Cempra, Inc., Announces Notification of Patent Allowance for U.S. Patent
Application on Taksta Loading Dose Formulation
Patent Protects U.S. Market Exclusivity to 2029 Excluding Possible Patent Term
CHAPEL HILL, N.C., May 30, 2013
CHAPEL HILL, N.C., May 30, 2013 /PRNewswire/ --Cempra, Inc., (Nasdaq: CEMP),
a clinical-stage pharmaceutical company focused on developing differentiated
antibiotics to meet critical medical needs in the treatment of bacterial
infectious diseases, today announced that the United States Patent and
Trademark Office (USPTO) issued U.S. Patent No. 8,450,300 on May 28, 2013 with
claims directed to the company's novel loading dose regimen for Taksta™. The
patent, entitled "Fusidic Acid Dosing Regimens for Treatment of Bacterial
Infections," provides protection until 2029, excluding possible patent term
"The issuance of this patent may add to the commercial value of Taksta as an
important antibiotic candidate, currently in a Phase 2 clinical study in
patients with prosthetic joint infections," said Prabhavathi Fernandes, Ph.D.,
chief executive officer of Cempra. "Our now proprietary loading dose regimen
for Taksta was a novel innovation designed so that the drug would rapidly
reach therapeutic blood levels and minimize the risk of drug resistance. The
patent provides protection in addition to the expected U.S. market exclusivity
obtained through Waxman-Hatch, the GAIN Act, pediatric testing and, possibly,
the Orphan Drug Act."
About Cempra, Inc.
Founded in 2006, Cempra, Inc. is a clinical-stage pharmaceutical company
focused on developing antibiotics to meet critical medical needs in the
treatment of bacterial infectious diseases. Cempra's two lead product
candidates are currently in advanced clinical development. Solithromycin
(CEM-101) is in a Phase 3 clinical trial for community-acquired bacterial
pneumonia (CABP) and is licensed to strategic commercial partner Toyama
Chemical Co., Ltd., a subsidiary of FUJIFILM Holdings Corporation, for certain
exclusive rights in Japan. Taksta™ (CEM-102) is Cempra's second product
candidate currently in a Phase 2 clinical trial for prosthetic joint
infections. Both seek to address the need for new treatments targeting
drug-resistant bacterial infections in the hospital and in the community. The
company also intends to use its series of proprietary lead compounds from its
novel macrolide library for uses such as the treatment of chronic inflammatory
diseases, endocrine diseases and gastric motility disorders. Additional
information about Cempra can be found at www.cempra.com.
Please Note: This press release contains forward-looking statements regarding
future events. These statements are just predictions and are subject to risks
and uncertainties that could cause the actual events or results to differ
materially. These risks and uncertainties include, among others: the possible
impairment of, or inability to obtain, intellectual property rights and the
costs of obtaining such rights from third parties; the results of studies of
our product candidates conducted by others; the results, timing, costs and
regulatory review of our studies and clinical trials; our need to obtain
additional funding and our ability to obtain future funding on acceptable
terms; our anticipated capital expenditures and our estimates regarding our
capital requirements; our ability to obtain FDA approval of our product
candidates; our dependence on the success of solithromycin and Taksta; and
innovation by our competitors. The reader is referred to the documents that we
file from time to time with the Securities and Exchange Commission.
Investor and Media Contacts:
Robert E. Flamm, Ph.D.
Russo Partners, LLC
Russo Partners LLC
SOURCE Cempra, Inc.
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