UNITED STATES SECURITIES AND EXCHANGE COMMISSION
`Washington, D.C. 20549
`Form 10-K
`
`Table of Contents
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`(Mark One)
`
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`o
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`ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)
`OF THE SECURITIES EXCHANGE ACT OF 1934
`
` For the fiscal year ended December 31, 2006
`TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)
`OF THE SECURITIES EXCHANGE ACT OF 1934
`
` For the transition period from to
`Commission file number: 0-19311
`
`Biogen Idec Inc.
`
`(Exact name of registrant as specified in its charter)
`
`
`
`
`33-0112644
`(I.R.S. Employer
`Identification No.)
`02142
`(Zip code)
`
`Delaware
`(State or other jurisdiction of
`incorporation or organization)
`14 Cambridge Center,
`Cambridge, Massachusetts
`
`(Address of principal executive offices)
`(Registrant’s telephone number, including area code)
`(617) 679-2000
`Securities registered pursuant to Section 12(b) of the Act:
`None
`Securities registered pursuant to Section 12(g) of the Act:
`Common Stock, $0.0005 par value and Series X Junior Participating Preferred Stock Purchase Rights
`(Title of class)
`Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
`Yes  No o
`Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act.. Yes o No 
`Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act
`of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to
`such filing requirements for the past 90 days. Yes  No o
`Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be
`contained, to the best of the Registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this
`Form 10-K or any amendment to this Form 10-K. oo
`Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of
`“accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one):
`Large accelerated filer  Accelerated filer oo Non-accelerated filer oo
`Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Securities Exchange Act of
`1934). Yes oo No 
`The aggregate market value of the Registrant’s Common Stock held by non-affiliates of the Registrant (without admitting that any person whose
`shares are not included in such calculation is an affiliate) computed by reference to the price at which the common stock was last sold as of the last
`business day of the Registrant’s most recently completed second fiscal quarter was $15,836,264,111.
`As of February 15, 2007, the Registrant had 342,436,836 shares of Common Stock, $0.0005 par value, issued and outstanding.
`DOCUMENTS INCORPORATED BY REFERENCE
`Portions of the definitive Proxy Statement for our 2007 Annual Meeting of Stockholders are incorporated by reference into Part III of this Report.
`
`MYLAN PHARMS. INC. EXHIBIT 1078 PAGE 1
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`BIOGEN IDEC INC.
`ANNUAL REPORT ON FORM 10-K
`For the Year Ended December 31, 2006
`TABLE OF CONTENTS
`
`
`PART I
`
` Business
` Overview
` Our Products — Approved Indications and Ongoing Development
` Our Other Research and Development Programs
` Research and Development Costs
` Principal Licensed Products
` Patents and Other Proprietary Rights
` Sales, Marketing and Distribution
` Competition
` Regulatory
` Manufacturing and Raw Materials
` Our Employees
` Our Executive Officers
` Risk Factors
` Unresolved Staff Comments
` Properties
` Legal Proceedings
` Submission of Matters to a Vote of Security Holders
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`Item 1.
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`Item 1A.
`Item 1B.
`Item 2.
`Item 3.
`Item 4.
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`Item 5.
`Item 6.
`Item 7.
`Item 7A.
`Item 8.
`Item 9.
`Item 9A.
`Item 9B.
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`Item 10.
`Item 11.
`Item 12.
`Item 13.
`Item 14.
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`PART II
` Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
` Selected Consolidated Financial Data
`
` Management’s Discussion and Analysis of Financial Condition and Results of Operations
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` Quantitative and Qualitative Disclosures About Market Risk
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` Consolidated Financial Statements and Supplementary Data
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` Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
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` Controls and Procedures
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` Other Information
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`PART III
` Directors and Executive Officers of the Registrant
` Executive Compensation
` Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
` Certain Relationships and Related Transactions
` Principal Accountant Fees and Services
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`PART IV
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` Exhibits, Financial Statement Schedules
`
`Item 15.
