- Cempra, a North Carolina-based pharma, on Tuesday announced the retirement of CEO and co-founder Prabha Fernandes, appointing a former United Therapeutics executive as acting chief.
- David Zaccardelli, who served most recently as chief operating officer at United Therapeutics, will join Cempra under an extendable three-month contract.
- Additionally, current Cempra chief commercial officer David Moore will be promoted to the newly created position of president.
Note: This post has been updated to clarify when the FDA placed Wockhardt Limited on import alert.
Cempra recently secured the backing of an advisory panel to the Food and Drug Administration, which narrowly recommended approval for the company's lead clinical candidate solithromycin.
Committee members unanimously agreed the drug effectively treats community-acquired bacterial pneumonia (CABP), but had serious concerns about safety, particularly surrounding risk to patient liver health.
While it's not guaranteed the FDA will follow the advice of the panel, Cempra is gearing up for a planned launch of solithromycin in the U.S. next year.
Cempra framed the leadership changes as part of its preparations for commercialization.
"With manufacturing and regulatory progress to achieve the approval of solithromycin as the company's top priority, we believe Dave Zaccardelli's operational and commercial pharmaceutical leadership experience will add tremendous value and direction to the Cempra team...," said Cempra chairman Garheng Kong.
The FDA is set to decide on approval for both the oral and intravenous forms of the drug shortly after Christmas.
In addition to navigating the final steps of the regulatory process, Zaccardelli and Moore will also need to resolve issues with Cempra's API manufacturing supply chain.
Cempra's original supplier of solithromycin API, the Indian drugmaker Wockhardt, recently had another one of its facilities placed on import alert by the FDA due to ongoing GMP problems.
Those problems were first flagged in two warning letters from 2013, which led the FDA to slap an import alert on two of Wockhardt's facilities in Maharashtra, India. That alert was then extended this past August to a plant in Ankleshwar, India, which in turn affected Cempra's supply.
According to a regulatory filing, Cempra believes the FDA will not allow the company to use Wockhardt for supply of solithromycin API. As a result, the company has ramped up its work with a Mexican supplier called Uquifa.
The FDA will have to sign off on the change, however, adding another layer of uncertainty for Cempra.