Trelstar® Six-Month Dosing for Prostate Cancer Patients Launches in Canada

Toronto, Canada and Lausanne, Switzerland – September 30, 2014 – Trelstar® (triptorelin pamoate), indicated in Canada for the palliative treatment of hormone dependent advanced prostate cancer(1), is now available in a six-month dosing option (22.5 mg). The new dosing option eases the burden on patients, with a decreased number of injections and a low incidence of injection site pain, while providing long-term sustained testosterone suppression(2).

The announcement comes out of Actavis Specialty Pharmaceuticals Co. and Debiopharm Group™, the original developer and sole manufacturer of Trelstar®. Trelstar® was previously marketed by Paladin in Canada, and is currently marketed by Actavis Specialty Pharmaceuticals Co. as of July 1st, 2014.

Prostate cancer is the most common cancer in Canadian men and is the second leading cause of male cancer deaths in Canada. Each year around 23,600 new cases are diagnosed, and close to 4,000 Canadian men die of the disease(3).

“In patients with advanced prostate cancer, we seek treatment options that will have the most benefit in terms of quality of life and survival,” says Dr. Laurence Klotz, Chief, Urology, Sunnybrook Health Sciences Centre and Professor, Department of Surgery, University of Toronto. “Six-month Trelstar® offers improved quality of life for patients – the requirement for half as many needles and clinic visits makes a difference.”

Trelstar® is an agonist analogue of natural gonadotropin-releasing hormone (GnRH). Similar to other GnRH agonists, it reduces the level of sex hormones, such as testosterone, in the body(4). Reducing testosterone levels helps slow disease progression in addition to reducing the bone pain, urinary problems and other symptoms of prostate cancer(5).

“We are committed to developing treatments that make a difference to patients,” says Rob Tessarolo, General Manager, Actavis Specialty Pharmaceuticals Co. “Prostate cancer is the most common cancer in men and a challenging illness. We are pleased to announce the new dosing option for Trelstar® and to welcome a trusted brand back to the Actavis family.”

“We are glad to further strengthen our collaboration with Actavis Specialty Pharmaceuticals Co. who becomes our unique commercial partner in North America for Trelstar®,” says Thierry Mauvernay, Delegate of the Board of Debiopharm Group™. “We share a common philosophy with Actavis, focused on improving quality of life for men suffering from prostate cancer.”

About Trelstar® (triptorelin pamoate)
Triptorelin is an agonist analogue of the natural gonadotropin-releasing hormone (GnRH), indicated for the palliative treatment of prostate cancer. Triptorelin was discovered by Professor Andrew Schally, who received the Nobel Prize in 1977 for this discovery. The one- and three-month formulations have been registered in numerous countries and are currently available under the name of Trelstar® in North America. The six-month formulation has been registered and is available in the US, Europe, and Singapore.

About Actavis plc
Actavis plc is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing, brand, biosimilar and generic products. Actavis has global headquarters in Dublin, Ireland and US administrative headquarters in Parsippany, New Jersey, USA. Actavis Specialty Pharmaceuticals Co. based in Oakville, Ontario, is the company’s branded specialty pharmaceutical business in Canada engaged in the marketing, sale and distribution of specialty pharmaceutical products within the Canadian market. Actavis Specialty Pharmaceuticals Co. is focused on delivering innovative products that address key therapeutic categories in gastroenterology, women’s health, urology, central nervous system, respiratory, cystic fibrosis, dermatology and osteoporosis.

About Debiopharm Group™
Debiopharm Group™ is a Swiss-based global biopharmaceutical group of four companies active in drug development, GMP manufacturing of proprietary drugs, diagnostics, and investments. Debiopharm International SA is focused on the development of prescription drugs that target unmet medical needs. The company in-licenses, develops and/or co-develops promising biological and small molecule drug candidates for global registration. The products are commercialized throughout-licensing to pharmaceutical partners to give access to the largest number of patients worldwide. For more information about Debiopharm Group™, please visit: www.debiopharm.com

References

(1) TRELSTAR Product Monograph, (Paladin Labs Inc.), August 11, 2014.
(2) Based on a 12-month, multicenter, open-label, non-comparative phase 3 clinical study evaluating the efficacy, pharmacokinetics, and safety of 2 injections of 6-month TRELSTAR 22.5 mg formulation in patients with advanced prostate cancer (N=120).
(4) Movember. http://ca.movember.com/mens-health/prostate-cancer. Accessed September 9, 2014.
(5) TRELSTAR Product Monograph, (Paladin Labs Inc.), August 11, 2014.
(6) TRELSTAR Product Monograph, (Paladin Labs Inc.), August 11, 2014.