`Signatures
`Consolidated Financial Statements
` EX-10.42 - BOARD OF DIRECTORS - ANNUAL RETAINER SUMMARY SHEET
` EX-10.49 - Proposed Resolution for Meeting of the Board of Directors
` EX-10.57 Amendment No. 1 to the 2006 Non-Employee Directors Equity Plan
` EX-21.1 - SUBSIDIARIES
` EX-23.1 - CONSENT OF PRICEWATERHOUSECOOPERS LLP
` EX-31.1 - SECTION 302 CERTIFICATION OF CEO
` EX-31.2 - SECTION 302 CERTIFICATION OF CFO
` EX-32.1 - SECTION 906 CERTIFICATION OF CEO AND CFO
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`MYLAN PHARMS. INC. EXHIBIT 1078 PAGE 2
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`Table of Contents
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`PART I
`
`Item 1. Business
`Overview
`Biogen Idec creates new standards of care in oncology, neurology, immunology and other specialty areas of unmet medical need. 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 five products:
`
`AVONEX® (interferon beta-1a)
`AVONEX is approved worldwide for the treatment of relapsing forms of multiple sclerosis, or MS, and is the most prescribed
`therapeutic product in MS worldwide. Globally over 135,000 patients use AVONEX.
`
`RITUXAN® (rituximab)
`RITUXAN is approved worldwide for the treatment of relapsed or refractory low-grade or follicular, CD20-positive, B-cell non-
`Hodgkin’s lymphomas, or B-cell NHLs. In 2006, the U.S. Food and Drug Administration, or FDA, approved RITUXAN for three
`additional uses in NHL. We believe that RITUXAN is the top-selling oncology therapeutic in the United States and has had more than
`960,000 patient exposures worldwide. In addition, in February 2006, the FDA approved the RITUXAN supplemental Biologics License
`Application, or sBLA, for use of RITUXAN, in combination with methotrexate, for reducing signs and symptoms in adult patients with
`moderately-to-severely active rheumatoid arthritis, or RA, who have had an inadequate response to one or more tumor necrosis factor, or
`TNF, antagonist therapies. We are working with Genentech and Roche on the development of RITUXAN in additional oncology and other
`indications.
`RITUXAN is the trade name for the compound rituximab in the U.S., Canada and Japan. MabThera is the trade name for
`rituximab in the European Union, or EU. In this Annual Report, we refer to rituximab, RITUXAN, and MabThera collectively as
`RITUXAN, except where we have otherwise indicated.
`
`TYSABRI® (natalizumab)
`TYSABRI is approved for the treatment of relapsing forms of MS. Under the terms of a collaboration agreement with Elan
`Corporation plc, or Elan, we are solely responsible for the manufacture of TYSABRI, and we collaborate with Elan on the product’s
`marketing, commercial distribution and on-going development activities. The collaboration agreement with Elan is designed to effect an
`equal sharing of profits and losses generated by the activities of the collaboration between Elan and us.
`
`ZEVALIN® (ibritumomab tiuxetan)
`The ZEVALIN therapeutic regimen, which features the ZEVALIN antibody, is a radioimmunotherapy that is approved for the
`treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell NHL, including patients with RITUXAN
`refractory NHL. During the third quarter of 2006, we began executing a plan to divest our ZEVALIN product line.
`
`FUMADERM® (dimethylfumarate and monoethylfumarate salts)
`FUMADERM was acquired with the purchase of Fumapharm AG, or Fumapharm, in June 2006. FUMADERM acts as an
`immunomudulator and has been approved in Germany for the treatment of severe psoriasis since 1994.
`
`Other Revenue and Programs
`In 2006, we recorded product revenues from sales of AMEVIVE® (alefacept) prior to our sale of this product line in April 2006.
`AMEVIVE is approved in the U.S. and other countries for the treatment of adult patients with moderate-to-severe chronic plaque psoriasis
`who are candidates for systemic therapy or phototherapy.
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`Table of Contents
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`We also receive royalty revenues on sales by our licensees of a number of products covered under patents that we control. In
`addition, we have a pipeline of research and development products in our core therapeutic areas and in other areas of interest.
