FDA Approves Sklice Lotion

Sanofi Announces FDA Approval of Sklice Lotion for the Treatment of Head Lice

BRIDGEWATER, N.J., Feb. 7, 2012 /PRNewswire/ -- Sanofi announced today that the U.S. Food and Drug Administration (FDA) has approved Sklice (ivermectin) lotion, 0.5% for the topical treatment of head lice, in patients 6 months of age and older. Effective and well-tolerated, Sklice Lotion treats lice in most patients with a single 10-minute application of the lotion, without nit combing.

"The approval of Sklice Lotion provides physicians and parents with a new treatment option for head lice, a condition that is notoriously frustrating to treat," said Kenneth P. Guito, General Manager, Sanofi-Topaz. "Through a unique mode of action, Sklice Lotion resolves most head lice infestations in one application, and is very well-tolerated."

Sklice will be commercialized by Sanofi Pasteur U.S., an established leader in the pediatric area with an extensive heritage of bringing innovative solutions to the pediatric healthcare community. "We are pleased that Sanofi Pasteur – through our longstanding relationships with pediatric professionals -- can help address the burden of head lice by bringing a well-tolerated, effective, single application treatment option to patients 6 months and older," added Chad Hoover, Vice President and Chief Commercial Officer, Sanofi Pasteur U.S.

Each year in the United States, head lice infest an estimated 6 to 12 million children aged 3 to 11 years. Estimates for direct and indirect costs, which include millions of lost school days and lost work for parents, are as high as 1 billion dollars.

Formulated with ivermectin, an antiparasitic that has been used orally for more than 20 years and more than 1 billion times to treat other parasites, Sklice Lotion was developed to meet the demand for an effective, convenient head lice treatment that works differently and is well-tolerated in children.

"This single treatment option provides parents with an additional choice to manage a head lice infestation. Helping children get back to school and parents back to work is a win-win situation for all involved," stated Dr. Bill Ryan, BVSc, consultant to Sanofi Pasteur U.S., who led the clinical trial programs for Sklice Lotion.

The FDA approval of Sklice Lotion was based on results of two randomized, double-blind phase 3 clinical trials that compared Sklice Lotion with a vehicle control (placebo) in 781 patients from the United States who were 6 months of age and older. Significantly more subjects in the Sklice Lotion group were louse-free, Sklice was well-tolerated and the majority of Sklice-treated patients were lice-free without any nit combing after two weeks. Fewer than 1% of patients experienced adverse events, which included conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin and skin-burning sensation.

About Head Lice

Head lice are wingless, parasites that feed on human blood and live close to the human scalp. They move by crawling and are mainly spread by head-to-head contact, most commonly among preschool children attending child care, elementary schoolchildren and the household members of infested children. Infrequently, transmission may occur by contact with items recently used by an infested person, such as clothing, brushes, towels or pillows.

Although head lice infestation is not related to cleanliness, patients experience social stigma, embarrassment and low self-esteem. The process of eradicating lice and their nits can be stressful, tedious and costly.

About Sklice Lotion

Sklice Lotion contains a broad-spectrum antiparasitic agent, ivermectin, which was developed from a soil bacterium that produces a family of compounds (avermectins) shown to bind selectively and with high affinity to certain ion channels present in invertebrate nerve and muscle cells but not in mammals. The resulting increased permeability of the cell membrane causes paralysis and death in certain parasites.

Widespread oral use of ivermectin began in 1987 to control river blindness (onchocerciasis) in humans. More than one billion treatments of ivermectin tablets have been administered to help alleviate the suffering caused by river blindness and other parasitic conditions.

Sklice Lotion was developed by Topaz Pharmaceuticals, which was acquired by Sanofi Pasteur in October, 2011.

Sklice Lotion Pivotal Trials

The FDA submission for Sklice Lotion included two identical multi-center, randomized, double-blind, vehicle-controlled studies conducted in subjects 6 months of age and older with head lice infestation. Sklice Lotion or placebo was dispensed to all subjects for application to dry hair and scalp followed by a rinsing after 10 minutes, with instructions not to use a nit comb. For the evaluation of efficacy, the youngest subject from each household was considered to be the index subject of the household (n=289). Other enrolled infested household members received the same treatment as the youngest subject. Subjects were also evaluated for safety and local tolerability.

The primary efficacy was assessed as the proportion of index subjects who were free of live lice at day 2 and through day 8 to the final evaluation 14 (+2) days following a single application. The secondary efficacy endpoint was the same assessment applied to the other enrolled subjects. Those with live lice present at any time up to the final evaluation were considered treatment failures.

Important Safety Information

No adverse events occurred at a rate greater than or equal to 1% in placebo-controlled trials using a single 10-minute treatment of Sklice Lotion in 379 patients ages 6 months and older. The most common adverse reactions (incidence <1%) were conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin and skin burning sensation.

The safety of Sklice Lotion has not been established in pediatric patients below the age of 6 months. Sklice Lotion is not recommended in pediatric patients under 6 months of age because of the potential increased systemic absorption and risk of ivermectin toxicity due to a high ratio of skin surface area to body mass and the potential for an immature skin barrier and risk of ivermectin toxicity.

There are no adequate and well-controlled studies with Sklice Lotion in pregnant women. Sklice Lotion should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

In order to prevent ingestion, Sklice lotion should only be administered to pediatric patients under the direct supervision of an adult.

Following oral administration, ivermectin is excreted in human milk in low concentrations. This has not been evaluated following topical administration. Caution should be exercised when Sklice Lotion is administered to a nursing woman.

Full prescribing information available at http://products.sanofi.us/Sklice/Sklice.pdf

About Sanofi Pasteur

Sanofi Pasteur, the vaccines division of Sanofi, provides more than 1 billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers the broadest range of vaccines protecting against 20 infectious diseases. The company's heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR 1 million in research and development. For more information, please visit: www.sanofipasteur.com or www.sanofipasteur.us

About Sanofi

Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer healthcare, emerging markets and animal health. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi is the holding company of a consolidated group of subsidiaries and operates in the United States as Sanofi U.S., also referred to as Sanofi-aventis U.S. LLC. For more information on Sanofi U.S., please visit http://www.sanofi.us or call 1-800-981-2491.

Forward Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of such products candidates, the absence of guarantee that the products candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2010. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Media Relations
Contacts:

U.S Media Relations
Amy Ba
T. +1-570-957-0717
Amy.ba@sanofipasteur.com
www.sanofipasteur.us


SOURCE Sanofi Pasteur

Posted: February 2012

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Sklice (ivermectin) FDA Approval History

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