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.

Stiefel Laboratories will acquire Barrier Therapeutics for approximately $148 million. The parties expect the transaction to close by the end of the third quarter of 2008.

"This acquisition demonstrates our continued commitment to advancing the field of therapeutic dermatology," said Charles W. Stiefel, chairman and chief executive officer of Stiefel Laboratories. "We are very impressed with Barrier Therapeutics' innovative products and pipeline. This strategic move will further expand our oral and topical product portfolio in development and increase our sales of novel treatments for skin conditions."

"We are very proud of the accomplishments of the entire Barrier Therapeutics team since we were founded in 2002, and we are pleased that Stiefel Laboratories recognizes the value that we have created," said Al Altomari, chief executive officer of Barrier Therapeutics. "We believe this transaction provides substantial value to our stockholders. We believe Barrier Therapeutics' product portfolio and innovative R&D pipeline candidates are among the greatest assets in dermatology and will strengthen Stiefel Laboratories' position in the global dermatology market."

Barrier's board has approved the merger agreement and will recommend that company stockholders tender their shares in connection with Stiefel's tender offer.

Rentschler Biotechnologie has started operation of a 2,500 L multi-process production suite for its bio-CMO operations. The company now has nine stand-alone GMP suites with volumes of 30, 250, 500 and 2,500 liters, allowing the production of material for clinical trials as well as commercial supply.

The new bioreactor is designed such that batch, fed-batch, or perfusion cell culture processes can be run. Protein purification is performed in two suites for pre- and post-virus inactivation, respectively.

The global market for biopharmaceutical products is growing constantly and rapidly. As a consequence, since 2002, Rentschler Biotechnologie has invested more than 70 million Euros to enhance its production capacities, while tripling its workforce since 2001 to 350.

Sigma-Aldrich has entered into a five-year collaboration to develop optimal cell lines for the production of monoclonal antibodies. Scientists at the University of California, San Francisco will lead the research into antibodies for a variety of cancer targets, autoimmune diseases, stem cell characteristics and commonly neglected disease targets, according to a company statement.

Under the terms of the agreement, research targets will be determined by a steering committee composed of leading scientists at UCSF, including Lewis Lanier, Ph.D. Professor and Vice Chair, Department of Microbiology & Immunology; Jeffrey Bluestone, Ph.D. Director, UCSF Diabetes Center; and Susan Fisher, Ph.D. Professor, Department of Cell & Tissue Biology. The committee will direct research into antibodies for cancer targets, stem cell surface markers and autoimmune disease targets. The University will have free access to the antibodies resulting from the partnership for its ongoing immunology and disease research.

"Sigma-Aldrich is committed to developing the most comprehensive and highly validated collection of monoclonal antibodies available for the cell biology research community," said Dr. David Smoller, President of Sigma-Aldrich's Research Biotech Business Unit. "By partnering with the highly regarded UCSF research team, Sigma-Aldrich is helping to further promote the study of a number of important cancer targets, regenerative medicine applications and neglected diseases."

Sigma-Aldrich is expanding its antibody content offering as part of its plan to become a leading developer and manufacturer of the next generation of monoclonal antibody products for life science researchers. Earlier this year, the company announced a partnership to distribute the highly-validated Prestige antibodies powered by Atlas Antibodies, the commercial arm of the Human Proteome Resource. The company is also collaborating with AbD Serotec, a Division of MorphoSys, to design, produce and distribute unique recombinant research antibodies using MorphoSys's proprietary HuCAL GOLD technology.

India-based Intas Biopharmaceuticals Ltd. has acquired Biologics Process Development, based in Poway, CA. With the acquisition process underway, both Intas Biopharma and BPD are actively pursuing plans to work closely toward fulfillment of common business objectives in the area of biologics Contract Research and Manufacturing Services (CRAMS), according to an Intas statement.

This acquisition is intended to facilitate Intas Biopharma’s foray into the U.S. market especially to expand its CRAMS business. Dr. Scott M. Brown, founder, president and chief scientific officer of BPD, will continue as president and chief scientific officer.

Intas Biopharma’s venture into the CRAMS business has opened up new vistas for R&D in the area of biopharmaceuticals and biosimilars, according to the company. Dr. Dhananjay Patankar, Intas' chief technology officer, commented, "IBPL has taken up the CRAMS opportunity in the biotechnology space as a focus area with tremendous potential and is preparing to scale up its facilities. IBPL offers a unique business model for offshore clients, providing competitive advantages in terms of developing new biotech products, technology transfer and contract manufacturing in a seamless manner and at committed costs, quality, and time."

Millie Tan has been named senior vice president, Global Marketing and chief marketing officer, and David Coman has been named senior vice president, Communications and Patient Recruitment at Quintiles Transnational.

"Both Dave and Millie bring a wealth of experience and impressive records of success in marketing and communication," said Mike Mortimer, chief administrative officer. "I am excited to have them join our senior management team to play key roles in our efforts to strengthen our presence in the marketplace."

Ms. Tan joins Quintiles from Monster Worldwide. Most recently, she was chief marketing officer of its European business, prior to which she led core marketing in the US. Previously, she held increasingly senior positions in consumer marketing with Polaroid and Gillette, including overseas assignments in Hong Kong and Tokyo.

Mr. Coman joined Quintiles from Dendrite International where he was the vice president of Global Marketing and led both marketing and corporate communications. Previously, he held executive leadership positions in telecommunications companies where he initiated direct-to-consumer strategies. He began his career with Young & Rubicam, a market-leading global advertising agency.

PacificGMP and Pacific Biopharma Group (PBG) have signed a definitive merger agreement and will develop a cGMP biologics CMO in Taizhou, China. At approximately 200,000 sq. ft., the new CMO, called China Quantitative Biomedicine (CQB), will be one of the largest single-use biomanufacturing facilities in the U.S. or China, according to a company statement. Construction of the facility in Taizhou is expected to be completed in August 2008 with internal construction and equipment installation expected to be completed by the end of 2008.

Under conditions of the merger agreement, PacificGMP will receive funds to expand its operation in San Diego and assist in the development of the Taizhou facility and preparations for FDA and EMEA audits. The new facility is a showcase laboratory and part of a new biopharmaceutical park called China Medical City (CMC), located two-and-a-half hours outside of Shanghai in Jiangsu Province. The facility will be modeled after PacificGMP's San Diego facility, which utilizes single-use technology throughout the biomanufacturing process.