`We devote significant resources to internal research and development programs, and intend to commit significant additional
`resources to external research and development opportunities. We intend to focus our research and development efforts on finding novel
`therapeutics in areas of high unmet medical need, both within our current focus areas of oncology, neurology and immunology as well as
`in new therapeutic areas. Our current late stage efforts include our collaboration with Elan on the development of TYSABRI as a potential
`treatment for Crohn’s disease; our work with Genentech and Roche on the development of RITUXAN in additional oncology indications,
`RA, MS and lupus and the co-development of additional anti-CD-20 antibody products: BG-12 for relapsing forms of MS in Phase III;
`galiximab for NHL in Phase III; and lumiliximab for chronic lymphocytic leukemia, or CLL, in Phase IIb and our collaboration with
`PDL BioPharma, Inc., or PDL, on development of two Phase II antibody products in a variety of indications.
`
`Merger
`On November 12, 2003, Bridges Merger Corporation, a wholly owned subsidiary of IDEC Pharmaceuticals Corporation, was
`merged with and into Biogen, Inc. with Biogen, Inc. continuing as the surviving corporation and a wholly owned subsidiary of IDEC
`Pharmaceuticals Corporation. At the same time, IDEC Pharmaceuticals Corporation changed its name to Biogen Idec Inc. The merger and
`name change were made under an Agreement and Plan of Merger dated as of June 20, 2003.
`
`Available Information
`We are a Delaware corporation with principal executive offices located at 14 Cambridge Center, Cambridge, Massachusetts 02142.
`Our telephone number is (617) 679-2000 and our website address is www.biogenidec.com. We make available free of charge through the
`Investor Relations section of our website our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on
`Form 8-K and all amendments to those reports as soon as reasonably practicable after such material is electronically filed with or
`furnished to the Securities and Exchange Commission, or the SEC. We include our website address in this Annual Report on Form 10-K
`only as an inactive textual reference and do not intend it to be an active link to our website. You may read and copy materials we file with
`the SEC at the SEC’s Public Reference Room at 450 Fifth Street, N.W., Washington, D.C. 20549. You may get information on the
`operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330. The SEC maintains an Internet site that contains reports,
`proxy and information statements, and other information regarding issuers that file electronically with the SEC at www.sec.gov.
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`MYLAN PHARMS. INC. EXHIBIT 1078 PAGE 4
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`Table of Contents
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`Our Products — Approved Indications and Ongoing Development
`Our products are targeted to address a variety of key medical needs in the areas of oncology, neurology, and immunology. Our
`marketed products and late stage product candidates are as follows:
`
`
`Product Indications
`Relapsing forms of MS
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`Certain B-cell NHLs
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`Rheumatoid arthritis
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` Relapsed CLL
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` Lupus
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`MS
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`Product
`AVONEX
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`RITUXAN
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`ZEVALIN
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`Certain B-cell NHLs
`(radioimmunotherapy)
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` Diffuse large B-cell lymphoma
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`TYSABRI
` Relapsing forms of MS
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` Crohn’s disease
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`FUMADERM
` Severe psoriasis
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`BG-12
` MS
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` Psoriasis
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`Anti-CD80 MAb/ galiximab Relapsed or refractory NHL
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`Anti-CD23 MAb/lumiliximab Relapsed or refractory CLL
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`Status
`Approved — numerous countries
`worldwide
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`Approved — numerous countries
`worldwide
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`Approved — U.S. for anti-TNF-
`inadequate responders
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`Phase III — DMARD inadequate
`responders
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`Development and/or
`Marketing Collaborators
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`None
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`All RITUXAN Indications:
`U.S. — Genentech
`Japan — Roche and Zenyaku
`Outside U.S. and Japan — Roche
`
`See above
`
`See above
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` Phase III
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` Phase II/III
`
` See above
`
` Genentech
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`Phase II/III
`
`Approved — U.S. and E.U.
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`
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`See above, except for PPMS indication
`which is only Genentech
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`Outside U.S. — Schering AG
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` Phase III
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` See above
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` Approved — U.S. and E.U.
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` Elan
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` Regulatory review — U.S. and E.U.
`
` See above
`
` Approved — Germany
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` Fumedica
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` Phase III
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` Phase III completed
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` Phase III
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` Phase IIb
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` None
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` None
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` None
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` None
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`AVONEX
`We currently market and sell AVONEX worldwide for the treatment of relapsing forms of MS. In 2006, sales of AVONEX generated
`worldwide revenues of $1.7 billion as compared to worldwide revenues of $1.5 billion in 2005.
