A Milestone Reached to Commercialize Leading OAB Drug in China
PLYMOUTH MEETING, Pa., May 6 /Xinhua-PRNewswire-FirstCall/ -- BMP Sunstone Corporation (Nasdaq: BJGP) (“BMP Sunstone” or the “Company”) today announced that its Clinical Trial Application (“CTA”) for Enablex(R) (Darifenacin) was officially accepted by China’s State Food & Drug Administration (“SFDA”). CTA acceptance is a key SFDA requirement prior to pursuing a clinical trial and, ultimately, completing commercialization of a pharmaceutical product in China. The Company hopes to begin the clinical trial in the first half of 2009, and estimates that receipt of a market license could occur sometime in 2011.
Enablex(R) is a prescription medicine used in adults to treat symptoms of urinary incontinence, urgency and frequency related to an Overactive Bladder (“OAB”). Global annual sales of OAB medication are estimated to be USD$2.25 billion. In China, OAB afflicts an estimated 24-29% of the population over the age of 24, or over 200 million people. However, the treatment rates are historically low, with less than 15% of OAB sufferers in China seeking treatment.
“Today’s announcement speaks to our unique ability to commercialize leading pharmaceutical products in the Chinese market,” stated David Gao, Chief Executive Officer of BMP Sunstone. “CTA acceptance is one key step toward reaching marketability and we remain excited about the growth prospects for Enablex(R) in China. The addressable market for OAB medicines in China is a huge potentially opportunity and we believe we have the necessary resources to meet this developing market demand with Enablex(R).”
In November 2007, BMP Sunstone signed an exclusive agreement to register, market and distribute Enablex(R) in the People’s Republic of China with Shanghai Novartis Trading Limited. Under the terms of the agreement, once approved, BMP Sunstone will have the exclusive rights to sell, market and distribute Enablex in China for ten years.
Gao continued, “Enablex(R) is a great example of our ability to target under-penetrated areas of China with drugs that improve the overall health of the population. We intend to continue to bring high value, niche-focused prescription drugs, with rigor and prudence, to the growing Chinese healthcare market.”
About BMP Sunstone Corporation
BMP Sunstone Corporation is a specialty pharmaceutical company that is building a proprietary portfolio of branded pharmaceutical and healthcare products in China and is pursuing partnerships with other companies seeking to enter the Chinese pharmaceutical market. It is the only U.S. public company to offer industry partners a comprehensive suite of market-entry services in China that includes pre-market entry analysis, clinical trial management, product registration, market research, as well as pharmaceutical marketing and distribution. The company provides distribution services for a wide range of products, including Western medicines, traditional Chinese medicines,
bio-chemical medicines, medical applications, branded generic pharmaceuticals, over-the-counter healthcare products, and home healthcare supplies and equipments. BMP Sunstone’s proprietary portfolio, primarily focusing on women’s health and pediatrics. The Company is headquartered in Plymouth Meeting, Pennsylvania.
About Shanghai Novartis Trading Co.
Shanghai Novartis Trading Co. is a wholly owned subsidiary of Novartis AG (NYSE: NVS).
Safe Harbor Statement
This news release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements that are other than statements of historical fact, including statements regarding commercialization and growth prospects of Enablex, the timing of clinical trials and receipt of a market license for Enablex, the addressable market for OAB medicine in China and whether the Company has the necessary resources to meet the market demand for Enablex. These statements are subject to uncertainties and risks including, but not limited to, product and service demand and acceptance, changes in technology, economic conditions, the impact of competition and pricing, government regulation, the non-acceptance by patients to accept a pharmaceutical treatment for OAB, the failure to obtain any necessary approvals to market Enablex(R) and other risks contained in reports filed by the Company with the Securities and Exchange Commission. All such forward-looking statements, whether written or oral, and whether made by or on behalf of the company, are expressly qualified by the cautionary statements and any other cautionary statements which may accompany the forward-looking statements. In addition, the company disclaims any obligation to update any forward-looking statements to reflect events or circumstances after the date hereof.
For more information, please contact:
BMP Sunstone Corporation
Fred M. Powell
Chief Financial Officer
Tel: +1-610-940-1675
Integrated Corporate Relations, Inc.
Ashley Ammon MacFarlane and Christine Duan
Tel: +1-203-682-8200 (Investor Relations)
