Contract Pharma news - World Wide

<div><strong>John Ryan, Ph.D., M.D.,</strong> has been named senior vice president, chief medical officer and <strong>Karen Roberts</strong> has been named senior vice president, finance and administration at <a target= _blank href= http://www.ceruleanrx.com/ >Cerulean Pharma</a>. Both appointments are newly established roles that reflect Cerulean&rsquo;s growth and are effective immediately.</div> <div></div> <div>Dr. Ryan has more than 20 years of experience in clinical research and development at AVEO Pharmaceuticals, Wyeth (formerly Genetics Institute), and Merck Research Laboratories. Most recently, Dr. Ryan served as chief medical officer at AVEO Pharmaceuticals, where he built a clinical group for the development of oncology drugs.</div> <div></div> <div>Karen Roberts joins Cerulean after serving as vice president, finance and administration at Elixir Pharmaceuticals, since that company's founding in 2001. Ms. Roberts was a core member of Elixir's executive management team and responsible for all aspects of accounting, finance and administration for that company. Prior to that, Ms. Roberts held senior financial positions at Frontline Group, Dyax Corp. and T Cell Sciences.</div><img src= http://feeds.feedburner.com/~r/ContractPharmaBreakingNews/~4/YLQ2BvLY7Lc height= 1 width= 1 />

<div><a target= _blank href= http://www.contractpharma.com/csd/company/Kendle%20International%20Inc. >Kendle</a> has implemented a new biostatistics infrastructure intended to significantly enhance the analysis and delivery of quality clinical trial data for customers. According to a company statement, &quot;The centralized SAS-based platform provides a virtual environment allowing for simultaneous access and analysis of clinical trial data by Kendle's global Biostatistics and Scientific Programming teams from anywhere in the world, creating significant time savings and further enhancing data security.&quot;</div> <div></div> <div>&quot;With this new environment data will be processed at the server level much faster than ever before, greatly improving the productivity of our teams around the world and expediting the delivery of quality data to our customers,&quot; said John A. Whitaker, Ph.D., vice president, Biostatistics and Statistical Programming. &quot;This investment allows Kendle to provide a more globally integrated solution to meet our customers' needs anywhere, any time.&quot;</div> <div></div> <div>In addition to improved efficiency, quality and security, the centralized platform also positions Kendle to better leverage its growing operations in India, according to the company. Other benefits of the new infrastructure implementation will include improved network performance and bandwidth availability, reduced licensing requirements, and simplification of the testing, production and recovery environments.</div><img src= http://feeds.feedburner.com/~r/ContractPharmaBreakingNews/~4/0OIiFryFfq8 height= 1 width= 1 />

<div><a target= _blank href= http://www.contractpharma.com/articles/2009/07/abbott-laboratories >Abbott Laboratories</a> will acquire <a target= _blank href= http://facetbiotech.com >Facet Biotech</a> for a net transaction value of approximately $450 million in cash (a purchase price of approximately $722 million minus Facet's projected cash and marketable securities at closing of approximately $272 million). Abbott will pay approximately $27 per share for Facet. In September 2009, <a target= _blank href= http://www.contractpharma.com/articles/2009/07/biogen-idec >Biogen Idec</a> attempted to buy Facet at a value of $14.50 per share; the offer rose to $17.50 in December 2009, but was rejected.</div> <div></div> <div>The acquisition boosts Abbott's biologics pipeline in immunology and oncology. Facet's pipeline includes daclizumab, a Phase II biologic intended to treat multiple sclerosis (MS) that is expected to move into Phase III development in the 2Q10, and oncology compounds in early- to mid-stage development. Daclizumab is being developed in collaboration with Biogen Idec; some oncology compounds are being developed in collaboration with other parties.</div> <div></div> <div>&quot;This acquisition will further strengthen Abbott's biologics capabilities and pharmaceutical pipeline,&quot; said John Leonard, M.D., senior vice president, global pharmaceutical research and development, Abbott. &quot;Daclizumab is a promising treatment for multiple sclerosis, a disease that has a significant unmet medical need, and has the potential to become an important treatment option for patients. We continue to explore multiple mechanisms to treat autoimmune diseases and cancer with both biologic and small molecule approaches.&quot;</div> <div></div> <div>&quot;We believe this transaction provides full and fair value for our stockholders and validates the potential of Facet's clinical and technology assets, all of which has resulted from the effort and dedication of our employees,&quot; said Faheem Hasnain, president and chief executive officer, Facet Biotech. &quot;Abbott's depth of expertise in immunology and oncology makes it an excellent organization to maximize the full potential of these promising clinical programs and technologies.&quot;</div> <div></div> <div>The transaction, expected to close in 2Q10, has been approved on behalf of the boards of directors of Facet and Abbott. Approval of the transaction by Abbott's shareholders is not required.</div><img src= http://feeds.feedburner.com/~r/ContractPharmaBreakingNews/~4/v_DXS3FJSJs height= 1 width= 1 />

