Health Canada Approves (Pr)POMALYST(TM) (Pomalidomide Capsules) Providing New Hope For Patients With Progressive Multiple Myeloma

POMALYST Is A New Option For Patients
Whose Disease Has Progressed Despite Treatment With Available Therapies

MISSISSAUGA, ON, Feb. 11, 2014 /CNW/ - Health Canada has approved POMALYST™ oral therapy (pomalidomide capsules) in combination with dexamethasone, for patients with multiple myeloma for whom both lenalidomide and bortezomib have failed, who have received at least two prior treatment regimens and have demonstrated disease progression on their last regimen. Until POMALYST, there have been few options for patients whose disease has progressed despite being treated with traditional therapies. Treatment with POMALYST has been shown to improve rates of overall survival and extend progression-free survival in patients who no longer respond to lenalidomide or bortezomib.¹

POMALYST received priority review status by Health Canada due to the high unmet medical need that exists and the clinical value that the treatment brings to patients and physicians.

"The approval of POMALYST is excellent news for the multiple myeloma community. Until now there have been no approved options for patients whose disease has progressed despite available treatments," said Dr. Donna E. Reece, a leading multiple-myeloma-treating hematologist and researcher in Toronto. "With POMALYST, we have a new option that extends periods of remission, is generally well-tolerated and can be taken in the convenience of a patient's home."

The Health Canada approval of POMALYST was based on the MM-003 pivotal study, which was published in The Lancet Oncology in October 2013. A total of 455 patients were enrolled in this Phase III, multi-centre, randomized, open-label study. Patients in the study had received a median of five prior lines of therapy. Median overall survival was significantly improved for the pomalidomide plus low-dose dexamethasone arm, compared with the high-dose dexamethasone only arm (12.7 months versus 8.1 months).² The MM-003 pivotal study also demonstrated significantly improved median progression-free survival of four months (p<0.001) for patients with relapsed refractory multiple myeloma who were treated with pomalidomide plus low-dose dexamethasone, compared with 1.9 months for those treated with high-dose dexamethasone only.³

Treatment with POMALYST has been generally well-tolerated.⁴ The most commonly reported Grade 3 or 4 adverse reactions outlined in the MM-003 study included: anemia (27 per cent), neutropenia (42 per cent) and thrombocytopenia (21 per cent). Other Grade 3 or 4 adverse events reported in this trial were predominately: pneumonia (9 per cent), fatigue (5 per cent), pyrexia (3 per cent) and peripheral edema (1 per cent).⁵

"Since the year 2000, life expectancy of multiple myeloma patients has almost doubled thanks to research and the development of new treatments," said Aldo E. Del Col, Co-founder and Chief Scientific Advisor for Myeloma Canada. "The approval of POMALYST marks another important milestone for Canadian patients and brings us one step closer to transforming multiple myeloma into a long-term, manageable disease."

POMALYST is expected to be commercially available in March 2014.

About Multiple Myeloma

Multiple myeloma is a blood cancer of the plasma cells. Plasma cells are found in the bone marrow, which is the tissue that lies in the hollow interior of bones that produces new blood cells. The word "multiple" is often used because the malignant cells usually affect multiple areas of the bone marrow.

At least 7,000 Canadians are currently living with multiple myeloma.⁶ Multiple myeloma is the second most common blood cancer after non-Hodgkin lymphoma and represents one per cent of all cancers and two per cent of all cancer deaths.⁷ In 2013, it was estimated that 2,500 people were diagnosed with multiple myeloma and 1,350 people died from the disease in Canada.⁸

About POMALYST™

POMALYST™ (pomalidomide capsules) is an oral immunomodulatory drug. Through its targeted action on treatment-resistant myeloma cells, POMALYST inhibits tumour cell growth, triggers cell death and enhances the body's own immune response to the tumour. POMALYST was discovered and developed by Celgene, and represents the third novel oral treatment for multiple myeloma to be approved in Canada.

About RevAid^®

POMALYST will be distributed through an existing controlled distribution program called RevAid^®. This risk management program was developed in 2008 and will now include POMALYST. The RevAid program is designed to prevent fetal exposure to POMALYST, due to its structural similarities to thalidomide, a known human teratogen. Under the program, only prescribers and pharmacists registered with RevAid are able to prescribe and dispense POMALYST. In addition, only those patients who are registered and meet all of the conditions of the RevAid program will receive POMALYST.

About Celgene

Celgene Corporation is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the company's website at www.celgene.com.

POMALYST is a trademark of Celgene Corporation.

---

¹ San Miguel J, Weisel K, Moreau P, Lacy M, Song K, Delforge M, Karlin L, Goldschmidt H, Banos A, Oriol A, Alegre A, Chen C, Cavo M, Garderet L, Ivanova V, Martinez-Lopez J, Belch A, Palumbo A, Schey S, Sonneveld P, Yu X, Sternas L, Jacques C, Zaki M, and Dimopoulos M. Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): A randomised, open-label, phase 3 trial. Lancet Oncol. October 2013; vol 14:1055-1066.
² Ibid
³ Ibid
⁴ Ibid
⁵ Pomalyst™ Product Monograph. Celgene Corporation (2014)
⁶ About myeloma: Incidence and prevalence in Canada [Internet]. Kirkland (QC): Myeloma Canada; 2013 [cited 2014 January 13]. http://www.myeloma.ca/en/incidence_prevalence.htm
⁷ About myeloma [Internet]. Kirkland (QC): Myeloma Canada; 2013 [cited 2014 January 13]. Available from: http://www.myeloma.ca/en/aboutmyeloma.htm
⁸ Multiple Myeloma Statistics [Internet]. Toronto (ON): Canadian Cancer Society; 2013 [cited 2014 January 13]. Available from: http://www.cancer.ca/en/cancer-information/cancer-type/multiple-myeloma/statistics/?region=on#ixzz2nxd169c0

SOURCE: Celgene Corporation

FOR MEDIA INTERVIEWS, PLEASE CONTACT:
Camille Beaubien, Weber Shandwick, [phone], [email protected]