► Home ﹥Our Projects ﹥Pharmaceutical Products ﹥GCTB Gemcitabine is an oncology drug administered as treatment for various carcinomas, including pancreatic cancer, non-small cell lung cancer, bladder cancer and breast cancer. It is being investigated for use in oesophageal cancer, and is used experimentally in the treatment of lymphomas and other tumor types. Gemcitabine represents a major advance in pancreatic cancer care, and has been shown to be less debilitating than other forms of chemotherapy. In 2007, sales of injection-formulated gemcitabine worldwide exceeded US$1.6 billion, with recent market growth reaching 12 percent. With its own patented novel production method, PharmaEssentia aims at securing 50 percent of the market in the first year following the launch of its gemcitabine product, GemFlor® between 2009 and 2010. PharmaEssentia plans to market gemcitabine API and GemFlor® initially in Asia, in markets such as Taiwan, China, Korea, and Southeast Asia in 2009, and plans to enter the US and European markets in 2011. PharmaEssentia estimates that the total revenue for the drug to be around NT$79 million (US$2.4 million) for 2009, the first year launched, and will grow to exceed NT$800 million (US$24.2 million) in 2012 resulted from M&S in such a highly regulated market. PharmaEssentia's Gemcitabine project As of January 2008, PharmaEssentia has successfully submitted six patent applications related to this gemcitabine synthesis method, among which one was granted in October 2008. Positioned as a research company that does not focus its business on manufacturing, marketing and sales, PharmaEssentia is seeking a qualified contract manufacturing organization (CMO) to mass-produce gemcitabine and is also looking for Taiwan-based generic pharmaceutical companies to market gemcitabine products, scheduled to be launched to the market in 2009. The following two product pipelines are related to gemcitabine: a. Gemcitabine API 18kg of gemcitabine API has already been producd for initial sales. Larger scale mass production and marketing will begin in Taiwan in 2009. Following this, plans are for international sales for gemcitabine API to begin in Southeast Asia and South America in late 2009. DMF (Drug Master File) for gemcitabine API in the US in March and in Europe is scheduled for June 2009. Large scale production (200-300kg) of gemcitabine API will be begin in 2009. In addition, the company is also in discussion with contracted distributors for the marketing of the product in Japan. b. Inject able GamFlor® GemFlor®, a formulated dosage form of gemcitabine injection produced by PharmaEssentia, received a product license from Taiwan's Ministry of Health in July 2006, and is in process for receiving an export permit. Negotiation is currently underway with potential contract manufacturing organizations and marketing distributors, with GemFlor® scheduled to be launched in Taiwan in 2009, with concurrent submission for a drug covered by Taiwan's National Health Insurance. Copyright © 2008 PharmaEssentia Corporation All Rights Reserved.