritis.

Integrated Service Solutions, Inc. (ISS) has relocated its corporate headquarters to a new facility in the Towamencin Corporate Center in Lansdale, PA. The new 20,000-sq.-ft., state-of-the-art facility was designed to expand service operations in support of pharma/biopharma companies nationwide.

Joseph Uricchio, founder and president of ISS, said, “Integrated Service Solutions move to this new facility represents a number of investments we are making to support the rapidly growing demand for our services. This facility is nearly four times the size of our former location and will serve as a showcase in design and location for our customers. In addition, future growth in staffing levels as well as the increase in our Metrology Laboratory business were key drivers behind the decision to expand to a much larger and more conveniently located facility"

In addition to housing executive, customer service, administration, and quality assurance departments, the facility also includes a 6,000-sq.-ft. environmentally controlled Metrology Lab that's ISO/IEC 17025 compliant and is equipped with ergonomic workbenches and sophisticated test and measurement devices for precisely calibrating customers' equipment. Two additional labs include the Mass Lab for the precision calibration of weights and the Total Organic Carbon (TOC) Lab for the testing and analysis of TOC ultra pure water.

Genentech

1Q Revenues: $2.8 billion (+43%)

1Q Income: $706 million (+68%)

Comments: U.S. sales rose 30% to $2.0 billion, driven by growth in Avastin sales (+34% to $533 million) and Rituxan (+12% to $535 million). R&D costs increased 63% to $610 million, including $33 million in stock-based compensation for employees.

Novartis has agreed to sell its Gerber baby food business to Nestle for $5.5 billion in cash, completing the company's divestiture program and allowing it to focus on healthcare with pharmaceuticals at the core. The sale is expected to close by the second half of 2007.

"Over the past decade we have continuously invested in R&D, strengthening our innovation power and building our healthcare businesses, particularly pharmaceuticals, while divesting over 50% of our non-core, non-healthcare businesses," said Dr. Daniel Vasella, chairman and chief executive officer of Novartis. "This transaction is also the right move for Gerber, as it will become a priority business in a leading global nutrition company."

In other news, Novartis has appointed Joseph Jimenez as chief executive officer of its Consumer Health division. He replaces Paul Choffat, who is retiring at the end of April after leading the division for many years. Mr. Jimenez previously worked at The Blackstone Group, and has also served as president and chief executive officer of the H.J. Heinz Company in Europe and the U.S.

Is MedImmune up for sale? According to a company statement, the board of directors at the company "has authorized management to evaluate whether third parties would have an interest in acquiring the company at a price and on terms that would represent a better value for its stockholders than having the company continue to execute its business plan on a stand-alone basis."

In February, the board announced that the company was sticking to its guns, but evidently MedImmune has received "indications of interest by major pharmaceutical companies, coupled with recent expressions by certain stockholders of dissatisfaction with the company's short-term stock price performance," leading to the search for a possible buyer.

The company has retained the services of Goldman, Sachs & Co. and Dewey Ballantine LLP to help with the process and contends that it is "well under way," which raises some questions with this editor about the validity of the February announcement.

Abbott has officially opened its new state-of-the-art biologics manufacturing facility in PR to support the long-term supply Humira and other future biologics. The facility, Abbott Biotechnology Limited (ABL), received FDA approval in February to commercially produce Humira for the U.S. market. This new plant has significantly more production capacity than Abbott’s Bioresearch Center (ABC) in Worcester, MA, where the drug was previously manufactured.

"This new facility is a key milestone for Abbott as we move to focus our resources and future growth on biologic and potent-drug manufacturing," said Lawrence Kraus, vice president of manufacturing, global pharmaceutical operations, Abbott. "The advanced, high-quality infrastructure of ABL can meet the exceptionally challenging and stringent processes of biologic manufacturing. With this state-of-the-art facility, we can supply HUMIRA to the growing number of patients who have come to rely on this breakthrough product."

The new plant cost Abbott approximately $450 million and is the company’s largest capital investment to date. In addition to producing Humira, the 330,000-sq.-ft. facility is designed for large-scale production of future products in Abbott's pipeline that will require advanced manufacturing technologies.

Parexel Consulting, a business unit of Parexel International has appointed five new consulting experts to support its growth. The consultants are based in Parexel's new Washington, D.C.-area office, in Bethesda, MD. The team of consultants is led by Carolyn Finkle, vice president of Parexel Consulting.

