DPT Laboratories has announced plans to restructure its facilities, creating three new Centers of Excellence, each focusing on a different area of expertise: Sterile & Specialty Products, Semi-solids & Liquids, and R&D.

“We feel each of these Centers of Excellence will provide our clients with access to experienced personnel who are experts in their field and who will provide comprehensive development and manufacturing services,” said Paul Johnson, president and chief operating officer of DPT.

DPT Laboratories in Lakewood, NJ is home to The Center for Sterile & Specialty Products. This center specializes in development and aseptic manufacturing of clinical trial material and commercial scale products to meet sterile requirements. The 175,000-sq.-ft. site recently underwent a multimillion-dollar transformation to provide state-of-the-art aseptic processing suites and filling equipment.

The Center for Semi-solids & Liquids in San Antonio, TX will provide cGMP pilot, clinical and commercial scale manufacturing for prescription and OTC products. The center also includes a dedicated cGMP aerosol and pMDI manufacturing facility. A multi-million-dollar investment was also made to this center to improve efficiency and increase capacity.

DPT’s Center for R&D in San Antonio provides pharmaceutical development services to include pre-formulation and formulation development as well as analytical development services. This center will perform R&D activities and support technical transfers to the applicable manufacturing center of excellence.

“We are committed to excellence and investing in our future. Our goal is to provide our clients the most efficient and the best development and manufacturing services,” said Mr. Johnson. “These strategic changes reflect our mission of providing enhancements to service, innovation, and technology for our customers as we move into our next strategic plan.”

Teva Pharmaceutical Industries has bid to acquire Germany-based generic drug manufacturer Ratiopharm, for an estimated $5.0 billion. The acquisition will provide Teva access to Germany’s generics market — the second largest in the world. Teva is currently holds fourth place in Germany's generics market, but the addition of Ratiopharm will put it at #2. Analysts suggest the takeover would move Teva's global generics market share to around 19%, widening the gap over its closest competitor Novartis's Sandoz unit, at about 11%.

Shlomo Yanai, Teva’s president and chief executive officer, said, “This is an important acquisition for Teva. This transaction is perfectly aligned with our long-term strategy in which Europe is an important pillar and growth driver. Ratiopharm will provide us with the ideal platform to strengthen our leadership position in key European markets, most notably in Germany, as well as rapidly growing generic markets such as Spain, Italy and France."

A Teva statement said the company was valuing Ratiopharm’s portfolio of 500 molecules as well as its background in biosimilars, a field where it has several products in late-stage development. The combined company’s 2009 revenues would have been $16.2 billion, and would have 40,000 employees, with 18,000 in Europe. Teva expects to pare out $400 million in operating costs within three years. The transaction is expected to close by the end of 2010.

John E. Murphy has been appointed head of clinical analytics within Quintiles’ consulting business. Mr. Murphy will help pharmaceutical and clinical scientists with strategies for translational and evidence-based medicine. He is currently directing development of a statewide clinical research data and software platform across New York to connect scientists with hospitals, physicians and patients for the analysis of disease-state, selection of study patients, point-of-care clinical information and managing follow-up and therapeutic safety.

Previously, Mr. Murphy served as senior executive advisor at Booz & Co., supporting the pharmaceutical, life sciences and health care partners’ business development activities. He also served as senior vice president Strategic Consulting Services at Pharsight Corp., where he managed scientific modeling and simulation consulting, directed a specialized CRO, and managed development of metabases used to analyze compound and clinical data. Other positions he held include, vice president and chief information officer at CuraGen Corp., chief technology officer at Predict Inc., founder, president and chief executive officer of Just Medicine, Inc., and vice president for clinical software engineering at Community Health Computing.

Marc Kamin, M.D., has been appointed vice president, Medical and Scientific Affairs, Neuroscience, PharmaNet Development Group. Dr. Kamin will advise clients in the area of neuroscience and will provide medical support to PharmaNet project teams conducting neuroscience clinical studies.

Dr. Kamin is a neurologist, certified by the American Board of Psychiatry and Neurology, and has 20 years of experience in the pharmaceutical industry. Most recently, he led the Central Trial Coordination group for Medical Affairs in Global Clinical Operations at Johnson & Johnson. Dr. Kamin has designed and managed trials in many areas of neuroscience including migraine, eating disorders, bipolar disorder, alcohol addiction, acute and chronic pain, multiple sclerosis, epilepsy, peripheral neuropathy, amyotrophic lateral sclerosis and fibromyalgia.

