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New National Survey: Majority of Moms Hold Incorrect Beliefs About Head Lice Management and Treatment

SNYNF | February 26, 2014

Fewer Moms are Aware of Prescription Treatments for Head Lice Compared to OTC Yet Those Who Used an Rx Report Greater Satisfaction

SWIFTWATER, Pa., February 26, 2014 /PRNewswire/ -- Although head lice are a common problem in families with school-aged children,^1,2,3 a new national survey reveals that despite 60% of moms – including 85% of those who have experienced head lice in their household as an adultⁱ – saying they know the facts about head lice, many still appear to be confused when it comes to common myths about head lice. Most moms believe that in order to get rid of an infestation you have to comb out the nits (88% of all moms and 90% of those with experience as an adultⁱ) and more than half (55% of all moms and 54% of those with experience as an adultⁱ) think that all head lice treatments require multiple applications. Yet, the U.S. Centers for Disease Control and Prevention (CDC) advises that the removal of all nits after successful treatment is not necessary⁴ and there are numerous treatment options with a range of application directions and safety profiles.^4,5

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Hey Mom! What’s Your Head Lice Experience?

The online survey was conducted by Harris Poll on behalf of Sanofi Pasteur during back-to-school season, among more than 2,000 U.S. moms aged 25 and older. Moms define the ideal head lice treatment as one that works quickly (78%), is safe (76%) and is easy to use (74%), but how do moms make a choice for their families? While 67% of moms are aware of prescription treatments and 80% are aware of over-the-counter (OTC) treatments, around seven in ten (71%) recognize that not all head lice treatments work the same. Only 32% of moms who used an OTC treatment the last time they or a member of their household had head lice say the infestation was eliminated with just one treatment; the remainder (68%) say they used two or more OTC applications to treat the infestation or report the treatment did not resolve the infestation.

Still, the majority of moms who have experienced head lice in their household as an adult (81%) used an OTC treatment the last time they had an infestation.ⁱⁱ Less than a third of moms (27%) chose a prescription option,ⁱⁱ but those who used a prescription were more likely to report being satisfied with their treatment (91% very satisfied/satisfied) than moms who used an OTC (79%).

"Head lice are common, so it is important for moms to get smart about the facts. A family doctor, pediatrician or other healthcare provider can help treat infestations," said family nurse practitioner, Susan Catchings. "There is a lot of head lice treatment information available online and elsewhere. Talking to your healthcare provider is a great way to learn more about FDA-approved options, how long each takes, how safety and efficacy compares, and what else you need to do to help prevent a reinfestation."

Findings also demonstrate that more than three-in-four moms (77% of all moms and 89% of those with experience as an adultⁱ) believe that they know where to find reliable information about head lice, but only 17% turned first to a doctor, nurse or other healthcare provider (HCP) and only 19% turned first to a pharmacist for treatment advice the last time they had an infestation in their household. This is surprising considering most moms (93%) know an HCP can help with determining treatment and many (67%) are aware that head lice are becoming resistant to some common treatments. For moms who did turn to a doctor, nurse or other HCP first for treatment advice, 90% found that the advice they received was very helpful or helpful in giving them the information they needed to treat the infestation.

Majorities of moms admit to feeling frustrated (67%), stressed (59%) and disgusted (58%) the last time a member of their household had lice. Nearly all moms who have experienced head lice in their household as an adult feel that dealing with it is a tremendous burden (93%), and a contributing factor in this may be that the majority (71% of all moms and 67% of those with experience as an adultⁱ) think that if one person in a household has head lice, the entire house should be cleaned and fumigated; however, CDC guidelines advise only a routine house cleaning and laundering of linens/clothing used by the infested person,^4,5 and the use of insecticide sprays or fogs is not recommended.⁴ Some experts recommend that items worn or used by the infested person, including hats, scarves, pillow cases, bedding, clothing and towels, in the two-day period just before treatment is started can be machine washed and dried using hot water and hot air.⁵ Items which may be contaminated by an infested person and cannot be laundered should be sealed in a plastic bag and stored for two weeks.⁵

Moms' treatment decisions and ideals suggest there are options they may not be considering. One prescription treatment option is Sklice^® (ivermectin) Lotion, 0.5%, a 10-minute prescription head lice treatment proven to be effective and well-tolerated after just one use.⁶Sklice Lotion was approved by the U.S. Food and Drug Administration (FDA) in February 2012, for topical use on the hair and scalp only, to treat head lice in people 6 months of age and older. In clinical studies approximately three-quarters of patients had no live lice 14 days after a one-time, 10-minute treatment.⁷ The most common side effects included eye redness or soreness, eye irritation, dandruff, dry skin and burning sensation of the skin – none of which occurred in more than one percent of treated patients.⁷Visit www.Sklice.com to learn more.

