Galapagos NV's service division, BioFocus DPI, will provide compound management and related services to Sepracor for a total contract value of $1.5 million. Under the terms of the agreement, BioFocus DPI will receive, register, and store selected compounds from Sepracor's compound library, and plate and replicate these compounds for three years. Services will be provided by BioFocus DPI's compound management facility in San Francisco, CA.
   
"We welcome Sepracor as a new client to BioFocus DPI," said Onno van de Stolpe, chief executive officer of Galapagos. "Our compound management site has been able to broaden its customer base over the last year, and with this agreement we further expand our list of pharma companies."

Michael J. Giuliani, M.D. has been appointed vice president of R&D for Covidien's Pharmaceutical Products and Imaging Solutions. He will lead the R&D organization's efforts to identify and deliver advancements to the pharmaceutical and imaging markets. Dr. Giuliani reports to Timothy R. Wright, president, Pharmaceutical Products and Imaging Solutions.
   
Dr. Giuliani has more than 25 years of medical experience and is a clinical neurology specialist who has served as a professor in the Department of Clinical Neurology at the University of Pittsburgh. Dr. Giuliani was also the co-director of the National Institutes of Health-sponsored Clinical Research Training Program and a member of the University of Pittsburgh Internal Review Board.
   
Dr. Giuliani joins the company from Xanodyne Pharmaceuticals, where he was chief medical officer and executive vice president of product development. Prior to that, he was the senior director of clinical neuroscience/ophthalmology at Merck and director of CNS Research at Wyeth.  
   
James L. Young, Ph.D. has joined the company as vice president of R&D operations for Pharmaceutical Products and Imaging Solutions. Dr. Young will guide all planning, operation and monitoring activities for the Pharmaceutical and Imaging R&D organizations. He will manage all R&D support activities for proprietary products, including pharmaceutical development operations and clinical development programs.
   
Dr. Young also joins the company from Xanodyne Pharmaceuticals, where he was vice president of product development. He has 20 years of experience in the pharmaceutical industry, having served in management, strategic development, sales and scientific roles at companies such as Nexeon, AstraZeneca and Merck.  
   
Ralph A. Heasley, Ph.D. has been appointed vice president of global R&D technology, Pharmaceutical Products. Dr. Heasley will be responsible for overseeing and directing pharmaceutical R&D activities, with a focus on creating better technical products and processes.
   
Dr. Heasley has more than 30 years of experience in pharmaceutical R&D, having held executive-level and other key positions at Xanodyne, Quintiles, and 3M Pharmaceuticals.
   
Randel Frazier will continue as vice president, global R&D, Imaging Solutions. He will lead all aspects of imaging development efforts, with an additional focus on exploring new uses for existing imaging capabilities and on developing new products using the company's competencies in radiology, nuclear imaging and contrast delivery systems.
   
Mr. Frazier has more than 25 years of experience in medical device and pharmaceutical R&D. He joined Tyco Healthcare in 1994 and became vice president, Imaging R&D in 2002. He has also served in R&D, manufacturing, sales and marketing roles for several other companies, including Colorado Medtech, , Gambro and 3M.

GlaxoSmithKline has submitted its response to questions raised by the FDA regarding its application for approval of Cervarix, its vaccine to prevent cervical cancer.
   
GSK will also submit Phase III efficacy study data from HPV-008, which is expected to be available later this year. GSK has decided to augment its application for approval with these data to ensure they are included in the U.S. label. The company anticipates submitting these data in the first half of 2009 and FDA action is expected within six months following this submission. Interim data from this study were filed in the original application for the vaccine in March 2007. The company does not expect that new clinical studies will be required for approval.
   
"Study 008 is a key study that will be completing later this year, and we expect the final results will strengthen the U.S. label for Cervarix," said Barbara Howe, M.D., vice president and director, North American Vaccine Development, GSK. "We continue to have positive and productive discussions with the FDA and remain confident in the vaccine's safety and efficacy profile. We look forward to bringing this important new cervical cancer vaccine to girls and women in the U.S."
   
