Biogen Idec creates new standards of care in oncology and immunology. As a global
leader in the development, manufacturing, and commercialization of novel therapies,
we transform scientific discoveries into advances in human healthcare. We currently
have four commercial products: AVONEX® (Interferon beta-1a) for the treatment
of relapsing multiple sclerosis, also known as MS, RITUXAN® (rituximab) and ZEVALIN®
(ibritumomab tiuxetan), both of which treat certain B-cell non-Hodgkin’s lymphomas,
also referred to as B-cell NHLs, and AMEVIVE® (alefacept) for the treatment of
adult patients with moderate-to-severe chronic plaque psoriasis who are candidates
for systemic therapy or phototherapy.
Our sales and marketing efforts are generally focused on specialist physicians
in private practice or at major medical centers. We utilize common pharmaceutical
company practices to market our products and to educate physicians, including
sales representatives calling on individual physicians and distributors, advertisements,
professional symposia, direct mail, selling initiatives, public relations and
other methods. We have also established uninsured patient programs in the U.S.
for our marketed products which provide qualified patients with products at
no charge. We also provide certain customer service and other related programs
for our products, such as disease and product-specific websites, insurance verification
services and order, delivery and fulfillment services.
Competition in the biotechnology and pharmaceutical industries is intense and
comes from many and varied sources. We do not believe that any of the industry
leaders can be considered dominant in view of the rapid technological change
in the industry. We experience significant competition from specialized biotechnology
firms in the U.S., the EU and elsewhere and from many large pharmaceutical,
chemical and other companies.
AVONEX
AVONEX competed in the U.S. and EU markets primarily with three products:
• BETASERON®, sold by Berlex in the U.S. and sold under the name BETAFERON®
by Schering A.G.
• REBIF®, which is co-promoted by Serono, Inc. and Pfizer in the U.S. and sold
by Serono AG in the EU.
• COPAXONE® glatiramer acetate, sold by Teva Neuroscience, Inc. in the U.S.
and co-promoted by Teva and Aventis Pharma in the EU.
RITUXAN is typically used after patients fail to respond or relapse after treatment
with traditional radiation therapy or standard chemotherapy regimes, such as
CVP and CHOP. ZEVALIN is typically used after patients fail to respond or relapse
following treatment with RITUXAN. ZEVALIN competes with BEXXAR® (tositumomab,
iodine I-131 tositumomab), a radiolabeled molecule developed by Corixa Corporation
and GlaxoSmithKline. BEXXAR received FDA approval in June 2003 to treat patients
with CD20+, follicular, NHL, with and without transformation, whose disease
is refractory to RITUXAN and has relapsed following chemotherapy.
AMEVIVE
AMEVIVE competes with several different types of therapies including:
• traditional therapies for moderate-to-severe chronic plaque psoriasis, such
as oral retinoids, steroids, methotrexate, cyclosporin, PUVA and UVB radiation.
• RAPTIVA® (efalizumab), a drug co-developed by Genentech and Xoma Corporation
that was approved by the FDA in November 2003 to treat moderate-to-severe psoriasis.
Serono has an exclusive license to RAPTIVA in the EU and other countries and
has filed for regulatory approval of the drug in the EU. Drugs approved for
other indications that are used to treat psoriasis. Among these drugs are ENBREL®
(etanercept), REMICADE® (infliximab) and HUMIRA®(adalimumab). ENBREL is sold
by Amgen, Inc. and Wyeth Pharmaceuticals, Inc. and is approved to treat psoriatic
arthritis. In January 2003, Amgen announced positive results from a Phase 3
clinical study of ENBREL in the treatment of moderate-to-severe plaque psoriasis
and is conducting a second Phase 3 clinical study in psoriasis. REMICADE is
sold worldwide by Centocor, Inc., a subsidiary of Johnson & Johnson, as
a treatment for other indications, including rheumatoid arthritis, and is currently
in a Phase 2 proof of concept study as a potential treatment for psoriasis.
HUMIRA is sold by Abbott Laboratories and is approved to treat rheumatoid arthritis.
Abbott is undertaking clinical trials in psoriasis and psoriatic arthritis.