"Our clients require a fusion of scientific, regulatory and business expertise to help them develop products for worldwide bio/pharmaceutical markets," said Alberto Grignolo, Ph.D., Corporate Vice President and General Manager of Parexel Consulting. "Our expanding team of consultants in Washington, D.C., many of whom have in-depth experience as former regulators, will assist our clients in gaining regulatory approval for important products."

Ms. Finkle has more than 24 years of experience in drug development, regulatory affairs, GMP, pharmacology, drug product safety evaluation, clinical development, post-approval requirements, and scientific research. She is responsible for management of the product development and regulatory consulting team in North America, focused on helping clients optimize all aspects of the development process for drugs, biologics, devices and combination products. Prior to joining the company, Ms. Finkle was vice president of regulatory affairs at Celsion Corp.

Lawrence Grylack, M.D., was appointed principal consultant. Prior to joining the company, Dr. Grylack served as medical officer in the Division of Pediatric Drug Development in the Office of Counterterrorism and Pediatric Drug Development, and the Division of Pulmonary and Allergy Drug Products at the FDA Center for Drug Evaluation and Research (CDER). In this role, he handled reviews of adverse event reports, INDs and NDAs, and performed consultations for other CDER Divisions and other FDA Centers.

David Morse, Ph.D., has been appointed as a principal consultant. Dr. Morse has more than 20 years of experience in pharmacology and toxicology. Prior to joining the company, he worked as a supervisory pharmacologist for CDER, where he provided strategic regulatory oversight for all phases of product development and safety testing for new therapeutics.

Sally Hargus, Ph.D., was appointed senior consultant. Dr. Hargus has more than 15 years of combined research, industry, and regulatory experience in pharmacology and toxicology aspects of drug development. Prior to joining the company she held senior positions in toxicology, including with 3M Pharmaceuticals and with the FDA's Center for Biologics Evaluation and Research (CBER), where she reviewed pharmacology and toxicology sections of IND, pre-IND, and BLA submissions for vaccines and allergenic products.

Patrick Guinn has been appointed manager. Prior to joining the company, Mr. Guinn served as Consumer Safety Officer/Regulatory Health Project Manager at the FDA's CDER. He has more than 10 years of FDA experience, including preparation and facilitation of regulatory meetings and negotiations, coordination of activities for multi-disciplinary review teams, management of the drug review process, and development of several regulatory Guidance documents for the industry.

Robert Bradway has been named executive vice president and chief financial officer, Amgen. He will be responsible for the company's finance, strategy and investor relations operations. Mr. Bradway replaces Richard Nanula, who is leaving the company to pursue other opportunities.

Mr. Bradway joined the company in 2006 as vice president, operations strategy. Prior to that, he spent 18 years at Morgan Stanley in New York and London, where he was a managing director in investment banking.

"Bob brings nearly 20 years of corporate finance experience to his new role and we are delighted to have him as part of our executive team," said Kevin Sharer, Amgen's chairman and chief executive officer. Mr. Nanula will remain at Amgen for the next 90 days to assist in the transition. "Richard has played an important role in Amgen's growth during the past six years, and I deeply appreciate his service to the company," said Mr. Sharer.

Cardinal Health has completed the sale of its Pharmaceutical Technologies and Services (PTS) segment to The Blackstone Group for approximately $3.3 billion. Cardinal Health announced in November of last year that it planned to divest PTS to focus resources on its four remaining segments serving healthcare provider customers.

"We are pleased to begin this new chapter in our history," said John Lowry, chief executive officer of PTS. "We have a long heritage of providing customers with creative solutions and consistent service, and we expect to create even more value for our customers in the future with Blackstone as our partner."

Commenting on the acquisition, Chinh Chu, senior managing director of The Blackstone Group, said, "We believe the pharmaceutical outsourcing sector is in its early stages of growth as pharmaceutical and biotechnology companies of all sizes will increasingly rely on third parties for the development, manufacture, and packaging of pharmaceutical and other products. Blackstone is pleased to be partnering with the existing PTS management team, led by John Lowry, who will be significant investors in PTS alongside Blackstone."

