Paul Liptak has joined DPT Laboratories as a business development manager. Mr. Liptak has more than 20 years of management experience in the pharmaceutical and packaging industries. He joins the company from Contract Pharmaceuticals Limited (CPL), where he oversaw business development in the U.S.

"Liptak brings strong business growth and management skills to DPT's team," said Paul Josephs, DPT's vice president of sales and commercial operations. "His experience will enhance DPT's strong sales team - a team that has helped develop DPT's dominance in the contract development and manufacturing industry. With our growing sales force, DPT is poised for a strong future."

Mr. Liptak also spent eight years with Bristol-Myers Squibb in various management positions and twelve years in the packaging industry, where he held the title of vice president of operations.

A.P. Pharma, Inc. is reducing its staff by approximately 34% (11 employees) in order to allow for the resources needed to continue advancing its lead program, APF530, towards regulatory approval and commercialization. APF530 is a long-acting formulation of granisetron that uses the company’s Biochronomer drug delivery system. The NDA for APF530 was submitted earlier this month for the prevention of chemotherapy-induced nausea and vomiting (CINV).

"A.P. Pharma’s recent NDA submission for APF530 was the result of the dedication of our entire team, making this reduction in our work force even more difficult,” said Ronald J. Prentki, A.P. Pharma’s president and chief executive officer. “Considering the continuing challenges of today’s economic environment, it is necessary for us to make additional reductions to our staff as we focus the Company’s resources on working towards approval of APF530 in the first half of 2010. I want to extend my thanks and gratitude to our departing colleagues and wish them the very best in their future endeavors.”

The company expects one-time costs associated with this headcount reduction to be approximately $350,000, which will be recorded in 2Q09.

Walt Johnston has been named vice president of marketing, Astellas Pharma U.S., Inc. Mr. Johnston will be responsible for leading all strategic marketing activities for on market and development products for the U.S. business. He reports to Patrick Shea, senior vice president of marketing and sales.

"Walt is a driven high performer who truly understands Astellas' core values. We are excited to add him to our management team," said Mr. Shea. "We believe Walt's extensive experience, proven leadership and ability to drive sales will add tremendous value to Astellas' current commercial efforts."

Prior to joining Astellas, Mr. Johnston worked at Pfizer for more than 18 years, most recently holding the position of national sales director, Vista Rx, responsible for driving sales initiatives for Lipitor and Caduet.

Doug Mendenhall, Ph.D. has been named interim head of Patheon's Pharmaceutical Development Services Unit and will also serve as interim chief scientific officer. Dr. Mendenhall is working under contract until a permanent president is named, but will be retained as an advisor to the company on an as-needed basis.

Dr. Mendenhall is a 35-year veteran in the pharmaceutical industry, having held executive positions at Abbott, GlaxoSmithKline and most recently, Merck. He has spent his career leading pharmaceutical and preclinical development teams with the development and commercialization of several blockbuster drugs.

"Doug brings a wealth of experience, maturity and strategic thinking to Patheon," said Wes Wheeler, chief executive officer and president. "With Doug on our Executive Committee, both leading the PDS unit and advising us on strategy, we will enable further strategic growth of our development services offering to clients. We look forward to Doug's leadership, as we continue our search for a permanent President."

Sanofi-aventis and Exelixis, Inc. have entered a global license agreement for XL147 and XL765 and a broad collaboration for the discovery of inhibitors of phosphoinositide-3 kinase (PI3K) for the treatment of cancer. The PI3K pathway in human tumors is related to promoting cell proliferation, survival and resistance to chemotherapy and radiotherapy.

Under the license, Sanofi-aventis will have a worldwide exclusive license to XL147 and XL765, which are currently in Phase I and Phase Ib/II trials, and will be responsible for all subsequent clinical, regulatory, commercial and manufacturing activities. Exelixis will participate in conducting ongoing and future trials and manufacturing activities.

Under the discovery collaboration, the two companies will combine efforts to establish several preclinical PI3K programs and will share responsibility for research and preclinical activities related to isoform-selective inhibitors of PI3K. Sanofi-aventis will be responsible for all subsequent clinical, regulatory, commercial and manufacturing activities of any products arising from the collaboration. Exelixis may be responsible for conducting certain trials.

Exelixis will receive an upfront cash payment of $140 million and will receive $21 million in funding during a three-year research term. Exelixis will be eligible to receive development, regulatory and commercial milestones of more than $1 billion, as well as royalties on sales of any products commercialized under the license or collaboration.

“Sanofi-aventis has a track record of success in commercializing innovative cancer therapies and is deeply committed to advancing the care of cancer patients,” said George A. Scangos, Ph.D., president and chief executive officer of Exelixis. “We believe that their expertise and resources will enable us to move aggressively in advancing the development of XL147 and XL765 and other potential PI3K inhibitors. The data generated to date in the XL147 and XL765 clinical programs suggest that these compounds may have utility in treating diverse cancers. Sanofi-aventis and Exelixis are committed to realizing the full potential of these compounds and other PI3K inhibitors to provide cancer patients with new treatment options.”

The license and collaboration are subject to antitrust clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary regulatory approvals.

Metrics has consolidated its quality-related operations and has promoted Thomas R. Wilson to vice president of quality operations. Mr. Wilson joined the company in 2000. Previously he managed the company’s quality control division, which was a separate function from quality assurance. The two functions have joined together as quality operations.

“By consolidating all quality operations and elevating their autonomy and authority to a vice president position, we at Metrics are sending a clear signal that quality control and assurance make up the foundation of everything we do here,” said Phil Hodges, president. “We grew quickly last year, so we are committed to ensuring that Metrics’ exacting quality operations stay focused and coordinated to deliver the excellence that our clients expect from us.”

Last year, the company doubled its facility size with an $18 million expansion. The expanded facility has the capacity to produce one billion tablets per year and includes four new analytical labs, stability storage, a segregated cytotoxic and potent compound development facility, and a microbiology lab.

Peg Connelly has been promoted to vice president of clinical operations, Kforce Clinical Research, Inc. She is responsible for strategic leadership and operational excellence for pharmaceutical client alliances.

Ms. Connelly has led the company's Pfizer alliance for site management since joining Kforce in July 2007. Under her leadership, the company was awarded the Pfizer 2008 Strategic Supplier Award. She has more than 17 years of industry experience in regional site management operations, study and data management, operational excellence skills and in-depth work across numerous therapeutic areas.

Prior to joining Kforce she worked for Pfizer in multiple positions, receiving Pfizer's Manager of the Year award in 2004.

PRA International has opened a Drug Safety Center in its São Paulo, Brazil office. Part of the company's safety and risk management unit, the center is responsible for serious adverse event and adverse drug reaction management. The drug safety center also supports clients with all other aspects of pharmacovigilance to help ensure regulatory compliance.

PRA currently operates two dedicated drug safety centers in Charlottesville, VA and Mannheim, Germany. The center in São Paulo adds to the company's presence in Latin America and provides additional global reporting capabilities. The safety and risk management team offers services throughout a product's life cycle. The company also provides services to support EU-RMP, FDA-REMS, annual safety reporting, IND reports and other services.

"The opening of the São Paulo Drug Safety Center enables us to expand our capabilities and level of service in Latin America and enhances our ability to provide standardized Drug Safety services globally, by growing and strengthening our overall safety team," noted Dr. Sabine Richter, PRA's vice president of safety and risk management. "This new center will allow us to create cost-effective and efficient global coverage that is enhanced with a local language and regulatory knowledge base. Both are key to our continued expansion of clinical trial and post-approval delivery in Latin America and globally."

Bristol-Myers Squibb received full approval from the FDA for Sprycel (dasatinib) for the treatment of adults in all phases of chronic myeloid leukemia (CML) (chronic, accelerated, or myeloid or lymphoid blast phase) with resistance or intolerance to prior therapy including Gleevec (imatinib mesylate).

The full approval was based in part on results from a Phase III randomized, open-label dose-optimization study that enrolled 670 chronic phase CML patients with resistance or intolerance to Gleevec. The primary endpoint was major cytogenetic response (MCyR), in Gleevec-resistant patients.

“Sprycel helps to fulfill a need for second-line treatments for CML patients with resistance or intolerance to Gleevec. The two-year follow-up data further support the use of Sprycel as an important treatment option for this patient population,” said Dr. Hagop Kantarjian, chairman and professor, Leukemia Department, M.D. Anderson Cancer Center.

Covance's clinical pharmacology business received Lilly's 2009 Global Supplier Award for helping Lilly meet its corporate objectives. The award acknowledges key suppliers who contribute the best in innovation and technology towards Lilly's success.

Covance was judged by a committee of Lilly representatives on criteria including delivery of quality, service, speed, total cost reduction, supplier relationship management, and supplier diversity.

"It's a true honor to be one of the dozen companies to win this award among Lilly's 6,500 global suppliers," said Covance chief operating officer Wendel Barr. "Delivering exceptional customer service is always a first priority for Covance, and being recognized for doing so by one of the world's most prominent pharmaceutical companies, for two consecutive years, is a tremendous achievement."

