TAIPEI, Jan. 15, 2014 /PRNewswire/ -- TaiGen Biotechnology Company, Limited ("TaiGen") today announced that they have signed an exclusive agreement with R-Pharm, a leading Russian pharmaceutical company, to develop and commercialize nemonoxacin (Taigexyn®) in the Russian Federation, Turkey and other members of the Commonwealth Independent States (CIS). Nemonoxacin is a novel antibiotic for the treatment of bacterial infections including those caused by drug-resistant bacteria. Under the terms of the agreement, R-Pharm will be responsible for the development, registration and commercialization of nemonoxacin in these territories and assume all associated costs. In exchange for the exclusive rights, TaiGen will receive an upfront payment and is eligible for additional regulatory and commercial milestones as well as royalties on product sales in the future.
Nemonoxacin is a novel non-fluorinated quinolone available in both oral and intravenous formulations. In the clinical trials conducted to this point, nemonoxacin has shown activity against drug-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and quinolone-resistant MRSA as well as quinolone-resistant Streptococcus pneumoniae. TaiGen has completed a multi-center Phase 2 and 3 of the oral formulation in community-acquired pneumonia (CAP) in Taiwan and mainland China and submitted NDA to regulatory authorities in both countries in 2013. In June 2012, TaiGen out-licensed the exclusive rights of mainland China to Zhejiang Medicine. In the U.S., TaiGen has completed two Phase 2 studies, one in CAP and the other in diabetic foot infections (DFI). In December 2013, the U.S. FDA granted nemonoxacin Qualified Infectious Disease Product (QIDP) and Fast Track designations for CAP and acute bacterial skin and skin structure infections (ABSSSI). TaiGen owns the worldwide patent portfolio of nemonoxacin that protects composition, use, and processes until 2029.
"We are very excited about the opportunity to bring this truly innovative anti-infective compound to patients in Russia, other former Soviet Union states, and Turkey and will use our clinical, regulatory and commercial capabilities to ensure speedy registration and successful launch," said Vasily G. Ignatiev, CEO of R-Pharm.
Dr. Ming-Chu Hsu, President and Chief Executive Officer of TaiGen, said, "We are very impressed with the R-Pharm's experience and their commitment to infectious diseases. The Russian Federation and Turkey are among the world's top twenty pharmaceutical markets and their growth in the next five years will outpace the U.S., EU and Japan, according to IMS. Both countries also have a very high incidence of drug-resistance bacterial infections.Together we can bring innovative medicines such as nemonoxacin to these areas where the medical need is very high."
R-Pharm is a leading Russian pharmaceutical company with commercial operations in the Russian Federation, CIS, and Turkey. In 2013, it has over 2,800 employees with sales revenue of US$1.8 billion. Key business areas of R-Pharm include manufacturing, sales and marketing of prescription drugs, laboratory diagnostics, medical equipment, and venture investment.
About TaiGen Biotechnology
TaiGen Biotechnology is a leading research-based and product-driven biotechnology company in Taiwan with a wholly-owned subsidiary in Beijing, China. In addition to nemonoxacin, TaiGen has two other in-house discovered NCEs in clinical development under IND with U.S. FDA: TG-0054, a chemokine receptor antagonist for stem cell transplantation and chemosensitization, in Phase 2 and TG-2349, a HCV protease inhibitor for treatment of chronic hepatitis infection, in Phase 1/2a. Both TG-0054 and TG-2349 are currently in clinical trials in patients in the U.S.
Certain statements in this press release are forward-looking. These forward-looking statements are based on TaiGen's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain regulatory authority clearances or approvals and noncompliance with regulatory regulations. As with any drugs under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. TaiGen does not undertake an obligation to update or revise any forward-looking statement.
Peter W. Tsao, PhD, Vice President of Business Development
Tel: +886-2-8177-7072 ext 1705
PJ (Joe) Hsueh, Vice President of Operations
Tel: +886-2-8177-7072 ext 1704
SOURCE TaiGen Biotechnology Co., Ltd.