Ontario Government Announces Reimbursement of Velcade* As First-Line Treatment For Newly-diagnosed Blood Cancer Patients

    - Myeloma Canada, Patients and Professionals Applaud Ontario for its
    Leadership in Providing Patients with Treatment Access -

    TORONTO, May 13 /CNW/ - Today, Ontarians diagnosed with multiple myeloma,
a severely painful and fatal form of blood cancer, will have access to funding
for VELCADE(*) (bortezomib), the first novel agent used as a first-line
treatment for the disease. VELCADE is now listed on Cancer Care Ontario's New
Drug Funding Program (NDFP) Formulary after a positive recommendation from the
Committee to Evaluate Drugs (CED) in Ontario. The CED also acts as an interim
review body on behalf of the Joint Oncology Drug Review, a
cross-jurisdictional review process for oncology drugs in all provinces except
    As a first-line therapy for patients who are not candidates for stem cell
transplants, VELCADE is combined with the current standard of treatment -
melphalan and prednisone (MP).(1) The combination of VELCADE and MP has
demonstrated improved efficacy compared to current standard of treatment
alone.(2) VELCADE received a Notice of Compliance from Health Canada in 2008
for first-line treatment of multiple myeloma(1) and is marketed by Ortho
Biotech, a division of Janssen-Ortho Inc.
    "Multiple myeloma continues to increase in prevalence in Canada. It is
essential that patients have access to the most effective and safest
combination treatment that provides them with the best opportunity for
survival," said John Lemieux, President, Myeloma Canada.
    Carolyn Henry, a multiple myeloma patient and leader of the London and
District Myeloma Support Group knows firsthand the challenges of the disease.
"Living with this cancer, I understand how important new treatment
combinations are to maintaining my health and quality of life. Ontarians are
fortunate to have access to VELCADE as a first-line treatment that will offer
newly-diagnosed patients a new approach and renewed hope in fighting this
tenacious disease."

    Addition of VELCADE Improves Overall Survival

    The recommendation for funding was based on the findings of the "VELCADE
as Initial Standard Therapy in Multiple Myeloma: Assessment with Melphalan and
Prednisone" (VISTA) trial, which demonstrated that the addition of VELCADE to
the current standard treatment significantly improved the time to progression
of the disease, complete response to treatment and the treatment-free interval
time.(2) The VISTA study results showed that the overall survival rate, at 24
months, for myeloma patients was 82.6 per cent for patients who received
VELCADE along with MP combination treatment compared to only 69.5 per cent for
those who received MP combination alone.(1)
    "As an oncologist, until now, I have diagnosed all too many patients with
advanced stage myeloma who could have benefited from VELCADE as a first-line
treatment," said
    Dr. Donna Reece, Hematologist, Toronto. "Today's news will allow me to
provide a highly effective, fast-acting treatment that will improve the life
expectancy of my patients. As the new standard of first-line care, VELCADE and
MP allows patients to experience longer treatment-free intervals so they can
live fuller, more productive lives."

    About Multiple Myeloma in Canada

    As of 2003, an estimated 6,200 Canadians were living with multiple
myeloma.(3) In 2009, new cases of multiple myeloma are estimated to reach
2,2004 and the number of deaths from this disease is estimated to reach

    About VELCADE (bortezomib) for Injection

    VELCADE offers a completely novel approach to treating multiple myeloma
by acting on a unique target in cells called the proteasome. By blocking the
proteasome, VELCADE disrupts processes related to the growth and survival of
cancer cells. The proteasome is a structure that exists in all cells and plays
an important role in breaking down proteins that control how the cell lives
and grows.(5)
    VELCADE was first approved in Canada under a Notice of Compliance with
Conditions in January 2005 for the treatment of patients with multiple myeloma
who have relapsed following front-line therapy and are refractory to their
most recent therapy.
    VELCADE was also recently approved for the treatment of patients with
mantle cell lymphoma (MCL), who have relapsed or are refractory to at least
one prior therapy. MCL is a type of non-Hodgkin's lymphoma, which is a cancer
of the blood that affects the white blood cells.
    VELCADE is currently funded across Canada for the treatment of relapsed
or refractory multiple myeloma. Ortho Biotech will continue to seek funding
across Canada for this new indication of front-line treatment of newly
diagnosed, previously untreated multiple myeloma patients.
    The safety profile of VELCADE in combination with melphalan/prednisone is
consistent with the known safety profiles of both VELCADE and
melphalan/prednisone. In most cases side effects are manageable with
appropriate monitoring and, if necessary, dose reduction. VELCADE is
contraindicated in patients with hypersensitivity to bortezomib, boron, or any
of the excipients. In the VISTA clinical trial, the most commonly reported
adverse events included thrombocytopenia, neutropenia, leucopenia,
lymphopenia, anemia, nausea, diarrhea, constipation, vomiting, peripheral
neuropathy, neuralgia, fever, fatigue and asthenia.
    VELCADE is co-developed by Millennium Pharmaceuticals, Inc. and Johnson &
Johnson Pharmaceutical Research & Development, L.L.C. Millennium is
responsible for commercialization of VELCADE in the U.S., Janssen-Cilag is
responsible for commercialization in Europe and the rest of the world. Janssen
Pharmaceutical K.K. is responsible for commercialization in Japan. VELCADE is
approved in more than 87 countries worldwide.

    Ortho Biotech - Division of Janssen-Ortho Inc.

    Ortho Biotech is a leading Canadian biopharmaceutical healthcare company
committed to bringing innovative treatments to Canadians in the areas of
anemia, oncology, and nephrology.

    (*) Trademark of Millennium Pharmaceuticals, Inc., all trademark rights
        used under license.


    (1) VELCADE Product Monograph, August 29, 2008.
    (2) San Miguel, Jesus F., "Bortezomib plus Melphalan and Prednisone for
        Initial Treatment of Multpile Myeloma," New England Journal of
        Medicine, vol. 359, August 28, 2008, pp 906-917.
    (3) Calculated Canadian estimate based on US prevalence (according to
        "Orphan Products: Hope for People With Rare Diseases" By Carol Rados,
        FDA Consumer magazine, November-December 2003 Issue, about 63,000
        people in the United States are affected by multiple myeloma).
    (4) Canadian Cancer Society/National Cancer Institute of Canada: Canadian
        Cancer Statistics 2009, available at:
    (5) Health Canada. Condition Approval of VELCADE Fact Sheet. January 27,

For further information:

For further information: Marc Esposito, MS&L, (416) 847-1344,
marc.esposito@mslworldwide.com; Maggie Wang, Janssen-Ortho Inc., (416)
382-5957, mwang12@its.jnj.com

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