Manufacturing issues trip up approval for Gilead, Impax

Once drugs are approved, manufacturing is supposed to kick in and get the product out the door so drugmakers can start making some money. But recently, questions about manufacturing have not only been a stumbling block for some companies to getting approvals--they have broken up a relationship.

In the last few days, the FDA told Gilead Sciences ($GILD) it needed to fix quality testing issues before it would consider approving a pair of new drug applications. And GlaxoSmithKline ($GSK) gave up waiting for approval of an extended-release version of a drug for Parkinson's disease developed by now ex-partner Impax Laboratories ($IPXL) after the agency again pointed to manufacturing issues.

For Gilead, the problems are holding up approval of the standalone use of elvitegravir and cobicistat, two of the four drugs in Stribald, AKA Quad, a four-drug HIV treatment approved last year. Gilead said it is seeing to the issues that came up during a recent inspection and assured investors they wouldn't bleed into Stribild's approval or use. That is important since analysts have forecast sales of $2.38 billion in 2016 for the treatment, with some estimates running to peak sales near $5 billion.

Impax has been struggling for two years to get its manufacturing practices down at a plant in California where it intends to produce Rytary, the extended-release Parkinson's drug. But a recent re-inspection of the plant was a train wreck, with Impax receiving a Form 483 with a dozen observations, three of them repeats. It was enough for GSK to break with Impax, the company said this week. That sends Impax back on the street looking for a partner and complicates an already difficult financial situation, CEO Larry Hsu acknowledged yesterday.  "With the receipt of the new Form 483 at the end of February, we are now faced with the fact that this will be a challenging year," he said. " We believe new product approval from our Hayward facility will continue to be delayed until we can resolve the warning letter."

These are not the only cases of plant problems holding up an approval. Just two weeks ago, Allergan ($AGN) acknowledged manufacturing problems at an inhaler plant were again standing in the way of a drug launch of Levadex, a new migraine treatment. It picked the drug up with its $958 million acquisition of MAP Pharmaceuticals in January. Levadex is an inhaled version of an existing drug, dihydroergotamine. The company said it has responded to the agency's concerns but has not yet heard back. The same issues came up last year when MAP sought approval for the drug.

- here's the Gilead release
- see the Impax release
- get a Seeking Alpha transcript of Impax call (reg. req.)

Related Articles:
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Gilead plant joins the FDA-warning club
Manufacturing problems keep Allergan from drug approval
Plant problems stymie Impax NDA, FDA says