Particulates raise concerns about Gilead's Vistide

Manufacturing challenges don't deter interest in growth area
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Sterile injectable drugs are a growing business that more companies would like to get into. But the drugs are known for being particularly difficult to manufacture, and it is not rare for production snafus to result in particulates being found in finished products.

Now Gilead Sciences is voluntarily recalling one lot of its AIDS drug Vistide for that very reason. The company said in a notice that some particles were found in vials during packaging and that it has undertaken an investigation to figure out what led to the problem.

Gilead ($GILD) said it is unaware of any complaints related to the recalled drug, but cautioned that patients injected with particulates face the chance of severe reactions, even death, depending on the size of the particles and the patient's underlying medical condition. Vistide is the brand name for cidofovir and is for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS. The recalled lot began shipping Oct. 12.

While it is at it, Gilead is reviewing the supply situation for Vistide. The company said there is nothing in the supply chain to replace the recalled lot. Gilead suggested doctors and hospitals check with other manufacturers about replacement stocks. The FDA last summer approved both Mylan ($MYL) and Indian drugmaker Emcure Pharmaceuticals to make generic cidofovir.

Last summer generics sterile injectables leader Hospira ($HSP) issued a huge recall of four injectable cancer drugs shipped throughout the U.S., as well as of other drugs shipped to about 15 countries around the world after particles of glass were found in some products. This time last year, the FDA cited an APP Pharmaceuticals' plant in New York, after inspectors said insects were found in several drug vials, including one that made its way into distribution.

But for all of the difficulties, some companies see great profit-making potential in manufacturing injectable drugs. In fact, several companies have reported high interest in buying the sterile injectable manufacturing operation of Indian drugmaker Strides Arcolab. The most recent report has Mylan in exclusive talks for the unit which could bring an offer as high as $2 billion. 

- here's the Gilead recall notice
- see the FDA notice

Related Articles:
Report: Mylan in 'exclusive talks' with Strides 
No shortages expected from Hospira cancer drug recall