Table of Contents
`
`
`
`
`
`
`¨
`
`UNITED STATES SECURITIES AND EXCHANGE COMMISSION
`Washington, D.C. 20549
`Form 10-K
`ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
`For the fiscal year ended December 31, 2012
`
`or
`
`TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
`Commission file number: 0-19311
`
`BIOGEN IDEC INC.
`
`(Exact name of registrant as specified in its charter)
`
`
`
`Delaware
`(State or other jurisdiction of
`
`incorporation or organization)
`133 Boston Post Road, Weston, Massachusetts 02493
`(781) 464-2000
`(Address, including zip code, and telephone number, including area code, of Registrant’s principal executive offices)
`Securities registered pursuant to Section 12(b) of the Act:
`
`33-0112644
`(I.R.S. Employer
`Identification No.)
`
`
`Name of Each Exchange on Which Registered
`Title of Each Class
`
`The Nasdaq Global Select Market
`Common Stock, $0.0005 par value
`Securities registered pursuant to Section 12(g) of the Act:
`None
`Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes  No ¨
`Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ¨ 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 ¨
`Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File
`required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was
`required to submit and post such files): Yes  No ¨
`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. ¨
`Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See
`the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
`
`Accelerated filer ¨
`
`Large accelerated filer 
`
`
`Non-accelerated filer ¨
` Smaller reporting company ¨
`
`
`
`
`(Do not check if a smaller reporting company)
`
`
`Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ¨ 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 $34,138,379,832.
`As of January 31, 2013, the registrant had 236,312,191 shares of common stock, $0.0005 par value, outstanding.
`DOCUMENTS INCORPORATED BY REFERENCE
`Portions of the definitive proxy statement for our 2013 Annual Meeting of Stockholders are incorporated by reference into Part III of this report.
`
`
`
`MYLAN PHARMS. INC. EXHIBIT 1080 PAGE 1
`
`

`

`Table of Contents
`
`
`
`
`
`BIOGEN IDEC INC.
`ANNUAL REPORT ON FORM 10-K
`For the Year Ended December 31, 2012
`TABLE OF CONTENTS
`
`PART I
`
`Page
`
`Item 1.
`Item 1A.
`Item 1B.
`Item 2.
`Item 3.
`Item 4.
`
`
`Item 5.
`Item 6.
`Item 7.
`Item 7A.
`Item 8.
`Item 9.
`Item 9A.
`Item 9B.
`
`
`Item 10.
`Item 11.
`Item 12.
`Item 13.
`Item 14.
`
`
`Business
`Risk Factors
`Unresolved Staff Comments
`Properties
`Legal Proceedings
`Mine Safety Disclosures
`
`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
`Quantitative and Qualitative Disclosures About Market Risk
`Consolidated Financial Statements and Supplementary Data
`Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
`Controls and Procedures
`Other Information
`
`PART III
`
`Directors, Executive Officers and Corporate Governance
`Executive Compensation
`Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
`Certain Relationships and Related Transactions, and Director Independence
`Principal Accountant Fees and Services
`
`Exhibits, Financial Statement Schedules
`
`Item 15.
`
`Signatures
`Consolidated Financial Statements
`Exhibit Index
`
`PART IV
`
`
`
`1
`20
`29
`29
`30
`30
`
`31
`33
`35
`6 6
`6 6
`6 6
`6 6
`67
`
`68
`68
`68
`68
`68
`
`6 9
`
`70
`F-1
`A-1
`
`MYLAN PHARMS. INC. EXHIBIT 1080 PAGE 2
`
`

