Neurobiological Technologies' Partner, Celtic Pharma, Provides Update on XERECEPT(R) Clinical Program and Planned Sale in 2009
16 Diciembre 2008 - 7:00AM
PR Newswire (US)
EMERYVILLE, Calif., Dec. 16 /PRNewswire-FirstCall/ --
Neurobiological Technologies, Inc. (NASDAQ:NTII) (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 - 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. For further
information, please visit Celtic Pharma's website at
http://www.celticpharma.com/. "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. (NASDAQ:NTII)
("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., (NASDAQ:NTII) 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. DATASOURCE:
Neurobiological Technologies, Inc. CONTACT: Matthew M. Loar, CFO of
Neurobiological Technologies, Inc., +1-510-595-6000 Web site:
http://www.ntii.com/
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