CLONICEL(R) Developed for the Treatment of Hypertension and
Attention Deficit and Hyperactivity Disorder (ADHD)
ATLANTA--(BUSINESS WIRE)--July 12, 2007--Sciele Pharma, Inc.
(NASDAQ: SCRX) today announced that it has signed an exclusive
agreement with Addrenex Pharmaceuticals, Inc. to market, upon approval
by the U.S. Food & Drug Administration (FDA), CLONICEL(R), a patented,
sustained-release formulation of clonidine hydrochloride for the
treatment of hypertension and attention deficit and hyperactivity
disorder in North America. Sciele will also have the right of first
refusal for other Addrenex products focused on pediatrics, women's
health, and cardiovascular/metabolic diseases. Under the terms of the
agreement, Sciele has purchased a $6 million equity stake in Addrenex
and will have the right to increase its equity stake in Addrenex by an
additional 10%. Sciele will also make regulatory milestone payments of
up to $11 million and royalty payments to Addrenex on product sales.
Clonidine hydrochloride is an alpha-2 agonist approved for the
treatment of hypertension. During the past year, approximately 11.7
million prescriptions were dispensed for clonidine hydrochloride
tablets and approximately 1.8 million prescriptions were dispensed for
clonidine patches, according to IMS Health's National Prescription
Audit Plus data. CLONICEL(R) is a 12-hour, sustained-release
formulation of clonidine hydrochloride, which currently is in pivotal
clinical trials for hypertension. A 505(b)(2) NDA filing with the FDA
is expected in the second half of 2007. A Phase III clinical trial
utilizing CLONICEL(R) for ADHD is expected to begin in the second half
of 2007.
Patrick Fourteau, Chief Executive Officer of Sciele Pharma, said,
"This agreement with Addrenex provides us with the opportunity to
further expand both our cardiovascular and pediatric product lines. We
continue to execute on our strategy to diversify our product portfolio
and expand our late-stage product pipeline through the licensing and
acquisition of products."
Moise Khayrallah, Ph.D., Chief Executive Officer of Addrenex,
said, "We are very happy that a successful company such as Sciele sees
the potential of our lead compound CLONICEL(R). We look forward to a
rewarding partnership that will allow Addrenex to develop and
commercialize this product as well as future compounds in our
adrenergic regulation portfolio."
About Sciele Pharma, Inc.
Sciele Pharma, Inc. is a pharmaceutical company specializing in
sales, marketing and development of branded prescription products
focused on Cardiovascular/Diabetes, Women's Health and Pediatrics. The
Company's Cardiovascular/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 Pharma 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, Speed
of Execution, 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 Morrisville, 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, migraine, and post-menopausal symptoms. Addrenex
will use 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 or renewing 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 future
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 sale of our promoted products, which could
adversely affect expected growth of our promoted products' sales or
increase our costs to sell our promoted products. We may not be able
to protect our competitive position for our promoted products from
patent infringers. If generic competitors that compete with any of our
products are introduced, our revenues may be adversely affected.
Certain of our products have experienced manufacturing issues. If
the issues recur and cannot be resolved, our ability to acquire
product for sale and sampling will be adversely affected. We may incur
unexpected costs in integrating new products into our operations.
We may be unable to develop or market line extensions for our
products including Prenate, Sular, Triglide, Nitrolingual, Altoprev
and Fortamet, or, even if developed, obtain patent protection for our
line extensions; further, introductions by us of line extensions of
our existing products may require that we make unexpected changes in
our estimates for future product returns and reserves for obsolete
inventory. If these risks occur, our financial results could be
adversely affected.
If we have difficulties acquiring new products or rights to market
new products from third parties, our financial results could be
adversely impacted. 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 if a
suitable replacement member could not be retained.
An adverse interpretation or ruling by one of the taxing
jurisdictions in which we operate could adversely impact our operating
results. 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
financial results and liquidity. 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 which would adversely affect our business. We
may be found noncompliant with applicable federal, state or
international laws, rules or regulations which could result in fines
and/or product recalls or otherwise cause us to expend significant
resources to correct such non-compliance.
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, substantially
and adversely impacting our financial results. If third-party payors
do not adequately reimburse patients for our products, doctors may not
prescribe them.
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).
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.
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.
CONTACT: Sciele Pharma, Inc., Atlanta
Joseph T. Schepers, 678-341-1401
ir@sciele.com
SOURCE: Sciele Pharma, Inc.