Comments: I know LGND is big in SERMs. Henry?
Axys Pharmaceuticals and Signal Pharmaceuticals Enter Collaboration to Develop and Market Small Molecule Anti-Cancer Compounds
SOUTH SAN FRANCISCO, Calif., and SAN DIEGO--(BW HealthWire)-- Oct. 28, 1999--
Agreement Based on Signal's beta-Selective Estrogen
Receptor Modulators (SERMs)
Axys Pharmaceuticals, Inc. (Nasdaq:AXPH) and privately held Signal Pharmaceuticals, Inc. announced today that Signal has granted to Axys exclusive, worldwide development and marketing rights to Signal's selective estrogen receptor-beta modulators (SERM-beta) for the treatment of cancer.
The SERM-beta compounds licensed from Signal under this agreement are novel small molecules that modulate the activity of the beta subtype of the estrogen receptor (ER-beta) found on breast, uterine and a number of other cancer cells. The closely related alpha subtype of the estrogen receptor (ER-alpha) is the target of two widely prescribed drugs, tamoxifen and raloxifene for treatment of cancer and osteoporosis respectively.
The exclusive worldwide license granted to Axys provides access to all of Signal's SERM-beta drug discovery technology and ER-beta selective compounds as used for the treatment or prevention of cancer. Signal will retain rights for all indications outside of oncology under the terms of the collaborative agreement. Axys will provide payments to Signal in the form of a license fee, research funding, research milestones and royalties. Signal may exercise a profit share option in the United States at a predetermined point during development in lieu of royalties on product sales. If exercised, Signal will share equally in the profits in the United States on product sales by Axys by paying an equal share of the remaining development and commercialization costs in the U.S. Other terms of the agreement were not disclosed.
"Axys' collaboration with Signal is a key accomplishment of our program to identify promising, early-stage products with unique advantages in the treatment of cancer," stated John Walker, chairman and chief executive officer of Axys. "Signal's ER-beta program has successfully generated potent drug candidates poised to enter in vivo testing utilizing Axys' proven preclinical capabilities in chemistry, pharmacology, pharmacokinetics and safety assessment."
Walker added, "We are very pleased with the agreement with Signal, our first in-licensed program in oncology. As we stated at the first of the year, we are clearly focused on developing and expanding our pipeline in oncology through internal programs as well as new collaborations that will enhance our portfolio with promising new therapeutics."
"Our arrangement with Axys will allow us to leverage our extensive drug discovery capability in the SERM field while enabling us to pursue several other important clinical indications outside of oncology," commented Alan Lewis Ph.D., President and CEO of Signal. "Through our collaboration, we will be able to expand the SERM-beta project's chemistry, preclinical and clinical development resources to build added value in our own product pipeline focused on oncology and infectious diseases."
Signal will commit resources in the areas of basic biology and chemistry to the collaboration, while Axys will commit resources in chemistry, lead optimization, preclinical biology and development, and clinical and regulatory development. Signal will continue to perform research and development on SERMs of the beta subtype of the estrogen receptor for indications outside of oncology.
SERMs Technology Platform
The female sex hormone, estrogen, is implicated in various diseases such as breast and uterine cancer, osteoporosis and cardiovascular disease. Both tamoxifen and raloxifene are modulators of the alpha subtype of the estrogen receptor. Tamoxifen is approved in the United States for the treatment and prevention of breast cancer in women. Raloxifene, approved in the U.S. for osteoporosis, is being tested clinically for prevention of breast cancer.
The ER-beta subtype represents an important new target for the treatment of cancer, providing the opportunity to develop selective compounds for the treatment of estrogen-related diseases. The ideal SERM would have anti-estrogen effects in the breast and uterus, but normal hormonal effects in the bone and lipid metabolism. In addition, while tamoxifen represents the established treatment for estrogen sensitive breast cancer, a significant number of breast cancer patients become resistant to this drug after prolonged use. Tamoxifen-resistant tumors in breast cancer will provide one focus for the collaborative R&D program.
Axys Pharmaceuticals is a drug discovery and development company with a proprietary focus in oncology. Axys is building shareholder value through (1) a broad and diversified pipeline of research and development programs partnered with world-class pharmaceutical companies; (2) expansion of a non-partnered research and development franchise in oncology; and (3) the spin out of affiliated businesses that leverage the company's technologies in order to provide capital for Axys' drug discovery and development programs. Axys' technology-leveraging businesses are: Axys Advanced Technologies, a combinatorial chemistry oriented business; PPGx, a majority owned pharmacogenomics company, and Akkadix, an agricultural biotechnology company.
Signal Pharmaceuticals is an integrated target and drug discovery company focused on identifying new classes of small molecule drugs that regulate genes and the production of disease-causing proteins. The Company applies advanced cellular, molecular and genomic technologies to map gene-regulating pathways in cells and to identify proprietary molecular targets that activate or deactivate genes and result in disease. Signal is advancing the application of genomics beyond identifying and elucidating the functions of genes to designing novel classes of disease-modifying drugs that selectively regulate the activation of disease causing genes. The Company conducts its target and drug discovery programs both independently and with several pharmaceutical partners.
Except for the historical information contained herein, this press release contains forward-looking statements that involve risks and uncertainties which could cause Axys' actual results to differ materially from those discussed here, including the reliance on the efforts of collaborative partners, the risk that this or other Axys collaborations will not be successful, the risk that clinical trials will not proceed as anticipated or may not be successful, the risks inherent in early stage development, the risk that Axys will not be successful in entering into new collaborations, competition and marketing risk, the risk of unexpected difficulties and delays in the development of new technologies and in expanding its manufacturing capabilities, and general economic conditions that may affect Axys' actual results and developments. Additional factors that could cause or contribute to such differences include, but are not limited to, those discussed in the sections entitled "What Factors Could Cause Our Results to Differ Significantly from Those You Might Expect?" and "Additional Risk Factors" in the Axys' SEC Reports, including Axys' report on Form 10-K for the fiscal year ended December 31, 1998.
For more information on Axys Pharmaceuticals, Inc., please visit the company's website at axyspharm.com.
For more information on Signal Pharmaceuticals, Inc., please visit the company's website at electriciti.com.
CONTACT:
Axys Pharmaceuticals, Inc.
John Walker or Kathleen Stafford, 650/829-1000
or
Signal Pharmaceuticals, Inc.
Alan J. Lewis, Ph.D. or Douglas E. Richards,
858/558-7500 |
