Graceway Pharmaceuticals Announces Health Canada Has Approved PrVylomaTM (Imiquimod) Cream 3.75% for the Treatment of External Genital Warts

Vyloma Offers a Short Daily-Dosing Cycle with Sustained Efficacy

TORONTO--(BUSINESS WIRE)--Graceway Pharmaceuticals Canada announced that Health Canada has approved Vyloma¹ (imiquimod) Cream 3.75%, a topical prescription for the treatment of external genital warts (EGW) and perianal warts for patients 18 years of age and older. Genital warts are usually painless but can cause itching or a burning sensation and occasionally, minor bleeding. They are very contagious and are spread during oral, vaginal or anal sex with an infected partner.²

“Imiquimod 2.5% and 3.75% applied daily for up to 8 weeks to treat external genital warts.”

Vyloma’s clinical studies demonstrated that using the once-daily treatment regimen for up to eight weeks safely and effectively clears genital warts. For patients who achieved complete clearance, nearly 70 per cent had sustained clearance measured at 12 weeks post-treatment.³ Most approved topical prescription treatments currently available to treat EGW are associated with lengthy treatment regimens, which may impact patient compliance. Vyloma was developed to meet the need for a shorter treatment regimen, while maintaining the efficacy (both initial and sustained clearance) that imiquimod has delivered in the past.

Two Phase III double-blind, placebo-controlled efficacy and safety studies of imiquimod 3.75% cream evaluated complete clearance of all warts - defined as clearance of baseline and emergent warts - across several anogenital locations.⁴

In an intent-to-treat analysis of all participants who began the study, regardless of whether they completed it, complete clearance of all warts was achieved in 28.3 per cent of patients on imiquimod 3.75% cream, compared to 9.4 per cent on placebo cream.⁵ Additionally, efficacy was greater in females than males for all primary and secondary efficacy measurements, and 43.1 per cent of females on the 3.75% formulation achieved complete clearance compared to 22.7 per cent of males.⁶ In subjects achieving complete clearance, 12-week sustained complete clearance was assessed. Of those who achieved initial complete clearance and entered the 12-week follow-up, complete clearance was sustained in 69.6 per cent of subjects on imiquimod 3.75% cream.⁷

“Vyloma offers patients with genital warts a short-term, once-daily dosing and convenient treatment option,” says Dr. Marc Steben, clinician at l’Actuel medical clinic and associate clinician at the Direction of Biological Risks and Health at Work at the National Public Health Institute of Quebec. “In my clinical experience, genital warts commonly recur after treatment. In clinical trials, Vyloma showed promising results in significantly reducing genital wart recurrence at twelve weeks in the majority of patients who previously cleared.”

“Many of the currently approved topical treatments for genital warts are not ideal due to lengthy and confusing dosing regimens,” says Jefferson J. Gregory, Chairman and CEO of Graceway Pharmaceuticals. “Our vision is to improve the patient experience by offering a more intuitive dosing regimen, once daily treatment for up to eight weeks, with the goal of improving patient compliance.”

The most frequently reported adverse events were local skin and application site reactions. Overall, less than one per cent of subjects treated with Vyloma discontinued due to local skin / application site reactions. Local skin reactions included erythema, edema, weeping/exudate, flaking/scaling/dryness scabbing/crusting and erosion/ulceration.⁸

Vyloma is self-applied, allowing for convenient treatment at home; it is available by prescription only.⁹

Canadian Attitudes and Opinions on Genital Warts

Research shows that Canadians may not be taking the risk of genital warts seriously. According to a new survey,¹⁰ only 28 per cent of Canadians say if they had a spot on their genitals that they did not recognize would they go to their doctor immediately.¹¹ In fact, more than half (52 per cent) say they would wait and monitor to see if the spot went away before seeing a doctor.¹² When asked about contracting genital warts, most Canadians cited judgement by family and friends (44 per cent),¹³ decreased self-esteem (53 per cent),¹⁴ shame (54 per cent)¹⁵ and embarrassment (34 per cent)¹⁶ as feelings commonly associated with the diagnosis.

According to the survey, 44 per cent of Canadians believe it is difficult to get rid of genital warts because they come back.¹⁷ Certain treatment options can help clear genital warts and keep them clear, despite the HPV virus remaining in the body. Until the introduction of Vyloma, treatments for patients with genital warts included other topical creams, cryotherapy, trichloroacetic acid (TCA), electrocautery and laser therapy.¹⁸ When polled, 58 per cent of Canadians say if they were to be treated for genital warts, they would prefer to use a prescription cream over an invasive treatment.¹⁹

External Genital Warts²⁰

Genital warts are caused by the HPV (human papilloma virus) on the surface skin. The virus lives in the outer layer of skin (epidermis) and just below the skin surface (sub-clinical area) and may not produce many changes on the skin surface when observed by the naked eye. Warts can exist alone, in a group, or in many groups.

