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Contract Pharma news - World Wide

Valeant, GSK Enter Retigabine Pact

<a href= http://www.valeant.com >Valeant Pharmaceuticals</a> and <a href= http://www.gsk.com >GlaxoSmithKline</a> have entered into an exclusive worldwide collaboration for the investigational drug retigabine, a neuronal potassium channel opener for treatment of adult epilepsy patients with refractory partial onset seizures. Retigabine has shown efficacy and safety in two Phase III trials in patients with refractory epilepsy receiving treatment with as many as three antiepileptic drugs (AEDs). The two companies plan to file a NDA in the U.S. and a MAA in Europe by early 2009. The drug is also being studied in patients with post-herpetic neuralgia (PHN), a painful and common complication of shingles.     Under the terms of the agreement, Valeant will grant GSK worldwide development and commercialization rights to retigabine, VRX698 and the other compounds from the potassium channel opener discovery program in exchange for an upfront payment of $125 million. Valeant is eligible to receive as much as $545 million based on certain regulatory, development and commercialization milestones, as well as the development of additional indications for retigabine. Valeant will co-commercialize and share as much as half of the profits in the U.S., Canada, Australia, New Zealand and PR, and will receive as much as a 20% royalty on sales outside those regions. The two companies will share global R&D expenses for retigabine, and GSK will fund the development of VRX698 and the other back-up compounds from the program. Valeant could receive an additional $150 million based on the achievement of certain milestones for VRX698 and the back-up compounds, and double-digit royalties on worldwide sales.     “We were pleased with the significant interest shown in retigabine and we have selected GSK as a collaborator because we believe they are ideally suited and strongly committed to the continued development of this important compound,” stated J. Michael Pearson, chairman and chief executive officer of Valeant. “GSK’s development expertise and strong commercial infrastructure will be critical to maximizing the worldwide potential of retigabine. We believe this collaboration will strengthen our ability to bring this medicine to patients suffering from epilepsy and a variety of other conditions.”     “GSK is looking forward to working with Valeant to provide important medicines like retigabine to the medical community and to the patients we serve,” commented Steve Stefano, senior vice president, GSK U.S. NeuroHealth Division. “There is a significant need for novel anti-epileptic drugs, as almost one-third of patients with epilepsy continue to experience seizures despite treatment with currently available medications. We believe that retigabine could potentially play a significant role in improving the management of epilepsy and is a welcome addition to GSK’s portfolio.”

Genentech Initiates Ovarian Cancer Trial

<a href= http://www.gene.com >Genentech, Inc.</a> will initiate a Phase II trial of GDC-0449, an orally administered small molecule Hedgehog antagonist, as a maintenance therapy for ovarian cancer patients in second or third complete remission. Genentech is developing the drug in collaboration with <a href= http://www.curis.com >Curis, Inc.</a> and will be the sponsor of this study.     GDC-0449 will be evaluated in approximately 100 patients in a randomized, placebo-controlled, double-blind, multi-center Phase II trial. Patients will be randomized to receive either GDC-0449 or a placebo comparator and will be separated based on whether their cancer is in a second or third complete remission. The primary endpoint of the trial is progression-free survival, and secondary outcome measures include overall survival, the amount of Hedgehog protein expression in archival tissue and tracking of adverse events.         “We believe that the dysregulation of developmental pathways such as Hedgehog may play a role in the formation or recurrence of cancer. Therefore, we are hopeful that a Hedgehog inhibitor, such as GDC-0449, may be a useful therapeutic tool in preventing cancer from returning in these ovarian cancer patients and may prove useful as a maintenance therapy,” said Curis president and chief executive officer Dan Passeri. “GDC-0449 is currently in Phase II testing in first-line metastatic colorectal cancer and Genentech has indicated that it expects to initiate an additional Phase II clinical trial in advanced basal cell carcinoma in the second half of 2008.”

Executive Moves: KPMG LLP

David Blumberg has joined KPMG LLP as a principal and advisory sector leader for the Pharmaceutical Industry practice, based in the firm’s Philadelphia office.     In his new role, Mr. Blumberg provides a full array of advisory services to pharmaceutical and life sciences clients. He has significant experience working in the global pharmaceutical space, including market evaluations, launch/entry strategy, product strategy, business transformation, performance improvement, strategic planning and merger integration.     Prior to joining the company, Mr. Blumberg served as executive vice president at I-Many, a provider of advanced Enterprise Contract Management (ECM) solutions, where he was responsible for all professional services, customer support, sustaining engineering functions, as well as formulating and directing marketing strategies in the Life Sciences and Healthcare business line.     He also served as global pharmaceutical and medical products industry leader for Accenture, where he serviced client accounts and led the industry team in developing strategy, positioning, awareness, thought capital, alliances and media/marketing programs.

