Cempra withdraws pneumonia drug application from European regulator

Chapel Hill pharmaceutical company Cempra Inc. is pulling its experimental pneumonia drug solithromycin’s application to gain approval from the European Medicines Agency — a regulatory agency for the European Union that is similar to the U.S. Food and Drug Administration.

Cempra said that based off feedback it received from the EMA, it believes the European regulator would need additional data before considering approval of the drug — something that would require additional and costly clinical trials.

This is another setback for solithromycin. Last year, the FDA declined to approve the drug after reviewing phase III trials and asked the company to expand its clinical trials. The FDA held reservations on the drug due to risk of liver damage to patients.

“By withdrawing the (application) at this time, Cempra will conserve considerable financial resources, and it will allow the company to align its strategy to provide additional data to both the EMA and FDA to support potential approval,” the company stated in its filing.

Cempra has $225 million in cash reserves, which the company said affords it some flexibility as its assesses the future of its pneumonia drug. In an attempt to preserve that cash, the company has been cutting costs and, earlier this month, reduced its workforce by 67 percent, from 136 to 45 employees.

“Our goal is to make solithromycin available in the (European Union) to address an important unmet medical need,” said David Zaccardelli, acting chief executive officer of Cempra, in a statement. “We believe the most efficient path to approval is to withdraw the (application) at this time and to resubmit it with the additional data requested by the FDA.”

Zaccardelli has been active CEO of Cempra since December, when the company announced the retirement of former CEO and founder Prabhavathi Fernandes.

Cempra, which was founded in 2006, currently has no drugs on the market and has spent more than $300 million developing solithromycin, which is to be marketed under the brand name Solithera, to address growing antibiotic resistance.

Cempra’s pipeline is heavily leveraged on the success of Solithera, but it recently received positive trial results for its fusidic acid drug CEM-102, which is branded as TAKSTA. That drug treats acute bacterial skin and skin structure infections.

If approved, solithromycin would be the first new oral and IV antibiotic available in the European Union in more than 15 years.

The company’s share price has declined more than 75 percent over the past 12 months. For its most recent quarter ending Dec. 31, Cempra reported a net loss of $31.4 million, or 60 cents per share — which was worse than the net loss of $21.2 million, or 48 cents per share, the year prior.

Cempra recently hired Morgan Stanley & Co. as a financial adviser to lead a review of its “strategic business options.” The company said the goal of that review “is for Cempra to determine the best use of its significant cash resources and clinical programs to deliver value to patients and shareholders through internal and/or potential external opportunities.”

Shares of the company ended trading Tuesday down 15 cents, or 3.45 percent, to $4.20 per share.

Zachery Eanes: 919-419-6684, @zeanes