Neurobiological Technologies Acquires Empire Pharmaceuticals, Further Expanding Pipeline With Late-Stage Stroke Compound Viprine
July 15 2004 - 8:30AM
PR Newswire (US)
Neurobiological Technologies Acquires Empire Pharmaceuticals,
Further Expanding Pipeline With Late-Stage Stroke Compound
Viprinex(TM) - Unique Viper Venom-Derived Viprinex(TM) (Ancrod)
Demonstrated Promising Results in Phase III Clinical Studies in
Stroke; Treatment Evaluated in More Than 2,000 Patients to Date -
RICHMOND, Calif., July 15 /PRNewswire-FirstCall/ -- Neurobiological
Technologies, Inc. (NTI(R)) (NASDAQ:NTII) today announced that it
has acquired Empire Pharmaceuticals, Inc., a privately held
company, in a stock and cash transaction valued at up to
approximately $22.8 million. As part of the transaction, NTI has
acquired the exclusive worldwide rights to Viprinex(TM) (ancrod), a
late-stage perfusion therapy for use in the treatment of acute
ischemic stroke, which affects more than 600,000 patients in the
U.S. annually. Under the terms of the agreement, NTI has initially
issued 2,399,168 shares of common stock and paid $2 million to
Empire shareholders. If pivotal Phase III trials for Viprinex(TM)
are commenced as currently planned, NTI will issue an additional
2,375,176 shares and pay an additional $2 million. "We are
delighted with the opportunity to obtain such a promising
late-stage product as Viprinex(TM), along with the team at Empire
that has been developing the compound, and believe this product may
represent a significant and much needed advancement in the field of
stroke treatment," said Paul Freiman, president and chief executive
officer of NTI. "Last March, we raised $19.4 million to expand our
pipeline with later-stage products that have ripe strategic
options. We are pleased to have made what we believe to be an
important step in meeting that objective and gaining an opportunity
to become an important player in the stroke market. Viprinex(TM),
combined with our Xerecept(TM) Phase III program for peritumoral
brain edema, coupled with studies of Namenda(TM) for neuropathic
pain, bolsters our line of potential product candidates and
underscores our commitment to building shareholder value." "We
believe that the combination of NTI and Empire is a great match
that will provide a perfect home for Viprinex(TM)," said Stephen J.
Petti, president and chief executive officer of Empire
Pharmaceuticals. "NTI's impressive management, commercial and
clinical development expertise should enable us to advance the
Viprinex(TM) program to approval and commercialization for the
benefit of stroke victims and their families. I am confident that
we will create a formidable partnership primed for growth, success
and treating patients in need." As part of the agreement, Petti
will join NTI as its vice president of product development.
Merriman Curhan Ford & Co. acted as financial advisors to NTI
in this transaction. About Stroke According to the American Stroke
Association, every 45 seconds someone in the U.S. suffers a stroke
and every three minutes someone dies of one. It is the nation's
third leading cause of death after diseases of the heart and all
forms of cancer and is the leading cause of serious, long-term
disability. A stroke occurs when a blood vessel that carries oxygen
and nutrients to the brain is either blocked (ischemic) by a clot
or ruptures (hemorrhagic). When the tissues are deprived of needed
blood they begin to die, affecting various parts of the body and
causing paralysis, speech, vision and other problems. It is
estimated that less than ten percent of stroke patients are
suitable for current therapies and less than five percent actually
receive treatment. The estimated direct and indirect costs of
stroke in the U.S. in 2004 are estimated to be $53.6 billion. About
Viprinex(TM) Viprinex(TM) has been studied in more than 2,000
patients in various clinical studies in the U.S. and Europe and has
the potential to double the available treatment window following
the onset of stroke symptoms. Currently, the only available therapy
for stroke must be administered within the initial three hours,
significantly limiting the number of patients that may be treated.
One of the primary goals for the treatment of acute ischemic stroke
is improving blood flow through a blocked vessel so that the flow
of oxygen and nutrient supply to brain tissue is not interrupted or
compromised. Brain tissue starved of oxygen can cause loss of
neurological function such as speech and mobility. Fibrinogen, a
protein involved in blood clotting, has been known to contribute to
high blood viscosity, which in turn may impede blood flow to
critical regions of the brain. Thus, an agent that reduces
fibrinogen levels may significantly impact stroke treatment.
