Searchlight Pharma Announces Launch of Bulkamid® for Treatment of Female Stress Urinary Incontinence

Facts About Female Stress Urinary Incontinence (SUI)

• One in three women have SUI at some point in their lives.
• SUI is caused by a weakness in the pelvic floor preventing the urethra (the tube that urine comes out of) from closing fully.
• The condition is very common among women of all ages and increases as women get older.
• Apart from aging, other factors include childbirth, obesity or some form of a pelvic floor disorder.

MONTREAL, May 10, 2018 /CNW Telbec/ - Searchlight Pharma, a Canadian specialty pharmaceutical company committed to improving life-long human health and wellness, today announced the launch of commercial activities for Bulkamid^® for the treatment of female stress urinary incontinence ("SUI"). Bulkamid^® which is manufactured by Contura International, and distributed and promoted by Searchlight Pharma, is available nationwide in Canada. Searchlight Pharma acquired the Canadian distribution rights in December 2017.

Bulkamid® is a soft hydrogel that consists of 97.5% water and 2.5% polyacrylamide. Once injected, Bulkamid® provides additional volume to the urethra and acts as a scaffold for cells to grow through, helping to provide long lasting relief of SUI symptoms. According to the Urology Care Foundation, one in three women have SUI at some point in their lives¹ and based on published data, three out of four women report that their SUI was cured or improved after treatment with Bulkamid®².

"Bulkamid® provides Canadian women with an effective and safe treatment alternative to surgical procedures that involve tapes, slings and meshes. While these surgical procedures are considered to be the current standard of care, with over 50,000 patients treated globally with Bulkamid® who report no long-term complications, we are confident that through our commercial activities Bulkamid® will become the new standard of care for SUI in Canada," said Mark Nawacki, President & CEO of Searchlight Pharma.

"We are pleased to support Searchlight Pharma in its commercial activities in the Canadian market," said Rakesh Tailor, Chief Operating Officer of Contura International. "The body of evidence supporting Bulkamid's genuine first-line use in the treatment of female SUI continues to grow, and we are confident that we have selected the best commercial partner and premier women's health specialist to help disseminate this message in Canada. In addition, given the current controversy surrounding the use of slings and meshes for SUI treatment, we look forward to the 1 year results later this year from the head to head study of TVT versus Bulkamid³. We expect that it will help to evolve both healthcare professional and patient perceptions regarding SUI treatment in Canada and favourably position Bulkamid as the genuine first choice."

About Stress Urinary Incontinence

Stress urinary incontinence (SUI) is very common among women of all ages and increases as women get older. Apart from aging, other factors include childbirth, obesity or some form of a pelvic floor disorder.

Stress urinary incontinence is caused by a weakness in the pelvic floor, preventing the urethra (the tube that urine comes out of) from closing fully when sudden pressure is put on the bladder. This can allow urine to leak out during normal daily activities for example when coughing, laughing, walking or exercising.

About Bulkamid®

Bulkamid® is a homogenous hydrophilic hydrogel used in the treatment of female stress urinary incontinence. The product was granted CE approval in 2003 and is currently sold in more than 25 countries worldwide. Bulkamid® is delivered to the patient under endoscopic control using the Bulkamid® Urethral Bulking System.

In 2014 the pivotal North American study for the product was published, reporting on the efficacy and safety of Bulkamid® for the treatment of female stress incontinence in a randomised, prospective, multicentre trial across 33 sites in the USA and Canada. This North American study formed the basis of Contura's Premarket Approval ("PMA") submission with the Federal Drug Administration  ("FDA") in the United States in July 2017, which is currently under review.

To learn more about Bulkamid® and SUI go to www.bulkamid.com.

About Searchlight Pharma Inc.

Searchlight Pharma Inc., headquartered in Montreal, aspires to become a leading Canadian-based specialty healthcare company through best-in class execution of the search, acquisition, commercialization, and focused development of innovative and unique specialty healthcare products that improve life-long human health and wellness. With a core focus on women's health, urology, and pediatrics, our team is committed to improving people's lives by bringing the right products to market. Follow us, learn more about what we do, and get to know our product portfolio at www.searchlightpharma.com.

About Contura International

Contura is a European group which specializes in the distribution and sale of healthcare products, both pharmaceuticals and medical devices, focused primarily upon the fields of urology and urogynaecology. Its lead products are: Bulkamid®, Aquamid®, Regurin® XL and Cystistat®.

Contura was founded as Speciality European Pharma ("SEP") in 2006. In 2013, SEP acquired Contura A/S, a Danish company based in Copenhagen. Contura A/S had two marketed products at the time of its acquisition by SEP, Bulkamid® and Aquamid®. It also had a number of development programmes focused upon additional uses of its hydrogel technology. In 2016, SEP was acquired by its management team in conjunction with new investors and subsequently rebranded as Contura in December 2017. Contura has established a sales and marketing infrastructure in the leading European markets, either through its own sales force or through distribution partners and has offices in the UK, Denmark, Germany, France and Italy.

¹ Urology Care Foundation, Stress Urinary Incontinence, the Official Foundation of the American Urological Association

² Sokol ER, Karram MM, Dmochowski R. Efficacy and safety of polyacrylamide hydrogel for the treatment of female stress incontinence: a randomized, prospective, multicenter North American study. J Urol. 2014 Sep;192(3):843-9

³ For more information about the TVT versus Bulkamid trial visit www.clinicaltrials.gov and enter identifier NCT02538991.

SOURCE Searchlight Pharma

for media representatives only: Mark Nawacki, CPA, CA, President & CEO Searchlight Pharma Inc., Phone: [phone], [email protected]; Patrick Banks, CEO Contura Limited, Phone: [phone], [email protected]