ALBANY, N.Y., April 17, 2012 /PRNewswire/ -- AMRI (NYSE: AMRI), a leading global contract research and manufacturing organization, was selected by Biota Holdings Limited (ASX: BTA), a leading anti-infective drug development company based in Australia, to further develop and manufacture the influenza antiviral CS8958 (laninamivir), a second-generation, long-acting neuraminidase inhibitor. AMRI will provide these services to support a New Drug Application for laninamivir to the United States Food and Drug Administration (FDA).
Biota is working to establish the U.S. manufacturing of laninamivir, optimize its manufacturing processes, and conduct clinical trials for safety and efficacy in adult and pediatric populations. These studies are needed to apply for FDA approval of the drug.
AMRI's role will initially involve the development and manufacture of the active pharmaceutical ingredient for use in clinical trials. In the future there is the potential for AMRI to be selected as the commercial manufacturer of the product.
"The agreement with Biota demonstrates AMRI's global reputation as a preferred partner for delivering best-in-class drug discovery, development and manufacturing services," said AMRI's Chairman, President and CEO, Thomas E. D'Ambra, Ph.D. "We look forward to working with Biota to accelerate the advanced development of laninamivir."
In March 2011, the Office of Biomedical Advanced Research and Development Authority (BARDA) at the U.S. Department of Health and Human Services awarded Biota a five-year contract estimated to be worth $231 million for the advanced development of laninamivir. The drug is already approved for sale in Japan and was launched as Inavir by Daiichi Sankyo in October 2010. It is not currently approved for sale in other markets.
AMRI is a global contract research and manufacturing organization with more than twenty years experience providing customers fully integrated drug discovery, development, and manufacturing services. AMRI supplies a broad range of services and technologies that support the discovery and development of pharmaceutical products and the manufacturing of API and drug product for existing and experimental new drugs. With locations in the United States, Europe, and Asia, AMRI maintains geographic proximity and flexible cost models. AMRI has successfully partnered certain programs and is actively seeking to out-license its remaining programs to strategic partners for further development.
Laninamivir is an influenza antiviral, known as a long acting neuraminidase inhibitor (LANI) and a unique treatment for influenza. Unlike vaccines, neuraminidase inhibitors offer the ability to treat an influenza infection, but may also be used preventatively. Current or first-generation neuraminidase inhibitors require twice daily dosing. LANI compounds offer the potential of a single administration for treatment and once a week for prevention. This represents a significant advantage compared with existing influenza antiviral treatments.
Biota is a leading anti-infective drug development company based in Melbourne Australia, with key expertise in respiratory diseases, particularly influenza. Biota developed the first-in-class neuraminidase inhibitor, zanamivir, subsequently marketed by GlaxoSmithKline as Relenza. Biota research breakthroughs include a series of candidate drugs aimed at treatment of respiratory syncytial virus (RSV) disease and Hepatitis C (HCV) virus infections. Biota has clinical trials underway with its lead compound for human rhinovirus (HRV) infection in patients with compromised respiration or immune systems.
In addition, Biota and Daiichi Sankyo co-own a range of second generation influenza antivirals, of which the lead product Inavir®, is marketed in Japan. Biota holds a contract from the US Office of Biomedical Advanced Research and Development Authority (BARDA) for the advanced development of laninamivir in the USA.
Relenza™ is a registered trademark of the GlaxoSmithKline group of companies.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Readers should not place undue reliance on our forward-looking statements. The company's actual results may differ materially from such forward-looking statements as a result of numerous factors, some of which the company may not be able to predict and may not be within the company's control. Factors that could cause such differences include, but are not limited to: (a) results of Biota's clinical trials involving laninamivir; (b) problems or delays which may arise during clinical trials or in the course of developing, testing or manufacturing laninamivir; (c) continued funding of Biota's laninamivir program by BARDA or other entities; (d) the planned timing of initiation and completion of clinical trials for laninamivir are subject to the ability of Biota to enroll patients, enter into agreements with clinical trial sites and investigators, and other technical hurdles and issues that may not be resolved; (e) efficacy of laninamivir as a treatment and/or a preventative and appropriate dosing levels; (f) delay or denial of regulatory approvals from the FDA resulting from, among other things, adverse FDA decisions or interpretations of data that differ from Biota's interpretations and that may require additional clinical trials or potential changes in the cost, scope and duration of clinical trials; and (g) those factors discussed in the company's Annual Report on Form 10-K for the year ended December 31, 2011 as filed with the Securities and Exchange Commission, and the company's other SEC filings. The company does not undertake any obligation to and does not intend to update any forward-looking statements contained in this press release.