Newswise — One of the Southwest Foundation for Biomedical Research's longest running departments is being spun off as a private, for-profit business enterprise based on the massive body of work the department has accumulated in female reproductive and related health issues.
SFBR president John Kerr, who first envisioned the concept, said the new company, Evestra Inc., is receiving all of the assets, personnel, and scientific know-how of the Foundation's Organic Chemistry Department, an internationally recognized research group in steroid chemistry, together with start-up funding from SFBR. In addition to funding provided by SFBR, which will initially be the majority shareholder of the new company, Evestra is raising a first round of financing primarily from San Antonio-area investors.
Evestra is being built on the department's 30-plus years' experience in the discovery and synthesis of novel steroid compounds used in a wide range of female healthcare applications, including contraception, gynecological diseases, hormone replacement therapy, and hormone-dependent breast cancer.
Dr. P.N. Rao, the distinguished chair of the department, is teaming with Dr. Ze'evShaked, the former chief operating officer and head of R&D at ILEX Oncology, who will serve as president and CEO of Evestra, and with Dr. Klaus Nickisch, the former senior vice president of Schering AG in Germany, who will serve as Evestra's chief scientific officer. Both Drs. Shaked and Nickisch hold Ph.D.s in Organic Chemistry.
By combining SFBR's steroid synthesis capabilities with the extensive drug development track record of Evestra's management, Evestra is commercializing a pipeline of products in fertility control, hormone replacement therapy, and oncology.
"Over the past 50 years at SFBR, Dr. P.N. Rao has been one of the world's foremost experts on steroid chemistry and women's fertility and cancer," said Kerr. Dr. Rao, who became chairman of the Organic Chemistry Department in 1977, later was given the Foundation's highest honor, being named "Senior Scientist" and receiving from the Board of Trustees the Maltese Cross, symbolic of intellectual acuity. "The lifetime body of work he has created and the incredible breadth and depth of his knowledge are invaluable assets to Evestra," Kerr added.
"Dr. Rao and his team's superb record in designing and synthesizing novel steroids has been recognized by the National Institutes of Health and by his peers around the world," said Dr. Shaked. "So the spin-off of his department into Evestra, especially when combined with the experience of the management team that's in place, creates a truly exciting opportunity."
Dr. Shaked said the company has the scientific know-how, the leadership, and the experience in the steroid world that are needed to "hit the ground running. That allows us immediately to execute our business plan based on the development and commercialization of steroid-based pharmaceuticals, giving Evestra great potential for success. And as Evestra becomes successful, that will benefit SFBR, as well as the San Antonio community."
THE PIPELINE
Evestra is pursuing a capital-efficient short-term and long-term drug development strategy. The short-term strategy is based on the reformulation of existing, approved steroid-based pharmaceutical products. The long-term strategy involves the in-house development of novel steroidal drugs based on the expertise of its organic chemistry team.
The leading drug candidate, a reformulated oral contraceptive, involves seeking an accelerated approval from the FDA. Four additional drug development candidates support the company's strategy of having "multiple shots on goal" " like a soccer team shooting at the goal five times instead of just once " to increase the odds of success.
In addition to the leading candidate, the Evestra team also is working on:"¢ Developing novel progestin drugs for fertility control"¢ The reformulation of a hormone replacement therapy with a superior safety profile"¢ Finding a new drug candidate for endometriosis and fibroids"¢ Developing new drugs to prevent the recurrence of breast cancer
Along with its primary focus of developing a solid pipeline of pharmaceutical products, Evestra will generate revenue from the synthesis of steroids for the National Institutes of Health pursuant to a contract SFBR has had for over 30 years, which is being transferred to Evestra.
THE TEAM
SFBR has assembled a leadership powerhouse to ensure the success of this new venture. Evestra will benefit from the great depth of scientific and corporate expertise of its management and board, including:
"¢ Ze'ev Shaked, Ph.D. " President and CEO. Before founding Evestra, Dr. Shaked was chief operating officer of ILEX Oncology and president of ILEX Products Inc. and held a number of senior R&D and management positions with other pharmaceutical companies, including Spherics Inc., ImmuLogic Pharmaceutical Corp., Berlex Biosciences Inc., Triton Biosciences Inc., CODON Corp. and Chiron Corp. He has extensive experience in the development of biologics and conventional drugs.
