Celgene Corporation announced that its intellectual property estate for the Company's unique distribution program expanded with two additional U.S. patents that issued today. The Celgene patent portfolio covers managed distribution programs for products or drugs that are either teratogens (causing birth defects) or have other adverse effects that require contraindication for certain patients. The Company's two previously issued patents cover distribution programs that register pharmacists, patients and physicians. The newly issued patents, U.S. Patents 6,561,976 and 6,561,977, expand the scope of coverage to include distribution programs that do not require the type of registrations described in the prior patents.

"We are very proud of S.T.E.P.S. and the high standard of controlled pharmaceutical distribution it offers our industry. These new patents broaden our existing intellectual property estate to include controlled distribution programs that do not require pharmacist, patient and physician registration," said Sol J. Barer, President and Chief Operating Officer of Celgene Corporation. "Furthermore, the issuance of these patents supports our strategy to vigorously protect and safeguard our Thalomid franchise."

Celgene developed S.T.E.P.S. (System for Thalidomide Education and Prescribing Safety), the first program in this proprietary type of managed drug distribution, to support the distribution of Thalomid (thalidomide). Thalomid, approved 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, potentially causes severe birth defects or death to an unborn baby. Thalomid is not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis.

S.T.E.P.S., the first FDA-approved managed distribution program, serves as a blueprint for the appropriate distribution of pharmaceutical products that offer important therapeutic benefits but have serious side effects. Celgene has effectively implemented S.T.E.P.S. since the launch of Thalomid in 1998 and during the past five years approximately 79,000 patients, 14,900 prescribers and 24,400 pharmacists have been successfully registered in S.T.E.P.S. to fill over 418,000 prescriptions for Thalomid.