The FDA has accepted for review an NDA from Progenics Pharmaceuticals and Wyeth for subcutaneous methylnaltrexone for the treatment of opioid-induced constipation (OIC) in patients receiving palliative care. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of January 30, 2008, to complete its review of the NDA. The companies also announced that the European Medicines Agency (EMEA) has validated for review Wyeth's Marketing Authorization Application (MAA) for the treatment.

Methylnaltrexone, an investigational drug, is a peripherally acting opioid-receptor antagonist that is designed to treat OIC without interfering with pain relief. There currently is no approved medication that specifically targets the underlying cause of OIC to relieve constipation in this patient population. The acceptance of the NDA submission results in a $5 million milestone payment to Progenics by Wyeth. Progenics previously earned a $4 million milestone payment from Wyeth based on the validation for review in the EU, as announced previously.

In December 2005, Wyeth and Progenics entered into an exclusive, worldwide agreement for the joint development and commercialization of methylnaltrexone for the treatment of opioid-induced side effects, including constipation and post-operative ileus (POI), a prolonged dysfunction of the gastrointestinal (GI) tract following surgery. Under the terms of the agreement, the companies are collaborating on worldwide development. Wyeth received worldwide rights to commercialize methylnaltrexone, and Progenics retained an option to co-promote the product in the U.S. Wyeth will pay Progenics royalties on worldwide sales and co-promotion fees within the U.S.

MDS Pharma Services has named Dr. Todd Johnson to the position of senior vice-president for Strategy and Corporate Development. He will lead efforts to accelerate profitable growth through strategic partnerships and acquisitions. Before joining MDS, Dr. Johnson spent five years at McKinsey & Co., where he led strategic consulting engagements at several major pharmaceutical and biotech firms. Prior to that, he was chief executive officer of Tangerine Technologies, a biotech software firm he founded in 1997. He started his career as a cancer biologist, conducting biomedical research at Harvard University's Dana-Farber Cancer Institute in Boston, the University of Pennsylvania in Philadelphia, and the National Institutes of Health in Bethesda.

"I am excited that Dr. Johnson has joined the MDS Pharma Services team to help drive our growth efforts," said David Spaight, president of MDS Pharma Services. "His expertise in medical research and consulting will help us to leverage industry trends to develop new services for our clients."

Wyeth has received FDA approval to market Torisel for patients with advanced renal cell carcinoma (RCC). Torisel is the first targeted renal cancer therapy proven to extend median overall survival versus interferon- alpha, an active comparator, in this patient population, according to Wyeth.

Torisel is the only marketed cancer therapy that specifically inhibits the mTOR (mammalian target of rapamycin) kinase, a key protein in cells that regulates cell proliferation, cell growth and cell survival. Wyeth anticipates that Torisel will be available to patients in July 2007.

In a three-arm, Phase III trial of 626 patients with advanced RCC and poor prognosis who had received no prior systemic therapy, Torisel increased median overall survival by 49% compared to interferon-alpha. It was also associated with a statistically significant improvement over interferon-alpha in the secondary endpoint of progression-free survival. As part of a postmarketing commitment, Wyeth has agreed to submit two completed study reports and data sets: one on a thorough QT prolongation study and one on an ongoing hepatic impairment study.

"The approval of Torisel for the treatment of advanced RCC reinforces the potential of mTOR inhibition as a new approach in oncology. This milestone demonstrates Wyeth's commitment to developing innovative therapies for cancer. In addition to Torisel, we have five oncology treatments currently in human trials for various cancers, and we are dedicated to research into new therapies that have the potential to address unmet medical needs," says Robert R. Ruffolo, Ph.D., president, Wyeth Research.

Novacea, Inc. and Schering-Plough have entered into an exclusive worldwide license agreement for the development and commercialization of Asentar, a novel, proprietary, high-dose oral formulation of calcitriol, a potent hormone that exerts its effects through the vitamin D receptor (VDR). Novacea is currently conducting a large international Phase IIII trial (ASCENT-2) evaluating Asentar in 900 patients with androgen-independent prostate cancer (AIPC).

Novacea will receive an upfront payment of $60 million, including $35 million as reimbursement for past R&D expenses, a license fee of $25 million, and a commitment by SP to purchase $12 million of Novacea common stock at a predetermined price within 10 days of the closing. Additionally, the agreement provides Novacea with potential pre-commercial milestone payments of as much as $380 million, along with tiered royalties on worldwide sales of Asentar. Closing of the transaction is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act (HSR) and is anticipated to occur following HSR clearance.

SP will be responsible for all forward development costs in exploring indications for earlier stages of prostate cancer, such as androgen-dependent prostate cancer (ADPC) and adjuvant therapy and will lead all global commercialization efforts for Asentar. Novacea will provide medical support to SP's commercial operations for Asentar in the U.S., including deployment of its Medical Science Liaisons, which will be funded by SP.

"A corporate partnership has been a significant corporate goal for 2007, and we are proud to be co-developing Asentar with a highly-respected pharmaceutical company such as Schering-Plough. The partnership leverages Novacea's existing capabilities with Schering-Plough's experienced development, regulatory and commercial teams and will provide Novacea with an opportunity to support the commercialization of Asentar in the U.S. Additionally, this agreement provides us with substantial funding for the continued development of our operations," said John P. Walker, Novacea's chairman and interim chief executive officer.

"This agreement with Novacea allows us the potential opportunity to extend our oncology pipeline into a tumor with significant unmet need," said Thomas P. Koestler, Ph.D. executive vice president and president of Schering-Plough Research Institute. "Asentar represents an innovative R&D and reinforces our continual commitment to patients."

Valeant Pharmaceuticals International has appointed Parexel International to develop, coordinate and prepare the New Drug Application (NDA) and the European Marketing Authorization Application (MAA) for Valeant's investigational compound retigabine. Retigabine is a novel neuronal potassium-channel opener that is being studied in Phase III trials as an adjunctive treatment for partial-onset seizures in patients with epilepsy. Valeant anticipates filing both applications in mid-2008.

"Parexel's regulatory expertise is anticipated to play a critical role in our development of retigabine," said Wesley P. Wheeler, Valeant's president North America and R&D. "Valeant is committed to developing innovative drugs for neurological disorders, with a special focus on epilepsy. Parexel's global presence and long experience with NDA and MAA filings will be invaluable in the regulatory filing process for retigabine."

"We are pleased to have this opportunity to assist Valeant with the development and submission of the NDA and MAA for retigabine," said Alberto Grignolo, Ph.D., Corporate Vice President and General Manager of PAREXEL Consulting. "We are looking forward to working with them on this important project."

In April, Valeant published positive Phase II data for retigabine. Two international pivotal Phase III trials (RESTORE1 and RESTORE2) are currently underway to further investigate the efficacy and safety of retigabine as an adjunctive treatment for partial-onset seizures in patients with refractory epilepsy.

Human Genome Sciences and GlaxoSmithKline have begun dosing for BLISS-52, the second of two Phase III trials of LymphoStat-B in patients with active systemic lupus erythematosus (SLE). Dosing in BLISS-76, the first Phase III trial of the drug, began in February 2007. LymphoStat-B is being developed by the companies under a definitive development and commercialization agreement initiated in August 2006.

"We believe that LymphoStat-B could address the significant medical need of patients suffering from SLE, and we are pleased to announce that both Phase III trials of this novel and potentially important compound are now underway," said H. Thomas Watkins, president and chief executive officer, HGS. "These trials, assuming that they are successful, will provide the pivotal data to support global marketing applications for LymphoStat-B."

BLISS-52 is being conducted primarily in Asia, South America and Eastern Europe, while BLISS-76 is being conducted primarily in North America and Europe.

"There is a great need for safer and more effective treatments for lupus," said Professor Sandra V. Navarra, M.D., a principal investigator and head of Rheumatology at the University of Santo Tomas, Manila, Philippines. "The results of previous studies suggest that LymphoStat-B significantly reduced SLE disease activity in serologically active patients. We look forward to further evaluation of LymphoStat-B in larger numbers of patients in these trials."

Genzyme Corp. has announced that it will buy Bioenvision, Inc. for approximately $345 million in cash. The purchase, which has unanimous support from Bioenvision's board, will enhance Genzyme's oncology business by yielding exclusive, worldwide rights to clofarabine. The two companies co-developed clofarabine in Europe, where Bioenvision currently markets the product for the treatment of acute lymphoblastic leukemia (ALL) in relapsed and refractory pediatric patients. Clofarabine is also being developed for significantly larger indications, including use as a first-line therapy for the treatment of adult acute myeloid leukemia (AML). Clofarabine is branded as Clolar in the U.S. and Canada, where it is marketed by Genzyme for relapsed and refractory pediatric ALL patients. Clofarabine has been granted orphan drug status for ALL and AML in both the U.S. and EU.

"Building an international commercial presence for our oncology business has been a focus for the corporation and we are very pleased to reach agreement with Bioenvision on this transaction," stated Henri A. Termeer, chairman and chief executive officer of Genzyme Corp. "We are deeply committed to furthering the clinical development of clofarabine and making it available on a global basis so that patients around the world with these very difficult forms of cancer will have access to the therapy."

Christopher B. Wood, M.D., chairman and chief executive officer of Bioenvision, said, "We believe this transaction brings significant value to Bioenvision shareholders [a 50% premium over the company's share price]. Genzyme has the global clinical, regulatory and commercial infrastructure to advance clofarabine, as well as very significant experience with the product from its U.S. approval, launch, and continued development and commercialization. We are confident that they will build upon the solid foundation our organization has established in Europe to further expand access to clofarabine for patients with serious unmet medical need."

In addition to clofarabine, Bioenvision also markets Modrenal, approved in the UK for the treatment of post-menopausal breast cancer following relapse from initial hormone therapy, and has a pipeline in development to address unmet needs in autoimmune disease and infectious disease.

Exelixis, Inc. has appointed Arthur DeCillis, M.D. to the position of vice president, clinical research, and Anne Champsaur, M.D. to the position of vice president, drug safety. Both appointees will report to Gisela M. Schwab, M.D., senior vice president and chief medical officer.

