In a March 13 research note, H.C. Wainwright & Co. analyst Ed Arce reported that Nabriva Therapeutics Plc (NBRV:NASDAQ) has two antibiotics up for approval this year, which H.C. Wainwright & Co. believes the FDA will grant. The medications are CONTEPO and lefamulin, whose Prescription Drug User Fee Act (PDUFA) dates are April 30 and August 19, respectively.
CONTEPO (intravenous fosfomycin) is a broad-spectrum antibiotic for complicated urinary tract infections. "Importantly, CONTEPO has activity against key multidrug-resistant organisms," Arce pointed out. CONTEPO has fast track and priority review statuses.
When its PDUFA date arrives in six weeks, CONTEPO is "very likely to be approved by the FDA," an event that "could represent a meaningful stock catalyst, especially as investors position themselves ahead of the PDUFA of lefamulin," Arce commented.
In support of such an outcome is the fact that IV fosfomycin is a generic in Europe where, in the 45 years of its use, it has proven to be both safe and efficacious. Also, in the ZEUS clinical trial, CONTEPO was shown to be noninferior to Zosyn (piperacillin-tazobactam).
Should the FDA approve CONTEPO in April, Nabriva is expected to launch it in mid-2019, noted Arce. The company intends to target facilities where antibiotic resistance rates are at a level that warrants use of a new antibiotic. Arce indicated such a "highly targeted approach" is appropriate and would likely result in "early-adopter sales and uptake," particularly in light of the drug's long-term history of use outside of the U.S.
However, significant demand-driven growth in sales of CONTEPO realistically will not likely occur until mid-2020, wrote Arce.
As for lefamulin, a larger opportunity with priority review status, according to Arce, it is expected to be approved and then launched in the fall. Nabriva anticipates it and CONTEPO, which are complementary in the hospital setting, will "share call points and utilize the same focused commercial, medical affairs and supply chain infrastructure."
In other lefamulin news, last month a licensee of the antibiotic, Sinovant Sciences Ltd., submitted a clinical trial application to Chinese regulators seeking approval to evaluate it for community-acquired bacterial pneumonia. That milestone spurred the first payment to Nabriva, which was $1.5 million. Nabriva plans to license lefamulin in additional regions outside of the U.S., such as the European Union and Japan, to generate additional nondilutive capital.
Finally, Arce relayed that in Q4/18, Nabriva reported a net loss of $30.8 million, or $0.46 per basic and diluted share. For 2018, the firm's net loss was $114.8 million, or $2.26 per basic and diluted share. At year-end 2018, the biopharma had $102.2 million of cash, sufficient to fund operations into Q2/20 according to management.
H.C. Wainwright & Co. has a Buy rating and a price target of $9 per share on Nabriva, which represents a triple, as the stock is currently trading at around $2.98 per share.
Editor's note: a earlier version of this article incorrectly referred to CONTEPO and lefamulin as vaccines. They are antibiotics. We apologize for this error.
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