Blog Coverage Cempra’s Stock Price Dropped Following US FDA Rejection of Its Pneumonia Drug

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LONDON, UK / ACCESSWIRE / December 30, 2016 / Active Wall St. blog coverage looks at the headline from Cempra Inc. (NASDAQ: CEMP). On December 29, 2016, Cempra’s stock price plunged to its lowest level since 2012 after the Company announced that it has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) relating to its new drug applications (NDAs) for oral and intravenous solithromycin for the treatment of community-acquired bacterial pneumonia (CABP) in adults. Register with us now for your free membership and blog access at: http://www.activewallst.com/register/.

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Cempra announced that the CRL stated that the FDA notified that it cannot approve the NDAs in their present form, and requires additional clinical safety information, and also satisfactory resolution of manufacturing facility inspection deficiencies. In November 2016, an independent FDA’s panel narrowly backed the drug, solithromycin, although a preliminary staff review by FDA’s scientists highlighted a potentially concerning rise in liver enzymes associated with its use.

Reason for Rejection

Cempra reported that the CRL stated that based on their review of the NDAs, the FDA determined that the risk of hepatotoxicity had not been adequately characterized. The FDA noted the size of the safety database, which is limited to 920 patients, is too small to adequately characterize the nature and frequency of serious hepatic adverse effects. The FDA recommended a comparative study to evaluate the safety of solithromycin in patients with CABP. Specifically, the CRL recommends that Cempra consider a study of approximately 9,000 patients exposed to solithromycin to enable exclusion of serious drug induced liver injury (DILI) events occurring at a rate of approximately 1:3000 with a 95% probability.

Labeling

The CRL noted that while the FDA reserves comment on the proposed labeling until the NDAs are otherwise adequate, even in the absence of a case of Hy’s Law or of another form of serious DILI in future studies, labeling will need to include adequate information about the potential for hepatotoxicity, limiting use to patients who have limited therapeutic options and limitations regarding duration of therapy. A comprehensive plan for post-marketing safety assessment including an enhanced pharmacovigilance program would also be required.

Manufacturing Deficiencies

The CRL also stated that during recent inspections of the Wockhardt Limited and Hospira, Inc. manufacturing facilities, the FDA field investigator conveyed deficiencies to representatives of the facilities. Satisfactory resolution of these deficiencies is required prior to approval. Details on these deficiencies were not provided in the CRL.

Going Forward

Cempra stated that it will request a meeting with the FDA as early as possible to discuss the issues identified in the CRL, including the design of the recommended clinical safety study and the steps necessary to resolve the deficiencies noted at Wockhardt and Hospira manufacturing facilities. The Company is also planning to provide the FDA with an update on manufacturing progress at Uquifia, an alternate GMP manufacturing facility for solithromycin active pharmaceutical ingredient (API).

“As the rates of antibiotic resistance continue to rise, there is an unmet medical need for new antibiotics to treat patients with CABP and Cempra is committed to working with the FDA to achieve the approval of solithromycin as quickly as possible,” said David Zaccardelli, Pharm.D., acting Chief Executive Officer of Cempra.

“With more than $225 million of cash on hand, patent protection for solithromycin through 2032 and a pipeline that includes fusidic acid and other potential programs for solithromycin, including an ophthalmic formulation, we have flexibility to determine the best course forward for solithromycin and Cempra,” Zaccardelli added.

Stock Performance

At the close of trading session on December 29, 2016, following the announcement, Cempra’s stock price nosedived 57.38% to end the day at $2.60. A total volume of 21.30 million shares were exchanged during the session, which was above the 3-month average volume of 2.21 million shares. The stock currently has a market cap of $129.61 million.

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