EpiCept Regains Rights to Azixa from Licensee Myrexis
TARRYTOWN, N.Y.--(BUSINESS WIRE)--Sep 5, 2012 - Regulatory News:
EpiCept Corporation (Nasdaq OMX Stockholm Exchange and OTCQX: EPCT) announced today it has received notice of termination, effective as of August 28, 2012, of its License and Collaboration Agreement with Myrexis, Inc. Among the compounds that had been licensed to Myrexis under the terminated agreement was EpiCept's anti-cancer drug candidate Azixa®.
Azixa® is a vascular disruption agent discovered by EpiCept that has demonstrated potent anti-cancer activity. Azixa® has received orphan drug status in the U.S. for the treatment of glioblastoma multiforme (GBM).
In February 2012, Myrexis suspended development activities of all its preclinical and clinical programs in oncology and autoimmune diseases, and in May 2012 stated that it is focused on the identification, evaluation and acquisition of appropriate commercial-stage assets. Accordingly, Myrexis has elected to terminate its efforts to develop and commercialize any product, including Azixa®, in any major market as such products and markets are defined in the License and Collaboration agreement dated November 19, 2003. As a result of the termination of the agreement, all rights and licenses granted under the agreement by EpiCept to Myrexis have terminated and reverted to EpiCept.
“We are pleased to regain rights to Azixa® following suspension of development efforts by Myrexis last September,” remarked Robert Cook, interim President and CEO of EpiCept. “We will now seek to exploit Azixa®'s potential with prospective partners.”
Azixa® was the subject of a two-arm Phase 2b trial in patients newly diagnosed with GBM initiated in December 2010, but not completed by Myrexis following its decision to suspend development in September 2011.
EpiCept engaged SunTrust Robinson Humphrey in January 2012 to assist in exploring strategic alternatives to maximize the commercial opportunity of AmiKet™ for the treatment of chemotherapy-induced peripheral neuropathy (CIPN) following taxane-based therapy. The engagement is focused on the identification and implementation of a strategy designed to optimize AmiKet™'s value for the Company's stockholders, which includes the evaluation of potential transactions involving the sale of the Company. Azixa® has now been added to the Company's portfolio of products available for partnering or other development.
About EpiCept Corporation
EpiCept is focused on the development and commercialization of pharmaceutical products for the treatment of pain and cancer. The Company's pain portfolio includes AmiKet™, a prescription topical analgesic cream in late-stage clinical development designed to provide effective long-term relief of pain associated with peripheral neuropathies. The Company's product Ceplene®, when used concomitantly with low-dose interleukin-2 (IL-2) is intended as remission maintenance therapy in the treatment of acute myeloid leukemia (AML) for adult patients who are in their first complete remission. The Company sold all of its rights to Ceplene® in Europe and certain Pacific Rim countries and a portion of its remaining Ceplene® inventory to Meda AB. Ceplene® is licensed to MegaPharm Ltd. to market and sell in Israel and EpiCept has retained its rights to Ceplene® in all other countries, including countries in North and South America. The Company has other oncology drug candidates in clinical development that were discovered using in-house technology and have been shown to act as vascular disruption agents in a variety of solid tumors.
This news release and any oral statements made with respect to the information contained in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements which express plans, anticipation, intent, contingency, goals, targets, future development and are otherwise not statements of historical fact. These statements are based on our current expectations and are subject to risks and uncertainties that could cause actual results or developments to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Factors that may cause actual results or developments to differ materially include: the risks associated with the adequacy of our existing cash resources and our ability to continue as a going concern, the risks associated with our ability to continue to meet our obligations under our existing debt agreements, the risk that Azixa® will not receive regulatory approval or achieve significant commercial success, the risk that clinical trials for AmiKet™ or crolibulinTM will not be successful, the risk that AmiKet™ or crolibulinTM will not receive regulatory approval or achieve significant commercial success, the risk that we will not be able to find a partner to help conduct the Phase III trials for AmiKet™ on attractive terms, a timely basis or at all, the risk that Ceplene® will not receive regulatory approval or marketing authorization in the United States or Canada, the risk that Ceplene® will not achieve significant commercial success, the risk that our other product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later-stage clinical trials, the risk that we will not obtain approval to market any of our product candidates, the risks associated with dependence upon key personnel, the risks associated with reliance on collaborative partners and others for further clinical trials, development, manufacturing and commercialization of our product candidates; the cost, delays and uncertainties associated with our scientific research, product development, clinical trials and regulatory approval process; our history of operating losses since our inception; the highly competitive nature of our business; risks associated with litigation; and risks associated with our ability to protect our intellectual property. These factors and other material risks are more fully discussed in our periodic reports, including our reports on Forms 8-K, 10-Q and 10-K and other filings with the U.S. Securities and Exchange Commission. You are urged to carefully review and consider the disclosures found in our filings which are available at www.sec.gov or at www.epicept.com. You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be wrong due to inaccurate assumptions, unknown risks or uncertainties or other risk factors.
*Azixa is a registered trademark of Myrexis, Inc.
Contact: EpiCept Corporation:
Robert W. Cook, (914)-606-3500
Feinstein Kean Healthcare
Greg Kelley, (617)-577-8110
Kim Sutton Golodetz, (212)-838-3777
Bruce Voss, (310)-691-7100
Posted: September 2012