"We believe a significant opportunity exists for global leadership in single-use contract manufacturing services," said Gary Pierce, chief business officer of PacificGMP and newly appointed chief operating officer of PBG. "PacificGMP brings know how and experience in single-use contract manufacturing and PBG brings management and operational know-how and experiences in both the U.S. and China, as well as significant investment expansion capital."

"We look forward to contributing to the development of a state-of-the-art biomanufacturing facility in China to address the growing demand for contract manufacturing services and the rise of the Asian market for protein therapeutics," added Mr. Pierce. "This marks an important development in our organization that will benefit our customers by allowing us to expand the breadth of cost-effective quality services in San Diego and give our customers the option of eventual overseas manufacturing."

Freda C. Lewis-Hall, M.D. has been named executive vice president, Medicines Development, of Vertex Pharmaceuticals. Dr. Lewis-Hall joins Vertex from Bristol-Myers Squibb, and has extensive leadership experience across multiple functional areas in the pharmaceutical industry. At Vertex, she will be responsible for regulatory affairs, clinical and non-clinical development, medical affairs and commercial development. Dr. Lewis-Hall will serve on the company's executive management team and will report directly to Joshua Boger, Ph.D., president and chief executive officer of Vertex.

"We are pleased to welcome Freda to Vertex," said Dr. Boger. "She has a proven track record as a leader of high-performing teams in the areas of clinical development, trial design and operations, regulatory, medical safety, product realization, program management and commercialization. I look forward to her contributions as we continue to advance our lead hepatitis C virus (HCV) protease inhibitor, telaprevir, through late-stage development and toward the market."

Most recently, Dr. Lewis-Hall served as senior vice president, U.S. Pharmaceuticals, Medical Affairs at BMS where she led a team of nearly 500 people responsible for medical strategy and execution across five major therapeutic areas. Her team was involved in the development and launch of eight new drugs during the last four years. Previously, Dr. Lewis-Hall held leadership positions at Pharmacia, Eli Lilly and Co., the National Institute of Mental Health and at the Howard University College of Medicine Department of Psychiatry.

Also, John Alam, M.D., Vertex’s chief medical officer, will retire from the company in October 2008.

"I would like to thank John for his many contributions which have led us to where we are today," said Dr. Boger. "In the 11 years that John has been with Vertex, we have grown from an early stage, research-focused company with a vision for great science to a company that is bringing forward breakthrough drugs for multiple major diseases with significant unmet medical needs. John has helped shape the medical thinking and strategy behind this transformation, and has been core to positioning us to become a fully integrated pharmaceutical company going forward."

Pfizer has entered into an agreement with generics manufacturer Ranbaxy Laboratories Ltd. of India to settle all their patent litigation worldwide involving Lipitor. Under the terms of the agreement, Ranbaxy will have a license to sell generic versions of Lipitor and Caduet in the U.S. effective November 30, 2011. Caduet is a medicine that combines the active ingredients of Lipitor and Norvasc and treats both high blood pressure and high cholesterol.

The agreement also provides a license for Ranbaxy to sell generic versions of Lipitor on varying dates in seven additional countries: Canada, Belgium, Netherlands, Germany, Sweden, Italy and Australia. Pfizer and Ranbaxy have also resolved their disputes regarding Lipitor in Malaysia, Brunei, Peru and Vietnam.

The lawsuits between Pfizer and Ranbaxy regarding Lipitor and Caduet will be dismissed in the specified countries, and Ranbaxy will no longer contest the validity of Pfizer's patents in the specified countries, including the U.S., according to the agreement. The settlement also resolves all patent litigation with Ranbaxy relating to Accupril in the U.S. and Viagra in Ecuador.

"This agreement is a win-win-win because it is pro-patient, pro-competition and pro-intellectual property," said Ian Read, president of Worldwide Pharmaceutical Operations for Pfizer. "The agreement provides patients with access to a generic product much earlier than if Ranbaxy were unsuccessful in obtaining approval for its product and overcoming the relevant patents. It provides substantial certainty regarding the timing of the entry of a generic version of Lipitor. Finally, the agreement clearly reaffirms the value and importance of intellectual property and this country's well-balanced system of creating incentives to develop innovative medicines while at the same time establishing a strong generic drug business."

The settlement provides Ranbaxy with licenses to all the patents it needs to make the generic product and enables Ranbaxy to manufacture and launch a generic version of Lipitor prior to the expiration of the crystalline and amorphous patents.

The Lipitor patents involved in this agreement are the basic compound patent, which expires in the U.S. in 2010; the enantiomer patent, which expires in the United States in 2011; as well as various process and crystalline form patents, which expire in 2016 and 2017; and the combination patent for Caduet, which expires in 2018.

The settlement complies with all applicable laws, and does not contain any of the practices -- such as "reverse payments" -- that have been identified as of concern recently by the U.S. Federal Trade Commission, according to a Pfizer statement.

Pfizer has been defending Lipitor patent challenges by Ranbaxy throughout the world since 2003. The agreement pertains solely to Ranbaxy and its affiliates and does not cover legal challenges to the Lipitor patents involving other generic manufacturers. However, Ranbaxy was the first generic challenger to the listed Lipitor patents and, as such, holds the rights to 180 days of marketing exclusivity in the U.S.

Patheon has selected locations in Research Triangle Park (RTP) and Durham, NC for its global headquarters and new analytical development laboratory facilities.

Said Wes Wheeler, chief executive officer and president of Patheon Inc., "Patheon has over 300 US based customers and derives approximately 50% of its revenues from U.S.-based companies. This move positions us to attract top talent from the industry and represents another step towards our vision of becoming best provider of manufacturing and development services to the pharmaceutical industry."

The analytical development facility will be built to support its current U.S.-based pharmaceutical development operations in Cincinnati and will initially offer stability studies, validation testing and analytical chemistry services. The company has already selected the location of the new site in Research Triangle Park and will be ready for operation in the next three months.

According to a company statement, there will be no impact to Patheon's significant regional presence in Ontario, Canada, where the company operates four facilities with more than 1,500 employees.

