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ePT--the Electronic Newsletter of Pharmaceutical Technology
Also, Schering-Plough's vaccine unit, Nobilon, formed an agreement with the World Health Organization; Ore Pharmaceuticals named president and CEO; more...
Akela Pharma (Montreal, Canada), a drug-development company focused on developing an inhaled fentanyl product for cancer pain and a growth hormone releasing hormone (GHRH) for chronic renal disease, announced that its subsidiary, PharmaForm, has signed a development agreement with an undisclosed global pharmaceutical company, to develop specialized oral dosage forms at its facility in Austin, Texas. Under the terms of the agreement, PharmaForm will develop products using hot-melt extrusion. In addition to providing contract formulation services, PharmaForm will be entitled to royalty payments upon product commercialization.
The contract manufacturing organization Cambridge Major Laboratories (CML, Germantown, WI) and Novacta Biosystems (Welwyn Garden City, UK) formed a collaboration focused on process development, custom synthesis, and biocatalysis. Novacta will develop biocatalytic approaches to target chiral intermediates that CML will then scale up in facilities in Weert, The Netherlands.
The biopharmaceutical company Cephalon (Frazer, PA) announced that its subsidiary, Cephalon International Holdings, intends to make a takeover offer for Arana Therapeutics (Macquarie Park, Australia), a biopharmaceutical company focused on developing next-generation antibody-based drugs, for A$318 million ($207 million). Arana has a pipeline of biologic compounds for inflammatory diseases and cancer at various stages of discovery and development.
Covance (Princeton, NJ), a drug-development services company, expanded its biotechnology services facility in Harrogate, United Kingdom. The expanded facility includes upgraded infrastructure and equipment for biopotency, molecular biology, and protein chemistry services. The company also became one of a few contract research organizations to receive a CGMP manufacturing license from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, according to the company.
Elan (Dublin) announced restructuring efforts that include a postponement of biologics manufacturing activities and a redesign and realignment of the research and development organization within the Biopharmaceutical division. These changes follow the realignment of components of Elan’s commercial organization announced in late 2008. The holding company, Elan Corporation, will continue to have two related but distinct operating divisions: Biopharmaceuticals and Elan Drug Technologies. The company will also reduce its workforce by approximately 230 positions, or 14%, globally.
United States Attorney George E.B. Holding of the Eastern District of North Carolina announced that Ravindra Kumar Sharma and Aniruddha Patel of the device manufacturer AM2PAT, Inc. (Angier, N.C.) received 54 months’ imprisonment for their role in distributing tainted heparin-filled syringes. They pleaded guilty to criminal complaints charging conspiring to commit a number of federal offenses including mail fraud, submitting false statements in a matter within the jurisdiction of the executive branch of the US Government, and knowingly sending misbranded medical devices into interstate commerce with the intent to defraud. The syringes were misbranded as “sterile” when the requisite sterility testing on these products had not been completed prior to their shipment. Court documents stated that between 200 and 300 medical patients around the country developed bacterial infections after having been injected with syringes from AM2PAT. Some of these infections resulted in serious illness such as spinal meningitis and permanent brain damages, while other infections led to death.
La Jolla Pharmaceutical (San Diego, CA) announced that, following the negative results of the “Riquent” Phase III interim efficacy analysis, the company is taking steps to reduce costs to preserve its remaining cash and other assets, including a substantial reduction in personnel and other operating expenses. Details of the reductions were not disclosed. The company is also evaluating options such as winding down the business or the sale of the company.
Novartis Vaccines and Diagnostics S.r.l. are recalling two batches of its Meningococcal group C conjugate vaccine, “Menjugate Kit,” in the UK as a precaution following an initial failure of a sterility test carried out as part of a shipping validation study of the batch of aluminium hydroxide solvent used in them. Details can be found here on the Medicines and Healthcare products Regulatory Agency (MHRA) website.
Otsuka America Pharmaceutical (OAPI, Rockville, MD) and Otsuka Pharmaceutical Development & Commercialization (OPDC, Princeton, NJ) have announced restructuring. The restructuring changes include the establishment of two governance committees responsible for ensuring regulatory compliance, cross-functional information sharing, reporting, CEO advisory, and the evaluation of new ideas and business proposals. Comprised of senior leadership, the Pharmaceutical Governance Committee will oversee OAPI business activities and ensure the strong governance of the company, while the Medical Device Governance Committee will oversee the medical device and diagnostics business activities for OAPI.
The board of directors of Panacos Pharmaceuticals (Watertown, MA) unanimously decided to voluntarily delist its common stock from trading on The Nasdaq Capital Market. Following the delisting, the company intends to voluntarily terminate the registration of its common stock under the Securities Exchange Act of 1934 and to cease filing reports with the Securities and Exchange Commission. Further in the interest of conserving capital, the board also decided to reduce its size from seven to three directors.