The vaccine is currently approved in 67 countries including the EU, Mexico, Australia, Singapore and the Philippines. Licensing applications have been submitted in more than 35 additional countries including Japan.

Schering-Plough and Merck withdrew the NDA for the Claritin (loratadine)/Singulair (montelukast) combination tablet. The companies also terminated the their respiratory joint venture formed in May 2000. The FDA issued a not-approvable letter in April for the proposed fixed-dose combination of the two drugs. This decision does not impact the companies' cholesterol joint venture.    
   
As a result of the termination, Schering-Plough expects to receive payments totaling $105 million from Merck per the joint venture agreements, which Schering-Plough will recognize over the remaining three quarters of 2008.

Exelixis and GlaxoSmithKline will end their six-year collaboration based on its success, on October 27, 2008, as scheduled. Under the terms of the collaboration, GSK has the right to select two compounds for further development and commercialization. Exelixis will have the right to develop and commercialize compounds not selected by GSK. Exelixis' exclusivity obligations will now be limited to the compounds selected by GSK. Exelixis will have the right to develop and commercialize any collaboration target or compound that does not infringe upon the intellectual property associated with compounds selected by GSK for further development and commercialization.
   
"This collaboration represents a successful alliance that has truly benefited both companies. With the selection of GSK089 (formerly XL880) and potentially one other compound, GSK has been able to strengthen its oncology pipeline. I am enthusiastic about the compounds remaining in the collaboration, and continue to be impressed by Exelixis' quality of science and productivity," said Paolo Poletti, M.D., senior vice president of the Oncology Medicines Development Center at GSK.
   
To date, Exelixis has received approximately $235 million from GSK, which includes upfront, milestone, and R&D support payments. If GSK selects a second compound, Exelixis will be entitled to receive an additional milestone payment of either $55 million or $27.5 million. Exelixis is eligible for development milestones and royalties on compounds selected for development and commercialization by GSK. Exelixis will pay GSK a small royalty on certain candidates not selected by GSK.

Centocor's BLA has been submitted to the FDA requesting approval of golimumab (CNTO 148) as a monthly subcutaneous treatment for adults with active forms of rheumatoid arthritis (RA), psoriatic arthritis and ankylosing spondylitis. Golimumab is the company's next-generation human anti-TNF-alpha monoclonal antibody. It's being studied as an every four-week subcutaneous injection and as an intravenous (IV) infusion therapy. In February 2008, the company submitted a MAA to the EMEA for golimumab as a monthly subcutaneous treatment for the same indications.
   
The submission is based on five Phase III trials: golimumab as the first-line option in the treatment of early onset RA before methotrexate; golimumab for patients with active RA despite methotrexate use; and golimumab administered subcutaneously in patients with active RA and previously treated with biologic anti-TNF-alpha agent.

Dave Mott, president and chief executive officer of AstraZeneca's biologics business unit, MedImmune, has decided to leave the company at the end of July for personal reasons. Tony Zook, chief executive officer of AstraZeneca’s North American business and executive vice president of global marketing, has been appointed head of MedImmune on an interim basis until a permanent successor is named.
   
David Brennan, chief executive officer of AstraZeneca, said, “Under Dave Mott’s leadership, the team at MedImmune has built a unique capability to discover, develop and deliver innovative biologic treatments — an important element of AstraZeneca’s future strategy. We will continue to build on that strong platform, maximizing the potential of products in the MedImmune portfolio while delivering innovative new biological medicines and vaccines that treat and prevent disease.”



Sanofi Pasteur, the vaccines unit of Sanofi-Aventis, has established a new automated vaccine production facility in Val de Reuil, France to respond to increased vaccine demand worldwide. This new $156 million facility incorporates the latest technology and is part of the $935 million that the company has invested in France between 2005 and 2008.
   