"With 14 compounds in clinical development, and more expected as we move forward, effective management of our clinical pipeline is critical for our success," said Dr. Schwab. "Drs. DeCillis and Champsaur each have contributed to the development and commercialization of multiple products that have advanced patient care. We believe their expertise will enhance our ability to bring innovative therapies to market safely and efficiently. Our continued ability to attract and retain such experienced individuals reflects the numerous opportunities at Exelixis to make a positive difference in the lives of patients with cancer and other serious diseases."

Dr. DeCillis joins Exelixis from Novartis, where he was senior and then executive director of Phase II/III Oncology Development. Previously, he held positions of increasing responsibility in Oncology Global Clinical Research at Bristol-Myers Squibb, culminating as group director. Prior to his career in the biopharmaceutical industry, Dr. DeCillis was a member of the National Surgical Adjuvant Breast and Bowel Project and the Alzheimer's Disease Research Center Outreach Program, both at the University of Pittsburgh.

Dr. Champsaur joins Exelixis from CV Therapeutics, Inc., where she was executive director, Drug Safety -- Medical Affairs. Previously, she held senior director positions in the departments of Regulatory Affairs as well as Medical and Safety Services at ALZA Corp. and Worldwide Pharmacovigilance at Sangstat Corp., where she also was deputy head, Clinical Research and Regulatory. She also served as  director of Clinical Development and Pharmacovigilance and director of Medical Affairs and Pharmacovigilance at the IMTIX Transplant Business Unit of Pasteur-Merieux Connaught.

Asuragen, Inc., an oncology molecular diagnostic company and molecular biology service provider, was selected to provide GLP compliant laboratory testing to assist in gene expression studies being conducted by Millennium Pharmaceuticals of Cambridge, MA.

"We are committed to applying our RNA expertise to produce the data quality required in clinical studies with organizations such as Millennium and believe that research like this may enable companion diagnostics and support the value of personalized medicine," commented Scott Hunicke-Smith, vice president and general manager of Asuragen Services.

Draxis Pharma, the contract manufacturing division of Draxis Health Inc., has appointed Bruce DeChambre as vice president commercial and business development. Mr. DeChambre's responsibilities include identifying prospective customers and developing new business opportunities within the "blue chip" pharmaceutical sector while continuing to service to the company's client base. He has more than  25 years of progressive pharmaceutical sales, marketing and business development experience with U.S.-based and international companies, including senior management responsibilities in the contract manufacturing sector.

Prior to joining DRAXIS Pharma, Mr. DeChambre was a pharmaceutical industry consultant to investment firms and healthcare advertising agencies. Previously, he was vice president sales and marketing at SAB-Pharma, the U.S. marketing arm of Sabex Inc., which was recently acquired by Novartis. He also
served as vice president bbusiness development for Cardinal Health's Sterile Technology Group. In addition, Mr. DeChambre has served in senior sales and marketing management positions at Abraxis Pharmaceutical (formerly American Pharmaceutical Partners, Inc.), Fujisawa USA, Inc. and Baxter Healthcare.

Mr. John Durham, president of Draxis Pharma, stated, "We are pleased and excited to have Bruce join our management team. He brings a wealth of business development experience plus a broad network of senior level contacts in the pharmaceutical and biotechnology industries. His expertise in the sterile products area of the contract manufacturing sector is particularly relevant, given our strength and focus in the production of sterile injectables, ointments and creams as well as our expanding capabilities in sterile lyophilization."

Dr. Frank Deane has been promoted to president, manufacturing at Lilly from his current role of vice president, quality. He will succeed Scott Canute, who has led the manufacturing organization since 2001. Mr. Canute, after six years of leading a transformation in the company's manufacturing operations, is taking a leave of absence from the company to "pursue a personal developmental opportunity," according to a Lilly statement.

Mr. Deane joined Lilly in 1979 at the company's manufacturing operations in Kinsale, Ireland, and held a number of manufacturing positions there until transferring to Lilly's Clinton Laboratories in Indiana in 1986. After a role in development projects management in Indianapolis, he moved to Puerto Rico, where he had general management responsibility for drug product and active pharmaceutical ingredient production. He returned to Indianapolis in 1993 as the general manager of Lilly's U.S. pharmaceutical manufacturing operations, and in 1997 assumed responsibilities for the company's worldwide API operations. He was named to his current role as vice president, quality, in 2001.

"Frank brings over 28 years of manufacturing and quality experience to his new role," said Sidney Taurel, chairman and chief executive officer. "He has been instrumental in ensuring global quality standards and systems throughout the company, and we are pleased that we will have his experience and leadership in the coming years as we continue to develop and manufacture important medicines."

Mr. Deane will report to John C. Lechleiter, Ph.D., president and chief operating officer. He will remain a member of the company's operations committee, and will also join the corporate policy and strategy committee. He will assume his new role effective June 1, 2007.

Mr. Canute, current president, manufacturing, will take a leave of absence from the company to pursue additional study in the field of business leadership and development. Mr. Taurel remarked, "Many changes have occurred during Scott's tenure as president of our manufacturing operations, and he has successfully led that important part of our business to the strong position it is in today. Not only did the organization achieve new levels of compliance and control under Scott's leadership, but it also exceeded its operational goals. On behalf of the entire company, I would like to personally thank Scott for his significant leadership during a challenging period for our manufacturing operations. We will miss his leadership and wish him the best as he undertakes this new personal endeavor."

Novartis and Nordic Biosciences have begun a Phase III clinical program of oral salmon calcitonin (SMC021) for the treatment of osteoarthritis, a chronic, irreversible and degenerative condition. SMC021 is a new drug candidate with potential to be the first disease-modifying drug for osteoarthritis.

The salmon calcitonin is formulated in tablet form using a novel eligen delivery technology Emisphere Technologies. The delivery system creates the potential for salmon calcitonin to be available as a convenient oral medication for the first time.

"We are pleased to announce the initiation of Phase III trials for oral calcitonin, which may represent the first disease-modifying drug for the treatment of osteoarthritis," said Michael V. Novinski, president and chief executive officer of Emisphere. "Currently, there are no available treatment options for osteoarthritis that actually help prevent disease progression or joint damage, and we are excited to be at the leading edge of research in this area. An unmet need facing osteoarthritis patients and physicians today is the lack of any proven disease-modifying drug for osteoarthritis. Oral Calcitonin would help prevent structural damage in at-risk joints, or the progression of structural damage in joints already affected. Current treatment options for osteoarthritis provide only symptomatic relief."

The Phase III clinical program is being conducted by Nordic Bioscience both in the European Union and in the U.S., and is planned to include more than 2000 patients. In 2000, Emisphere and Novartis entered into a license agreement for the development of oral salmon calcitonin for the treatment of osteoarthritis and osteoporosis. A Phase III clinical trial of oral calcitonin for the treatment in osteoporosis started also early this year.

Exelixis has submitted an IND application to the FDA for XL019. In preclinical studies, the compound has shown to be a potent, selective and orally available small molecule inhibitor of the cytoplasmic tyrosine kinase JAK2, according to the company. Activating mutations in JAK2 are frequently observed in patients with myeloproliferative disorders such as myelofibrosis, polycythemia vera and essential thrombocythemia. JAK2 activity is also upregulated via multiple mechanisms in many lymphomas and solid tumors.

"This is our fourth IND filing this year, reflecting the integration and productivity of our discovery and development processes," said Gisela M. Schwab, M.D., senior vice president and chief medical officer at Exelixis. "XL019 is a potent inhibitor of the JAK/STAT signaling pathway, which plays a critical role in cell growth and survival in a number of diseases where few clinical options currently exist. We believe that evaluation of XL019 in such indications may allow us to early on in clinical development observe biologic activity and potentially affect clinical outcome."

Nektar Therapeutics has announced plans to restructure, reducing its annual spending by $65 million. As part of this initiative, the company will fire 200 full-time workers, comprising nearly one-quarter of its workforce. In its press announcement, reducing costs and reworking its organizational structure will "allow the company to accelerate the development of its proprietary pipeline, and improve innovation, focus, and accountability across the enterprise." Nektar develops PEGylated and pulmonary technology-based therapeutics.

"During the past several months, we have enacted change at Nektar that prioritizes strong management, timely decision-making, and efficient use of resources," said Howard W. Robin, chief executive officer and president of the company. "These actions greatly strengthen our ability to build a world-class therapeutics company."

Hoyoung Huh M.D., Ph.D. has been promoted to chief operating officer and head of the PEGylation Business Unit. Nevan Elam was promoted earlier to serve as the head of the company's Pulmonary Business Unit. In addition, Michael Simms was named senior vice president of operations, replacing Truc Le, who is leaving the company. Chief financial officer Louis Drapeau is retiring and will leave the company in the coming months.

Overall, the restructuring and layoffs will reduce spending by $65 million. This amount includes reductions of $21 million from general and administrative costs, $23 million from non-cost-of-goods operations, $16 million from R&D, and $5 million from capital spending. Approximately $27 million of this annual spending reduction will be realized in 2007, according to the company.

Nektar reports that it is "making excellent progress" developing its proprietary pipeline. The company plans to complete a Phase IIb trial of NKTR-061 (inhaled amikacin) to treat hospital-acquired gram-negative pneumonia by the end of 2007. Nektar also plans to initiate Phase II trials by the end of the year in its two leading PEGylated small molecule programs, NKTR-102 (PEGylated-irinotecan) for solid tumors and NKTR-118 (PEGylated-naloxol) for opioid-induced constipation.

Draxis Pharma, the CMO division of Draxis Health Inc., recently received word from the FDA that its Montreal facilities passed inspection. FDA conducted inspections of all six production and quality systems at Draxis Pharma in January 2007. The inspection was conducted primarily with regard to two products manufactured on behalf of clients in the Draxis Pharma sterile lyophilization  production site.

According to Draxis, there were no Form 483 Inspectional Observations issued during the evaluation. The FDA inspections also involved evaluations in Draxis' radiopharmaceutical business unit, DRAXIMAGE. The inspections were part its clients' FDA regulatory applications to authorize Draxis to manufacture products for distribution in the U.S.

"The achievement of this positive inspection of our facilities and systems is a tangible result of our strong commitment to providing the highest level of quality and regulatory compliance for our clients and their products," said Dr. Martin Barkin, president and chief executive officer of Draxis Health, Inc. "By continually meeting the increasingly stringent standards established by the FDA and other international regulators, we have been able to grow our contract manufacturing business by more than 300% over the past five years."