Dr. Reddy’s drug discovery operations at Hyderabad will be absorbed into Aurigene, a wholly owned subsidiary of the company, effective July 1, 2009. As part of the reorganization, the company will close its Atlanta research facility in the U.S.

Aurigene is a partnership based drug discovery biotechnology company headquartered in Bangalore, India. The discovery research resources, employees, facility and infrastructure, will transition into Aurigene, which will now operate from two sites in Bangalore and Hyderabad.

In addition, Dr. Reddy’s will be creating a new group to focus on new product development, which will be responsible for building the proprietary and branded R&D portfolio in collaboration with various partners and service providers. This organization will work with Aurigene and other biotech companies to manage ongoing and future drug discovery programs. This group will also have responsibility for the development portfolio and the company’s differentiated formulations efforts.

G V Prasad, vice chairman and chief executive officer, said, “We have been working at delivering sustained growth with profitability to significantly improve shareholder returns. As we prioritize our company-wide research and development spending, we will now be placing greatest emphasis on R&D activities that can have a significant impact on near-term earnings, while not losing focus on long-term interests of the company.”

The discovery research arm will report into CSN Murthy, chief executive officer, Aurigene. Dr. Rajinder Kumar, president of R&D and commercialization will step down to pursue other interests once the transition is completed, but will continue to advise the proprietary products group beyond July 1, 2009.

Sanofi Pasteur received a $190 million order from the U.S. Department of Health and Human Services (HHS) to begin production of a vaccine to help protect against the A(H1N1) flu virus.

This order was issued under an existing pandemic stockpile contract between Sanofi Pasteur and the U.S. government that allows HHS to purchase vaccines for viruses with pandemic potential.

The HHS order provides for the production of the bulk vaccine and related activities. The dosage requirements for the new vaccine are yet to be determined and will be based on clinical trials, which could begin as early as August. Final formulation, filling and distribution of the vaccine have not been established yet.

"This initial order for A(H1N1) vaccine under our existing contract is part of a major effort by Sanofi Pasteur to support global public health efforts to prepare the world for the possibility of an influenza pandemic," said Wayne Pisano, president and chief executive officer of Sanofi Pasteur. "Production of a new vaccine is not a simple task and there are a number of necessary and complex steps that must be taken before a vaccine can be made available to the public, but we have experience on our side. Previously, we developed and licensed the first pre-pandemic vaccine for H5N1 and we look forward to further demonstrating our experience and expertise in vaccine development as we prepare for this new threat from A(H1N1)."

Sanofi Pasteur is waiting to receive the seed virus to be used for vaccine production from the U.S. Centers for Disease Control and Prevention (CDC). The company will then begin development efforts to prepare a working seed for vaccine production. Sanofi Pasteur is prepared to begin commercial scale production in June following FDA certification of the working seed. The company currently estimates it will have the first bulk concentrate vaccine in a few months.

Production of the A(H1N1) vaccine will initially occur in Sanofi Pasteur's recently licensed flu vaccine production facility in Swiftwater PA. Once ongoing seasonal flu production is finished in the second facility in Swiftwater, the A(H1N1) vaccine will be produced in both Swiftwater facilities.

Amgen has exercised its option to obtain an exclusive worldwide license (excluding Japan) to Cytokinetics Inc.'s cardiac contractility program. The license includes CK-1827452, a cardiac myosin activator being developed for the treatment of heart failure.

Under the terms of the companies' 2006 collaboration, Amgen has agreed to pay Cytokinetics an exercise fee of $50 million and has assumed responsibility for development and commercialization of CK-1827452 and related compounds, subject to specified development and commercial participation rights of Cytokinetics.

"After reviewing the data from the CK-1827452 clinical trials, we are excited about the opportunity to advance this molecule," said Amgen executive vice president, R&D, Roger M. Perlmutter, M.D., Ph. D. "At Amgen, we are focused on developing medicines for patients suffering from grievous illnesses, including heart failure. CK-1827452, with its novel mechanism of action, has potential utility in the treatment of heart failure patients around the world. We intend to move this molecule forward rapidly into larger and more definitive clinical trials."

"Recently completed clinical trials of CK-1827452 suggest that this drug candidate may represent a major step forward in the treatment of heart failure," stated Cytokinetics' president and chief executive officer, Robert I. Blum. "We are looking forward to now expanding our collaboration with Amgen to provide for the advancement of this novel cardiac muscle activator into studies that are designed to further assess the clinical benefit of this exciting compound. Amgen has consistently demonstrated a successful track record with first-in-class mechanism compounds and we are pleased to be moving forward together."

Johnson & Johnson and Cougar Biotechnology, Inc. entered a definitive agreement under which J&J will acquire Cougar Biotechnology for approximately $1.0 billion in cash.

Cougar Biotechnology, a development stage biopharmaceutical company with an oncology focus, has compounds in development for the treatment of prostate cancer, breast cancer and multiple myeloma. The company will work with J&J's Ortho Biotech Oncology R&D, a unit of Centocor R&D, Inc.

Cougar Biotechnology is currently conducting two Phase III trials for abiraterone acetate for the treatment of prostate cancer. The first trial is testing the drug in patients with metastatic, castration-resistant prostate cancer who have progressed after docetaxel-based chemotherapy has failed. The second Phase III trial is studying abiraterone acetate in patients with metastatic, castration-resistant prostate cancer who have yet to receive chemotherapy.

"The acquisition of Cougar Biotechnology with its talented team will strengthen our growing capabilities toward a leadership position in the global oncology market," said William N. Hait, M.D., Ph.D., global therapeutic head, oncology, Ortho Biotech Oncology Research & Development. "We are developing new treatments that we anticipate will change the course of cancer treatment by targeting the tumor and its microenvironment and thereby will provide a meaningful difference in the lives of millions of patients worldwide."

Alan H. Auerbach, chief executive officer, president and founder of Cougar Biotechnology, said, "Since the founding of Cougar approximately six years ago, our employees have been relentlessly dedicated to the development of innovative oncology drugs and the creation of shareholder value. We believe that this transaction strongly positions abiraterone acetate for future success with a leading healthcare company that has the expertise, resources, dedication and motivation to deliver it to the cancer patients who need it."

The boards of directors of both companies have approved the transaction. The closing is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other closing conditions.

Jeffrey M. Stamps has been named senior vice president, pharmacy operations, Beth A. Kinerk has been named senior vice president, sales and customer development, and Jonathan D. Borman has been named vice president strategic sourcing, Omnicare, Inc.

Jeffrey M. Stamps has 25 years of experience in the pharmacy industry and most recently served as a corporate vice president and senior vice president, field operations for the company’s Pharmacy Operations Group. He also served as corporate vice president and senior vice president of the central division of the Pharmacy Operations Group. Mr. Stamps joined Omnicare in 1990 and has since held positions of increasing responsibility.

Beth A. Kinerk most recently served as vice president customer development. She assumed additional responsibility for the company’s sales efforts in May 2007. Ms. Kinerk has more than 18 years of pharmacy and healthcare/sales management experience. She joined Omnicare in 2005 with its acquisition of NeighborCare, Inc. where she served as vice president of sales. Prior to NeighborCare, Ms. Kinerk served as a director of sales for Innovatix, from 2001 to 2004. From 1998 to 2001, she served as Eastern divisional sales manager and national accounts manager for NCS Healthcare, Inc.

Jonathan D. Borman most recently served as vice president, strategic sourcing for the company’s Pharmacy Operations Group, a position he has held since joining the company in August 2007. Previously, Mr. Borman spent 15 years at the General Electric Co. in its Aircraft Engines and Engine Services Divisions where he held positions of increasing responsibility in its procurement and indirect sourcing organization.

“We are fortunate to have three such talented individuals as part of Omnicare’s management team,” said Joel F. Gemunder, Omnicare’s president and chief executive officer. “We expect their skills, experience and leadership to contribute significantly to Omnicare’s future growth and development.”

Almac, Pfizer and the PETACC3 Translational Research Working Party (PTRW) will conduct a collaborative study involving gene expression profiling of formalin-fixed paraffin-embedded (FFPE) samples from the Pan-European Trials in Adjuvant Colon Cancer (PETACC 3) trial. The study will use Almac Diagnostic's Colorectal Cancer DSA research tool to identify molecular subtypes, biomarkers and drug targets.

The samples to be used in the study are taken from the PETACC 3 study, an international randomized trial of adjuvant chemotherapy in patients with stage II and III colon cancer. This study represents a new resource in advancing the molecular understanding of colon cancer.

Prof. Paul Harkin, president and managing director of Almac Diagnostics, stated, "As understanding grows of the heterogeneity of cancer, it is becoming increasingly clear that molecular subtypes are important both in patients' prognosis and in predicting their response to chemotherapy. This has already been shown in breast cancer, and the study to be led by Almac, Pfizer and PTRW aims to examine this in colorectal cancer."

Argenta Discovery and Porsolt have entered into an alliance to provide CNS and pain drug discovery services. The collaboration allows the two companies to undertake fully integrated CNS and pain-focused drug discovery programs for their clients, from hit identification to development candidate nomination.

