While both product candidates are designed to produce weight
loss, we expect to position Contrave and Excalia to target
different segments of the obese population. The two components
of Contrave, bupropion and naltrexone, are both approved to
treat addictive disorders: smoking in the case of bupropion, and
alcoholism and opioid addiction in the case of naltrexone.
Recent research suggests that for many obese patients,
overconsumption of food is an addiction, much like smoking and
alcoholism. Notably, women report substantially greater food
craving than men, according to a 1991 study. In addition, women
were responsible for 90% of all weight loss prescriptions
written in the United States from 1998 to 2003, according to
IMS Health. Given its profile, we believe that Contrave may
be particularly well-suited for
obese women who report food cravings.
We believe that Excalia, given its profile, may be more
effective than Contrave in reducing weight, at least in the
early stages of treatment. The overall tolerability of Excalia
has yet to be determined. However, it is likely to have labeling
which would recommend appropriate birth control for women of
childbearing age and to be contraindicated in women who are
pregnant or breast feeding. As a result, we believe that Excalia
may be especially well-suited for men and post-menopausal women
who are heavier and require greater weight reduction. We expect
that the experience gained from future clinical trials will
enable us to further refine the positioning and brand
characteristics of both products.
To date, we have focused our clinical development efforts
exclusively in the United States. This appears to be the largest
commercial market for obesity therapeutics and the market which
we believe we best understand. However, we have also sought to
establish intellectual property covering our product candidates,
primarily in the form of patent application filings, in various
foreign markets. We recognize that there is a significant
emerging obesity market in Europe, Asia and Latin America. We
believe that conducting the necessary supplemental trials,
engaging in local regulatory dialogue and conducting local
market research is likely best done through strategic
collaborators in territories outside the United States or
possibly in partnership with a global pharmaceutical company. We
will continue to consider international opportunities, and
appropriately prioritize these opportunities in the context of
the opportunity in the United States.
We rely on a combination of in-licensed patent rights, our own
patent rights, trademarks, trade secrets and know-how to protect
Contrave and Excalia. We own or have exclusive rights to
14 patent applications currently pending in the United
States with respect to various compositions, methods of use and
formulations relating to Contrave and/or Excalia. We also have a
number of patent applications currently pending in various
foreign countries that correspond to some of the pending U.S.
applications. We also seek to protect our trade secrets and our
know-how relating to our products and our business. These
intellectual property rights are in addition to any regulatory
exclusivity that we may be able to obtain.
Contrave is currently protected in the United States by U.S.
Patent Nos. 5,817,665 and 5,512,593, which we have in-licensed
on an exclusive basis from Dr. Lee Dante pursuant to a
patent license agreement described in further detail below.
These patents, which we refer to as the Dante patents, provide
basic composition of matter coverage for the Contrave
naltrexone/bupropion combination. In addition to the Dante
patents, we own a U.S. patent application and a related
continuation patent application, each of which stem from a
provisional patent application that we own but that is the
subject of agreements with OHSU and Duke University, or Duke,
requiring us to pay them specified royalties on sales of
products covered by the patent applications. These agreements
are described in further detail below. These patent
applications, which we refer to as the Weber/Cowley patent
applications, are directed to the current composition of our
Contrave product candidate, including our SR formulation of
naltrexone, and methods for using that composition to effect
weight loss. We and/or our licensors have also filed a number of
international counterparts to these patent applications in
foreign countries. If patents ultimately issue from these U.S.
patent applications and their international counterparts, we
expect to have coverage through at least 2024. The
CONTRAVE mark is the subject of trademark
applications that we have filed in the United States and in
certain countries overseas.
Excalia is currently protected in the United States by U.S.
Patent Number 7,109,198, which is based on the work of
Dr. Kishore Gadde, and which we refer to as the Gadde
patent and have licensed on an