“We are delighted to have a physician of his caliber at the forefront of our neuroscience team,” commented Dr. Pablo Fernandez, senior vice president, Worldwide Medical Affairs. “Marc’s vast experience and valuable expertise strengthens our neuroscience service offering.”

PPD and Southern Research Institute have entered into a collaborative agreement for pandemic and seasonal influenza vaccine R&D in an effort to provide clients with a full spectrum of vaccine development services. Southern Research will transfer its seasonal assays and reagents to PPD, adding to PPD’s flu vaccine testing services. In return, PPD will help build Southern Research's preclinical flu and clinical pandemic/highly pathogenic avian influenza (HPAI) testing business through client referrals.

"This key collaboration enhances PPD’s position as the first CRO to offer a comprehensive menu of vaccine assay development and testing services to support vaccine clinical trials with faster, more cost-efficient laboratory solutions," said Christine Ding Ivan, M.D., chief medical officer of PPD. "Our agreement with Southern Research further expands our large collection of commercial vaccine assays with very important capabilities in the influenza vaccine field and enables us to expand our partnerships with influenza vaccine developers in the commercial, government and nonprofit sectors."

Nancy M. Gray, Ph.D., vice president of corporate development, Southern Research Institute, added, "By partnering with PPD, Southern Research has the opportunity to expand its client base for the well-recognized work our scientists perform in the influenza research field. By working closely with one of the world's top clinical CROs and leaders in the fields of vaccine clinical trials conduct and laboratory testing, we can provide an unmatched breadth of influenza services to our clients. Together, we will offer a full spectrum of influenza research capabilities with highly respected bench-to-market support."

“The opening of the new GVK BIO Clinical Pharmacology unit reflects our commitment to offer faster recruitment solutions to our customers. The facility has been audited by the DCGI and we have initiated our first study at the Ahmedabad facility”, said Manni Kantipudi, president, GVK Biosciences.

Jubilant Organosys’ two contract manufacturing facilities in North America have successfully completed regulatory cGMP audits. HollisterStier Contract Manufacturing, based in Spokane, WA, completed a successful audit by the Japanese Pharmaceutical and Medical Device Agency (PMDA) for the review of a sterile injectable product for a client.Also, Montreal–based Draxis Pharma, successfully completed an audit by the FDA and Health Canada.

The PMDA revealed no significant observations, resulting in a recommendation to the MHLW that HollisterStier be listed as an approved manufacturing site for the client’s product. That facility was also recently approved by the European Medicines Agency (EMA) as a manufacturing site for this same product.

The FDA audit of Draxis Pharma included a comprehensive cGMP review of both sterile parenteral and non-sterile semi-solid manufacturing capabilities and a Pre-Approval Inspection for three client products. No observations were received from this audit. Recommendations for site approvals for the three new client products are expected. The audit of Draxis Pharma by Health Canada focused on a cGMP review of a dedicated packaging capability and revealed no significant audit observations.

Marcelo Morales, chief executive officer of both groups, said, "We are extremely pleased with the audit findings at both our HollisterStier and Draxis Pharma facilities.Maintaining a rigorous quality culture and robust quality systems, combined with effectively managing our clients' projects, assures the success of these projects in the global market place.”

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ICON will open an office in Manila, Philippines, further expanding its footprint in the Asia-Pacific region. The company also recently expanded its operations in Seoul, Korea and moved its Central Laboratories to a larger facility in Singapore.

“With over 800 employees in 14 Asia-Pac countries and 13 years of successful operations in the region, Asia-Pacific is a key market for ICON,” commented Peter Gray, chief executive officer at ICON. “Philippines’ large population, coupled with the country’s well-established network of hospitals, physicians and investigators has made it an attractive location for our clients, and one which we have supported for a number of years through home-based employees. Investing in local support and infrastructure through the office in Manila will ensure that we can support future client demand as they increasingly look to include Asia in their drug development programs.”

ICON conducts a wide range of clinical studies across all therapeutic areas in Asia-Pacific, with a particular focus on managing oncology, cardiovascular, CNS and metabolic disorder trials in the region. Current studies range from small local trials to pan-Asia-Pacific and large global programs, supported by its central labs in Singapore and Bangalore, India.