Dr. Christopher Ashton, chief executive officer of Argenta said, "Argenta has undertaken many successful medicinal chemistry-driven CNS and pain contract drug discovery research projects, but we have been looking at ways of enhancing our capabilities in these important therapeutic areas. Argenta has partnered with Porsolt to provide clients with dedicated access to specialist CNS and pain models and expertise, offered by a world leader in the field. We have several ongoing contract research programs in these therapeutic areas and a number of projects in the pipeline, which are likely to benefit from Porsolt’s support and know-how. This alliance will enable Argenta to offer an even better integrated drug discovery service in the future. We are looking forward to working with Porsolt.”

Dr. Mark Duxon, chief executive officer of Porsolt added, “Porsolt is delighted to be entering into a partnership with Argenta to deliver full lead optimization drug discovery on a contract research basis. Porsolt have recently announced a significant laboratory expansion in France and the Argenta partnership fits with our strategy of offering a diverse array of deal structure opportunities to suit the broad range of our clients’ needs. Indeed, our increased business flexibility is entirely complementary to our client-oriented scientific expertise. Porsolt has always sought to deliver quality scientific solutions tailored to client needs. In this respect, we believe we have found a like minded partner in Argenta.”

ACORN CRO has developed a new technology called STAR (Site Tracking And Recruitment) to help speed the site selection process as well as automate the study feasibility process.

STAR is designed to increase transparency and efficiency in the study feasibility/site selection process. The Site Repository contains all known information about each oncology research site, and enables rapid selection of potential study sites based on sponsor/study requirements. According to the company, it reduces the need for repetitive tasks and is estimated to save approximately 75% of the time sites traditionally spend on completing study feasibility forms.

The technology allows sponsors to view a report summarizing site identification metrics in real time. STAR automatically sends reminder notifications throughout the process, allows complete tracking of the status of each site contacted, helping to reduce the time needed to definitively identify study sites.

"STAR was developed under the guidance of ACORN CRO's experienced project managers who sought to save valuable time during the study start-up phase. The resulting system delivers solutions that provide meaningful cost benefits to both sponsors and participating sites," said Edward J. Stepanski, Ph.D., chief operating officer.

Novartis has signed an agreement to acquire the specialty generic injectables business of Ebewe Pharma for $1.2 billion. The deal covers Ebewe's injectable oncology unit, but excludes Ebewe's injectable neurological products business. The unit will be folded into Sandoz, Novartis' generics division.

Several of Ebewe's products — including paclitaxel, epirubicin, methotrexate, oxaliplatin, carboplatin, doxorubicin and gemcitabine — are essential components of standard-of-care guidelines for treating many types of cancers.

"The addition of Ebewe Pharma's leading portfolio of oncology medicines fits our strategy and improves our ability to help cancer patients around the world by providing easier access to therapies. These medicines will remain the backbone of multi-drug treatments in the fight against cancer, one of the world's leading causes of death," said Dr. Daniel Vasella, chairman and chief executive officer of Novartis. "Ebewe Pharma will further strengthen our pipeline with many planned near-term launches."

Since becoming independent in 2001 through a management buyout, Ebewe Pharma has built a strong position in Europe and in many emerging markets, while also establishing a presence in the U.S. The company's business is growing dynamically, delivering 20% compound annual sales growth since 2006. Net sales for the fiscal year 2008 were $272 million and operating income was $77 million. Ebewe has approximately 500 associates, and has a differentiated development portfolio with more than 20 distinct molecules that include significant near-term launch opportunities, according to a Novartis statement.

"As the world market for generic injectables to treat cancer continues to expand, our specialty generics business will enjoy a much broader global reach as part of Sandoz. We will also be able to offer greater benefits to patients and healthcare providers while creating a more competitive growth platform for our complementary businesses," said Friedrich Hillebrand, chief executive officer of Ebewe Pharma.

Sandoz will form a new global center of excellence around this business, which will be led by Mr. Hillebrand and will be based in Unterach, Austria. Key priorities for this new unit include capitalizing on Ebewe's capabilities in hospital marketing and strong customer partnerships, skills in developing differentiated generics and expertise in injectables manufacturing, according to Novartis.

Asymchem Laboratories has opened its high potency Active Pharmaceutical Ingredient (API) and Drug Product facility in TEDA Tianjin, China.

The dedicated facility is located at Asymchem's TEDA Tianjin 1 location, and provides state-of-the art containment for production of potent API's, as well as tablet and capsule manufacturing that incorporate potent ingredients. The new facility allows Asymchem to operate two separate API manufacturing trains of 50 and 100L, as well as additional facilities for smaller-scale research and production and oral dosage form manufacturing.

"We are pleased to expand our capabilities in process research and manufacturing into the potent compound arena, and provide our partners with cost-effective and quality-driven means for undertaking this type of work in China," said Dr. Hao Hong, Asymchem's chief executive officer.

Also, the company has named Dr. Chris Huber to the role of director of Chemical Development. Dr. Huber has more than 15 years of experience in the pharmaceutical industry, developing process technology for API manufacturing of small molecules. Prior to Asymchem, Dr. Huber directed early phase projects for API manufacturing at Achaogen and Arena Pharmaceuticals. Much of his career was spent in Pfizer and legacy companies in process chemistry, with focus on optimization, characterization and validation of Phase III processes in preparation for commercial manufacturing of API.

In his new role, Dr. Huber will help expand and strengthen Asymchem's pilot scale-up, tech transfers and production efforts into commercial manufacturing. He will report directly to Dr. Jim Gage, vice president of Chemical Development.

"I am very pleased to have Dr. Huber on board to help expand and strengthen Asymchem's already well-established large scale manufacturing services," Dr. Hong remarked. "With his broad experience in the pharmaceutical industry and proven track record of API manufacturing, I am confident that our commercial capabilities will be further strengthened and solidified."

Pfizer has entered into licensing agreements with two pharmaceutical companies based in India, boosting its position in emerging markets and significantly expanding its portfolio of medicines in its Established Products Business Unit.

The company has expanded its pact with Aurobindo Pharma Ltd., acquiring rights to 55 solid oral dose products and 5 sterile injectable products for patients in more than 70 emerging market countries. “This deal illustrates the types of innovative partnerships which will help to advance Pfizer’s presence in developing markets and enhance access to needed medicines for billions worldwide,” said Jean-Michel Halfon, president and general manager of Pfizer’s Emerging Markets Business Unit. “The expansion of our product portfolio from this deal provides a foundation for us to commercialize branded generics based on patient needs within specific regions.”

The acquisition includes antibiotics and anti-infectives, and covers a broad range of disease areas like cardiovascular and central nervous system disorders. Pfizer will commercialize the 60 products in phases tailoring its approach for different regions. Pfizer also expanded agreements with Aurobindo in developed markets, adding products in the U.S. and Europe. Financial terms of the deal were not disclosed.

Pfizer has also entered into agreements with Claris Lifesciences Ltd. to commercialize sterile injectable medicines after the products are no longer patent protected, and have lost market exclusivity in North America, Europe, Australia and New Zealand. The Claris agreements advance Pfizer’s Established Products strategy, which focuses on the commercialization of products where market exclusivity has been lost. Pfizer’s global annual sales of established products are approximately $10 billion.

As part of the deal, Pfizer has acquired rights to 15 injectable products covering a broad range of therapeutic areas including anti-infectives and pain. Financial terms were not disclosed.

“These agreements advance our goals to expand our steriles portfolio and provide hospitals and patients with a wide offering of affordable medicines they can trust. Pfizer’s reputation for high quality and supply reliability is unrivaled in the industry, and this is critical in the area of sterile injectables,” said David Simmons, president and general manager of Pfizer’s Established Products Business Unit.

To date, 128 non-Pfizer products - 98 solid oral dose and 30 sterile injectables – have been added to the Company’s existing diversified portfolio of established brands.

Morphotek and Lonza have executed a manufacturing services agreement to support the development and manufacturing of a subset of antibodies in Morphotek's therapeutic antibody pipeline. The agreement will reserve capacity for commercial manufacturing of Morphotek's lead compound farletuzumab (also known as MORAb-003), which recently entered Phase III clinical trials for ovarian cancer under a Special Protocol Assessment (SPA) agreement with the FDA. The collaboration between both parties already encompasses several other monoclonal antibodies currently in clinical or preclinical development.

"Lonza is an ideal partner and collaborator on this project," said Philip Sass, Ph.D., executive vice president and chief operating officer of Morphotek. "They have a great deal of experience and expertise with large scale expression and purification of commercial antibody products. They have demonstrated their ability to develop high-quality material and documentation with several of our programs and serve as an extension of our development team at Morphotek. Based on our working experience, we are confident that Lonza will meet our production, quality goals and timelines for our antibody programs."

"Lonza is excited to participate in supporting the commercial manufacturing of Morphotek's lead compound, farletuzumab," said Stephan Kutzer, head of Lonza Biopharmaceuticals. "Lonza looks forward to continuing and expanding the Morphotek relationship for both development and manufacturing services using Lonza's proprietary GS Gene Expression System toward their pipeline of promising compounds."

