Download CELGENE CORP /DE/ (Form: 8-K, Received: 12/11/2007 09:36:15)

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 10, 2007
CELGENE CORPORATION
(Exact name of registrant as specified in its charter)
Delaware
(State or other Jurisdiction of
Incorporation)
0-16132
(Commission File Number)
86 Morris Avenue, Summit, New Jersey
(Address of Principal Executive Offices)
22-2711928
(IRS Employer Identification No.)
07901
(Zip Code)
Registrant’s telephone number, including area code: (908) 673-9000
(Former name or former address if
changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant
under any of the following provisions:
 Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
ITEM 8.01 OTHER EVENTS
On December 10, 2007, Celgene International Sarl reported that researchers from the M.D. Anderson Cancer Center in Houston,
TX, presented early evidence of efficacy from a Phase I/II study evaluating lenalidomide with rituximab for the treatment of
relapsed/refractory mantle cell lymphoma, or MCL. The study indicated that 70% of patients achieved responses with 30% of
patients achieving complete responses when given the combination therapy. The data were presented at the 49 th annual American
Society of Hematology, or ASH meeting and the combination therapy is further being evaluated by the center as part of the
ongoing Phase II trial.
Attached hereto and incorporated herein by reference as Exhibit 99.1 is the Press Release announcing such information.
ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS.
(d) Exhibit 99.1 – Press Release dated December 10, 2007
SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of 1934, the Registrant has duly caused this report to be signed on its
behalf by the undersigned hereunto duly authorized.
CELGENE CORPORATION
Date: December 11, 2007
By:
/s/ David W. Gryska
Name: David W. Gryska
Title: Sr. Vice President and Chief Financial Officer
Exhibit 99.1
Contact:
Marie-France Tschudin
Director, Strategic Marketing
Europe
Celgene International
+41 32 729 84 30
Catarina Edfjäll
Head of Regulatory Affairs
Europe
Celgene International
+41 32 729 87 63
REVLIMID ® (lenalidomide) IN COMBINATION WITH RITUXIMAB DEMONSTRATES 70 % OVERALL
RESPONSE RATE IN HARD TO TREAT RELAPSED/REFRACTORY MANTLE CELL LYMPHOMA
•
Revlimid Mechanism of Action Enhances Cancer Fighting Activity
•
Study Results Expand the Potential of Revlimid in New Indications
SUMMIT, NJ — (December 10, 2007) — Celgene International Sàrl (NASDAQ: CELG) reported that researchers from the M.D.
Anderson Cancer Center in Houston, TX, presented early evidence of efficacy from a Phase I/II study evaluating lenalidomide with
rituximab for the treatment of relapsed/refractory mantle cell lymphoma (MCL). The study indicated that 70% of patients achieved
responses with 30% of patients achieving complete responses when given the combination therapy. The data were presented at the 49
th annual American Society of Hematology (ASH) Meeting and the combination therapy is further being evaluated by the center as
part of the ongoing Phase II trial.
Study investigators believe that lenalidomide may target the microenviroment of the MCL cells and enhance the antibody dependent
cell-mediated cytoxicity (ADCC) activity of rituximab. Therefore, patients in whom rituximab had previously stopped working were
able to achieve responses on the combination therapy. Revlimid’s impact on ADCC is a newly described mechanism of action
growing out of these studies.
The data presented showed that seven out of ten patients achieved responses including three complete remissions (30%), four partial
remissions (40%), one patient with stable disease, and two patients with progressive disease. The most common Grade 3/4 adverse
events observed were neutropenia, febrile neutropenia, thrombocytopenia and myalgia.
“With rituximab cancer patients can develop resistance over time. Revlimid may enhance the activity against the cancer cells to
restores ritiximab efficacy,” said Dr. Wang, M.D. Anderson Cancer Center. “These promising efficacy and tolerability results warrant
additional studies to further evaluate the benefits.”
18 patients were involved in the trial, all of whom had previously been treated with rituximab, and were given lenalidomide daily for
the first 21 days of a 28 day cycle and rituximab (375 mg/m 2 ) by IV infusion weekly for four weeks only during the first cycle with
the first dose on Day 1 in Cycle 1. A standard dose escalation was used to determine that the maximum tolerated dose (MTD) of
lenalidomide was 20 mg.
Mantle cell lymphoma (MCL) is a subtype of non-Hodgkin’s lymphoma (NHL). There are approximately 59,000 new cases of NHL
diagnosed each year in the U.S. with MCL cases accounting for approximately 6% of these diagnoses. MCL is most frequently found
in older adults and the average age of diagnosis is the mid-60s.
About REVLIMID ®
REVLIMID has obtained Orphan Drug designation in the EU, U.S., and Australia. REVLIMID is approved for use as an oral
treatment in multiple myeloma in combination with dexamethasone by the European Medicines Agency (EMEA). REVLIMID is
currently approved in the US by the U.S. Food and Drug Administration (FDA) for multiple myeloma in combination with
dexamethasone for patients who have received at least one prior therapy. REVLIMID is also approved for treatment of patients with
transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q
cytogenetic abnormality with or without additional cytogenetic abnormalities by the FDA.
About Mantle Cell Lymphoma
Mantle cell lymphoma (MCL) is one of several subtypes of non-Hodgkin’s lymphoma (NHL) and results from a malignant
transformation of a B lymphocyte in the outer edge of the lymph node follicles called the mantle zone. The transformed lymphocytes,
or lymphoma cells, grow in an uncontrolled way causing tumors to form in the lymph nodes leading them to enlarge and the cells can
also spread to other tissues such as the marrow, liver and gastrointestinal tract. MCL is distinguished from other subtypes of B-cell
lymphoma by the overexpression of cyclin D1, a protein that stimulates cell growth, which in approximately 85% of cases is caused
by a genetic change involving chromosomes 11 and 14 and may be a result of constant mutations occurring in many cells, possibly
independent of the effects of an outside, environmental factor.
About Celgene International Sárl
Celgene International Sárl, 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.
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.
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