About Head Lice
Head lice are wingless parasites that feed on human blood and live close to the human scalp. Preschool children attending child care, elementary school children and the household members of infested children are most commonly affected.¹ Head lice are spread by direct contact with the hair of an infested person,¹ but nearly all moms (92% of all moms and 93% of those with experience as an adultⁱ) mistakenly believe they are most commonly spread from hats, combs or other personal items. Infrequently, transmission may occur by contact with items recently used by an infested person, such as clothing, brushes, towels or pillows.¹ Itching, the most common symptom, may take four to six weeks to develop the first time a person has head lice, and many may not experience any symptoms at all.⁸ In the United States, girls are somewhat more likely than boys to become infested, perhaps due to the sharing of brushes and combs.^9,10

About Sklice Lotion
Sklice Lotion is a prescription head lice treatment approved by the FDA in 2012. In clinical studies approximately three-quarters of patients had no live lice 14 days after treatment.⁷ Nit combing is not required when using Sklice Lotion, but a fine-tooth comb or special nit comb may be used to remove dead lice and nits.⁶ As with all head lice treatments, it should be used in the context of an overall lice management program, which includes washing 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.

Sklice^® (ivermectin) Lotion, 0.5%

Indication:
Sklice Lotion is a prescription medication for topical use on the hair and scalp only, for treatment of 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.

Before using Sklice Lotion, tell your doctor if you or your child:

have any skin conditions or sensitivities
have any other medical conditions
are pregnant or plan to become pregnant. It is not known if Sklice Lotion can harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if Sklice Lotion passes into your breast milk.

Important Safety Information for Sklice Lotion:
To prevent accidental ingestion, adult supervision is required for pediatric application. Avoid contact with eyes.

The most common side effects from Sklice Lotion include eye redness or soreness, eye irritation, dandruff, dry skin, and burning sensation of the skin.

Talk with your doctor if you or your child have any side effect that bothers you or that does not go away. You may report side effects to the FDA at 1-800-FDA-1088.

Please see full Prescribing Information available at http://products.sanofi.us/Sklice/Sklice.pdf.

Survey Methodology
This survey was conducted online within the United States by Harris Poll on behalf of Sanofi Pasteur from August 28 to September 11, 2013 among 2,002 females, age 25+, who are the parent or guardian of at least one child under the age of 18 living in their household. This online survey is not based on a probability sample and therefore no estimate of theoretical sampling error can be calculated. For complete survey methodology, including weighting variables and subgroup sample sizes, please contact Cristine Schroeder (Cristine.Schroeder@sanofipasteur.com, +1-570-957-3027).

About Nielsen & The Harris Poll
On February 3, 2014, Nielsen acquired Harris Interactive and The Harris Poll. Nielsen Holdings N.V. is a global information and measurement company with leading market positions in marketing and consumer information, television and other media measurement, online intelligence and mobile measurement. Nielsen has a presence in approximately 100 countries, with headquarters in New York, USA and Diemen, the Netherlands. For more information, visit www.nielsen.com.

About Sanofi
Sanofi, an integrated global 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", "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 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, 2012. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

www.sanofipasteur.us

ⁱMoms who experienced head lice in their household as an adult include those who report that someone in their household (including their child(ren), their spouse/partner as an adult, another member of their household, and/or themselves as an adult) has had a confirmed case of head lice (n=638).
ⁱⁱMoms were able to select more than one treatment method.

References

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 November 12, 2013.
Meinking T, Taplin D, Vicaria M. Infestations. In: Schachner LA, Hansen RC, eds. Pediatric Dermatology, 4th ed. Mosby Elsevier; 2011:1535-1583.
Centers for Disease Control and Prevention (CDC). Head lice: epidemiology and risk factors. http://www.cdc.gov/parasites/lice/head/epi.html. Accessed November 12, 2013.
Centers for Disease Control and Prevention (CDC). Head lice: Treatment Frequently Asked Questions. http://www.cdc.gov/parasites/lice/head/gen_info/faqs_treat.html. Accessed November 12, 2013.
Centers for Disease Control and Prevention (CDC). Head lice: Treatment. http://www.cdc.gov/parasites/lice/head/treatment.html. Accessed November 12, 2013.
SKLICE Lotion [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.; 2012.
Pariser et al. Topical 0.5% Ivermectin Lotion for Treatment of Head Lice. N Engl J Med. 2012; 367(18);1687-1693.
Centers for Disease Control and Prevention (CDC). Parasites: Lice: Head Lice: Disease. http://www.cdc.gov/parasites/lice/head/disease.html. Accessed November 12, 2013.
Mumcuoglu KY, Hemingway J, Miller J, et al. Permethrin resistance in the head louse Pediculus capitis from Israel. Med Vet Entomol. 1995:9, 427-432.
Sim S, Lee IY, Lee KJ, et al. A survey on head lice infestation in Korea (2001) and the therapeutic efficacy of oral trimethoprim/sulfamethoxazole adding to lindane shampoo. Korean J Parasitol. 2003;41 :57– 61.