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Sciele Pharma Raises 2006 and Reaffirms 2007 Revenue and Earnings Guidance.


Provides Business Update at JPMorgan Healthcare Conference

ATLANTA -- Speaking today at the JPMorgan Healthcare Conference in San Francisco San Francisco (săn frănsĭs`kō), city (1990 pop. 723,959), coextensive with San Francisco co., W Calif., on the tip of a peninsula between the Pacific Ocean and San Francisco Bay, which are connected by the strait known as the Golden ; Patrick Fourteau, President and Chief Executive Officer of Sciele Pharma, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:SCRX), raised the Company's revenue guidance for full-year 2006 to between $290 million and $292 million from the previously announced range of $287 million to $290 million, and raised the earnings guidance to between $1.18 and $1.20 per share from the previously announced range of $1.16 to $1.19 per share. Mr. Fourteau also reaffirmed the Company's previously announced full-year 2007 revenue guidance of $335 million to $350 million and diluted earnings per share diluted earnings per share

An earnings measure calculated by dividing net income less preferred stock dividends for a period by the average number of shares of common stock that would be outstanding if all convertible securities were converted into shares of
 guidance of $1.53 to $1.62.

Mr. Fourteau reported that Sciele Pharma will begin promoting Zovirax,([R]) which has been licensed from Biovail, in January 2007. "Zovirax, a well-established and highly recognized brand, is an excellent fit for our business model. We are confident that strong promotion of Zovirax by both our Women's Health Women's Health Definition

Women's health is the effect of gender on disease and health that encompasses a broad range of biological and psychosocial issues.
 and Primary Care sales forces will drive growth for the product." Mr. Fourteau added that the Company is also on track to launch its new OptiNate([R]) formulation in the first half of 2007.

In other developments, Sciele Pharma has completed the initial review of the bioequivalence bioequivalence /bio·equiv·a·lence/ (-e-kwiv´ah-lens) the relationship between two preparations of the same drug in the same dosage form that have a similar bioavailability.  trial for its new Sular formulation. Based on the trial results, the Company confirmed that it expects to file a supplemental New Drug Application (sNDA) in the first half of 2007. Preliminary results demonstrated that the new Sular formulation, utilizing SkyePharma's Geomatrix([R]) technology, can provide bioequivalence at a lower dose. The Company plans to conduct an additional trial during the first quarter of 2007 to supplement the information from this initial trial. Clinical results from the initial trial will be combined with data from the additional study in the sNDA filing that the company expects to submit to the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
.

Sciele Pharma, Inc. Background

Sciele Pharma, Inc. is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on Cardiovascular/Metabolic and Women's Health. The Company's Cardiovascular/Metabolic products treat patients with high cholesterol Cholesterol, High Definition

Cholesterol is a fatty substance found in animal tissue and is an important component to the human body. It is manufactured in the liver and carried throughout the body in the bloodstream.
, hypertension, high triglycerides Triglycerides
Fatty compounds synthesized from carbohydrates during the process of digestion and stored in the body's adipose (fat) tissues. High levels of triglycerides in the blood are associated with insulin resistance.
, unstable angina un·sta·ble angina
n.
Angina pectoris characterized by pain of coronary origin that occurs in response to less exercise or other stimuli than usually required to produce pain.
 and Type 2 diabetes type 2 diabetes
n.
See diabetes mellitus.
, and its Women's Health products are designed to improve the health and well-being of mothers and their babies. Headquartered in Atlanta, Georgia and founded in 1992, Sciele Pharma employs more than 800 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. For more information about Sciele Pharma and its products, visit www.sciele.com.

Safe Harbor Safe Harbor

1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.

2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive.
 Statement

This press release contains forward-looking statements forward-looking statement

A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections.
 (in addition to historical facts) 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 forward-looking 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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 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 sales 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.

Altoprev has experienced manufacturing issues; if the issues recur and cannot be resolved, our ability to acquire the product for sale and sampling will be adversely affected. 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 that we make unexpected changes in our estimates for future product returns and reserves for obsolete inventory Obsolete Inventory

Term that refers to inventory that is at the end of its product life cycle and has not seen any sales or usage for a set period of time usually determined by the industry. This type of inventory has to be written down and can cause large losses for a company.
. 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. Our new Sular formulation is presently undergoing clinical trial testing. There can be no assurance that the trial results will be positive, and if they are not, we may not be able to market and sell our new Sular formulation.

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 re·im·burse  
tr.v. re·im·bursed, re·im·burs·ing, re·im·burs·es
1. To repay (money spent); refund.

2. To pay back or compensate (another party) for money spent or losses incurred.
 patients for our products, doctors may not prescribe pre·scribe
v.
To give directions, either orally or in writing, for the preparation and administration of a remedy to be used in the treatment of a disease.
 them. Further, our business is subject to increasing government price controls and other healthcare cost-containment measures. Side effects Side effects

Effects of a proposed project on other parts of the firm.
 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 (1) See IP Multimedia Subsystem.

(2) (Information Management System) An early IBM hierarchical DBMS for IBM mainframes. IMS was widely implemented throughout the 1970s under MVS and continues to be used under z/OS.
, 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 An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called 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 ex·pend  
tr.v. ex·pend·ed, ex·pend·ing, ex·pends
1. To lay out; spend: expending tax revenues on government operations. See Synonyms at spend.

2.
 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 herein. 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.
COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Jan 10, 2007
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