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Vernalis and Biogen Idec to collaborate on research for Parkinson’s disease
Reading,
UK and Cambridge, Mass., USA, June 24th 2004 –
Vernalis plc (LSE: VER, Nasdaq: VNLS) and Biogen Idec (Nasdaq: BIIB) today
announce that they have entered into an agreement to advance research into
Vernalis’ adenosine A2A receptor antagonist program, which targets
Parkinson’s disease and other central nervous system disorders. Under
the agreement, Biogen Idec receives exclusive worldwide rights to develop and
commercialize Vernalis' lead compound, V2006, which recently completed an
initial Phase I clinical study in healthy volunteers.
In addition, Biogen Idec has the right to develop one back-up compound to
V2006 and receives option rights over Vernalis' A2A
antagonist research program. Initially,
the collaboration will focus on completing the Phase I program for V2006, with
the goal to begin Phase II proof of concept studies of V2006 in Parkinson’s
disease patients in 2005. Biogen
Idec will pay Vernalis an initial license fee of $10 million, a series of
further payments if program milestones are met, and royalties on commercial
sales of collaboration products. Biogen Idec will make an immediate investment
of $6 million through subscription for 6,218,487 new Vernalis ordinary shares,
representing 4.19 percent of Vernalis’ enlarged issued share capital, at a
price of 53 pence per share and has committed to purchase an additional $4
million in the event of a future Vernalis financing. Excluding royalties, total
potential payments to Vernalis could exceed $100 million. Biogen Idec will fund
future development under the collaboration, and Vernalis will retain an option
to co-promote collaboration products in the United States. “This
is an important program for Vernalis, and we are delighted to have attracted a
partner of Biogen Idec’s calibre to help us take it forward,” said Simon
Sturge, chief executive officer, Vernalis. “Parkinson’s disease can be a
very difficult and debilitating condition. Today’s announcement is a valuable
endorsement of our A2A program, and fulfills our promise to announce
a strong product collaboration in the second quarter.” James
Mullen, president and chief executive officer of Biogen Idec, added, “We look
forward to applying the expertise we have developed with our neurology franchise
to V2006, a promising product that will bolster our growing small molecule
portfolio. In addition, this
partnership brings us one step closer to our corporate goal to in-license 50
percent of our pipeline by 2010.” Parkinson’s
disease is a progressive movement disorder that affects approximately one
percent of the population over the age of 65, or about 1.5 million people in the
United States. Common symptoms of the disease include stiffening of the muscles,
difficulty in moving, tremors and shaking. Parkinson’s is caused by nerve
degeneration and cell death in the brain, leading to the loss of dopamine, a
neurotransmitter that is involved in the control of voluntary movement. Most
conventional treatments for Parkinson’s disease are based on the replacement
or enhancement of dopamine in the brain. These treatments are generally
effective in the short term, but efficacy tends to diminish over time and the
emergence of side effects increases the level of disability. Vernalis’
adenosine A2A receptor antagonist program is designed to restore the
imbalance of neurotransmitters caused by the loss of dopamine. Enquiries: Vernalis
plc
Simon
Sturge, Chief Executive Officer Tony
Weir, Chief Financial Officer +44
(0)118 977 3133 Brunswick
Group (for analyst, financial media enquiries) Jon
Coles; Wendel Carson +44
(0)20 7404 5959 Biogen
Idec
Amy
Ryan (media contact) +1
617-914-6524 Elizabeth
Woo (investor community contact) +1
617-679-2812 Safe
Harbor/Forward Looking Statements
This
news release contains forward-looking statements regarding the clinical and
therapeutic expectations of Vernalis’ compounds. These statements are based on
the companies’ current beliefs and expectations. They are subject to the risks
inherent in drug development, including the risks that the effects of the
compounds in larger clinical trials may not be as expected or that there may be
safety issues or other problems or delays in clinical trials,
unexpected technical or manufacturing hurdles, or intellectual property
disputes. Drug development involves
a high degree of risk. Only a small
number of research and development programs result in the commercialization of a
product. Success in animal models
or early stage clinical trials does not ensure that later stage or larger scale
clinical trials will be successful.
.
For more detailed information on the risks and uncertainties associated with the
companies’ drug development and other activities, see the periodic reports of
Biogen Idec Inc. and Vernalis plc filed with the Securities and Exchange
Commission. The companies assume no obligation to update any forward-looking
statements, whether as a result of new information, future events or otherwise. NOTES
TO EDITORS Adenosine
A2A receptor antagonists The
use of selective adenosine A2A receptor antagonists helps to restore
the imbalance of neurotransmitters that is caused by the loss of dopamine in
Parkinson’s disease. This may provide a novel approach to treat the symptoms
of Parkinson’s disease and it is hoped that this mechanism of action may also
slow or stop the progression of the disease. In particular, A2A
receptor antagonists may be able to restore function in Parkinson’s disease
patients without inducing side effects such as nausea and dyskinesias
(uncontrolled movements). Laboratory studies also suggest that the adenosine A2A
receptor may be a novel target for the discovery of a new class of
antidepressant drugs. V2006
V2006
(formerly VR 2006) was selected as a development candidate from the Vernalis A2A
antagonist research program in April 2002. Vernalis has recently completed an
initial Phase I single ascending dose study of V2006 in healthy male volunteers.
The results showed that the drug was well tolerated and that exposure increased
with dose. Potentially therapeutic blood levels (based on predictions from
pre-clinical studies) were achieved following the lowest dose tested. The drug
also had a mean plasma half-life that would be consistent with a simple,
once-daily dosing regimen. About
Biogen Idec
Biogen
Idec creates new standards of care in oncology and immunology. As a global
leader in the development, manufacturing, and commercialization of novel
therapies, Biogen Idec transforms scientific discoveries into advances in human
healthcare. For product labeling, press releases and additional information
about the company, please visit www.biogenidec.com.
About
Vernalis
Established
in September 2003 following the merger of British Biotech and Vernalis Group,
Vernalis plc is pursuing a growth strategy based upon successful pipeline
development and further consolidation within the biotechnology sector. Operating
from state-of-the-art R&D facilities in Reading (UK) and in Cambridge (UK),
the company is equipped to undertake the full development of compounds from
discovery through to product registration. In May 2004 Vernalis reacquired the
North American rights to frovatriptan, its first approved product, and the
Company is in the process of selecting a new partner to market this product in
the US and realise the significant potential of frovatriptan in the treatment of
menstrually-associated migraine. For more information, please visit www.vernalis.com. ### |
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