Biostar Pharmaceuticals, Inc. and Fmmu to Jointly Conduct Phases I To III Clinical Trials for Viacom Drug
XIANYANG, China, June 13, 2012 /PRNewswire-Asia/ -- Biostar Pharmaceuticals, Inc. (NASDAQ GM: BSPM) ("Biostar" or "the Company"), a PRC-based manufacturer and marketer of pharmaceutical and health supplement products in China for a variety of diseases and conditions, today announced that it signed a Letter of Intent ("LOI") with The Fourth Military Medical University ("FMMU") to jointly conduct Phases I to III clinical trials for Viacom Pine II Cream ("Viacom") drug. The LOI has been submitted to China's military authorities for approval.
Viacom is a prescription drug developed by the First Affiliated Hospital of Dermatology of FMMU specifically for the needs of China's military and will be used to treat skin diseases such as bacterial and fungal infections, dermatitis and eczema. Viacom has passed all standard tests related to quality, stability, toxicology and efficiency. Phases I to III clinical trials must be conducted for a period of three years prior to receiving final approval from military authorities to start production.
FMMU is one of China's most prestigious military medical universities and research centers and its primary purpose is to advance China's military medicine. In January 2012, Biostar was one of nine PRC pharmaceutical companies selected to cooperate with FMMU in the fields of research and product development.
According to the terms of the LOI, FMMU will be responsible for:
- Submitting applications and receiving approvals to commence clinical trials; coordinating with China's military authorities during clinical trials and securing all needed approvals to continue Phases I to III of these clinical trials for the next three years at FMMU's facilities; securing final production approvals by October 2015; and providing the technology to ensure the quality and effectiveness of the product.
Biostar will be responsible for:
- Coordinating with FMMU to complete the clinical trials before October 2015; bearing all costs of clinical trials and approvals; completing the construction of the production line and obtaining the GMP certification on time; and manufacturing the drug using the technology provided by FMMU.
Ronghua Wang, Biostar's Chief Executive Officer and Chairman, commented, "Following the initial clinical research, Viacom has demonstrated encouraging results for the treatment of several skin diseases such as bacterial and fungal infections, dermatitis and eczema which are common among members of the PRC armed forces. Additionally, these types of skin diseases affect a large portion of China's population and, if not treated properly, could result in severe health complications. Once Viacom receives approval from the military authorities to be sold in military hospitals, we will apply to receive SFDA's approval to sell it in health care centers and hospitals all over the country."
Mr. Wang continued, "This LOI follows the Cooperation Agreement we signed in January 2012, according to which Biostar was selected to work with FMMU's staff to share resources and ideas and to carry out Phases I to IV of clinical trials for products which, when approved, will be sold directly to China's military and to the three hospitals managed by FMMU. We are targeting additional LOIs with FMMU to conduct clinical trials for new products, which will help us become a production base for manufacturing drugs specifically for the needs of China's military."
About Biostar Pharmaceuticals, Inc.
Biostar Pharmaceuticals, Inc., through its wholly owned subsidiary and controlled affiliate in China, develops, manufactures and markets pharmaceutical and health supplement products for a variety of diseases and conditions. The Company's most popular product is its Xin Aoxing Oleanolic Acid Capsule, an over-the-counter ("OTC") medicine for chronic hepatitis B, a disease affecting approximately 10% of the Chinese population. For more information please visit: http://www.biostarpharmaceuticals.com
Safe Harbor relating to the Forward-Looking Statements
Certain statements in this release concerning our future growth prospects are forward-looking statements, within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended, which involve a number of risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements. The company uses words and phrases such as "guidance," "forecasted," "projects," "is expected," "remain confident," "will" and similar expressions to identify forward-looking statements in this press release, including forward-looking statements. Undue reliance should not be placed on forward-looking information. Forward-looking information is based on current expectations, estimates and projections that involve a number of risks, which could cause actual results to vary and in some instances to differ materially from those anticipated by Biostar and described in the forward-looking information contained in this news release. The risks and uncertainties relating to these statements include, but are not limited to, risks and uncertainties regarding the Company's ability to complete the contemplated clinical trials and capitalize on this opportunity, the state of consumer confidence and market demand or the Company's products, success of our investments, risks and uncertainties regarding fluctuations in earnings, our ability to sustain our previous levels of profitability including on account of our ability to manage growth, intense competition, wage increases in China, our ability to attract and retain highly skilled professionals, time and cost overruns on fixed-price, fixed-time frame contracts, client concentration, our ability to successfully complete and integrate potential acquisitions, withdrawal of governmental fiscal incentives, political instability and regional conflicts and legal restrictions on raising capital or acquiring companies outside China. Additional risks that could affect our future operating results are more fully described in our United States Securities and Exchange Commission filings including our most recent Annual Report on Form 10-K for the year ended December 31, 2011, and other subsequent filings. These filings are available at www.sec.gov. We may, from time to time, make additional written and oral forward-looking statements, including statements contained in our filings with the Securities and Exchange Commission and our reports to shareholders. We do not undertake to update any forward-looking statements that may be made from time to time by or on our behalf.
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