Sklice® (ivermectin) Lotion, 0.5% Now Available in the US for Topical Treatment of Head Lice

SWIFTWATER, Pa., Aug. 20, 2012 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN andNYSE: SNY), announced today that Sklice^® (ivermectin) Lotion, 0.5% is now commercially available by prescription in U.S. pharmacies for the topical treatment of head lice infestations in patients 6 months of age and older, in the context of an overall lice management program.¹

(Photo: http://photos.prnewswire.com/prnh/20120820/NY55765)

Head lice cases have been rapidly increasing in the United States affecting an estimated 6 to 12 million children aged 3 to 11 years each year.^2,3

Sklice Lotion was developed to meet the demand for an effective head lice treatment option that is well-tolerated in children 6 months of age and older. In phase 3 trials, Sklice Lotion was proven to resolve most head lice infestations with one well-tolerated, 10-minute application. Two weeks following initial treatment, 71-76 percent of patients treated with Sklice Lotion were lice-free. Fewer than 1 percent of patients experienced side effects which included eye redness or soreness, eye irritation, dandruff, dry skin and burning sensation of the skin.¹  

Sklice Lotion should be used in the context of an overall lice management program, which includes washing (in hot water) or dry-cleaning all recently worn clothing, hats, used bedding and towels, as well as washing personal care items such as combs, brushes and hair clips in hot water. No nit combing is required; however, if desired, a fine-tooth comb may be used to remove dead lice and nits.¹

Sklice Lotion is being commercialized by Sanofi Pasteur U.S., an established leader in the pediatric marketplace with an extensive heritage of bringing innovative solutions to the pediatric healthcare community.

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.¹

Developed by Topaz Pharmaceuticals, which was acquired by Sanofi Pasteur in October 2011, Sklice Lotion was approved by the U.S. Food and Drug Administration (FDA) in February 2012.

Sklice Lotion is only available by prescription. Parents must contact their health care provider before going to the pharmacy.

Indication
Sklice Lotion is a prescription medication for topical use on the hair and scalp only, used to treat head lice in people 6 months of age and older.

Adjunctive Measures
Sklice Lotion should be used in the context of an overall lice management program:

• Wash (in hot water) or dry-clean all recently worn clothing, hats, used bedding and towels.
• Wash personal care items such as combs, brushes and hair clips in hot water.
• A fine-tooth comb or special nit comb may be used to remove dead lice and nits.

Important Safety Information for Sklice
In order to prevent accidental ingestion, Sklice Lotion should only be administered to pediatric patients under the direct supervision of an adult. Avoid getting Sklice Lotion in your eyes.

The most common adverse reactions (incidence < 1%) were conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin, and skin burning sensation.

For more information, please see Full Prescribing Information for Sklice Lotion located at www.Sklice.com or call 855-4-SKLICE.

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.³

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, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

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

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", "intend", "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 labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product 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, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding 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, 2011. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Contact:

Sanofi Pasteur
Media Relations
Sean Clements
T. +1-570-957-0717
[email protected]
www.sanofipasteur.com  

References

1. [Product label]
2. Meinking TL, Vicaria M, Eyerdam DH, Villar ME, Reyna S, Suarez G. Efficacy of a reduced application time of Ovide lotion (0.5% malathion) compared to Nix creme rinse (1% permethrin) for the treatment of head lice. Pediatr Dermatol. 2004;21(6):670-4.
3. Centers for Disease Control and Prevention (CDC). Parasites: Lice: Head Lice: Frequently Asked Questions. http://www.cdc.gov/parasites/lice/head/gen_info/faqs.html. Accessed January 26, 2012.

SOURCE Sanofi Pasteur