Celgene Announces New Drug Application Filing for REVLIMID® in Japan

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Tue Jul 7, 2009 1:30am EDT

REVLIMID filing based on safety and efficacy results of two large, randomised
pivotal Phase III trials, as well as specific Japanese studies

NDA is for REVLIMID in combination with dexamethasone for multiple myeloma
patients who have received at least one prior therapy
BOUDRY, Switzerland--(Business Wire)--
Celgene International Sàrl (NASDAQ:CELG) today announced it has filed a New Drug
Application (NDA) with the Japanese Ministry of Health, Labour and Welfare
(MHLW) for REVLIMID (lenalidomide) in combination with dexamethasone for the
treatment of patients with multiple myeloma who have received at least one prior
therapy. Approximately 11,000 people in Japan suffer from multiple myeloma and
around 4,000 patients are diagnosed each year. 

"The filing of an NDA in Japan for multiple myeloma represents an important step
towards achieving our goal of delivering REVLIMID to patients in need in one of
the world`s largest oncology populations," said Joseph Melillo, General Manager
of Celgene KK. 

The filing with the MHLW is based upon the safety and efficacy results of two
large, randomised pivotal Phase III special protocol assessment trials: North
American Trial MM-009 and International Trial MM-010 evaluating REVLIMID plus
dexamethasone in multiple myeloma patients who have received at least one prior
therapy. Both studies were published in the New England Journal of Medicine in
November 2007. Phase I clinical results with Japanese patients, including those
from MM-017, confirm similar efficacy and further support the filing. 

REVLIMID was granted orphan drug status in February 2008 by the MHLW in Japan
for two indications - the treatment of anaemia due to low- or
intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion
5q cytogenic abnormality with or without other cytogenic abnormalities, and in
combination with dexamethasone for multiple myeloma patients who have received
at least one prior therapy. 

REVLIMID is approved in combination with dexamethasone for the treatment of
patients with multiple myeloma who have received at least one prior therapy in
nearly 50 countries, encompassing Europe, the Americas, the Middle-East and
Asia, and in combination with dexamethasone for the treatment of patients whose
disease has progressed after one therapy in Australia and New Zealand. 

REVLIMID® is also approved in the United States, Canada and several Latin
American countries, as well as Malaysia and Israel, for transfusion-dependent
anaemia due to low- or intermediate-1-risk MDS associated with a deletion 5q
cytogenetic abnormality with or without additional cytogenetic abnormalities.
Marketing Authorisation Applications are currently being evaluated in a number
of other countries. 

About REVLIMID

REVLIMID is an IMiDs® compound, a member of a proprietary group of novel
immunomodulatory agents. REVLIMID and other IMiDs compounds continue to be
evaluated in over 100 clinical trials in a broad range of oncological
conditions, both in blood cancers and solid tumors. The IMiDs pipeline is
covered by a comprehensive intellectual property estate of issued and pending
patent applications including composition-of-matter and use patents. 

About Multiple Myeloma

Multiple myeloma (also known as myeloma or plasma cell myeloma) is a cancer of
the blood in which malignant plasma cells are overproduced in the bone marrow.
Plasma cells are white blood cells that help produce antibodies called
immunoglobulins that fight infection and disease. However, most patients with
multiple myeloma have cells that produce a form of immunoglobulin called
paraprotein (or M protein) that does not benefit the body. In addition, the
malignant plasma cells replace normal plasma cells and other white blood cells
important to the immune system. Multiple myeloma cells can also attach to other
tissues of the body, such as bone, and produce tumors. The cause of the disease
remains unknown. 

About Celgene International Sàrl

Celgene International Sàrl, located in Boudry, Switzerland, is a wholly owned
subsidiary and international headquarters of Celgene Corporation. Celgene
Corporation, headquartered in Summit, New Jersey, is an integrated global
pharmaceutical company engaged primarily in the discovery, development and
commercialization of innovative 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. 

REVLIMID® is a registered trademark of Celgene Corporation.

This release contains certain forward-looking statements which involve known and
unknown risks, delays, uncertainties and other factors not under the Company's
control, which may cause actual results, performance or achievements of the
Company to be materially different from the results, performance or other
expectations implied by these forward-looking statements. These factors include
results of current or pending research and development activities, actions by
the FDA and other regulatory authorities, and those factors detailed in the
Company's filings with the Securities and Exchange Commission such as Form 10-K,
10-Q and 8-K reports.



Celgene International Sàrl
Kevin Loth, +41-32-729-86-21
Director of External Relations 

Copyright Business Wire 2009

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