"¢ Klaus Nickisch, Ph.D. " Chief Scientific Officer and Managing Director, Evestra-Germany. Dr. Nickisch spent over 28 years with Schering, AG, one of the leading international pharmaceutical companies, in a wide range of positions before the recent merger of Schering with Bayer. Beginning as a medicinal chemist, Dr. Nickisch moved from research to product development and project management, leading a number of major programs in oncology and female healthcare and finally serving as senior vice president and head of global project management.
"¢ P.N. Rao, Ph.D. " Senior Vice President of Research. Dr. Rao joined SFBR 50 years ago and has served as chair of its Organic Chemistry Department since 1977. He holds 17 patents in steroid hormone synthesis and the immunoassay methodologies that have had a marked impact on physicians' abilities to diagnose and effectively treat reproductive disorders and various forms of cancer. He and his research team also have made significant contributions in the development of novel steroid hormones that inhibit the action of progesterone, which plays a major role in breast and ovarian cancer and endometriosis. Proellexâ„¢, a drug his team developed at SFBR in collaboration with the NIH and licensed to a Houston-based company, Repros, is currently undergoing late-stage human clinical trials and showing great promise in treating endometriosis and shrinking fibroid tumors without surgery. Other steroid compounds synthesized and patented by Dr. Rao have shown significant anti-cancer activity by interfering with the blood supply to the tumor, with potential application to the treatment of breast and prostate cancer.
The Evestra Board of Directors consists of Kerr, J.R. Hurd (chairman of the SFBR Board of Trustees), Dr. Shaked and Dr. Nickisch.
Evestra also boasts an impressive Scientific Advisory Board. Chaired by Dr. Nickisch, its other members include Dr. Rao and a team of experts from the United States and abroad:"¢ Walter Elger, M.D. " Former head of Female Health Research, Schering AG and Jenapharm"¢ Irving Spitz, M.D., Ph.D. " Director of the Institute of Hormone Research in Jerusalem, emeritus professor of endocrinology at Ben Gurion University in Israel, and adjunct professor of medicine at Weill Medical College of Cornell University"¢ Werner Raff, M.D. " Former head of Female Health SBU, Schering AG"¢ James W. McGinity, Ph.D. " Professor and division head of Pharmaceutics, College of Pharmacy, University of Texas at Austin"¢ Robert Shenken, M.D. " University of Texas Health Science Center at San Antonio, chair of the Department of Clinical Gynecology
"One rarely sees a new company being formed with such an impressive scientific and management team," said Kerr. "Truly, each of these men is world class in his own right. Their coming together for this new venture presents us with a tremendous opportunity to build a company that will be an industry leader in the area of women's health and cancertreatment."
Kerr continued, "That's exciting for San Antonio, and it's exciting for the Foundation. The spin-off of Evestra advances our mission to improve human health through innovative biomedical research, and it could ultimately be of tremendous financial importance to SFBR, its largest stockholder, as the value of its holdings increases."
Looking back on his 50 years' work and forward to the future of Evestra, Dr. Rao said: "It's gratifying to see the potential of the work we've done in reproductive health. By commercializing this work, we may be able to improve the lives of people in all parts of the world and at the same time produce a financial dividend for SFBR that will support this great institution's research for many years to come. I'm honored to be a part of it."
Southwest Foundation for Biomedical Research is one of the leading independent biomedical research institutions in the United States, dedicated to advancing human health through innovative biomedical research. It is recognized within scientific and academic communities worldwide for the quality of its basic research into the nature, causes, preventions, and treatments for disease. SFBR's staff of more than 85 doctoral-level scientists conducts nearly 200 major research projects, with marked success in the areas of genetics, neonatal development, metabolic disorders and infectious diseases.
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