Novartis’ Enablex Given Green Light for Clinical Trials By China’s SFDA

SHANGHAI - China's State FDA has officially accepted BMP Sunstone's clinical trial application for Novartis' Enablex (darifenacin), the company announced May 6.

CTA acceptance is a key SFDA requirement needed for BMP Sunstone to pursue clinical trials for Enablex. The company now hopes to begin clinical trials in the first half of 2009, and estimates that a market license will be received sometime in 2011.

BMP entered into an exclusive licensing agreement with Novartis subsidiary, Shanghai Novartis Trading Limited, for marketing and selling Enablex in China in late 2007 (Also see "Beijing Med Pharm To Exclusively Market Novartis’ Enablex In China" - Scrip, 10 Dec, 2007.).

Under terms of the agreement, BMP will be responsible for attaining SFDA approval of Enablex, a process that is expected to last through 2010. Once approved, BMP will have exclusive rights to sell, market and distribute Enablex in China for a period of 10 years.

"We have a confidentiality agreement with Novartis which prevents us from discussing the trial, costs, timeline as well as other information without receiving their approval," Fred Powell, CFO of Plymouth Meeting-based BMP Sunstone, told PharmAsia News, as he declined to disclose further information beyond the company press release.

Enablex is a prescription medicine used in adults to provide overactive bladder symptom relief by targeting specific receptors in the bladder that cause involuntary muscle spasms, thereby providing better control of the bladder muscle to restore control of urination in adults.

According to BMP Sunstone, formerly Beijing Med-Pharm, global annual sales of OAB medication is estimated to be about $2.25 billion. At present, Procter & Gamble and Novartis market the drug in the U.S.

OAB afflicts an estimated 24-29 percent of China's population over the age of 24, or over 200 million people. However, the treatment rates are historically low, with less than 15 percent of OAB sufferers in China seeking treatment, BMP Sunstone said.

"CTA acceptance is one key step toward reaching marketability," BMP Sunstone CEO David Gao said. "The addressable market for OAB medicines in China is a potentially huge opportunity and we believe we have the necessary resources to meet this developing market demand with Enablex."

Beijing Novartis told PharmAsia News in a previous interview that partnering with BMP will bring Novartis China a strong presence in urology and gynaecology, as BMP has particular distribution and marketing focues in these sectors, and will maximize the interests of Novartis assets.

"Due to a lack of presence in the urology and gynecology sectors, Novartis Pharmaceutical decided not to register the brand in China on its own and out license its commercial rights to BMP," the company said.

In China, only three pharmaceutical companies have received approval for drugs that treat urinary frequency, urgency and incontinence: Guangdong Kangmei Pharmaceutical, Shijiazhuang Xinhua Pharmaceutical and Tianjin Pacific pharmaceutical.

According to the Approval Procedure for Clinical Trials, which SFDA issued in February 2006, within five days after application submission, drug administration officials at the provincial level have to begin site inspection, R&D sampling and reviewing the dossier content and format. The complete process has to be completed within 30 days.

The drug testing institute then has 60 days to complete sample testing and standards verification, after which the application has to be formally accepted by SFDA within 5 days. The Center of Drug Evaluation will then conduct technical evaluation within 100 to 120 days, before granting or denying fast-track approval.

Novartis recently broke ground on an R&D center in Shanghai's Zhangjiang Hi-Tech park, which En Li - Novartis VP and head of research for Novartis Institutes for Biomedical Research Shanghai - told PharmAsia News will focus on liver cancer, gastric cancer and nasopharyngeal carcinoma (Also see "Novartis’ Paul Herrling And En Li On R&D Strategy In China, India And The Pacific Rim: An Interview With PharmAsia News (Part 2 of 2)" - Scrip, 8 May, 2008.).

- Ying Huang ([email protected])