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GlaxoSmithKline and Vitae Pharmaceuticals Establish Strategic Alliance to Develop and Commercialize Novel Hypertension Treatment
Companies to Advance Renin Inhibitors as New Class of Cardiovascular Drugs
LONDON and FORT WASHINGTON, Pa., June 20 /PRNewswire-FirstCall/ --
GlaxoSmithKline (GSK) (NYSE: GSK) and Vitae Pharmaceuticals Inc. announced
today that they have formed an exclusive worldwide strategic alliance to
develop and commercialize novel drug compounds for the treatment of
hypertension and related cardiovascular disorders.
Vitae will receive an upfront payment from GSK which is comprised of both
cash and an equity investment in Vitae. Vitae will also receive committed
funding to support research activities conducted by Vitae and further payments
upon the achievement of research, development and regulatory milestones.
Aggregate payments to Vitae during pre-commercial activities for the lead
product would be $175 million. GSK will pay Vitae royalties on the sale of
all products upon commercialization. In addition, Vitae retains the right to
co-promote any product in the US resulting from this alliance. The agreement
will become effective upon the completion of customary closing conditions and
regulatory approvals, including Hart-Scott-Rodino clearance.
Vitae has created multiple, novel chemical series of renin inhibitors
which are very potent and highly orally bioavailable using its proprietary
drug discovery engine, Contour(TM). These series have progressed from
discovery to achievement of animal model proof of concept in less than 12
months. Under the alliance, the parties will pool their respective renin
programs and collaborate to identify and select compounds for clinical
development. GSK will then lead and fund development and commercialization of
renin inhibitors.
"This alliance enables GSK to capitalize on Vitae's research and discovery
efforts in the area of renin inhibition and continue to build on GSK's
capabilities and commitment to cardiovascular disease," said Dr. Eliot
Ohlstein, Senior Vice President, Cardiovascular and Urogenital Centre of
Excellence for Drug Discovery, GlaxoSmithKline. "We are enthusiastic about
the potential of renin inhibitors to offer a new approach for the growing
number of patients impacted by this disease."
"GSK, a world-class global pharmaceutical partner, will provide Vitae with
significant resources and the expertise needed to successfully develop and
commercialize our renin inhibitors," said Jeffrey Hatfield, CEO of Vitae
Pharmaceuticals. "Offering significant potency and oral availability, our
unique renin inhibitor compounds show promise as a breakthrough treatment for
hypertension. We are very excited to work with GSK to create best-in-class
medicines that make a difference and meaningfully improve patient outcomes."
About Hypertension
Hypertension is a common disorder in which blood pressure is abnormally
high, placing undue stress on the heart, blood vessels and other organs such
as the kidney and brain. Hypertension is a major contributing factor to
cardiovascular diseases and death. In North America and Europe it is
estimated that more than one third of the population over the age of 35
suffers from hypertension, including an estimated 70 million people in the US
alone. Consequences of hypertension include heart attack, stroke, renal
disease, aneurysms, retinal vascular damage, left ventricular hypertrophy and
failure, and cerebrovascular disease.
About Renin Inhibition
Renin plays an important role in the regulation of blood pressure. Renin
is an enzyme secreted by the kidney in response to a decrease in blood
pressure and circulating blood volume. Within the bloodstream, renin
initiates a series of reactions in the renin-angiotensin pathway to induce
vascular constriction and increase vascular resistance, correspondingly
increasing blood pressure. Suppression of the renin-angiotensin system (RAS)
using drug therapies has been shown to reduce blood pressure and associated
cardiovascular events.
Renin inhibitors offer a novel approach because they act further upstream
in the renin-angiotensin pathway than currently available treatments. Renin
inhibitors work through a mechanism of action that simultaneously inhibits
renin and reduces plasma renin activity (PRA), in contrast to other therapies
which act on the RAS but result in increased PRA which is believed to be
harmful to end organs, such as the heart, kidney and brain.
About Vitae Pharmaceuticals
Vitae Pharmaceuticals is an emerging pharmaceutical company dedicated to
the discovery and development of innovative drugs by advancing its pipeline of
product candidates. Vitae is uniquely able to discover innovative compounds
by accelerating and enhancing the drug discovery skills and experience of
proven drug hunters with world-class, proprietary drug design technologies
developed in collaboration with Intel Corporation. Vitae Pharmaceuticals is
financed by leading corporate and venture capital investors and is
headquartered in Fort Washington, Pennsylvania. For additional information,
please visit the company's website, http://www.vitaepharma.com.
About GlaxoSmithKline
GlaxoSmithKline, one of the world's leading research-based pharmaceutical
and healthcare companies, is committed to improving the quality of human life
by enabling people to do more, feel better and live longer. For more
information, please visit the company's web site at http://www.gsk.com.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the US Private Securities Litigation
Reform Act of 1995, the company cautions investors that any forward-looking
statements or projections made by the company, including those made in this
Announcement, are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Factors that may affect
the Group's operations are described under 'Risk Factors' in the Operating and
Financial Review and Prospects in the company's Annual Report on Form 20-F for
2004.
SOURCE GlaxoSmithKline
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