Baxter International is proceeding with the voluntary recall of all remaining lots and doses of its heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products. The company initially recalled nine lots of heparin sodium injection vials on January 17, 2008 as a precaution due to reports of adverse patient reactions and suspended production earlier this month.
   
The FDA and Baxter held off on recalling all lots of the drug at once to avoid a product shortage, which would impact operating rooms, dialysis centers and other critical care areas. The FDA has concluded that there is now sufficient capacity on the part of other suppliers to provide access to the drug, and has told Baxter that it can now proceed with recalling its remaining heparin products.
   
Although most of the reports of adverse reactions have been associated with the multi-dose products, Baxter is recalling all remaining heparin sodium injection and heparin flush products that are currently on the market. This recall does not involve Baxter's heparin pre-mix IV solutions in bags: heparin sodium in 5% dextrose injection and heparin sodium in 0.9% sodium chloride injection.
   
"We have assurance from the FDA that there is an adequate supply in the market to meet the demand for these critical and lifesaving drugs," said Peter J. Arduini, president of Baxter's Medication Delivery business. "The safety and quality of our products is always our highest priority, and we will continue to collaborate with the FDA as we work to determine the cause of the increased rate of adverse reactions and resolve this issue."
   
Customers have been instructed to discontinue use and to contact Baxter to arrange for return and replacement product.  

Wyeth Pharmaceuticals has ended its collaboration agreements with Solvay Pharmaceuticals for the development and commercialization of bifeprunox, an investigational atypical antipsychotic drug, as well as other compounds in earlier stages of development for the potential treatment of schizophrenia and other psychiatric conditions.
   
The collaboration was terminated after Wyeth assessed the opportunity for bifeprunox, and determined it would not have sufficient commercial value for the two companies to share. All development and commercialization rights in North America for bifeprunox, as well as global rights for the other compounds will now revert to Solvay.

DPT Laboratories has added preparation of the chemistry, manufacturing and controls documents (CMC) in the Common Technical Documents (CTD) format as an optional service for customers applying for approval of new drugs.

The new service provides preparation of CMC modules 2 and 3 documentation throughout formulation and process development in the common format established by the International Commission on Harmonization for submitting NDAs to the FDA and regulatory agencies in the EU and Japan.
   
“An increasing number of pharmaceutical companies are choosing to format the documentation in the CTD format throughout development on an ongoing basis, rather than waiting until the end of the drug development process and having to reconstruct years of paper work,” said Kay Mary Harrell, senior director, Regulatory Affairs for DPT. “Drafting the documentation in the CTD format from the beginning of development and/or manufacturing can shorten the already lengthy drug approval process. At the end of the process, the customer has a submission-ready CMC section.”

Hospira

4Q Revenues: $946.1 million (+34%)

4Q Earnings:  $76.1 million (+61%)

FY Revenues: $3.4 billion (+28%)

FY Earnings: $136.8 million (-43%)

Comments: Sales in the quarter and FY excluding Mayne Pharma sales grew 8% and 4%, respectively. Injectable pharmaceutical contract manufacturing revenues dropped 14% to $37.4 million in 4Q07 and 19% to $149 million for FY07. R&D expenses in 4Q were down 2% to $53.8 million and acquired in-process R&D expenses were $3.2 million, down 68%. Results include assets amortization of $12.5 million related to the Mayne Pharma acquisition; charges of $4.1 million related to the closures of the Donegal, Ireland; Ashland, OH; Montreal, Canada; and North Chicago, IL facilities (part of Hospira's manufacturing optimization initiatives); Mayne Pharma integration charges of $927 million; and $7.5 million related to the impairment of the intangible asset for brain-function monitoring devices.

Eli Lilly and Co. received a not approvable letter from the FDA for Zyprexa long-acting injection (olanzapine LAI) for the treatment and maintenance of schizophrenia in adults. Zyprexa LAI is an investigational formulation that combines the antipsychotic medication Zyprexa (olanzapine) with a pamoate salt, for an extended delivery of up to four weeks.
   
In its letter, the FDA said it needs more information to better understand the risk and underlying cause of excessive sedation events that have been observed in about 1% of patients in clinical trials.  
   
"We are disappointed by the FDA's decision and we are committed to ongoing discussions to better understand the agency's perspective regarding this recent case of excessive sedation and to define the path forward and the associated timeline," said Dr. Jennifer Stotka, vice president of U.S. regulatory affairs, Eli Lilly and Co. "Given the chronic and severe nature of schizophrenia, persistent challenges with adherence, and the limited number of approved depot formulations, we continue to believe that, if approved, Zyprexa LAI would provide a valuable treatment option for patients suffering from schizophrenia."
   
Regulatory reviews of Zyprexa LAI applications are ongoing in the EU and other countries including Canada and Australia.

Cobra Biomanufacturing Plc has entered into a manufacturing development agreement with an undisclosed pharmaceutical partner to produce a protein from the SARS virus in CHO (Chinese Hamster Ovary) cells under cGMP.

Simon Saxby, Cobra Biomanufacturing's chief operating officer, remarked, "We are delighted to work with the company, which is one of the top global players on the biopharmaceutical market. This agreement will leverage Cobra's significant expertise in manufacturing recombinant proteins in compliance with worldwide cGMP requirements."
 
Cobra's partner will carry out the upstream manufacturing of the SARS protein and ship media containing the protein of interest to Cobra. Cobra will perform the downstream work to isolate and purify the protein at its Oxford facility. The SARS protein will be used in Phase I clinical trials.

Vito Mangiardi has been appointed chief executive officer, Bilcare Global Clinical Supplies. Mohan Bhandari, chairman and managing director, Bilcare Ltd., said, "Vito is an exceptional leader and strategist. He has vast experience in global business management, pharmaceutical and biotech contract research and development services, and extensive expertise in clinical supplies. Vito's breadth and depth of experience is unsurpassed in the industry and he is a perfect fit for Bilcare GCS as we continue to experience steady growth."
   
Mr. Mangiardi has 30 years of experience in the clinical supplies, pharmaceutical and biotech industries. He has held key leadership positions throughout his career, most recently serving as president of North American Operations for AAI Pharma where he was responsible for Phase I, formulation development, analytical development, bio-analytical, manufacturing and stability testing, as well as Phase II-IV clinical trials.  
   
Prior to joining AAI Pharma, Mr. Mangiardi served as senior vice president and chief operating officer of global Phase IV services at Quintiles Transnational. He also held other executive level positions at Quintiles including head of the International Clinical Development Services group in Japan, head of the Asia Pacific Business and executive vice president of Operational Services of Quintiles Americas.  
   
Bilcare GCS has also added to its global management team. Reporting to Mr. Mangiardi are: David Laskow Pooley, leading the company's European operations, Vincent Santa Maria, leading the American operations, and Ajit Dubhashi, leading the Asian operations.  

The FDA is launching a new effort for post-approval drug safety, called "Safety First," meant to strengthen its supervision of prescription drugs after approval.
   
The plan, first reported by the Wall Street Journal and confirmed by FDA spokesman Christopher DiFrancesco, includes the creation of a new database of possible side effects from drugs, and to establish schedules for following up on safety concerns.
   
The FDA's plan is an effort to address criticism that the agency has been slow to respond to potential side effects that surface after a medicine reaches the market. A prime example would be Merck's arthritis pill Vioxx, which the company withdrew in 2004 after research found it doubled heart attack and stroke risk.
   
The new plan will help to empower the office that monitors post-approval drug safety. According to some critics, the office that grants approval to new drugs often overrules concerns from the safety office.
   
According to FDA Deputy Commissioner, Janet Woodcock, "The drug safety office will be playing an expanded role in the resolution of certain drug-related safety issues. The safety group will also take the lead on epidemiological studies and medication error prevention."
   
The FDA is expected to testify about the plan today at a congressional hearing.

Vetter Pharma-Fertigung GmbH & Co. has been granted approval by the FDA for the production of a client's new drug. The company will begin filling the drug at its Ravensburg Vetter South (RVS) facility. Vetter provides contract manufacturing services for pharmaceutical and biotech companies and specializes in aseptically pre-filled injection systems used in the production of biotechnological and complex medications.
   
"For us, the approval by the FDA is a vital step in our corporate development," said Thomas Otto, Vetter's managing director. "It means that we can continue expanding our business. It also secures our jobs, our investments and our future projects. In addition, it reinforces our position as an expert in the filling of sensitive substances."

Bayer HealthCare AG has entered into a worldwide, non-exclusive license agreement with Millipore to use its UCOE (Ubiquitous Chromatin Opening Element) technology to manufacture its biologic drugs. The license will enable Bayer to manufacture recombinant proteins in mammalian cells more efficiently by generating higher protein yields in its upstream bioprocessing operations. Financial terms were not disclosed.
   
Bayer HealthCare, based in Leverkusen, Germany, includes Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The company plans to expand the use of the UCOE technology from small-scale use in R&D to large scale manufacturing in an effort to reduce the high cost of manufacturing recombinant protein-based drugs.
   