Draxis Pharma expanded the lyo capacity in its Montreal facility in late 2005 with the addition of a second, in-line integrated lyo unit. Today, the company has a total of 374 square feet of lyo shelf space capacity.

Albany Molecular Research, Inc. (AMRI) has signed anagreement to acquire two pharmaceutical manufacturing sites, along with additional land for future expansion, in Aurangabad and Navi Mumbai, India. AMRI will acquire the assets -- including facilities, employees, products and equipment-- of Ariane Orgachem Pvt. Ltd. in Aurangabad and Ferico Laboratories Ltd. in Navi Mumbai for approximately $11 million in cash. In fiscal 2006, the assets generated around $5 million in revenue.

All of the facilities are currently owned by the Runwal Group and manufacture a range of pharmaceutical intermediates and bulk active ingredients, including treatments for diabetes, heart disease and asthma. As part of the purchase, AMRI will obtain additional land in Aurangabad and plans to invest approximately $15 million to expand capabilities there during the next three years. The proposed expansion includes increasing capacity, as well as bringing these facilities into compliance with FDA regulations for manufacturing clinical trial materials and commercial drug substances.

AMRI chairman, president and chief executive officer Thomas E. D'Ambra, Ph.D., remarked, "Initially, the purchase of these sites augments and provides a reliable and cost-effective supply chain for AMRI's U.S.-based manufacturing operations. It offers us the flexibility to produce raw materials and process intermediates to support our Rensselaer, NY plant. Longer-term, as we increase capabilities in India, we expect to leverage AMRI's small-scale / development resources on two continents, including our laboratory operations in Hyderabad, India."

He added, "This announcement culminates a multi-year search. Just as we have expanded our lab scale operations to include global facilities operating in a range of lower cost structure environments, we have continued to believe that globalization of our manufacturing operations was also critical to the survival and growth of this component. During our search for this facility, we evaluated a range of options, from large volume, existing large revenue-based operations, to several greenfield sites. While the purchase announced today is small in comparison to some of the options we evaluated, it gives us an immediate presence and base we can capitalize and build on; something that a greenfield location would have taken years to achieve. I am confident that, long term, this expansion of our business will provide our customers with increasing options and solutions, provide our business the opportunity to accelerate our future growth and expand our global market, and provide our shareholders increasing returns as AMRI becomes a larger, more successful competitor on the world stage."

"As we invest in additional capacity and ramp up production, we expect these facilities to add significantly to our Large Scale
Manufacturing contract revenue in future years," noted AMRI chief financial officer Mark T. Frost. "Ultimately, we expect to realize cost savings resulting from re-engineering our supply chain operations. That cost savings will be used to improve competitiveness and productivity in our Large Scale Manufacturing business component."

The size of the facilities, including both the Aurangabad and Navi Mumbai sites, is more than 9,100 square meters, with additional land available for expansion. To ensure a smooth transition, AMRI has established an integration team and plans to continue the employment of the approximately 200 people working at the facilities. Harold Meckler, Ph.D., vice president of science, technology and support services at AMRI, will lead the integration effort during the transition process.

The transaction is expected to close during the second or third quarter of 2007.

Quintiles Transnational Corp. and Thermo Fisher Scientific has established Cenduit, a joint venture to provide Interactive Response Technology (IRT) services for pharmaceutical and biotechnology product development. IRT is a technology platform that integrates patient interaction systems through a combination of Interactive Voice Response (IVR) systems, Web interfaces and handheld electronic patient diaries. The use of IRT is expected to grow as pharmaceutical companies look to streamline and better control increasingly complex drug development processes, according to a joint statement by the companies.

Thermo Fisher will contribute to the JV with its Fisher Clinical Services IRT operations in three locations -- Horsham, U.K., Allentown, PA, and Basel, Switzerland. Quintiles will provide its IRT operations in Bangalore, India, and Research Triangle Park, NC. The RTP site will also serve as the venture's headquarters.

"Cenduit brings together best-in-class technology, exceptional customer service and global clinical trial expertise to give biotechnology and pharmaceutical companies a seamless, integrated 'one-stop' service for support of their clinical development programs," said Jogin Desai, chief executive officer of Cenduit. "Our efficiency and experience in IRT services and clinical project management offers the drug development industry a conduit to the broadest, most accurate, real-time view of every detail in the process -- and a very competitive solution." Dr. Desai previously served as executive director of Quintiles Cardiac Safety Services. A medical doctor, he has experience in clinical research in the U.S. He joined Quintiles India in 2002 and helped build and expand the global ECG business, which has staff in India, the UK, the U.S. and Japan.

Dr. Desai added, "IVR is used in an estimated 30% of all Phase II-III clinical trials, and this rate is expanding rapidly. With advances in technology leading to even broader application through IRT, we believe the market will grow at a rate of about 20% per year, and we plan to offer a service that can aggressively capitalize on this opportunity."

Cenduit will be guided by a joint venture board of directors, composed of representatives from each of the founder companies. The board will provide guidance on operational and strategic matters. "Our companies have been looking for an opportunity to leverage the particular service strengths we bring to the drug development process," said Marijn E. Dekkers, president and chief executive officer, Thermo Fisher Scientific.

"These are two businesses that know the complexity of clinical trials and the optimal cohesiveness and integration of their many work and data streams," said Oppel Greeff, Quintiles' Vice Chairman, Operations. "The joint venture that we have created through Cenduit offers the drug development industry the broadest, most accurate view of every detail in the process."

Several Contract Research Organizations have formed a CRO Service Alliance (CROSA) in Shanghai's Zhangjiang HiTech Park. According to a press report, this is a first for China and is intended to take advantage of "specialized expertise from the three CRO companies to provide efficient and high quality CRO services in all related fields for drug discovery and development of clients worldwide."

The CROs that have formed the alliance are Sundia MediTech Co. Ltd., United PharmaTech Ltd. and HD Biosciences. The alliance will act as a single entity in the CRO market, and will explore ways to cooperate even closer in the future. "Allying with United PharmaTech and HD BioSciences is the best way to quickly and successfully expand our business into the complete range of CRO services to fit the increased demands from our clients world wide while maintaining high quality and efficiency and minimizing cost," said Sundia's chief executive officer Dr. Xiaochuan Wang. "It will change the landscape of China's pharmaceutical CRO industry.

The companies will provide services in new pharmaceuticals synthesis, lead optimization, molecular bio-assay development and tests, in vitro and in vivo PK/ADME research, and cGMP-required intermediates and API for clinical trials, according to HD Biosciences' chief executive officer and president Dr. Xuehai Tan.

"The current CRO industry in China is unique. Pharmaceutical companies in developed countries desperately need new drugs, but cannot afford the prohibitive cost of research in their home countries," said United PharmaTech's chief executive officer Dr. Xiongwei Shi. "Their best option is to outsource R&D work."

Sundia MediTech, United PharmaTech and HD BioSciences were all founded between 2002-04 in Shanghai by veterans of U.S. pharmaceutical companies to provide drug discovery and development CRO services in different stages and fields.

Morphotek, Inc., a U.S. subsidiary of Eisai has entered into agreement with CMC Biopharmaceuticals of Copenhagen, Denmark for development, GMP manufacturing and regulatory documentation support of MORAb-028, a therapeutic antibody targeting advanced melanoma and other cancers. MORAb-028 is a human IgM monoclonal antibody that specifically recognizes a cell surface antigen over-expressed on a significant fraction of metastatic melanoma, brain cancers and non-small cell lung carcinoma.

"We are extremely pleased to have selected CMC as our contract manufacturer for this IgM monoclonal antibody," said Philip Sass, Ph.D., executive vice president and chief operating officer of Morphotek. "CMC has production and scaleup experience with IgM monoclonal antibodies and a team of dedicated scientists that have tackled difficult purification and analytical development programs. We are confident that CMC will meet both our production and quality goals as well as timelines for product supply to support our planned clinical trials."

According to Morphotek, its antibody development technologies and expertise have enabled it to successfully develop this unique IgM antibody and establish a process for large-scale production. Historically, IgM MAbs have been underrepresented in human therapeutic development due to production difficulties and other manufacturing constraints. MORAb-028 is being prepared to enter clinical evaluation in 2008.

Eden Biodesign Ltd. has been licensed by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to manufacture Investigational Medicinal Products (IMPs) at its new facility in Liverpool, UK. The UK National Biomanufacturing Centre came on-line for process and analytical development in May 2006. The MHRA inspection took place earlier this year to certify Eden’s processes and facilities as having reached cGMP standards. The new license will provide legal authority for Eden to manufacture biopharmaceutical drug substances under contract for clients for use in EU clinical trial sites.

Dr. Crawford Brown, Eden Biodesign's chief executive officer, commented, "Eden is now fully on track and able to deliver a full range of services for the production of mammalian, microbial and virus-based experimental medicines for a worldwide client base."

Following the successful inspection, the company will provide Cambridge, UK-based ImmBio with a range of development and manufacturing services to rapidly advance its influenza vaccine towards a Clinical Trial Application. Eden has also started to supply cGMP clinical manufacturing services to Onyvax, a private UK Biotech, for its ovarian cancer vaccine, and extended a project with Silence Therapeutics plc (formerly SR Pharma) to deliver a whole cell microbial immunotherapeutic for the treatment of asthma and as a therapeutic in cancer and tuberculosis.

Pfizer Global R&D president Dr. John LaMattina will retire from Pfizer by the end of this year, after 30 years with the company. Pfizer has begun a search both inside and outside the company for his successor, and Dr. LaMattina will remain during this period to ensure a smooth transition, according to the company. Chief financial officer Alan Levin has resigned to "pursue career opportunities outside Pfizer" after 20 years with the company.

Speaking on Dr. LaMattina's retirement, Jeff Kindler, Pfizer's chairman and chief executive officer, remarked, "Pfizer now has a significant array of early- and mid-stage product candidates across a range of important therapeutic areas, and John has made a critical contribution to building this foundation. With that in place, John felt it was the right time to retire as we look to the future and accelerate the development of our most promising compounds so that they will be ready for commercialization as rapidly as possible."

Mr. Kindler added, "During John's tenure we have grown our pipeline in oncology while substantially increasing our investment in biologics and vaccines, where we see attractive opportunities to combine our science with new technologies. Our progress in oncology, which was a relatively small program just 10 years ago, is especially noteworthy, and we are now in an excellent position to deliver important new cancer medicines."