Derived from the venom of the Malayan pit viper, Viprinex(TM) is a
thrombin-like enzyme that is highly specific to fibrinogen. When
administered systemically, Viprinex(TM) has been shown to rapidly
deplete plasma fibrinogen (it is a defibrinogenating agent). The
effects are anticoagulation, improved blood viscosity and a
secondary fibrinolytic or clot lysing action. Combined, these
effects constitute a perfusion strategy that appears to restore and
enhance oxygen flow to the affected area of the brain. Studies have
shown that in patients receiving Viprinex(TM) within six hours of
stroke onset, blood viscosity is progressively reduced by 20-30%
from pretreatment levels, resulting in an improvement in blood flow
and microcirculation. After stopping treatment with Viprinex(TM),
viscosity levels have been shown to return to pretreatment levels
very slowly, within about 10 days. A randomized, double-blind,
placebo-controlled U.S. Phase III clinical study was completed in
1998 to evaluate the safety and efficacy of Viprinex(TM) given
within three hours after the onset of acute, ischemic stroke in 500
patients. In this study, Viprinex(TM) was shown to be effective in
preserving neurological function in this patient population. A
separate randomized, double-blind, placebo-controlled Phase III
study was completed in Europe in 2000, enrolling patients within
six hours of onset of acute ischemic stroke. The trial was stopped
after a planned interim analysis indicated lack of efficacy and
increased incidence of intracranial hemorrhage. The higher dosing
levels in the European trial and the use of protocol criteria that
permitted entry of patients at higher risk of hemorrhage are
thought to have contributed to the trial's failure. A retrospective
review of the relative strength of the positive U.S. findings
versus the European findings has suggested the need for a revised
Viprinex(TM) dosing strategy, which will be one objective of
further Phase III study. Empire acquired the exclusive worldwide
rights to Viprinex(TM) in a royalty-bearing license from Abbott
Laboratories in March 2002. The prior development work on
Viprinex(TM) was conducted by Knoll AG, prior to its acquisition by
Abbott in 2001. Conference Call Information A conference call to
discuss the Empire Pharmaceuticals acquisition and Viprinex(TM) has
been scheduled for 11:00 a.m. EDT today. To participate, please
call (800) 289-0485. The call will be webcast at
http://www.shareholder.com/ntii/index.cfm and a moderator-activated
slide presentation during the call may be viewed at the same
location. A replay will be available from 2:00 p.m. ET through
midnight Friday, July 23, by calling (888) 203-1112 (U.S. and
Canada) (719) 457-0820 (International) access code 121273. About
Neurobiological Technologies, Inc. NTI is an emerging drug
development company focused on the clinical evaluation and
regulatory approval of neuroscience drugs. The company's strategy
is to in-license and develop early-and later-stage drug candidates
that target major medical needs and which can be rapidly
commercialized. The company's experienced management team oversees
the human clinical trials necessary to establish preliminary
evidence of efficacy and seeks partnerships with pharmaceutical and
biotechnology companies to complete development and marketing of
its product candidates. Except for the historical information
contained herein, the matters discussed in this press release are
forward-looking statements that involve risks and uncertainties,
including, but not limited to, risks relating to: the company's
ability to successfully develop and meet regulatory requirements
for its product candidates, including Viprinex(TM); design, recruit
patients for and complete clinical trials; outsourcing and
manufacturing of supplies for clinical trials; intellectual
property; the acquisition of companies and new technologies and
other risks detailed from time to time in Securities and Exchange
Commission filings. Actual results may differ materially from those
projected. These forward-looking statements represent management's
judgment as of the date of the release. The company disclaims,
however, any intent or obligation to update these forward-looking
statements. DATASOURCE: Neurobiological Technologies, Inc. CONTACT:
Paul E. Freiman, President & CEO of Neurobiological
Technologies, Inc., +1-510-262-1730; or Roger Pondel or Rob
Whetstone, both of PondelWilkinson Inc., +1-310-279-5980 Web site:
http://www.ntii.com/
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