Manufacturing biologic drugs such as recombinant proteins often begins with growing mammalian cells in a bioreactor. These cells then produce the proteins that form the basis of biologic drugs. According to Millipore, its UCOE technology helps biopharma companies to effectively identify which cells will be most effective in producing proteins during large-scale manufacturing. By more effectively isolating stable and highly productive cell lines, biopharma manufacturers can improve the yield and consistency of their processes.  
   
"We have built successful relationship with Bayer over a number of years, and we are excited about their commitment to the UCOE technology," said Andrew Bulpin, Ph.D., vice president of Millipore's Upstream Bioprocessing business unit. "This license is another example of how we can help pharmaceutical and biotech companies efficiently manufacture biologic drugs for both commercial use and for use in clinical development."

Jay J. Schnitzer, M.D., Ph.D. has been named vice president and associate chief medical officer for Boston Scientific Corp.'s clinical leadership team, effective March 24.
   
Dr. Schnitzer will be responsible for leading the medical input process for the company's Endosurgery, Neurovascular and Neuromodulation businesses. He will also be involved in the formulation and execution of technology strategies for both internal R&D, as well as external business development activities. He will also oversee development and dissemination of scientifically based education materials relating these areas. Dr. Schnitzer will report to chief medical and scientific officer, Dr. Donald S. Baim, M.D.
   
Dr. Schnitzer most recently has served as associate professor of surgery at Harvard Medical School, visiting surgeon at Massachusetts General Hospital (MGH) and pediatric surgeon at Shriners Burns Hospital in Boston. Dr. Schnitzer's major research interests are related to developmental biology of the lung and congenital diaphragmatic hernia (CDH), and combat casualty care.

Douglas W. Axelrod, M.D., Ph.D., has been appointed senior vice president for clinical R&D, Ambrx, Inc.
   
Dr. Axelrod joins the company after a 20-year career at Procter & Gamble Pharmaceuticals. Most recently, he served as vice president of R&D for Discovery, Early Development and Product Development where he accelerated the discovery process, improved the discovery to early development transition and led efficiencies in product development. Dr. Axelrod also led the P&G Worldwide Clinical Bone group, leading drugs such as Didronel and Actonel through late clinical development and regulatory approvals.
   
"Doug has tremendous depth and breadth of experience in drug discovery and development and has been successful in delivering innovative medicines to patients," said Steve Kaldor, Ph.D., Ambrx's president and chief executive officer. "He will be integral to the ongoing build out of Ambrx's development capabilities in support of our rapidly maturing pipeline of clinical and preclinical phase protein drug candidates."
   
Dr. Axelrod added, "I am pleased and excited to join Ambrx at this exciting stage of its development. The company has moved rapidly from proof of concept of the ReCODE technologies to the creation and development of a family of important and practical biologics-based products. I look forward to playing a role in bringing these important products to clinical reality and into the marketplace, both with our collaborators and as independent Ambrx efforts."

United BioSource Corp. (UBC) has expanded its regulatory affairs group led by Mark Ammann, Pharm.D. and LaVonne Lang, Dr. PH. The group, based in Ann Arbor, MI, will provide a full range of services to pharma and biopharma clients, including creating and implementing development plans to satisfy regulatory requirements for the approval of new drugs and providing life-cycle management for marketed products
   
The regulatory affairs group will be headed by Dr. Mark Ammann, a 17-year veteran of the pharmaceutical industry, who has worked with products from early development to post-marketing product support in therapeutic areas as CNS, oncology, dermatology, inflammation, endocrinology and cardiovascular disorders. Dr. Ammann most recently held the position of global head of regulatory affairs at Pfizer Corp., where he was responsible for several therapeutic areas including CNS, inflammation and dermatology.
   
"We are thrilled to welcome Dr. Ammann and Dr. Lang to the UBC team. They give us world-class experience and expertise in navigating through the drug development process with the FDA. This capability complements our specialized regulatory knowledge in areas like health outcomes and post-approval research to provide clients unique regulatory insight in both the pre- and post-approval environment," according to Ethan Leder, UBC chief executive officer and founder.
   
Dr. Lang will serve as senior director, regulatory affairs. Dr. Lang has 18 years of experience in pharmaceutical development, with 12 years in positions of increasing responsibility in regulatory strategy at Parke-Davis and Pfizer.
   
The group will conduct global strategic planning, manage submission and liaison activities with health authorities and handle medical writing of regulatory documents. They will offer services to both emerging and established life science companies.  

Genentech received accelerated approval from the FDA for Avastin in combination with paclitaxel chemotherapy for the first-line treatment of patients with locally recurrent or metastatic breast cancer. The approval is based on Phase III study (E2100) results showing that patients with metastatic breast cancer receiving Avastin with paclitaxel compared to paclitaxel alone, doubled progression-free survival. In Europe Avastin received full approval for the treatment of metastatic breast cancer in March 2007.
   
Avastin was approved in advanced breast cancer under the FDA's accelerated approval program, which allows the FDA to approve products for life-threatening diseases based on initial positive clinical data. Genentech is expecting results from a third Phase III trial in first-line metastatic breast cancer in late 2008. Full approval will be based on the results of two Phase III trials: AVADO (Avastin plus docetaxel chemotherapy vs docetaxel alone), and RIBBON-1 in first-line metastatic breast cancer.
   
"Today’s decision represents a major milestone for patients and oncologists in the U.S.," said William M. Burns, chief executive officer, division Roche Pharmaceuticals. "The FDA has recognized that Avastin is a breakthrough drug which is now approved in Europe and the U.S. for the three cancers with the highest death toll — breast, lung and colorectal cancer."
   
Avastin, an anti-angiogenic agent, has been shown to deliver improved overall and/or progression-free survival in colorectal, lung, breast and, renal cell cancer patients.

Abbott received FDA approval to market Humira as a treatment to reduce signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients four years of age and older. The approval is based on safety and efficacy results from a study of JIA patients four to 17 years old. Humira is the first biologic treatment to receive FDA approval for this condition since 1999.
   
JIA is the most common chronic rheumatic disease in children with onset before age 16. Typical symptoms include stiffness when awakening, limping, and joint swelling, which may limit the mobility of the affected joints. JIA is the sixth approved indication for Humira since 2002.

Azopharma Product Development Group, Inc. has opened a new facility in South Florida. The new 22,000-sq.-ft. facility will house the company’s formulation development services, small-scale manufacturing, development services and specialized analytical services, as well as Azopharma's new drug delivery company, ApiCross. The expanded facility allows for small scale manufacturing from 30 Kg to 50 Kg.

 

According to Phil Meeks, chief executive officer of Azopharma, “Our new facility allows us to expand our service offerings and take on larger scale projects to meet the needs of our pharmaceutical, biotechnology and medical device clients.”

 

The facility supports formulation development services including semi-solids, liquids, solids, multi-layer tablets, lotions/creams, gels, transdermal patches, cytotoxic and highly potent compound development services.  

 

This new facility allows Azopharma to provide the full spectrum of development services required to be a leader in the industry. Mr. Meeks continued, “Azopharma Product Development Group is only one of a few organizations in the U.S. that are capable of developing a full spectrum of dosage forms from discovery through commercialization. By bringing together the best scientists in the field, state-of-the-art facilities and our focus on quality means that we can provide our partners a winning combination in total product development.”

The NDA for prasugrel, a treatment for patients with acute coronary syndrome being managed with percutaneous coronary intervention (PCI), has received priority review status from the FDA. Prasugrel, submitted by Daiichi Sankyo Co. and  Eli Lilly, is likely to receive notice of action within six months of its Dec. 26, 2007 submission date.

"We are greatly pleased to learn that the FDA has determined the application meets its criteria for such a review, and we look forward to working with the agency as it continues its review process," said Dr. J. Anthony Ware, Lilly vice president for cardiovascular/acute care.

"If approved, prasugrel will provide physicians and acute coronary syndrome patients an alternative medicine that may further help reduce the risk of heart attacks," said John Alexander, M.D., M.P.H., global head of research and development, Daiichi Sankyo Co., Ltd.

Prasugrel could be positioned as a competitor to Plavix, which is marketed by Bristol-Myers Squibb and Sanofi-Aventis.

Molecular Profiles, a contract research services provider, has named Dr. Mike Fanfarillo as operations director and Dr. Robert Sherry as associate director in pharmaceutics. "We are delighted to announce these two new appointments as an expansion to our team", comments Dr. Nikin Patel, Molecular Profiles' chief executive officer. "Following on from the recent successful recruitment of a number of experienced scientists, both Mike's and Robert's extensive specialisms reinforce Molecular Profile's commitment to enhancing our in-house expertise and service offering."

