CHENGDU, China, July 31 /Xinhua-PRNewswire-FirstCall/ -- Tianyin Pharmaceutical, Co., Inc. (OTC Bulletin Board: TYNP), a manufacturer and supplier of modernized traditional Chinese medicine ("TCM") based in Chengdu, China, today announced that it has received approval from the Chinese State Food and Drug Administration (SFDA) to produce Simvastatin Tablets (SFDA approval number H20083478).
Simvastatin is a Statin drug which is used to control hypercholesterolemia and treat coronary heart diseases. This is the only Statin type drug approved by SFDA to treat these conditions and is highly effective, with fewer side effects when compared to other similar drugs. Simvastatin can reduce the mortality rate of coronary heart diseases, coronary artery diseases, and cerebral stroke by 17%, 24% and 25%, respectively. The China Cholesterol Education Program recommends Simvastatin to treat these conditions. Simvastatin is also listed in the National Medical Insurance Program, thus allowing insured patients to receive reimbursement for the costs of this prescription.
Research report from Tulane University published on American Heart Association's Journal of Circulation shows that due to lifestyle changes in China, high levels of hypercholesterolemia and low levels of awareness, treatment, and information regarding same has made cardiovascular disease the leading cause of death in China. As a leading Statin class drug, Simvastatin had total sales of over $190 million in China during 2006. Less than 40% of Simvastatin sold in China's market is produced by domestic manufacturers. Simvastatin Tablets from Tianyin are expected to gain large market share from companies that currently import Simvastatin due to Tianyin's competitive pricing advantages.
Tianyin's Simvastatin Tablets are sold by prescription in hospitals, which is the major sales channel for drugs in China. Tianyin will start producing Simvastatin Tablets in early August, while selling it through our strategic distributor partners throughout China.
"We are very pleased to receive approval of Simvastatin from the Chinese SFDA, a very important step and positive progress for our business which further diversifies and complements our product portfolio," Dr. Jiang, Chairman and CEO of Tianyin Pharmaceutical Co., Inc., commented. "This favorable decision by the SFDA provides further evidence of our ability to get drugs through the approval process and to market. We are optimistic that the additional drugs that are currently in our development pipeline for SFDA approval will be able to move through this process toward commercialization."
"We are well positioned to take advantage of this new growth opportunity. This approval will enable us to immediately leverage our production capacity and distribution network to facilitate commercialization of this new drug. We expect to begin production of record revenues of Simvastatin Tablets by August 2008 and currently maintain the capacity to produce approximately $2 million of this product annually. The margin profile is anticipated to be slightly better than our current product mix. We will be announcing our June 30, 2008 year end earnings date in the near term but we would like to reiterate that the company expects to exceed its FY2008 make good of $5.6 million in net income or fully diluted EPS of $0.16 per share," concluded Dr. Jiang.
About Tianyin Pharmaceuticals
Tianyin is a manufacturer and supplier of modernized Traditional Chinese Medicine ("TCM") in China. It was established in 1994 and acquired by the current management team in August 2003. It has a comprehensive product portfolio of 34 modernized TCMs in the market, 22 of which are listed in the highly selective National Medicine Catalog of the National Medical Insurance Program. Tianyin owns and operates two GMP manufacturing facilities and an R&D platform supported by leading Chinese academic institutions. The Company has a pipeline of 51 pharmaceutical products pending approval. Tianyin has an extensive nationwide distribution network throughout China with a sales force of 523 salespeople. Tianyin is headquartered in Chengdu, Sichuan Province with two manufacturing facilities and a total of 1,187 employees. Tianyin achieved revenue of $20.4 million and net income of $3.95 million in FY2007 ending June 30, 2007. For more information about Tianyin Pharmaceuticals, please visit http://www.tianyinpharma.com .
Safe Harbor Statement
The Statements which are not historical facts contained in this press release are forward-looking statements that involve certain risks and uncertainties including but not limited to risks associated with the uncertainty of future financial results, additional financing requirements, development of new products, government approval processes, the impact of competitive products or pricing, technological changes, the effect of economic conditions and other uncertainties detailed in the Company's filings with the Securities and Exchange Commission.
SOURCE Tianyin Pharmaceutical, Co., Inc.