[CELGENE LOGO]
Exhibit 99.1
Contact: Robert J. Hugin Brian P. Gill
President and COO Senior Director PR/IR
Celgene Corporation Celgene Corporation
(908) 673-9102 (908) 673-9530
THALOMID(R) sNDA GRANTED FDA APPROVAL FOR
TREATMENT OF NEWLY DIAGNOSED
MULTIPLE MYELOMA
SUMMIT, NJ - (MAY 25, 2006) - Celgene Corporation (NASDAQ: CELG) announced that
the U.S. Food and Drug Administration (FDA) has granted accelerated approval to
its Supplemental New Drug Application (sNDA) for THALOMID (thalidomide) in
combination with dexamethasone for the treatment of newly diagnosed multiple
myeloma. The effectiveness of THALOMID is based upon response rates. There are
no controlled trials demonstrating a clinical benefit, such as an improvement in
survival. Multiple myeloma is the second most common blood cancer in the United
States affecting approximately 50,000 people. About 14,600 new cases of multiple
myeloma are diagnosed each year and about 12,000 Americans are expected to die
of multiple myeloma in 2006.
THALOMID is available through a THALOMID Education and Prescribing Safety
Program, called S.T.E.P.S.(R). Through the use of our S.T.E.P.S. PROGRAM, more
than 130,000 U.S. patients have had safe access to THALOMID since its market
introduction in July 1998. This FDA approval for the indication of THALOMID in
the treatment of newly diagnosed multiple myeloma allows physicians and their
patients to be treated with another therapy option for this incurable blood
cancer.
The safety profile for THALOMID in multiple myeloma has shown an increase in
side effects with THALOMID and dexamethasone as compared to dexamethasone alone.
The most common adverse events were constipation, sensory neuropathy, confusion,
hypocalcemia, edema, dyspnea, thrombosis/embolism, and rash/desquamation,
occurring in 20% of patients with a frequency less than or equal to 10% in
patients treated with THALOMID/dexamethasone compared with dexamethasone alone.
"The approval of our sNDA represents a significant milestone for Celgene and an
important step toward fulfilling our mission of making innovative treatment
options available to patients with significant unmet medical needs," said Sol
Barer, Ph.D., Chief Executive Officer at Celgene. "We are committed to the
ongoing clinical development of our investigational therapies being studied in
blood and solid tumor cancers, and we are
proud that our efforts have resulted in this approval of THALOMID for use in
combination with dexamethasone in newly diagnosed multiple myeloma patients."
SAFETY NOTICE
THALOMID(R) (THALIDOMIDE) CAPSULES 50 MG, 100 MG, & 200 MG
WARNING: IF THALIDOMIDE IS TAKEN DURING PREGNANCY, IT CAN CAUSE SEVERE BIRTH
DEFECTS OR DEATH TO AN UNBORN BABY. THALIDOMIDE SHOULD NEVER BE USED BY WOMEN
WHO ARE PREGNANT OR WHO COULD BECOME PREGNANT WHILE TAKING THE DRUG. EVEN A
SINGLE DOSE, ONE CAPSULE (50 MG, 100 MG AND 200 MG), TAKEN BY A PREGNANT WOMAN
CAN CAUSE SEVERE BIRTH DEFECTS. BECAUSE THALIDOMIDE IS PRESENT IN THE SEMEN OF
MALE PATIENTS, MALES RECEIVING THALIDOMIDE MUST ALWAYS USE A LATEX CONDOM DURING
SEXUAL CONTACT WITH WOMEN OF CHILDBEARING POTENTIAL EVEN IF HE HAS UNDERGONE A
SUCCESSFUL VASECTOMY. THALIDOMIDE CAN ONLY BE MARKETED UNDER A SPECIAL
RESTRICTED DISTRIBUTION PROGRAM. THIS PROGRAM IS CALLED THE "SYSTEM FOR
THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY (S.T.E.P.S.(R)). UNDER THIS
PROGRAM, ONLY REGISTERED PRESCRIBERS AND PHARMACISTS MAY DISPENSE THE DRUG. IN
ADDITION, PATIENTS MUST BE ADVISED OF, AGREE TO AND COMPLY WITH THE REQUIREMENTS
OF S.T.E.P.S.