Departing CFO Alan Levin commented, "I have been fortunate to work with many outstanding colleagues at this great company. Pfizer has grown in ways that none of us could have imagined, but always with a keen focus on serving patients and doing everything we can to address unmet medical needs. My colleagues in Finance, both in the U.S. and around the world, do an extraordinary job of managing the array of financial issues and challenges that come with a global corporation of Pfizer's size and complexity. I am proud of their dedication and of our many accomplishments. With a strong finance organization in place, and after 20 years of service with Pfizer, I feel that now is the appropriate time for me to explore career opportunities outside of the company. I have the deepest admiration for Pfizer and look forward to its success in the future."

William J. Sharbaugh has been named chief operating officer, PPD, effective May 31. Mr. Sharbaugh joins the company from Bristol-Myers Squibb, where he most recently served as vice president, global development operations, responsible for strategic direction for clinical operations in 55 countries. In this position he provided operational leadership for global clinical operations, data management, patient recruitment and retention, contracting and outsourcing management, clinical supply operations, training and quality management. Prior to BMS, he spent 10 years at Merck & Co. in a variety of assignments in clinical supply operations, sales and manufacturing.
   
"Bill Sharbaugh brings extensive leadership experience and skills as well as a vision that complements and aligns well with the strategic direction we have charted for PPD," said Fred Eshelman, chief executive officer of PPD. "We are pleased to welcome him to our organization and look forward to his leadership and contributions to our growing business."

AstraZeneca received approval from the FDA for Seroquel XR Extended-Release Tablets, a once-daily medicine for the treatment of schizophrenia in adult patients. The Seroquel XR development program was based on the need for a wider choice of medicines that offer convenient once-daily dosing.

Schizophrenia is a serious brain disorder with symptoms including distorted perceptions of reality, hallucinations and delusions, illogical thinking, and flat or blunted emotions, and affects more than two million American adults.

The FDA approval was based on clinical data showing effectiveness of the extended-release tablets at doses of 400, 600, and 800 mg/day. The trial was a placebo-controlled study of patients experiencing an acute exacerbation of symptoms of schizophrenia with efficacy assessed using the Positive and Negative Syndrome Scale (PANSS) ratings scale. After six weeks of treatment, patients recorded a significant improvement in PANSS total scores from baseline for Seroquel XR doses of 400, 600, and 800 mg/day, compared with placebo-treated patients. Seroquel XR was generally well tolerated. The most commonly observed adverse reactions associated with the use of Seroquel XR were dry mouth, somnolence, dizziness, and dyspepsia.

Patricia A. Steigerwald, MS, RN has been promoted to vice president, Global Late Phase, Kendle. In this role she will provide executive leadership to drive continued growth of the company's Late Phase brand globally, with a focus on the design and conduct of Phase IIIb/IV trials, health economics and outcomes research and product/disease registries.

Ms. Steigerwald was most recently senior director, Late Phase and has more than 20 years of CRO and clinical experience. Prior to joining the company she spent seven years with a leading CRO in a variety of positions in the late stage trials division, serving most recently as executive director, where she was responsible for the strategic direction and the development of goals, systems and procedures to ensure timely delivery of Phase IIIB/IV trials. Her experience also includes providing strategic guidance and oversight in the conduct of one of the world's largest global cardiovascular medical outcomes trials ever conducted.

"Phase IIIb/IV continues to be an area of significant customer need, with the global outsourcing market estimated to reach $4.7 to $4.8 billion by 2010," said Kendle chairman and chief executive officer, Dr. Candace Kendle, Pharm.D. "Pat's expertise in the strategic and operational design and execution of large clinical endpoint trials will further position Kendle to capitalize on this exciting and growing marketing opportunity in the global late phase market."

AAIPharma, Inc. completed the acquisition of Instituto de Pesquisa Clinica de Sao Paulo, Ltd. (IPCSP), a CRO in Brazil. The acquisition of IPCSP adds to the company's existing operations in South America, in Argentina and Peru.

"Expanding AAIPharma's presence in Brazil is important for our customers who want access to the substantial South American patient populations," said Ludo Reynders, Ph.D., AAIPharma's president and chief executive officer. "Brazil is a highly populous gateway to South America which is a key region for the continued growth of clinical development worldwide. With the highly trained clinical research professionals from IPCSP and their network of physicians, AAIPharma can offer pharmaceutical and biotech customers broader reach for their large multinational trials."

IPCSP has experience managing Phase I-IV trials across a wide range of therapeutic areas. The company's service offerings include medical and clinical monitoring, project management, regulatory affairs, pharmacovigilance, clinical supplies, drug importation, drug storage, drug distribution, and sample exportation.

"AAIPharma's global presence and experience will create significant value for our customers," said Andrea Saud Martinez, Pharm.D., M.Sc., IPCSP founder and chief executive officer, who will become general manager of AAIPharma's South American Operations. "We look forward to enhancing our breadth and depth of services, and remain focused on continued growth throughout South America."

The terms of the transaction were not disclosed.

Millennium Pharmaceuticals has initiated patient dosing in a clinical program designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of MLN0002 derived from a newly engineered, commercially scaleable cell line. MLN0002 is a novel monoclonal antibody that binds to the T-cell integrin alpha 4 beta 7 with potential in a variety of gastrointestinal diseases, including ulcerative colitis.

The new program includes two studies: a Phase II dose-ranging trial in ulcerative colitis patients and Phase I study in normal healthy volunteers. These studies were initiated following positive results from a Phase II trial involving 181 ulcerative colitis patients that showed MLN0002 was well tolerated and achieved a statistically significant improvement in clinical remission.

"MLN0002 is differentiated by its unique mechanism of action that selectively inhibits trafficking of inflammatory cells to the gastrointestinal tract. This innovative approach has the potential to increase the level of efficacy and reduce the risk of unwanted side effects seen with currently available therapies," said Nancy Simonian, M.D., chief medical officer, Millennium. "The return of MLN0002 to clinical trials is exciting for Millennium and ulcerative colitis patients. MLN0002 is one of only a few novel product candidates being investigated as alternatives to anti-TNF and other immunosuppressive therapies for ulcerative colitis and potentially other inflammatory bowel diseases."

Braham Shroot, Ph.D. has been appointed chief scientific officer of Barrier Therapeutics. In this role, he will manage the company's R&D activities, reporting to Geert Cauwenbergh, Ph.D., chief executive officer.

"Dr. Shroot's extensive scientific background, as well as his established record in dermatological product development, makes him an ideal leader for Barrier's research and development organization, where we have a broad pipeline of product candidates for the treatment of dermatological conditions, including onychomycosis, psoriasis, acne, skin allergies, and acute fungal infections," said Dr. Cauwenbergh. "Braham is an internationally recognized leader in dermatology by the industry as well as by academia, and we welcome him to Barrier."

Dr. Shroot joins the company with more than 35 years of experience in dermatology drug development. Most recently, he served as chief scientific officer, vice president of R&D for DFB Pharmaceuticals, a specialty pharmaceutical company with branded products that treat skin and soft tissue disorders. Prior to DFB, Dr. Shroot spent 13 years in various R&D positions with Galderma S.A., including serving as president, Galderma Research, Inc. in the U.S. and as vice general manager of Galderma's R&D organization in France. Dr. Shroot began his career in pharmaceuticals at Pfizer, where he was part of the team that developed fluconazole and thioconazole.

Chuck Nomides, Barrier's chief R&D officer, will continue to oversee development activities under Dr. Shroot.

Azopharma has established relationships with iQ Synthesis and Cyanta Drug Development, expanding its Product Development Group.

Phil Meeks, chief executive officer of the Azopharma Product Development Group of companies, said, “These two additions, combined with our four current companies, will round out our service offering portfolio and enhance our position as a major resource in the global contract product development arena. We are now poised to capitalize on the emerging trends transforming the pharmaceutical industry. Our entire network now consists of a family of six companies with capabilities ranging from preclinical to manufacturing. Working either individually or in conjunction, these companies offer tailored choices to the pharmaceutical and medical device industries of North America, Europe, and Asia.”

This group of companies includes: Azopharma Contract Services, offering product development and CTM manufacturing; IQ Synthesis, offering synthetic chemistry services from discovery to clinical materials; ApiCross Drug Delivery for insoluble compounds; Aniclin Preclinical Services in support of early product development, Cyanta Drug Development, offering analytical chemistry services from development to QC testing, and AvivoClin Clinical Services, offering human clinical pharmacology services for Phase I trials.

Pall Corp. opened its new Life Sciences Centre of Excellence in Bangalore, India that will provide a full range of fluid management solutions. According to the company, the Centre will drive process optimization innovations for the global life sciences market to meet the evolving opportunities and challenges throughout Asia. The new Centre includes a state-of-the-art proteomics lab and houses a validation lab and a training facility with experts to support Indian and regional customers.

"Pall's growth in the Asian life sciences market is a reflection of our focus on this important region and our continuing commitment to undertake several customer-centric initiatives there," said Roberto Perez, president, Pall Life Sciences Worldwide. "The new Centre of Excellence will be instrumental in helping the life sciences industry in India and throughout the region apply the latest technologies and services to their operations, so they have the optimal tools and expertise to bring new and innovative drugs to market more efficiently."

"The success of our customers depends on their ability to carry out all stages of drug development—research, discovery and full-scale production—efficiently and cost-effectively," said Vinay Joban, general manager, Pall BioPharmaceuticals India. "The new Centre provides the region with a complete range of services to support their operations from upstream through downstream while also facilitating their ability to comply with increasingly rigorous global requirements."

Dennis Gillings, CBE, chairman and chief executive officer of Quintiles Transnational Corp., dedicated a new facility in Overland Park, KS, with Secretary David Kerr of the Kansas Department of Commerce.

The 236,000-sq.-ft. building will house Quintiles' regional Clinical Development Services (CDS) and clinical pharmacology units previously located in Kansas City, MO, as well as the Phase I clinical research unit that had been in Lenexa, KS. The new Phase I unit has a 150-bed capacity—three times the size of the Lenexa unit—and can accommodate an additional 200 employees.

