POZEN Inc., headquartered in Chapel Hill, NC, is a pharmaceutical company committed to
transforming medicine that transforms lives. Since its founding in 1996, POZEN has
successfully created novel pharmacologic agents primarily for pain and pain-related
conditions by combining existing drug therapies that result in superior patient outcomes.
Moving forward, POZEN is poised to become a model 21st century pharmaceutical
company dedicated to ensuring that they produce cost-effective, evidence-based
medicines; take a fresh approach to sales, marketing and medical education;
and deliver high-quality, affordable pharmaceuticals to their customers.
Since its founding in 1996, POZEN has had a long, successful
history of creating novel pharmacologic agents by combining existing
drug therapies that result in superior patient outcomes, primarily
for pain and pain-related conditions. This approach allows for a
potentially higher success rate than NCE (new chemical entity)
POZEN pioneered the concept of a strategic outsource drug
development company whose products would be marketed by strong
commercial partners. This model has allowed POZEN to commit nearly
all its resources to developing new products while avoiding the high
costs associated with basic research, manufacturing, and marketing.
By virtue of the initial upfront payments, milestone payments, and
ongoing royalties from partnerships, POZEN has been totally
self-funding since the 2000 Initial Public Offering (IPO).
POZEN is evolving from solely a product development company into
a company that retains control of the commercialization of its
pipeline going forward. This allows us to utilize revenues from
licensing and development agreements to fund the development and
commercialization our own pipeline, beginning with our next
generation of product candidates- the PA aspirin franchise. We
believe this model will allow us to increase POZEN's future
potential revenues and profits and deliver better shareholder value.
POZEN intends to stay at the leading edge of change in the
pharmaceutical industry. To accomplish this, we are building a 21st
century pharmaceutical company – evidence-based, patient-centered,
efficient and cost-effective. Instead of trying to emulate the "old
school" approach now being abandoned by the major pharmaceutical
companies, POZEN is taking a fresh approach to sales, marketing and
medical education. This will allow us to deliver high-quality,
evidence-based, and affordable products to our customers while also
providing shareholders with an appropriate return on investment.
In April 2008, the Food and Drug
Administration (FDA) approved Treximet® (sumatriptan
and naproxen sodium) for the acute treatment of migraine attacks,
with or without aura, in adults. The product is formulated
with POZEN’s patented technology of
combining a triptan with a non-steroidal anti-inflammatory drug (NSAID)
and GlaxoSmithKline’s (GSK) RT Technology™. This migraine
medication works in two ways - the triptan
component shrinks the swollen blood vessels in the head, which
correlates to the relief of migraine pain, while the NSAID component
inhibits the enzyme responsible for the production of prostaglandins,
which are the mediators of pain and inflammation. As a result of
this dual mechanism of action, Treximet®
has been shown to provide superior sustained pain relief compared to
placebo and to both of the single mechanism of action components.
The FDA approval was an important milestone for the partnership
between the two companies. The partnership began in 2003, when GSK
signed an agreement with POZEN for the development and
commercialization of this product.
In May 2008, POZEN officially transferred the Investigational New
Drug (IND) and New Drug
Application (NDA) for the product to GSK.
GSK is responsible for the commercialization of Treximet®
in the US.
POZEN receives royalties based on net sales of Treximet®
from GSK and, beginning January 1, 2010, that royalty rate more
than tripled to 18 percent.
For Full Prescribing Information,
POZEN also has ex-US rights to develop and market a lower
dose sumatriptan and naproxen combination.
Another major licensed product program is for VIMOVO, (naproxen and
esomeprazole magnesium) delayed release tablets, co-developed by
POZEN Inc. and AstraZeneca, a fixed-dose combination of
delayed-release enteric-coated naproxen, a pain-relieving
non-steroidal anti-inflammatory drug (NSAID), and immediate release
esomeprazole, a proton pump inhibitor (PPI). On April 30, 2010, the
Company announced that the U.S. Food and Drug Administration (FDA)
approved VIMOVO delayed-release tablets for the relief of the signs
and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and
ankylosing spondylitis (AS), and to decrease the risk of developing
gastric ulcers in patients at risk of developing NSAID-associated
gastric ulcers. VIMOVO is not recommended for initial treatment of
acute pain because the absorption of naproxen is delayed compared to
the absorption from other naproxen-containing products. Controlled
studies do not extend beyond six months.
VIMOVO received positive agreement for approval in 23 countries
across the European Union in October 2010, which was followed by
marketing and pricing approval in the United Kingdom, the first
major ex-U.S. territory. In June 2010, POZEN officially transferred
to AstraZeneca the Investigational New Drug (IND) and New Drug
Application (NDA) for the product. AstraZeneca is responsible for
the commercialization of VIMOVO.
For Full Prescribing Information see
POZEN is creating a safer form of aspirin
franchise of product candidates – the PA product platform. The PA
family of product candidates is intended to significantly reduce GI
ulcers and other GI complications compared to taking aspirin alone.
The first candidate is PA32540.
It is a coordinated-delivery tablet combining immediate-release
omeprazole, a PPI, layered around pH-sensitive aspirin. This novel,
patented product is administered orally once a day and will be
indicated for use for the secondary prevention of cardiovascular
disease. POZEN has started enrolling patients in two pivotal Phase
3 trials and a long-term, open-label safety trial for secondary
cardiovascular disease (CVD) prevention in October 2009.
Additionally, POZEN is considering
investigating PA32540 for the secondary prevention of colorectal
neoplasias (secondary recurrence of colonic polyps). PA32540 may
improve the risk/benefit of aspirin therapy in this population and
could provide an important agent for the chemoprevention of colon
The POZEN pipeline also includes
earlier-stage work evaluating the application of aspirin
combinations for pain and pain-related conditions.