ATLANTA--(BUSINESS WIRE)--Nov. 19, 2007--Sciele Pharma, Inc.
(NASDAQ:SCRX) today announced that it has signed an exclusive
agreement with Novo Nordisk Inc. to market Prandin(R) (repaglinide).
Under the terms of the agreement, Sciele will exclusively market
Prandin(R) and, upon approval by the U.S. Food & Drug Administration
(FDA), PrandiMet(R) (the name submitted to the FDA for a
repaglinide/metformin fixed dose combination tablet) to physicians in
the U.S., and will have the right of first refusal to obtain marketing
rights in the U.S. to other Novo Nordisk products containing
repaglinide, the active pharmaceutical ingredient in both Prandin(R)
and PrandiMet(R).
Prandin(R) is an oral blood glucose-lowering drug of the
meglitinide class used in the management of Type 2 diabetes mellitus.
PrandiMet(R) is a combination tablet of repaglinide and metformin.
"This partnership in the U.S. will enable us to increase the oral
treatment options for people with Type 2 diabetes to help them gain
good glycemic control," said Martin Soeters, president of Novo Nordisk
Inc. "It will also allow Novo Nordisk to concentrate on bringing our
complete portfolio of three insulin analogs to health care providers,
which provides the most viable opportunity to both help improve
patient outcomes and realize our business aspirations, in the name of
Changing Diabetes(R)."
Patrick Fourteau, president and CEO of Sciele Pharma, Inc., added,
"We are pleased to initiate this partnership with Novo Nordisk, a
company that is widely recognized as a global leader in diabetes care.
Prandin(R) and potentially PrandiMet(R) (upon FDA approval) fit well
within our Diabetes product portfolio and will be an excellent
complement to Fortamet(R). Promoted by our Primary Care sales force,
Prandin and PrandiMet will strengthen our presence in the diabetes
treatment market."
While specific terms of the agreement were not disclosed, Sciele
Pharma may receive revenue based on certain dollar baseline targets
being met. The Company expects this agreement to be immediately
accretive, and as a result, is increasing its full-year 2008 revenue
guidance to $440 million to $455 million, up approximately $10 million
over previously announced guidance. The Company also expects full-year
2008 earnings per share to increase to $1.97 to $2.07 per share, up
approximately $0.10 from its previously announced guidance. This
guidance does not include any unapproved products except the new Sular
formulation, or any potential one-time charges related to the new
Sular conversion.
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 Heath 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 Pediatric products treat allergies, asthma, coughs and colds, and
attention deficit and hyperactivity disorder (ADHD). Founded in 1992
and headquartered in Atlanta, Sciele Pharma employs more than 900
people. The Company's success is based upon 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 Novo Nordisk Inc.
Novo Nordisk is a healthcare company with an 84-year history of
innovation and achievement in diabetes care. The company has the
broadest diabetes product portfolio in the industry, including the
most advanced products within the area of insulin delivery systems. In
addition to diabetes care, Novo Nordisk has a leading position within
areas such as hemostasis management, growth hormone therapy, and
hormone therapy for women. Novo Nordisk's business is driven by the
Triple Bottom Line: a commitment to economic success, environmental
soundness, and social responsibility to employees and customers. With
headquarters in Denmark, Novo Nordisk employs more than 23,600
employees in 79 countries, and markets its products in 179 countries.
Novo Nordisk's B shares are listed on the stock exchanges in
Copenhagen and London. Its ADRs are listed on the New York Stock
Exchange under the symbol 'NVO'. For global information, visit
www.novonordisk.com; for United States information, visit
www.novonordisk-us.com.
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 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 60mg. dose size of this product has
not yet met our expectation. We may not experience the beneficial
results of our acquisitions that we expect to receive, and the
acquired products may not meet our sales expectations.
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.
Joseph T. Schepers, 678-341-1401
Director of Investor Relations
ir@sciele.com
SOURCE: Sciele Pharma, Inc.
