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, 2005
`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.
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`(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. o
`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 o Non-accelerated filer o
`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 o 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 $11,592,394,752.
`As of February 1, 2006, the Registrant had 344,098,779 shares of Common Stock, $0.0005 par value, issued and outstanding.
`DOCUMENTS INCORPORATED BY REFERENCE
`Portions of the definitive Proxy Statement for our 2006 Annual Meeting of Stockholders are incorporated by reference into Part III of
`this Report.
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`MYLAN PHARMS. INC. EXHIBIT 1077 PAGE 1
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`BIOGEN IDEC INC.
`ANNUAL REPORT ON FORM 10-K
`For the Year Ended December 31, 2005
`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
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` 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 and Financial Statement Schedule
`
`Item 15.
`Signatures
`Consolidated Financial Statements and Schedule
` Ex-10.51 Letter regarding employment arrangement, dated October 4, 2004
` Ex-10.52 Letter regarding relocation arrangement, dated September 2, 2004
` Ex-10.53 Letter regarding employment arrangement, dated October 8, 2001
` Ex-10.54 Memorandum regarding reimbursement arrangement, dated August 28, 2002
` Ex-12.1 Computation of Ratio of Earnings to Fixed Charges
` Ex-21.1 Subsidiaries
` Ex-23.1 Consent of PricewaterhouseCoopers LLP
` Ex-31.1 Section 302 Certification of C.E.O.
` Ex-31.2 Section 302 Certification of C.F.O.
` Ex-32.1 Section 906 Certification of C.E.O. & C.F.O.
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`MYLAN PHARMS. INC. EXHIBIT 1077 PAGE 2
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`

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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 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 five products:
`AVONEX® (interferon beta-1a). AVONEX is approved for the treatment of relapsing forms of multiple sclerosis, or MS, and is the most
`prescribed therapeutic product in MS worldwide. Globally over 130,000 patients have chosen AVONEX as their treatment of choice. In 2005, sales of
`AVONEX generated worldwide revenues of $1.5 billion as compared to worldwide sales of $1.4 billion in 2004.
`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 February 2006, RITUXAN was approved by the U.S. Food and Drug Administration, or
`FDA, to treat previously untreated patients with diffuse, large B-cell NHL in combination with anthracycline-based chemotherapy regimens. In
`addition, in February 2006, the FDA approved the 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 TNF antagonist therapies. We market RITUXAN in the U.S. in collaboration with Genentech, Inc., or
`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 2005, RITUXAN generated U.S. net sales of $1.8 billion of which we recorded $513.8 million as our share of copromotion profits as compared
`to U.S. net sales of $1.6 billion in 2004 of which we recorded $457.0 million as our share of copromotion profits. F. Hoffmann-La Roche Ltd., or
`Roche, sells rituximab 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 rituximab outside of the U.S. of $147.5 million in 2005 as compared to
`$121.0 million in 2004. 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 tradename for rituximab in the EU. In
`this Form 10-K, we refer to rituximab, RITUXAN, and MabThera collectively as RITUXAN, except where we have otherwise indicated.
`TYSABRI® (natalizumab). TYSABRI was 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 Corporation plc, or Elan, voluntarily suspended the marketing and
`commercial distribution of TYSABRI, and we informed physicians that they should suspend dosing of TYSABRI until further notification. In
`addition, we suspended dosing in clinical studies of TYSABRI in MS, Crohn’s disease and RA. These decisions were 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. We and Elan conducted a safety evaluation of patients treated with TYSABRI in MS, Crohn’s disease
`and RA clinical studies. The safety evaluation included the review of any reports of potential PML in MS patients receiving TYSABRI in the
`commercial setting. In October 2005, we completed the safety evaluation and found no new confirmed cases of PML. Three confirmed cases of PML
`were previously reported, two of which were fatal. In September 2005, we submitted an sBLA for TYSABRI to the FDA for the treatment of MS.
`The sBLA includes: final two-year data from the Phase 3 AFFIRM monotherapy trial and SENTINEL combination trial with AVONEX in MS; the
`integrated safety assessment of patients treated with TYSABRI in clinical trials; and a revised label and a risk minimization action plan. We and
`Elan have also submitted a similar data package to the European Medicines Agency, or EMEA. This information was supplied as part of the
`ongoing EMEA review process, which was initiated in the summer of 2004 with the filing for approval of TYSABRI as a treatment for MS. In
`November 2005, we were granted Priority Review status for the sBLA, which will result in action by the FDA approximately six months from the
`submission date, which is in March 2006. In January 2006, we and Elan announced that we had received notification from the FDA that the
`Peripheral and Central Nervous System Drugs Advisory Committee would review TYSABRI for the treatment of MS on March 7, 2006. In
`February 2006, we and Elan announced that the FDA informed the companies
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`Table of Contents
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`that the FDA removed the hold on clinical trial dosing of TYSABRI. We and Elan expect to begin an open-label, multi-center safety extension study
`of TYSABRI monotherapy in the U.S. and internationally in the first quarter of 2006. We plan to work with regulatory authorities to determine the
`future commercial availability of TYSABRI. See “Item 1A — Risk Factors — Safety Issues with TYSABRI Could Significantly Affect our
`Growth.”