"The new facility gives the Overland Park office the room it needs to expand its activities in support of regional and global clinical research," said Mr. Gillings. "Ultimately, however, this building is about even more than the creation of jobs in Overland Park and the growth of Quintiles, it's about improving healthcare for people in Kansas, across the U.S. and around the world."

Quintiles employs approximately 750 full-time workers in the Kansas City area in CDS, Clinical Pharmacology and Phase I.

While the number of postmarketing studies for newly approved drugs have increased during the past six years, drug developers feel that the results offer little to their understanding of safety, efficacy, or quality, according to a recently completed assessment by the Tufts Center for the Study of Drug Development. The Tufts CSDD survey found that 68% of clinical study sponsors and 79% of nonclinical study sponsors said results contributed either marginally or not at all to their understanding of the safety, efficacy, or quality of their product. However, 32% said clinical studies significantly or very significantly increased their understanding of their products.

"A lot of progress has been made in the area of postapproval studies since 2001, when the FDA regulation requiring sponsors to provide annual reports on the status of postmarketing studies went into effect," said Tufts CSDD associate director Christopher Paul Milne. "But a major challenge drug sponsors face is completing the studies on time."

The study found that more than half of all postmarketing studies submitted were finished by their projected completion date, but 45% were delayed due to enrollment problems, technical difficulties, additional FDA requirements, or sponsors expanding the scope of their studies.

The Prescription Drug User Fee Act (PDUFA), which authorizes the FDA to request postmarketing study reports, is due for renewal in Congress later this year.

The analysis also found that: clinical studies took approximately 10 months longer to complete and cost nine times as much as nonclinical studies; postmarketing studies are typically the responsibility of applicable R&D departments and not marketing departments, as some PDUFA critics claim; and between 1998 and 2005 sponsors spent approximately $5.3 million per postmarketing study, compared to $610,000 per nonclinical study.

Dr. John Yates has been appointed to the newly created position of chief medical officer at Array BioPharma, Inc. Dr. Yates will oversee the medical strategy and clinical development of the company's cancer and inflammation pipeline.

"John will bring strong leadership to Array's growing clinical drug pipeline," said Robert E. Conway, chief executive officer. "We believe John's expertise in advancing blockbuster drugs through the clinic will be a competitive advantage for Array as we project to have as many as ten programs in human clinical development by the end of 2007."

Dr. Yates has 17 years of pharmaceutical business experience at Merck & Co. and Takeda Pharmaceuticals. He also has ten years of research experience at academic medical institutions around the world. Most recently, he was president of Takeda's global R&D center where he was responsible for pharmaceutical development from first in man through commercialization. From 2004 to 2007, Dr. Yates was involved in the development of more than 25 compounds. During his tenure at Takeda, he supported four successful NDAs.

Dr. Yates spent 13 years at Merck where he held positions of increasing responsibility. He served as vice president of U.S. medical and scientific affairs in 2000 where he was responsible for all U.S. Phase IV studies, supporting 15 marketed or soon-to-be-marketed products as well as conducting outcome research and health economic studies. Dr. Yates was also responsible for all other aspects of medical and scientific support for the U.S., including medical services, academic affairs and the regional medical director program. From 1990 through 2000, Dr. Yates led the clinical development of Fosamax.

Sartorius signed a new supply agreement with Thermo Fisher Scientific, Inc. for the non-exclusive reciprocal supply of products for biopharmaceutical process applications between the two companies. Under the agreement, Thermo Fischer Scientific's TC Tech will supply Sartorius with disposable process containers through 2007 and with disposable process containers assembled with Sartorius filter capsules through 2012. In turn, Sartorius will supply TC Tech with filter units for an additional five years.

Sartorius and TC Tech have been partners for several years in the area of disposables for biopharmaceutical applications. However, for both companies, merger and acquisition activities have created changes in the ownership structure and/or in the product array, respectively, which required a new contractual arrangement. While TC Tech was acquired last year by Fisher Scientific, Sartorius is currently taking over the controlling stake in Stedim Biosystems S.A., a provider of disposable containers.

“The main target of this agreement is to optimally satisfy customer needs and to enable a continued product supply for their validated process applications," said Reinhard Vogt, senior vice president of sales and marketing of the biotechnology division at Sartorius.

Mylan Laboratories, Inc. has signed a definitive agreement to acquire Merck KGaA's generics business (Merck Generics) for $6.7 billion in cash. The combination of the two companies will create an integrated global generics and specialty pharmaceuticals company with differentiated dosage form expertise and increased API capacity. On a pro forma basis, combined 2006 revenues were $4.2 billion, EBITDA was approximately $1 billion, and the integrated company will have approximately 10,000 employees, ranking it among the largest global generic companies.

Mylan will retain Hank Klakurka, president and chief executive officer of Merck Generics, and has entered employment agreements with Merck Generics' senior management team.

Robert J. Coury, Mylan's vice chairman and chief executive officer, commented, "Mylan's acquisition of Merck Generics would substantially complete the execution on one of its long-term visions: to create a world class global quality generics leader. The fit between our two companies is truly outstanding. Mylan is already a leader in the U.S., the world's largest market, and through Matrix Laboratories controls one of the broadest API platforms in the world. Merck Generics provides us with leading positions in many of the world's other key regions. Together, we will form a powerful, diverse, robust and vertically integrated generics platform.

The transaction is subject to regulatory review and certain other customary closing conditions and is expected to close in the second half of 2007.

Lee Babiss, Ph.D. has been named head of global pharma research, Roche, effective July 1, 2007. In this new role, Dr. Babiss will be based in Basel, Switzerland, and focus on leading and managing research within the company's five disease biology areas: virology, inflammation, oncology, CNS and metabolism, at research sites located in Palo Alto, CA, Nutley, NJ, Basel, Switzerland, Penzberg, Germany, and Shanghai, China. He will report to William M. Burns, chief executive officer, pharmaceuticals division, Roche, and will join the pharma executive committee.

Dr. Babiss is currently vice president, preclinical R&D in Nutley, where he is responsible for developing and directing oncology, metabolic diseases and inflammation research strategy. He also serves as a member of the international research management team, involved in developing global research strategy, and chairs the Roche biomarker leadership team, focused on the development and implementation of the company's biomarker strategy.

"Lee is an insightful scientist who has demonstrated strong leadership for Roche. His efforts have helped the company build and maintain one of the strongest and most diverse industry pipelines," said Mr. Burns. "In his new role, I know he will use his considerable talents to drive innovation within our disease biology areas enabling us to not only bring clinically differentiated medicines to the market, but also maintain our leadership in key therapeutic areas well into the future."

Prior to joining the company, Dr. Babiss was vice president of biological sciences and genetics at Glaxo Wellcome, where he focused on the development of antisense technology and cancer therapeutics, headed the department of molecular cell biology, and played a key role developing and implementing the cell cycle program. He was also a member of the U.S. research senior management team, which formulated and implemented Glaxo's U.S. research strategy and was involved in creating the Glaxo Wellcome corporate genetic strategy, which led to the creation of the company's Genetics Division.

Dan Zabrowski, Ph.D., currently Roche's global head of pharma development operations in Nutley, will assume the position of global head, Roche Pharma Partnering effective July 1, 2007. In his new role, Dr. Zabrowski will oversee Roche's network of strategic alliances with biotech companies and create new alliances. He will report to Mr. Burns. Dr. Zabrowski succeeds Peter Hug, who will become head of the Roche Pharmaceuticals Western Europe Region.

According to Mr. Burns, "Roche's focus on building strong and lasting partnerships has become an industry standard, and Dan's strong background in drug development and regulatory affairs will be particularly important as we continue to expand our network of more than 60 global partners."

Dr. Zabrowski is currently responsible for both the U.S. development organization in Nutley and the management of all global clinical trials for the Pharma Division. Prior to this, he served as head, global regulatory affairs at Roche. He joined the company in 1995 following the company's acquisition of Syntex, Inc., where he held a variety of positions in regulatory affairs. Prior to that, he led regulatory affairs in North America for Fujisawa Pharmaceutical Co.

Manni Kantipudi has been named president, GVK Biosciences and will be based out of the corporate office in India. Mr. Manni will be responsible for operations and helping the company grow as a service provider to global pharmaceutical and biotechnology companies.

Mr. Manni Kantipudi joins the company with more than 15 years of experience in the IT industry where he held several leadership positions. Mr. Kantipudi was with Intel Corp. since 1992 and was the first director of Intel India from 2000-2003 where he was responsible for strategic and operational aspects of starting, growing and sustaining its R&D development center in Bangalore. From 2003-2004, he was chief information officer Asia responsible for all internal IT for the Greater Asia region including Japan, China, Malaysia, Singapore, Taiwan, Philippines and South Asia.

Most recently, Mr. Kantipudi was based in the U.S. as director of software and validation for Intel's WiFi technology Centrino laptop product line where he managed a global team of engineers and was responsible for innovative product designs and bringing key Intel products to market in high volume.

G.V. Sanjay Reddy, GVK Bio's chief executive officer, said, “With several years of strong operational and management experience in one of the largest global companies, we are confident that Mr. Manni will be a very valuable addition to GVK BIO."

Bristol-Myers Squibb Co. and Asterand have extended their collaboration providing BMS access to Asterand's products and services for as long as three years. The agreement will focus on access to Asterand's PhaseZERO drug discovery services and XpressBANK of human tissue and clinical samples for the continued validation of early drug targets and support for compound optimization. Financial terms were not disclosed.

"BMS's decision is an important validation of Asterand's products and services," said Asterand chief executive officer, Martyn Coombs. "Our goal is to assist BMS and other pharmaceutical companies in making the drug development process more effective and we want to help them reach the clinic with less cost and more confidence. Access to Asterand's human tissue-based approach through PhaseZERO Services and XpressBANK Samples can help assist in the early identification of possible adverse events in humans, and thus may help reduce the high attrition rates and costs associated with drug discovery and development."

Under the extended collaboration, Asterand will continue to take on a range of PhaseZERO studies for BMS in the areas of compound profiling and target validation. PhaseZERO studies include gene and protein expression profiling and cell-based pharmacology assays. BMS will be granted access to Asterand's XpressBANK of human tissue, bio-fluid, and cell lines and may also use Asterand's ProCURE custom clinical sample collection service.