`

`Table of Contents
`
`NOTE REGARDING FORWARD-LOOKING STATEMENTS
`This report contains forward-looking statements that are based on our current beliefs and expectations. These forward-looking statements may be
`accompanied by such words as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “project,” “target,”
`“will” and other words and terms of similar meaning. Reference is made in particular to forward-looking statements regarding:
`•
`the anticipated amount, timing and accounting of revenues, contingency payments, milestone, royalty and other payments under licensing, collaboration
`or acquisition agreements, tax positions and contingencies, doubtful accounts, cost of sales, research and development costs, compensation and other
`expenses, amortization of intangible assets, and foreign currency forward contracts;
`the anticipated regulatory actions relating to and the commercial launch of TECFIDERA (BG-12);
`our plans to develop further risk stratification protocols for TYSABRI and the impact of such protocols;
`anticipated regulatory filings for, regulatory actions relating to, and commercial launch of our long-lasting blood clotting factor candidates;
`additional planned launches and future development costs of FAMPYRA;
`the timing, outcome and impact of proceedings related to: patents and other intellectual property rights; tax audits, assessments and settlements; product
`liability and other legal proceedings;
`
`•
`•
`•
`•
`•
`
`•
`•
`•
`•
`•
`•
`
`•
`
`•
`•
`•
`•
`•
`•
`•
`•
`
`•
`•
`•
`
`loss to be incurred in connection with Genentech's ongoing arbitration with Hoechst;
`the deferral of TYSABRI revenue in Italy;
`
`the expected lifetime revenue of AVONEX and amortization recorded in relation to its core technology;
`the costs, timing and therapeutic scope of the development and commercialization of our pipeline products;
`
`our arrangement with Knopp Neurosciences related to dexpramipexole;
`the timing and impact of U.S. healthcare reform, including the annual fee on prescription drug manufacturers, and other measures worldwide designed
`to reduce healthcare costs;
`
`the impact of the deterioration of the credit and economic conditions in certain countries in Europe and our collection of accounts receivable in such
`countries;
`patent terms, patent term extensions, patent office actions and market exclusivity rights;
`fair value estimates in connection with our acquisitions of Stromedix and other entities;
`lease commitments and purchase obligations;
`our ability to finance our operations and business initiatives and obtain funding for such activities;
`the impact of new laws and accounting standards;
`the availability of our unrepatriated foreign earnings and dividend activity;
`repayment of outstanding debt;
`the timing and expected financial impact of relocating our corporate headquarters from our facility in Weston, Massachusetts to Cambridge,
`Massachusetts;
`manufacturing capacity;
`the licensure of and plans for our manufacturing facility in Hillerød, Denmark; and
`the drivers for growing our business, including our plans to pursue business development and research opportunities, and competitive conditions.
`
`These forward-looking statements involve risks and uncertainties, including those that are described in the “ Risk Factors” section of this report and
`elsewhere within this report that could cause actual results to differ materially from those reflected in such statements. You should not place undue reliance on
`these statements. Forward-looking statements speak only as of the date of this report. We do not undertake any obligation to publicly update any forward-
`looking statements.
`
`MYLAN PHARMS. INC. EXHIBIT 1080 PAGE 3
`
`

`

`Table of Contents
`
`NOTE REGARDING COMPANY AND PRODUCT REFERENCES
`Throughout this report, “Biogen Idec,” the “Company,” “we,” “us” and “our” refer to Biogen Idec Inc. and its consolidated subsidiaries. References to
`“RITUXAN” refer to both RITUXAN (the trade name for rituximab in the U.S., Canada and Japan) and MabThera (the trade name for rituximab outside the
`U.S., Canada and Japan), and “ANGIOMAX” refers to both ANGIOMAX (the trade name for bivalirudin in the U.S., Canada and Latin America) and
`ANGIOX (the trade name for bivalirudin in Europe).
`
`NOTE REGARDING TRADEMARKS
`AVONEX®, AVONEX PEN® and RITUXAN® are registered trademarks of Biogen Idec. FUMADERM TM and TECFIDERATM are trademarks of
`Biogen Idec. TYSABRI® and TOUCH® are registered trademarks of Elan Pharmaceuticals, Inc. The following are trademarks of the respective companies
`listed: ACTEMRA® — Chugai Seiyaku Kabushiki Kaisha; AUBAGIO ® — Sanofi Societe Anonyme France; ANGIOMAX ® and ANGIOX® — The
`Medicines Company; ARZERRA® — Glaxo Group Limited; BENLYSTA® — Human Genome Sciences, Inc.; BETASERON® and
`BETAFERON® — Bayer Schering Pharma AG; CAMPATH® and LEMTRADA® — Genzyme Corporation; CIMZIA ® — UCB Pharma, S.A.;
`COPAXONE® — Teva Pharmaceutical Industries Limited; ENBREL® — Immunex Corporation; EXTAVIA® and GILENYA® — Novartis AG;
`FAMPYRA® — Acorda Therapeutics, Inc.; HUMIRA® — AbbVie Biotechnology Ltd.; ORENCIA® — Bristol-Myers Squibb Company; REBIF ® — Ares
`Trading S.A.; REMICADE® — Centocor Ortho Biotech Inc.; SIMPONI ® — Johnson & Johnson; and TREANDA ® — Cephalon, Inc.
`
`MYLAN PHARMS. INC. EXHIBIT 1080 PAGE 4
`
`