`ZEVALIN® (ibritumomab tiuxetan). The ZEVALIN therapeutic regimen, which features ZEVALIN, 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
`relapsed or refractory NHL. In 2005, sales of ZEVALIN in the U.S. generated revenues of $19.4 million as compared to revenues of $18.7 million
`in 2004. ZEVALIN is approved in the EU for the treatment of adult patients with CD20¡ follicular B-cell NHL who are refractory to or have relapsed
`following RITUXAN therapy. We sell ZEVALIN to Schering AG for distribution in the EU, and receive royalty revenues from Schering AG on sales
`of ZEVALIN in the EU. Rest of world product sales for ZEVALIN in 2005 were $1.4 million as compared to $4.3 million in 2004. The $4.3 million
`of rest of world product sales in 2004 relates to ZEVALIN sold to Schering AG in 2003 and 2004, recognition of which had been deferred when the
`selling price was fixed and determinable.
`AMEVIVE® (alefacept). 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. In 2005, sales of AMEVIVE generated worldwide revenues of
`$48.5 million as compared to sales of $43.0 million in 2004. We are seeking to divest AMEVIVE as part of a comprehensive strategic plan which is
`discussed below.
`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 research and development programs. In connection with the strategic plan discussed below, we intend to
`commit significant additional capital to external research and development opportunities. We intend to focus our internal and external research and
`development efforts on finding novel therapeutics in areas of high unmet medical need and finding therapeutics in our focus areas of oncology,
`neurobiology and immunology. Our current 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 and MS; our
`collaboration with Fumapharm AG, or Fumapharm, on development of an oral therapy as a potential treatment for psoriasis and MS; and our
`collaboration with PDL BioPharma, Inc., or PDL, on development of three Phase 2 antibody products in a variety of indications.
`Comprehensive Strategic Plan. In September 2005, we began implementing a comprehensive strategic plan designed to position us for long-
`term growth. The plan builds on the continuing strength of AVONEX and RITUXAN and other expected near-term developments. The plan has three
`principal elements: reducing operating expenses and enhancing economic flexibility by recalibrating our asset base, geographic site missions, staffing
`levels and business processes; committing significant additional capital to external business development and research opportunities; and changing
`our organizational culture to enhance innovation and support the first two elements of the plan. In conjunction with the plan, we consolidated or
`eliminated certain internal management layers and staff functions, resulting in the reduction of our workforce by approximately 17%, or
`approximately 650 positions worldwide. These adjustments took place across Company functions, departments and sites, and have been
`substantially implemented. In February 2006, we sold our NICO clinical manufacturing facility in Oceanside, California to Genentech. In addition,
`we are seeking to divest several non-core assets, including AMEVIVE and certain real property in Oceanside, California. Our AMEVIVE assets held
`for sale include $8.0 million related to intangible assets, net, and $5.4 million for property, plant and equipment, net. In addition, our AMEVIVE
`inventory balance at December 31, 2005 was $49.8 million, of which $24.8 million related to the historical manufacturing costs and $25.0 million
`related to the increase in fair market value of inventory acquired at the merger, as described below.
`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
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`an Agreement and Plan of Merger dated as of June 20, 2003. As a result of the merger, each issued and outstanding share of Biogen, Inc. common
`stock was converted into the right to receive 1.15 shares of Biogen Idec common stock. Our stock trades on the Nasdaq National Market under the
`symbol “BIIB.” The results of Biogen, Inc.’s operations from November 13, 2003, the day after the effective date of the merger, to December 31,
`2003 have been included in the 2003 consolidated financial statements filed in this Annual Report on Form 10-K.
