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Cempra (CEMP) Seals Merger Deal With This Antibiotics Biopharmaceutical



8/9/2017 7:18:43 AM

Cempra Seals Merger Deal With This Antibiotics Biopharmaceutical August 9, 2017
By Alex Keown, BioSpace.com Breaking News Staff

CHAPEL HILL, N.C. – Six months after antibiotic drugmaker Cempra Inc. (CEMP) terminated nearly two-thirds of its employees, the company appears to be poised for a comeback with the planned merger with Connecticut-based Melinta Therapeutics. The new company will be under the Melinta Therapeutics name.


Privately-held Melinta focuses on the development of novel antibodies targeting serious bacterial infections. Under terms of the agreement, Melinta will merge with a subsidiary of Cempra. The merger means that current Cempra shareholders will own approximately 48 percent of the combined company and current Melinta shareholders will own approximately 52 percent of the combined company. The combined entity is expected to trade on the Nasdaq exchange. The merger is expected to be finalized by the fourth quarter of 2017.

The new company is expected to be the main driver behind Melinta Therapeutics recently approved drug, Baxdela. In June, the U.S. Food and Drug Administration approved Baxdela for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria. Baxdela is a fluoroquinolone that exhibits activity against both gram-positive and gram-negative pathogens, including MRSA. Melinta is also evaluating Baxdela in an ongoing Phase III study in patients with community-acquired bacterial pneumonia (CABP) and plans to initiate a clinical trial in patients with complicated urinary tract infections (cUTI), the company said in the merger announcement.

“This transaction creates a leading antibiotics company to drive the commercial launch of Baxdela, and build over time by developing market-leading pipeline assets meeting the tremendous need for novel antibiotics that treat serious infections,” John Temperato, president and chief operating officer of Melinta, said in a statement.

In addition to Baxdela, the combined companies will look to develop other pipeline opportunities. For its part, Cempra is still in the process of responding to the Complete Response Letter from the FDA in December 2016. The FDA rejected Cempra’s solithromycin, an oral and intravenous drug being evaluated for the treatment of community-acquired bacterial pneumonia (CABP) in adults. In its CRL, the FDA raised a concern regarding insufficient characterization of hepatotoxicity and requested more clinical safety data.
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While Cempra looks to try again with solithromycin, that company also has an ongoing ophthalmic development program for solithromycin and is completing preclinical work to support a potential IND filing in 2018 with the FDA. Cempra also has Fusidic acid for ABSSSI, which continues to progress after completion of a successful Phase III study with a clear path to NDA submission, the company said.

In addition to Baxdela, Melinta has Radezolid, which is nearing Phase I completion in acne vulgaris. The company anticipates the potential for expansion for additional indications.

Cempra and Melinta will work together through a joint selection committee to identify the chief executive officer and leadership of the combined company. The board of directors of the company will include four appointed from each company, as well as the newly dubbed CEO.


Read at BioSpace.com


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