"We are very pleased that Patheon has chosen North Carolina for its global headquarters and new laboratory facility," said NC Commerce Secretary Jim Fain. "This exciting announcement demonstrates clearly the leadership role North Carolina has developed in the life sciences sector as well as our strong and ongoing economic relationship with our Canadian neighbors."

Appian Labs, a biopharmaceutical company specializing in advanced therapeutic design, has launched itself as a company focused on providing comprehensive and strategic drug delivery and design solutions for pharmaceutical and other bioactives companies worldwide. The company provides solutions for a number of drug delivery problems, including poor bioavailability or solubility, dose timing, toxicity and many others. Appian Labs is funded and managed by venture firm Emergent Technologies, Inc.

Appian's laboratory is led by chief scientist Nicholas Peppas, Sc.D., Dr. Peppas has published more than 1,050 peer-reviewed articles and 33 books, covering drug delivery, hydrogels, and related controlled release.

Brian Windsor, Ph.D., president of Appian Labs, said, "Building on the drug delivery leadership of our scientific team, we can design delivery solutions tailored to pharma companies' drugs and that improve bioavailability, dosing, or timing of a drug. Our breadth of expertise and technologies enables us to match virtually any kinetic profile desired.” The company's first marketing initiative to potential pharmaceutical partners is an invitation to 'Draw your own profile'; Appian Labs will design a custom drug delivery system to match.

Dr. Windsor added, "Having worked with pharmaceutical companies for several decades to solve drug delivery problems, our scientific team knows both the common needs and the far-reaching goals of drug manufacturers."

The company is named after the Appian Way, "the leading delivery route of the ancient world," according to a company statement.

Genzyme Corp. has submitted marketing applications in both the U.S. and the EU for Mozobil, a drug intended to enhance mobilization of hematopoietic stem cells for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma. The company has requested priority review of its U.S. application and, if granted, Mozobil could be approved by the end of this year. European approval is expected in 2009. Additional global applications in up to 60 countries are expected to follow.

Mozobil is designed to mobilize stem cells from the bone marrow into the bloodstream where they can be collected, making it more likely for a patient with certain types of cancers to receive a successful transplant. Specifically, patients with non-Hodgkin's and Hodgkin's lymphomas and multiple myeloma often receive high-dose chemotherapy, a process that destroys bone marrow. A stem cell transplant is required to replenish blood-forming bone marrow cells destroyed by high-dose chemotherapy. Stem cells differentiate into the mature red blood cells, white blood cells, and platelets that a healthy person needs.

"There is a lot of excitement among treating physicians about Mozobil," said Mark Goldberg, M.D., senior vice president of clinical research at Genzyme. "The product has great potential to meet an important, unmet medical need and has numerous potential benefits for patients."

More than 900 patients have received Mozobil through a compassionate use program in the U.S., and similar compassionate use programs have recently begun in Europe.

Genzyme plans to launch Mozobil in the U.S. and Europe in 2009. Upon commercial launch, Mozobil will be marketed and sold by Genzyme's existing Transplant sales force, which has a commercial presence in more than 55 countries worldwide. In addition, the company will leverage its Oncology business and clinical infrastructure.

PharmEng International's wholly owned subsidiary, Keata Pharma Inc., is relocating contract manufacturing operations from its Perth, Ontario facility to their its pharmaceutical manufacturing facility in Sydney, Nova Scotia. Included in the relocation from Perth are existing pharmaceutical supply contracts, manufacturing equipment and personnel.

The 46,400-sq.-ft. Sydney facility includes offices for PharmEng's pharmaceutical consulting division, pilot laboratories for formulation development, production rooms with various capabilities such as high shear mixing, container blending and equipment for modified release technologies. The facility provides formulation development and testing services to manufacture and package products in solid and liquid dosage forms. The Sydney facility has been designed to meet all cGMP requirements, the company assures.

Keata's long-term goal is to develop capabilities in other dosage forms, such as suppositories, topicals and injectables. The facility is located on five acres in the Northside Industrial Park, a 300 acre business park in North Sydney, NS. The transition from the Perth facility to the Sydney facility was completed at the end of May.

Mpex Pharmaceuticals and GlaxoSmithKline (GSK) have entered into a worldwide strategic alliance for the discovery, development and commercialization of novel medicines for bacterial diseases. The collaboration provides GSK access to Mpex's efflux pump inhibitors (EPI) and related technology for use in combination with a variety of antibiotics. The collaboration will focus on drug regimens using Mpex's EPIs combined with GSK's development stage compounds as well as existing antibiotics to improve potency and broaden the spectrum of antibacterial activity.

Under the terms of the agreement, GSK will have rights to product candidates directed at three different targets with the potential to deliver as many as seven treatment options. Mpex will be responsible for the discovery of EPI drug candidates and the development of combination product candidates through clinical proof of concept, at which point GSK will have an option to exclusively license each product candidate for further development. Mpex will retain rights to product candidates GSK does not select. Mpex will receive an $8.5 million upfront payment and a $6.5 million equity financing commitment from GSK. Mpex is also eligible to receive development, regulatory and commercial milestones of as much as $250 million for each product candidate. If GSK exercises its option, Mpex will receive tiered royalties based on sales.

"The critical role of antibiotic efflux has been well recognized in bacterial resistance, but to date, safe and effective efflux pump inhibitors have not been developed. Given the progress Mpex has made in this program over the last several years, we are optimistic that combining our efforts with an industry leader such as GlaxoSmithKline will maximize our chances of success to develop a portfolio of products from this platform technology that is greater than we could hope to develop on our own," said Daniel Burgess, president and chief executive officer of Mpex Pharmaceuticals.

 

 

 

DSM Biologics and Crucell N.V. have achieved a record yield of more than 27 grams per liter in the production of IgG antibodies using PER.C6 technology. In March 2008 a yield of 15 grams per liter was reported. Higher yields can mean lower production costs and reduced risk in drug development. Also, the glycosylation of monoclonal antibodies and proteins, produced using PER.C6 technology, is fully human.

Scientists at Percivia PER.C6 Development Center , a joint venture between DSM and Crucell, have shown that they can reproduce the manufacture a record amount of product with more than 95% viability and unchanged product quality. This was achieved using standard bioreactor equipment and readily available cell culture medium. The result of this effort provides the biotechnology industry with a reliable production platform to economically manufacture large amounts of therapeutic proteins more easily.