Chiltern Integrates Early Phase Operations

<a href= http://www.chiltern.com >Chiltern</a> has fully integrated its two early Phase units into a single operation branded as Chiltern Early Phase. This follows the acquisition of Drug Development Solutions (DDS) in February.     Chiltern Early Phase provides early phase services for the pharmaceutical industry through its two units in Slough (just outside of London) and Dundee, Scotland. Chiltern Early Phase has a total of 72 beds, 42 of which are based at Ninewells Hospital in Dundee and can cover all therapeutic areas and all types of clinical pharmacology studies, with specialization in first in man, drug photosensitivity, drug-drug interaction, Japanese bridging and vaccine studies.     Glenn Kerkhof, Chiltern's chief executive officer, said, "When we created Chiltern Early Phase, our vision was to develop a brand that would be synonymous with quality and service excellence. We now have the team, organization and facilities to deliver on this vision and provide a truly expert Early Phase service at reasonable cost."     Dr. Brian Sanderson, medical director of Chiltern Early Phase commented, "I am delighted to see the integration completed so thoroughly and ahead of schedule. We are now looking to build on our units' long histories of good science and medicine, both in the areas where we have traditionally been strong but also in new areas of specialization such as diabetes and cardiovascular medicine. We are also looking forward to forging academic links to provide specialist studies involving new biomarkers."

Executive Moves: Aptuit

Timothy C. Tyson has been appointed executive chairman and acting chief executive officer of <a href= http://www.aptuit.com >Aptuit, Inc.</a> Michael A. Griffith, the company’s founder and chief executive officer since 2005, has resigned to pursue other opportunities.      “The board wishes to thank Mike for his outstanding success in creating a world-class organization that is a trusted partner to hundreds of innovative clients throughout the world,” said Tony Ecock, outgoing chairman of Aptuit’s board of managers. “With 2,700 employees working with more than 800 clients throughout the world, Aptuit has established a solid foundation for continued growth and success.”     Tim Tyson is the former chief operating officer, president and chief executive officer of Valeant Pharmaceuticals International, where he served from 2002-2008. Prior to Valeant, Mr. Tyson spent 14 years at GlaxoSmithKline, where he was president of global manufacturing and supply and ran Glaxo Dermatology and Cerenex Pharmaceuticals. He managed all sales and marketing for GlaxoWellcome’s U.S. operations. Mr. Tyson has also held executive positions at Bristol-Myers in commercial and technical operations and R&D. Previously he was a manufacturing manager for Procter & Gamble.

BMS, Pfizer's Apixaban Trial Misses Endpoint

<a href= http://www.bms.com >Bristol-Myers Squibb</a> and <a href= http://www.pfizer.com >Pfizer</a> reported that an interim analysis of results from a Phase III study of apixaban for the prevention of venous thromboembolism (VTE) in patients undergoing knee replacement indicate that the primary endpoint of this study was not met.     The Phase III VTE prevention study known as ADVANCE-1 compared apixaban, an oral Factor Xa inhibitor given at a dose of 2.5 mg, twice daily, to the FDA-approved dose of Sanofi-Aventis' enoxaparin, 30 mg given twice daily. The primary efficacy outcome was the total of symptomatic or asymptomatic deep vein thrombosis, pulmonary embolism, and death by any cause. The rate of the primary efficacy endpoint on apixaban was similar to enoxaparin (9.0% vs. 8.9%), but did not meet the pre-specified statistical criteria for non-inferiority compared to enoxaparin, which was expected to be 16%, based on previous trials.     The companies are considering further studies with different protocols in preventing VTE in knee surgery and will not submit the U.S. filing for VTE prevention in 2009 as planned. Programs directed towards VTE prevention including EMEA registrational studies, treatment of VTE, and the prevention of stroke in atrial fibrillation continue as planned.     Full results of the ADVANCE-1 trial will be presented in December. Also, new Phase II data of apixaban in acute coronary syndrome patients (ACS) will be presented at the upcoming meeting of the European Society of Cardiology (ESC).     “Bristol-Myers Squibb and Pfizer remain enthusiastic and committed to the clinical development program for apixaban,” said Jack Lawrence, vice president, R&D, Bristol-Myers Squibb. “[The companies] anticipate that the results of APPRAISE-1 being presented at ESC will provide important insight into the potential use of apixaban for the secondary prevention of cardiovascular events in patients with acute coronary syndrome, which affects an estimated 2.7 million people around the world every year.”