<a href= http://exelixis.com >Exelixis, Inc. </a>is restructuring as part of its continued strategy to focus resources on the development of its key late-stage compounds, XL184, XL147 and XL765. The restructuring also includes cutting its workforce by approximately 40%, or 270 employees. Although Exelixis will continue its efforts to advance other new compounds into development, the number will be reduced for the foreseeable future. The company has retained the ability to meet all of its existing obligations to partners and expects that future business development discussions for unpartnered clinical and preclinical compounds, will be unaffected.<br /> <br /> As a result of the restructuring, the company estimates that its costs through 2011 will by reduced by approximately $90 million after restructuring costs. The savings are primarily related to reductions in compensation and benefits, lab supplies and clinical trial costs. The company expects to record a restructuring charge of approximately $15 million in 1Q10.<br /> <br /> &ldquo;The restructuring reflects our commitment to the strategic goals that we presented at our R&amp;D Day in December 2009. We are focused on the aggressive development of our most advanced clinical compounds XL184, XL147 and XL765. Along with our investigators and partners, we remain enthusiastic about their potential as new anti-cancer agents and have retained the development expertise and capabilities to advance these compounds expeditiously. Our priority is to see ourselves through to the anticipated filing of our first NDA for XL184 in the second half of 2011,&rdquo; said George A. Scangos, president and CEO of Exelixis, Inc. &ldquo;We are convinced that the restructuring is the right step for the company and positions us well to move into the future. However, it is extremely difficult to release many people who have contributed substantially to the company over the years and who are our friends and colleagues.&rdquo;<br /> <br /> In addition to XL184, XL147 and XL765, the company will pursue development of XL888, an orally available small molecule inhibitor of HSP90 currently in Phase I, XL139 and XL413, compounds co-developed with BMS, as well as its preclinical program focused on PI3K delta.<br /> <br /><img src= http://feeds.feedburner.com/~r/ContractPharmaBreakingNews/~4/LfSAT1X1rQA height= 1 width= 1 />

<a href= http://www.lonza.com >Lonza</a> and <a href= http://www.odysseythera.com >Odyssey Thera, Inc. </a>have signed an agreement under which Lonza will make Odyssey's Protein-fragment Complementation Assay (PCA) technology, as part of compound profiling services, available to life science researchers. Additionally, Lonza has an option to certain exclusive global technology licenses. The companies have also initiated collaborative technology, product development and marketing activities. <br /> <br /> Odyssey will also receive an equity investment, making Lonza a minority shareholder, as well as and technology development funding, eligibility to receive additional payments, as well as milestones and royalties on Lonza sales. <br /> <br /> PCA enables a precise visualization and localization of protein complexes within living human cells. A key benefit of the technology is the applicability to any target, pathway, or disease process. When new targets or drugs are screened on the platform, their mechanisms and safety issues are identified, allowing critical decisions to be made at an earlier stage of the development process.<br /> <br /> &quot;Odyssey Thera has created unique strategies for analyzing cellular targets in their native context and for expediting drug development. Our partnerships with top-tier pharmaceutical companies have validated the approach,&quot; said John Westwick, Ph.D., president and chief executive officer of Odyssey. &quot;The alliance with Lonza will accelerate technology development while driving commercialization of our PCA-based tools and services. Working with Lonza's industry-leading capabilities in primary cell culture, transfection and marketing creates an excellent growth opportunity for both companies.&quot;<br /> <br /> &quot;Access to the PCA technology patent portfolio enables Lonza to expand its product and service offering for drug discovery and safety testing. We are excited by the product pipeline that this alliance gives Lonza and look forward to contributing to the further development of Odyssey's unique technology,&quot; said Teun van der Heide, Ph.D., head of Research Solutions at Lonza.<br /><img src= http://feeds.feedburner.com/~r/ContractPharmaBreakingNews/~4/SwJGHQLU8hw height= 1 width= 1 />