Marcel Lubben, vice president business development at DSM Biologics, said, "We are extremely pleased with this achievement. This milestone coincides with our commitment to provide the most inherently robust manufacturing platform and ensure the utmost product quality for protein manufacturing. Our mission of only the best quality for manufacturing is echoed by the PER.C6 technology platform."

 

 

Eli Lilly and Co. received approval from the FDA for Cymbalta (duloxetine HCl) for the management of fibromyalgia, a chronic widespread pain disorder. Cymbalta is the first serotonin-norepinephrine reuptake inhibitor that has shown efficacy in reducing pain in patients with fibromyalgia. Cymbalta is also approved for the management of diabetic peripheral neuropathic pain (DPNP), the treatment of major depressive disorder, and generalized anxiety disorder.

"The approval of Cymbalta is important because it provides physicians and patients with a new treatment option shown to help reduce pain and improve functioning in this difficult-to-treat disorder," said Madelaine Wohlreich, M.D., medical advisor and research physician at Lilly.

 

 

Invitrogen Corp. has agreed to pay $6.4 billion in cash to acquire Applera's Applied Biosystems (AB) Group. AB develops DNA analysis devices for sequencing human genes. Earlier this year, the company announced it had sequenced an entire human genome for less than $60,000, down from the $3 billion spent on the Human Genome Project five years ago. Invitrogen makes a broad range of biochemicals and equipment used in government, academic and corporate medical research labs.
   
The two companies' complementary technologies "will drive the price of decoding that genome ever lower," said Invitrogen's chief executive officer, Greg Lucier.
   
The new company will take the Applied Biosystems name and be led by Mr. Lucier. AB chief operating officer Mark Stevenson will serve as chief operating officer and Invitrogen chief financial officer, David Hoffmeister, will retain his position. The new company's board will include Invitrogen's nine current directors along with three members from the current Applera board.
   
"Certainly the promise of personalized medicine — getting the right drug at the right time to the right patient — is absolutely a driver in thinking about future markets," Mr. Stevenson said.
   
"With this acquisition, we are nearly doubling our consumables business as almost half of Applied Biosystems's revenues are consumable in nature," said Mr. Lucier.
   
The acquisition, which needs to be approved by both companies' shareholders, is expected to close this fall.

Parexel International has reached an agreement to acquire ClinPhone, a clinical technology organization headquartered in Nottingham, UK. The acquisition is based on the offer price of approximately $182 million.
   
Josef von Rickenbach, chairman and chief executive officer of Parexel, said, "As the use of technology has expanded in the conduct of clinical research, Parexel has been a leader in helping to advance the convergence of services and technology in the market. Biopharmaceutical companies have increasingly demanded Parexel technology solutions and expertise to support the full range of clinical development activities while improving the speed and efficiency of clinical programs. We anticipate that this acquisition will bring the many technologies and capabilities of ClinPhone into the Parexel organization and advance our position as a clinical technology leader."
   
The acquisition is expected to close by September 30th.

GlaxoSmithKline plans to cut 350 jobs, or 2% of its research staff, as part of an ongoing restructuring plan aimed at increasing productivity, according to a company statement.
   
"We continue to reshape our R&D operations to take advantage of new scientific opportunities and improve GSK's productivity," according to a company statement. "Regrettably some job reductions are necessary and we will do everything we can to support those employees who are affected."
   
In October, the company announced plans to cut jobs and possibly close some sites as part of a $3.1 billion program to cut costs, increase R&D, and streamline manufacturing. The program is expected to save as much as $1.4 billion in costs by 2010.

Almac Group has created a separate division called Almac Discovery, focussed exclusively on the discovery and development of novel approaches to the treatment of cancer and associated conditions, with the goal of developing a biomarker or diagnostic with each potential new drug. According to the company, projects will generally be taken to clinical proof of concept (or earlier) before out-licensing or partnering for further development. Almac Discovery is looking to build its internal pipeline through partnerships and in-licensing.
   
Sir Allen McClay, chairman and founder of the Almac Group, said, "The launch of Almac Discovery is an exciting opportunity to drive forward  a dedicated effort toward the development of novel therapeutics for the treatment of cancer. Almac Discovery provides us the opportunity to build upon the strong research base already established within the  academic community within Northern Ireland in the basic biology of  cancer, and make a real and lasting contribution towards the  advancement of human health."

AMRI will receive a $4 million milestone payment from Bristol-Myers Squibb following BMS's submission of a Clinical Trial Application (CTA) to the Health Products and Food Branch (HPFB), Health Canada for approval to initiate Phase I studies on an AMRI compound licensed to BMS. Upon approval, BMS may begin Phase I testing in Canada.
    
This compound is a biogenic amine reuptake inhibitor, which may represent a new class of therapeutic agent that could lead to an improved treatment for depression or other CNS disease indications. The two companies are researching treatments for depression and diseases of the central nervous system (CNS) as part of their collaboration. AMRI and BMS will continue to evaluate additional compounds under this pact.

"We are pleased to announce the achievement of a second milestone in our research collaboration with Bristol-Myers Squibb," said AMRI chairman, president and chief executive officer Thomas E. D'Ambra. "The advancement of our licensed compound to a Phase I trial is a significant first for AMRI, demonstrating the ability of AMRI's internal R&D efforts to generate valuable assets with commercial potential. We continue to believe that the biological mechanism underlying this approach has the potential to ultimately generate multiple clinical candidates."
    
AMRI received its first milestone payment of $1.5 million in June 2007, when this compound was chosen by BMS for development. Under the agreement, AMRI is eligible to receive as much as $66 million per compound in development and regulatory milestone payments for the first two compounds, and additional payments of as much as $22 million on subsequent compounds. The company will also receive royalties on worldwide sales of commercialized compounds.

Sylvain Mandeville, Ph.D. has been named director of bioanalytical services, Ricerca Biosciences, LLC.  Dr. Mandeville will be responsible for all bioanalytical services and will be based in Concord, OH.
   
Dr. Mandeville has extensive management experience with bioanalytical services, including more than 15 years of varied experience in the contract research industry. He also has experience as a research scientist and was responsible for the development and implementation of new bioanalytical methods required for maintaining and expanding activities of the Analytical Research Center (ARC).
   