Executive Moves: BioReliance

James J. Kramer, Ph.D., has been appointed vice president, Global Biologics Operations, a newly created position at <a href= http://bioreliance.com >BioReliance Corp.</a> Dr. Kramer joined the company in December 2007 as vice president, operations, U.S. Biologics. In his new position, his responsibilities will be expanded to include all operations at the company’s three facilities in Scotland, located in Glasgow, Stirling and Edinburgh, Scotland. He will continue to report to president, chief executive officer and chairman David A. Dodd, and will be based at the company’s headquarters in Rockville, MD. “Jim is an excellent choice to lead our global biologics operations as we aggressively proceed in developing our organization to more effectively serve our clients. His leadership will ensure that BioReliance remains highly competitive as we develop and expand our customer base globally,” said Mr. Dodd. “Since joining the organization, Jim has consistently demonstrated expertise in creating and leading a highly customer-oriented management team. Our focus is to provide the highest levels of client support and service through operational excellence, and I am confident that under Jim’s direction we will achieve that goal.” Prior to joining BioReliance, Dr. Kramer served as senior vice president/general manager, Talecris Plasma Resources, Talecris Biotherapeutics. Previously, he served as vice president, Global Manufacturing Operations at Serologicals Corporation, and held management positions at Ortho-Clinical Diagnostics, Inc. (a Johnson & Johnson Company), and Pacific Hemostasis Division of Curtin Matheson Scientific. BioReliance provides biologics safety testing, toxicology, viral manufacturing and laboratory animal diagnostic services.

Morphotek Opens Clinical Sites in EU

<a href= http://morphotek.com >Morphotek, Inc.,</a> a subsidiary of Eisai Corp. of North America, has opened clinical sites in the EU as part of its Phase II study of MORAb-009. A monoclonal antibody to mesothelin, MORAb-009 is being studied as a first-line treatment for patients with pancreatic cancer. The randomized, controlled, double-blinded trial will compare MORAb-009 plus gemcitabine with a placebo plus gemcitabine. Morphotek has currently qualified 33 clinical sites in the U.S. and Canada to conduct its Phase II study that started earlier this year. The company has opened four clinical sites in Spain and received regulatory approval in Spain, Belgium and Germany and 17 sites have been qualified in these countries. Regulatory approval for this study is also pending in Argentina. These approvals expand the ability to evaluate the efficacy of this compound in patients outside of the U.S. “We are extremely pleased to receive approval for the MORAb-009 Phase II trial sites in the EU,” said Martin D. Phillips, M.D., chief medical officer of Morphotek. “A distinguished group of clinical investigators treating pancreatic cancer patients throughout the EU have expressed an interest in novel biologic therapies for this typically fatal disease. We look forward to the possible involvement of additional European clinical sites for this compound as well as others in our pipeline.” MORAb-009 is an IgG1 antibody that recognizes a cell surface glycoprotein called mesothelin, which is over-expressed on a number of epithelial-derived cancers. The antibody has been found to elicit anti-tumor effects via blockade of mesothelin to bind to its ligand present on neighboring cells and immune-effector responses. Phase I studies of the antibody in patients found the molecule to be well tolerated at, or below, the maximum tolerated dose and clinical observations from those studies suggested anti-tumor responses in a number of patients.

Algorithme Acquires Simbec in Wales

<a href= http://algopharm.com >Algorithme Pharma</a> has acquired Simbec Research in Merthyr Tydfil, Wales. The move gives the Laval, Quebec-based clinical research and bioanalysis provider, a foothold in Europe, and comes six weeks after the company's acquisition of a Baltimore, MD-based CRO. Simbec has provided contract clinical research services to large pharmaceutical R&D companies for more than 30 years. The staff of the new Algorithme Pharma division in the UK is composed of a core team of approximately 100 employees who will join those already working at company locations in Montreal, Laval and Baltimore. "Given the considerable growth of our 'international' clientele, it became necessary to acquire a location in Europe in order to better serve our fast-growing market once we had expanded to the U.S. The acquisition of this strategically-located and highly-respected clinical research centre is the first step in our European expansion strategy and provides us with an important base for future growth in the European market," explained Algorithme president and chief executive officer, Louis Caillé. The Phase I and IIa UK location for clinical research includes a 38,000-sq.-ft. facility with 48 beds, all used by the Intensive Monitoring Unit. With this addition, Algorithme will increase its production capacity in Phase I and IIa drug development clinical trials.