Pfizer (New York) entered into a series of agreements with Aurobindo Pharma (Hyderabad, Andhra Pradesh, India) to commercialize medicines that are no longer patent protected, and have lost market exclusivity in the United States and Europe, further progressing its Established Products Business Unit strategy. Pfizer’s Established Products Business Unit, focused on the commercialization of products where market exclusivity has been lost, was launched in 2008 as part of the company’s initiative to create smaller, more accountable business units aligned with customer needs. Under the terms of the agreements, Pfizer acquired rights to 39 generic solid oral dose products in the United States and 20 in Europe, plus an additional 11 in France. These medicines cover a range of therapeutic areas including cardiovascular disease and central nervous system disorders, and will be commercialized in the US through Pfizer’s Greenstone subsidiary.
In a separate announcement late last month, Pfizer said it is terminating Phase III development programs for the investigational compounds esreboxetine for fibromyalgia and “PD 332,334” for generalized anxiety disorder. The decision to terminate these programs will enable the company to allocate additional resources to higher-potential development programs.
Schering-Plough’s (Kenilworth, NJ) human vaccine business unit, Nobilon, formed an agreement with the World Health Organization (WHO) to provide access to pandemic influenza vaccine manufacturing technology to developing countries. Under the agreement, Nobilon granted WHO a nonexclusive license to develop, register, manufacture, use, and sell seasonal and pandemic live, attenuated, influenza vaccines (LAIV), produced on embryonated chicken eggs. WHO will be permitted to grant a sublicense to vaccine manufacturers in developing countries working within the framework of the WHO Global Vaccine Action Plan. Vaccine manufacturers to whom a sublicense will be granted will be able to provide vaccines to the public sector of developing countries royalty-free.
Sinovac Biotech (Beijing), a provider of vaccines in China, has received the good manufacturing practice (GMP) certification for its recently opened filling and packaging production facility. The certificate of compliance has a five-year term and was issued by China's State Food and Drug Administration (SFDA) following a site inspection. The certification provides for an annual production capacity of 20 million doses, with the capability to produce up to 40 million doses.
Systech International (Cranbury, NJ), a provider of packaging execution systems (PES) for the pharmaceutical industry, announced that more than 150 packaging lines are currently installed or under contract with its "Serialized Product Tracking" application. European activity is particularly brisk due in part to regulatory expectations such as coding requirements in France and serialization in Turkey. The software addresses pharmaceutical packaging and supply-chain needs and is based on a PES approach that enables bidirectional communication between packaging and IT environments.
The US Food and Drug Administration’s Center for Biologics Evaluation Research (CBER) released data on the number of inspections performed at sites that produce human cells, tissues, and cellular- and tissue-based products (HCT/P) for the last 10 fiscal years (FYs). CBER conducted 10% fewer inspections of sites in FY 2008 than in FY 2007, and it averaged less time per inspection, dropping from 46.7 hours per inspection in 2007 to 37.5 hours in 2008.
TheUS Food and Drug Administration and KV Pharmaceutical entered into a consent decree of permanent injunction filed March 2, 2009, which prohibits KV Pharmaceutical, its subsidiaries Ethex Corporation and Ther-Rx Corporation, and its principal officers from making and distributing adulterated and unapproved drugs. The injunction against KV and the other defendants, once entered by the court, will prevent them from manufacturing and shipping drugs until the firm obtains FDA approval. It will remain in place until the defendants sustain continuous compliance with FDA's current good manufacturing practices (CGMP) and new drug approval requirements for five years. KV Pharmaceutical announced the voluntary recall of affected products and restructuring plans in early February.
Vanda Pharmaceuticals (Rockville, MD) issued a statement saying it opposes the proposal by its major shareholder, Tang Capital Partners (TCP), to liquidate the company. TCP sent two letters to Vanda and filed documents with the US Securities and Exchange Commission stating its intent to, among other things, nominate two directors to stand for election at Vanda's 2009 annual meeting of stockholders and submit proposals at the meeting to amend Vanda's bylaws and request that the board of directors of Vanda take action to liquidate the company. Vanda says it is close to receiving a response from the FDA regarding its lead compound, iloperidone, according to the company press release.
Akorn (Lake Forest, IL), appointed Raj Rai strategic consultant to the special committee of the board of directors. As the company previously announced, the special committee was established following the departure of Arthur Przybyl, formerly president and CEO, to oversee the operations of the company while the search for a new CEO is underway.
AMRI (Albany, NY) promoted Chief Financial Officer Mark T. Frost to senior vice-president of administration and chief financial officer. In this expanded role, Frost will add to his responsibilities for finance and accounting the leadership for investor relations, sourcing, legal, communications, information technology, facility management and logistics. He will continue to report to Thomas E. D’Ambra, chairman, CEO, and president.
Greenleaf Health (New York) announced that former FDA Commissioner Andrew C. von Eschenbach joined the firm as senior advisor. Greenleaf Health is a regulatory consulting firm that provides guidance to companies regulated by FDA.
The drug-development company Ore Pharmaceuticals (Gaithersburg, MD) named Mark J. Gabrielson president and CEO. He has more than 30 years of experience in the pharmaceutical industry and presently serves on the company’s board of directors. Gabrielson replaces Charles Dimmler, III.
Pearl Therapeutics (Redwood City, CA), a biopharmaceutical company developing products for the treatment of respiratory diseases, appointed Perry Karsen chief executive officer. Karsen has more than 25 years of experience in the biotechnology and pharmaceutical industries, and he recently served as regional president of Asia/Pacific and head of worldwide business development at Celgene (Summit, NJ).