As contrary to previous expectations, Gendicine's approval in India has not yet happened.
"HUBEI PROVINCE, China -- Benda Pharmaceutical, Inc. ("Benda" or the "Company") (OTCBB: BPMA), a China-based pharmaceutical company producing traditional Chinese and conventional medicines, as well as Gendicine([R]), the world's first commercialized gene therapy medicine for the treatment of cancer, announced today that Gendicine([R]) has passed major milestones in its clinical trials in India and is expected to be approved for sale in India in 2008. This anticipated approval would mark Benda's entry into the $204 MM Indian oncology drug market, and would make Gendicine([R])available to treat cancer in the two most populous nations on the planet. The Indian market is just one of many in which Benda is seeking approval for Gendicine([R])and represents the first step in Benda's progressive globalization plan for the drug.
Benda Mitigates Risk, Leverages Established Distribution System through Joint Venture
In May 2007, Benda subsidiary SiBiono entered into a joint venture with a leading Indian pharmaceutical firm (name releasable upon drug approval) to launch Gendicine([R]) in the Indian market. Per the terms of the agreement, SiBiono has licensed Gendicine([R]) to its Indian partner and has assisted it in the initiation of clinical trials. The Indian partner is responsible for completing the clinical trials and seeking approval from the Indian Food and Drug Administration; Benda expects both to occur in 2008. The Indian partner bears all expenses incurred during the process. Upon drug approval, the Indian partner will purchase Gendicine([R]) directly from SiBiono at the prevailing market price and utilize its established distribution system to introduce Gendicine([R]) to the Indian market.
The market price (price to pharmaceutical distributors) is currently approximately $237 per vial and the typical treatment process requires 16 - 24 vials per patient, depending on the patient's specific situation.
"We are confident that Gendicine([R]) will be approved and available for sale in India in 2008. The anticipated success in India would not only substantially add to Benda's top line and bottom line growth, but it could also pave the way for Gendicine([R])'s entry into other important foreign markets. Each new market entrance requires adherence to that country's regulatory requirements and approval process, but prior countries' endorsements could have a positive impact during the application process," commented Mr. Yiqing Wan, Benda chairman and CEO. "We are executing our staged, strategic plan to bring Gendicine([R])to the world, one key country at a time."
Indian $204 MM Oncology Drug Market
After China, India is the second most populous country in the world with over 1.12 billion people (Source: India's National Commission on Population). As reported by IRIS News Digest, the Indian domestic oncology drug market exceeded $204 MM in 2006 and is expected to grow at 22% annually over the next 10 years. According to The Hindu, India's national newspaper, there are 700,000 new cancer cases each year in India, of which almost 230,000 are tobacco-related and occur in the head and neck region. Gendicine([R]) has already been approved to treat head and neck cancer in China; in clinical trials in China for 135 patients affected by head and neck tumors, 64% had their tumors eliminated after one month of Gendicine([R]) treatment, marking a 340% increase in efficacy relative to traditional treatments.
About Benda Pharmaceutical, Inc.
Benda Pharmaceutical, Inc. (www.bendapharma.com), a China-based pharmaceutical company, is a pure play on explosive Chinese pharmaceutical spending and the global search for a cancer cure. Benda produces traditional Chinese and conventional medicines, as well as Gendicine([R]), the world's first commercialized gene therapy medicine for the treatment of cancer."
