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| What is the history of POZEN?
Nearly 15 years ago, Dr. Plachetka created POZEN Inc. to develop
new pharmaceutical products utilizing an innovative and efficient
new business model for small pharmaceutical companies. A key
element of his vision was his belief that combining two known
mechanisms of action would often produce a superior product,
with either greater efficacy, improved safety, or both, and
would generate a higher hit rate than basic test-tube research.
After initially focusing on improving the acute treatment of
migraine, the company has expanded into the treatment of
other pain-related diseases, cardiovascular disease, as well
as exploratory work in the prevention of cancer.
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| What are POZEN's major accomplishments?
POZEN completed several development programs for combination products for
the acute treatment of migraine. One of those products, Treximet®
(sumatriptan and naproxen sodium), was approved by Food and Drug
Administration (FDA) in 2008 and is now the 4th leading branded product
based on total expected 2009 sales.
An NDA is currently under review at FDA for VIMOVO™, an innovative
new combination product for the treatment of osteoarthritis, rheumatoid
arthritis and ankylosing spondylitis, for patients who are at risk for
developing non-steroidal anti-inflammatory drug-associated gastric ulcers.
POZEN is currently in Phase 3 development for an innovative combination
product designed to deliver the benefits of aspirin to patients who use
it for the secondary prevention of strokes or cardiovascular events,
but who are at risk for developing a gastric ulcer.
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| What are POZEN's currently licensed products?
In April 2008, FDA approved Treximet® 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 IND and 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 will more than triple to 18%.
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™, an investigational
product under development by AstraZeneca (AZ) and POZEN that combines
enteric coated naproxen (an NSAID) with immediate-release esomeprazole,
a proton pump inhibitor (PPI). VIMOVO™ is under investigation for the
treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis
in patients who are at risk of developing NSAID-associated gastric ulcers.
On August 31, 2009, the FDA informed AZ and POZEN that it had accepted the
NDA for VIMOVO™, submitted on June 30, 2009. AZ submitted a Marketing
Authorization Application (MAA) to the European Union via the Decentralized
Procedure for VIMOVO™ on October 16, 2009.
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| What is the current status of POZEN products under development?
POZEN is creating a "safer 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 product 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, if approved, will be indicated for use for the
secondary prevention of cardiovascular disease. POZEN 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 neoplasias.
The POZEN pipeline also includes earlier-stage work evaluating the
application of aspirin combinations for pain and pain-related
conditions.
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| What is the market for the PA franchise?
Secondary Prevention of Cardiovascular disease
PA is currently being investigated for the secondary prevention CVD.
It is estimated that 80 million people in the US have one or more forms
of CVD. Coronary heart disease affects almost 17 million people and
causes about 445,000 deaths annually. It is the leading single cause
of death in the US. Each year about 600,000 people experience a stroke
and 185,000 people have a recurrent stroke. Approximately 144,000
people die from stoke each year.
Aspirin is the gold standard in anti-platelet therapy and is already
incorporated into the American Heart Association (AHA) clinical guidelines
for the secondary prevention of cardiovascular events. About 50 million
Americans use aspirin regularly for cardiovascular disease prevention.i
PPIs such as omeprazole are likewise recommended for concomitant use
in patients on anti-platelet therapy at risk for GI bleeding, as
recommended by AHA and the American College of Gastroenterology (ACG).
Our task is to broaden education around these established guidelines
and provide products that make it easier for both doctors and patients
to comply with them.
Secondary prevention of colorectal cancer
POZEN is also considering investigating PA the secondary prevention of
colorectal cancer (CRC). CRC is the second most common cancer in
developed countries with a lifetime risk of five percent. In the
US there were 149,000 new cases and 50,000 related deaths in 2008.ii
Adenomas are precursors of most colorectal cancers and prevention
of adenomas will most likely also prevent colorectal cancers. More
than 80 percent of colorectal cancers arise from adenomatous polyps.iii
Over the past 30 years, compelling data have emerged suggesting that
aspirin can suppress carcinogenesis in the large bowel.iv In 2008, the
5th International Conference on Cancer Prevention produced an international
consensus statement that "evidence clearly shows a chemopreventive
effect for aspirin."
Other pipeline products
The POZEN pipeline also includes earlier-stage work evaluating the
application of aspirin combinations for pain and pain-related conditions.
i Campbell CL, Smyth S, Montalescot G, and Steinhubl SR. Aspirin dose for the prevention of
cardiovascular disease. JAMA 2007; 297:2018-2024
ii Jernal, 2008
iiii USPSTF, 2007
iv Cole, 2009
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| What are POZEN's current revenue sources?
Currently, POZEN has several sources of revenue – milestone payments and
royalties. When we have engaged a partner to take our new product
candidate to market in the past, we received an upfront payment. Under
our existing agreements, we receive additional payments when we meet
certain milestones during the development of the product. The amount
and timing of these payments depends on when in the development cycle
we engage the partner. Typically, once our partner begins to sell the
drug, we receive royalties (as is the case with Treximet®, which is an
agreed-upon percentage of net sales of that product). Our products and
product candidates include Treximet®, licensed to GSK, and VIMOVO™,
licensed to AZ.
POZEN also has ex-US rights to develop and market a lower-dose sumatriptan
and naproxen combination.
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| What has been the POZEN business strategy prior to employing its own commercialization team?
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 its resources to developing new
products and avoid 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 its 2000 initial public offering (IPO).
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| What is the POZEN business strategy today?
POZEN is evolving from solely a product development company into a company
that will retain control of the commercialization of its pipeline going
forward. We will 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 that, 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.
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| What is POZEN's commercialization approach?
Our commercialization approach will continue POZEN's successful corporate
philosophy of owning core capabilities and strategically partnering for the rest.
To realize our aspirations, we will acquire some of the most experienced,
top commercial talent from either the pool that big pharma is shedding to
reduce costs, or from other successful smaller pharma companies. Strategic
partners who are the best at what they do will be engaged for the execution
of various commercial elements.
Technology and social media are completely changing the way healthcare
professionals and patients communicate and receive new information.
We will take advantage of these trends and make use of these cutting-edge
communication technologies to engage in meaningful and educational dialogues
with a broad base of customers (patients, physicians, and payors) in
cost-effective ways previously not possible.
Our leading-edge pharmaceutical company model will allow us to develop
and deliver high-quality, safe and effective branded products at prices
that are more affordable than big pharma branded products.
This will maximize patient access and their ability to afford our products.
We will seek strong commercialization partners for the markets outside of the US.
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| What exchange is POZEN stock listed and what is the stock symbol?
POZEN is listed on the NASDAQ Exchange under the symbol POZN.
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| How can I obtain additional financial information about POZEN or contact Investor Relations?
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