Dr. James M. Pusey has been appointed vice president and general manager of MDS Pharma Services global clinical development business, which manages late-stage drug trials. Dr. Pusey has more than 25 years of experience in medicine, global clinical trial management, CRO services, and global pharmaceutical sales, marketing and operations. Dr. Pusey will lead a business area that is focused on enhancing client service through its LeanSigma and other initiatives to improve process efficiency and support client needs.

Prior to joining the company, he was president and chief executive officer of OrthoLogic, Inc., a biotech company, where he established a strategic plan involving collaborative agreements and acquisitions. Prior to that he was executive vice president for Neurology at Serono, Inc., where he was responsible for late-stage drug development, including development projects with Pfizer. He has also held the positions of vice president of marketing and therapeutic area leader for central nervous system, pain and infection at Astra-Zeneca.

"Dr. Pusey's vast industry experience combined with his medical background will enhance our ability to assess client needs and provide exceptional service managing their most demanding clinical trials," said MDS Pharma Services president David Spaight.

Gene Logic, Inc. has entered into an agreement with Abbott to discover additional development paths for several of Abbott's drug candidates, all of which have successfully completed Phase I trials.

Under the agreement, Gene Logic is eligible to receive success-based milestone payments for each drug candidate Abbott returns to clinical development. Gene Logic will also receive royalties for each drug candidate that is marketed. Gene Logic has the option to receive an exclusive license to any drug candidate that Abbott chooses not to pursue, in which case Abbott will receive success-based milestone and royalty payments. Financial terms of the agreement were not disclosed.

Gene Logic's Drug Repositioning Program seeks to find alternative indications for high-quality drug candidates with good safety records that have been de-prioritized or discontinued in clinical trials.

Charles L. Dimmler, III, Gene Logic's chief executive officer and president said, "We are delighted that Abbott chose Gene Logic as its partner to find new development paths for their drug candidates. Our program is designed to provide a comprehensive picture of the drug candidates' biological activities and determine if there are new therapeutic uses for these potential medicines."

Pacific Biometrics, Inc. (PBI) has been awarded a $1.2 million contract with a top pharmaceutical company related to a biological treatment for rheumatoid arthritis (RA). Under the contract, PBI will provide lab data and autoantibody testing for a global Phase III program. The sponsor plans to submit a NDA with the FDA and equivalent filings with regulatory agencies in other countries. Testing is expected to begin in Q32007 and may extend as long as five years.

"Our inclusion in this pivotal, international Phase III arthritis program is exciting on multiple fronts," said Ron Helm, chief executive officer of PBI. "These studies will further strengthen our relationship with this sponsor, who accounts for an important and growing percentage of our more diversified customer base. Furthermore, our selection for this project is validation for our worldwide, best-in-class testing of biomarkers as they relate to the diagnosis and treatment of arthritis -- a growing area of expertise for the company. Finally, assuming the scope of the studies remains unchanged, the contract should have a meaningful impact on our fiscal 2008 financial results."

Aptuit has plans to expand its clinical operations capacity with a new clinical packaging and logistics facility on the east coast of the U.S. The Clinical Operations business line is comprised of Clinical Packaging and Logistics (CPL), Aptuit Informatics, and a global distribution network. During the past 18 months, CPL management has integrated several processes, facilities and systems into a single, coordinated global operation.

The company is considering several site locations around the greater Philadelphia area for its 400,000 - 500,000-sq.-ft. CPL facility, which will more than double the CPL operations currently in NJ and provide expansion for formulation development, analytical testing and manufacturing. The site is expected to be qualified and operational next summer. The company is also planning a facility expansion in Deeside, Wales, which is expected to be operational in 2008.

As part of this expansion, Gerry Hepburn has been promoted to president, Clinical Operations. According to a company statement, Mr. Hepburn has been influential in the growth of the CPL business as senior director, Clinical Packaging and Logistics responsible for Aptuit's European operations in Bathgate, Scotland and Deeside. Since joining the company in 2003, he has driven positive change in quality, service, customer acceptance and leadership. He has also led the initial deployment of the Clinicopia system within Aptuit and will continue to oversee the development of the Clinicopia product suite in his new role.

"Gerry brings tremendous experience to this global role, and his natural humor and leadership skills have added fuel to our success to date. His promotion recognizes his many achievements and provides our employees and customers with continued stability," stated Scott L. Houlton, chief operating officer.

Paul Carter has been named senior vice president, international commercial operations, Gilead Sciences, Inc. Mr. Carter is responsible for the company's commercial organization in all territories outside North America, reporting to Kevin Young, Gilead's executive vice president, commercial operations. Mr. Carter will also join the company's executive committee.

Mr. Carter joined Gilead in April 2006 to lead the company's European commercial organization. In October 2006 his role was expanded to encompass all commercial markets outside of North America. Prior to joining the company, Mr. Carter spent 14 years in positions of increasing responsibility at GlaxoSmithKline, including serving as general manager in Europe and regional head of international business in Asia. Previously, he worked for Arthur Andersen's London-based practice.

"Gilead's International Operations have grown significantly under Paul's leadership, with international sales now accounting for more than 40 percent of Gilead's product revenues," said Mr. Young. "Paul's experience and in-depth knowledge of international markets will be instrumental as our portfolio of commercial products continues to grow and as we expand our geographic reach."

Draxis Health

1Q Revenues: $21 million (+10%)

1Q Earnings: $2 million (+19%)

Comments: Contract manufacturing revenues for 1Q2007 were $14.2 million (+5%), due to new product introduction activities. The result was weaker compared to the fourth quarter of 2006 due in part to a delay in receiving components for Hectorol production, which resulted in reduced volumes manufactured during the quarter. Sterile products represented approximately 78% of manufacturing revenues compared to 81% for 1Q2006.

Sigma-Aldrich Corp. has acquired Molecular Medicine BioServices Inc., a biopharma CMO located in Carlsbad, CA, to enhance the biologics capabilities within its SAFC Pharma business segment. The acquisition of MMB, which had $12 million in revenues last year, is expected to help Sigma-Aldrich "achieve its growth goals in key high technology markets over the next several years," according to the company.

David Backer, president of MMB, an equity holder and one of the company's founders, will continue as Site Director. All current employees "in good standing," including all of MMB's existing management team, will be retained.

MMB was founded in 1997 and employs 60 people at its state-of-the-art 23,700-sq.-ft. laboratory and HQ building and 21,400-sq.-ft. manufacturing facilities in Carlsbad. Its core expertise is in the development and clinical manufacturing of viral products, drawing on cutting-edge technology to deliver DNA, RNA and critical active ingredients for the production of novel vaccines and gene therapies.

Since its inception, the company has expanded its capabilities from the use of flat-stock cell factories to the extensive use of stir tanks and economic, disposable bioreactor systems. Significantly enhancing SAFC Pharma's oncology offer, MMB has produced clinical grade drug products for a variety of different cancer indicators, including head, neck, prostate and pancreatic cancers, as well as for other therapeutic indicators, including Alzheimer's disease and cardiovascular disease.

SAFC president Frank Wicks commented, "The acquisition of MMB continues our push into niche biologics, giving us the critical capability to manufacture virus. It also complements both our new transgenic extraction and purification facility which opened last month in St. Louis and our potent bacterial fermentation facility currently under construction in Israel. MMB's experienced team, capabilities and relationships with key end-users, combined with SAFC's global presence and financial strength, will allow us to work together to provide the pharmaceutical industry with better, more specialized, high-quality materials to meet customer needs and demand."

Mr. Backer added, "As part of SAFC, MMB remains committed to providing high quality viral products and services in support of our clients' clinical trials. Our integration into SAFC Pharma brings large scale commercial manufacturing expertise, significant investment capabilities and a strong distribution network, enabling us to expand our service offering and help progress our partner clients' products more quickly through to market."

The transaction was initiated by Fairmount Partners, a specialty healthcare investment banking firm based in Philadelphia, PA, who acted as advisor to Molecular Medicine. Bryan Cave LLP acted as legal advisor to Sigma-Aldrich. Terms of the purchase, which were not disclosed, were paid in cash.

AstraZeneca has begun construction on a $100 million R&D expansion at the company's Waltham, MA facility. The expansion will accommodate up to 100 additional researchers who will join the more than 450 existing employees focused on discovering treatments for infectious diseases and cancer.

"This is the right investment at the right time, as hospital-acquired infectious diseases -- also known as superbugs -- are on the rise and cancer remains the third leading killer in the world," said Tony Zook, president and chief executive officer of AstraZeneca U.S. "This expansion is a strategic global decision to increase our capabilities at R&D Boston because Massachusetts gives us access to some of the leading scientific talent, potential partners and collaborators, and emerging science in a worldwide biotechnology hub."

Since the opening of AstraZeneca R&D Boston, scientists there have discovered three potential drugs that are under development to treat different cancers including breast, ovarian, thyroid, and prostate cancer, and two novel-class candidate drugs to potentially treat serious incidences of skin infections, chronic bronchitis, and pneumonias, according to the company.

"We have a remarkable team of researchers here in Boston that is focused on discovering novel agents for the treatment and cure of serious infections and cancer. This expansion will provide critical space to support future delivery in these two areas of breaking science and profound unmet medical need," said Jan Lundberg, executive vice president, head of Global Discovery Research.

Construction of the 132,000-sq.-ft. facility is scheduled to conclude by mid-2009. Upon completion, the total size of the AZ research facility will be 382,000 sq. ft. AZ established a research presence in Boston in 1995. In 2000, the company opened its state-of-the-art research facility in Waltham, where it has continued to invest and expand, growing from 170,000 sq. ft. to the current 250,000-sq.-ft. facility.

The architect for the project is KlingStubbins, whose offices are based in Cambridge, Mass. and Philadelphia, Pa. Construction management is being provided by Bovis Lend Lease LMB Inc's Boston office in association with The Richmond Group of Hopkinton, Mass. The design of the additional buildings will continue the theme created by Swedish architect Gert Wingardh.

Parexel has appointed Joe Avellone, M.D. to the position of vice president of operations for Clinical Research Services, Americas. Dr. Avellone will lead operational aspects of the company's Phase II-IV clinical development programs for clients, including project management, clinical operations, and management of the Americas Medical Affairs group. In addition to North America, his responsibilities will span Parexel's operations in Latin America.