Through the use of its proprietary Morphodoma technology, Morphotek develops optimized antibodies, including antibodies optimized for affinity and/or titer, for therapeutic applications and high-titer manufacturing cell lines. The antibodies within the company's pipeline are targeted against antigens licensed from its collaborative partners.

Genentech and Biogen Idec have submitted two supplemental Biologics License Applications (sBLAs) to the FDA for Rituxan plus standard chemotherapy for people with previously untreated or treated chronic lymphocytic leukemia (CLL). The companies will request a priority review, and if granted, anticipate the FDA will make a decision within six months.

CLL is the most common type of adult leukemia, accounting for one-third of all leukemias in the U.S. It is a slow-growing disease that occurs when too many abnormal white blood cells develop in the blood and bone marrow. The abnormal cells outnumber the normal white blood cells, making it difficult for the body to fight infection.

The applications are based on positive results from two of the largest global Phase III clinical trials conducted in patients with CLL. The randomized, comparative studies, known as CLL8 and REACH, showed that Rituxan plus standard chemotherapy for CLL extended the time patients lived without the cancer advancing (progression-free survival or PFS) compared to those receiving chemotherapy alone. In CLL8, previously untreated patients who received Rituxan plus chemotherapy had a 69% improvement in PFS (41% risk reduction, hazard ratio=0.59; p<0.0001; 95% confidence interval: 0.44,0.72) compared to those who received chemotherapy alone. In REACH, patients whose cancer relapsed after previous treatment had a 54% improvement in PFS after receiving Rituxan plus chemotherapy compared to patients receiving chemotherapy alone (35% risk reduction, hazard ratio=0.65; p=0.0002; 95% confidence interval: 0.51, 0.82). These findings were based on assessments made by the study investigators.

“There is no cure for CLL, and the primary goal of treatment is to keep the cancer from getting worse,” said Cecil Pickett, Ph.D., Biogen Idec’s president of R&D. “These data showed that Rituxan was able to extend the period of time before cancer progression by about 10 months for people with newly diagnosed or recurrent disease.”

“Results from these two large studies, which involved nearly 1,500 patients, give us confidence in Rituxan’s efficacy and safety in CLL,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer, Genentech. “We believe the data support the potential role of Rituxan as both an initial and second-line treatment for CLL, and look forward to working with the FDA during the review period.”

XenoBiotic Laboratories (XBL), a contract lab focused on bioanalytical and ADME, will open XBL-China this summer.

XBL-China's new 36,000-sq.-ft. laboratory in Nanjing has a 12,000-sq.-ft. vivarium and analytical instrumentation. With additional offices in Shanghai, XBL-China will provide bioanalytical and metabolism services to the standards standards comparable to XBL's New Jersey facility. Jinn Wu, president and chief executive officer of XBL, "The initial goal for XBL-China is to offer GLP-level bioanalytical as well as discovery PK services to support drug development programs being conducted in Asian countries. Additional services such as synthetic chemistry, formulation services, Phase I clinical trial conduct, and SFDA registration are planned for the future. This is a significant expansion for XBL and will allow us to provide services to global pharmaceutical companies." An open house ceremony is planned for October 2009.

XBL has also boosted its U.S.-based services with the addition of a large molecule bioassay/cell-based assay group, Debra LIMS, QWBA and in-house NMR services.

"With the addition of a state-of-the-art laboratory and expertise to conduct Quantitative Whole Body Autoradiography (QWBA) studies, in-house NMR (500 MHz) and the industry standard Debra LIMS software, we now offer a complete and comprehensive package of services for ADME studies," saidDennis Heller, XBL's vice president of Pharmaceutical Development. "In addition, we recognized the expanding need for quantitative bioanalytical services for biologics (biotherapeutics and biomarkers) and, as a result, invested in a new biologics group that will provide ELISA-based services for quantitative PK bioanalysis for biotherapeutics, immunogenicity screening and biomarker assays. Our biologics group is also developing key cell-based assays to screen the biological activity of macromolecules."

Fredric N. Eshelman, vice chairman and chief executive officer of PPD, Inc., has been named to the newly created position of executive chairman of the board of directors. Ernest Mario, Ph.D., who has served as the non-executive chairman of the board of PPD since 1993, has been appointed lead independent director. PPD also announced that Brigadier General David L. Grange (ret.), a member of PPD’s board of directors since 2003, has been named PPD’s new chief executive officer. General Grange will report to Mr. Eshelman in his new capacity as executive chairman. These appointments will be effective July 1, 2009.

In his new position, Mr. Eshelman will continue to be responsible for providing strategic direction to the company and overseeing the implementation of the company’s strategic and business plans, including the company’s compound partnering business. Working closely with General Grange, he will also focus on key initiatives, strategic outsourcing plans and core aspects of the company’s operations.

General Grange most recently had a decade of service at the McCormick Foundation, first as executive vice president and chief operating officer, and as president and chief executive officer since 2005. The foundation is a nonprofit organization that conducts grant-making programs and other operations, and has $1.2 billion in assets. Prior to joining the foundation in 1999, he had a 30-year career in the U.S. Army, with his final position as commanding general of the First Infantry Division, known as the Big Red One. During his military career, Brig Gen. Grange served as a Ranger, Green Beret, Aviator, Infantryman and a member of Delta Force. While stationed at the Pentagon, he served as the deputy director and director of Army Current Operations and Readiness and Mobilization, and was responsible for coordinating military support within the U.S. in response to natural disasters and for domestic preparedness against acts of terrorism.

“General Grange brings a great combination of global geographical experience and knowledge, demonstrated leadership from his business and military careers, financial management experience and first-hand knowledge of PPD as a member of our board since 2003,” said Mr. Eshelman. “I look forward to working closely with General Grange and his executive management team to chart our course and execute our business plans to drive long-term shareholder value.”

Mr. Eshelman added, “On behalf of the board of directors, I extend our sincere appreciation to Dr. Mario for his outstanding service as our non-executive chairman for the past 16 years. He and I have worked closely together over this period to grow PPD, and I look forward to his continued leadership and counsel as our lead independent director.”

Schering-Plough and Novartis have amended their global collaboration for the development and commercialization of fixed-dose combination therapies for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Schering-Plough will assume exclusive worldwide rights to develop and commercialize a fixed-dose combination of its inhaled corticosteroid Asmanex (mometasone furoate inhalation powder), and Novartis' long-acting beta2-adrenergic receptor agonist, Foradil (formoterol fumarate). Novartis will assume exclusive worldwide rights to develop and commercialize a fixed-dose combination of Schering-Plough's inhaled corticosteroid mometasone furoate with its investigational beta2-agonist QAB149 (indacaterol).

"Schering-Plough has a long history in developing therapies for treating respiratory diseases. This strategic action will allow us to focus our efforts within the asthma and COPD market," said Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute. "The investigational fixed-dose combination of ASMANEX and FORADIL, both of which are currently approved and marketed as individual products, is in Phase III development for the treatment of asthma and COPD. Schering-Plough anticipates filing the mometasone furoate/formoterol combination for the treatment of asthma with the FDA in the first half of 2009," added Dr. Koestler.

This is the latest development in a long-term relationship between the companies, dating back to 2002. The collaboration was expanded in August 2006 to include the joint development and commercialization of a fixed-dose combination of indacaterol and mometasone furoate. The collaboration has completed the mometasone furoate/formoterol combination's phase II (asthma, COPD) and phase III (asthma) development, while phase III (COPD) continues. Meanwhile, the indacaterol/mometasone combination is in phase II development (asthma, COPD).

Combination products containing inhaled corticosteroids and long-acting beta2-agonists are the largest segment of the worldwide market for asthma and COPD medications, in terms of dollar sales, according to statement by SP.

With the new pact, SP will assume the remaining development and commercialization costs of the mometasone furoate/formoterol fixed-combination product, which will utilize a meter-dose inhaler device, while Novartis will assume the remaining development and future commercialization costs of the indacaterol/mometasone furoate combination including the SP Twisthaler multi-dose dry powder inhaler device. There will be a royalty-sharing arrangement based on sales. SP will recognize sales worldwide for mometasone furoate/formoterol upon commercialization. In addition, SP will receive royalties and other compensation for Novartis' use of the Twisthaler device.

Patheon has launched cell based assay services to support biopharmaceutical product development. The new services will strengthen Patheon's existing analytical capability in biopharmaceutical analysis, according to a company statement.

Cell based assays are a key technology used in determining the biological potency of biopharmaceuticals required for product licensing procedures. Biological potency analytics and the required supporting capabilities for tissue culture, such as assessment of cell viability and production of master and working cell banks, will take place at Patheon's Swindon, UK facility. This will enable all the analytical needs for biopharmaceutical product development to be completed in one location.

Wes Wheeler, president and chief executive officer of Patheon, commented, "Expanding the services provided through using cell based assays at our Swindon facility, is a testament to the commitment Patheon has to enhancing and growing the Pharmaceutical Development Services provided to our customers. This new capability allows us to better meet the needs of customers in the early stages of drug development."

