A team of outside experts has been taking steps to help Impax Laboratories get back on track after manufacturing issues sidetracked a key drug application and a key partnership with GlaxoSmithKline ($GSK). The company earlier this month said it would lay off 10% of its workforce to save money and now it says co-founder and CEO Larry Hsu is stepping down to make room for new leadership.
Impax said today that Hsu will remain in the top spot until his replacement is found, and he will remain on the board, but someone else will soon be calling the shots. "Larry has been instrumental in every step of Impax's development," said Bob Burr, chairman of the board. Dr. Allen Chao, one of the three outside experts brought into help Impax and himself a cofounder of Watson Pharmaceuticals, is on the search committee with Burr and Hsu.
Burr went on to say the company will remain "focused on our highest corporate priority, promptly and successfully addressing our FDA compliance, while simultaneously continuing to execute on our core competencies," even as it searches for a new CEO.
In 2011 Impax received a warning letter for its Hayward, CA, plant where it intended to manufacture Rytary, its drug for idiopathic Parkinson's. In January, Impax said the FDA continued to find problems with its manufacturing processes and would not consider its Rytary application until they were fixed. But instead of getting the go-ahead after reinspection, the FDA left Impax with a new Form 483 with a dozen observations, three of them repeats. It was enough for GSK to break ties with Impax in May, costing it a bunch of future payouts. And that was enough for Impax earlier this month to announce it was cutting 110 jobs, most of them at the California manufacturing facility that has been at the heart of its troubles.
- here's the release