Toronto, ON (Press Release) – Teva Canada Limited, a sub­sid­i­ary of Teva Pharma­ceu­tical Industries Ltd., announced that Health Canada has approved its appli­ca­tion for the generic version of ^PrBortezomib for Injection for the fol­low­ing indi­ca­tions:

• As part of com­bi­na­tion ther­apy for the treat­ment of patients with pre­vi­ously untreated multiple myeloma who are unsuitable for stem cell trans­plan­ta­tion.
• For the treat­ment of progressive multiple myeloma in patients who have received at least one prior ther­apy and who have already undergone or are unsuitable for stem cell trans­plan­ta­tion.
• For the treat­ment of patients with mantle cell lym­phoma who have re­lapsed or were refractory to at least one prior ther­apy.

Teva Canada was the lead litigator in suc­cess­fully chal­leng­ing the patents protecting Velcade® that would have other­wise impeded generic entry until Jan­u­ary­ 2022. ^PrVelcade® had annual sales of approx­i­mately $93.6 million in Canada, based on IMS Brogan sales data as of Jan­u­ary­ 2015. ^PrBortezomib for Injection is avail­able im­medi­ately in hos­pi­tal pharmacies across Canada.

"Our lit­i­ga­tion success in bringing Bortezomib for Injection to mar­ket sooner will save Canadian hos­pi­tals millions of dollars be­tween today and when the patent was set to expire in Jan­u­ary­ 2022," said Doug Sommerville, Senior Vice Pres­i­dent and General Manager, Teva Canada Limited. "We take pride in our compliance with Health Canada reg­u­la­tions as well as with our lit­i­ga­tion leadership to suc­cess­fully advocate on behalf of patients, provinces and hos­pi­tals to bring more affordable, safe medications to the mar­ket as soon as possible, leaving value in the sys­tem for inno­va­tion into the next generation of med­i­cines."

Multiple myeloma is a term that refers to cancer of the plasma cells, found in the bone marrow (the hollow area within the bones of the body).^[i] According to the Canadian Cancer Society, it is esti­mated that 2,600 new cases of multiple myeloma were diag­nosed in 2014 (1,450 men and 1,100 women).^[ii] Multiple myeloma is the second most prevalent blood cancer after non-Hodgkin's lym­phoma.^[iii] The second indi­ca­tion for Bortezomib for Injection is for mantle cell lym­phoma, which develops in the outer edge of a lymph node, also called the mantle zone. This type of lym­phoma makes up about six per cent of all non-Hodgkin lym­phomas, usually in adults over the age of 50.^[iv]

About Teva Canada Limited

Teva Canada Limited, headquartered in Toronto, has provided affordable health­care solu­tions for 50 years, with nearly 200,000^[v] prescriptions filled with our prod­ucts every day. Originally Novopharm Limited, Teva Canada specializes in the devel­op­ment, pro­duc­tion and mar­ket­ing of high-quality generic prescription pharma­ceu­ticals and through our branded division, Teva Canada Innovation, focuses on a diverse line of inno­va­tive prod­ucts in a variety of thera­peutic areas. Teva Canada employs more than 1,300 individuals, mar­kets more than 400^[vi] prod­ucts in Canada and is a sub­sid­i­ary of Teva Pharma­ceu­tical Industries Ltd., the world's largest generic drug maker. For more in­for­ma­tion, visit: www.tevacanada.com or www.tevamakesmedicines.ca.

About Teva Pharma­ceu­tical Industries Ltd.

Teva Pharma­ceu­tical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharma­ceu­tical com­pany that de­livers high-quality, patient-centric health­care solu­tions to millions of patients every day. Headquartered in Israel, Teva is the world's largest generic med­i­cines producer, leveraging its port­folio of more than 1,000 molecules to produce a wide range of generic prod­ucts in nearly every thera­peutic area. In specialty med­i­cines, Teva has a world-leading position in inno­va­tive treat­ments for disorders of the central nervous sys­tem, in­clud­ing pain, as well as a strong port­folio of res­pira­tory prod­ucts. Teva integrates its generics and specialty capabilities in its global research and devel­op­ment division to create new ways of addressing unmet patient needs by combining drug devel­op­ment capabilities with devices, services and tech­nolo­gies. Teva's net revenues in 2014 amounted to $20.3 billion. For more in­for­ma­tion, visit www.tevapharm.com.

References

1. Myeloma Canada. What is Myeloma. http://www.myelomacanada.ca/en/whatismyeloma.htm. Accessed March 2015.
2. Canadian Cancer Society. Canadian Cancer Statistics 2014. http://www.cancer.ca/~/media/cancer.ca/CW/cancer%20information/cancer%20101/Canadian%20cancer%20statistics/Canadian-Cancer-Statistics-2014--EN.pdf. Accessed March 2015.
3. Myeloma Canada. Incidence and prev­a­lence in Canada. http://www.myelomacanada.ca/en/incidence_prevalence.htm. Accessed March 2015.
4. Canadian Cancer Society. Non-Hodgkin lym­phoma. http://www.cancer.ca/en/cancer-information/cancer-type/non-hodgkin-lymphoma/non-hodgkin-lymphoma/types-of-nhl/mantle-cell-lymphoma/?region=on. Accessed March 2015.
5. IMS Compuscript TRx MAT Sep­tem­ber 2014
6. IMS CD&H MAT Sep­tem­ber 2014

Source: Teva Canada.