Pfizer and Renovis have extended the term of their worldwide collaboration to research, develop and commercialize small molecules that target the vanilloid receptor, VR1. This extension provides Renovis with additional research funding through June 30, 2008 and reflects the goal of Pfizer and Renovis to advance multiple, small molecule VR1 antagonists toward clinical development.

The VR1 receptor is a member of a related group of ion channel proteins known as the transient receptor potential (TRP) family that mediate and influence cell signaling. Inhibitors of VR1 are predicted to be useful in the treatment of pain, urinary incontinence and other diseases and disorders.

"We partnered our VR1 program with Pfizer in June 2005 at a preclinical stage because we believed that safe and effective antagonists of VR1 could potentially address major medical needs in multiple therapeutic areas and we wanted to work with a partner capable of aggressively pursuing this broad potential with us," commented Corey S. Goodman, Ph.D., president and chief executive officer of Renovis. "Since then, the collaboration has produced its first advanced candidate, which we expect to enter human testing in 2007, as well as several other small molecule VR1 antagonists that we hope to advance into IND-enabling studies and clinical development with Pfizer during the term of this extension."

Under the terms of the extension, Pfizer will continue to fund all aspects of the collaboration including the research and preclinical development efforts at Renovis through June 30, 2008. Other terms of the collaboration and licensing agreements between Pfizer and Renovis have not been changed.

Emisphere Technologies has appointed Michael V. Novinski to the position of president and chief executive officer effective immediately. Mr. Novinski had previously served as  president of Organon USA Inc., a business unit of Organon BioSciences, for the last four years. During that tenure, Organon USA received FDA approval for a number of ethical pharmaceutical products in the areas of Women's Healthcare, Fertility, Neuroscience, Anti-thrombotics and Anesthesia.

Mr. Novinski replaces Lewis Bender, who was appointed interim chief executive officer on January 16, 2007. He has more than 28 years of industry and specialty product experience, which is critical to Emisphere as it moves to late stage product development. Mr. Novinski held several senior executive positions within Organon BioSciences prior to his recent role at Organon USA. On March 12, 2007, Akzo Nobel announced the intended sale of Organon BioSciences to Schering-Plough for $14.4 Billion in cash.

"I am very excited about this opportunity to join Emisphere," said Mr. Novinski. "The company's technology is exciting and well advanced and I believe that it will yield important improvements in healthcare. Many key Emisphere programs have the potential to create brands with substantial value and unique profiles and benefits for both prescribers and patients."

Pharmatek Laboratories, a chemistry development organization, has opened its new 34,000-sq.-ft. facility in San Diego. The new location will initially more than triple Pharmatek's available laboratory and manufacturing space and house more than 100 employees focused on analytical development, preformulation testing, formulation development, GMP manufacturing, and stability storage and testing. The facility strengthens Pharmatek's drug development capabilities and its ability to continue the growth it has experienced during the past eight years. The company's lease includes an option to expand to 64,000 sq. ft.

"The new facility will support our rapidly growing pharmaceutical development business with space for additional expansion in the future," said Timothy Scott, president of Pharmatek. "The increased space enables us to enhance both our capacity and services. We can now conduct a larger number of projects and provide our clients with better service on those projects."

"From the GMP viewing area to the layout and flow of the manufacturing, analytical and formulation labs, the entire facility was built with our clients' needs in mind," said Dr. Jeffrey Bibbs, chief executive officer and chief scientific officer of Pharmatek. "Our focus has always been on our clients. This larger facility, built to our specifications, will better meet their growing need for drug development outsourcing."

Gary Kedgley has been named vice president, sales and marketing, Romaco. He will support president Tom Luken in directing and growing the company’s worldwide business, including production centers in Germany, Italy and Switzerland, and all sales channels. He is based at Romaco’s European headquarters in Karlsruhe, Germany.

Mr. Kedgley has spent more than 30 years in manufacturing and engineering-led businesses, developing change management to deliver improved performance. He has developed key strengths in team building, coaching and relationships through roles in both operations and project sales management functions.

With qualifications in mechanical engineering, Mr. Kedgley has been involved for most of his career in the supply of capital equipment to the global processing industry. He has devised and implemented appropriate technology solutions in the dairy, beverage and food sectors. His most recent role was vice president, global project sales and management for Invensys APV, with responsibility for 300 staff.

