Sciele Pharma, Inc. (NASDAQ:SCRX) today announced that it has signed an
exclusive agreement with Addrenex Pharmaceuticals, Inc. to develop and
market ADX415, a novel patented, centrally-acting alpha adrenergic
receptor agonist, specific to Alpha-2 receptors, for the treatment of
hypertension and other potential indications. Under the terms of the
agreement, Sciele will have the worldwide marketing rights for ADX415,
will pay the product development costs, and will also make regulatory
milestone payments and royalty payments to Addrenex on product sales.
Sciele and Addrenex expect to begin the Phase II clinical studies in the
second half of 2008.
Ed Schutter, President and Chief Operating Officer of Sciele Pharma,
said, “This agreement further expands our
relationship with Addrenex and provides the Company with a product in
Phase II clinical development, expanding our pipeline beyond 2010. This
is the first new chemical entity (NCE) that will be developed by Sciele.
We are optimistic about the potential of ADX415 for the treatment of
hypertension. According to a recent report from the American Health
Association, hypertension has developed resistance to existing drugs and
has become increasingly difficult to treat. By analyzing studies of
patients with high blood pressure, an AHA panel concluded that 20% to
30% could not manage their condition with three or more medicines, even
when used exactly as specified.”
Moise Khayrallah, Ph.D., Chief Executive Officer of Addrenex, said, “This
second partnership agreement with Sciele is particularly rewarding
because it provides tangible proof that our compounds are valuable and
that they fill a critical gap in the treatment of debilitating
conditions. Although ADX415 is an NCE, we will benefit from valuable
data already accumulated from several pre-clinical and clinical studies
completed by Procter and Gamble and will therefore be able to move
swiftly into clinical trials.”
About Sciele Pharma, Inc.
Sciele Pharma, Inc. is a pharmaceutical company specializing in sales,
marketing and development of branded prescription products focused on
the therapeutic areas of Cardiovascular, Diabetes, Women’s
Health and Pediatrics. The Company’s
Cardiovascular and Diabetes products treat patients with high
cholesterol, hypertension, high triglycerides, unstable angina and Type
2 diabetes; its Women’s Health products are
designed to improve the health and well-being of women and mothers and
their babies; and its Pediatrics products treat allergies, asthma,
coughs and colds, and attention deficit and hyperactivity disorder
(ADHD). Founded in 1992 and headquartered in Atlanta, Georgia, Sciele
employs more than 900 people. The Company’s
success is based on placing the needs of patients first, improving
health and quality of life, and implementing its business platform –
an Entrepreneurial Spirit, Innovation, Execution Excellence, Simplicity,
and Teamwork.
About Addrenex Pharmaceuticals, Inc.
Addrenex Pharmaceuticals is a focused, specialty pharmaceutical company
that develops and commercializes drugs to treat adrenergic
dysregulation. Addrenex Pharmaceuticals is based in Durham, North
Carolina, on the edge of Research Triangle Park. The company was formed
in 2006 by a practicing physician and a drug development expert with the
mission to explore the impact that neurotransmitter regulation has on a
variety of diseases and disorders. Addrenex identified adrenergic
regulation as its initial research focus. Adrenergic dysregulation is
implicated in medical conditions such as hypertension, ADHD and
migraine. Addrenex is using the knowledge and experience gained from
developing CLONICEL(R) as the foundation for additional discovery and
development in the area of adrenergic regulation.
Safe Harbor Statement
This press release contains forward-looking statements that are
subject to risks and uncertainties that could cause actual results to
materially differ from those described. Although we believe that
the expectations expressed in these statements are reasonable, we cannot
promise that our expectations will turn out to be correct. Our
actual results could be materially different from and worse than our
expectations. With respect to such forward-looking statements, we
seek the protections afforded by the Private Securities Litigation
Reform Act of 1995. These risks include, without limitation:
We may not attain expected revenues and earnings. If we are
unsuccessful in obtaining third party payor contracts for our products,
we may experience reductions in sales levels and may fail to reach
anticipated sales levels. If demand for our products exceeds our
initial expectations or the ability of our suppliers to provide
demand-meeting quantities of product and samples, our ability to sell
these products could be adversely impacted. The potential growth
rate for our promoted products may be limited by slower growth for the
class of drugs to which our promoted products belong and unfavorable
clinical studies about such class of drugs. We may encounter
problems in the manufacture or supply of our products, for which we
depend entirely on third parties.
Strong competition exists in the sales of our promoted products,
which could adversely affect the expected growth of our products’
sales or increase our selling costs. We may not be able to
protect our competitive position for our promoted products from
infringers. Sales of our Robinul product have been adversely
affected by the introduction of knock-off and generic product.
We may incur unexpected costs in integrating new products into our
operations. If we have difficulties acquiring new products or
rights to market new products from third parties, our financial results
could be adversely impacted. We may be unable to develop or
market line extensions for our products including Sular, Triglide,
Fortamet, and our Prenate Line or, even if developed, obtain patent
protection for our line extensions. Further, introductions by us
of line extensions of our existing products may require us to make
unexpected changes in our estimates for future product returns and
reserves for obsolete inventory. If these risks occur, our
operating results would be adversely affected. Our
licensor/supplier can terminate our rights to commercialize Nitrolingual
and the 60 dose size of this product has not yet met our expectation.
We depend on a small senior management group, the departure of any
member of which would likely adversely affect our business. An
adverse interpretation or ruling by one of the taxing jurisdictions in
which we operate could adversely impact our operating results. A
small number of customers account for a large portion of our sales and
the loss of one of them, or changes in their purchasing patterns, could
result in substantially reduced sales and adversely impact our financial
results. If third-party payors do not adequately reimburse
patients for our products, doctors may not prescribe them. Further,
our business is subject to increasing government price controls and
other healthcare cost-containment measures. Side effects or
marketing or manufacturing problems with our products could result in
product liability claims which could be costly to defend and could
result in the withdrawal or recall of products from the market.
We rely on operational data obtained from IMS, an industry accepted
data source. IMS data may not accurately reflect actual
prescriptions (for instance, we believe IMS data does not capture all
product prescriptions from some non-retail channels). An adverse
judgment in the securities class action litigation in which we and
certain current and former directors and executive officers are
defendants could have a material adverse effect on our results of
operations and liquidity.
If we fail to obtain, or encounter difficulties in obtaining,
regulatory approval for new products or new uses of existing products,
or if our development agreements are terminated, we will have expended
significant resources for no return. Our business and products
are highly regulated. The regulatory status of some of our
products makes these products subject to increased competition and other
risks, and we run the risk that we, or third parties on whom we rely,
could violate the governing regulations; if generic competitors that
compete with any of our products are introduced, our revenues may be
adversely affected.
Some unforeseen difficulties may occur.
The above are some of the principal factors that could cause actual
results to differ materially from those described in the forward-looking
statements included above. These factors are not intended to
represent a complete list of all risks and uncertainties inherent in our
business, and should be read in conjunction with the more detailed
cautionary statements and risk factors included in our other filings
with the Securities and Exchange Commission.
Sciele Pharma, Inc.
Joseph T. Schepers, 678-341-1401
ir@sciele.com