The facility will be managed and supported by a team of scientists with approximately 18 years of combined experience in tissue culture and cell based assays. The facility will be fully available for use at the end of May.

Quotient Bioresearch Ltd. has acquired Charles River Laboratories’ Edinburgh clinical research facility. This represents the sixth acquisition in approximately three years for Quotient.

The Charles River facility, formerly Inveresk Clinical Research, will combine with Pharmaceutical Profiles, which Quotient acquired in December 2008, to form a new strategic business unit within Quotient. The group will be known as Quotient Clinical.

The Edinburgh clinical unit will combine with Pharmaceutical Profiles to offer a suite of integrated services stretching from First-in-Human (FIH) through to Phase IIa patient studies. Founded almost 20 years ago, the clinical unit is an industry leader in FIH studies. It was awarded Supplementary Accreditation status by the Medicines and Healthcare products Regulatory Agency (MHRA) in January 2009, demonstrating its experience and capabilities to conduct FIH trials for small molecules and biologics.

Quotient Clinical will have a workforce of approximately 160 medical, scientific and clinical staff across the two facilities in Edinburgh and Nottingham. With an existing strong customer base in the U.S., Europe and Japan, the principal focus of Quotient Clinical is "to provide a unique and comprehensive range of early development services to a broad range of pharmaceutical and biotechnology customers," according to a company statement.

Paul Cowan, chairman and chief executive officer of Quotient, remarked, “The creation of Quotient Clinical represents the next step in expanding the range of specialised services we offer pharmaceutical and biotech customers worldwide. We are delighted to have completed the acquisition of the Charles River Edinburgh clinical facility. With the Inveresk heritage we are bringing a world-class facility and clinical experience to Quotient Clinical.”

Quotient Clinical will be headed by Mark Egerton, formerly chief executive officer of Pharmaceutical Profiles.

GlaxoSmithKline and Oxford BioTherapeutics (OBT) have formed a strategic alliance to discover, develop and commercialize novel, therapeutic antibodies for the treatment of primary, metastatic and recurring forms of cancer. GSK will develop novel antibody therapies against selected OBT targets. In parallel OBT will develop one of its own monoclonal antibodies through to clinical proof of concept, at which point GSK will have an exclusive option to in-license this monoclonal antibody and will thereafter assume responsibility for further clinical development and commercialization on a worldwide basis.

OBT will receive an undisclosed upfront payment and will be eligible for as much as $370 million in discovery, development, regulatory and commercialization milestones. In addition to the upfront and milestone payments, OBT will receive double-digit royalties on sales of any product that it develops to clinical proof of concept and single-digit royalties on worldwide sales of marketed GSK antibody products aimed at OBT targets. OBT may also opt to carry forward the OBT or GSK collaboration programs that GSK chooses not to develop further.

The alliance integrates OBT’s expertise in the discovery of novel oncology targets and therapeutic antibody discovery with GSK’s in-house therapeutic antibody discovery and development capabilities. OBT’s antibody discovery platform builds on its OGAP proteomic database, which represents one of the world’s largest proprietary human protein collections including data on 5,000 cancer membrane proteins combined with highly disease relevant genomic and clinical information derived from human blood and cancer tissue studies.

“We are extremely pleased to be collaborating with GSK given their proven commitment to innovation and their expertise in the development and commercialization of novel oncology medicines,” said Christian Rohlff, OBT's chief executive officer.

He added, “This strategic alliance provides important validation of our scientific expertise in the fields of cancer target discovery and broadens OBT’s antibody pipeline. In addition, we gain access to significant non-dilutive financing to support the development of our pipeline of fully human therapeutic antibodies which we believe have the potential to significantly impact clinically unmet needs in certain important cancer indications.”

On the eve of BIO 2009, DSM has announced that its proprietary XD Technology can boost bioreactor productivity and titers of mammalian cell culture processes by 5-10 fold for the production of proteins and antibodies. The company said that recent studies completed at the R&D labs of DSM Biologics in Groningen, The Netherlands, demonstrated that the yields from CHO-based cell cultures "can be increased 5-10 fold over previous fed-batch processes using only off the shelf, commercially available media." DSM's XD Technology has been tested for antibody and recombinant protein production across multiple cell lines, and the increase was realized in all cases.

Jaap Schilder, site director Groningen, remarked, "This opens the door to a completely novel way of supplying drug substance for clinical trials and for market needs. The XD process increases the overall output of a facility dramatically and the process duration and handling is similar to any fed-batch process. Development spending, time to market and cost of goods will all be significantly reduced by applying this technology. Now, up to several kilograms of drug substance can be manufactured in a single batch from small disposable bioreactors."

Karen King, president at DSM Biologics, added, "Clients can use the XD Technology within their existing infrastructure or it can be the basis of an optimized new plant design offering costs-of-goods advantages and reductions in capital expenditure."

SGS Life Science Services expanded its Phase I Unit in Antwerp, Belgium, adding 22 new hospitalization beds to its clinical pharmacology unit in the Stuivenberg hospital. This addition includes a new subunit of six wards with 3-5 beds, a new recreational room, sample preparation lab, and additional auxiliary services, bringing the total number of beds to 102 for Belgium, and the company's global capacity to 184 beds.

The additional beds and auxiliary services will be used to support larger trials. Also, this new subunit can be isolated from the others and used for smaller stand-alone trials running in parallel. The new infrastructure is in place and is scheduled for use in several upcoming trials.

"We wanted to boost the capacity of the unit to increase our flexibility in study scheduling, which will be a significant advantage for our clients. This extension allows us to maintain the same level of quality that has always existed at SGS," said Omer Van Schoor, the director of clinical pharmacology at the SGS Antwerp facility.

WuXi PharmaTech 1Q

1Q Revenues: $59.1 million (+5%)

1Q Earnings: $23.3 million (-11%)

Comments: Growth in the quarter was driven primarily by 28% growth in revenues for China-based Lab Services to $41.6 million, offset by an 81% decline in manufacturing services revenue. Lab services revenue grew 33% to $56.5 million, driven by organic growth and the AppTec acquisition.

Enzon Pharmaceuticals, Inc. received approval from the FDA for Cimzia for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). Cimzia (certolizumab pegol), is a PEGylated anti-TNFa (Tumor Necrosis Factor alpha). The product is currently being developed by UCB. Cimzia is one of several products that use Enzon’s PEGylation technology.

“Our PEGylation technology continues to enable very important therapeutics like Cimzia, benefiting patients with a wide variety of diseases,” said Jeffrey H. Buchalter, Enzon's chairman and chief executive officer.

Minakem Group has completed the acquisition of AstraZeneca's APIs plant in Dunkirk, France and has signed a long-term supply contract for Budesonide, Omeprazole and Esomeprazole.

Dunkirk's three sites can produce multiple API’s simultaneously, with one unit dedicated to the production of corticosteroids. This acquisition adds to Minakem's manufacturing capabilities, including injectable grades, and micronization services, and raises its custom synthesis capacity to about 450 m3 of batch reactors. These resources allow Minakem to provide process and synthesis development, clinical production, short campaigns for niche API’s as well as high volume API’s.

The three FDA-inspected factories at the plant include: Leuna for hazardous chemistry, large volume intermediate and short multi-step syntheses for medium scale API’s; Beuvry-la-Forêt for complex multi-step syntheses, short campaigns and niche API’s; Dunkirk for high-volume API’s, solid treatments and corticosteroids.

Minakem will have a unified commercial and marketing team and will implement a key account management policy for its major custom-synthesis clients. Chemtec Leuna GmbH will be renamed Minakem Leuna GmbH and remains managed by Karsten Fischer. Minakem SAS will be renamed Minakem Dunkerque SAS and Alexandre Gruman will serve as managing director.

Regulus Therapeutics, Inc. achieved the initial milestone in its worldwide strategic alliance with GlaxoSmithKline to discover, develop and market novel microRNA-based therapeutics to treat inflammatory diseases. The two companies are working to identify drugs directed at four different microRNA targets related to inflammatory disease. Regulus received an undisclosed payment for the first demonstration of pharmacological effect in immune cells by specific microRNA inhibition.

“This milestone is further evidence that microRNAs represent disease targets whose therapeutic modulation could revolutionize the way we treat immune diseases,” said Peter S. Linsley, Ph.D., chief scientific officer at Regulus. “We believe that we are the leaders in microRNA and are delighted to have such a good partner as GSK supporting the translation of our groundbreaking research into therapeutic opportunities. We are particularly pleased that this has been achieved in the first year of the collaboration.”

The alliance, which has a potential value of nearly $600 million, was established in April 2008. Regulus is responsible for the development of antagonists to four microRNA targets from discovery through completion of clinical proof of concept. GSK has an exclusive license for worldwide development and commercialization of drugs developed by Regulus under each program for the relevant microRNA.

Microtest Laboratories is adding dissolution testing to its current suite of analytical testing and stability testing services. Dissolution is a compendial method used to measure a drug’s rate of release from its dosage form. It is a complement to other analytical assays — potency and related substances — that characterize the dosage form.