<a href= http://www.almanac.com >Almac</a> has received the Aer Lingus Viscount Award for Overall Excellence. The annual award is given for contributing to the Northern Irish economy and improving business relationships between the UK and Ireland. Aer Lingus, in association with UTV and Business Eye, recognized Almac&rsquo;s enhancement of the Northern Irish knowledge economy and for its continued growth in highly competitive global markets.<br /> <br /> Almac&rsquo;s chief executive officer, Alan Armstrong, said, &ldquo;We are tremendously proud of what Almac has achieved over the last 30 years and the company&rsquo;s Northern Irish roots. This award is testament to the excellence we have achieved across all divisions of our business, and in particular, the excellent team we have built, enabling Almac to grow into the successful company that it is today.&rdquo;<br /> <br /> <a href= http://contractpharma.com/csd/company/Almac >Click here to learn more about Almac</a><br /><img src= http://feeds.feedburner.com/~r/ContractPharmaBreakingNews/~4/7Tzbp_IRElM height= 1 width= 1 />

<a href= http://www.lilly.com >Lilly</a> has signed an agreement to acquire the European rights to a portfolio of certain <a href= http://www.pfizer.com >Pfizer </a>Animal Health products that include vaccines, parasiticides and feed additives used in both the production animal and companion animal markets. In return, Pfizer will receive an undisclosed upfront payment.<br /> <br /> The products were previously marketed by Pfizer and Wyeth's Fort Dodge operations. The European Commission requested that Pfizer divest these products as a result of its acquisition of Wyeth last year, including Wyeth's Fort Dodge Animal Health business.<br /> <br /> Elanco, Lilly&rsquo;s animal health division, will acquire a manufacturing facility in Sligo, Ireland for the production of animal vaccines, and as part of the agreement, all Sligo employees will be offered positions with Elanco. Additionally, to ensure an uninterrupted supply of product, both companies have signed corresponding manufacturing supply agreements. Financial terms of the transaction were not disclosed.<br /> <br /> &ldquo;The addition of this attractive portfolio of products and a world-class manufacturing facility is a natural fit for Elanco and positions us well for sustained growth,&rdquo; said Jeff Simmons, president, Elanco. &ldquo;Through this acquisition, we will expand and diversify our European presence with new market-leading products, augment our growing portfolio of companion animal medicines, and acquire new biologic and vaccine capabilities. We are excited about these new opportunities to improve animal health and protein production, and deliver greater value to our customers.&rdquo;<br /> <br /><img src= http://feeds.feedburner.com/~r/ContractPharmaBreakingNews/~4/jj0pPz1MVh8 height= 1 width= 1 />

The FDA has completed its inspection of <a href= http://www.celltherapeutics.com >Cell Therapeutics, Inc.&rsquo;s </a>(CTI) facility at NerPharMa, a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences in Nerviano, Italy. FDA found the site in compliance for continued manufacture of CTI&rsquo;s pixantrone product. CTI&rsquo;s NDA for pixantrone is currently under review to treat relapsed/refractory aggressive non-Hodgkin's lymphoma. The FDA is expected to make a final decision on approval by April 23rd.<br /> <br /> &ldquo;FDA approval of the NerPharMa facility to manufacture our drug product is a major milestone in the drug approval process and we are pleased that our manufacturing partner is prepared to provide commercial supplies when pixantrone is approved,&rdquo; said Craig W. Philips, president of CTI.<br /> <br /><img src= http://feeds.feedburner.com/~r/ContractPharmaBreakingNews/~4/Q_MEyVGrpPo height= 1 width= 1 />

<a href= http://www.quintiles.com >Quintiles </a>has opened its expanded research facility in London, UK, increasing Phase I capacity and extending its capabilities in translational medicine. The expansion brings the total number of Phase I beds in London to 105 and globally to 385. Additionally, the company has plans to open a Phase I unit in Hyderabad, India, in late 2010. This facility initially will have 50 beds, with capacity for expansion to 100.<br /> <br /> &ldquo;Declining productivity in R&amp;D means that the biopharmaceutical industry is under intense pressure to increase efficiency and overcome complexity,&rdquo; said Eddie Caffrey, senior vice president, Global Phase I at Quintiles. &ldquo;With our expanded facility in London and our planned facility in Hyderabad we will be better able to provide an integrated Phase I research solution that facilitates robust decision making early.&rdquo;<br /> <br /><img src= http://feeds.feedburner.com/~r/ContractPharmaBreakingNews/~4/JfbPzaWOm9I height= 1 width= 1 />

