PALO ALTO, Calif., March 17 -- Pharmagenesis, Inc., a research and development company based in Palo Alto developing anti-cancer therapies, has signed an agreement with Pierre Fabre Medicament (PFM), a European company that has pioneered the use of natural extracts for pharmaceutical and dermatological products, to license PG490-88Na, a patented derivative of a compound from a plant widely used in Chinese medicine. Preclinical studies have shown that using PG490-88Na can significantly inhibit growth of a broad range of human tumor cells.
The license agreement gives PFM worldwide rights to develop, register, manufacture, market and sell PG490-88Na, except in Taiwan, China and Hong Kong. Pharmagenesis may distribute PG490-88Na in those territories through its two joint ventures, PhytoHealth (Taiwan) and Tianjin Hualong (China and Hong Kong).
"Pharmagenesis and PFM share a similar philosophy that traditional Chinese medicine applied to modern science can lead to new discoveries and treatments," said Nicholas Druz, Chairman and CEO, Pharmagenesis. "Together, our companies are collaborating to further therapies for the field of oncology based on Chinese extracts."
Under the terms of the agreement, PFM will cover all related costs associated with development, manufacturing and marketing activities for PG490-88Na. Pharmagenesis currently organizes and monitors Phase I clinical trials in the United States for PG490-88Na, and submits back-up compounds, if necessary. PFM will pay Pharmagenesis an up-front fee, milestone payments and
royalties based on worldwide sales.
In preclinical studies, PG490-88Na reduced tumor growth, or caused marked regression or complete eradication of human colon and prostate tumors implanted into mice. PG490-88Na appeared in those preclinical studies to have direct anti-cancer effects, and to potentiate effects of commonly prescribed chemotherapy drugs such as 5-FU, Camptosar(R) (irinotecan) and Taxol(R) (paclitaxel).
"We have seen encouraging results from the preclinical trials on the use of PG490-88Na for the treatment of cancer," said Dr. Patrick Hurteloup, Director of Oncology, Pierre Fabre Medicament. "We're interested in making this promising anti-cancer therapy made from Chinese herbs available for use with Western medicine techniques."
PG490-88Na will become one of PFM's anti-cancer drugs. PFM currently sells Navelbine(R) (Vinorelbine tartrate) originally extracted from periwinkle as a plant alkaloid. Registered in more than 80 countries, Navelbine is currently available in the United States through GlaxoSmith Kline, one of the world's leading research-based pharmaceutical companies. Pierre Fabre Medicament is developing a second oncology product named Vinflunine for the treatment of ovarian, bladder, lung and breast cancer. Phase III clinical trials will begin in early 2003 after obtaining promising results from Phase II trials.
Pharmagenesis Inc. is a leading developer of pharmaceutical drugs derived from purified plant extracts aimed at both Eastern and Western markets. The company concentrates on the examination of herbs used for more than 4,000 years in traditional Chinese medicine. All drugs are validated by clinical trials, approved by regulatory authorities.
The privately held company develops anti-cancer therapies, treatments for chemotherapy-related bone marrow suppression and drugs to manage transplant rejection. The company plans to begin marketing and distributing PG2, a highly purified extract proven to restore blood cells after chemotherapy destroys bone marrow, in China in Fall 2003. Other Pharmagenesis drugs are currently undergoing clinical trials in Taiwan and the United States.
Pharmagenesis' corporate headquarters and R & D facility, employing cutting-edge Western medical research techniques, are located in Palo Alto, Calif. Pharmagenesis also has operations in Beijing and Taipei.
About Pierre Fabre Medicament
The Pierre Fabre Group, a privately owned French company, is organized into four separates branches: ethical pharmacy (with an emphasis in oncology, central nervous system and cardiovascular), consumer pharmaceuticals, dermo-cosmetics and homeopathy. The company's worldwide sales in 2001 were 1.239 billion euros, with 45 percent of its revenue generated outside France. The company has 8,400 employees worldwide and a presence in more than 130 countries.
The Pierre Fabre Medicament Group, via its Pierre Fabre Oncologie business unit, is a major player in the field of oncology. In 2001, NAVELBINE I.V. sales exceeded 200 million euros generated by Pierre Fabre's subsidiaries and its licensees (GSK, Asta/Baxter, Kyowa-Hakko). This investment in oncology is also illustrated by major efforts in R&D partnerships, such as the licensing agreement with Orphan Medical for Busulfex in 1999, and research agreements signed last year with Celera Genomics and other biotechnology companies.