Executive Moves: Metrics, Inc.

Dr. Michael D. Ruff has recently been appointed vice president of pharmaceutical development at <a href= javascript:void(0);/*1219676807518*/ >Metrics, Inc.</a> He recently received his clinical doctor of pharmacy degree from the Shenandoah University Bernard J. Dunn College of Pharmacy. Dr. Ruff completed his Pharm.D. degree shortly after becoming the ninth person in the world to earn the new Certified Pharmaceutical Industry Professional (CPIP) credential, awarded by the International Society for Pharmaceutical Engineering’s Professional Certification Commission and is the first competency-based international certification for pharmaceutical professionals. Those who qualify for the credential demonstrate global competency through education, experience and rigorous examination. Dr. Ruff has been with Metrics for 11 years, where his responsibilities have included providing formulation development, clinical trial material manufacture and consultation services to clients. “In his many years here at Metrics, Mike has consistently demonstrated a personal commitment to excellence, including his pursuit of continuing education that allows him to remain at the forefront of industry knowledge and technology,” said Phil Hodges, president. “We congratulate Mike on earning his doctorate.” Dr. Ruff has been a member of ISPE since 2005 and is a registered pharmacist with more than 20 years’ experience in developing new chemical entities with a focus on oncology, central nervous system and anti-viral drugs. He holds several U.S. patents for pharmaceutical applications and has authored numerous technical papers. He also is a member of the American Association of Pharmaceutical Scientists.

FDA Approves Amgen's Nplate

The FDA has approved <a href= javascript:void(0);/*1219676455894*/ >Amgen</a>'s Nplate, the first and only platelet producer for the treatment of thrombocytopenia in splenectomized (spleen removed) and non-splenectomized adults with chronic immune thrombocytopenic purpura (ITP). Nplate, the first FDA-approved peptibody protein, works by raising and sustaining platelet counts, representing a novel approach for the long-term treatment of this chronic disease. The FDA approval of Nplate was based on efficacy and safety results from two Phase III studies of adult patients with chronic ITP, including both splenectomized and non-splenectomized patients. The overall response rate for Nplate was 83% of treated patients, and platelet counts were raised and sustained in these six-month studies. Additionally, patients treated with Nplate were able to reduce or discontinue their use of concomitant ITP medications and emergency medications. Chronic ITP is a serious autoimmune disorder characterized by low platelet counts in the blood (thrombocytopenia), which can lead to serious bleeding events. Recognized as an orphan disease, chronic ITP affects an estimated 60,000 adult patients in the U.S. and is considered an unmet need by the FDA. “Until now, patients suffering from chronic ITP have had limited available treatment options, many of which are often unsuitable for long-term use due to side effects and tolerability issues,” said David J. Kuter, M.D., Chief of Hematology, Massachusetts General Hospital, Boston. “Nplate represents the first long-term treatment for adult chronic ITP patients, providing a new treatment approach for this chronic disease.” Said Roger M. Perlmutter, M.D., Ph.D., Amgen's executive vice president of R&D, “The FDA approval of Nplate is the result of more than 15 years of research and represents an important biotechnology milestone as it is the first FDA-approved peptibody protein, an innovative platform for delivering targeted therapies.” Nplate was also approved for ITP by Australia’s Therapeutic Goods Administration (TGA) in July 2008. Amgen has filed for regulatory approval of Nplate in the European Union (EU), Canada, and Switzerland and these applications are currently under review. Nplate has also received orphan designation for ITP in the EU (2005), Switzerland (2005) and Japan (2006). Amgen is continuing to study the long-term efficacy and safety of Nplate for which there is more than three years of follow up safety and efficacy data.