`

`Table of Contents
`
`Item 1.
`
`Business
`
`PART I
`
`Overview
`Biogen Idec is a global biotechnology company focused on discovering, developing, manufacturing and marketing therapies for the treatment of multiple
`sclerosis (MS) and other autoimmune disorders, neurodegenerative diseases and hemophilia. We also collaborate on the development and commercialization of
`RITUXAN and anti-CD20 product candidates for the treatment of non-Hodgkin's lymphoma and other conditions. Summary information about our marketed
`products is set forth in the table below.
`
`
`
`
`
`Product
`AVONEX (1)
`TYSABRI (2)
`
`FAMPYRA (3)
`
`FUMADERM (4)
`
` Indications
` Multiple sclerosis
`Multiple sclerosis
`Crohn’s disease
`Multiple sclerosis
`
`(walking ability)
` Psoriasis
`
`
`
`
`
`
`
`Product
`RITUXAN (5)
`
` Indications
`Non-Hodgkin’s lymphoma
`Rheumatoid arthritis
`Chronic lymphocytic leukemia
`ANCA-associated vasculitis
`
`
`
`
`Development or
`
`Marketing Collaborator
` None
`Elan Pharma International
`
`
`
`Acorda Therapeutics
`
`
` None
`
`
`
`
`Development or
`Marketing Collaborator
`Genentech
`(Roche Group)
`
`
`
`
`
`
` $
`$
`
`
`
`$
`
`
` $
`
`
`
`
`
`
`
`Product Revenues
`to Biogen Idec (in millions)
`
`
`2012
`2,913.1 $
`1,135.9
`$
`
`
`
`
`2011
`2,686.6 $
`1,079.5
`$
`
`
`
`57.4
`
`$
`
`13.6
`
`$
`
`
`
`54.7 $
`59.7 $
`Unconsolidated Joint Business
`Revenues to Biogen Idec (in millions)
`
`2012
`1,137.9
`
`$
`
`$
`
`
`
`
`
`2011
`996.6
`
`$
`
`
`
`
`
`2010
`2,518.4
`900.2
`
`—
`
`51.2
`
`2010
`1,077.2
`
`(1) AVONEX (interferon beta-1a) is indicated for the treatment of patients with relapsing forms of MS to slow the accumulation of physical disability and
`decrease the frequency of clinical exacerbations.
`
`(2) TYSABRI (natalizumab) is indicated (1) for the treatment of relapsing forms of MS as a monotherapy to delay the accumulation of physical disability
`and reduce the frequency of clinical exacerbations and (2) in the U.S. for inducing and maintaining clinical response and remission in adult patients
`with moderately to severely active Crohn's disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate,
`conventional Crohn's disease therapies and TNF inhibitors.
`
`(3) FAMPYRA (prolonged-release fampridine tablets) is indicated for the improvement of walking ability in adult patients with MS who have walking
`disability.
`
`(4) FUMADERM (fumaric acid esters) is only approved in Germany and is indicated for the treatment of adult patients with moderate to severe plaque
`psoriasis for whom topical therapy is ineffective.
`
`(5) RITUXAN (rituximab) is indicated for the treatment of (1)(a) relapsed or refractory, low-grade or follicular, CD20-positive, B-cell Non-Hodgkin's
`lymphoma (NHL) as a single agent, (b) previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in
`patients achieving a complete or partial response to RITUXAN in combination with chemotherapy, as a single-agent maintenance therapy, (c) non-
`progressing (including stable disease), low-grade, CD20-positive, B-cell NHL, as a single agent, after first-line CVP chemotherapy, and (d) previously
`untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or other anthracycline-based chemotherapy regimens, (2) CD20-positive
`chronic lymphocytic leukemia in combination with fludarabine and cyclophosphamide, (3) moderately- to severely-active rheumatoid arthritis, in
`combination with methotrexate, in adult patients who have had an inadequate response to one or more TNF antagonist therapies, and (4) Wegener's
`Granulomatosis and Microscopic Polyangiitis, in combination with glucocorticoids, in adult patients.
`
`Additional financial information about our product revenues, other revenues and geographic areas in which we operate is set forth in our consolidated
`financial statements, in Note 26, Segment Information to our consolidated financial statements, and in Item 6. Selected Consolidated Financial Data
`included in this report. A discussion of the risks attendant to our international operations is set forth in the “ Risk Factors” section of this report.
`
`1
`
`MYLAN PHARMS. INC. EXHIBIT 1080 PAGE 5
`
`