`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 on 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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`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, dermatology and rheumatology. Our
`marketed products and late stage product candidates are as follows:
`
`
`Product
`AVONEX
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`RITUXAN
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`ZEVALIN
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`AMEVIVE
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`TYSABRI
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`Anti-CD80
`antibody
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`BG-12/
`PANACLAR
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`Product Indications
` Certain forms of MS
`
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`Chronic Inflammatory
`Demyelinating
`Polyradioneuropathy
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`Relapsed or refractory indolent B-cell NHL
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` Newly diagnosed diffuse, large B-cell NHL
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`RA
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` Newly diagnosed indolent NHL
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` Relapsed chronic lymphocytic leukemia
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` Lupus/MS
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` Certain B-cell NHLs (radioimmunotherapy)
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` Diffuse large B-cell lymphoma
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`Moderate-to-severe chronic plaque psoriasis
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`MS
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`Crohn’s disease
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`Relapsed or refractory follicular lymphoma
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`MS
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` Psoriasis
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`Status
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` Approved worldwide
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`Phase 2
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` None
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`None
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`Development and/or
`Marketing Collaborators
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`Approved worldwide
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` U.S — Approved
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`U.S. — Approved for certain patients who
`have inadequately responded to one or more
`anti-TNF antagonist therapies
`Phase 3 — DMARD failures
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`Phase 3
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`Phase 3
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`Phase 3
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`All RITUXAN Indications:
`U.S. — Genentech
`Outside U.S. and Japan —
`Roche Japan — Roche and Zenyaku
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` See above
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`See above
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` See above
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` See above
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` See above
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` Approved — U.S. and EU
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` Outside U.S. — Schering AG
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`Phase 3
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` Outside U.S. — Schering AG
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`Approved — U.S. and other countries;
`seeking to divest
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`U.S. — Approved in U.S. in November 2004;
`marketing, commercial distribution and dosing
`in clinical studies suspended in February
`2005; clinical trial hold removed in February
`2006; sBLA currently under Priority Review
`EU — Under regulatory review
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`EU — Under regulatory review
`Phase 3 — Three Phase 3 trials completed;
`dosing in clinical studies suspended in
`February 2005
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`Phase 2 completed
`Phase 3 expected to begin in
`second half of 2006
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`Phase 2 completed
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`None; seeking to divest
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`Elan
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`Elan
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`None
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`Fumapharm
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`Fumapharm
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` Under regulatory review — Germany
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`AVONEX
`We currently market and sell AVONEX worldwide for the treatment of relapsing forms of MS. In 2005, sales of AVONEX generated
`worldwide revenues of $1.5 billion as compared to worldwide revenues of $1.4 billion in 2004. AVONEX was sold by Biogen, Inc. until
`November 12, 2003. Our consolidated financial statements include only the results of operations of Biogen, Inc. since November 13,
`2003. Our revenues from AVONEX during the period from November 13, 2003 to December 31, 2003 were $142.6 million.
`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 more than 60 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 130,000 patients have selected AVONEX as their treatment of choice.
`We continue to work to expand the data available about AVONEX and MS treatments. In September 2005, we announced the
`initiation of 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 will investigate
`factors that influence non-adherence to MS therapies. The study aims to enroll over 1,800 patients with relapsing remitting MS in 24
`countries who are currently taking one of the following therapies: AVONEX, Betaseron® (Interferon beta-1b), Copaxone® (glatiramer
`acetate), or Rebif® (Interferon beta-1a). Patients will be evaluated through a validated MS quality of life scale, as well as a self-reported
`questionnaire that collects data on disease status, treatment, and factors that may have affected adherence to treatment during the course of
`their therapy.
`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 4 investigator-run studies
`evaluating AVONEX in combination with other therapies. In addition, we are conducting a Phase 2 study of AVONEX as a treatment for
`Chronic Inflammatory Demyelinating Polyradioneuropathy.
`In February 2005, in consultation with the FDA, we and Elan voluntarily suspended the marketing and commercial distribution of
`our other MS drug, TYSABRI, and suspended dosing in all clinical studies of TYSABRI, including clinical studies of TYSABRI in
`combination with AVONEX. These decisions were based on reports of two cases of PML, a rare and frequently fatal, demyelinating
`disease of the central nervous system, that have occurred in patients treated with TYSABRI in combination with AVONEX. For
`additional information related to TYSABRI and PML, see “Our Products — Approved Indications and Ongoing
`Development — TYSABRI.”
`
`RITUXAN
`Overview. 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 February 2006, RITUXAN was approved
`by the FDA to treat previously untreated patients with diffuse, large B-cell NHLs in combination with a chemotherapy regimen consisting
`of cyclophosphamide, doxorubicin, vincristine and prednisone, also known as CHOP, or other anthracycline-based chemotherapy
`regimens. In addition, in February 2006, the FDA approved the sBLA for use of RITUXAN, in combination with methotrexate, for
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`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.
`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 2005, RITUXAN generated U.S. net sales of $1.8 billion, of which we recorded
`$513.8 million as our share of copromotion profits, as compared to U.S. net sales of $1.6 billion in 2004, of which we recorded $457.0 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. We received royalties through Genentech on sales of RITUXAN outside of the U.S. of $147.5 million in 2005 as compared to
`$121.0 million in 2004. In the U.S., we also 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 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 is currently finishing Phase 1/2 trials for use in RA.
`RITUXAN in Oncology. 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 February 2006, RITUXAN was
`approved by the FDA to treat previously untreated patients with diffuse, large B-cell NHLs in combination with CHOP or other anthracycline-based
`chemotherapy regimens. The approval was based primarily on the results of the following studies:
`
`• A randomized Phase 3 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 3 randomized study of 824 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
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`• 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.
`In an effort to identify additional applications for RITUXAN, we, in conjunction with Genentech and Roche, continue to support RITUXAN
`post-marketing studies. Ongoing and completed Phase 2 and 3 studies have helped support filings for approval of additional indications in the U.S.
`and EU, and suggest that RITUXAN may have promise as a single agent in the treatment of relapsed chronic lymphocytic leukemia, or CLL, and
`as maintenance therapy in indolent B-cell NHLs. These studies include:
`
`• A randomized Phase 3 study of the addition of RITUXAN to a chemotherapy regimen of cyclophosphamide, vincristine and prednisone, also
`known as CVP, in previously untreated, or front line patients with indolent non-Hodgkin’s lymphoma. In this investigator-run study,
`321 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 2 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 3 study, known as E1496, designed to compare RITUXAN maint