An FDA advisory committee voted unanimously in favour of agency draft guidelines for developing generic versions of ViroPharma’s antibiotic Vancocin (vancomycin) that do not require comparative studies in humans to establish bioequivalence, the company reported on Wednesday.

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The proposed guidelines allow the use of in vitro testing to establish bioequivalence for generic versions of the product, which is approved to treat severe infections of the gastrointestinal tract, Clostridium difficile infection (CDI) and enterocolitis caused by Staphylococcus aureus. Committee member Thomas Moore remarked that given the increase in cases of serious Clostridium difficile infection, “it seems more important than ever to increase access to oral vancomycin.”

The drugmaker argued that “the proposed in vitro test conditions do not mimic the in vivo environment of the CDI patient and the qualitative and quantitative sameness…is inadequate given formulation and critical manufacturing process controls, and lacks correlation with clinical effects.” ViroPharma CEO Vincent Milano said he believes the favourable vote “puts patients seriously at risk.” The FDA is scheduled to render its final decision on whether to adopt the draft guidelines later this year.

Commenting on the news, Deutsche Bank analyst Robyn Karnauskas said investors had anticipated the panel decision and are looking at potential future growth to be driven by the company’s hereditary angioedema drug, Cinryze. Vancocin generated sales of $232 million in 2008.

Source: FirstWord

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Merck & Co., Medarex and Massachusetts Biologic Laboratories (MBL) announced on Tuesday the signing of a licence agreement that gives Merck global rights to develop and market CDA-1 and CDB-1 for the treatment of Clostridium difficile infection (CDI). The deal for the investigational human monoclonal antibody combination, which was co-developed by Medarex and MBL, includes an upfront payment of $60 million to be paid by Merck.

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Under the terms of the agreement, Medarex and MBL are also eligible to receive further cash payments of up to $165 million related to the potential development and approval of a drug candidate which is accounted for in the deal. In addition, the companies could receive sales milestones and double-digit royalties if a drug reaches market. All payments will be shared equally between Medarex and MBL.

The three companies said Phase II study results, which “provided evidence” of a significant reduction in the rate of recurrence of CDI in patients taking CDA-1/CDB-1 compared with placebo, are scheduled to be presented at a medical conference in June. The randomised study involved 200 patients who were symptomatic with an acute episode of CDI and who were receiving standard care antibiotics.

Source: FirstWord

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