“The addition of dissolution testing is the perfect complement to our portfolio of services,” said Steven Richter, Ph.D., president and scientific founder of Microtest Laboratories. “By offering an even more comprehensive array of assays, we’re increasing the convenience, efficiency, and value that we deliver as a single, preferred provider of contract laboratory services.”

Dissolution is typically used in a number of settings, including: optimization of drug delivery rate during development studies; routine QC analysis for lot release and measurement of lot-to-lot variability; stability studies to examine the effects of time, temperature, and humidity on the dosage form; comparison of one dosage form to another; and estimated release and absorption rates in humans after an in vitro - in vivo correlation is established.

Dissolution is a sample preparation technique. Samples still need to be analyzed separately. Typical samples are oral dosage forms, although it can also be used on topicals and transdermal systems. Microtest’s analytical testing processes follow guidelines from the United States Pharmacopeia (USP), the Japanese and European Pharmacopoeias, the FDA, the International Organization for Standardization (ISO), and the Association for Advancement of Medical Instrumentation (AAMI).

GE Healthcare has launched GE Healthcare Facility Validation Services, a new global service that will provide customers with comprehensive international regulatory compliance for facilities and manufacturing systems compared with complex traditional approaches. The service applies to new and existing facilities.

The Facility Validation Services will use a Modular Validation Platform to work with customers as they plan and design their facilities and manufacturing processes to the required regulatory standards. GE Healthcare Facility Validation Services will employ the company’s project and business management expertise, as well as operational methodologies such as Lean and Six Sigma, aimed at providing an integrated global service.

Victor Bornsztejn, global growth director, GE Healthcare, said, “We aim to help eliminate the current disconnection between drug/process development and facility validation. GE Healthcare has played a pivotal role in biopharmaceutical drug and process development for decades, so we believe we are uniquely positioned to drive this change in the industry.

“The launch of GE Healthcare Facility Validation Services is a major milestone for GE Healthcare, combining many of the Company’s capabilities,” Mr. Bornsztejn added. “Drug manufacturers are regularly receiving citations and warnings that are linked to their validation, usually for reasons that are easily avoidable. We believe our range of solutions and expertise enables us to offer a very broad range of complete product/lifecycle services at a time when compliance and cost-containment are key industry concerns.”

Cory Lewis has been named director of business development for the global biopharmaceutical contract development and manufacturing division of Cook Medical.

Mr. Lewis has more than a decade of biopharmaceutical experience. Most recently, he served as vice president of sales and marketing at Althea Technologies, Inc. supporting the contract manufacturing division. Prior to Althea, he worked for Baxter Healthcare in a variety of global businesses and functional areas spanning across finance, marketing and business development.

“Cory has a strong, cross-functional background including specific experience in contract manufacturing of biologics API and parenteral injectable products. His experience will be of great value to our team and customers as Cook Pharmica furthers efforts to become a full service provider and global leader in the contract manufacturing market,” said Cook Pharmica president Tedd Green.

Eden Biodesign has completed a successful second audit by the UK Medicines and Healthcare Products Regulatory Agency (MHRA), European Medicines Agency (EMEA) to manufacture Investigational Medicinal Products (IMPs) at its facility in Liverpool, UK.

The three-day MHRA inspection took place in March 2009 and demonstrates that the company’s processes, facilities and quality systems meet cGMP standards, with no critical or major deficiencies found by the inspector.

“I am delighted that our world-class cGMP production facilities have passed their second audit,” said Dr. Crawford Brown, co-founder and chief executive officer of Eden Biodesign. “The inspection recognizes that we have a highly trained and knowledgeable team and appropriate and well-developed quality systems in place at Eden Biodesign. We have a growing track record with a global client base, and we deliver a full-service offering for the production of new medicines across all major biopharmaceutical production platforms.”

GlaxoSmithKline has agreed to extend its strategic relationship with South African-based Aspen Pharmacare Holdings Ltd., and will acquire a 16% share in the company. This is part of a broader agreement that includes combining commercial activities in Sub-Saharan Africa and the divestment of several assets to Aspen.

Abbas Hussain, president emerging markets, GSK said, "Extending our strategic relationship with Aspen supports GSK's strategy to accelerate sales growth in emerging markets. The combination of our commercial activities in Sub-Saharan Africa is highly complementary and will mean that together we can provide more medicines of value to more patients in these countries. At the same time, GSK will also benefit from investing in one of Africa's leading healthcare companies with a formidable track record of delivery."

On completion, Aspen will issue 68.5 million new shares as non-cash consideration to GSK in exchange for the transfer of several assets. Aspen will appoint a non-executive director, nominated by GSK, to its board of directors upon closing of the transaction. GSK will divest its manufacturing facility in Bad Oldesloe, Germany to Aspen, and the following medicines: Alkeran (excluding US), Kemadrin, Lanvis, Leukeran, Myleran, Purinethol, Septrin and Trandate. The Bad Oldesloe manufacturing site produces some of these divested products and several other products Aspen previously acquired from GSK.

Under the terms of the agreement, GSK and Aspen will collaborate on the commercialization of their current and future product portfolios in Sub-Saharan Africa (excluding South Africa). The collaboration aims to build a broader and more diverse portfolio for these countries, with Aspen's pipeline of new products expected to benefit from leveraging GSK's existing commercial infrastructure. In South Africa, where Aspen has extensive commercial capability, GSK will transfer marketing and distribution rights to Aspen for its pharmaceutical products.

The agreement, subject to regulatory approvals, is expected to be complete before the end of this year.

Sanofi-aventis U.S. has acquired commercial rights to Oforta (fludarabine phosphate film-coated tablets), an oral B-cell chronic lymphocytic leukemia (CLL) drug, from biotechnology company Antisoma. Oforta is currently approved in the U.S. for use as a second-line therapy to treat adults with B-cell CLL.

"We are extremely pleased to add Oforta to our existing oncology portfolio, and believe it represents an exciting opportunity for Sanofi-aventis U.S.," said John Harrington, vice president and head of the Oncology Business Unit at sanofi-aventis U.S. "Sanofi-aventis is a company committed to identifying and exploring new treatment options for patients facing serious diseases, such as CLL. This agreement further supports our efforts to help patients and complements our strong heritage of providing therapies to treat cancer."

Antisoma currently licenses certain rights and purchases Oforta from Bayer Schering Pharma AG. As part of this transaction, Sanofi-aventis U.S. will also acquire these agreements.

Sartorius Stedim Biotech expanded its technology portfolio with the addition of two prototypes of single-use bioreactors that operate based on novel mixing technologies. These cell culture systems were developed in cooperation with the German company Bayer Technology Services GmbH (BTS) and the Swiss cell culture specialist ExcellGene SA. The new bioreactors have been designed for the manufacture of monoclonal antibodies, recombinant proteins and vaccines.

The company has been offering two types of single-use bioreactor: the BIOSTAT CultiBag STR product line, which features a stirred tank design as in reusable bioreactors, and the BIOSTAT CultiBag RM that uses rocking motion for mixing of cell cultures. In 2010, the company plans to extend its technology portfolio with two additional systems: a rotationally oscillating bioreactor and an orbital shake bioreactor. Each of these four agitation technologies offers specific advantages depending on the cells being produced, the scale-up level of the cell cultures and additional process parameters.

“Based on this comprehensive technology platform, we are taking a huge step forward towards achieving our goal of becoming the global market leader in single-use bioreactors," commented Dr. Oscar-Werner Reif, who is responsible for R&D on Sartorius Stedim Biotech’s board of directors. “Whatever our customers’ application, we offer the best solution, both technically and economically."

Tekmira Pharmaceuticals Corp. has entered into a product development agreement with Roche to advance Roche's first two RNA interference (RNAi) product candidates into human trials. Both of the product candidates will be based on Tekmira's stable nucleic acid-lipid particle (SNALP) technology.

Under the terms of the agreement, Roche will pay Tekmira as much as $18.4 million to support IND applications for the product candidates. Tekmira is also eligible to receive as much as $32 million in milestones plus royalties on product sales should the first two products advance to commercialization. Tekmira will develop and manufacture the drug product for use in all preclinical studies as well as one batch of clinical product for a Phase I trial.

Dr. Mark J. Murray, Tekmira's president and chief executive officer, said, "We are extremely pleased to be working with Roche, a global pioneer in the development of important therapeutic products and a leader in the RNAi field. This agreement is consistent with our strategy of working with leading pharmaceutical companies to help them advance products based on our SNALP technology, and to leverage this work in order to advance our own products."

Dr. Louis Renzetti, head of RNA therapeutics at Roche, said "We are enthusiastic about the potential of RNAi therapeutics for patients with hard-to-treat diseases. We believe Tekmira's SNALP is the leading lipid nanoparticle delivery technology and we are confident that Tekmira's research and manufacturing capabilities will help us to meet our product development objectives."

The two companies expect an IND for the first product candidate to be filed before the end of 2010.

Kristie H. Lively, RN, BSN has been appointed vice president, ACORN CRO. Ms. Lively will oversee all aspects of the company's operations and services.

