REVLIMID(R) (LENALIDOMIDE): REVLIMID(R) is an oral immunomodulatory drug recently
granted approval by the FDA for the treatment of patients with transfusion-dependent
anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated
with a deletion 5q cytogenetic abnormality with or without additional cytogenetic
abnormalities, or MDS, with the 5q chromosomal deletion. REVLIMID(R) is being
distributed through contracted pharmacies under the RevAssist(sm) program, which
is a proprietary risk-management distribution program tailored specifically
for REVLIMID(R). The FDA based its decision to grant marketing approval on data
from the open label Phase II trial (MDS-003) that evaluated REVLIMID(R) in transfusion-dependent
patients with myelodysplastic syndromes with deletion 5q chromosomal abnormality.
THALOMID(R) (THALIDOMIDE): THALOMID(R), was approved by the FDA in July 1998
for the treatment of acute cutaneous manifestations of moderate to severe erythema
nodosum leprosum, or ENL, an inflammatory complication of leprosy. Although
leprosy is relatively rare in the United States, the disease afflicts millions
worldwide. ENL occurs in about 30% of leprosy patients and is characterized
by skin lesions, acute inflammation, fever and anorexia. While approved for
the treatment of ENL, THALOMID(R) is widely prescribed off-label for treating
multiple myeloma and other cancers. The FDA is currently reviewing our sNDA
for THALOMID(R) in multiple myeloma and has set a Prescription Drug User Fee
Act, or PDUFA, date of May 25, 2006.
Working with the FDA, we developed S.T.E.P.S.(R), or "SYSTEM FOR THALIDOMIDE
EDUCATION AND PRESCRIBING SAFETY," which is a proprietary strategic
comprehensive education and risk-management distribution program with the
objective of providing for the safe and appropriate use of THALOMID(R).
ALKERAN(R): In March 2003, we entered into a supply and distribution agreement
with GlaxoSmithKline, or GSK, to distribute, promote and sell ALKERAN(R) (melphalan)
in all dosage forms in the United States under the Celgene label. ALKERAN(R)
is approved by the FDA for the palliative treatment of multiple myeloma and
of carcinoma of the ovary. ALKERAN(R) use in combination with other therapies
for the treatment of hematological diseases continues to grow, driven by clinical
data reported at major medical conferences around the world. Under the terms
of the agreement, we purchase ALKERAN(R) tablets and ALKERAN(R) for injection
from GSK and distribute the products in the United States under the Celgene
label. The agreement has been extended through March 31, 2009.
RITALIN(R) FAMILY OF DRUGS: We developed FOCALIN(TM), which is formulated by
isolating the active d-isomer of methylphenidate using advanced single-isomer
chemistry technology. Isomers are any of two or more chemical substances that
are composed of the same elements in the same proportions but can differ in
properties because of differences in the arrangement of atoms. FOCALIN(TM) provides
favorable tolerability and dosing flexibility at half the dose of RITALIN(R).
In April 2000, we licensed to Novartis the worldwide rights (excluding Canada)
to FOCALIN(TM) and FOCALIN XR(TM), the extended release version, in exchange
for milestone payments, a FOCALIN(TM) product supply agreement (whereby we supply
FOCALIN(TM) exclusively to Novartis) and royalties on FOCALIN XR(TM) and the
entire RITALIN(R) family of drugs including RITALIN(R), RITALIN LA(R) and RITALIN
SR(R). We have retained the exclusive commercial rights to FOCALIN(TM) and FOCALIN
XR(TM) for oncology-related disorders, such as chronic fatigue associated with
chemotherapy. On November 15, 2001, FOCALIN(TM) was approved by the FDA for
the treatment of attention deficit hyperactivity disorder, or ADHD, in children
and adolescents. On May 27, 2005, FOCALIN XR(TM) was approved by the FDA for
the treatment of ADHD in adults, adolescents and children.
ABRAXANE® was obtained in the acquisition of Abraxis in October 2010 and
was approved by the FDA in the treatment of metastatic breast cancer.