As operations director, Dr. Fanfarillo is responsible for the management of research projects and the development of the technical team and services. He is also a study director on numerous patent-related projects. He has more than 20 years' experience in the pharmaceutical industry having worked for ICI/Zeneca Pharmaceuticals, Boots Healthcare International and Reckitt Benckiser Healthcare International. His expertise covers the range of preparative, analytical and characterization techniques used in the pharmaceutical development of medicinal products, from chromatography to spectroscopy. Dr. Fanfarillo also has extensive experience of writing and assembling Drug Product License applications, writing Pharmaceutical Expert Reports and assessment of API Drug Master Files from third-party manufacturers.

Dr. Sherry is an expert in a wide range of product dose forms. In his role as associate director in pharmaceutics, he will consult on a range of formulation issues facing pharmaceutical companies in the development of their products, including utilizing outputs from investigations to assert intellectual property rights for these clients. He is also responsible for directing technical studies to resolve complex formulation issues and for developing collaborations with academic and industrial experts. Dr. Sherry has more than 20 years of industrial experience at Boots Healthcare International covering a wide range of formulation types and product formats. He has particular experience of regulatory requirements for new license submissions, clinical trials manufacture and significant patent experience, with several formulation and process patents granted.

Fred Larimore, Ph.D. has been named vice president of scientific affairs and chief scientific officer for Cook Pharmica, the global contract biopharmaceutical manufacturing division of Cook Medical.
   
Dr. Larimore has more than 25 years of biotech experience beginning at Eli Lilly with the development and manufacturing of recombinant human insulin. His career at Eli Lilly included integral work for recombinant human growth hormone, recombinant human parathyroid hormone, bovine somatotropin, and several research monoclonal antibodies and antibody conjugates. Additionally, he led multiple initiatives in process aspects of facility design, scale-up and start-up. He was responsible for the redevelopment of the recombinant human insulin and recombinant human growth hormone processes and provided technical leadership and oversight for the company’s protein product portfolio.
   
“Fred has provided critical leadership for the development group for the last two years and has been extremely effective in building a strong team,” said Cook Pharmica president Jerry Arthur. “His extensive industry experience, scientific expertise, and strong leadership qualities have been foundational to the success of our company and will continue to be as we expand.”

Genmab and PDL BioPharma, Inc. have entered into an agreement under which Genmab will acquire PDL's antibody manufacturing facility in Brooklyn Park, MN, for $240 million in cash. The transaction includes land, equipment and access to a leased space with a development lab.        
   
The facility has a production capacity of 22,000 liters, which the company expects will be sufficient to sustain both clinical and commercial scale material for its pipeline. The facility has two 1,000 liter and two 10,000 liter bioreactors, which support the simultaneous manufacture of multiple antibody products and will allow the company to transition three antibodies from research to manufacturing per year.
   
"Over the past few years Genmab has been preparing for the market launch of our late stage antibodies and we continue to build a broad pipeline of antibody products, which currently includes 10 products in clinical development. Consequently, the need to secure significant manufacturing capacity has become an increasing priority," stated Lisa N. Drakeman, Ph.D., chief executive officer of Genmab. "We believe that the new PDL manufacturing facility, with its complete antibody process development platform, represents our best option to secure manufacturing capacity, allowing Genmab to produce antibodies more efficiently and cost effectively while adding key manufacturing expertise to our capabilities we continue to build for a commercial future."
  
"We are pleased to enter into this agreement with Genmab, which we believe is the optimal transaction to fully realize the value of our biologics manufacturing facility. Importantly, it also represents another step in delivering on our commitment to maximize the value of PDL's assets for our stockholders, following on the recent sale of our commercial assets," said L. Patrick Gage, Ph.D., interim chief executive officer of PDL.
   
Following the acquisition, Genmab plans to retain approximately 170 employees currently working at the facility. As part of the transaction, under a clinical supply agreement, Genmab will produce clinical material to supply PDL's investigational studies for certain PDL pipeline products.
   
Genmab's Torben Lund-Hansen, Ph.D. will serve as president of the manufacturing facility. Dr. Lund-Hansen has served as vice president, head of manufacturing at Genmab since 2002. Previously, he was responsible for establishing manufacturing facilities for Novo Nordisk.
   
The transaction, subject to customary closing conditions, is expected to close by the end of 1Q2008.  

Eurand's NDA for Zentase was accepted and has been granted priority review by FDA. Gearoid Faherty, chief executive officer of Eurand, commented, "We are extremely pleased with the FDA decision to grant Zentase priority review. We understand that the typical FDA review period of a drug with priority review status is six months versus a standard 10-month review. In the interim, we remain focused on the build-out of our U.S. specialty sales force in preparation for the potential commercialization of Zentase.''
   
Zentase is a porcine-derived pancreatic enzyme replacement therapy being developed to treat pancreatic insufficiency, a condition associated with CF, chronic pancreatitis and other conditions. The product is a highly stable formulation that includes eight key enzymes, a number of coenzymes and cofactors, and is biologically similar to human pancreatic secretions necessary for proper human digestion. The company completed its rolling NDA submission in December 2007.

Patheon, Inc. has revised the roles of several senior executives at the company. Nick DiPietro, president and chief operating officer, will assume a new role as executive vice president, corporate development, effective March 1, 2008. In his new role, Mr. DiPietro will lead the development of a long-term corporate strategy and assist in evaluating future growth opportunities. He will continue to report to Wesley P. Wheeler, chief executive officer.

Clive Bennett, president, Patheon U.S.A., will assume a new role as chief technical officer, reporting to Mr. Wheeler, effective March 1, 2008. In this newly created role, Mr. Bennett will be responsible for the company's global quality, supply chain, information technology and engineering functions. He also will continue to lead the company's divestiture of its Carolina operations facility in PR.

Steve Liberty has been appointed senior vice president, operations, Canada and U.S.A., and will assume responsibility for the company's Cincinnati and Burlington Century Lab facilities in addition to his current leadership of the Toronto Region, Whitby and York Mills sites. Mr. Liberty will report to Terence Novak, who recently joined Patheon as president, North American operations and chief marketing officer.

"This realignment of responsibilities will result in a more focused and effective executive team, enabling us to move forward to build and grow our business," said Mr. Wheeler. "I look forward to Nick's leadership and capitalizing on his creativity and entrepreneurial talent as we develop a new strategic plan for Patheon," said Mr. Wheeler.

Hans Engels has been appointed president and business unit director of DSM Pharmaceuticals Inc. Mr. Engels will continue to be based out of the Greenville, NC facility.
   
Mr. Engels joined the company in 2000, and most recently served as chief operating officer, DSM Pharmaceutical Products. During his eight years with the company, Mr. Engels served as chief operating officer and site director for DSM Pharmaceuticals, Inc. Prior to joining the company, he was the vice president of production and engineering for Alpha Therapeutics and has held various executive leadership positions for Bayer AG.  

Pfizer has entered into an agreement to acquire Encysive Pharmaceuticals, Inc., a publicly held biopharma company, for an equity value of approximately $195 million.

Pfizer will acquire the rights to Thelin, an oral, endothelin A receptor antagonist (ETRA) for the treatment of pulmonary arterial hypertension (PAH), as well as Encysive's other pipeline candidates. Thelin is approved for marketing in the EU and is currently available in the UK, Germany, Ireland, Spain, France, Italy, Belgium, Luxembourg and the Netherlands. The drug has also been approved in Australia and Canada. In the U.S., it has been the subject of three approvable letters from the FDA; Pfizer plans to conduct a Phase III trial to support registration in the U.S.

"The process initiated in July of 2007 to review Encysive's strategic alternatives led us to consider a range of opportunities for increasing shareholder value," commented George W. Cole, president and chief executive officer of Encysive. "After a thorough analysis, Encysive's board of directors concluded that this cash transaction with Pfizer represents the best option for our shareholders now. Pfizer has come with a superior offer and with an in-depth understanding of pulmonary arterial hypertension, our primary therapeutic focus."

"The acquisition of Encysive will add growing, near-term revenue from the European market and increase our already strong presence in the cardio-respiratory arena with a product that complements Revatio, a PAH treatment that was discovered and developed by Pfizer researchers," said Ian Read, president of Pfizer's Worldwide Pharmaceutical Operations. "We look forward to applying Pfizer's significant resources to the launch of Thelin in additional countries."

The transaction is expected to close in 2Q08, subject to customary closing conditions.

Abbott received approval from the FDA for Simcor, the first fixed-dose combination of cholesterol therapies, Niaspan (Abbott's niacin extended-release) and simvastatin. Simcor is approved for use along with diet to lower levels of elevated total cholesterol, LDL "bad" cholesterol and triglycerides, and to raise HDL "good" cholesterol in patients with complex lipid disease when treatment with simvastatin or Niaspan monotherapies are not adequate.
   
"Managing cholesterol encompasses many factors, not just lowering LDL. There is a clear need for medicines that both raise good and comprehensively lower the bad components of cholesterol," said Christie Ballantyne, M.D., of the Methodist DeBakey Heart and Vascular Center, Houston, and lead Simcor investigator. "Simcor represents an important new option to help patients reach healthy lipid levels."
   