Quintiles has relocated its Global Central Lab in Japan from Saitama to Tokyo to allow for further expansion. The new facility has expanded testing capabilities with an initial focus on safety testing. The lab started receiving and testing clinical trial samples and has received National Glycohemoglobin Standardization Program Level 1 certification for diabetes testing. Additionally, the new Japan lab is working towards certification by the College of American Pathologists (CAP).

“The growth of clinical research in Asia-Pacific is driving this move as we continue to reduce complexity and help our customers get new medicines to patients faster,” said Alan Ong, vice president and general manager, Quintiles Global Central Laboratories Asia. “We are building on a strong record of high quality and outstanding customer service, and with an expanding test menu, it makes sense to move into new facilities that provide room for growth.”

Savient Pharmaceuticals has resubmitted its BLA to the FDA for Krystexxa as a treatment for chronic gout in patients refractory to conventional therapy. The submission received a complete response letter (CRL) in July 2009.

The resubmission includes data from three consecutive manufacturing validation batches of the pegloticase API, additional and improved analytical methods for the control and release of pegloticase API and Krystexxa and other data which are designed to address the issues in the letter. It also includes a Safety Update from the remaining studies that were ongoing at the time of the previous 120-Day Safety Update. Additional documents included in the resubmission are proposals for product labeling and prescribing information, REMS program materials and a patient Medication Guide, all of which were requested in the CRL.

"We believe that this resubmission combined with the submissions made and planned by our third party contract manufacturer fully addresses the deficiencies and observations raised and provides the additional materials requested in the CRL that we received from the FDA on July 31, 2009, which were further clarified in our meeting with the FDA on September 14, 2009," stated Paul Hamelin, president of Savient. "We look forward to the advancement of this novel biologic through the regulatory review process including the potential reinspection of our contract manufacturer in the months ahead. We continue to believe that Krystexxa has the potential to fill a void in an area of significant unmet medical need and are confident that this is a quality resubmission package that can support a favorable determination by the FDA."

Sigma-Tau PharmaSource (formerly Enzon) is the contract manufacturer for Krystexxa. The crux of the CRL issues were related to the drug's API manufacturing process, not its fill/finish. The API supplier is BTG.

Chronic gout that is refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.

Patheon 1Q

1Q Revenues: $154.8 million (+5%)

1Q Loss: $11.1 million (loss of $6.0 million in 1Q09)

Comments: Revenues from commercial operations increased 9% to $128.1 million in the quarter, aided by currency fluctuations. North American commercial revenues increased by $1.2 million or 2%, and revenues from European operations increased by $9.2 million, or 15%. The operating loss was $6.6 million compared to operating income of $3.9 million in 1Q09. Loss in the quarter included $2.4 million of repositioning expense related to the consolidation of the Puerto Rico operations into the Manati site. Pharmaceutical Development Services revenues dropped 9% to $26.7 million. “Our commercial operations performed reasonably well despite several disappointing supplier-related delays," Patheon chief executive Wes Wheeler said in a statement. "However, pharmaceutical development service revenue was somewhat lower as we continued to see soft market demand, which appears to be consistent with the rest of the industry. New commercial business has been slow in coming due primarily to pending post-merger decision-making at large pharmaceutical companies."

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Amylin Pharmaceuticals, Lilly and Alkermes received a complete response letter from the FDA for their NDA for Bydureon (exenatide extended-release injectable suspension). Bydureon is an investigational, extended-release medication for type 2 diabetes designed to deliver continuous levels of exenatide in a single weekly dose.

The letter requested the finalization of the product labeling along with Risk Evaluation and Mitigation Strategy (REMS) and clarification of existing manufacturing processes. There were no requests for new clinical trials and the letter does not include the December 2009 observations from the FDA's pre-approval inspection at the Ohio manufacturing facility, as those observations have been addressed.

"This is a significant step forward in our ability to bring this important therapy to patients," said Orville G. Kolterman, M.D., senior vice president of research and development, Amylin Pharmaceuticals. "We have a clear path forward and are working diligently to submit our response to the FDA in the next few weeks."

The NDA was submitted in May 2009 and accepted by the FDA in July 2009.

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