`

`Table of Contents
`
`We devote significant resources to research and development programs and external business development opportunities, as summarized in the table
`below:
`
`(In millions)
`Research and development
`Amortization of acquired intangible assets
`Fair value adjustment of contingent consideration
`Acquired in-process research and development
`* $145.0 million attributed to noncontrolling interests, net of tax.
`
`
` $
` $
` $
` $
`
`
`2012
`1,334.9 $
`202.2 $
`27.2 $
`— $
`
`
`2011
`1,219.6 $
`208.6 $
`36.1 $
`— $
`
`
`2010
`1,248.6
`208.9
`—
`245.0
`
`*
`
`Additional information about our research and development programs and business development activity during 2012 is set forth below under the
`subsections entitled “Research and Development Programs” and “Business Development.”
`
`We were formed as a California corporation in 1985 and became a Delaware corporation in 1997. In 2003, we acquired Biogen, Inc. and changed our
`corporate name from IDEC Pharmaceuticals Corporation to Biogen Idec Inc. Our principal executive offices are located at 133 Boston Post Road, Weston, MA
`02493 and our telephone number is (781) 464-2000. Our website address is www.biogenidec.com. We make available free of charge through the Investors
`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 (SEC). We include
`our website address in this report only as an inactive textual reference and do not intend it to be an active link to our website. The contents of our website are
`not incorporated into this filing.
`
`Marketed Products
`AVONEX
`AVONEX is one of the most prescribed treatments for relapsing forms of MS worldwide. 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 the interferon beta protein produced in the body in response to viral
`infection.
`
`•
`
`2012 Developments
`In February 2012, the U.S. Food and Drug Administration (FDA) approved two separate dosing innovations designed to improve the treatment
`experience for patients receiving once-a-week AVONEX for relapsing forms of MS: AVONEX PEN and a new dose titration regimen. AVONEX PEN is
`the first intramuscular autoinjector approved for MS and is designed to enhance the self-injection process for patients receiving AVONEX therapy. A new
`dose titration regimen, facilitated by the AVOSTARTGRIP titration devices, provides patients with the option to gradually increase the dose of AVONEX
`at treatment initiation to reduce the incidence and severity of flu-like symptoms that patients may experience with therapy. These AVONEX dosing
`innovations are commercially available in the E.U., U.S. and other countries.
`
`TYSABRI
`TYSABRI has advanced the treatment of MS patients with its established efficacy. TYSABRI is a monoclonal antibody approved in numerous
`countries as a monotherapy for relapsing MS and is also approved in the U.S. to treat Crohn's disease, an inflammatory disease of the intestines.
`
`TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic infection of the brain by the JC virus that usually
`leads to death or severe disability. Infection by the JC virus (JCV) is required for the development of PML and patients who are anti-JCV antibody positive
`have a higher risk of developing PML. Factors that increase the risk of PML are presence of anti-JCV antibodies, prior immunosuppressant use, and longer
`TYSABRI treatment duration. Patients who have all three risk factors have the highest risk of developing PML. Reports of cases of PML in patients treated
`with TYSABRI in clinical studies led us to voluntarily suspend the marketing and commercial distribution of TYSABRI in February 2005 until its
`reintroduction to the market in July 2006. Because of the risk of PML, TYSABRI has a boxed warning and is marketed under risk management or
`minimization plans approved by regulatory authorities. In the U.S., for example, TYSABRI is marketed under the TOUCH Prescribing Program, a restricted
`distribution program designed to assess and minimize the risk of PML, minimize death and disability due to PML, and promote informed benefit-risk
`decisions regarding TYSABRI use.
`
`2
`
`MYLAN PHARMS. INC. EXHIBIT 1080 PAGE 6
`
`