`MS is a progressive neurological disease in which the body loses the ability to transmit messages along nerve cells, leading to a loss
`of muscle control, paralysis and, in some cases, death. Patients with active relapsing MS experience an uneven pattern of disease
`progression characterized by periods of stability that are interrupted by flare-ups of the disease after which the patient returns to a new
`baseline of functioning. AVONEX is a recombinant form of a protein produced in the body by fibroblast cells in response to viral
`infection. AVONEX has been shown in clinical trials in relapsing forms of MS both to slow the accumulation of disability and to reduce
`the frequency of flare-ups. AVONEX is approved to treat relapsing forms of MS, including patients with a first clinical episode and MRI
`features consistent with MS. Biogen, Inc. began selling AVONEX in the U.S. in 1996, and in the EU in 1997. AVONEX is on the
`market in 70 countries. Based on data from an independent third party research organization, information from our distributors and
`internal analysis, we believe that AVONEX is the most prescribed therapeutic product for the treatment of MS worldwide. Globally over
`135,000 patients use AVONEX.
`We continue to work to expand the data available about AVONEX and MS treatments. In September 2006, we presented at the
`European Committee for Treatment and Research in Multiple Sclerosis, or ECTRIMS, Congress results from the Global Adherence
`Project, or GAP, the largest multi-national study of its kind to date to evaluate patient adherence to long-term treatments for MS in a real-
`world setting. GAP is a global multi-center, cross-sectional observational study that investigated factors that influence non-adherence to
`MS therapies. The study enrolled 2,566 patients with relapsing remitting MS at 176 sites in 22 countries taking one of the following
`therapies: AVONEX, Betaseron® (Interferon beta-1b), Copaxone® (glatiramer acetate), or Rebif® (Interferon beta-1a). Patients were
`evaluated through a validated MS quality of life scale, as well as a self-reported questionnaire that collected data on disease status,
`treatment, and factors that may have affected adherence to treatment during the
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`Table of Contents
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`course of their therapy. Overall 25% of patients reported non-adherence, with patients on AVONEX reporting statistically significantly
`better adherence than any of the other therapies.
`
`We have also extended the Controlled High Risk AVONEX Multiple Sclerosis Prevention Study In Ongoing Neurological
`Surveillance, or CHAMPIONS. CHAMPIONS was originally designed to determine whether the effect of early treatment with AVONEX
`in delaying relapses and reducing the accumulation of MS brain lesions could be sustained for up to five years. The study results showed
`that AVONEX altered the long-term course of MS in patients who began treatment immediately after their initial MS attack compared to
`initiation of treatment more than two years after onset of symptoms. The five-year study extension is intended to determine if the effects of
`early treatment with AVONEX can be sustained for up to ten years. We also continue to support Phase IV investigator-run studies
`evaluating AVONEX in combination with other therapies.
`In November 2006, we launched AVONEX in Japan, following the approval of the Japanese Ministry of Health, Labour and Welfare
`of AVONEX for the prevention of MS relapse. AVONEX is the first new MS treatment available in Japan in six years. It is the second
`disease-modifying therapy approved to treat MS in Japan and the only one that can be administered once a week.
`
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`RITUXAN
`RITUXAN is approved worldwide for the treatment of relapsed or refractory low-grade or follicular, CD20-positive, B-cell NHLs,
`which comprise approximately half of the B-cell NHLs diagnosed in the U.S. In the U.S., RITUXAN is approved for NHL with the
`following label indications:
`
`• The treatment of patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin’s lymphoma;
`
`• The first-line treatment of patients with diffuse large B-cell, CD20-positive, non-Hodgkin’s lymphoma (or “DLBCL”) in
`combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based
`chemotherapy regimens;
`• The first line treatment of previously untreated patients with follicular, CD20-positive, B-cell NHL in combination with CVP
`(cyclophosphamide, vincristine and prednisone) chemotherapy;
`• The treatment of low grade CD20-positive, B-cell NHL in patients with stable disease or who achieve a partial or complete
`response following first line treatment with CVP chemotherapy.
`In addition, in February 2006, the FDA approved the RITUXAN sBLA for use of RITUXAN, in combination with methotrexate,
`for reducing signs and symptoms in adult patients with moderately-to-severely active rheumatoid arthritis, or RA, who have had an
`inadequate response to one or more TNF antagonist therapies.
