Neurobiological Technologies' Partner, Celtic Pharma, Provides Update on Xerecept Clinical Program and Planned Sale in 2009
EMERYVILLE, Calif., Dec. 16 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. (NTI(R)) today announced that Celtic Pharmaceutical Holdings L.P. (Celtic) has provided an update on XERECEPT(R).
NTI sold the worldwide rights and assets related to XERECEPT to Celtic in November 2005. NTI is entitled to receive milestone payments upon the achievement of certain regulatory approvals, and if XERECEPT is approved for commercial sale, NTI is also entitled to receive profit-sharing payments on sales in the United States and royalties on sales elsewhere in the world.
"We are very pleased at the effort Celtic has applied to this project, bringing it to the point of producing, understanding and presenting solid clinical data to the medical community while simultaneously undertaking a preclinical program to expand the future potential applications of XERECEPT," said Paul E. Freiman, president and chief executive officer. "Further, our partnership has flourished on a personal basis and we both feel each party has added value to the collaboration."
The text of the press release from Celtic is as follows: "Celtic Pharma Announces Update on Status of XERECEPT(R) Program Sale Planned in 2009" "New York, London and Bermuda, December 16, 2008, 2008 - Celtic Pharmaceutical Holdings L.P. ("Celtic Pharma")announced today that the databases have been locked and preliminary analyses completed on the two double-blinded studies of XERECEPT(R) (corticorelin acetate), as a treatment for peritumoral brain edema, as well as an initial database lock on the open-label study of XERECEPT's long-term safety and efficacy. "The results of these studies are the subject of several abstract submissions for the American Society of Clinical Oncology (ASCO) annual meeting in May 2009, as well as the American Association of Cancer Research annual meeting (AACR) in April 2009. In conformance with the requirements of both ASCO and AACR, XERECEPT(R) data will be published only after presentation at these meetings. "Celtic Pharma has also retained a top-tier investment bank to serve as its financial advisor in the planned sale in 2009 of Neutron Holdings Limited and its geographical subsidiaries who are the owners of the worldwide commercial rights to XERECEPT(R). "We believe that the trial data we now have in hand indicate the efficacy and long term safety of Xerecept as a treatment for cerebral edema associated with primary and metastatic brain tumors, permitting substantial reductions or elimination of cortico-steroid dosing in this patient population, and that Xerecept has the potential to become part of the generally accepted standard of care for these patients." said Stephen Evans-Freke, Managing General Partner of Celtic Pharma. "We believe we have built substantial value in Xerecept(R) and we look forward to achieving superior returns for our investors through the sale of this important program in 2009." said John Mayo, co-Managing General Partner of Celtic Pharma. "About Celtic Pharmaceutical Holdings L.P. Celtic Pharmaceutical Holdings L.P. (Celtic Pharma) is a global private equity investment firm focused on the biotechnology and pharmaceutical industries. Celtic Pharma was founded by Stephen Evans-Freke and John Mayo, CBE and is based in Bermuda, with offices in New York and London. Celtic Pharma acquires and invests in late stage pharmaceutical programs and manages these programs through their development to regulatory approval. Celtic Pharma's aim is to bridge the gap between the established pharmaceutical companies' new product pipeline crisis and the biotech industry's capital drought. "Forward-Looking Statements Certain statements in this press release are not historical facts, including statements that are preceded by, or followed by, or that include words such as "may," "expect," "anticipate," "believe," or "plan," or similar statements, are forward-looking statements that involve risks and uncertainties, including risks relating to the results of the clinical trials for XERECEPT(R) and the ability of Celtic Pharma or Neurobiological Technologies, Inc. ("NTI") to obtain regulatory approval for XERECEPT(R), as well as other risks detailed from time to time in NTI's Securities and Exchange Commission filings. Copies of these filings are available from NTI upon request. Actual results may differ materially from those projected. These forward-looking statements represent our judgment as of the date of release. We disclaim, however, any intent to update these forward looking statements."
About Neurobiological Technologies, Inc.
Neurobiological Technologies, Inc., is a biopharmaceutical company focused on developing novel, first-in-class agents for central nervous system conditions and other serious unmet medical needs. The Company's most advanced product candidate, Viprinex(TM) (ancrod), is in Phase 3 clinical testing as a novel investigational drug for the treatment of acute ischemic stroke. Viprinex has multiple mechanisms of action and is specifically designed to extend the time period that patients can be treated after the onset of a stroke. Acute ischemic stroke is one of the most prevalent, debilitating and costly diseases in the world for which there are few acceptable treatment options. NTI also has early-stage development programs for Alzheimer's and Huntington's diseases and rights to receive payments on an approved drug for Alzheimer's disease and an investigational drug in Phase 3 trials for brain swelling.
NOTE: Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties, including uncertainties regarding the development and/or sale of XERECEPT(R) by Celtic, the development of Viprinex for acute ischemic stroke by NTI, delays or other problems with our clinical trials, the outcome of the Viprinex interim analysis, the time and costs for obtaining approval for drugs under development, including Viprinex and XERECEPT(R), and levels of future expenditures and capital resources needed to fund operations, as well as other risks detailed from time to time in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K, as updated periodically in Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Actual results may differ materially from those projected. These forward-looking statements represent our judgment as of the date of the release and we undertake no obligation to update these forward-looking statements.
Posted: December 2008