Prior to joining the company, Dr. Mandeville led bioanalytical and business development efforts for LAB Research Ltd. As the senior director, he was responsible for reengineering the analytical department and setting up a bioanalytical department as well as supervising the operations and promoting sales and marketing activities. Dr. Mandeville also managed bioanalytical services for Phoenix International Life Sciences in Montreal, Canada.
   
"We are extremely pleased to have someone with Sylvain's knowledge and abilities join our team," said Dr. James Szabo, vice president of Biology Services. "He has demonstrated excellence in operating contract bioanalytical services in the domestic and international marketplace. Dr. Mandeville's contributions will complement Ricerca's successes in building a unique preclinical services team based in Concord."

Daiichi Sankyo Co. plans to purchase a controlling stake in Ranbaxy Laboratories Ltd. for approximately $4.6 billion, acquiring 50.1% of the company, according to a company statement. Ranbaxy's chief executive officer, Malvinder Singh, will retain his current position.
   
The purchase would position Daiichi Sankyo third in the generic drug market behind Teva Pharmaceutical Industries Ltd. and Novartis AG's Sandoz unit. The acquisition also gives the company more reach in emerging regions including India, China and Eastern Europe.
   
Mr. Singh said, "I am delighted to announce our association with Daiichi Sankyo, that puts us on a new and much stronger platform to harness our capabilities in drug development, manufacturing and global reach. Together with our pool of scientific, technical and managerial resources and talent, we would enter a new orbit to chart a higher trajectory of sustainable growth in the medium and long term in the developed and emerging markets organically and inorganically."
   
The closing of the transaction is subject to approval of shareholders of Ranbaxy and customary regulatory and statutory approvals. The acquisition is expected to be completed by the end of March 2009. Upon completion, Ranbaxy will become a subsidiary of Daiichi Sankyo.

Patheon, Inc. is expanding its Manati, PR facility to add a dedicated high potency and controlled substance manufacturing area. The company will invest $2.8 million in a new 3,386-sq.-ft. area that will include three manufacturing suites, air lock containment areas, and humidity controlled air systems.
   
The three manufacturing suites will create one manufacturing area technology transfer, bulk production, bulk packaging, and storage. The production area will have capacity for high potency and humidity-controlled solid dosage form products. Construction is expected to be complete by the end of September 2008.
   
"The Manati expansion is part of our strategy to satisfy the special manufacturing needs of our current and future customers," said Terry Novak, Patheon's president of North America and chief marketing officer. "Other Patheon sites have extensive capabilities to manufacture products of this type. The addition of this capability in Puerto Rico provides another high quality manufacturing site option to our customers."

WuXi PharmaTech has signed a new three-year collaboration agreement with AstraZeneca, expanding a two-year, $14 million collaboration from April 2006 under which WuXi delivered more than 100,000 compounds ahead of schedule. Under the new agreement, WuXi PharmaTech will synthesize compounds, according to AZ's designs, which will further expand AZ's global compound collection.
   
"This new collaboration agreement further strengthens our already productive relationship with AstraZeneca, and it is the direct result of our research capability and firm commitment to quality and customer satisfaction," commented Dr. Ge Li, Chairman and chief executive officer of WuXi PharmaTech, "We are hopeful that with our strong and growing drug R&D capabilities the expansion of our collaboration will help AstraZeneca achieve its strategic goals."
   
"The collaboration with WuXi PharmaTech has exceeded our expectations delivering value to AstraZeneca beyond the cost savings in labor and materials," said Deborah Hartman, vice president, Lead Generation Discovery Enabling Capabilities and Sciences (DECS), AZ, "We are looking forward to the prospect of building on this success through our expanded relationship."

UCB and Otsuka Pharmaceuticals Co. have signed collaboration agreements under which the two companies will co-promote the anti-epileptic drug, Keppra and Cimzia for the treatment of Crohn's Disease, in Japan. They will also co-develop and co-promote these drugs in other indications. UCB will join Otsuka in co-promoting the anti-platelet agent Pletaal to selected accounts for a limited period. UCB will receive as much as $178 million in upfront and milestone payments as well as funding for the clinical development of Keppra and Cimzia.
   
"We are excited to enter into this important strategic relationship with Otsuka, which is one of the top Japanese pharmaceutical companies and which has an excellent reputation in drug development, marketing and sales and an entrepreneurial culture that is consistent with our own," said Roch Doliveux, chief executive officer UCB. "This relationship will ensure that together we can successfully launch and maximize the potential of Keppra and Cimzia in Japan and accelerate market access for the benefit of patients in Japan."
   
"We highly evaluate these compounds and UCB's experience in this area," said Tatsuo Higuchi, president and representative director of Otsuka Pharmaceutical Co. "We are delighted to have this opportunity to collaborate with UCB to address the unmet medical needs of patients suffering from these diseases and to develop these innovative products and expand our businesses together."
   
The companies plan to submit filing dossiers for Keppra in epilepsy and Cimzia in Crohn's disease to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) by early 2009.

Daniel G. Franklin has been appointed regional manager, compliance services, Integrated Project Services (IPS), based in Indiana. Also, Matthew Stefanowicz has been appointed regional manager, compliance services based in North Carolina.
   
“With their depth of experience and background, we anticipate that Dan and Matt will deliver tangible, long-term value for our clients located in the Midwest and the South,” said Dave Goswami, PE, president and chief operating officer, IPS. “Our commitment to attract, hire and retain the industry’s best talent is a result of our ongoing commitment in helping our clients succeed by delivering technical expertise.”
   
Mr. Franklin has 23 years of technical expertise in development and execution of Commissioning & Qualification (C&Q), preventive maintenance and project information management programs. Throughout his career, Mr. Franklin has focused on increasing the effectiveness and improving cost and schedule performance of asset delivery and life cycle operations and maintenance programs. Mr. Franklin’s experience includes engineering and C&Q positions of increasing responsibility with Eli Lilly and Co. and providing senior level validation experience for pharmaceutical services at Performance Solutions, LLC. He was also employed by Rockwell International, where he provided maintenance and logistics operations for NASA and United States Air Force aerospace programs.
   
Mr. Stefanowicz brings 15 years of professional experience specializing in developing, executing and managing engineering and C&Q projects in accordance to good engineering practice and project life cycle. He has both client side and consulting expertise and offers extensive pharmaceutical and biotechnology experience with companies such as Novo Nordisk, Bayer Biologics, and Wyeth. On the consulting side, he has project management and C&Q expertise with SOP Validation, Inc., Barry-Wehmiller Design Group, Inc. and JM Hyde Consulting. He has completed project work for clean-in-place, steam-in-place, bioreactors, autoclaves, incubators, isolators, major utility systems packaging systems and cleaning validation.  