The approval was based on Simcor safety and efficacy trial data from more than 640 patients with mixed dyslipidemia and type II hyperlipidemia. In the SEACOAST trial, patients receiving Simcor achieved significant cholesterol improvements over simvastatin alone and had additional lipid improvements, with LDL reductions of 12% and an additional 21% HDL increase compared to a 7% decrease and an 8% increase, respectively, with simvastatin alone. Also, Simcor reduced triglycerides by an additional 27% compared to 15% with simvastatin alone.

GlaxoSmithKline has licensed exclusive world-wide rights to EUSA Pharma, Inc.'s preclinical human anti-interleukin-6 antibody for a consideration of as much as $44 million, which includes an upfront fee, development milestones and royalties on future sales. As part of the agreement, EUSA will pay approximately half of this total amount to its development partner, Vaccinex, Inc. GSK will be responsible for all future development, production and commercialization of the product.
   
Interleukin-6 is a pro-inflammatory cytokine and B-cell growth factor and acts as a resistance factor to standard chemotherapy. EUSA's product, OP-R003, is the first fully human anti-interleukin-6 antibody — which has the potential to offer improved tolerability and safety profile — with target indications in oncology and inflammatory diseases.
   
EUSA acquired OP-R003 as part of the company's 2007 acquisition of OPi SA. OPi had previously entered into a development collaboration with Vaccinex for OP-R003 as a therapy for rheumatoid arthritis and lymphoma.
   
"The out-licensing of this early-stage antibody is another strategic milestone for EUSA, as we continue to focus our business on marketed and late-stage products in the oncology, pain control and critical care areas," said Bryan Morton, chief executive officer of EUSA Pharma.
   
Brian McVeigh, GSK's worldwide business development director of M&A strategy and transactions, said, "Interleukin-6 is increasingly recognized as an important biological target in a range of diseases, and consequently OP-R003 has great potential to meet a number of unmet medical needs."

Memory Pharmaceuticals Corp. plans to conduct a clinical study of MEM 3454, the company's lead nicotinic alpha-7 partial agonist, in patients with schizophrenia based on two biomarkers, P50 sensory gating and mismatch negativity. Development partner, Roche, will fund the biomarker study and additional formulation and manufacturing activities for MEM 3454 under the companies' development collaboration for nicotinic alpha-7 receptor agonists.
   
"This new study will greatly enhance our ability to measure and predict the efficacy of MEM 3454 and other compounds in the nicotinic alpha-7 receptor program," said Stephen Murray, M.D., Ph.D., chief medical officer of Memory Pharmaceuticals. "The study should be underway this summer with data available by early 2009. The biomarker data, together with the results of our ongoing Phase 2a study in CIAS, will help with the design of later-stage trials in schizophrenia."
   
The study will enroll approximately 12 patients with stable schizophrenia who are receiving atypical antipsychotic therapy. Subjects will be randomized to receive MEM 3454 and placebo in a 5-way crossover design. The primary objective of the trial is to study P50 sensory gating and mismatch negativity as potential efficacy biomarkers for nicotinic alpha-7 agonists, such as MEM 3454, in schizophrenia. P50 sensory gating and mismatch negativity are two neurophysiological measurements that have been shown to be closely associated with nicotinic alpha-7 function and schizophrenia.
   
In December 2007, Memory began a Phase IIa trial of MEM 3454 in schizophrenia as part of the development program. To maintain its license to MEM 3454, Roche would have to make an additional milestone payment to the company upon completion of the ongoing Phase IIa CIAS trial, which is expected to be completed in 4Q2008.

AstraZeneca has spun off part of its gastrointestinal research operation into a new biopharmaceutical company called Albireo. The move is part of the company's realignment plans, announced in 2006, to refocus its research away from certain areas within cardiovascular and gastrointestinal medicine.
   
AZ will retain a minority shareholding in the new company. New investors, Nomura Phase4 Ventures, TVM Capital and Scottish Widows Investment Partnership, have invested $27 million in the company, with a further $40 million expected from a second round of financing.
   
AstraZeneca's head of venture strategy, Veronique Bouchet, said, "This represents an innovative approach to product development. Without it we would not have taken forward the products that will now be developed by Albireo."

Baxter International, Inc. has temporarily suspended production of heparin, a blood-thinner, due to reports of allergic reactions, including four deaths, primarily in patients undergoing kidney dialysis and heart surgery. Heparin, a generic drug, is widely used in hospitals and dialysis centers. Baxter said it isn't suspending sales of heparin that was already produced, a decision made in concert with FDA officials to avoid shortages. Baxter supplies about half of the heparin used in the U.S.
   
The company previously concluded that the reactions were confined to nine lots of the drug, which were recalled on January 17th, but now say the adverse reactions have spread beyond those lots and to a wider range of dosages. The product, derived from pig intestines, is made at the company's Cherry Hill plant in NJ. An investigation has linked the active ingredient in the drug to Scientific Protein Laboratories of Waunakee, WI, which in turn obtains the ingredients from Changzhou SPL in Changzhou, China through a joint venture. Scientific Protein has been making the heparin active ingredient at the Chinese plant since 2004. The company said that it “engages in the same testing and quality-control procedures as U.S. facilities that produce bulk heparin and meets FDA standards."
   
David G. Strunce, president of Scientific Protein, said that most of its active ingredient for heparin is made in China, but some comes from a Wisconsin factory. “There’s nothing that would explain these reactions, and we are very concerned about this,” he said. “We have no idea if these reactions have anything to do with our product.”
   
According to a statement by the FDA, it has never inspected the Chinese plant that makes Baxter's heparin.

Wilson Blaine Knight, Ph.D., a former executive with GlaxoSmithKline, has been named vice president of Southern Research Institute's Drug Discovery Division.
    
“We are very pleased that Dr. Knight has joined us to lead our very successful drug discovery research program,” said John A. “Jack” Secrist, III, Ph.D., president and chief executive officer of Southern Research Institute. “His global pharmaceutical industry experience will be extremely valuable to Southern Research as we expand our service offering to clients worldwide. In addition, Dr. Knight’s scientific background is solid, and he has a great appreciation for basic research and how it can be translated into products that prevent and cure diseases.”
    
Dr. Knight has served in a number of roles at GSK including vice president of non-clinical globalization projects/preclinical development; vice president of strategic alliances; vice president of screening sciences; and vice president of systems research in the discovery research directorate. In the last two roles, he was responsible for leading more than 200 scientific staff members in the U.S., UK, Spain, Italy and Japan in comprehensive compound profiling and integrated lead discovery strategies. While at GSK, Dr. Knight was instrumental in placing several compounds into development, particularly in the oncology therapeutic area.

Terry Novak has been appointed president, North American Operations and chief marketing officer, effective February 18, 2008, Patheon Inc. Mr. Novak will be responsible for managing and growing the company's North American commercial manufacturing operations, a network of five sites that include three plants in Canada, three in PR and one in Cincinnati. Two of the company's North American sites, York Mills and Carolina, will be sold as part of a previously announced rationalization program.
   
Mr. Novak has more than 28 years of pharmaceutical industry experience, including senior commercial management positions at Bristol-Myers Squibb, Quintiles and Cytogen. Most recently, Mr. Novak was president of DSM Pharmaceuticals Inc., the contract manufacturing business of Netherlands-based Royal DSM, N.V. Mr. Novak is a highly regarded speaker at industry conferences and also serves on the Editorial Advisory Board of Contract Pharma magazine and the North Carolina Biotechnology Advisory Board.  
   
"We are extremely privileged to have Terry as a new member of our executive management team," said Wesley P. Wheeler, chief executive officer, Patheon Inc. "Terry has a unique perspective on the pharmaceutical manufacturing outsourcing market and has a demonstrated track record of success in this business."

The College of American Pathologists (CAP) has certified Quintiles Transnational Corp.'s central lab in Mumbai, India. The lab began supporting clinical trials in 1Q2007. Since then, the facility has been adding to its services and analytical capabilities.
   
"CAP certification validates our commitment to providing high-quality central laboratory services that fulfill rigorous regulatory requirements worldwide," said Tom Wollman, senior vice president, Quintiles Global Central Laboratories. "With the certification of the India laboratory, Quintiles Central Laboratory Services now has the largest wholly owned CAP-accredited laboratory network in the world. This tightly controlled network with CAP-certified laboratories in the US, Europe, South Africa, China, India and Singapore allows us to support global and regional trials in almost every country in the world. Because our customers are looking for the quality, flexibility and speed that come from running multi-regional global trials, we are well-positioned to meet this demand."
   
CAP certification is intended to improve patient safety by enhancing the quality of pathology and lab services through education, setting standards and ensuring labs meet or exceed regulatory requirements.
   
In addition to lab testing, the Mumbai lab provides project management and logistics support, study specific lab kits for sites, local investigator support and samples management, storage and processing using consistent global methods.  

Gary Swan has been appointed vice president of operations, Laureate Pharma, Inc. In this newly created position, Mr. Swan will be responsible for leading the company's manufacturing operations, which include upstream and downstream processing, formulation and filling, facilities maintenance, warehouse operations, and environmental health and safety regulations.
   