“Romaco has a superb portfolio of products, a strong service network, and the recently-completed restructuring process has created a very agile and focused organization which is poised to capitalize on the many opportunities arising from the rapid evolution of the markets it serves. The company is also fortunate to have a great team of people already on board and I look forward to working with them all as Romaco enters a new and exciting chapter,” said Mr. Kedgley.

John Chickosky has been appointed chief operating officer of Xcellerex, Inc. Mr. Chickosky joins the company with more than 20 years of senior management experience in life science technology companies including Kendro Laboratory Products, CARR Separations, and Sepracor.

"John brings a wealth of experience and an outstanding track record in marketing, sales, corporate development and building successful organizations to commercialize advanced life science technologies," said Mike Masterson, Xcellerex's chief executive officer. "His appointment comes at a key point in the evolution of the company to commercialize its enabling and proprietary disposable biomanufacturing systems. We are both growing our contract manufacturing services business using these systems and are now poised to accelerate the commercialization of our disposable bioreactor products and FlexFactory integrated manufacturing system for vaccines and biotherapeutics."

Mr. Chickosky previously held senior positions at life science equipment companies, including at Kendro Laboratory Products (now part of Thermo Electron), where he was vice president, global bioprocessing and drug discovery sales, and at CARR Separations, where he was senior vice president, sales and marketing. Prior to that, he served as vice president, sales and marketing at AquaAir, Inc. and at Sepracor as vice president, marketing and vice president, business development.

Cangene Corp. received approval from the FDA for HepaGam B for the prevention of hepatitis B recurrence following liver transplantation in hepatitis B surface antigen (HBsAg)-positive patients. HepaGam B is Cangene's Hepatitis B Immune Globulin Intravenous, which is a purified antibody or hyperimmune that is specific for the hepatitis B virus. Clinical data showed HepaGam B was highly effective at preventing hepatitis B recurrence and the dosing regimen used demonstrated anti-HBsAg levels that exceeded target therapeutic levels.

HepaGam B is distributed in the U.S. by Apotex Corp., which recently expanded its distribution by placing the drug within Novation, LLC's product line, making HepaGam B directly available to Novation's healthcare organizations in the U.S.

"This is a very important approval and addresses a significant medical need," said Dr. John Langstaff, Cangene's president and chief executive officer. "And with the recent agreement for distribution of this product with Novation, the timing could not be better," he said.

HepaGam B was approved by the FDA last year for treatment following acute exposure to blood containing HBsAg, and was approved earlier this year by Health Canada for prevention of Hepatitis B recurrence following liver transplantation in adult patients.

Roche will acquire BioVeris for approximately $600 million. This acquisition will expand Roche Diagnostics' immunochemistry business from the human diagnostics field into life science research, development, patient self-testing, veterinary testing, drug discovery and development, and clinical trials. With the acquisition, Roche will own the electrochemiluminescence (ECL) technology deployed in its Elecsys product line, which gives Roche Diagnostics the opportunity to take advantage of the immunochemistry market.

Samuel J. Wohlstadter, chairman and chief executive officer of BioVeris, said, "We are pleased that this transaction will deliver substantial value to BioVeris shareholders. Given the history between the parties and the scope of Roche's existing diagnostics business, Roche is the natural buyer for BioVeris. We look forward to working with our colleagues at Roche to facilitate a timely close and orderly integration."

Severin Schwan, chief executive officer, division Roche Diagnostics, said, "ECL is a highly innovative technology. In comparison with other detection technologies ECL offers distinct advantages such as enhanced sensitivity, short incubation times and broad measuring ranges. This acquisition ensures that Roche will be able to provide unrestricted access to all customers and therefore represents a significant growth opportunity for our immunochemistry business."

The transaction, which expected to close during the third quarter of this year, is subject to the approval of BioVeris's shareholders, receipt of certain regulatory approvals and other customary closing conditions.

In connection with the acquisition, two newly formed entities established by Mr. Wohlstadter will purchase rights to certain intellectual property and related assets from BioVeris associated with its vaccines research and a non-exclusive license to use the ECL technology. A committee of independent directors of BioVeris's board approved these transactions.

Shawn L. Silvestri, Ph.D. has been appointed vice president, new product development, Akorn, Inc. Dr. Silvestri brings 15 years' experience in pharmaceutical R&D with Abbott Laboratories.