`Our interest in RITUXAN is recognized as revenue from unconsolidated joint business, and is made up of three components:
`• We copromote RITUXAN in the U.S. in collaboration with Genentech. All U.S. sales of RITUXAN are recognized by
`Genentech, and we record our share of the pretax copromotion profits on a quarterly basis. In 2006, RITUXAN generated
`U.S. net sales of $2.1 billion, of which we recorded $555.8 million as our share of copromotion profits, as compared to
`U.S. net sales of $1.8 billion in 2005, of which we recorded $513.8 million as our share of copromotion profits;
`• Roche sells RITUXAN outside the U.S., except in Japan where it co-markets RITUXAN in collaboration with Zenyaku Kogyo
`Co. Ltd., or Zenyaku. We received royalties through Genentech on sales of RITUXAN outside of the U.S. of $194.0 million in
`2006 as compared to $147.5 million in 2005;
`• Finally, we receive reimbursement from Genentech for our selling and development expenses.
`In the U.S., we share responsibility with Genentech for continued development. Such continued development includes conducting
`supportive research and post-approval clinical studies and seeking potential approval for additional indications. Genentech provides the
`support functions for the commercialization of RITUXAN in the U.S. and has worldwide manufacturing responsibilities. See “Sales,
`Marketing and Distribution — RITUXAN and
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`ZEVALIN” and “Manufacturing and Raw Materials.” We also have the right to collaborate with Genentech on the development of other
`humanized anti-CD20 antibodies targeting B-cell disorders for a broad range of indications, and to copromote with Genentech any new
`products resulting from such development in the U.S. The most advanced such humanized anti-CD20 antibody under development has
`finished a Phase II trial for use in RA, and has entered a Phase III program.
`
`RITUXAN in Oncology
`We believe that RITUXAN is the top-selling oncology therapeutic in the United States and has had more than 960,000 patient
`exposures worldwide. RITUXAN is generally administered as outpatient therapy by personnel trained in administering chemotherapies or
`biologics. RITUXAN is unique in the treatment of B-cell NHLs due to its specificity for the antigen CD20, which is expressed only on
`the surface of normal B-cells and malignant B-cells. Stem cells (including B-cell progenitors or precursor B-cells) in bone marrow lack
`the CD20 antigen. This allows healthy B-cells to regenerate after treatment with RITUXAN and to return to normal levels within several
`months. RITUXAN’s mechanism of action, in part, utilizes the body’s own immune system as compared to conventional lymphoma
`therapies. In 2006, the FDA approved RITUXAN for three additional uses in NHL: (1) for the treatment of previously untreated patients
`with diffuse, large B-cell NHL in combination with anthracycline-based chemotherapy regimens (February), (2) for first-line treatment of
`previously-untreated patients with follicular NHL in combination with CVP chemotherapy (September), and (3) for the treatment of low-
`grade NHL in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP
`chemotherapy (September). A summary of important clinical data follows:
`
`• A randomized Phase III study, known as ECOG 4494, of patients age 60 or older with newly diagnosed, diffuse, large B-cell, or
`aggressive non-Hodgkin’s lymphoma, comparing CHOP alone to a regimen of RITUXAN plus CHOP, also known as R-CHOP,
`as a front-line or induction therapy followed by RITUXAN maintenance therapy or observation for those patients who responded
`positively to either R-CHOP or CHOP alone. The study is a U.S. Intergroup study led by the Eastern Cooperative Oncology
`Group, or ECOG, and enrolled 632 subjects. The primary endpoint of the induction and maintenance phases of the study was
`time to treatment failure. Due to the observed interaction between RITUXAN maintenance and induction therapy, additional
`analyses were performed to compare induction therapy with R-CHOP versus CHOP alone, removing the effects of subsequent
`RITUXAN maintenance therapy. Based on these additional analyses, the investigators concluded that patients who received R-
`CHOP induction therapy experienced prolonged time to treatment failure and overall survival compared to patients who received
`induction therapy with CHOP alone. In the maintenance phase of the study, patients treated with RITUXAN maintenance therapy
`for up to an additional two years after completing induction therapy had a statistically significant delay in time to treatment
`failure compared to patients who did not receive RITUXAN maintenance therapy following induction. This advantage appears
`predominantly confined to patients who received CHOP alone during the induction phase;
`• A large Phase III randomized study of 823 patients, known as MinT, designed to evaluate RITUXAN in combination with
`chemotherapy as a front-line treatment for aggressive large, B-cell NHL in patients age 18 to 60. This study, which was
`conducted by an international cooperative group and sponsored by Roche, met its pre-specified primary efficacy endpoint early.