"We are delighted to welcome Gary to Laureate's senior leadership team," said Robert J. Broeze, Ph.D., president and chief executive officer of Laureate. "With his strong background and extensive experience of more than 30 years in biopharmaceutical manufacturing operations, Gary will play a key leadership role in driving and managing Laureate's tremendous growth."
   
Mr. Swan's experience includes biopharmaceutical manufacturing, engineering, technical services, validation, and quality control. Most recently, he served as senior director of manufacturing at Nastech Pharmaceuticals, a biopharmaceutical company developing products based on molecular biology-based drug delivery technologies. At Nastech, Mr. Swan directed the operations at two manufacturing sites in New York and Washington and led the planning and production of R&D, clinical, and licensed products. Prior to Nastech, he was the vice president of operations at VI Technologies, where he was responsible for strategic planning and daily operation of a sterile product facility with a staff of 200.  

Biogen Idec and Cardiokine, Inc. initiated a Phase III study of lixivaptan for congestive heart failure patients who suffer from hyponatremia, which is an electrolyte disturbance marked by low sodium levels in the blood. The trial will compare treatment with lixivaptan to placebo in approximately 650 patients in the U.S. and Europe.
   
Lixivaptan is an oral vasopressin V2 receptor antagonist that works by causing a decrease in renal water reabsorption (an increase in urine volume) and a decrease in urine osmolality. Previous studies showed patients treated with lixivaptan had improved serum sodium concentrations, decreases in body weight, and increases in urine volume. The safety profile supports continued development.
   
THE BALANCE (Treatment of HyponatrEmia BAsed on LixivAptan in NYHA Class III/IV Cardiac Patient Evaluation) study is a multi-center, randomized, placebo controlled, double-blind study of lixivaptan. The primary endpoint of the study is to evaluate the safety and effectiveness of lixivaptan, when compared to placebo, in increasing serum sodium from baseline in heart failure patients with hyponatremia. Hyponatremia is common in patients who have been hospitalized with worsening heart failure.
   
Under the terms of the collaboration, the two companies plan to jointly develop the drug. Biogen Idec will be responsible for global commercialization and Cardiokine will have an option for co-promotion in the U.S.

Genzyme

4Q Revenues: $1.0 billion (+21%)

4Q Earnings: $78.9 million (loss of $268.2 million 4Q06)

FY Revenues: $3.8 billion (+20%)

FY Earnings: $480.2 million (loss of $16.8 million FY06)

Comments: Revenue growth was driven by strong sales of its newest drug, Myozyme, with sales up 107% in the quarter to $62 million. For the year sales reached $201 million compared to the first-year sales of $59 million. 4Q Fabrazyme sales were $114 million (+18%) and FY sales were up 18% to $424 million. Cerezyme sales were $301 million (+15%) in the quarter and $1.1 billion for the year (+13%). Sales of Renagel in the quarter were $167 million (+23%) and for the year were to $603 million (+17%). Results include charges for the purchase of in-process R&D of $106,350 related to the acquisition of Bioenvision, Inc. in October 2007 and $552,900 related to the AnorMED, Inc. acquisition in November 2006. R&D expense was $191.6 million in the quarter (+15%) and $732.0 million for the year (+13%). Renvela was approved by the FDA in October for the treatment of hemodialysis patients, and the company expects to launch the product this quarter.

Metrics Inc. has opened its newest analytical lab space. The four new analytical labs add to the company’s capacity for service by 40%. The labs will be fully operational and validated by 2Q 2008.

     “We have been operating at capacity at Metrics for some time now, so our employees are delighted to have more room in which to work,” said Phil Hodges, president. “We are especially glad that we can offer our clients the greater capacity they want and need.”

     The addition to Metrics’ existing 44,000-sq.-ft. pharmaceutical development laboratories includes larger scale manufacturing, Phase III to commercial, stability storage, a dedicated lab for cytotoxic and potent compounds, and a microbiology laboratory.

     The new lab space is part of an $18 million, 47,000-sq.-ft. facility addition that will allow the company to provide both development and commercial manufacturing projects.

Schering-Plough

4Q Revenues: $3.7 billion (+41%)
 
4Q Loss: $3.3 billion (earnings were $204 million in 4Q06)

FY Revenues: $12.7 billion (+20%)

FY Loss: $1.5 billion (earnings were $1.1 billion FY06)

Comments: Global pharmaceutical sales for the quarter totaled $3.0 billion (+34%). Growth in the quarter was driven by Remicade sales, up 35% to $455 million; Nasonex sales, up 7% to $271 million; Sales of Pegintron, up 15% to $239 million; Temodar sales, up 23% to $234 million; Clarinex sales, up 6% to $174 million; and Avelox sales, up 12% to $115 million. For the year Global pharmaceutical sales were $10.2 billion (+19%). Global cholesterol joint venture sales, which include Vytorin and Zetia, totaled $1.4 billion in the quarter and $5.2 billion for the year, with FY U.S. sales up 26% and international sales up 70%. Schering-Plough does not record sales of its cholesterol joint venture with Merck and incurs substantial costs related to the venture, such as selling, general and administrative costs. 4Q and FY sales both include $626 million of Organon BioSciences (OBS) net sales for the period subsequent to the acquisition closing date. Results in the quarter and FY include special and acquisition related charges of $52 million and $84 million, respectively, related to the OBS acquisition. R&D expenses were $855 million in the quarter (+35%) and  $2.9 billion for the year (+34%). Acquired in-process R&D for the quarter and FY include a charge of $3.8 billion related to the OBS acquisition. 4Q and FY R&D expenses also include $21 million and $197 million, respectively, related to upfront R&D payments.

Catalent Pharma Solutions

2Q Revenues: $464 million (+11%)

2Q Loss: $30.2 million (earnings were $18.5 million 4Q06)

YTD Revenues: $902 million (+11%)

YTD Loss: $41.5 million (earnings were $19.6 million YTD06)

Comments: Revenue growth was primarily due to demand for Oral Technologies pharmaceutical products and increased volumes and throughput in the Sterile Technologies segment, including increased output from the new sterile facility in Belgium. Oral Technologies revenue in the quarter was $256.9 million (+11%). Sterile Technologies revenue in the quarter was $74.1 million (+22%) Packaging Services revenue was $143.7 million (+7%). The weaker U.S. dollar favorably impacted revenue growth by approximately 6%. Results in the quarter include the impact of purchase accounting adjustments of $2.1 million.

ICON has acquired Healthcare Discoveries, Inc., a wholly owned subsidiary of Catalyst Pharma Group, Inc., for $12 million in cash, and if certain performance milestones are achieved in 2008, a further consideration of as much as $10 million. Healthcare Discoveries operate an 85-bed clinical pharmacology unit in San Antonio, TX and have experience with early phase development programs.
   
“The acquisition of Healthcare Discoveries is an important step for ICON,” commented ICON chief executive officer, Peter Gray. “It gives us a clinical pharmacology platform in the United States to complement our existing European Phase I operations. As well as gaining an outstanding facility, we are bringing into ICON an experienced team that has an excellent market reputation”
   
Healthcare Discoveries will become part of a comprehensive early phase development portfolio within the ICON Development Solutions division, which includes an 80-bed clinical pharmacology unit based in Manchester, England. Dr. Thomas Frey, president of this division, added, “The investment in Healthcare Discoveries will enable us to meet the growing demand for highly scientific first-in-human and full spectrum of clinical pharmacology studies that are a critical part of the drug development process. We look forward to integrating these additional capabilities into our broad drug development service portfolio.”
   
Dr. Richard Anthony, chief executive officer of Catalyst Pharma Group commented, “We are delighted that Healthcare Discoveries will become part of the ICON group. Catalyst has worked with Dr. Dennis Ruff, president of Healthcare Discoveries, for the past four years to build a reputation for excellence in Phase I research." Dr. Anthony added, “We believe ICON’s early phase development experience, focus on quality and business culture is an ideal fit with Healthcare Discoveries. Catalyst looks forward to continuing to work with Healthcare Discoveries in the future."

Schering-Plough Corp. has made leadership and organizational changes at Schering-Plough Research Institute (SPRI), the R&D arm of the company.
   
Jacqueline Elbonne, Ph.D., has been named vice president, global research quality, SPRI. Dr. Elbonne will build and lead a worldwide research quality team overseeing all SPRI activities governed by cGMP, GLP, GCP and Good Pharmacovigilance Practices (GPP). She will also direct the design, implementation and performance management of global research quality management systems to meet regulatory requirements worldwide. She will report to Thomas P. Koestler, Ph.D., executive vice president and president of SPRI, with shared accountability for SPRI quality systems to Richard S. Bowles III, senior vice president, global quality operations.
   
Dr. Elbonne joined the company in 2000 and has held various positions of increasing responsibility in SPRI, analytical development and global quality. She recently served as vice president, pharmaceutical sciences quality, overseeing global clinical manufacturing operations, which included meeting all commitments under the U.S. consent decree.  
   