"Sanofi Pasteur's commitment to global health is exemplified by significant investments in vaccine production infrastructures. These efforts are aimed at meeting a world demand for vaccines expected to double by 2016," said Wayne Pisano, president and chief executive officer of Sanofi Pasteur, who inaugurated the new production unit. "The new facility will provide high-end production work environment for dedicated people who produce vaccines for the world."
   
The new facility can produce vaccines against 20 diseases and is designed to respond to pandemic flu, once the flu strain is identified by the World Health Organization. Construction of the 7,800-square-meter building began in 2006 and is projected to be operational by the end of this year. The facility is scaled to fill 200 million syringes and vials per year, twice the current capacity at this site.

Dr. Lori McDonald has been named vice president, quality and compliance at MDS Pharma Services. Dr. McDonald will lead the company's ongoing program to build and manage quality and regulatory compliance systems across its global business platforms.
   
"I'm delighted that Dr. McDonald has joined our leadership team," said president David Spaight. "By enabling process improvements and compliance with regulatory requirements, she and her staff will be instrumental in helping MDS Pharma Services deliver high-quality, on-time services. This will help our clients expedite their drug discovery and development programs."
   
Dr. McDonald previously served as vice president, regulatory affairs with Alder Biopharmaceuticals. From 2001 to 2006, Dr. McDonald held a series of leadership roles with Cardinal Health, most recently having served as executive director, regulatory affairs. Prior to that, she worked at Ligand Pharmaceuticals and Abbott Laboratories.

DSM Biologics and Crucell have entered into an agreement with Avid Bioservices to bring Avid into their Vendor Network. Under the terms of the agreement, Avid will be a pre-approved CMO for licensees of the PER.C6 cell line in the western U.S. Avid is the first U.S.-based CMO to be awarded this status. Other terms of the agreement were not disclosed.

Karen King, president of DSM Biologics, noted, "We are confident that Avid's excellent reputation and service level will be instrumental in making the PER.C6 technology available to licensees on the west coast, bringing our technology to a wider regional base as we continue to grow globally."

Steven W. King, president of Avid Bioservices, added, "We are honored to achieve the distinction of being the first pre-approved U.S.-based CMO to manufacture proteins and antibodies using the PER.C6 cell line. This technology is recognized throughout our industry as providing important advantages compared to other platforms, including serum-free medium, scalability and high productivity levels, making the system an ideal fit for Avid."

The PER.C6 technology platform has been developed for the large-scale manufacture of biopharmaceutical products such as recombinant proteins, including monoclonal antibodies.

WuXi PharmaTech and Covance have entered into a Memorandum of Understanding to create a 50/50 joint venture to provide preclinical contract research services in China. Operations of the proposed joint venture will be located in a 323,450-sq.-ft., purpose-built facility in Suzhou, China, which is currently being built by WuXi. This facility, expected to be completed in 2009 and designed to meet the FDA and worldwide regulatory standards, will provide GLP toxicology, drug metabolism and bioanalytical chemistry services. In addition to the facility, which will be provided by WuXi, Covance plans to make an initial investment of approximately $30 million. Financial and structural details of the joint venture are expected to be disclosed once definitive terms are agreed and the entity is officially formed later this year.

Said Joe Herring, Covance chairman and chief executive officer, "Covance and WuXi share a common commitment to quality, people, and building client relationships based on trust and performance. Covance's market-leading and high-quality preclinical operations, combined with WuXi's track record of delivering world-class drug discovery and development services, will enable us to provide superior drug development solutions to our global pharmaceutical and biotech clients in the region."

Dr. Ge Li, chairman and chief executive officer of WuXi PharmaTech, added, "We will be able to immediately leverage Covance's world-class expertise and global network. This will allow us to accelerate bringing a full-range of preclinical services and GLP toxicology capabilities to this facility. The partnership is important to our mission of building a global R&D outsourcing service platform that will ultimately help our partners to improve the success of discovery and shorten the time of development."