"Dr. Avellone's extensive management experience, in-depth healthcare industry knowledge, and client focus will further strengthen our ability to deliver superior clinical development programs,”" said Mark A. Goldberg, M.D., president of Clinical Research Services and Perceptive Informatics, PAREXEL. "We look forward to benefiting from the additional leadership depth Dr. Avellone adds to the senior management team, and his contributions in meeting our clients' evolving clinical research needs.”

Prior to joining Parexel, Dr. Avellone was the former chief executive officer of Veritas Medicine, a healthcare technology company supporting clinical research trials. Previously, he held senior management positions at Healthvision and served as Chief Operating Officer for BlueCross BlueShield of Massachusetts. With more than 20 years of experience in healthcare management, Dr. Avellone's expertise includes establishment of strategic direction; developing and growing products, services and technologies; managing operations of major business lines; directing senior management teams; and managing major care networks and contractual relationships.

IPS has appointed Eugene K. Martini, P.E. to the role of senior director, Project Delivery Operations. In this role, Mr. Martini will oversee day-to-day operations of Project Delivery Operations at IPS. He brings 25 years of experience in the management of capital projects for technically complex facilities. During the last 15 years, he has been exclusively involved with FDA-regulated manufacturing and development projects. His most recent experience was with CDI Corporation as director of Project Management. Prior to that, he served in a variety of roles with Life Sciences International, ultimately serving as project manager, where his responsibilities included management of capital projects for biotechnology and pharmaceutical clients, proposal development and management of client relations.

David J. Brown has been appointed director, Project Services. In this role, Mr. Brown will lead the project services and project controls teams to develop strategies that yield 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.

The Blackstone Group, the private equity firm that recently acquired Cardinal PTS, has acquired the Klockner Pentaplast Group for $1.8 billion. The sale is subject to approval by various regulatory authorities, and is  expected by June.

According to Lionel Assant, managing director of The Blackstone Group, "Klockner Pentaplast has a strong international market position and performance. It is committed to providing its customers with the most innovative and comprehensive solutions to meet their films needs. The group’s high-quality films, superior technical expertise and support, and its global manufacturing platform have earned its position as a recognized industry leader. We will continue to support Klöckner Pentaplast's aggressive growth and investment strategy."

The management of the Klockner Pentaplast Group will remain in place. According to Tom Goeke, the group's chief executive officer, "The Blackstone Group is committed to the company’s strategic goals. With their backing, we will continue to pursue the expansion of Klöckner Pentaplast."

Affitech AS, a human antibody therapeutics company based in Norway, has signed a research and licensing agreement with Roche to produce fully human monoclonal antibodies against an unnamed oncology target. The agreement tasks Affitech with using its proprietary phagemid library, high throughput screening technology and antibody engineering platforms to identify candidate antibodies which Roche would then utilize for further development and commercialization. The financial terms of the collaboration include research fees, milestone payments and royalties on net sales upon commercialization of any product.

"These are exciting times for Affitech," commented Martin Welschof, Ph.D., chief executive officer of Affitech. "We are delighted that Roche has chosen to partner with us based on our significant achievements to date in the human antibody field. Partnering is a key part of our twin-track strategy of generating revenue streams from collaborations parallel to developing our own therapeutic candidate pipeline. This new agreement is the latest in a series of collaborations, also in oncology that we have made with some of the other global antibody companies including the US based Xoma and Peregrine Pharmaceuticals".

Eli Lilly and Co. has announced changes in the company's senior leadership team. Alex M. Azar II will be joining the company as senior vice president of corporate affairs and communications, reporting directly to chairman and chief executive officer Sidney Taurel. He will be a member of the company's policy and strategy committee, the corporate operations committee, and the senior management council.

Mr. Azar will lead the company's teams that are responsible for international, federal, and state government affairs, public policy planning and development, external and internal communications, corporate branding, and community and public relations. He will also lead the company's efforts in maximizing the value of health information technology and in fighting against the spread of counterfeit medicines.

He was previously U.S.Deputy Secretary of Health and Human Services (HHS), where he supervised all operations of the HHS, including the regulation of food and drugs, Medicare, Medicaid, medical research, public health, welfare, child and family services, disease prevention, Indian health, mental health services, emergency preparedness and response, and many other activities. Agencies under his direction included, among others, the FDA, the Centers for Medicare and Medicaid Services, the National Institutes of Health, and the Centers for Disease Control and Prevention. He was a key member of President Bush's leadership team, contributing extensive policy, legal, and management expertise.

"We are very pleased to have someone of Alex's caliber join the leadership team here at Lilly," said Taurel. "He brings a combination of distinguished government service and private practice, and he has a track record of strong leadership. Alex has been a leading advocate for the role that pharmaceuticals play in preventing, treating and curing disease, and he will be a great addition to the company."

Anne Nobles will assume the role of vice president for compliance and enterprise risk management, and she will serve as Lilly's chief compliance officer. Nobles, a graduate of Harvard University and Georgetown University Law School, has been with Lilly for more than 16 years and has held a variety of leadership roles in public affairs, regulatory affairs, public policy, business customer strategies, product team leadership, and corporate affairs. She will report directly to Taurel and will be a member of both the corporate operations committee and the senior management council.

Said Taurel, "Anne's legal background and her broad experiences here at Lilly make her the ideal person to assume the role of the company's chief compliance officer. We are committed to conducting ourselves with integrity and to being in compliance with all laws and regulations, and having someone with Anne's qualifications in this important role is evidence of this commitment."

Joseph Zakrzewski has been appointed chief executive officer of Xcellerex, Inc. and a member of the company's board of directors. Mr. Zakrzewski joins the company after a 20-year career at Eli Lilly and Co. and most recently as chief operating officer of Reliant Pharmaceuticals. He succeeds Mike Masterson as part of a planned transition to the company's next stage of growth in commercializing its proprietary manufacturing technology for biotherapeutics and vaccines. Mr. Masterson will continue to serve as an advisor and member of the board.

"Joe brings an enormous range of commercial, corporate and business development experience coupled with an in-depth knowledge of biomanufacturing," said Thomas Monath, M.D., a partner at Kleiner Perkins Caufield and Byers and a member of Xcellerex's board of directors. "He is ideally suited to lead Xcellerex as it expands the commercialization of its proprietary disposable biomanufacturing systems through its contract manufacturing business, as well as its disposable bioreactor products and integrated manufacturing systems."

"I would like to acknowledge the outstanding contributions Mike has made in building the Xcellerex organization, setting its strategy and strengthening its financial position," Dr. Monath added. "I am pleased he will remain an active advisor to the company and board member."

At Reliant Pharmaceuticals, a specialty pharmaceutical company focused on cardiovascular products, Mr. Zakrzewski was responsible for the company's pharmaceutical operations, including supply chain/manufacturing, R&D, business development, IT, quality and compliance. He spent more than 17 years with Lilly and served in a variety of capacities of increasing responsibility in research, manufacturing, finance and corporate business development. His most recent position at Lilly was vice president, corporate business development where he had global responsibility for business development activities.

AMRI

1Q Revenues: $48.4 million (+12%)

1Q Earnings: $3.2 million (+70%)

Comments: Total contract revenue in the quarter was $41.2 million, up 14%. Revenue from Discovery Services was $9.9 million, up 21%. Development and Small Scale Manufacturing revenue was $10.3 million, up 17%. Large Scale Manufacturing revenue was up 9% to $21 million. Royalties from Allegra were flat at $7.1 million. In the quarter, the company restructured its Large Scale Manufacturing operations contributing to an improvement in this segment's gross margin from 4% during 1Q2006 to 14% during 1Q2007.

Array BioPharma, Inc. has initiated dosing in a Phase I trial with ARRY-520, a targeted small molecule anticancer drug. ARRY-520 is a potent Kinesin Spindle Protein (KSP) inhibitor that caused marked tumor regression in preclinical models of human cancer at tolerated doses, often leading to complete, durable responses.

The Phase I open-label, dose-escalation trial is designed to evaluate the safety, tolerability and pharmacokinetics of ARRY-520 following intravenous administration to patients with advanced cancer. The trial will also examine indicators of therapeutic activity in these patients.

ARRY-520 inhibits KSP, a protein that plays an essential role in mitotic spindle formation with subnanomolar potency in both enzymatic and cellular assays. Unlike current cancer therapies -- taxanes and vinca alkaloids -- KSP inhibitors do not demonstrate side effects such as peripheral neuropathy because the KSP protein is not expressed in non-proliferating nerve cells.

In studies comparing the most clinically advanced competitor compound and standard of care agents like taxanes and vinca alkaloids, ARRY-520 has shown superior efficacy in multiple preclinical models.

Bristol-Myers Squibb recently began construction at the site of its new biologics manufacturing facility in Devens, MA. The company has committed $750 million for the construction of the large-scale, multi-product bulk facility, which will be designed to accommodate potential future expansion. Phase I of the project will consist of four main buildings: a manufacturing structure that will house six 20,000-liter cell culture vessels and one purification train, a central utility building, an administrative/quality control building and a warehouse/storage structure. The facility is projected to be operational in 2009, and the company plans to submit the site for regulatory approval in 2010. Phase I of the facility will require a workforce of approximately 350 employees. Future expansion of the site could lead to a total of 550 or more employees.

"The commitment to build this facility represents the single largest capital investment in the history of BMS, demonstrating the critical role we believe biologics will play in the future of our company," said Jim Cornelius, chief executive officer, Bristol-Myers Squibb. "Building this facility provides additional manufacturing capacity to meet future patient need for our biologic therapies and helps position the company for long-term growth in this important area of medicine."

The facility will support increased production capacity for Orencia and manufacture commercial quantities of compounds currently in development, should they receive regulatory approval. The company's investigational biologic compounds include treatments for certain types of cancers and solid organ transplant rejection.

BMS currently manufactures biologic compounds in a company-owned facility in Syracuse, NY, and finishes and packages biologic compounds in Manati, PR. The Syracuse site will serve as the center of excellence in process development and early product launch for the company's biologic compounds. The Manati facility will continue to finish and package biologic compounds. BMS also has biologic manufacturing agreements with third-party partners Lonza Biologics, Inc. and Celltrion, Inc.

Diosynth Biotechnology signed an agreement with VGX Pharmaceuticals for process development activities and cGMP production of clinical trial material for their biological drug candidate VGX-100 for the treatment of cancer.