Also, two positions were created as a result of the expanded product portfolio following the acquisition of Organon BioSciences. Martin H. Huber, Jr., M.D., and Hans Rekers, M.D., will report to Robert J. Spiegel, M.D., chief medical officer and senior vice president. Dr. Huber was appointed vice president, global pharmacovigilance, and deputy chief medical officer. He will continue his current responsibilities and will also serve on Schering-Plough's safety review board. He will  work on product-related issues with health authorities and professional societies, manage medical aspects of litigation issues and work with medical directors from country operations on risk management and product-specific issues.
   
Dr. Huber has served as vice president, global pharmacovigilance, since joining the company in July 2006. He has played a key role in the development of a globally aligned organization for global pharmacovigilance as part of Schering-Plough's global clinical harmonization program and on the design and rollout of a computerized system for the collection, tracking and reporting of drug safety information.  
   
Dr. Rekers was appointed deputy chief medical officer for Europe. In this role, he will continue his current responsibilities and will serve on Schering-Plough's safety review board and on the company's PReP (preparedness response) team. He will also work on product-related issues with worldwide health authorities and professional societies, manage medical aspects of litigation issues and work with medical directors from country operations on risk management and product-specific issues.
   
Dr. Rekers has been with Organon International for the past 20 years serving in a range of positions of increasing responsibility, most recently as vice president, medical affairs.

AMRI

4Q Revenues: $47.2 million (+1%)

4Q Loss: $844,000 (loss of $764,000 in 4Q2006)

FY Revenues: $192.5 million (+7%)

FY Earnings: $8.9 million (earnings were $2.2 million FY2006)

Comments: Total contract and milestone revenue for the quarter was $41.1 million (+2%) and for the year was $165.5 million (+8%). Milestone revenue for the year was $2.1 million, which includes $1.5 million resulting from the company’s collaborative research agreement with Bristol-Myers Squibb. Development/small scale manufacturing revenue was $11.4 million (+22%) in the quarter and $45.4 million (+26%) for the year. Discovery services revenue was $11.5 million (-6%) in the quarter and $41.6 million (+5%) for the year. Large scale manufacturing revenue for the quarter was $17.7 million (-6%) and for the year was $76.3 million (-1%). Recurring royalties from Allegra in quarter were $6.1 million (-4%) and for the year were flat at $27.1 million. FY results include large scale manufacturing restructuring charges of $177,000.

Merck has agreed to pay more than $671 million to settle allegations of fraud concerning Medicaid and other public healthcare programs across the U.S., according to a federal Settlement Agreement. According to qui tam lawyers Steven H. Cohen, Mark Kleiman and BethAnne Yeager, Merck employed four marketing tactics to maintain market share for drugs including Vioxx, Zocor, Cozaar, Fosamax, Maxalt, and Singulair. This practice known as "nominal pricing" concerned discounts on drugs allegedly offered to certain customers but not to Medicaid. The suit alleged Merck offered discounts of 90% or more on Zocor, Mevacor and Vioxx to hospitals that helped Merck achieve market-share goals, and that it improperly gave doctors incentives to use the products.
   
Merck said it had taken the initiative to enhance its compliance program in 2001, and that the pricing allegations resulted from interpretation of Medicaid rules. "We believe this is the best and most appropriate way to resolve these lengthy investigations," said a Merck spokesman. The settlement allocates $218 million to the federal government and $181 million to 49 states and the District of Columbia. The costs and a separate $250 million settlement in a Louisiana rebate case brought the total to $671 million. The investigation among federal and state authorities and the qui tam legal team lasted seven years.
   
H. Dean Steinke, a former Merck district sales manager, who filed a so-called whistleblower suit under the False Claims Act in U.S. District Court for the eastern district of Pennsylvania in 2000, and filed a separate suit in Nevada in 2005 — alleging both pricing and kickback schemes — will receive $68.2 million from the settlement.
   
Although Merck did not admit to the allegations, in addition to the settlement, the company has agreed to a Corporate Integrity Agreement, according to Mr. Cohen, who, along with Ms. Yeager is associated with the Whistleblower Action Network in Chicago.     
   
"Our relator, a former Merck sales manager, blew the whistle on Merck which resulted in a nationwide investigation by federal and state prosecutors that returned hundreds of millions of taxpayer dollars to the Medicaid program," Mr. Cohen said.
   
"When we realized the extent of the fraud, we took the evidence straight to the Government. Taking on Merck required close coordination and cooperation between us and the state and federal prosecutors. This taskforce approach and unrelenting commitment won a huge victory for the taxpayers." Mr. Kleiman said.
   
"This landmark case exposed abuses of Medicaid's Best Price nominal price exception, and strengthened the Medicaid Rebate program to reduce the states' drug costs," Ms. Yeager said.

GlaxoSmithKline

4Q Revenues: $12.1 billion (+5%)

4Q Earnings: $2.2 billion (-6%)

FY Revenues: $45.4 billion (+6%)

FY Earnings: $10.6 billion (+4%)
 
Comments: Advair sales were $7.0 billion for the year (+15%) and $1.9 billion in the quarter (+12%). Lamictal sales were $2.2 billion for the year (+22%) and $610 million in the quarter (+22%). Avandia sales dropped 31% to $1.8 billion for the year, and $327 million in the quarter (-48%), due to reports that linked the drug to an increased risk of heart attacks. Restructuring costs were $522 million in the quarter. R&D expenses for the year were $6.7 billion (+5%), and $2.1 billion in the quarter (+11%).

MedImmune has made three key promotions in its research, human resources and regulatory affairs and has also hired a new head of vaccine manufacturing. Peter A. Kiener, D. Phil. has been appointed to executive vice president, research; Katy Strei to vice president, people and organization development, human resources; and Eileen Valenta to vice president, operations and compliance, regulatory affairs. Also, Shou-Bai Chao, Ph.D. has been named vice president of vaccine manufacturing.
   
"As MedImmune prepares for the next phase of its corporate growth, including dramatic acceleration within its product portfolio, it is imperative that we have strong leadership at the helm of all aspects of our business, but particularly within the research, HR and regulatory affairs functions," said David M. Mott, chief executive officer and president.
   
"Peter is now driving forward our global research efforts, which span from our core antibody research center in Maryland's biotech corridor to our discovery and development center in Cambridge, UK to our vaccine research facilities in the San Francisco Bay area of CA. Katy is ensuring that we have the right people — with the right skills — at the right time, which is critical for us to deliver on the promise of our pipeline. Eileen's contributions will grow significantly with our maturing product portfolio and its need for regulatory affairs and compliance oversight. And, as we carry forward the potential next-generation of innovative vaccines, Shou-Bai is a welcome addition to the organization," Mr. Mott added.
   
Dr. Kiener, promoted from senior vice president, research, will oversee all global research activities for the company. Since joining the company in 2001, Dr. Kiener has made expert and strategic contributions in supervising MedImmune's expanding product portfolio, particularly in the areas of cancer and inflammatory disease research as well as translational sciences. Prior to joining the company, he spent 18 years with Bristol-Myers Squibb's Pharmaceutical Research Division, finally holding the position of director, immunology, inflammation, pulmonary and oncology drug discovery at the BMS facility in Princeton, NJ.
   
Ms. Strei, promoted from senior director, corporate capabilities, is responsible for the strategy and implementation of the company's key people processes and programs, including performance management, succession planning and leadership development. In addition she oversees training and development initiatives. She has nearly 20 years of strategic leadership and talent development experience. Prior to joining the company in 2005, Ms. Strei served as director of executive development for Fannie Mae and served in various training and organization development roles at ManorCare Health Services and Sallie Mae.  
   
Ms. Valenta, promoted from senior director, product promotion review, regulatory affairs, is responsible for guiding product promotion review and for ensuring that overall operations of the regulatory affairs group are compliant with federal guidelines and consistent with the company's global regulatory strategy. Prior to joining MedImmune in 2005, Ms. Valenta served as senior director, global regulatory affairs specializing in advertising and promotion for Baxter Healthcare, where she developed and managed promotional standards and processes and drove strategy for promotional efforts in the U.S. and Europe. Throughout her career she has served in regulatory affairs roles at Takeda Pharmaceuticals North America, Wellmark International and Schering Plough Animal Health.
   
Dr. Chao is responsible for all aspects of global vaccine manufacturing and supply. Dr. Chao will also contribute to the company's commitments to pandemic preparedness. Prior to joining the company, Dr. Chao most recently served as assistant vice president, technical operations and product supply at Wyeth Biotech, where he gained experience bringing FluMist through development at Wyeth Pharmaceuticals. He was also responsible for global technical operations for the vaccine, Prevnar. He has more than 15 years of experience at Wyeth, Sanofi-Pasteur and Philom Bios in global vaccine and bio/pharmaceutical process and product development, manufacturing operations and quality assurance.