Prior to joining the company, Dr. Silvestri served as director for Abbott Diagnostics Division (ADD) focused factory and technical services from 2005 to 2007. Prior to that, he held diversified positions of increasing responsibility in pharmaceutical product and process development with Global Pharmaceutical Operations (GPO), Pharmaceutical Product Division (PPD) and Abbott International (AI). Dr. Silvestri joined Abbott as group leader, pharmaceutics and drug delivery in 1992.

Arthur S. Przybyl, president and chief executive officer, commented, "We are excited to have Shawn join our senior management team. He brings substantial new product and process development experience in specialty pharmaceuticals to Akorn and we are confident that his technical expertise and leaderships skills will be a great asset. Shawn will be responsible for transitioning our product development efforts from our manufacturing site locations to a centralized location near our corporate headquarters."

Bayer HealthCare Pharmaceuticals, Inc. has officially launched in the U.S. The new company incorporates the former Berlex, Inc. into Bayer HealthCare Pharmaceuticals, as part of Bayer's acquisition of Schering AG, Berlex's former parent company.

Bayer HealthCare Pharmaceuticals, headquartered in Wayne, NJ, is the U.S.-based pharmaceuticals unit of Bayer HealthCare. Bayer HealthCare's pharmaceutical business develops, manufactures and markets human health products. The global pharmaceutical business employs more than 40,000 people, with approximately 5,500 employees in the U.S.

The company's global oncology and specialized therapeutics business units, as well as certain U.S.-based drug development groups and other business support functions, will be housed in its Montville, NJ offices. The establishment of Bayer HealthCare Pharmaceuticals is expected to create 300 new jobs in NJ.

"As the largest single pharmaceutical market in the world, the U.S. offers our organization a tremendous opportunity to strengthen our position in the specialty pharmaceuticals arena," said Reinhard Franzen, president of Bayer HealthCare Pharmaceuticals. "New Jersey is one of the most important centers for the U.S. pharmaceutical industry and offers access to a highly skilled workforce and close proximity to future business partners."

As a result of these two companies combining forces, R&D activities have been consolidated into three major sites, Berkeley, CA, Berlin and Wuppertal, Germany. Research in Diagnostic Imaging, Women's Healthcare and Oncology will be based in Berlin. Wuppertal will house the core of the company's Cardiology research. Also, Bayer will continue operations in WA to manufacture the company's white blood cell growth factor.

Parexel International has opened a Washington, D.C.-area office, located in Bethesda, MD, as part of an effort to provide clients with improved access to its team of regulatory and product development experts.

"Building upon our existing consulting network in Washington, D.C., Parexel is formalizing its presence in this important government center to better meet client needs," said Josef H. von Rickenbach, chairman and chief executive officer of Parexel. "With several recent appointments of senior level, Washington, D.C.-based experts who have extensive FDA backgrounds, including Dr. George Mills, formerly a division director at the Agency, we believe Parexel is prepared to meet increasing demand for regulatory expertise from international clients seeking product approval in the U.S."

"Clients are looking to Parexel Consulting to optimize their product development plans, help them identify the best path to approval, and prepare for and attend milestone meetings with U.S. regulatory authorities. The Washington, D.C.-area office will allow us to promote even more productive interactions between our clients and the FDA, other government agencies, and scientific organizations," said Kurt Brykman, president of Parexel Consulting and Medical Communications. "Additionally, this location positions us closer to key clients in the Eastern U.S. bio/pharmaceutical corridor, who increasingly need specialized consulting support."

Genzyme Corp. and Bayer HealthCare have submitted a sBLA to the FDA to expand the current product label for Campath to include first-line treatment of B-cell chronic lymphocytic leukemia (B-CLL). Campath is currently approved for the treatment of B-CLL patients who have been previously treated with an alkylating agent and have failed fludarabine therapy. Genzyme also plans to make a similar filing in Europe to support this label expansion.

The product is marketed outside the U.S. as MabCampath, by Bayer Schering Pharma AG, Germany and in the U.S. by Bayer HealthCare Pharmaceuticals, as Campath. The Phase III study was an international, randomized, controlled trial to satisfy a post-approval commitment to the FDA to show clinical benefit of Campath in B-CLL, and to complete the conversion to regular approval. Genzyme's confirmatory study was completed in accordance with FDA timelines.

