Week of June 11, 2012: Basilea, Stiefel Enter into Hand-Eczema Treatment Pact; Sandoz Recalls Generic Oral Contraceptive Drug; and More - Pharmaceutical Technology

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Week of June 11, 2012: Basilea, Stiefel Enter into Hand-Eczema Treatment Pact; Sandoz Recalls Generic Oral Contraceptive Drug; and More

ePT--the Electronic Newsletter of Pharmaceutical Technology

Basilea Pharmaceutica has entered into an exclusive worldwide agreement with Stiefel, a GlaxoSmithKline company, for the hand-eczema treatment Toctino (alitretinoin). Under the agreement, Stiefel will assume responsibility for the development, manufacturing, commercialization, and distribution of the product. Existing Toctino distribution agreements in Europe, Canada, Mexico, Israel and South Korea will be assigned to Stiefel. Basilea will receive a £146 million ($227.4 million) upfront payment and is eligible for additional milestone payments of between £30 million ($46.7 million)­ and £50 million ($77.9 million) related to a regulatory milestone of alitretinoin in the US. Basilea will also receive low double-digit participation in US sales starting three years after launch. Read More

The Kansas Bioscience Authority announced the creation of BioResearch Central, a newly formed collaboration involving more than 90 contract research organizations and related service providers. The primary focus of BioResearch Central will be on accelerating the development of new medicines and medical devices. Read More

Merck & Co. has announced that FDA has issued a Complete Response Letter regarding the new drug application for ridaforolimus. Ridaforolimus is an investigational oral mTOR inhibitor under development for maintenance therapy for patients with metastatic soft tissue or bone sarcoma who have stable disease or better after four or more cycles of chemotherapy. The complete response letter states that FDA cannot approve the application in its present form, and that additional clinical trial(s) would need to be conducted to further assess safety and efficacy. Merck also is in ongoing discussions with health authorities in Europe and other countries as part of their application procedures for ridaforolimus for the treatment of metastatic soft-tissue or bone sarcomas in patients who had a favorable response to chemotherapy. Additionally, Merck is studying ridaforolimus in combination with other mechanisms in several tumor types. Read More

Pfizer has announced the next steps in the company’s review process for its animal-health business. Preparations are underway to file a registration statement in the US for a potential initial public offering of a minority ownership stake in the new company. Pfizer expects to provide details regarding the proposed transaction as part of its 2012 second-quarter earnings announcement. Pfizer Animal Health will continue to be treated as a continuing operation for Pfizer’s financial reporting purposes. The name of the new standalone company will be Zoetis. Read More

Sandoz is conducting a voluntary recall of 10 lots of its generic oral contraceptive Introvale (ethinyl estradiol; levonorgestrel) in the US, following a recent report of a packaging flaw. The probability of this packaging flaw causing serious adverse health consequences is remote and Sandoz is not aware of any reports of related adverse events, according to a June 5, 2012 FDA press release. This recall—conducted with the knowledge of FDA—is being undertaken as a precautionary measure to minimize any potential of patients being impacted. Read More

Industry Briefs:

A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. Read More


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