Millennium 

4Q Revenues: $181.2 million (+30%)

4Q Earnings: $41.0 million (earnings were $8.3 million in 4Q2006)

FY Revenues: $527.5 million (+8%)

FY Earnings: $14.9 million (loss of $44.0 million FY2006)

Comments: U.S. sales of Velcade were $265.2 million, up 20% for the year, and royalties were $166.9 million, up 24% due to growth in Velcade sales outside of the U.S., which were more than $500 million. This growth led to achievement of a non-recurring $40 million milestone from Ortho Biotech Products. FY results include a $17.0 million decrease in stock-based compensation expense and a $7.5 million decrease in restructuring charges. 4Q and FY R&D expenses were $76.4 million (-6%) and $287.1 million (-8%).
 

PPD, Inc. has signed an agreement to acquire InnoPharm Ltd., an independent CRO based in Smolensk, Russia. The acquisition will expand PPD's global reach with offices in both Russia and Ukraine.
   
InnoPharm offers Phase II-IV clinical trials support, data management and biostatistics services to pharma and biopharma companies. InnoPharm has offices in Moscow and St. Petersburg, Russia, and Kiev, Ukraine, and employs more than 300 people.
   
"With more than 143 million people in Russia alone, Eastern Europe is a high-growth market for clinical trials and a region PPD has targeted for expansion," said Fred Eshelman, chief executive officer of PPD. "We have subcontracted work to InnoPharm since 2004 and have great confidence in the team's clinical research capabilities and its commitment to quality. In addition to extending our geographic footprint and enhancing our ability to conduct global studies for our clients, we are gaining a high-caliber group of clinical research professionals."
   
Sergey Sudilovsky, M.D., Ph.D., currently director general of InnoPharm, will oversee operations in Russia and Ukraine for PPD. Dr. Sudilovsky has more than 15 years of experience with InnoPharm, and spent the past 10 years as director general.
   
The acquisition is expected to close in 2Q2008.

Cook Pharmica, the biopharmaceutical contract manufacturing division of Cook Medical, will invest $80 million in an 80,000-sq.-ft. expansion at its existing site in Bloomington, IN. The expansion is expected to add another 200 jobs when completed and fully operational.
   
“We could not be more thrilled with the acceptance we have gained from our customers and everyone involved that has made this expansion possible,” said Jerry Arthur, president of Cook Pharmica. “This expansion, which further diversifies our expansive portfolio of services, marks the dawn of a new era in our company’s growth, and is a testament to Cook’s commitment to contract biopharmaceutical manufacturing.”
   
The plan includes two filling lines and complementary finishing lines, one high-speed syringe filling line and one low to medium-speed vial filling line with lyophilization capacity up to 250 sq. ft. Both lines will feature isolator technology. Construction will begin in mid-2008, with completion planned for early 2010. Additional space of more than 600,000 sq. ft. will remain for potential future expansion.
   
The expansion is aimed at developing and manufacturing mammalian cell culture-based products, as well as offering formulation, filling and finishing services. The facility will expand into aseptically filled parenteral vial and syringe products including simple solutions and diluents, suspensions, vaccines, proteins and biologics. With the addition of this capability, the company will be able to meet clients’ needs from cell development through finished packaging.

Biogen Idec

4Q Revenues: $893 million (+26%)

4Q Earnings: $201 million (+84%)

FY Revenues: $3.2 billion (+18%)

FY Earnings: $638 million (+193%)

Comments: FY07 growth was primarily driven by Tysabri, Rituxan and Avonex sales. Through the Tysabri partnership with Elan, Biogen Idec  recognized revenue of $90 million in the quarter and $229.8 million for the year. 4Q06 and FY2006 Tysabri revenues were $17.6 million and  $35.8 million, respectively. The safety data for Tysabri continues to support a favorable benefit-risk profile since the drug's relaunch in July 2006. FY07 Rituxan revenues (co-promoted in the U.S. with Genentech) were up 14% to $926 million, and Avonex sales were up 9% to $1.9 billion. In the quarter, Avonex sales were up 15% to $503 million, and Rituxan sales were up 17% to $254 million. 4Q and FY R&D expenses were $229.3 million (+15%) and $925.2 million (+29%), respectively. FY results include charges of $107 million for in-process R&D related to the consolidation of Neurimmune and Escoublac, reduction of debt related to the 2003 Biogen and Idec merger, the 2006 acquisitions of Conforma and Fumapharm, the 2007 acquisition of Syntonix, as well as income of $34 million due to the consolidation of Neurimmune.

Alpharma Inc. has announced plans to sell its API business to 3i, a global private equity and venture capital company, for $395 million in cash.

Alpharma's API business develops, manufactures and markets a line of fermentation-based APIs and one chemically-synthesized API that are used, primarily by third parties, in the manufacture of finished dose pharmaceutical products. For the nine months ended September 30, 2007, the API unit, which employs 700 people, had net sales of $138.7 million and operating income of $30.7 million. The sale includes manufacturing facilities in Copenhagen, Denmark; Oslo, Norway; Budapest, Hungary; and Taizhou, China.

Dean Mitchell, president and chief executive officer of Alpharma, remarked, "The divestiture of the API business for an attractive price will provide funds to capitalize on future growth opportunities in our Pharmaceuticals and Animal Health businesses. We believe this diversified combination positions us well to deliver strong growth with a stable foundation in the years to come. In addition, the increased focus and decreased complexity of our business mix, combined with a potential share buyback, will enable us to enhance value to our shareholders."

The final purchase price is subject to adjustment based on the closing net cash balance and working capital of the business and is expected to generate net proceeds, after taxes, fees, and expenses, of approximately $365 million. The transaction is expected to close in the second quarter of 2008.Alpharma Sells API Business to 3i

Alpharma Inc. has announced plans to sell its API business to 3i, a global private equity and venture capital company, for $395 million in cash.

The company's API business develops, manufactures and markets a line of fermentation-based APIs and one chemically-synthesized API that are used, primarily by third parties, in the manufacture of finished dose pharmaceutical products. For the nine months ended September 30, 2007, the API unit, which employs 700 people, had net sales of $138.7 million and operating income of $30.7 million. The sale includes manufacturing facilities in Copenhagen, Denmark; Oslo, Norway; Budapest, Hungary; and Taizhou, China.

Dean Mitchell, president and chief executive officer of Alpharma, remarked, "The divestiture of the API business for an attractive price will provide funds to capitalize on future growth opportunities in our Pharmaceuticals and Animal Health businesses. We believe this diversified combination positions us well to deliver strong growth with a stable foundation in the years to come. In addition, the increased focus and decreased complexity of our business mix, combined with a potential share buyback, will enable us to enhance value to our shareholders."

The final purchase price is subject to adjustment based on the closing net cash balance and working capital of the business and is expected to generate net proceeds, after taxes, fees, and expenses, of approximately $365 million. The transaction is expected to close in the second quarter of 2008.

DSM Pharmaceuticals, Inc. has signed a manufacturing agreement with APT Pharmaceuticals, Inc. DSM will produce the commercial drug supply as a sterile product for pulmonary delivery for APT. The agreement will utilize DSM's commercial facilities in Greenville, NC.

"DSM has a superior reputation in sterile manufacturing, experience with similar drug products, and an excellent working relationship with the FDA," commented Howard Raff, Ph.D., APT's chief operating officer, "In addition to their experience, they also have the capability to provide increased scale through commercialization."

"DSM Pharmaceuticals Inc. is pleased to welcome APT as a client. APT is a specialty drug development company with an outstanding staff that is focused on effective treatments for significant unmet medical needs and we at DSM are proud to be part of those efforts," stated Terry Novak, president, DSM Pharmaceuticals Inc.

Amgen and Takeda Pharmaceutical Co. Ltd. entered an agreement under which Takeda will develop and commercialize as many as 13 molecules from Amgen’s pipeline for the Japanese market. The collaboration includes early to mid-clinical-stage candidates across a range of therapeutic areas, including oncology, inflammation, and pain.     
    
Under the terms of the agreement, Amgen will receive an upfront cash payment of $200 million. Takeda will also pay to Amgen as much as $340 million in expected worldwide development costs for these molecules during the next few years, $362 million in success-based milestone payments, and royalties on sales in Japan. Also, Takeda plans to acquire all the shares of Amgen’s Japanese subsidiary, Amgen KK. The share transaction is expected to close in the first quarter.
   
Takeda will become Amgen’s worldwide partner for motesanib diphosphate (AMG 706), and will pay Amgen $100 million upfront, $175 million in success-based milestones for the first two indications, and royalties on sales in Japan. Takeda will also pay 60% of ongoing clinical development expenses outside Japan and the two companies will share profits outside Japan.
   
“We are excited about the agreements with Amgen, and also to welcome Amgen KK into Takeda Group,” said Takeda president Yasuchika Hasegawa. “The target indications of the molecules we licensed from Amgen, such as cancer and bone/joint diseases, are in our core therapeutic areas. We believe they will enhance our R&D pipeline and we are looking forward to offering novel treatment options to the patients with such diseases and to physicians as early as possible, through conducting development activities in close collaboration with Amgen.”
   