THE USE OF THALOMID(R) (THALIDOMIDE) IN MULTIPLE MYELOMA RESULTS IN AN INCREASED
RISK OF VENOUS THROMBOEMBOLIC EVENTS, SUCH AS DEEP VENOUS THROMBOSIS AND
PULMONARY EMBOLUS. THIS RISK INCREASES SIGNIFICANTLY WHEN THALIDOMIDE IS USED IN
COMBINATION WITH STANDARD CHEMOTHERAPEUTIC AGENTS INCLUDING DEXAMETHASONE. IN
ONE CONTROLLED TRIAL, THE RATE OF VENOUS THROMBOEMBOLIC EVENTS WAS 22.5% IN
PATIENTS RECEIVING THALIDOMIDE IN COMBINATION WITH DEXAMETHASONE COMPARED TO
4.9% IN PATIENTS RECEIVING DEXAMETHASONE ALONE (p = 0.002). PATIENTS AND
PHYSICIANS ARE ADVISED TO BE OBSERVANT FOR THE SIGNS AND SYMPTOMS OF
THROMBOEMBOLISM. PATIENTS SHOULD BE INSTRUCTED TO SEEK MEDICAL CARE IF THEY
DEVELOP SYMPTOMS SUCH AS SHORTNESS OF BREATH, CHEST PAIN, OR ARM OR LEG
SWELLING. PRELIMINARY DATA SUGGESTS THAT PATIENTS WHO ARE APPROPRIATE CANDIDATES
MAY BENEFIT FROM CONCURRENT PROPHYLACTIC ANTICOAGULATION OR ASPIRIN TREATMENT.
THALIDOMIDE IS CONTRAINDICATED IN PATIENTS WHO HAVE DEMONSTRATED
HYPERSENSITIVITY TO THE DRUG AND ITS COMPONENTS. IT IS NOT KNOWN WHETHER
THALOMID IS EXCRETED IN HUMAN MILK. BECAUSE OF THE POTENTIAL FOR ADVERSE
REACTIONS IN NURSING INFANTS, A DECISION SHOULD BE MADE WHETHER TO DISCONTINUE
NURSING OR THE DRUG, TAKING INTO ACCOUNT THE IMPORTANCE OF THE DRUG TO THE
MOTHER. THALIDOMIDE IS KNOWN TO CAUSE NERVE DAMAGE THAT MAY BE PERMANENT.
PERIPHERAL NEUROPATHY IS A COMMON, POTENTIALLY SEVERE, SIDE EFFECT OF TREATMENT
WITH THALIDOMIDE THAT MAY BE IRREVERSIBLE. DECREASED WHITE BLOOD CELL COUNTS,
INCLUDING NEUTROPENIA, HAVE BEEN REPORTED IN THE CLINICAL USE OF THALIDOMIDE. IN
PLACEBO CONTROLLED CLINICAL TRIALS OF HIV-SEROPOSITIVE PATIENT POPULATIONS,
THERE HAVE BEEN REPORTS OF INCREASED PLASMA HIV RNA LEVELS ASSOCIATED WITH
THALIDOMIDE THERAPY. THE MOST FREQUENTLY REPORTED ADVERSE EVENTS WERE
CONSTIPATION (55%), SENSORY NEUROPATHY (54%), CONFUSION (28%), HYPOCALCEMIA
(72%), EDEMA (57%), DYSPNEA (42%), THROMBOSIS/EMBOLISM
(23%), AND RASH/DESQUAMATION (30%) (OCCURRING IN (is greater than or equal to)
20% OF PATIENTS AND WITH A FREQUENCY (is greater than or equal to) 10% IN
PATIENTS TREATED WITH THALOMID/DEXAMETHASONE COMPARED WITH DEXAMETHASONE ALONE).
PATIENTS SHOULD BE ADVISED ABOUT THESE ASSOCIATED ADVERSE EVENTS AND ROUTINELY
MONITORED BY A PHYSICIAN DURING TREATMENT WITH THALIDOMIDE. PATIENTS SHOULD BE
INSTRUCTED TO NOT EXTENSIVELY HANDLE OR OPEN THALIDOMIDE CAPSULES AND TO
MAINTAIN STORAGE OF CAPSULES IN BLISTER PACKS UNTIL INGESTION.
ABOUT THALOMID(R)
THALOMID (thalidomide), manufactured by Celgene Corporation, received U.S. Food
and Drug Administration (FDA) clearance on July 16, 1998 for the acute treatment
of cutaneous manifestations of moderate to severe erythema nodosum leprosum
(ENL) and as maintenance therapy for prevention and suppression of the cutaneous
manifestations of ENL recurrence. Thalidomide is not indicated as monotherapy
for ENL treatment in the presence of moderate to severe neuritis. Thalidomide is
indicated for use as a treatment in combination with dexamethasone for newly
diagnosed multiple myeloma.
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
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.
THIS RELEASE CONTAINS FORWARD-LOOKING STATEMENTS WHICH ARE SUBJECT TO 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 EXPRESSED OR 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 OTHER
FACTORS DESCRIBED IN THE COMPANY'S FILINGS WITH THE SECURITIES AND EXCHANGE
COMMISSION SUCH AS OUR 10K, 10Q AND 8K REPORTS.
# # #