Tomahawk, WI 9/17/2013 (BasicsMedia) – A biotechnology company, BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX)’s strength lies in its structure guided drug design process for the research and development of small molecule pharmaceuticals by effectively integrating the broader disciplines of biology, medicinal chemistry, crystallography and computer modeling. Its business collaborators for drug discovery and development includes Shionogi & Co Ltd (TYO: 4507), Green Cross Corp (KRX: 006280) and Mundipharma International Holdings Limited. Its focus is on development of targeted enzyme inhibitors.

BioCryst’s key drug candidates include Peramivir (in Phase III clinical trials for acute influenza), Ulodesine (completed Phase II clinical trials for the treatment of gout) and Forodesine (in Phase II clinical trials for oncology). It’s pharmaceutical portfolio also include drug molecule 4161 (in Phase I trial for kallikrein hereditary angioedema) and 4430 (preclinical inhibitor for treating filoviruses).

Recently, while briefing on company’s strength and pipeline products at the Morgan Stanley Global Healthcare Conference 2013, Tom Staab, Senior Vice President and Chief Financial Officer, reminded that the BioCryst’s focused operational strategy revolving around three programs, namely 4161, Peramivir and 4430, has certainly created value for its investors as apparent through more than 45% rise in its stock prices during the trailing twelve months.

The things that are grabbing attention of analysts and investors are exciting Phase l clinical data for hereditary angioedema drug molecule 4161 and secondly, that BioCryst is planning to file its first ever New Drug Application for Peramivir before the end of this fiscal.

Drug Molecule 4161: HAE Program

BioCryst’s hereditary angioedema program met all of the objectives of Phase I clinical trial with regards to drug tolerability, drug safety, drug exposure and intended inhibitory effect on target that is plasma kallikrein. These findings best support the proof of concept to move ahead with Phase ll trial that BioCryst is planning to initiate by 4Q13. 4161 can revolutionize the HAE treatment by being the first oral and prophylactic therapy for HAE, if it demonstrates clinical effectiveness to inhibit attacks in HAE patients during the study trials.

The company is also in plan to announce host of molecules before the end of this year that it is developing as a part of its second generation program to overcome bioavailability issues faced with 4161.

Drug Molecule Peramivir: Ready for NDA 

This molecule is under development with the Biomedical Advanced Research and Development Authority under a $235 million contract for the treatment of influenza. Recently BioCryst is focused on completing the New Drug Application (NDA) for Peramivir and submitting before the end of this year. It has also secured funding from BARDA to file the prerequisites necessary to complete the NDA filings. Up to $12.8 million, which largely covers the funding required to file NDA, has been set aside.

Funding from government certainly emphasizes the unmet medical need and hence the company looks forward for the government stockpiling aspect alongside exploring commercial opportunities for Peramivir.

Drug Molecule 4430: Announcements likely Before the Year End

BioCryst is under process to get a scientific publication with regards to molecule’s pharmacological activity against the filoviruses after submission of data and study results. This third program, has been partially funded by the government, involving 4430 is a viral program for the treatment of filoviruses and the initiative is expected to get more funding under government contracts. The company is positive on securing additional government funding and the announcement is likely before the year end.

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