Procter &
Gamble Pharmaceuticals, Inc., a division of The Procter & Gamble Company
(NYSE: PG) and ARYx Therapeutics, a private drug discovery and development
company, today announced a strategic alliance under which P&G will develop
and commercialize ARYx's novel drug, ATI-7505, for the treatment of
gastrointestinal disorders such as gastroesophageal reflux disease (GERD)
and gastroparesis (delayed emptying of the stomach).
GERD affects approximately four to seven percent of the global
population, or approximately 250 to 450 million people worldwide. It can
manifest itself as symptoms such as heartburn and regurgitation. More than
50 percent of all diabetics suffer from gastroparesis, or more than 85
million people worldwide. Gastroparesis can lead to severe symptoms such as
pain, nausea and vomiting, and even malnutrition.
ATI-7505 is an oral, serotonin type 4 (5HT4) agonist that is in Phase 2
development. ATI-7505 has been shown to have prokinetic properties
(increases upper GI motility, which is believed to play a beneficial role
in GI symptom reduction). Based on its mechanism of action, initial studies
show that ATI- 7505 prevents the regurgitation of stomach contents into the
esophagus and accelerates the emptying of the stomach. This action may help
relieve the symptoms of conditions where motility of the gastrointestinal
tract is a problem. A prior 5HT4 agonist, Propulsid(R) (cisapride),
achieved nearly $1 billion in global sales, but was withdrawn from the
market in 2000 due to side effects. ATI-7505 was designed using ARYx
technology to retain the identical mechanism of action, while eliminating
the safety issues. Clinical trial results to date support this target
product profile, but larger studies are required to confirm the drug's
efficacy and safety.
Under terms of the agreement, which remains subject to clearance under
the Hart-Scott-Rodino Improvements Act, ARYx will grant P&G rights to the
worldwide development and commercialization of ATI-7505 in exchange for a
$25 million upfront fee, milestone payments, and royalties on product
sales. In addition, ARYx has an option to co-develop and co-promote
ATI-7505. In total, payments could reach $435 million over the life of the
project, including $250 million that could be earned prior to
commercialization. These payments are contingent upon the successful
completion of specified development, regulatory, and commercialization
goals. ARYx will receive royalties, with the rate escalating upon the
achievement of varying sales targets. No other financial terms of the
agreement were disclosed.
"We're impressed with ARYx's scientific innovation in its novel
approach to make proven therapeutic mechanisms safer by engineering out
specific metabolic and other problems that can cause significant side
effects," said Mark Collar, President, Global Pharmaceuticals & Personal
Health, Procter & Gamble. "The proven capabilities of Procter & Gamble
Pharmaceuticals in prescription healthcare, combined with many years of
deep GI consumer understanding developed through our successes with Asacol,
Prilosec OTC, Pepto-Bismol and Metamucil will, if the drug is approved,
allow us to provide physicians around the world a better treatment option
for millions of people suffering from GI motility disorders."
"P&G's profound understanding of consumer behavior, coupled with its
proven product development skills for prescription pharmaceuticals, makes
them an ideal partner for the continued clinical development and
commercialization of ATI-7505," said Dr. Paul Goddard, chairman and chief
executive officer of ARYx Therapeutics. "P&G's experienced sales force, and
close relationships with gastroenterologists and general practitioners,
also makes this collaboration an excellent strategic fit for ARYx. We are
gratified that P&G shares our passion for improving the safety of drug
therapy which has been the major focus of ARYx since it was founded."
About GERD and gastroparesis
GERD and gastroparesis are common gastrointestinal diseases that, if
untreated, can cause extreme discomfort and medical complications. It is
estimated that 25-40 percent of adults experience heartburn or related
symptoms associated with GERD each year, resulting in four to five percent
of all primary care physician visits.
Gastroparesis is a disorder of the stomach in which contents from the
stomach do not move efficiently into the intestine. The digestive system,
including the stomach, uses muscular contractions to move its contents
along. Gastroparesis results when there is some damage or malfunction to
this process in the stomach, resulting in symptoms ranging from nausea to
severe abdominal pain and consequences such as bacterial infections and
weight loss. Diabetics are particularly susceptible to gastroparesis, which
is estimated to affect over 50 percent of this patient population.
About ARYx Therapeutics
ARYx Therapeutics is a privately-held pharmaceutical research and
development company focused on addressing safety concerns in
well-established and commercially successful existing therapies through
application of its proprietary ARYx RetroMetabolic (ARM)(TM) drug design.
ARYx improves today's drugs, making proven therapies safer. ARYx currently
has three products in clinical trials. For more information, please see the
company's web site at aryx.
About Procter & Gamble (NYSE: PG)
Three billion times a day, P&G brands touch the lives of people around
the world. The company has one of the strongest portfolios of trusted,
quality, leadership brands, including Pampers(R), Tide(R), Ariel(R),
Always(R), Whisper(R), Pantene(R), Mach3(R), Bounty(R), Dawn(R),
Pringles(R), Folgers(R), Charmin(R), Downy(R), Lenor(R), Iams(R), Crest(R),
Oral-B(R), Actonel(R), Duracell(R), Olay(R), Head & Shoulders(R), Wella,
Gillette(R), and Braun. The P&G community consists of almost 140,000
employees working in over 80 countries worldwide. Please visit
pg for the latest news and in-depth information about P&G
and its brands.
Procter & Gamble Forward Looking Statements
All statements, other than statements of historical fact included in
this release, are forward-looking statements, as that term is defined in
the Private Securities Litigation Reform Act of 1995. In addition to the
risks and uncertainties noted in this release, there are certain factors
that could cause actual results to differ materially from those anticipated
by some of the statements made. These include: (1) the ability to achieve
business plans, including with respect to lower income consumers and
growing existing sales and volume profitably despite high levels of
competitive activity, especially with respect to the product categories and
geographical markets (including developing markets) in which the Company
has chosen to focus; (2) the ability to successfully execute, manage and
integrate key acquisitions and mergers, including (i) the Domination and
Profit Transfer Agreement with Wella, and (ii) the Company's merger with
The Gillette Company, and to achieve the cost and growth synergies in
accordance with the stated goals of the Gillette transaction; (3) the
ability to manage and maintain key customer relationships; (4) the ability
to maintain key manufacturing and supply sources (including sole supplier
and plant manufacturing sources); (5) the ability to successfully manage
regulatory, tax and legal matters (including product liability, patent, and
other intellectual property matters), and to resolve pending matters within
current estimates; (6) the ability to successfully implement, achieve and
sustain cost improvement plans in manufacturing and overhead areas,
including the Company's outsourcing projects; (7) the ability to
successfully manage currency (including currency issues in volatile
countries), debt (including debt related to the Company's announced plan to
repurchase shares of the Company's stock), interest rate and certain
commodity cost exposures; (8) the ability to manage the continued global
political and/or economic uncertainty and disruptions, especially in the
Company's significant geographical markets, as well as any political and/or
economic uncertainty and disruptions due to terrorist activities; (9) the
ability to successfully manage competitive factors, including prices,
promotional incentives and trade terms for products; (10) the ability to
obtain patents and respond to technological advances attained by
competitors and patents granted to competitors; (11) the ability to
successfully manage increases in the prices of raw materials used to make
the Company's products; (12) the ability to stay close to consumers in an
era of increased media fragmentation; and (13) the ability to stay on the
leading edge of innovation. For additional information concerning factors
that could cause actual results to materially differ from those projected
herein, please refer to our most recent 10-K, 10-Q and 8-K reports.
Procter & Gamble Pharmaceuticals, Inc.
pg
View drug information on Asacol; Prilosec.