Cold Chain Technologies (CCT) has opened its new plant in Reno, NV and has expanded its plants in Massachusetts and Tennessee, doubling its Massachusetts thermal testing facility. Also, CCT has named Jeff Bernardi, Reno plant manager and Jamie Chasteen as the new West coast sales engineer, based in San Francisco.
   
According to Larry Gordon, president of CCT, “We’ve made a major investment in expanding our facilities and establishing partnerships in direct response to our customer’s needs for local, on-time delivery and support. We’ve located our plants near pharmaceutical distribution centers and logistics providers.”
   
Bob Bohne, CCT’s vice president, general manager, said, “As always, our lean operation is focused on improving efficiency and service levels as we increase capacity in production and distribution. We recognize the impact of being close to our customer’s distribution network. As our business grows, we’re committed to expanding our presence even further in the U.S. and Europe.”

Anna S. Richo has been appointed senior vice president, Worldwide Compliance, Amgen. Ms. Richo will head the organization responsible for the company’s corporate compliance and business ethics programs. She will report to Amgen chairman and chief executive officer, Kevin Sharer.
   
Ms. Richo joined the company in 2003 and was most recently vice president, Law, responsible for worldwide management of all corporate litigation and law department operations. Prior to Amgen, she spent 12 years at Baxter Healthcare Corp. in roles of increasing responsibility in law, including vice president, Law, for Baxter’s BioScience Division. Also, Ms. Richo served on the board of directors of Cytyc Corp. and was a member of the audit and finance committees.
   
“As the compliance demands on biopharmaceutical companies are increasing, we want to ensure Amgen’s continued excellent performance in this area in the interests of patients and all our stakeholders,” said Mr. Sharer.

Takeda Global R&D Center reported results from five Phase III studies of alogliptin as an oral treatment for type 2 diabetes, which has been shown to be a highly selective inhibitor of dipeptidyl peptidase-4 (DPP-4). Alogliptin administered once daily demonstrated statistically significant reductions in hemoglobin A1c (HbA1c) versus placebo as a monotherapy and as an add-on therapy with the major classes of type 2 diabetes medications: metformin, thiazolidinediones, insulin and sulfonylureas.
   
In the alogliptin monotherapy study, a significantly greater percentage of patients achieved HbA1c levels of less than or equal to 7%. Similar results were seen in the add-on to metformin, thiazolidinedione and sulfonylurea studies. Across all studies, patients achieved significant reductions in HbA1c of as much as .80%, depending on alogliptin dose and treatment regimen. Greater HbA1c reductions were seen in patients with higher baseline HbA1c. Safety results showed that alogliptin was weight neutral and well tolerated in patients with type 2 diabetes, with an incidence of hypoglycemia similar to placebo.

Amylin Pharmaceuticals, Lilly and Alkermes announced results from a 30-week study comparing the efficacy of exenatide once weekly (a long-acting release formulation of exenatide) to Byetta (the injectable version of exenatide), in type 2 diabetes. Patients treated with exenatide once weekly, an investigational therapy, showed statistically significant improvements in A1c and fasting plasma glucose from baseline compared with Byetta. Patients in both treatment groups also reported significant weight loss (average of 8 pounds) and 77% of patients treated with exenatide achieved an A1c of 7% or less.  
   
Byetta is indicated as adjunctive therapy to improve glycemic control in patients with type 2 diabetes mellitus who are taking metformin, a sulfonylurea, a thiazolidinedione, a combination of metformin and a sulfonylurea, or a combination of metformin and a thiazolidinedione but have not achieved adequate glycemic control.
   
The 30-week study was randomized, open-label study of 295 patients with type 2 diabetes who were treated with exenatide once weekly 2.0 mg or Byetta twice daily subcutaneously. Patients in both groups who completed the randomized portion of the study continued in an open-ended portion of the study to receive exenatide once weekly.
   
Exenatide once weekly uses a technology for long-acting medications developed by Alkermes, which encapsulates active medication into polymer-based microspheres that are injected into the body where they degrade slowly, gradually releasing the drug in a controlled manner to provide continuous therapeutic concentrations.

Patheon

2Q Revenues: $186 million (16%)

2Q Loss: $8.5 million (loss of $22 million in 2Q07)

YTD Revenues: $350 million (+14%)

YTD Loss: $23.7 million (loss of $24 million YTD07)

Comments: Commercial manufacturing revenues in the quarter increased 15% to $151.2 million driven by strong growth in Europe particularly in Bourgoin-Jallieu, France and growth in North America led by Whitby. Pharmaceutical Development Services revenues increased 23% to $34.8 million, with growth in both North America and Europe. Total North American revenues YTD08 increased 3% and European revenue increased 30%.  

GlaxoSmithKline has completed its acquisition of Sirtris Pharmaceuticals, Inc. for approximately $720 million in cash. Through the acquisition GSK has enhanced its metabolic, neurology, immunology and inflammation research efforts by establishing a presence in the field of sirtuins, a recently discovered class of enzymes believed to be involved in the ageing process.
   
Sirtris will become part of GSK's Drug Discovery organization, while continuing to operate from labs in Cambridge, MA as an autonomous unit. Christoph Westphal, chief executive officer and vice chair of Sirtris, and the management team will continue to lead this unit.

Charles E. Triano has been named senior vice president, investor relations, Pfizer, effective June 23. Mr. Triano will be responsible for all investor relations functions, including communicating the financial and operational performance of the company with institutional and retail investors. He will report to chief financial officer Frank D’Amelio.
   
Mr. Triano served as the vice president of investor relations at Forest Laboratories since 2000, where he initiated the company’s first formal investor relations and corporate communications program. Previously, Mr. Triano served as director of investor relations at Bristol-Myers Squibb Co. and as managing director at The Carson Group (acquired by Thomson Financial in 2000).
   
“We are pleased to welcome Chuck to Pfizer,” said Mr. D’Amelio. “As a seasoned investor relations executive who has earned the trust of the investment community and built a highly respected investor relations program, Chuck will be a clear asset to our company. In addition, he brings a deep knowledge of the pharmaceutical industry and its regulatory environment combined with extensive investor relations experience, which will continue to strengthen our relationship with the investment community and our shareholders.”

