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Company
Fabre-Kramer Pharmaceuticals, Inc. (“FKP”
or the “Company”), was formed to identify, develop
and commercialize psychotropic drugs with significant market
potential. Louis Fabre, M.D., Ph.D., Chairman of the Board of
FKP, has over 30 years of experience in the clinical development
of new psychotropic drugs and has conducted pivotal studies of
most drugs approved by the FDA in psychiatry, including Prozac,
Zoloft, Paxil, Effexor, Celexa, Seroquel, Zyprexa, and Abilify.
Dr. Fabre has also been involved in clinical studies of numerous
anxiolytic drugs, including BuSpar, and studies of drugs used
to treat other psychiatric illnesses, including bipolar disorder,
social phobia and sleep disorders. Stephen Kramer, M.D., Chief
Executive Officer and President of FKP, has over 30 years experience
in inpatient and outpatient psychiatry. Both doctors have intimate
knowledge of the treatment of Central Nervous System (“CNS”)
disorders and have analyzed many other potential psychotropic
compounds from the standpoint of receptor activity, efficacy,
tolerability, side effect/benefit ratio, formulation, ease of
administration, cost, and ease of manufacturing.
The Company’s lead drug is Gepirone, a compound developed
to treat depression and other related illnesses. The Company re-acquired Gepirone from its
previous development partner (Organon), conducted a successful
Phase III program, and recently filed an amendment to the NDA
in May 2007. Worldwide commercialization rights were licensed
to GlaxoSmithKline (www.gsk.com) in early 2007. Gepirone extended
release (ER) is a 5HT1A partial agonist. Antidepressant effects
are believed to be due to an agonist effect on post synaptic
serotonin receptors. In November 2007, the FDA issued a non-approved letter for major depressive disorders. FKP is currently assessing further development opportunities for Gepirone for other indications.
In addition to Gepirone, FKP has continued
to pursue opportunities to acquire and develop additional psychotropic
drugs that it believes have significant market potential. The
Company is in an excellent position to identify
and acquire additional promising psychotropic drugs that, for
a variety of reasons, are available from major pharmaceutical
companies and other industry and academic sources. The compounds discussed in our Products section represent FKP's
present pipeline.
In contrast to most pharmaceutical or biotechnology companies,
FKP has lower overhead costs and has completed the development
of a major new drug (Gepirone) with an extremely efficient use
of capital. Additional drugs are also being developed on FKP’s
more efficient outsourced structure and accelerated timelines.
FKP can economically and efficiently further develop these products,
and then outlicense them for the completion of development and
marketing. FKP has developed this pipeline of pharmaceutical
products at costs far below those of major pharmaceutical companies;
and expects to be an attractive acquisition candidate to companies
seeking a major presence in the CNS therapy area. Additionally,
as a multi-product company with an attractive pipeline of product
opportunities, the Company will consider outlicensing individual
compounds or groups of compounds, as well as raising additional
capital from institutional investors to further develop the compounds.
FKP was formed in 1992, and has been funded
to date largely by the capital of its founders. A small group
of private individuals own approximately 5% of the Company. There
are no institutional or venture capital shareholders. Milestone
payments and products sales under licensing agreements have provided
additional funding.
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