GlaxoSmithKline ($GSK), Pfizer ($PFE) and Shionogi have gotten off to a bit of a rocky start with Tivicay, the first FDA-approved drug to come out of their their joint venture into HIV meds. Tivicay, a combo drug pegged to become a blockbuster, was only approved last summer, but the companies are having to recall a small portion of it because of cross-contamination.
According to the April 9 FDA Enforcement Report, ViiV is recalling 1,056 bottles from the U.S. and Puerto Rico because tablets contain Promacta (eltrombopag), a GSK drug approved for treating chronic immune thrombocytopenia. It is manufactured at a GSK facility.
Tivicay is an integrase inhibitor taken once a day in combination with antiretroviral drugs Ziagen and Zeffix. It was developed by Japan-based Shionogi and offered to the ViiV partnership as part of Shionogi's 10% buy-in. The FDA gave the drug priority review and then approved it in August. Analysts believe it should be a strong competitor to Gilead Sciences' ($GILD) rival treatments and a sure blockbuster. Some estimates put peak sales at $5 billion. The drugmakers have been criticized for its $14,000-a-year cost, but the partnership has opened up the patent for use to make less expensive versions in developing countries.
This is the second recall GSK has had in recent weeks due to manufacturing issues. The drugmaker recently started retrieving some batches of its antidepressants Paxil and Seroxat because the active ingredient used to make them might have been tainted. The drugmaker took the step after the FDA sent a warning letter to a GSK plant in Ireland criticizing the drugmaker for releasing some products made with solvents contaminated from a "waste tank."
- here's the FDA notice
Special Report: An ominous trend resurfaces as new drug approvals plunge in 2013 - Tivicay