Ipsen, S.A. and Tercica have entered into a definitive merger agreement under which an affiliate of Ipsen will acquire all outstanding shares (approximately 43%) of Tercica for approximately $663 million in cash. This transaction, which is subject to approval by Tercica stockholders, has been approved by Tercica's board of directors.

"The combination of Ipsen's and Tercica's development and product portfolios provides the opportunity to create a leading global endocrinology company," said John A. Scarlett, M.D., chief executive officer of Tercica. "We believe this transaction recognizes the value we have created at Tercica and provides our stockholders with attractive financial terms."

Merck Serono and development partner ZymoGenetics have initiated a Phase II/III trial of atacicept in patients with systemic lupus erythematosus (SLE) to evaluate the efficacy and safety of the drug for the treatment of SLE.

The study is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. A second Phase II/III study in lupus nephritis, a severe form of SLE in which the kidneys are affected, was initiated in December 2007. These two studies are part of a potential registration package to support worldwide applications for marketing authorization.

The one-year, randomized, double-blind, placebo-controlled international trial will enroll approximately 500 patients with SLE. The trial will evaluate the efficacy and safety of atacicept compared to placebo in preventing SLE flares. The primary endpoint is the proportion of subjects experiencing a new disease flare, based on BILAG (British Isles Lupus Assessment Group) measurements, during the treatment period.

Michael Faughnan has been named business development director of Eden Biodesign's U.S. subsidiary, Eden Biodesign, Inc. He will support Dr. Roger Lias, president of Eden Biodesign, Inc. and group commercial director, with the company’s expansion in the U.S. and is responsible for North American Business Development activities.
 
Located in southern California, Mr. brings more than 14 years of experience in successfully aiding clients in accelerating their biopharmaceutical products into and through clinical development and to commercial launch, according to a company statement. Said Dr. Lias, "Michael brings tremendous experience and will be an invaluable asset as we continue to build our U.S. infrastructure and expand our services to clients in the North American market."
 
Most recently, Mr. Faughnan was manager of sales and business development at Cytovance Biologics, where he was responsible for North American commercial activities.  Previously he spent five years as territory manager in the industrial cell culture media division of Irvine Scientific. Prior to that, he was a sales professional at Woodside Biomedical, now part of Abbott Laboratories.

Novartis plans to acquire Protez Pharmaceuticals for as much as $400 million. Protez is a privately held biotechnology company based in Malvern, PA. Its lead drug candidate, PZ-601, is an injectable antibiotic in Phase II development for the potential treatment of drug-resistant staph infections, known as MRSA, and other hospital infections. Novartis would acquire licensing rights to the drug in North America and Europe.
   
"We believe the growing presence of Novartis in the specialty field of hospital infections provides Protez the support required to fully execute its vision, advance its product pipeline and positively impact human health," said Protez chief executive officer, Christopher Cashman.
   
As part of the transaction terms, Novartis would pay $100 million upfront and as much as $300 million in milestone payments. The company would run as a stand-alone unit of Novartis, which has its U.S. pharmaceuticals headquarters in East Hanover, NJ.

Microtest Laboratories has doubled its microbial identification and analytical services with the purchase of an additional MicroSeq Microbial Identification System. The MicroSeq is a DNA sequence-based system used to identify bacteria isolates that are not viable or easily identified. Using the MicroSeq system, according to the company, can provide precise and reliable bacteria, mycoplasma, and mold identification in a 24-hour time period.
   
"With the purchase of our second MicroSeq system, we are not only complimenting our existing unit but doubling our analytical capacity and ability to service our clients," stated Dr. Steven Richter, Microtest president and chief scientific officer. "As one of the only testing labs in the area with this technology, we are providing our customers with a significant competitive advantage."
   
The MicroSeq system is integrated for use across all Microtest services including analytical testing services in: contract manufacturing, pharmaceutical testing and validation, medical device testing and validation, environmental control and testing, water validation, mold identification, and biologics/virology.

Kathleen Hodges has been appointed to the new position of vice president of quality, BASi (Bioanalytical Systems, Inc.). Ms. Hodges has corporate-wide responsibility for all matters relating to quality and regulatory issues. She has a background in quality, documentation and compliance in the pharmaceutical industry. She is a Certified Quality Auditor and a Certified Manager of Quality/Organization Excellence. Ms. Hodges reports directly to the chief executive officer, Richard M. Shepperd.

Patheon, Inc. has established a Japanese subsidiary based in Tokyo, Japan. Patheon K.K. will operate from a new office located in the Nihonbashi district of central Tokyo and will support Patheon's business requirements in the region. Local staff will be added to the Tokyo office to fulfill the company's Asian business development and service support requirements.
   
"This provides Patheon with a permanent presence in Japan to target new customers and support existing ones in Japan and other Asian markets. It demonstrates our commitment to build on our existing customer base in this very important region," said Wes Wheeler, president and chief executive officer, Patheon. "Patheon's growing number of development projects in Asia, particularly Japan, has highlighted the need to establish a physical presence in this key market to more efficiently support and service our valued customers in the region."

Kendle has acquired DecisionLine Clinical Research Corp., a privately held, early phase CRO with a state-of-the-art medical facility in Toronto, Canada. DecisionLine specializes in Phase I studies involving the measurement of pharmacodynamic effects of central nervous system (CNS) drugs. The company adds scientific expertise with psychopharmacology exploratory/translational medicine capabilities as well as drug development consulting, medical writing, data management, biostatistics and other support services. The acquired business will report into Philip J.W. Davies, vice president, early phase, Kendle. Terms of the transaction were not disclosed.
   
"With Phase I growth expected to outpace the broader outsourcing market at approximately 15% annually, early phase development remains an important need for our customers and an area of significant growth opportunity for Kendle," said president Simon Higginbotham. "The addition of DecisionLine is an important step in building Kendle's global capabilities for exploration of early phase drug candidates and supports our strategic initiative to drive growth in our Phase I business."
   