VGX has developed technology using specific viral proteins that can induce selective apoptosis (programmed cell death) in rapidly dividing cancer cells, leaving normal cells unharmed. VGX-100, a recombinant viral protein, induces tumor cell death through apoptosis in number of tumor tissues including breast, prostate and brain. Initial trials will target patients with Non-Hodgkin’s Lymphoma and gastric cancer. Diosynth's development and manufacturing program employs the Dowpharma Pfenex Expression Technology, a Pseudomonas-based technology that can increase yields of recombinant protein in biomanufacturing applications.

"We are excited to work with VGX Pharmaceuticals, an innovative and progressive biopharmaceutical company developing treatments for infectious and immunological diseases and cancer,” said Jacques van Kimmenaede, president of Diosynth Biotechnology.
“We are very interested in applying our skills in fermentation development and manufacturing for the production of VGX-100 and we are also very enthusiastic about using the Pfenex Expression Technology to do so.”

“We are pleased to have contracted Diosynth Biotechnology to manufacture VGX-100, given their extensive experience and broad capabilities in manufacturing of biologics and their commitment to high-quality cGMP manufacturing,” said J. Joseph Kim, Ph.D., president and chief executive officer of VGX Pharmaceuticals.

Cardinal Health will integrate RFID technology into the operations of its Sacramento, CA pharmaceutical distribution center by Fall 2007, to comply with CA's pedigree legislation that will require all drugs distributed within the state to be tracked and traced throughout the supply chain.

The results of the company's RFID pilot program confirmed that RFID technology using UHF as a single frequency is a feasible solution to track and trace pharmaceuticals at the unit, case and pallet levels. The pilot also confirmed that RFID technology offers significant promise to provide added safety within the pharmaceutical supply chain, by enabling item-level pedigrees to be tracked and traced as they pass from manufacturer to wholesaler to pharmacy.

The recently passed state legislation in CA requires pharmaceutical manufacturers to originate item-level pedigrees for drugs distributed within the state's borders. This legislation also requires companies within the pharmaceutical supply chain (including companies that distribute drugs) to update item-level drug pedigrees upon each change of ownership.

"While the Sacramento project is designed to support the pedigree legislation in CA, it's also an extension of the end-to-end RFID pilot that we completed last year," said Steve Inacker, executive vice president of Global Supplier Services for Cardinal Health. "We look forward to leveraging this work to further validate the effectiveness and viability of RFID technology in real-world settings, should it be adopted as an industry standard."

As part of this effort, the company will also leverage the new data, made available by RFID technology, to identify efficiency opportunities in key areas including returns and order accuracy.

BioServe has acquired Genomics Collaborative from SeraCare Life Sciences, Inc. Genomics Collaborative facilitates biomarker discovery and validation through its Global Repository, a comprehensive library of 600,000 human DNA, tissue and serum samples linked to detailed clinical and demographic data from 140,000 patients collected on four continents.

With this acquisition BioServe expands its preclinical product and service capabilities in drug discovery and diagnostic development with a "biomaterial to validated data" services platform. This service platform includes molecular research products and services such as DNA and RNA purification reagents, DNA sequencing, oligonucleotide synthesis and genotyping to ready-made large epidemiologically sound case-control studies of inflammatory disorders, endocrine disorders, cardiovascular disease, diabetes, hypertension, obesity and cancers including breast, prostate, lung and colorectal, according to the company.

"The acquisition of Genomics Collaborative firmly positions BioServe as a preferred partner for preclinical discovery and validation studies. Working with BioServe, drug discovery researchers have the flexibility to tap the Bio Repository to augment their in-house sample sets, design entire genomic studies around our sample library, and further benefit from BioServe's proven ability to process and analyze vast quantities of genomic content," said Rama Modali, president, BioServe.

Genomics Collaborative will operate as a fully integrated division of BioServe. The Genomics Collaborative clinical team, led by vice president of medical affairs, George Taylor M.D., has joined BioServe.

BioServe will continue to offer the GCI Access program, which allows researchers to access human DNA, RNA, serum and tissue samples with comprehensive informed consent and detailed clinical data, on a fee for service basis.

Biogen Idec

1Q Revenues: $716 million, (+17%)

1Q Earnings: $132 million (+7%)

Comments: Growth in the quarter was driven by Avonex sales, up 14% to $449 million, and Rituxan revenues from the joint business arrangement with Genentech, up 13% to $207 million. Global in-market net sales of Tysabri in the quarter were $48 million, of which Biogen recognized $30 million based on its collaboration with Elan. R&D expenses were $191.4 million, up 31%. In the quarter, the company completed its acquisition of Syntonix Pharmaceuticals, which included an in-process R&D charge of $18 million.

CuraGen Corp. and TopoTarget initiated a Phase I/II open-label, multi-center trial evaluating the efficacy and safety of intravenous belinostat (PXD101), an HDAC inhibitor, in combination with doxorubicin for the treatment of Soft Tissue Sarcomas (STS).

During the initial dose escalation part of the trial, as many as 24 patients with solid tumors for whom no standard therapy exists will be enrolled in order to define the maximal tolerated dose (MTD) of belinostat in combination with doxorubicin. Once MTD is established, the trial will advance into Phase II and enroll an additional 20 to 40 STS patients who have not received prior chemotherapy. Patients will receive their standard chemotherapy of doxorubicin every three weeks and belinostat will be added in a five-day intravenous regimen. Patients demonstrating complete or partial response will continue to receive treatment with the combination for up to eight cycles or until disease progression.

The primary objectives for the study are to determine the MTD and to assess the anti-tumor activity of belinostat and doxorubicin combination treatment as defined by RECIST criteria. Secondary objectives include the time to disease progression, overall survival, and duration of response. The pharmacokinetic profile and aspects of pharmacodynamic activity of belinostat will also be evaluated.

Contract sales organization PDI, Inc. has been selected to recruit a sales team of as many as 60 specialty representatives and five managers for a global healthcare products company by the end of the second quarter.

Susanne P. Reilly, Ph.D., vice president of talent management at PDI, said, "We are very excited to have been selected to partner with this client. We believe we were awarded this critical assignment based on our proven expertise in efficiently providing top talent to industry-leading companies, our award-winning time-to-fill rates, and the performance results of the talent we have recruited over the past two decades. Each phase of our process is coordinated to optimize the end result: selecting highly successful and motivated candidates who become long term assets for their sales team."

Michael Marquard, PDI's chief executive officer, commented, "We are very pleased to have been chosen to address this new client's staffing needs and are energized by the prospect of building a long-standing and mutually beneficial relationship. Additionally, this reinforces our strategy of providing stand-alone talent acquisition services and meeting the growing demand for the flexible and innovative solutions offered under our "PDI ON DEMAND" suite of products."

Linda Baddour, chief financial and accounting officer of PPD, Inc., is resigning from her position effective May 31, 2007. Ms. Baddour will provide consulting services to the company for the next six months to assist with the transition of her responsibilities to other members of senior management. The company is looking for a new CFO.

As part of the transition, the company has promoted Peter Wilkinson to vice president of finance and chief accounting officer and Brian Tuttle to vice president of finance and corporate controller. Mr. Wilkinson, CPA, joined the company as executive director of finance and internal auditor in 2003.

Mr. Wilkinson has served an integral role in the company's implementation of the requirements of the Sarbanes-Oxley Act and compliance with the U.S. SEC requirements and Generally Accepted Accounting Principles (GAAP). Mr. Wilkinson also assisted in structuring the financial aspects of the company's recent compound partnering collaborations. Mr. Wilkinson reports to the finance and audit committee of the board of directors of PPD regarding internal audit matters. Prior to joining the company, he served as a senior manager with Deloitte & Touche LLP for 10 years.

Mr. Tuttle, CPA, served as corporate controller since 1999, and joined the company as corporate tax manager in 1998. He coordinates external audits of financial statements and is responsible for management of various company and financial functions, including disbursement services, tax matters, financial systems, treasury and the travel department. He also negotiates the annual indirect rate agreements on all federally funded contracts. Prior to joining the company, Mr. Tuttle worked with Coopers & Lybrand LLP for eight years, including three years as the tax manager on PPD's account.

"We extend our appreciation to Ms. Baddour for her service to PPD throughout the last 11 years," said Fred Eshelman, chief executive officer of PPD. "We also congratulate Mr. Wilkinson and Mr. Tuttle, who have demonstrated leadership and acumen through their significant contributions to our financial and business operations. We look forward to continuing to work with them in advancing the growth and performance of PPD.

"In addition," Dr. Eshelman continued, "I'd like to take this opportunity to say that we are pleased with the progress of our ongoing chief operating officer search, and hope to be in a position to make an announcement on that front soon."

Covance

1Q Revenues: $376.9 million (+13%)

1Q Earnings: $38.9 million (+16%)

Comments: Operating income for the quarter increased 23% to $43.7 million. Late-Stage Development revenue was flat at $179.1 million. Early Development revenue was $179.2 million, up 26%. Net orders were up 36% in the quarter to $510 million. Backlog grew 39% to $2.4 billion in the quarter.

Albany Molecular Research, Inc. has changed its brand name and is now conducting its business throughout the world as AMRI. This rebranding "reflects the company's 16-year evolution into a global contract services and R&D organization," according to a company statement. AMRI provides a broad range of scientific services, products and technologies to the life sciences industry, encompassing all of the company's subsidiaries, including operations in the U.S., Europe and Asia.

"This rebranding of Albany Molecular Research, Inc. to AMRI reflects the company's evolution from a small regional operation to a much larger business on a global scale," said AMRI chairman, president and chief executive officer, Thomas E. D'Ambra, Ph.D. "The new brand allows us to connect to our past to retain and build on our commitment to customer satisfaction and loyalty; at the same time creating a modern and dynamic global identity as we continue our transition into a larger company. Additionally, it is an opportunity for us to reinforce a common mission and purpose across all of our locations and technologies, versus the multiple and sometimes confusing identities of several different site names."

While the legal name of the company will not be affected by the rebranding, the name of Organichem Corp.—a wholly owned subsidiary of AMRI located in Rensselaer, NY—has been legally changed to AMRI Rensselaer, Inc., and will be included under the AMRI brand.

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