<a href= http://wacker.com target= _blank >Wacker Chemie</a> has opened a new production facility for biologics in Jena, Germany. The new plant is part of the Munich-based chemical company&rsquo;s investment program to enlarge its biotech operations. The expansion, together with the new building for process development and quality control already completed last year, brings Wacker&rsquo;s total investment in the Jena facility to some $24 million.<br /> <br /> Wacker has substantially boosted capacity at Jena in order to cope with a growing need for high-efficiency biologics production processes, and to meet rising customer demand. The existing GMP-certified facility has doubled its production area. A completely new facility for product-purification enables as much as three times higher product yields per batch, the company boasts, and the new unit meets the GMP requirements of both the FDA and the EMEA.<br /> <br /> To accommodate growing customer inquiries, the facilities of Wacker Biotech GmbH have been greatly expanded over the last two years. The investment by the Wacker Group at Jena&rsquo;s Beutenberg campus encompassed two projects: expansion of the GMP facility, and a new lab building for process development and quality control. The latter was built and put into operation in 2009.<br /> <br /> &ldquo;We now have an ideal system for developing the sophisticated processes and analytical techniques of modern, microbe-based biologics,&rdquo; explained Dr. Thomas Maier, managing director of Wacker Biotech GmbH. &ldquo;This allows Wacker to optimize the entire process chain, from lab operations to industrial GMP production. Customers thus benefit from a full process and analysis package provided from a single source. And with the expansion of our production capacities, we can now make our innovative Esetec secretion technology available to still more customers.&rdquo;<br /><img src= http://feeds.feedburner.com/~r/ContractPharmaBreakingNews/~4/yHPVSno478w height= 1 width= 1 />

<strong>Gary Buehler,</strong> the director of the <a href= http://www.fda.gov >FDA&rsquo;s</a> Office of Generic Drugs, has changed positions at the agency and will now serve in the Office of Pharmaceutical Science, which oversees the generics area. Mr. Buehler led the generics office for 10 years. <strong>Keith Webber,</strong> the deputy director of the Office of Pharmaceutical Science, will take over for Mr. Buehler on an interim basis.<br /> <br /> According to information presented by the FDA at the Generic Pharmaceutical Association convention last month, Mr. Buehler's division has a backlog of 2,000 generic-drug applications, with more than 500 additional applications anticipated by the end of this year. <br /> <br /> Also, concerns were expressed at the meeting about the two-year-plus waiting time for FDA approval and the costs in lost sales. It was also suggested that, like branded pharmaceutical companies, generic drug companies should pay user fees to help cover the cost of FDA reviews.<br /> <br /> FDA Commissioner Margaret Hamburg stated at the conference that she endorses user fees and will work with the administration to get them into legislation. The amount of the fees and whether they could be applied to reduce the current backlog remains unclear.<br /> <br /><img src= http://feeds.feedburner.com/~r/ContractPharmaBreakingNews/~4/MvBBsY-heM8 height= 1 width= 1 />

<a href= http://www.pfizer.com >Pfizer</a> and <a href= http://www.bms.com >Bristol-Myers Squibb's </a>oral anticoagulant apixaban achieved positive results in the late-stage Advance-2 study. Apixaban was shown to be statistically superior to 40 mg once daily enoxaparin (Lovenox) in reducing the incidence of venous thromboembolism in patients undergoing total knee replacement surgery. The study results also showed lower rates of bleeding in patients treated with apixaban compared to enoxaparin.<br /> <br /> Apixaban is an oral, highly selective Factor Xa inhibitor, part of a class of agents being studied for their potential to prevent and treat blood clots in the veins and arteries. Pfizer and BMS began their apixaban co-development pact in April 2007.<br /> <br /> &ldquo;One of the major concerns for orthopedic surgeons using oral anticoagulants for venous thromboembolism prevention in knee surgery is the significant risk of bleeding,&rdquo; said Michael Rud Lassen, M.D., Hoersholm Hospital in Copenhagen, Denmark, lead investigator for the study. &ldquo;We are encouraged by the Advance-2 data, which demonstrated better antithrombotic effect and comparable bleeding rates for apixaban compared with enoxaparin.&rdquo;<br /> <br /><img src= http://feeds.feedburner.com/~r/ContractPharmaBreakingNews/~4/dpBDUCzJ1G8 height= 1 width= 1 />