Executive Moves: AAIPharma

Scott Neilson has been appointed to the position of chief operating officer of <a href= javascript:void(0);/*1219676098337*/ >AAIPharma</a>. Mr. Neilson will be responsible for the company's global drug development services operations, reporting to chief executive officer and president Dr. Ludo Reynders.   Mr. Neilson is an accomplished leader with over 25 years multi-functional experience in all phases of drug development on a global basis. During the past 10 years he has led the turnaround of two of the top six Global Central Laboratories, dramatically improving market share, revenues and profitability, according to an AAIPharma statement. He has also held senior operations positions in clinical research and has a broad spectrum of functional experience including finance, regulatory affairs, human resources and business development. His experience spans pharmaceuticals and CROs, having worked at MDS Pharma Services, LabCorp, Covance and SmithKline Beecham (now GlaxoSmithKline).   “As a company, we have made significant progress across the major lines of business over the last three years,” said Dr. Reynders. “Scott’s appointment underscores our commitment to continuing this progress and our goal of a global leadership position in the markets we serve."

Sancilio Expands Manufacturing Facility

<a href= http://www.sancilio.com >Sancilio & Company, Inc. (SCI)</a> opened its newly expanded 2,000-sq.-ft. contract manufacturing facility. The GMP facility specializes in small batch manufacturing of tablets and capsules as well as packaging and labeling services.     The facility is adjacent to the company’s pharmaceutical laboratory, a climate-controlled facility for pharmaceutical, biotechnology and nutraceutical clients providing analytical services, which include formulation development, quality control, quality assurance and regulatory affairs.     According to Fred D. Sancilio, Ph.D., chief executive officer and chief scientist of SCI, “The new, fully cGMP compliant combined operation is FDA registered, and licensed for DEA Schedule 2, 3 and 4. The key attributes of both the manufacturing facility and the laboratory are rapid turnaround and competitive pricing.”     Nealie Newberger, Ph.D., vice president of laboratory services, said, “We anticipate that the addition of small batch contract manufacturing to our roster of services strategically positions the company as a full-service pharmaceutical and nutritional enterprise.”

CDC To Implement Pilgrim's Compliance Software

<a href= http://www.cdc.gov >The Centers for Disease Control and Prevention</a> (CDC) will implement <a href= http://www.pilgrimsoftware.com >Pilgrim Software's</a> automated platform for document control, complaints and corrective and preventive action (CAPA) systems management throughout the Laboratory Response Network (LRN) under the Division of Bioterrorism Preparedness & Response.     Pilgrim's SmartCAPA solution is a web-based, closed-loop system that allows users to investigate and resolve an issue and prevent recurrence. SmartCAPA will be integrated with the CDC’s internal LRN Website where complaints and product deviations are currently recorded. The complaints will then funnel into the SmartCAPA solution where they will automatically be routed through a closed-loop Investigation and CAPA process for follow-up and resolution.     The SmartDoc™ Solution helps organizations create, manage and share critical documents and best practices. SmartDoc will automate the review, approval and change management of controlled documents used throughout the LRN, and all current documents will be made available through the LRN Website.     “In selecting Pilgrim’s SmartSolve system, the LRN will elevate the harmonization and streamlining of processes that increase efficiency and enable quicker response to internal and external needs and expectations,” said Prashanth Rajendran, Pilgrim’s chief operating officer. “With the efficiencies it gains, the LRN will further solidify its reputation as a responsive division of the CDC.”

Biogen Idec Begins Phase III Adentri Trial

<a href= http://www.biogenidec.com >Biogen Idec </a>initiated a Phase III trial of intravenous (IV) Adentri (BG9928), an adenosine A1 receptor antagonist for acute decompensated heart failure (ADHF) patients with renal insufficiency. The trial will evaluate Adentri — developed under a licensing agreement with CV Therapeutics — against placebo in addition to standard of care in approximately 900 patients in 21 countries globally, including the U.S.     The TRIDENT-1 (TReatment with Intravenous BG9928 for patients with acutely DEcompensated heart failure and reNal insufficiency Trial) study is a randomized, multi-center, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of IV ADENTRI dosed as many as five days on body weight in ADHF patients with impaired renal function. Body weight is a measure of fluid accumulation, which is considered an important cause of symptoms experienced by heart failure patients.     “In previous clinical studies, ADENTRI has exhibited the potential to optimize fluid management without harmful effects on renal function. Heart failure patients with renal insufficiency are at risk for poor clinical outcomes and are among the most difficult to treat, as currently available therapies negatively impact renal function,” said lead investigator William Abraham, M.D., Professor of Internal Medicine and Director of the Division of Cardiovascular Medicine, The Ohio State University Medical Center.