"Kristie Lively brings exceptional skills, knowledge and resources to our organization that will benefit our clients and their projects enormously as ACORN CRO continues it growth," said ACORN CRO's chief operating officer, Edward J. Stepanski, Ph.D.

Ms. Lively previously served as vice president for a large CRO, conducting community-based clinical trials in oncology and other therapeutic areas. She has more than 15 years of healthcare industry experience with a strong background in quality assurance and operations, including all phases of CRO service operations and management.

"Kristie's leadership capabilities, commitment to quality, and deep understanding of our customer needs make her an excellent fit for ACORN CRO as we expand operations," added Lee S. Schwartzberg, president and medical director, ACORN CRO.

Eurand received approval from the FDA for EUR-1048, to be marketed as GlaxoSmithKline's Lamictal ODT (lamotrigine) Orally Disintegrating Tablets. Co-developed by Eurand and GSK, Lamictal ODT uses Eurand's AdvaTab orally disintegrating tablet and Microcaps taste-masking technologies.

Lamictal ODT is indicated for the long-term treatment of Bipolar I Disorder to lengthen the time between mood episodes in people 18 years or older, and is also used together with other medicines to treat certain types of seizures in people 2 years or older or alone when changing from other medicines used to treat partial seizures in people 16 years or older. Lamictal ODT will be available in 25 mg, 50 mg, 100 mg, and 200 mg strengths and is expected to be available in early July 2009.

Eurand will receive an undisclosed milestone payment upon launch, revenue for manufacturing, royalties on sales, and milestone payments based on Lamictal ODT achieving predetermined sales in the U.S.

ChemWerth entered a manufacturing partnership with Tianjin Tianyao Pharmaceuticals Co., Ltd., a China-based manufacturer and exporter of corticosteroid products. Tianjin Tianyao Pharmaceuticals is chair to the Chinese state steroid hormone association and is the first to authenticate cGMP for production of corticosteroid APIs in China. The company has been recognized for its technical and research capabilities, and has a portfolio of more than 40 new technologies and products. Through the partnership, the two can now offer customers a new line of hormonal API products.

“The significant resources of Tianjin Tianyao Pharmaceuticals adds much to our existing competencies in generic APIs,” said Peter Werth, chief executive officer and chairman of ChemWerth, Inc. “Given ChemWerth’s successful track record, robust new product development capacity and superior cGMP regulatory resources, we believe our customers will benefit greatly from this new partnership,” he added.

Gilead's DAR-311 (DORADO) Phase III trial evaluating its once-daily oral endothelin receptor antagonist (ERA) darusentan as an add-on treatment for resistant hypertension, achieved positive results. DAR-311 is an international Phase III double-blind, placebo-controlled parallel group trial, in which 379 patients were randomized to receive once-daily doses of darusentan 50 or placebo for up to 14 weeks as an add-on to existing antihypertensive regimens. The co-primary efficacy endpoints were change from baseline to week 14 in trough sitting systolic blood pressure (SBP) and trough sitting diastolic blood pressure (DBP). Secondary endpoints included change from baseline in mean 24-hour SBP and DBP and percent of patients reaching SBP goal.

In DAR-311, mean reductions in trough sitting SBP from baseline of 16.5 mmHg, 18.1 mmHg, 18.1 mmHg and 8.6 mmHg from baseline were observed for the darusentan 50 mg, 100 mg, 300 mg and placebo groups, respectively, after 14 weeks of treatment. Mean reductions in trough sitting DBP from baseline of 10.1 mmHg, 9.9 mmHg, 10.7 mmHg and 5.3 mmHg were observed for the darusentan 50 mg, 100 mg, 300 mg and placebo groups, respectively, after 14 weeks of treatment.

Ambulatory blood pressure monitoring (ABPM) performed at week 14 revealed highly significant reductions from baseline in 24-hour SBP and DBP in patients treated with darusentan. Reductions in ambulatory SBP were maintained throughout the 24-hour monitoring period and there were no significant changes in heart rate.

According to guidelines, SBP of less than 140 mmHg is recommended for patients with hypertension and no other serious conditions. For patients with diabetes and CKD, target SBP is more stringent, with a goal of less than 130 mmHg. In DAR-311, more than half of patients treated with darusentan achieved goal blood pressure, as compared to approximately one quarter of patients receiving placebo.

AAIPharma has acquired the Xcelodose 600S capsule filling system, enhancing the company’s preclinical and early phase clinical GMP supply capabilities. The Xcelodose 600S can accommodate batch sizes up to several thousand capsules in sizes from 00 to size 4 with a variety of fills including neat drug substance, granulations, and blends.

Some of the benefits this technology provides include: decreased development time with clinical supplies available in less than three months; reduced active ingredient requirements through dosing into capsules reducing waste; reduced cleaning requirements through the use of dedicated product contact parts; and lower potential for stability issues by eliminating the possibility of excipient interactions and uniformity problems.

The company plans to install the unit in its solid dose manufacturing facility in Wilmington, NC within a specially designed containment system that will allow for enhanced operator safety. The unit is expected to be available and validated by June 2009. Xcelodose is 21CFR Part 11 compliant.

Isotechnika entered a strategic investment and collaboration with Paladin Labs under which Paladin will provide Isotechnika with $7.0 million of cash upfront and $4.4 million in R&D funding during the next 12 months. Under the proposed plan, Isotechnika will own 81% of a new company, Isotechnika Pharma Inc., and Paladin will own 19%.

Isotechnika will focus its efforts on finding partnerships for the clinical development of voclosporin in the transplant indication, and expects to have the capital to fund operations until the anticipated milestones from Lux Biosciences are met.

"The combination of this financing and share reorganization provides Isotechnika shareholders with a solid balance sheet to deliver on key milestones and business objectives," said Dr. Robert Foster, president and chief executive officer of Isotechnika. "We are pleased to be able to secure capital on favorable terms in such a difficult market, while retaining the rights to market voclosporin in the largest, most strategic markets. In the process we gain a strategic partner in Paladin Labs for key pharmaceutical markets, including Canada. We continue to look forward to milestone and royalty payments from our partners, Lux Biosciences and Atrium Medical."

"We are pleased to partner with Isotechnika for the development and commercialization of voclosporin. With positive results from a recently completed Phase III trial in psoriasis, we intend to submit voclosporin for Canadian regulatory approval. We are also excited by the much larger market opportunity for voclosporin in the transplant indication. We look forward to participating with current Isotechnika shareholders in a new, well-funded company that will continue to develop voclosporin for the benefit of its shareholders," stated Jonathan Ross Goodman, president and chief executive officer of Paladin Labs.

The transaction is expected to close in June of this year.

Enzon 1Q

1Q Revenues: $48.6 million (flat)

1Q Earnings: $6.2 million (earnings were $1.5 million in 1Q08)

Comments: Oncaspar sales were up 15% to $14.1 million. DepoCyt sales were $2.5 million (+25%). Abelcet sales were down 16% to $5.9 million. Adagen sales were $7.2 million (+18%). Royalty revenue was $13.6 million (-7%). Contract manufacturing revenue was $5.3 million (-20%).

Merck Serono and partner Newron Pharmaceuticals SpA have initiated the SETTLE study to evaluate the efficacy and safety of a dose range of safinamide (50-100 mg once daily) as an add-on therapy to levodopa, in mid- to late-stage Parkinson's disease patients.

The SETTLE study is one of the Phase III trials for a development program designed to support an application for marketing authorization. SETTLE is a six-month, randomized, double-blind, placebo-controlled trial that includes more than 450 patients with Parkinson's disease treated with levodopa for at least four weeks whose motor fluctuations have more than one and a half hours of "OFF" time during the day. After a four-week levodopa dosage stabilization phase, study participants will be randomized in one of the two arms of the trial to receive either safinamide or placebo, as adjunctive treatment to levodopa therapy.

The primary endpoint is the change in daily "ON" time, as assessed by patient diaries, from baseline to week 24. Secondary endpoints include changes in measures of activities of daily living, global clinical status and health-related quality of life.

"Managing motor fluctuations and reducing the time during which anti-Parkinson drugs are not working and symptoms return, the so-called 'OFF' times, are still unmet medical needs for patients with mid- to late-stage Parkinson's disease," said Bernhard Kirschbaum, Merck Serono's head of Global R&D. "After the encouraging results we obtained for study 016, we aim to confirm the efficacy of safinamide as an add-on therapy to levodopa in a flexible dosing regimen."

Charles River 1Q

1Q Revenues: $301.5 million (-11%)

1Q Earnings: $25.4 million (-42%)

Comments: Preclinical Services revenue was $140.0 million (-17%) due primarily to slower market demand. Sales for the Research Models and Services segment were $161.5 million in the quarter (-4%).

GlaxoSmithKline has entered into an agreement to divest full commercial rights to Wellbutrin XL in the U.S. to Biovail International Laboratories, for $510 million. GSK will retain existing rights to Wellbutrin XL for countries outside the U.S., excluding Canada.