<a href= http://xcellerex.com >Xcellerex, Inc.</a> and <a href= http://humacyte.com >Humacyte, Inc.</a> have entered into a strategic collaboration under which Xcellerex will develop a manufacturing process enabling the production of Humacyte&rsquo;s lead regenerative drug product using its XDR single-use bioreactor system. <br /> <br /> Humacyte&rsquo;s product is a large vascular graft using the company&rsquo;s platform technology for engineering human, extracellular matrix-based tissues that have properties similar to native tissues. The grafts will first be used for arterio-venous access in patients on hemodialysis and eventually would be used as a replacement of diseased or damaged blood vessels. <br /> <br /> Xcellerex will provide development and product manufacturing in exchange for manufacturing development fees from Humacyte. Humacyte will use the initial grafts produced for preclinical development, and the parties may continue their collaboration for the large-scale manufacturing of vascular grafts for clinical and commercial use. Xcellerex&rsquo;s FlexFactory will enable Humacyte to later scale up its production to meet late-stage clinical and commercial market demands. <br /> <br /> &ldquo;We are pleased to utilize our unique manufacturing technology and development know-how to enable the rapid development of a potent single-use manufacturing platform for Humacyte. Our technology offers Humacyte a cost-effective and novel manufacturing solution. We are excited to see our single use manufacturing technologies applied in such an important application that holds such great promise for significant advances in improving treatment options for patients,&rdquo; stated Joseph Zakrzewski, Xcellerex&rsquo;s chairman, president and chief executive officer. <br /> <br /> <a href= http://contractpharma.com/csd/company/Xcellerex%2C%20Inc. >Click here to learn more about Xcellerex</a><br /><img src= http://feeds.feedburner.com/~r/ContractPharmaBreakingNews/~4/O73oGRM4gfU height= 1 width= 1 />

<a href= http://www.andersonpackaging.com >Anderson Packaging</a> has received the International Quality and Productivity Centre (IQPC) excellence award in the small-to-mid-sized corporation category for the competition&rsquo;s Best Process Improvement in a Manufacturing Project. Anderson submitted a detailed summary of its Lean Six Sigma project for the company&rsquo;s pharmaceutical bottle packaging lines. The award was received at the recent IQPC&rsquo;s Lean Six Sigma and Process Improvement Summit in Orlando, FL.<br /> <br /> Anderson was recognized for its effectiveness in implementing improvements in pharmaceutical bottling, including delivering increased capacity and turnaround of production orders, as well as scrap minimization and downtime initiatives. The project achieved 30% reductions in downtime for individual programs, 10% increases in Overall Operational Effectiveness (OEE), and 40% scrap reductions. Anderson instituted its Lean Six Sigma program companywide in 2004 and the project encompasses more than 10 production lines across multiple facilities. <br /> <br /> According to Chuck Aubrey, vice president of performance excellence at Anderson Packaging, &ldquo;This award is recognition of the efforts of many individuals at Anderson. We maintain a culture of continuous improvement and the principles of Lean Six Sigma methodology are involved in every aspect of the business.It helps maintain Anderson&rsquo;s competitiveness in the pharmaceutical packaging market, but ultimately it&rsquo;s about delivering the best possible service and performance to our customers. The Lean Six Sigma program is delivering powerful and measurable results.&rdquo;<br /> <br /> <a href= http://contractpharma.com/csd/company/Anderson%20Packaging%2C%20Inc. >Click here to learn more about Anderson Packaging </a><br /><img src= http://feeds.feedburner.com/~r/ContractPharmaBreakingNews/~4/pvISID1AX68 height= 1 width= 1 />

<a href= http://www.kendle.com >Kendle </a>received approval from Indian authorities to proceed with development of a new operations center in a Special Economic Zone (SEZ) in the Ahmedabad-Gandhinagar Knowledge Corridor. The new SEZ center is part of the company&rsquo;s strategic plan to further invest in Asia/Pacific to meet customer needs. The new unit is expected to be operational in April.<br /> <br /> &quot;Continued expansion throughout the Asia/Pacific region is crucial to the future growth of Kendle,&quot; said Stephen Cutler, Ph.D., senior vice president and chief operating officer. &quot;Our increased capacity in the region will allow us to better meet the growing demands of our customers who are seeking to capitalize on India's rapidly expanding high-quality biopharmaceutical capabilities. The new SEZ operations center will be ideally suited to deliver best-in-class services to our customers seeking high-quality, innovative and cost-effective solutions for their clinical development needs.&quot;<br /> <br /> The SEZ operations center will focus on quality delivery of clinical data management, medical writing, pharmacovigilance/safety, biostatistics/programming and other knowledge processing-related services. Initially the center will house approximately 50 associates and is expected to scale up to approximately 300 associates in the near term. <br /> <br /><img src= http://feeds.feedburner.com/~r/ContractPharmaBreakingNews/~4/ExbgMfIf8t0 height= 1 width= 1 />