VELCADE® for injection receives EU marketing authorisation for second-line use in multiple myeloma

April 28, 2005

HIGH WYCOMBE, UK, 28th April 2005 - Ortho Biotech, the biopharmaceutical division of Janssen-Cilag, today announced that the European Commission has approved the use of VELCADE® (bortezomib) for Injection as a second-line treatment in patients with multiple myeloma. It is indicated as monotherapy for use in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplantation. With today's announcement, more multiple myeloma patients can hope to receive earlier access to VELCADE® treatment. This decision formally ratifies the Committee for Human Medicinal Product Opinion made on 16th March 2005.

VELCADE® received U.S. Food and Drug Administration (FDA) approval for second-line use in multiple myeloma in March of this year. It is indicated in the U.S. for patients who have received at least one prior line of therapy.

Multiple myeloma is the second most common blood cancer, representing approximately one percent of all cancers and two percent of all cancer deaths.(ref 1) In 2002 there were approximately 85,700 cases of multiple myeloma worldwide, with over 26,000 of these cases occurring in the EU.(ref 2) Only 30 percent of multiple myeloma patients survive longer than five years.(ref 3) More than 18,000 people in the EU die each year from the disease. (ref 2)

Professor Jesus San Miguel, Professor of Medicine at the University Hospital in Salamanca, Spain, commented, "The results we've seen in patients who have received VELCADE® as the backbone at an earlier stage in the treatment cycle have been highly promising."

VELCADE® offers a completely novel approach to treating multiple myeloma by acting on a unique target in cells called the proteasome. First approved in Europe on 26th April 2004 for the treatment of multiple myeloma patients who had received at least two prior therapies, VELCADE® was the first treatment in more than a decade to be approved for this group of patients.

Assessment of Proteasome Inhibition on EXtending (APEX) Remission Results

The second line approval is based on the results of the APEX trial (ref 4), an international phase III study comparing VELCADE® against standard therapy high-dose dexamethasone in patients with relapsed multiple myeloma. The study demonstrated a significant survival advantage with VELCADE® in patients who had received one to three prior therapies. Importantly, this pronounced survival advantage also was observed in the second-line multiple myeloma patients where 55 percent fewer patients died in the VELCADE® arm relative to dexamethasone.(ref 4)

Eric Low, Executive Director, International Myeloma Foundation U.K. commented, "If cutting-edge treatments such as VELCADE® can be used to treat at an early stage, this is good news for patients. The myeloma community will continue to support any advances in the treatment of this disease."

VELCADE® has a predictable safety profile and a favourable risk-to-benefit ratio. The most common side effects reported with VELCADE® include reversible new or worsening neuropathy; orthostatic hypotension - an abnormal decrease in blood pressure upon standing; congestive heart failure; and gastrointestinal adverse events.

VELCADE® is currently available in more than 46 countries worldwide including the U.S., most of Europe, and a number of countries within Latin America and South-East Asia such as Argentina, China, Korea, Singapore and Thailand. There are approximately 80 ongoing clinical trials (in Europe and the U.S.) investigating the use of VELCADE® in all stages of multiple myeloma and other solid tumour and haematological cancers.

VELCADE® is being co-developed by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and Millennium Pharmaceuticals, Inc. Millennium is responsible for the commercialization of VELCADE® in the U.S.; Ortho Biotech and Janssen-Cilag are responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for Japan.
2. GLOBOCAN 2002,
3. Brenner H. Long-term survival rates of cancer patients achieved by the end of the 20th century: a period analysis. Lancet 2002; 360:1131-1135.
4. Abstract 336.5 presented at American Society of Hematology 47th Annual Meeting. Richardson P et al. Bortezomib demonstrates superior efficacy to high-dose dexamethasone in relapse multiple myeloma: Final report of the APEX Study.


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