AAIPharma, Inc. completed more than $2 million in upgrades to its parenteral manufacturing facility in Charleston, SC and its sterile product release operation in Wilmington, NC. The improvements were made to increase capacity and to help ensure compliance with EU aseptic processing and testing guidelines for products exported to the EU.

Lee Karras, AAIPharma's senior vice president of North American pharmaceutical operations, remarked, "By making this investment, we have made a commitment to existing and future customers that parenteral manufacturing is important to AAIPharma. Although the facility is already fully FDA compliant, this upgrade positions the Charleston facility to meet the expectations of the MHRA in the UK. This is of particular importance to customers who wish to conduct clinical trials in the EU as well as export marketed product to the EU. In addition, this complements our formulation and biotech analytical development businesses where we expect to see continued growth."

The Charleston facility upgrades included improvements in plant material and people flow as well as HVAC capacity for greater control of the plant environment. To support sterile product release for material to be supplied in the EU, the company has added two Skan AG ARIS Isolators equipped with integrated vaporized hydrogen peroxide decontamination technology to its microbiology laboratory in Wilmington, NC.

"These facility enhancements are part of AAIPharma's strategic commitment to process improvement and innovation," said Ludo Reynders, Ph.D., AAIPharma president and chief executive officer. "We are continuing to make significant investments in capabilities and technologies aimed toward the evolving needs of our global customer base." The company expects both facilities to be fully validated and granted EU approval for the Charleston facility in the second quarter of 2007.

Diosynth Biotechnology has signed an agreement with Talecris Biotherapeutics for process development and cGMP production of clinical trial material for a specific form of recombinant Plasminogen. Recombinant Plasminogen is an intermediate material used in the manufacture of recombinant Plasmin, a second-generation therapy Talecris is developing for ophthalmic and thrombolytic indications.

"We are pleased to have the opportunity to work with Talecris, a dynamic, global company with an increasing interest in the development of recombinant therapeutics,” said Jacques van Kimmenaede, president of Diosynth Biotechnology.

“We were confident in the selection of Diosynth Biotechnology as our CMO, said Steve Petteway, senior vice president, R&D, Talecris Biotherapeutics. “They have a strong track record in process development and cGMP production of both clinical and commercial products, which demonstrates a level of excellence in manufacturing and quality systems, “Additionally, they have accomplished this across a range of molecule classes that goes beyond a typical CMO offering.”

Also, Talecris has entered a long-term distribution agreement with Crucell N.V. Under the terms of the agreement, Crucell will serve as the exclusive distributor of Talecris' Prolastin in nine western European countries, replacing Bayer.

Dr. Ronald H.P. Brus, Crucell's president and chief executive officer, commented, "We are very proud to work with such a well-established and respected company and take over the distribution from Bayer. Not only does this deal match with our mission to advance in the therapeutic proteins arena but it also strengthens Crucell's global credibility and serves as a major step on our expansion path." Crucell will make use of its newly integrated European marketing and sales organization created through the acquisitions of Berna Biotech and SBL Vaccines in 2006.

Joseph Marchese has been named senior director, business manager, Sterile Injectables for DSM Pharmaceuticals Inc. Prior to joining the company, Mr. Marchese was vice president sales and marketing at West-Ward Pharmaceutical Corp.

Mr. Marchese will be based in Parsippany, NJ, reporting to DSM's chief marketing officer, Terry Novak. Terry Smith, the current business manager, has been appointed vice president business management for the Sterile CTM and Cytotoxic business. Mr. Smith will also report to Mr. Novak and will be based in Greenville, NC.

GlaxoSmithKline and Tata Consultancy Services have entered an agreement to establish a global drug development support center in Mumbai, India to help GSK meet the demands of its growing pipeline.

Under the multi-year, multi-million dollar contract, TCS will provide clinical research services, including clinical data management and clinical submissions support. The partnership will help GSK expand capacity, leverage India's high-quality talent pool, and streamline cost and process improvements, according to a TCS statement.

The center will house a TCS professional team of skilled pharmacologists, Ph.D.s in life sciences, post-graduates in Pharmacy, and with a life sciences background experienced in clinical data management and programming. TCS will contribute its domain expertise, talent management skills, flexible operating models, transition capabilities and performance driven processes.