`Positive results from the study were announced in June 2004. The study authors concluded that data from the study
`demonstrated a significant improvement in time to treatment failure, the primary endpoint of the study. At two years, 81% of
`patients who received RITUXAN and chemotherapy did not experience treatment failure compared to 58% of patients who
`received chemotherapy alone. An analysis performed in 2005 showed a survival advantage to adding RITUXAN to
`chemotherapy; and
`• The Group d’Etude des Lymphome d’Adulte study, also known as the GELA trial, designed to evaluate the efficacy and safety
`of R-CHOP in patients 60 years of age or older with diffuse, large B-cell lymphoma. Previously untreated patients were
`randomized to receive eight cycles of CHOP alone or eight doses of R-CHOP. In this multi-center trial, with median follow-up of
`five years, overall survival for patients who had received RITUXAN plus CHOP was significantly prolonged compared with
`those who had received CHOP alone.
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`• A randomized Phase III study of the addition of RITUXAN to a chemotherapy regimen of CVP in previously untreated, or front
`line patients with indolent non-Hodgkin’s lymphoma. In this investigator-run study, 322 patients who had not received previous
`treatment for CD20-positive follicular or indolent non-Hodgkin’s lymphoma were randomized to receive either CVP alone or CVP
`with RITUXAN. Results of the study updated in 2005 indicated that the addition of RITUXAN to CVP prolonged time to
`treatment failure, the primary endpoint of the study, to 34 months compared to 15 months for patients treated with CVP alone;
`• A multi-center, randomized Phase II study of 114 patients with relapsed indolent non-Hodgkin’s lymphoma designed to compare
`the efficacy of RITUXAN maintenance therapy to retreatment with RITUXAN. Maintenance therapy was defined as treatment
`with RITUXAN every six months for two years with the objective of keeping lymphoma from returning or progressing.
`Retreatment was defined as waiting until the disease progressed prior to administering another course of RITUXAN. The initial
`results of this investigator-run study showed that patients who received RITUXAN maintenance therapy experienced 31 months
`of progression-free survival as compared to 8 months of progression-free survival for those patients who received retreatment; and
`• A Phase III study, known as E1496, designed to compare RITUXAN maintenance therapy versus observation in patients with
`previously untreated indolent non-Hodgkin’s lymphoma who achieved stable disease or better after induction therapy with CVP.
`The study, which was led by ECOG, met its pre-specified primary efficacy endpoint early. Positive results from the study were
`announced in June 2004. The study authors concluded that there was a significant improvement in progression free survival, the
`primary endpoint of the study. The authors estimated that 56% of patients who received RITUXAN maintenance therapy were
`free of disease progression and alive at 4 years compared to 32% of patients who received no further treatment. In this trial,
`maintenance therapy began four weeks after the last cycle of chemotherapy and was defined as four doses of RITUXAN every
`six months for two years.
`In an effort to identify additional applications for RITUXAN, we, in conjunction with Genentech and Roche, continue to support
`RITUXAN post-marketing studies. We, along with Genentech and Roche, are also conducting a multi-center global Phase III registrational
`study in patients with relapsed chronic lymphocytic leukemia, or CLL, comparing the use of fludarabine, cyclophosphamide and
`RITUXAN together, known as FCR, versus fludarabine and cyclophosphamide alone. This study is open at multiple sites worldwide.
`Additional clinical studies are ongoing in other B-cell malignancies such as lymphoproliferative disorders associated with solid organ
`transplant therapies, relapsed aggressive non-Hodgkin’s lymphoma and mantle cell non-Hodgkin’s lymphoma.
