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Also, FDA debars clinical investigators; Jubilant Organosys forms deal with Endo Pharmaceuticals; AMRI makes changes to its India management team; more...
Boehringer Ingelheim (Ingelheim, Germany) and Vitae Pharmaceuticals (Fort Washington, PA) signed a drug-development deal focused on beta-secretase (BACE) inhibitors for the treatment of Alzheimer’s disease. Under the terms of the agreement, Vitae will receive $42 million in upfront payments and will be eligible to receive $200 million in precommercial milestone payments based on the achievement of clinical and regulatory goals, as well as further milestone payments based on additional compounds and/or other approved indications.
Dr. Reddy’s Laboratories (Hyderabad, Andhra Pradesh, India) formed a pact with GlaxoSmithKline (GSK, London) to develop and market products across emerging markets outside India. The products will be manufactured by Dr. Reddy’s and will be licensed and supplied to GSK in various emerging markets such as Africa, the Middle East, Latin America, and Asia Pacific, excluding India. Revenues will be reported by GSK and shared with Dr. Reddy’s as per agreed terms. In certain markets, products will be comarketed by Dr. Reddy’s and GSK.
Eli Lilly (Indianapolis, IN) launched the Lilly Phenotypic Drug Discovery Initiative, or PD2, a portal that houses Lilly-developed disease-state assays through a secure web portal to evaluate the therapeutic potential of compounds synthesized in university and biotechnology laboratories. Findings from this initiative could ultimately form the basis for collaboration or licensing agreements between Lilly and external institutions, according to a company press release.
Genzyme (Cambridge, MA) temporarily stopped production at its Allston Landing manufacturing facility in Allston, Massachusetts, after detecting a virus that impairs cell growth in one of six bioreactors. The virus strain, Vesivirus 2117, has not been shown to cause human infection, but is known to interfere with the growth of Chinese hamster ovary cells used to produce biologic drugs and was likely introduced through a nutrient used in the manufacturing process, according to a company press release. Genzyme is collaborating with regulatory agencies and expects the plant to be fully operational by the end of July.
The contract manufacturing organization Jubilant Organosys (Noida, Uttar Pradesh, India) announced its Bangalore-based subsidiary, Jubilant Biosys, entered into a discovery and development collaboration with Endo Pharmaceuticals (Newark, DE), a specialty pharmaceutical company. Jubilant and Endo agreed to initially develop a portfolio of targets in the area of oncology. Endo will own any compounds developed under the collaboration and will be responsible for worldwide commercialization. Under an initial three-year agreement, Jubilant will receive research funding and success-based development milestones and royalties.
MannKind (Valencia, CA) began clinical development of a new inhalation system to optimize the delivery of drug powders based on the proprietary Technosphere technology platform. The inhalation system is the size of a whistle and designed to be discreet and patient-friendly when used with therapies such as the investigational ultra-rapid acting insulin Afresa (insulin human [rDNA origin]) inhalation powder, according to the company. The delivery system technology can also be used with other therapeutic proteins.
Millipore (Billerica, MA), a provider of technologies and services, opened a new manufacturing facility in Danvers, Massachusetts. The more than 30,000 ft2 facility will produce a wide range of the company’s Mobius single-use product lines used for biopharmaceutical manufacturing.
The US Food and Drug Administration approved Caldolor, the first injectable dosage form of ibuprofen, to treat pain and fever. Caldolor is manufactured by Cumberland Pharmaceuticals (Nashville, TN) and will be available for hospital use only.
Velesco Pharmaceutical Services (Plymouth, MI), a company providing analytical method development, drug formulation, stability testing and consulting services, opened a manufacturing facility and office in Kalamazoo, Michigan, and has moved its Ann Arbor, Michigan, laboratories to the Michigan Life Science and Innovation Center in Plymouth. Velesco’s new 10,000 ft2 office and manufacturing facility at the Kalamazoo Commerce Center will manufacture nonsterile CGMP clinical-trial supplies. Product offerings include powder-in-capsules, powder-in-bottles, ointments/creams, oral and topical liquids, over-encapsulation for blinded studies, and packaging.
Yissum Research Development Company (Tel Aviv, Israel), the technology transfer company of the Hebrew University of Jerusalem, signed an agreement with Aurum Ventures MKI, the technology investment arm of Morris Kahn, for the development of a nanotechnology controlled-release drug-delivery platform that increases the bioavailability of orally administered lipophilic drugs.