External genital warts are found most often in the areas of highest friction during sexual activity; they can be found anywhere in the genital or anal area. Genital warts are usually without symptoms therefore it is possible to be unknowingly infected with HPV. Lumps and bumps may be visible and also can be felt as they grow bigger. Symptoms can include itching, bleeding, or mild burning. With proper treatment genital wart sufferers can live a normal life.

For more information on genital warts, visit genitalwarts.ca, or to join a discussion group visit genitalwartspatients.com.

About Graceway Pharmaceuticals^TM

Graceway Pharmaceuticals Canada ("Graceway Canada"), headquartered in London, ON, is a wholly-owned subsidiary of Graceway Pharmaceuticals, LLC, based in Bristol, TN in the United States. Graceway is a pharmaceutical company focused on acquiring, in-licensing, and developing branded prescription pharmaceutical products. Graceway initially acquired the imiquimod franchise as part of its acquisition of 3M’s (NYSE: MMM) branded pharmaceutical business in the United States and Canada. Graceway has also completed acquisitions of other molecules or compounds from, among other companies, Pfizer, Inc. (NYSE: PFE) and Gilead Sciences, Inc. (NASDAQ: GILD).

Current prescription products marketed by Graceway Canada include, among others, Zyclara^® (imiquimod) 3.75%, Aldara^TM (imiquimod) 5%, QVAR™ (beclomethasone dipropionate metered dose aerosol), Nidagel^TM (0.75% vaginal gel) and other products in women’s health and cardiology. For more information on Graceway's products, including important safety information, please visit www.gracewaypharma.ca

Graceway, Vyloma, Zyclara, Aldara, QVAR and Nidagel are registered or pending trademarks of Graceway Pharmaceuticals, LLC.

¹ [Health Canada NOC announcement]

² HPVInfo.ca http://hpvinfo.ca/hpvinfo/adults/complications-risks.aspx

³ Ferris D et al. “Imiquimod 2.5% and 3.75% applied daily for up to 8 weeks to treat external genital warts.” Poster presented at Human Papillomavirus Conference 2010. Abstract: Results section.

⁴ Ferris D et al. “Imiquimod 2.5% and 3.75% applied daily for up to 8 weeks to treat external genital warts.” Poster presented at Human Papillomavirus Conference 2010. Abstract: Methods section.

⁵ Ferris D et al. “Imiquimod 2.5% and 3.75% applied daily for up to 8 weeks to treat external genital warts.” Poster presented at Human Papillomavirus Conference 2010. Abstract: Results section.

⁶ Ferris D et al. “Imiquimod 2.5% and 3.75% applied daily for up to 8 weeks to treat external genital warts.” Poster presented at Human Papillomavirus Conference 2010. Clearance rates by gender graph.

⁷ Ferris D et al. “Imiquimod 2.5% and 3.75% applied daily for up to 8 weeks to treat external genital warts.” Poster presented at Human Papillomavirus Conference 2010. Clearance rates by sustained clearance table.

⁸ Vyloma Product Monograph p. 6-7 of 27

⁹ Vyloma Product Monograph p. 25 of 27

¹⁰ Leger Marketing Survey – Vyloma Poll Questions: Report. February 2011

¹¹ Leger Marketing Survey – attitudes and opinions on genital warts. February 2011 p 1

¹² Leger Marketing Survey – attitudes and opinions on genital warts. February 2011 p 1

¹³ Leger Marketing Survey – attitudes and opinions on genital warts. February 2011 p 22

¹⁴ Leger Marketing Survey – attitudes and opinions on genital warts. February 2011 p 25

¹⁵ Leger Marketing Survey – attitudes and opinions on genital warts. February 2011 p 28

¹⁶ Leger Marketing Survey – attitudes and opinions on genital warts. February 2011 p 31

¹⁷ Leger Marketing Survey – attitudes and opinions on genital warts. February 2011 p 45

¹⁸ Ashastd.org http://www.ashastd.org/hpv/hpv_learn_warts.cfm#7

¹⁹ Leger Marketing Survey – attitudes and opinions on genital warts. February 2011 p 51

²⁰ Genitalwarts.ca http://www.genitalwarts.ca/do_i_have_genital_warts.html