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Also, WACKER expands Iowa facility; EMEA releases a Q&A document for PIPs; Metrics consolidates quality operations; more...
The contract manufacturer AMRI (Albany, NY) announced that Bristol-Myers Squibb Company (BMS, New York) submitted a clinical trial application (CTA) to the Medical Products Agency in Sweden for approval to initiate Phase I studies on an AMRI compound exclusively licensed to BMS. AMRI will receive a $4-million milestone payment from BMS as a result of the submission of this CTA per the collaborative agreement between the two companies. This is the second AMRI compound from this collaboration to be selected by BMS for Phase I testing.
A.P. Pharma (Redwood City, CA), a specialty pharmaceutical company, reduced approximately 34% of its workforce. The company implemented the staff reduction in order to continue advancing its lead program, APF530, toward regulatory approval and commercialization. APF530 is a long-acting formulation of granisetron that uses the company’s proprietary Biochronomer drug-delivery system. The new drug application for APF530 was submitted in May 2009 for the prevention of chemotherapy-induced nausea and vomiting.
AstraZeneca and Merck & Co. will collaborate to research a combination anticancer regimen composed of two investigational compounds, MK-2206 from Merck and AZD6244 (ARRY-886) from AstraZeneca. AstraZeneca acquired exclusive worldwide rights to AZD6244 (ARRY-886) from Array Biopharma in December 2003. Under the terms of the agreement, AstraZeneca and Merck will evaluate co-administration of the compounds in a Phase I clinical trial for the treatment of solid cancer tumors. All development costs will be shared jointly.
Johnson & Johnson (New Brunswick, NJ) filed an arbitration demand with the American Arbitration Association requesting a ruling that the planned merger between Merck & Co. and Schering-Plough constitutes a change of control that would permit the termination of the agreements between Schering-Plough and Johnson & Johnson’s subsidiary Centocor Ortho Biotech regarding the product Remicade (infliximab) and Simponi (golimumab). Ending the agreements would return full rights to Johnson & Johnson for the distribution of these products in markets outside the United States where Schering-Plough currently has distribution rights.
Patheon, a provider of contract development and manufacturing services, initiated legal action against JLL Partners on May 22, 2009. A Statement of Claim filed in the Ontario Superior Court of Justice outlines Patheon's allegations against the JLL Board nominees and JLL, and requests that the court make findings of breach of fiduciary duties, oppression, conspiracy and breach of contract. On June 2, 2009, JLL announced it extended its tender offer for Patheon an additional 10 days and said it held approximately 39% of outstanding restricted voting shares of Patheon, according to a Reuters report.
SAFC Pharma (St. Louis, MO), a business segment of the Sigma-Aldrich Group member SAFC, announced the certification of its highly potent active pharmaceutical ingredient (HPAPI) conjugation suite by SafeBridge Consultants for the safe handling of potent drug substances. The 600-ft2 HPAPI suite, commissioned in September 2008, enables the conjugation of HPAPIs to a variety of targeted delivery molecules known as antibody drug conjugates. The suite produces early-stage clinical supplies to kilogram quantities, and is expandable to commercial-scale.
In other news, SAFC and Cherokee Pharmaceuticals (Riverside, PA), a PRWT Services company, formed a partnership involving sourcing, analytical testing, warehousing, packaging, and distribution of large-scale raw materials for pharmaceutical manufacturing meeting CGMP quality standards. Under the agreement, SAFC will be responsible for product sourcing, including processing reagents and excipients, and Cherokee Pharmaceuticals will conduct analytical testing, storage, packaging and distribution services.
The Society of Chemical Manufacturers and Affiliates (SOCMA) released a statement urging Congress to support newly introduced legislation, H.R. 2477, which would extend existing chemical security standards until 2012. SOCMA does not support the expected introduction of a House bill next month that includes product substitution provisions, which the organization said would increase US reliance on foreign-made pharmaceutical ingredients, as American companies become barred from manufacturing chemicals that customers will still demand. SOCMA believes more time is needed to implement the Department of Homeland Security’s new chemical-site security measures and supports the three-year extension of current standards until 2012.
WACKER (Munich, Germany) expanded its cyclodextrin facility in Eddyville, Iowa. The new facility increases the company’s capacity for alpha (α) and beta (β) cyclodextrins by 50%, respectively, and doubles its capacity for gamma (γ) cyclodextrins. The facility can produce up to 7500 metric tons of cyclodextrins a year. Investment in the entire facility was more than $21 million.
Z-Cube (Bresso, Italy), the corporate venture arm of Zambon, and Yissum Research Development Company (Jerusalem), the technology-transfer company of the Hebrew University of Jerusalem, formed a license agreement for Z-Cube to develop and commercialize a nanotechnology drug-delivery system for the treatment of pain. The technology was developed by Professor Elka Touitou from the Department of Pharmaceutics, Faculty of Medicine, at the Hebrew University of Jerusalem.
The European Directorate for the Quality of Medicines & HealthCare (EDQM) established confidentiality agreements with the United States Food and Drug Administration and the Australian Therapeutic Goods Administration (TGA) to share nonpublic information regarding inspections of active pharmaceutical ingredient and excipient manufacturers. The agreements are part of a pilot program between EDQM, FDA, and TGA designed to rationalize international good manufacturing practice inspections.
The European Medicines Agency (EMEA) posted a question-and-answer document reviewing the application process for drugmakers submitting pediatric investigation plans (PIPs). The document details the procedures and information required to submit PIPs, including an overview of the agency’s electronic template used in submissions. PIPs are required as of July 2008 for all drug marketing authorization applications to EMEA.
On May 22, 2009, Health and Human Services Secretary Kathleen Sebelius announced that approximately $1 billion in existing funds will be used to prepare for potential commercial-scale production of a candidate vaccine for the novel Influenza A ( H1N1). The funds will be used for clinical studies that will take place over the summer and for commercial-scale production of two potential vaccine ingredients for the prepandemic influenza stockpile. New orders will be placed on existing contracts with companies that hold US licenses for flu vaccines, and these orders will produce a bulk supply of vaccine antigen and adjuvant.
Catalent Pharma Solutions (Somerset, NJ) appointed Steve Leonard senior vice-president of global operations. Leonard will be located at Catalent’s corporate headquarters in Somerset, NJ. He previously served as general manager of global operations for GE Healthcare’s Medical Diagnostics business.
Elan (Dublin, Ireland) appointed Renee P. Tannenbaum executive vice-president and chief commercial officer. Tannenbaum will be based at the company’s South San Francisco, California, site and report to Elan President Carlos Paya.
IGI Laboratories (Buena, NJ), a provider of formulation development, manufacturing, and packaging services, named Hem Pandya president, CEO, and as a member of the board of directors, effective June 29, 2009. Joyce Erony, the company’s chairwoman of the board, will act as interim president and interim CEO until then. Philip S. Forte will assume the role of corporate controller. Rajiv Mathur resigned as CEO, president, and as a member of the board of directors.
Metrics (Greenville, NC) consolidated its quality-related operations and promoted Thomas R. Wilson to vice-president of quality operations. Wilson, who joined Metrics in 2000, previously managed the company’s quality-control division, which was a separate function from quality assurance. The two divisions were consolidated into quality operations.
Patheon (Research Triangle Park, NC), a provider of drug-development and manufacturing services, named Doug Mendenhall interim head of its Pharmaceutical Development Services Unit as well as interim chief scientific officer. Mendenhall will work under contract until a permanent president is named, but will be retained as an advisor to the company on an as-needed basis.