The US Food and Drug Administration is enforcing the laws that protect consumers from illegal products marketed through the Internet related to the 2009 H1N1 flu virus. FDA warned consumers about these products on May 1, 2009. Since then, FDA has issued more than 50 warning letters to offending websites and as a result, more than 66% of these websites have removed the offending claims and/or products. Read more information about fraudulent H1N1 influenza products on FDA’s website.
Sen. Edward Kennedy (D-MA) introduced the Affordable Health Choices Act in the Senate last week, a bill designed to overhaul healthcare. Included in the bill are provisions for comparative-effectiveness research in an effort to reduce costs.
Draft legislation that would allow patients to seek treatment in any European Union country was debated at the annual congress of the European Federation of Public Services Union (EPSU), which urged European Union health ministers to redraft the proposal so that its legal basis encompasses public health and not just the internal market. According to EPSU, member states need to ensure that all citizens have equal rights to high-quality healthcare based on medical need, and not just the ability to pay their travel, accommodation, and other costs. There is also a concern that the healthcare systems of individual EU nations compete with one another for patients.
Comments on a European Medicines Agency (EMEA) draft guideline that would place more stringent requirements on the assessment of possible carcinogenic risk for HIV drugs showed that drugmakers and an industry group disagreed with the proposal. The European Federation of Pharmaceutical Industries and Associations (EFPIA), Merck, and Bristol-Myers Squibb said in comments posted on EMEA’s website that the guideline should not place more stringent requirements for the assessment of carcinogenic risk on drugs to treat HIV infection in order to maintain marketing authorization.
In other EMEA news, following changes to European legislation, the agency plans to make public some information in EudraCT, a database that contains information on clinical trials in Europe. EMEA is conducting a survey to find out which aspects of this information are of most interest to the public, how the information might be used, and how it should be accessed. Responses to this survey will help the agency to design a website that is appropriate for the needs of the public and other interested parties. The survey deadline is June 23, 2009.
On June 12, 2009, FDA permanently debarredDr. Mary E. Sawaya, also known as Marty Sawaya from participating in clinical investigations after she was convicted of fraud. Sawaya plead guilty and was convicted of one count of making a false statement to a Federal agency, a federal felony offense. FDA also announced on June 12, 2009 a 5-year debarment of Dr. Allyn M. Norman in an unrelated case. Norman pleaded guilty to one count of failure to maintain adequate and accurate records relating to the use of investigational new drugs, a federal misdemeanor offense.
FDA announced that some stolen vials of long-acting insulin Levemir (Novo Nordisk, Bagsværd, Denmark) have reappeared and are being sold in the US market. Three lots, or a total of 129,000 vials, of this product were stolen. These stolen vials may not have been stored and handled properly and may be dangerous for patients to use. Read more about the advisory on FDA’s website.
AMRI (Albany, NY) announced changes to its India operations and leadership team. Rajesh Shenoy was appointed as managing director of India operations. Shenoy will report to Steven R. Hagen, AMRI vice-president of pharmaceutical development and manufacturing. Sivakumar Sivasubramanian was appointed director of general operations to assume oversight for all general plant operations and engineering services for AMRI in India. Sridhar Vaddeboina, most recently manager of analytical quality services for India operations, was promoted to director of analytical services for India Operations. Vaddeboina will lead all analytical and quality functions in India.
Astellas Pharma Global Development (Deerfield, IL), a subsidiary of Astellas Pharma Inc. (Tokyo), named Peter Carberry senior vice-president and head of global development operations. Carberry previously served as the vice-president of clinical operations, development planning, and performance analysis and the office of international development at Genentech (South San Francisco, CA).
Anavex Life Sciences (Geneva), an emerging biopharmaceutical company, appointed Hervé de Kergrohen CEO and director. De Kergrohen has more than 25 years in senior and executive management positions and experience with various life sciences companies.
Hollis-Eden Pharmaceuticals (San Diego) appointed James M. Frincke president, CEO, and as a member of the board of directors. Frincke joined Hollis-Eden as vice-president of research and development in 1997, was promoted to executive vice-president in 1999, and to chief scientific officer in 2001.
The biopharmaceutical company Insmed (Richmond, VA) announced that Geoffrey Allan resigned as president, CEO, chairman of the board of directors, effective immediately, due to a health condition. Allan has held these positions since the company's inception in November 1999. Melvin Sharoky, who has been a member the board of directors since 2001, will assume the role of chairman of the board.
Sartorius Stedim Biotech (Goettingen, Germany), a provider of equipment and services for the biopharmaceutical industry, appointed Yujing Yang director of purification technologies for North America. Yang reports to Uwe Gottschalk, vice-president of marketing, purification technologies.