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Week of Nov. 28, 2011: BioMarin Announces FDA Approval of Expanded Biologics Manufacturing Facility; Par Pharmaceuticals Makes Executive Appointments; and More
Aeterna Zentaris and Hikma Pharmaceuticals have signed an exclusive commercialization and licensing agreement for the registration and marketing of perifosine, Aeterna Zentaris’ lead anticancer compound for the MENA (Middle East and North Africa) region. Perifosine, a novel oral Akt inhibitor, is currently in two Phase III programs for the treatment of colorectal cancer and multiple myeloma in the United States and Europe. Under the terms of the agreement, Aeterna Zentaris is entitled to receive an upfront payment and additional payments upon achieving certain pre-established milestones in the aggregate of $2 million. Furthermore, Aeterna Zentaris will be supplying perifosine to Hikma Pharmaceuticals on a cost–plus basis and is entitled to receive double-digit royalties on future net sales of perifosine in the MENA region. Hikma Pharmaceuticals will be responsible for the registration and commercialization of perifosine in the MENA territory.
Amgen has announced the issuance of US Patent No. 8,063,182 related to Enbrel (etanercept). This patent is owned by Roche and exclusively licensed to Amgen. Immunex Corporation (acquired by Amgen in 2002) originally licensed this patent application from Roche in 1999, and in 2004, Amgen paid Roche a one-time payment and obtained an exclusive, fully paid-up license to the application. The patent has a term of 17 years from Nov. 22, 2011.
Asahi Kasei Pharma has acquired all shares in Artisan Pharma, making it a wholly owned subsidiary. The company name has been changed to Asahi Kasei Pharma America, and the new subsidiary will serve as a base for the development of pharmaceuticals in the United States. Additionally, Asahi Kasei Pharma is constructing a new research complex in its pharmaceutical research center in Shizuoka, Japan, to advance research on new drugs, with operations scheduled to begin in fiscal 2013.
AstraZeneca has agreed to invest an additional $100 million to its venture-capital arm, MedImmune Ventures, increasing the total capital under management to $400 million. MedImmune Ventures is a venture-capital fund that focuses on equity investments in private companies in the areas of biopharmaceuticals and medical and healthcare technology.
BioMarin Pharmaceutical announced that it has received FDA-approval for its proposed manufacturing facility expansion in Novato, California. The facility will support up to $1 billion in revenue for BioMarin’s growing enzyme replacement therapy portfolio, which is comprised of complex glycoprotein products produced by mammalian cells.
The CRO GVK Biosciences (GVK BIO) has entered into a drug-discovery alliance with the Moulder Center for Drug Discovery Research at Temple University in Philadelphia. As part of the multiyear drug-discovery collaboration, GVK BIO will be responsible for the target validation, identification, and optimization of small molecules in selected therapeutic areas, including cardiovascular, metabolic, and central nervous system disorders.
Mylan received a Warning Letter from FDA for “significant violations” of GMP for finished pharmaceuticals at the company’s facility in Caguas, Puerto Rico. FDA cited the company for not having appropriate laboratory determination of satisfactory conformance to final specifications for every batch of drug product prior to release. Some specific violations were failure to complete a content uniformity test for a particular product and not providing sufficient scientific rationale for out-of-specification (OOS) results. FDA issued the letter on Oct. 13, 2011.
The specialty pharmaceutical company Par Pharmaceutical Companies has completed its acquisition of Anchen Pharmaceuticals, a privately held, specialty pharmaceutical company focused on developing and commercializing extended release and niche generic products. The $410-million purchase price was financed with cash on hand and a $350-million term loan.
Pfizer has agreed to acquire the biotechnology company Excaliard Pharmaceuticals. The acquisition is expected to close before the end of 2011. While specific financial terms are confidential, Pfizer will provide to Excaliard an upfront payment and contingent payments if certain milestones are achieved.
The Sanford Consortium for Regenerative Medicine opened a new collaborative research facility dedicated to stem-cell science on Nov. 29, 2011. The collaborative laboratory, named the “collaboratory,” will bring together leading biomedical research institutions to pursue collaborative research projects that advance the search for breakthrough cures. The collaboratory is located in La Jolla, California.
Shire, a biopharmaceutical company, has submitted regulatory filings with FDA and EMA for the production of VPRIV (velaglucerase alfa) in its Lexington, Massachusetts, manufacturing facility. Subject to regulatory approval, which is anticipated in early 2012, Shire expects the new plant to significantly increase manufacturing capacity and allow for increased global supply of VPRIV. These approvals will also make available further capacity for the manufacture of Replagal (agalsidase alfa) at Shire’s Alewife facility, which is located in Cambridge, Massachusetts, where both VPRIV and Replagal are currently manufactured.
Stevanto, a manufacturer of pharmaceutical packaging, is expanding its plant in Monterrey Mexico. The investment plan will initially open with the amount of EUR 4.5 million ($6 million), which is expected to double early in 2012, and will reach EUR 30 million ($40 million) by the time the plant has been completed. The facility is situated on a 40,000-m2 lot, 20,000 m2 of which will be covered upon completion of the project. It will employ 250 people and will be capable of supplying enough glass containers, ampoules, vials, and cartridges for pharmaceutical use to satisfy demand in North, Central, and South American markets.
Unilife, a developer and commercial supplier of advanced drug-delivery systems, has signed a clinical-development and supply agreement with an undisclosed pharmaceutical company for a device for targeted organ delivery. The proprietary Unilife device is intended to be used in a drug clinical trial that is scheduled to commence in early 2012. The terms of the agreement and the pharmaceutical company are to remain confidential at this time. Unilife will receive $1.4 million in development fees and revenue from initial unit sales of the devices for the clinical trial under the first phase of this program. Upcoming phases of the clinical development program are expected to generate additional revenues for Unilife over the coming year.
Coldstream Laboratories, a provider of drug-product research and manufacturing services, has named Vickie Hall as vice-president of manufacturing. She will assume responsibility of Coldstream’s manufacturing, facilities, and warehouse operations.
The CRO ICON has appointed Daniel Tang as general manager of the Asia-Pacific region for the company’s development solutions division. Tang will lead the development of ICON’s early phase activities across the region.
Par Pharmaceutical Companies has appointed Thomas J. Haughey to the role of president and Paul V. Campanelli to the role of chief operating officer, effective immediately. Both executives will continue to report to Patrick G. LePore, chairman of the board of directors and CEO.
MPI Research has appointed Roger N. Hayes as vice-president and general manager of laboratory sciences, effective Nov. 14, 2011.