`
`
`
`RITUXAN in RA
`In February 2006, the FDA approved the sBLA for use of RITUXAN, in combination with methotrexate, for reducing signs and
`symptoms in adult patients with moderately-to-severely active RA who have had an inadequate response to one or more TNF antagonist
`therapies. The sBLA was based primarily on the results of a Phase III study known as REFLEX (Random Evaluation of Long-Term
`Efficacy of Rituximab in RA), announced in April 2005, which met its primary endpoint of a greater proportion of RITUXAN-treated
`patients achieving an American College of Rheumatology (ACR) 20 response at week 24, compared to placebo. REFLEX included patients
`with active RA who had an inadequate response or were intolerant prior to treatment with one or more anti-TNF therapies. In November
`2005, we, along with Roche, announced the following additional 24-week efficacy data from REFLEX: 51% of patients achieved
`ACR 20, the primary endpoint of the study, versus 18% of placebo patients; 27% of patients achieved ACR 50, versus 5% of placebo
`patients; and 12% of patients achieved ACR 70, versus 1% of placebo patients. We, along with Genentech and Roche, initiated a Phase III
`program of RITUXAN in RA patients who are inadequate responders to disease-modifying anti-rheumatic drugs, or DMARDs, in the
`first half of 2006.
`
`RITUXAN in Other Immunology Indications
`Based primarily on results from the studies of RITUXAN in RA, as well as other small investigator-sponsored studies in various
`autoimmune-mediated diseases, we, along with Genentech, are conducting Phase III clinical
`
`6
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`MYLAN PHARMS. INC. EXHIBIT 1078 PAGE 8
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`

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`Table of Contents
`
`studies of RITUXAN in MS and Systemic Lupus Erythematosus, SLE. In August 2006, we and Genentech announced that a Phase II
`study of RITUXAN in relapsing-remitting MS met its primary endpoint. The study of 104 patients showed a statistically significant
`reduction in the total number of gadolinium enhancing T1 lesions observed on serial MRI scans of the brain at weeks 12, 16, 20 and 24
`in the RITUXAN-treated group compared to placebo. Genentech and Biogen Idec will continue to analyze the study results and has been
`accepted for presentation at an upcoming medical meeting in the first half of 2007.
`In December 2006, we and Genentech issued a dear healthcare provider letter informing healthcare providers that two cases of
`progressive multifocal leukoencephalopathy, or PML, resulting in death were reported in patients receiving RITUXAN for treatment of
`SLE, an indication where RITUXAN is not approved for treatment. We are working with regulatory authorities to update the prescribing
`information for RITUXAN.
`
`TYSABRI
`TYSABRI is approved for the treatment of relapsing forms of MS. On June 5, 2006, we and Elan announced the FDA’s approval
`of the sBLA for the reintroduction of TYSABRI as a monotherapy treatment for relapsing forms of MS to slow the progression of
`disability and reduce the frequency of clinical relapses. On June 29, 2006, we and Elan announced that the EMEA had approved
`TYSABRI as a similar treatment.
`TYSABRI was initially approved by the FDA in November 2004 to treat relapsing forms of MS to reduce the frequency of clinical
`relapses. In February 2005, in consultation with the FDA, we and Elan voluntarily suspended the marketing and commercial distribution
`of TYSABRI based on reports of cases of progressive multifocal leukoencephalopathy, or PML, a rare and frequently fatal demyelinating
`disease of the central nervous system, in patients treated with TYSABRI in clinical studies. In consideration of these events, TYSABRI
`is marketed under risk management or minimization plans as agreed with local regulatory authorities. In the U.S. TYSABRI was
`reintroduced with a risk minimization action plan, or RiskMAP, known as the TYSABRI Outreach: Unified Commitment to Health, or
`TOUCH, Prescribing Program, a rigorous system intended to educate physicians and patients about the risks involved and assure
`appropriate use of the product.
`In September 2004, Elan submitted a Marketing Authorisation Application, or MAA, to the EMEA for approval of TYSABRI as a
`treatment for Crohn’s disease. The filing is based on the results of three randomized, double-blind, placebo-controlled, multi-center trials
`of TYSABRI assessing the safety and efficacy as both an induction and maintenance therapy — ENCORE (Efficacy of Natalizumab in
`Crohn’s Disease Response and Remission), ENACT-1 (Efficacy of Natalizumab as Active Crohn’s Therapy) and ENACT-2 (Evaluation
`of Natalizum