Week of June 9, 2011: Company and People Notes: Aveo Forms Drug-Development Pact with Centocor; GPhA Appoints Jim Fenton as Senior Vice-President of Government Affairs; and More. - Pharmaceutical

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Week of June 9, 2011: Company and People Notes: Aveo Forms Drug-Development Pact with Centocor; GPhA Appoints Jim Fenton as Senior Vice-President of Government Affairs; and More.

ePT--the Electronic Newsletter of Pharmaceutical Technology

Company Notes

The specialty chemicals and technologies provider Ashland has agreed to acquire International Specialty Products (ISP), a specialty chemical manufacturer of ingredients and technologies for $3.2 billion. The deal, which is subject to customary closing conditions and regulatory approvals, is expected to close before the end of the September quarter.

AstraZeneca and the drug-discovery and development company Heptares have entered into a four-year collaboration for the discovery and development of new medicines targeting G-protein coupled receptors. Under the terms of the agreement, AstraZeneca has worldwide commercial rights to product candidates emerging from the collaboration. Heptares will receive an upfront $6.25-million cash-payment fee plus committed research funding and also qualifies for future payments depending on delivery of agreed milestones. Heptares will also receive royalties on sales of all products discovered through the joint research.

Aveo, a company developing cancer therapeutics, has formed a drug-development pact with Centocor Ortho Biotech, a subsidiary of Johnson & Johnson (J&J) for the worldwide development and commercialization of Aveo's internally discovered antibodies targeting the RON receptor, which is believed to be involved in tumor growth. Under the terms of the agreement, Aveo will initially receive $15 million, half as an upfront payment from Centocor, and the remaining half through a separate equity private placement and stock purchase agreement of Aveo common stock to an affiliate of Centocor Ortho Biotech, Johnson & Johnson Development Corporation. Under the license agreement, Aveo is eligible to receive up to $540 million in milestone payments based upon the achievement of specified development, regulatory, and commercialization goals. Upon commercialization, Aveo will be entitled to a tiered, double-digit royalty on net sales worldwide. Centocor Ortho Biotech will be responsible for all clinical development, manufacturing, and commercialization activities and costs. Centocor Ortho Biotech will also fund certain research conducted by Aveo, including translational research studies.

Bristol-Myers Squibb and Roche have entered into a clinical collaboration agreement to evaluate the effectiveness of Bristol-Myers Squibb's CTLA-4 inhibitor, Yervoy (ipilimumab), in combination with Roche's investigational oral BRAF inhibitor, vemurafenib, in treating patients with a specific type of metastatic melanoma. Under the terms of the agreement, the two companies will conduct a Phase I/II study to evaluate the safety and efficacy of the combination and may conduct further development of the combination.

Bruker, an analytical instrumentation company, has opened an applications, training, and technical services center in Shanghai. The new facility features multitechnology applications, training, and demonstration capabilities to support research collaborations in China. Bruker also intends to open an additional service and sales office in Guangzhou, China, later this year.

Elite Pharmaceuticals, a specialty pharmaceutical company, has entered into a commercial manufacturing and supply agreement with the pharmaceutical company Mikah Pharma. Under the terms of the agreement, Elite will perform the laboratory stability studies, manufacturing, and packaging for two generic products: isradipine capsules USP, 2.5 mg and 5 mg and phendimetrazine tartrate tablets USP, 35 mg. Elite will be compensated at an agreed-upon transfer price for the manufacturing and packaging of the products. For the isradipine product, Elite will receive a 10% royalty on net profits of the finished products. It will also receive a one-time milestone payment for each product for the work associated with the technology transfer.

Fujifilm Diosynth Biotechnologies, a contract biologics manufacturing organization, has added a 1000-L single-use bioreactor from the biomanufacturing company Xcellerex to its Research Triangle Park, North Carolina, cGMP manufacturing plant. The expansion is slated to be validated and operational by the first quarter of 2012. The project is the continuation of a cell-culture capacity expansion by Fujifilm Diosynth Biotechnologies. The addition complements the 200-L Xcellerex single-use bioreactor already in operation at the company's process-development laboratories in Cary, North Carolina, and the existing 2000-L stainless steel train located in the Research Triangle Park, North Carolina, facility.

GE Healthcare has opened a new technology facility, called the GE Healthcare Life Sciences Demonstration Laboratory, at the Science for Life Laboratory (SciLifeLab) in Stockholm, Sweden, a national resource center for large-scale molecular biosciences and biomedical research.

The contract manufacturing organization Goodwin Biotechnology and Alethia Biotherapeutics, a biotechnology company, have formed a collaboration for the development of a mammalian cell line-based IgG monoclonal antibody project for AB-165, an anticancer therapy.

Haupt Pharma, a contract development and manufacturing organization (CDMO), has passed an FDA inspection at its site in Regensburg, Germany, without any FDA-483 observation being issued.

The J&J subsidiary Ortho-McNeil-Janssen Pharmaceuticals (OMJPI) has returned the rights of the GAD65-based diabetes therapy Diamyd, to Diamyd Medical, a Swedish pharmaceutical company. The companies had formed a development and commercialization agreement in June 2010, under which Diamyd Medical received a nonrefundable upfront payment of $45 million and the parties began sharing the costs for the development program equally. Following termination of the agreement by OMJPI, all rights regarding Diamyd and the active substance GAD65 are returned to Diamyd Medical.

The German excipients manufacturer Meggle Business Group will begin operating its first American production site in Le Sueur, Minnesota, in September 2011.

Patrys, an Australian biopharmaceutical company, has extended its agreement with the biopharmaceutical CDMO Laureate Biopharmaceutical Services to manufacture the anticancer product PAT-LM1 for preclinical and clinical use. PAT-LM1 is a natural human antibody that has been shown to have anticancer properties. The companies also have an existing agreement for the production of another anticancer product, PAT-SM6.

Pfizer and Zhejiang Hisun Pharmaceuticals, a Chinese pharmaceutical company, have signed a memorandum of understanding (MOU) for a joint venture in China. Under the MOU, the two companies will explore a potential business collaboration focused on manufacturing cooperation, broader commercialization of medicines through a local and global sales and marketing infrastructure, and research and development of off-patent medicines.

R-Pharm, a Russian pharmaceutical company, has purchased a 2000-L FlexFactory line from Xcellerex. Under the agreement, Xcellerex will provide R-Pharm with the FlexFactory production line, along with bioprocess services and training. R-Pharm will use the line for large-scale production of innovator biologics and biosimilars.

People Notes

The Generic Pharmaceutical Association has appointed Jim Fenton as senior vice-president for government affairs, effective June 6, 2011. Fenton joins the association from the office of former Sen. Christopher Dodd (D-CT), where he served for 15 years, most recently as chief of staff.

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Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
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