"We are actively reshaping our U.S. business and managing the transition occurring in our product portfolio," said Deirdre Connelly, president North American Pharmaceuticals, GSK. "This transaction is one of a series of actions we are taking to maximize the value of our current assets and to enable us to resource and invest in new products and upcoming launches."

Generic competition for Wellbutrin XL began at the end of 2006 for the 300mg tablet and during 2Q08 for the 150mg tablet. U.S. sales of Wellbutrin XL in 1Q09 were $59.8 million (-70%). Wellbutrin XL is indicated for the treatment of major depressive disorder and seasonal affective disorder. It was developed by Biovail and has been distributed by GSK in the U.S. since September 2003.

As a result of the divestment, GSK expects to record a pre-tax gain of approximately $455 million in 2009. The agreement is subject to Hart-Scott-Rodino regulatory clearance in the U.S.

Randy Kehrmeyer has been promoted to group president, Kforce Clinical Research Inc. (KCR). He is responsible for all business development functions, with an emphasis on enhancing relationship management and service levels for key customer partnerships with pharmaceutical clients.

Mr. Kehrmeyer previously served as senior vice president of strategic customer partnerships, responsible for strategic account management, business and alliance operations and client-dedicated alliance teams. He joined the company in 1999 as a director of staffing and has since held responsibility for every area of business. In 2002, Mr. Kehrmeyer received Kforce’s Dick Maddock Award for Leadership Excellence.

Prior to joining the company, he was a Marine Corps Combat Arms officer for nine years serving in multiple positions of increasing responsibility, culminating in two years as a company commander with First Tank Battalion.

Jubilant Biosys Ltd., a Bangalore-based subsidiary of Jubilant Organosys, has signed a research collaboration agreement with AstraZeneca focused on delivering preclinical drug candidates into AZ's pipeline. The shared risk-reward collaboration will initially focus on neuroscience.

AZ will own the compounds developed under the collaboration with worldwide development and commercialization rights. Jubilant will be eligible to receive research funding for an initial five-year period. AZ will also pay Jubilant success-based development milestones as well as royalties on global commercialization of any compounds.

Shyam S. Bhartia, chairman and managing director, and Hari S. Bhartia, co-chairman and managing director, of Jubilant Organosys, said, "We are very pleased to partner with AstraZeneca, this collaboration will leverage the innovative capabilities of AstraZeneca and Jubilant Biosys in providing a robust global drug discovery model. Through this partnership, Jubilant is confident of contributing to AstraZeneca's preclinical portfolio and anticipates significant rewards from successful downstream milestones. This partnership furthers Jubilant's strategy to be India's largest provider of innovative and integrated pharmaceutical solutions, enabling the global pharmaceutical industry's quest to discover affordable innovative medicines."

Jan Lundberg, executive vice president, Global Discovery, AZ, said, "This collaboration complements our internal capabilities and increases the capacity of our preclinical programs. It is a concrete example of the innovative approaches we are taking to deliver a sustainable discovery pipeline with a lean and agile organization. Ultimately, this will provide us with more shots on goal as we look to sustain a competitive portfolio and provide meaningful medicines to patients."

Azmi Nabulsi, M.D., M.P.H., has been named president, Takeda Global R&D Center, Inc., U.S. Dr. Nabulsi will report to Nancy Joseph-Ridge, M.D., general manager, pharmaceutical development division, Takeda Pharmaceuticals International. He will direct all aspects of Takeda's U.S. drug development activities, including the identification of new product candidates, execution of clinical trial programs and support for new lifecycle management approaches for the company's marketed products.

Dr. Nabulsi brings more than 20 years of experience to his new position. Previously he was general manager for Takeda's Strategic Development Department based in Osaka, Japan, where he was responsible for overseeing the company's global portfolio strategies, development plans, and performance and productivity initiatives. Prior to that, he held roles within R&D operations for Takeda Global R&D Center. Dr. Nabulsi joined Takeda in 2004 after a 10-year career at Abbott, where he held multiple global leadership positions in the development division.

Merck Serono, a division of Merck KGaA, has launched Glucophage Powder for Oral Solution in Sachets, indicated for the first-line treatment of type 2 diabetes mellitus, in France and the UK. Marketing authorizations in other European countries for the new formulation of Glucophage are expected in the coming months.

The new powder formulation is bioequivalent to the existing Glucophage tablets and is packaged in individual sachets of 500mg, 850mg and 1000mg. Glucophage powder dissolves in water.

"Adherence to therapy is increasingly being recognized by physicians as a key condition to achieve glycemic control for patients with diabetes," said Roberto Gradnik, executive vice president commercial Europe at Merck Serono. "We are pleased to provide this innovative powder formulation of Glucophage to patients seeking a convenient alternative to tablets which may facilitate their adherence to treatment."

Althea Technologies, Inc. has opened its new commercial-scale cGMP manufacturing facility in San Diego, CA. The new facility provides additional capacity and expands the company's services from early clinical development through Phase III and commercial supply.

"We are very excited to launch our 30,000-sq.-ft. commercial-scale cGMP manufacturing facility because it allows Althea Technologies to take an integrated approach in the manufacturing of exciting new biotechnology-derived therapies. The completion of this building marks a significant milestone in our ultimate goal of accelerating the development and delivery of novel therapies to the people who need them most," stated Dr. Magda Marquet, co-chairman and founder.

The cGMP facility complies with both U.S. and European manufacturing regulations and according to the company, the building management system ensures a sterile manufacturing environment.

"The commercial expansion will enable Althea to contribute to the economic vitality of the region through the addition of personnel and the ability to help ensure the continued success of more biotech companies," said Dr. Franxcois Ferre, co-chairman and founder of Althea Technologies.

AstraZeneca submitted an NDA to the FDA seeking approval for low-dose aspirin combined with esomeprazole magnesium (Nexium) to reduce the risk of low-dose aspirin-associated side effects, such as gastric and/or duodenal ulcers.

AstraZeneca also submitted a sNDA for Nexium for the risk reduction of low-dose aspirin-associated gastric and/or duodenal ulcers. Nexium is approved for the risk reduction of gastric ulcers associated with continuous non-steroidal anti-inflammatory drug (NSAID) therapy in patients at risk for developing ulcers.

Low-dose aspirin is used for the prevention of cardio- and cerebrovascular events such as heart attack and stroke. However, low-dose aspirin is associated with a risk of peptic ulcers and gastrointestinal symptoms.

Both of the submissions are based on the results of two studies evaluating the safety and efficacy of Nexium in reducing the risk of gastric and/or duodenal ulcers in patients who take low dose aspirin. One study compared Nexium 40 mg or 20 mg with placebo, while the other study compared Nexium 20 mg with placebo.

Tom Reilly has been appointed manager of service and manufacturing for Index Encapsulation. Mr. Reilly has 28 years of experience servicing encapsulators, liquid fillers, sterilizing tunnels, baggers and other packaging equipment in the food and pharmaceutical industries. He will manage all aspects of the company's service including troubleshooting, repairs/rebuilds, new equipment manufacturing, installations, and training.

Lancaster Laboratories has been awarded the 2009 Eli Lilly Global Supplier Award for having a measurable impact on the company’s objectives and priorities. The award acknowledges delivery of exemplary quality, service, speed, total cost reduction and other value adds.

“Since our founding in 1961, a key strength of ours has been our ability to form partnerships and collaborate effectively with our customers for their success and ours,” said Dr. Wilson Hershey, Lancaster Laboratories president. “We are delighted our customer service and scientific expertise has served Lilly well.”

Allergan 1Q

1Q Revenues: $1.0 billion (-6%)

1Q Earnings: $45.0 million (earnings were $107.9 million in 1Q08)

Comments: Product sales were $994.6 million in the quarter. Specialty pharmaceuticals revenue (including Botox) was down 4% to $826.9 million and medical device sales were down 18% to $167.7 million.

Novozymes Biopharma's Recombumin and albucult products are the first to comply with the new excipient monograph standard for recombinant human albumin, published in the U.S. Pharmacopoeia - National Formulary (USP-NF). First published in November 2008, the monograph has become official. The use of these products is intended to ease the regulatory process for customers and set the industry benchmark for recombinant human albumin.

Recombumin offers the stabilizing and formulation benefits of human derived albumin and is GMP compliant. Novozymes' yeast expression technology is animal-free, and recombinant human albumin is available for use in the manufacture of licensed and developmental therapeutics in the U.S. and Europe. Albucult is also a yeast-derived recombinant albumin, targeted for use in specialized cell culture and as a bulk drug manufacturing raw material, such as in peptide or small molecule drug chemical coupling for delivery or half-life extension.

The monograph refers to recombinant human albumin as "rAlbumin Human NF" listed as a "sterile vehicle" intended for injection into humans together with the active ingredient, and needs to be of the highest safety and quality.

Wayne Prestwood, principal regulatory associate at Novozymes Biopharma said, "We are delighted to be setting the gold standard with our Recombumin and albucult products by being the first to comply with the new monograph. This is of significant benefit to our customers, providing peace of mind whilst facilitating regulatory agency review and approval."

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