The FDA has extended by three months its review of the NDA for Effient, which was previously known by its generic name of prasugrel. The drug's application was accepted in February 2008 and its deadline for action was this week. The new action date is September 26, 2008.

The proposed indication for Effient is for the treatment of patients with acute coronary syndromes (ACS) being managed with an artery-opening procedure known as percutaneous coronary intervention (PCI).

The three-month extension is intended to give FDA more time to complete its review of the drug, which demonstrated greater efficacy that market-leader Plavix, but also a possibility of greater side effects. The agency did not request additional trials from co-developers Daiichi Sankyo and Lilly as part of the NDA, but the companies do plan to begin a large Phase III trial to compare Effient and Plavix in medically managed ACS patients.

"We remain confident in our prasugrel submission package," said Jennifer Stotka, M.D., vice president for Global Regulatory Affairs at Lilly. "The TRITON trial encompassed a large amount of data from over 13,000 patients. We will continue to work closely with the FDA throughout the review process and continue discussions to determine if any requirements under the new FDA Amendment Act (FDAAA) legislation will apply."

Diana Wood has been named vice president, business development for Stason Pharmaceuticals, where she will be responsible for all business development functions, including guiding the company's global business development activities. Ms. Wood is a senior executive with extensive experience in sales, marketing, business and strategic planning, product development and general management on a worldwide basis. She will report directly to chief executive officer Harry T. Fan.

Most recently, she served as the executive vice president, business development at Chiltern International, where she oversaw the company's global business development and marketing functions, and advised clients on their product development platforms. Prior to joining Chiltern, she served as the director, product development for oncology at Chugai Pharma USA.

"We are pleased to welcome Diana to Stason," said Mr. Fan. "As a seasoned business development executive, she has built a highly respected track record and earned the trust of the pharmaceutical community. Diana will be a strategically important asset to our company."

Penn Pharmaceutical Services U.S. Inc, asubsidiary of UK-based Penn Pharmaceutical Services Ltd., has expanded its clinical trial supplies distribution capabilities with the opening of a 75,000-sq.-ft., temperature-controlled storage and distribution facility in South Wales, UK.
 
The new facility has 2,400 pallet locations, making it one of the EU's largest facilities with regulatory approval for the storage and distribution of investigational medicinal products (IMPs), according to the company. Paul Wituschek, U.S.-based director of business development, remarked, "The opening of our new storage and distribution facility in the UK means that we have increased our offering to non-EU pharma companies who are looking to break into the EU marketplace."

Mr. Wituschek added that Penn's storage and distribution services act as a 'portal' into Europe and beyond for U.S. companies, enabling them to import and distribute pharma products, including IMPs, for use in clinical trials programs.
 
Penn has global reach through an international sales force and strategic alliances for its services offered from its single site operation in South Wales. It is a Welsh company that provides a range of fully integrated and cost effective pharmaceutical development, clinical trial supply and custom manufacturing services to the international health care industry.

Dr. Patrice Hugo has been named vice president of scientific affairs for the global central lab network of MDS Pharma Services. In this role, he will lead the development of innovative biomarkers and esoteric assays to enhance clinical development productivity from Phases I through IV.

"We're delighted to offer our clients access to Dr. Hugo's experience and expertise in the development and application of biomarkers," said MDS Pharma Services' president David Spaight. "The importance of biomarkers has grown as the industry shifts toward personalized medicine and seeks to expedite drug discovery and development while controlling costs. Dr. Hugo's appointment reflects our intention to remain a key player in this important arena."

Dr. Hugo has more than 15 years of relevant experience in discovery, preclinical, clinical development, diagnostics and biotechnology, with a focus on biomarker evaluation and development. His biomarker experience crosses various therapeutic areas including oncology, infectious disease, inflammation, metabolic disease, and women's health. He comes to MDS Pharma Services from Caprion Proteomics, where he was executive vice president, R&D. From 1997 to 2003, he was with PROCREA BioSciences, first as the vice president of scientific research and then as chief scientific officer.