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Cempra EU Filing Follows the Letters of the Law - and More

 

-- Shutterstock image

Cempra is a Chapel Hill company that’s developing antibiotics to treat scary bacterial infections.

This week it filed for European Union (EU) authorization for market approval of its lead product, solithromycin.

Great news. But sadly for Cempra, (and this is between us, on the QT), the company may also be caught up in the most convoluted form of "lettergy" to confront any mortal, any company, any news site or website outside of D.C. in a hot while.

Cempra (CEMP:NASDAQ) has found itself in the "acronymonious" position of submitting its marketing authorization application (MAA) to the European Medicines Agency (EMA), the EU version of the United States (US) Food and Drug Administration (FDA), for the treatment of community-acquired bacterial pneumonia (CABP). The MAA is for Cempra’s intravenous (IV) and oral capsule formulations of its CABP drug solithromycin.

You with me? If so, cool, because in my humble opinion (yes, grandpa, that’s what grammy meant when she typed IMHO), I’m not sure I’m with me. And it gets WRS.

Prabhavathi Fernandes, Ph.D., Cempra president and CEO -- Cempra photo

MAA to EU's EMA for CABP OK

“The submission of this application to the EMA represents an important achievement in Cempra’s effort to bring a potentially important new antibiotic treatment option to critically ill patients in the EU with CABP, where it could help to offset the rising problem of bacterial resistance.” That’s what Prabhavathi Fernandes, Ph.D., Cempra’s president and CEO, is quoted as saying in the company’s news release.

She added that the recent referendum vote in the UK to leave the EU over the next two years is not expected to affect the review of Cempra’s submission. Still with me? We’ve added … what … Ph.D., CEO and UK, to say nothing of IMHO and Brexit referendum stuff.

And there were NDAs to US FDA for CABP, IV etc., after QIDP

Regardless, this MAA to the EMA follows the completed submission of two new drug applications (NDAs) to the FDA in late April (spelled out) 2016. Both regulatory submissions include safety and efficacy data from two Phase 3 (some styles call for Phase III) studies of solithromycin in the treatment of CABP. The first study was a pivotal Phase 3 clinical trial of solithromycin oral capsules, and the second was a global, pivotal Phase 3 clinical trial of IV solithromycin progressing to oral solithromycin. Positive topline results were announced for both Phase 3 trials during 2015.

A year ago the FDA gave its Qualified Infectious Disease Product  (QIDP) “fast track” designation to solithromycin for CABP.

Adding to the alphabet soup, earlier this year Cempra became eligible for $25.5 million as part of a contract with the federal Biomedical Advanced Research and Development Authority (BARDA) to develop solithromycin for pediatric use. Three formulations -- IV, oral capsules and a suspension formulation – are in a phase one-b trial in children.

BARDA and PAHPA, ASPR and PHEMCE, HHS, DoD, NIH, NIAID, CBRN ... oh my!

In case you forgot, BARDA was established by the Pandemic and All Hazards Preparedness Act (PAHPA) within the office of the Assistant Secretary for Preparedness and Response (ASPR), operating within the structure of the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) as part of the U.S. Department of Health and Human Services (HHS) to sometimes partner with the Department of Defense (DoD), the National Institutes of Health (NIH) and its National Institute of Allergy and Infectious Diseases (NIAID) to manage, among other things, the procurement and advanced development of medical countermeasures for chemical, biological, radiological, and nuclear agents (CBRN).

Whew.

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