DecisionLine was founded in 1997 by president and chief executive officer, Edward M. Sellers, M.D., Ph.D., FRCPC, FACP and senior vice president, research development and medical affairs, Myroslava K. Romach, MSc, M.D., FRCPC. The 36,000-sq.–ft. facility has 82 beds and is staffed by a team of approximately 110 full-time and 130 part-time associates. Dr. Sellers will serve as general manager, early phase, Toronto and senior scientist, Kendle International and Dr. Romach will serve as head of clinical operations and medical affairs, early phase, Toronto and senior scientist, Kendle International.

Sartorius Stedim Biotech has entered into an agreement with WuXi AppTec, Inc., a subsidiary of WuXi PharmaTech, to work on viral clearance studies. Under this agreement, WuXi AppTec will provide the relevant viruses, materials and methodologies to Sartorius Stedim Biotech to employ in conducting non-GLP viral clearance testing of its technologies with customer products and for supporting its own R&D activities.
    
Sartorius Stedim Biotech markets an orthogonal and integrated three-step viral clearance technology platform to the biopharmaceutical industry. To support its customers and to meet regulatory expectations, the company has built an in-house lab for non-GLP viral clearance testing of its technologies.
   
The non-GLP viral clearance testing during early-stage process development will allow Sartorius to recommend the best viral clearance technology option. Sartorius and WuXi AppTec will be using the same viruses, materials and methodologies so that customers can anticipate predictive study results of what might be expected from WuXi AppTec´s GLP Viral Clearance testing of the same product as part of the IND process and eventually the Phase III validation process.
   
“Viral clearance studies are gaining more importance at early stage process development and with WuXi AppTec we have found an excellent partner to realize both early stage non-GLP testing at Sartorius and GLP testing at WuXi AppTec,” said Reinhard Vogt, vice chief executive officer sales and marketing and member of the board of Sartorius Stedim Biotech.
   
“We are very pleased to be able to partner with Sartorius Stedim Biotech in offering this unique benefit for biopharmaceutical manufacturers,” said WuXi AppTec vice president Larry Thomas. “It is a perfect fit with our company’s commitment to providing clients with seamless single-source solutions to help shorten the time from initial process development to a successful IND.”

Dr. Philip William Small has been named managing director of European operations, AMRI. Dr. Small joined the company as director of chemistry in November 2007 to lead all scientific efforts at the Hungarian-based organization. He replaces Dr. Michael Guaciaro, who returns to AMRI’s headquarters in Albany, NY, upon completing a short-term assignment related to the former Hungarian business known as Comgenex, acquired by AMRI in 2006.
   
“Dr. Small will play a critical role in managing the site’s efforts and focus on increasing profitability and accelerating growth of the business as AMRI seeks to expand its presence in the European marketplace,” said AMRI chief executive officer, Thomas E. D’Ambra, Ph.D. “His prior demonstrated experience in strategic growth, direction and leadership, combined with his knowledge of the AMRI business acquired to date sets the stage for Dr. Small and his team to execute against defined opportunities and plans for the future of our European operations."
   
Prior to joining AMRI, Dr. Small was vice president and head of high-throughput chemistry operations at Tripos Discovery Research, where he played a major role in growing the company as well as influencing strategic direction and corporate objectives. Dr. Small has more than 20 years of experience leading combinatorial chemistry/drug discovery companies in addition to Tripos including scientific leadership positions at OSI Pharmaceuticals, Oxford Diversity/OAI and Unilever Research.  

Mylan, Inc. has acquired Merck KGaA's Central and Eastern Europe (CEE) generics businesses, which include operations in Poland, Hungary, Slovakia, Slovenia and the Czech Republic. Mylan exercised its option to acquire these businesses as part of a previous agreement from October 2007 in which Mylan acquired Merck KGaA's generics business (Merck Generics) in Western Europe, Asia-Pacific, Africa and North America.
   
"Our acquisition of the CEE businesses gives us access to an additional area with significant growth opportunities for generics," said Mylan vice chairman and chief executive officer, Robert J. Coury. "It reflects our global strategy to leverage existing platforms, rather than create start-up organizations. In that respect, we believe the CEE businesses will benefit significantly from Mylan's scale, vertical and horizontal integration, and robust product portfolio."
   
"My team and I are excited to have back the CEE businesses, which I helped establish when I was a part of the Merck Generics organization," said Didier Barret, president of Mylan Europe, Middle East and Africa. "We're eager to continue to build upon our pan-European presence and execute the growth strategies we've always had in mind for this region."

Amgen reported results from three denosumab studies in cancer patients. A Phase II study of metastatic patients previously treated with IV bisphosphonates found that denosumab normalized a key marker of bone resorption at a greater rate than with IV bisphosphonates. Patients also experienced fewer skeletal-related events (SREs) with denosumab. A separate analysis comparing these results to another Phase II study of patients never treated with an IV bisphosphonate showed that the effect of denosumab on bone turnover markers was similar regardless of previous exposure to bisphosphonates. In addition, analysis of a Phase III trial in an earlier-stage cancer population of non-metastatic breast cancer patients showed that denosumab increased bone mineral density (BMD) at all sites measured, including cortical bone.
   
The II study evaluated patients whose urinary N-telopeptide (uNTx) levels had not normalized despite treatment with IV bisphosphonates. The primary endpoint of patients with uNTx less than 50 at week 13 was achieved by 71% of patients in the denosumab arms compared with 29% in the IV bisphosphonate arm. Denosumab also induced suppression of uNTx levels faster than IV bisphosphonate (9 days versus 65 days, respectively). At week 25, denosumab treatment was associated with fewer on-study SREs (8% versus 20%) in those receiving IV bisphosphonate therapy. Skeletal-related events include fractures, radiation or surgery to bone, and spinal cord compression.
   
The comparison of the effect of denosumab on bone turnover markers in two Phase II trials studied changes in serum-C telopeptide (sCTx), a marker of bone breakdown, from baseline to week 25. This analysis showed that at six months denosumab suppressed bone resorption by 85% in bisphosphonate-naive patients compared with 80% in patients with prior exposure to IV bisphosphonates. In patients previously treated with IV bisphosphonates, denosumab suppressed bone resorption by 80% compared with 45% in patients who continued on IV bisphosphonates.
   
Analysis of the Phase III study showed consistent increased BMD at the lumbar spine, total hip, femoral neck, and distal 1/3 radius at 12 months, regardless of duration or type of AI therapy, prior tamoxifen use, age, body mass index, or baseline T-score.  

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