Thursday March 15, 8:21 am Eastern Time
Press Release
SOURCE: Neurogen Corporation
Neurogen Announces Pfizer's Initiation of Phase II
Studies of Alzheimer's Disease Drug Candidate
Candidate Uses Novel Mechanism to Treat Alzheimer's Disease
BRANFORD, Conn., March 15 /PRNewswire/ -- Neurogen Corporation (Nasdaq: NRGN
- news), a leading small molecule drug discovery and development company, today
announced that its research collaboration with Pfizer has successfully resulted in the initiation
of a Phase II efficacy study of NGD 97-1, Neurogen's lead drug candidate to treat
Alzheimer's disease.
``Working through a different mechanism than currently available drugs, NGD 97-1 has
demonstrated an ability to improve memory in normal as well as memory-impaired animals,''
commented James V. Cassella, Ph.D., Neurogen's Vice President - Clinical Research and
Development. ``We believe that NGD 97-1 could be the first of a new class of drugs to treat
Alzheimer's disease.''
The Phase II study of NGD 97-1 is being conducted by Pfizer in multiple centers in the U.S.
and follows recently completed Phase I human clinical studies that have demonstrated NGD
97-1 to be safe and well tolerated across a broad dose range. Approximately 200 patients
suffering from Alzheimer's disease will be enrolled in the placebo and active-controlled,
double-blinded study. Patients will be randomly separated into groups that receive a three-
month dosing regimen of either placebo, a currently marketed drug used to treat Alzheimer's
disease, or one of three doses of NGD 97-1. The study will seek to demonstrate a
therapeutic effect on memory.
Neurogen's Expertise in the GABA Memory Pathway
NGD 97-1 exerts its effects through precise modulation of the GABA (gamma- aminobutyric
acid) neurotransmitter system. GABA is the major inhibitory neurotransmitter in the brain,
and a number of existing drugs, including Valium®, Versed® and Ambien®, work through
the GABA system to relieve anxiety, to impair memory in connection with surgical
operations, and to treat insomnia. Neurogen research over the last decade has enabled the company to design drug candidates
which act on the GABA system far more specifically than currently marketed drugs and are designed to produce desirable
therapeutic memory effects without side effects.
Also in partnership with Pfizer, Neurogen is applying its GABA expertise to develop drugs to treat anxiety and insomnia.
Neurogen recently announced that NGD 91-3, another Neurogen drug candidate, is being tested by Pfizer in Phase II studies
as a treatment for patients suffering from generalized anxiety disorder.
The Alzheimer's Disease Market
Alzheimer's disease is a progressive degenerative disease of the brain resulting in loss of brain function and dementia. According
to the Alzheimer's Association, Alzheimer's disease affects approximately 4 million Americans, and the numbers are expected
to grow as the population ages. Existing therapies used to treat memory impairment associated with Alzheimer's disease work
through the acetylcholine neurotransmitter system.
Harry Penner, Neurogen's President and CEO, will host a conference call to discuss the advancement of NGD 97-1 into Phase
II clinical trials at 10 a.m. EST on March 15, 2001. The call will be broadcast live via the internet at www.neurogen.com
(http://www.neurogen.com) in the Replays and Reprints section, and will be archived on the website for at least one week
following the call. A replay of the call will also be accessible by telephone after 1 p.m. EST, available through midnight, March
21, 2001. To replay the call, dial 719-457-0820, both in the US and internationally, using the passcode 481888.
About Neurogen
Neurogen is a leader in both the discovery and development of new drug candidates to treat large market psychiatric,
metabolic and inflammatory disorders, and in the development and integration of new drug discovery technologies with its
AIDD(TM) (Accelerated Intelligent Drug Discovery) program. Neurogen has generated a growing portfolio of compelling new
drug programs that promise improved efficacy and reduced side effects. Through strategic collaborations with world-class
pharmaceutical companies, Neurogen combines its ability to generate multiple drug candidates with the proven drug
development and marketing expertise of its partners. These collaborations help to finance the company's operations and hold
the promise of valuable royalties and profit sharing upon the commercialization of Neurogen's products.
The information in this press release contains certain forward-looking statements that involve risks and uncertainties as detailed
from time to time in Neurogen's SEC filings, including its most recent 10-K. Actual results may differ materially from the
statements made as a result of various factors, including, but not limited to, risks associated with the inherent uncertainty of
Company research, difficulties or delays in development, testing, regulatory approval, production and marketing of any of the
Company's drug candidates, adverse side effects or inadequate therapeutic efficacy of the Company's drug candidates,
advancement of competitive products, dependence on corporate partners, sufficiency of cash to fund the Company's planned
operations and patent, product liability and third party reimbursement risks associated with the pharmaceutical industry.
SOURCE: Neurogen Corporation |