“The development programs included in this collaboration represent the growth engine for Amgen in the next decade,” said Amgen chairman and chief executive officer, Kevin Sharer. “Takeda’s confidence in these programs validates their potential to become innovative therapies for patients in Japan and worldwide. We value and respect Takeda’s strong development and marketing capabilities and look forward to working with the leading pharmaceutical company in Japan.”
   
The partnership includes Amgen’s Vectibix (panitumumab), motesanib diphosphate and additional molecules in oncology, inflammation and neurology/pain. With the exception of oncology candidate motesanib diphosphate, all molecules included in the partnership are biologics. Amgen retains certain co-promotion rights in Japan on all programs.

Althea Technologies, Inc. has entered a manufacturing supply agreement with Quintessence Biosciences to produce the firm's first drug candidate, QBI-139. The drug is effective in cancer models against a broad range of solid tumors. Quintessence plans to file an IND with the FDA for QBI-139 in 1Q2008. Althea will provide protein production, purification, and aseptic filling services to produce the clinical trial materials.
   
"Althea is an outstanding company with significant experience in the contract manufacture of protein therapeutics," said Ralph Kauten, Quintessence Biosciences chief executive officer. "We are confident in their ability to produce the quality of drug we need for our upcoming clinical trials."
   
"We are very pleased to begin work on Quintessence's leading drug candidate," stated president and Co-CEO of Althea, Dr. Magda Marquet. "The Quintessence QBI-139 therapeutic program is exciting as it represents a new and potentially safer approach to combat a broad array of devastating cancer types."

A recent study by the Tufts Center for the Study of Drug Development found that how drug developers organize their companies affects operational and financial performance. The research, developed by Tufts CSDD and PRTM, an operations management consulting firm, found that: globally positioned operations correlate with higher sales per product, annual number of approvals, and levels of operating efficiency; operations with diverse product portfolios correlate with higher levels of operating efficiency and commercial and innovation effectiveness; organizations with centralized decision-making structures correlate with higher levels of innovation efficiency; and organizations with more integrated business units correlate with higher levels of revenue growth.
   
"Moving forward, no company—big, medium, or small pharma, or biotech—will develop new drugs entirely alone," said Tufts CSDD Director Kenneth I Kaitin, who co-chaired the panel. "Increasingly, R&D productivity gains will depend on developers focusing on what they contribute best to the drug development value chain and partnering with organizations that provide capabilities that are too expensive to develop or maintain internally, or are outside of the company's core competencies."
   
He added, "While traditional responses to boost R&D productivity, such as full or partial vertical integration strategies, still carry validity, they are not the wave of the future, since they tend to divert attention away from what a company does best."
   
Panelists in the study agreed that to speed the pace of new drug development, pharma and biopharma companies will partner with each other and also form strong alliances with organizations outside the drug development industry, such as overnight shipping companies. The panel, part of the Tufts CSDD Management R&D Roundtable Series, was organized to identify operating models that can improve R&D productivity.  

AMRI has purchased FineKem Laboratories Pvt. Ltd., a manufacturing facility located in Aurangabad, India. This acquisition will add to the company’s ability to make custom pilot scale intermediates in India, which is expected to begin 2Q2008, and also adds another compound, ISMN (Isosorbide Mononitrate), to AMRI’s generics portfolio.
   
In the next few months, AMRI plans to upgrade the existing facilities to make them compliant with FDA regulations for manufacturing clinical trial materials and commercial drug substances.
   
FineKem’s managing director, Rakesh Doshi, will join AMRI India PVT Ltd. as executive director and chief operating officer reporting to Dr. Prasad Raje, managing director of AMRI’s current Aurangabad and Navi Mumbai facilities.
   
“We are pleased to announce the addition of this new product offering,” said AMRI chairman, president and chief executive officer, Thomas E. D'Ambra, Ph.D. “As we continue to explore and expand the ability of AMRI to provide value and flexibility around the globe, the purchase of this site increases the cost-competitive solutions available to our customers for their outsourcing needs.”

David Laskow-Pooley, MRPharmsS, QP, has been named president of Bilcare Global Clinical Supplies (Europe) Ltd. Mr. Laskow-Pooley will head the EU Region of Bilcare GCS. A subsidiary of Bilcare Ltd., Bilcare GCS provides packaging and global distribution of clinical trial materials. "David is a tremendous addition to our team," said Bilcare Ltd. chairman and managing director, Mohan Bhandari. "His wealth of global industry experience and the depth of his expertise is a perfect fit for our expanding European operation."
   
Mr. Laskow-Pooley has 30 years of experience in the discovery, development and commercialization of pharmaceutical and healthcare products. He worked for a number of pharmaceutical and life sciences companies including GlaxoSmithKline, Abbott, Invitrogen and Amersham in Europe, the U.S. and Japan, and OSI Pharmaceuticals. He was previously chief executive officer of Surface Therapeutics.

R. Ian Lennox has been appointed chairman of the board and chief executive officer of Ricerca Biosciences, LLC. Mr. Lennox has served executive chairman at the company since 2006.
   
Mr. Lennox previously served as chief executive officer, pharmaceutical and biotechnology markets, at MDS, Inc., chief executive officer, Phoenix International Life Sciences, and executive chairman and chief executive officer, Drug Royalty Corp. His career began at Monsanto, where he held various leadership positions in both the U.S. and International operations.
   
"We are extremely pleased to have Ian as the leader as well as an important stakeholder of Ricerca. He brings global life sciences experience to Ricerca and an impressive track record of accomplishment in our industry,” stated fellow director Darren Black, SV Life Sciences. “Ian’s leadership and commitment to success will serve Ricerca well in accelerating its growth in the preclinical services industry.  During his tenure as executive chairman, Ian led a profitable business turnaround, recapitalized the company, fostered new capital and business process investments and instituted a successful recruiting program attracting new scientific and management talents.”

Azopharma Product Development Group, Inc. has acquired Coastal Medical Research, Inc. (CMR), a clinical pharmacology facility in Daytona Beach, FL. The facility will operate under AvivoClin Clinical Services, Azopharma's clinical pharmacology division. The facility will provide Phase I-III clinical services for all major therapeutic areas.
   
Phil Meeks, Azopharma's chief executive officer, said, "We are truly excited about expanding our clinical pharmacology services. Not only does this expand the capabilities of AvivoClin it allows the Azopharma Product Development Group to more completely serve companies seeking full product development."
   
The 15,000-sq.-ft. CMR facility includes 48 beds and the company plans to expand the facility to house more than 100 beds. Mr. Meeks added, "We believe we will provide added benefit to CMR’s current clients not only through our investment in the facilities and infrastructure, but by providing services critical to support clinical studies such as formulation, CTM manufacturing, and bioanalytical testing."

Albemarle Corp. has entered into a manufacturing agreement with Anthera Pharmaceuticals in preparation for the Phase III trial of Varespladib (A-002), a potential new, oral anti-inflammatory drug for treating preconditions that can lead to heart disease. Anthera licensed the drug from Eli Lilly.
   
Albemarle will be responsible for process optimization and manufacture of cGMP quantities of the API. The agreement also provides an option for the commercial production of Varespladib in the future.
       
Varespladib is aimed at helping patients who use statin therapies reduce harmful cholesterol levels and inflammation, two factors that can lead to hardening of the arteries. Phase II results showed that A-002 treatment resulted in significant positive changes on lipoproteins and inflammation -- major factors believed to lead to narrowing or hardening of the arteries among cardiovascular patients treated with statins.
   
As part of the manufacturing agreement, Albemarle's Fine Chemistry Services (FCS) scientists at the company's South Haven, MI facility will conduct additional research on the chemical synthesis of Varespladib and enhance the production process to make a larger-scale quantity of the drug in preparation for Phase III trials.
       
"The Albemarle FCS group was selected as our primary API supplier because of their technical skill set, and their expertise in the chemical development of small-molecule APIs and cGMP manufacturing," said Debra Odink, Ph.D., vice president of pharmaceutical R&D at Anthera Pharmaceuticals. "We are very pleased that they will be working with us on the Varespladib program."

Somaxon Pharmaceuticals, Inc. has submitted a NDA to the FDA for Silenor for the treatment of insomnia.The FDA is expected to make a decision within 60 days. If the NDA is accepted, the FDA will complete its review and provide an action letter within 10 months following submission of the NDA, or in December 2008.
   
"The completion and submission of our NDA for Silenor represents a significant milestone for Somaxon," said David F. Hale, Somaxon’s executive chairman and interim chief executive officer. "It is the culmination of a thorough development program that includes six well controlled clinical trials, all of which met their primary endpoints. We believe that the improvements in sleep onset, sleep maintenance and sleep duration and the favorable safety and tolerability profile demonstrated by our clinical development program are sufficient to support a determination by the FDA that Silenor can be approved for the treatment of insomnia."

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