"This strategic partnership with TCS represents a significant step towards GSK's vision of leveraging key talent globally to develop innovative medicines, said Dr. Amber Salzman, senior vice president, development operations, GSK. “GSK has chosen to partner with TCS because of its strong record in knowledge process outsourcing, underpinned by operational excellence. I am confident our collaboration will benefit both partners and, most important, help to deliver new medicines to patients.”

Commenting on the partnership, J. Rajagopal, TCS' executive vice president and global head, life sciences and healthcare, TCS said, "The engagement with GSK is an endorsement of TCS's strategy to focus on services supporting the drug development processes and the investments made in building our domain competencies in this area. The opportunity to work with GSK will further enhance our capabilities across therapeutic areas and help us build a long term relationship with an acknowledged industry leader."

In response to an FDA request, Novartis has suspended U.S. marketing and sales of Zelnorm, a treatment for irritable bowel syndrome (IBS) with constipation and chronic constipation. This action is the result of a retrospective analysis of data from more than 18,000 patients in the clinical trial database, as well as an ongoing review involving a number of health authorities including the FDA. A public discussion and an advisory committee meeting is expected to take place to determine the risks and benefits of this medicine.

The recent analysis revealed a statistically significant imbalance in the incidence of cardiovascular ischemic events in patients taking Zelnorm compared to those taking placebo. These events included myocardial infarction, stroke, and unstable angina pectoris. The data showed that events occurred in 13 out of 11,614 patients treated with Zelnorm (0.11%), compared to one case in 7,031 placebo-treated patients (0.01%). All patients affected had pre-existing cardiovascular disease and/or CV risk factors.

"My review of the data suggested that a causal relationship is unlikely between tegaserod [Zelnorm] and the rare cardiovascular ischemic events observed in clinical trials," said Jeffrey L. Anderson, M.D., Professor of Internal Medicine at the University of Utah and Associate Chief, Cardiology Division, LDS Hospital in Salt Lake City, UT—an independent cardiologist. "Furthermore, the data did not show any consistent pattern of event type, time to event or dose relationship in tegaserod-treated patients."

Novartis is in discussions with the FDA and other health authorities in other countries where Zelnorm is available to determine next steps.

Zelnorm received FDA approval for the short-term treatment of women with IBS with constipation on July 24, 2002. Zelnorm also received FDA approval for the treatment of men and women less than 65 years of age with chronic idiopathic constipation on August 20, 2004.

MedImmune, Inc. has promoted three senior leaders within its R&D and medical organizations. The new executive appointments include Iksung Cho, vice president, biostatistics; Anthony J. Coyle, Ph.D., vice president, R&D, and head, inflammation and autoimmunity research; and Barbara White, M.D., vice president, clinical development, inflammatory disease.

Mr. Cho will manage a team of almost 20 statisticians who conduct activities such as clinical trial design and analysis for the company's research, development, clinical, regulatory and manufacturing organizations. He previously served as the primary statistician for Aviron's influenza vaccine program. MedImmune acquired Aviron in 2002. Prior to that, Mr. Cho worked at Merck Research Labs within the vaccines development group.

Dr. Coyle will oversee MedImmune's preclinical research in disease areas such as asthma, lupus, rheumatoid arthritis and sepsis. Prior to joining the company as a senior director in 2005, he served as director, inflammation biology, at Millennium Pharmaceuticals in Cambridge, MA. He also worked as a research scientist in the immunology department at the Glaxo Institute for Molecular Biology in Geneva, Switzerland. He has more than six years of experience as a post-doctoral research assistant in immunology and pharmacology at Institut Pasteur in Paris and the National Jewish Center of Immunology in Denver.

Dr. White joined the company in January 2006 as senior director, and was appointed head of the inflammatory disease group in clinical development in November 2006. Prior to joining the company, she was a director of medical affairs, inflammation therapeutic area, at Amgen where her activities included leading non-registration internal and external clinical research programs. Prior to 2003, Dr. White served as professor of medicine in the division of rheumatology, department of medicine, at the University of Maryland School of Medicine. She was formerly associate chief of staff of the research service at the Baltimore Veteran Administration (VA) Medical Center, where her research focused on immune-mediated mechanisms of lung fibrosis in scleroderma. Dr. White also served as co-director of the Johns Hopkins University and University of Maryland Scleroderma Center. She has been active in the American College of Rheumatology and has served as an ad hoc member of the FDA Arthritis Advisory Committee.

News from our sister sites