Cempra Stashes Cash to Focus on Marketing Its New Anti-Bacterial Once FDA Gives It Thumb’s-Up

July 7, 2016
By Mark Terry, BioSpace.com Breaking News Staff

After its July 5 announcement that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for Solithera, Chapel Hill, North Carolina-based Cempra is developing its financial strategy to market the anti-bacterial drug.

The FDA accepted its NDA for Solithera (solithromycin) to treat community-acquired bacterial pneumonia (CABP) in July and is expected to make a final decision before the end of the year. The acceptance was based on two Phase III studies, which evaluated the drug as oral capsules and as an intravenous solution transitioning to oral.

Solithromycin is a next-generation macrolide that shows potent activity against macrolide-resistant strains of S. pneumoniae, as well as broad activity against methicillin resistant S. aureus (CA-MRSA), streptococci, haemophilus, enterococci, mycobacterium avium and in animal models of malaria. It has also shown activity against so-called atypical bacteria, which includes legionella, chlamydia, mycoplasma and ureaplasma, as well as gonococci and other bacteria that cause genitourinary tract infections.

With approval likely, and the world in need of new antibiotics and specifically something to treat CABP, which is responsible for almost 140,000 hospital readmissions annually, Cempra is focused on marketing efforts. It hopes to launch very quickly after approval.

To date is has $224 million in cash, up 45 percent from Dec. 31, 2015. The company plans a targeted sales approach, largely based on market research showing that a very small number of prescribers, 4 percent, account for 40 percent of CABP prescriptions.

One of the key traits that will undoubtedly help sell Solithera is that it is immune to antibiotic resistance. In a survey conducted with physicians, 66 percent of those doctors surveyed indicated they were very likely to prescribe the antibiotic, largely on the basis of it not being affected by antibiotic resistance.

“The FDA’s acceptance of our two NDA filings brings us one step closer to the potential approval by the end of 2016 and U.S. commercial launch of Solithera,” said Prabhavathia Fernandes, Cempra’s president and chief executive officer, in a statement on July 5. “If approved, Solithera would be a significant milestone in the treatment of CABP, as bacterial resistance to older treatments has continued to rise. The FDA will convene a meeting of the Antimicrobial Drugs Advisory Committee for Solithera prior to its action on the applications.”

Earlier this year, on May 9, Cempra hired Cowen and Company to handle the sale of up to $150 million in new shares.

Cempra is currently trading for $17.61 per share. The company’s shares are down about 45 percent from the beginning of the year.