`

`Table of Contents
`
`U.S. and E.U. regulators continue to monitor and assess on an ongoing basis the criteria for confirming PML diagnosis, the number of PML cases, the
`incidence of PML in TYSABRI patients, the risk factors for PML, and TYSABRI's benefit-risk profile, which could result in modifications to the approved
`labels or other restrictions on TYSABRI treatment. We continue to research and develop protocols and therapies that may reduce risk and improve outcomes of
`PML in patients.
`
`We collaborate with Elan Pharma International, Ltd (Elan) on the development and commercialization of TYSABRI. For information about this
`collaboration, please read Note 21, Collaborative and Other Relationships to our consolidated financial statements included in this report.
`
`•
`
`2012 - 2013 Developments
`In January 2013, we and Elan Corporation, plc announced the submission of applications to the FDA and European Medicines Agency (EMA)
`requesting updates to the TYSABRI product labels. The applications request an expanded indication that would include first-line use for people living
`with certain relapsing forms of MS who have tested negative for antibodies to the JC virus.
`
`•
`
`In January 2012, the FDA approved the inclusion in the U.S. product label for TYSABRI of anti-JCV antibody status as an additional factor in
`stratifying patients for developing PML. The FDA also approved the inclusion of a table summarizing the estimated incidence of PML according to the
`duration of TYSABRI treatment, prior immunosuppressant use and anti-JCV antibody status. In addition, the FDA granted Quest Diagnostics a de
`novo classification petition for the STRATIFY JCV Antibody ELISA testing service, which allows neurologists to determine their MS patients' anti-JCV
`antibody status.
`RITUXAN
`RITUXAN is a widely prescribed monoclonal antibody used to treat non-Hodgkin's lymphoma, rheumatoid arthritis, chronic lymphocytic leukemia
`and two forms of ANCA-associated vasculitis. Non-Hodgkin's lymphoma and chronic lymphocytic leukemia are cancers that affect lymphocytes, which are
`a type of white blood cell that help to fight infection. Rheumatoid arthritis is a chronic disease that occurs when the immune system mistakenly attacks the
`body's joints, resulting in inflammation, pain and joint damage. ANCA-associated vasculitis is a rare autoimmune disease that largely affects the small blood
`vessels of the kidneys, lungs, sinuses, and a variety of other organs.
`
`We collaborate with Genentech, a wholly-owned member of the Roche Group, on the development and commercialization of RITUXAN. For information
`about this collaboration, please read Note 21, Collaborative and Other Relationships to our consolidated financial statements included in this report.
`
`FAMPYRA
`FAMPYRA is the first treatment that addresses the unmet medical need of walking improvement in adult patients with MS who have walking disability.
`FAMPYRA is a prolonged-release tablet formulation of the drug fampridine. FAMPYRA is commercially available throughout the European Union and in
`Canada, Australia, New Zealand, Israel and South Korea, and we anticipate making FAMPYRA commercially available in additional markets in 2013.
`We have a license from Acorda Therapeutics, Inc. to develop and commercialize FAMPYRA in all markets outside the U.S. For information about this
`relationship, please read Note 21, Collaborative and Other Relationships to our consolidated financial statements included in this report.
`
`•
`
`2012 Developments
`The European Commission previously granted a conditional marketing authorization for FAMPYRA in the E.U. in July 2011. A conditional marketing
`authorization is renewable annually and is granted to a medicinal product with a positive benefit-risk assessment that fulfills an unmet medical need
`when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. This marketing
`authorization was renewed as of July 2012. To meet the conditions of this marketing authorization, we will provide additional data from on-going clinical
`studies regarding FAMPYRA's benefits and safety in the long term.
`
`FUMADERM
`FUMADERM is approved for the treatment of moderate to severe psoriasis in Germany. Psoriasis is a skin disease in which cells build up on the skin
`surface and form scales and red patches.
`
`3
`
`MYLAN PHARMS. INC. EXHIBIT 1080 PAGE 7
`
`

`

`Table of Contents
`
`Other Sources of Revenue
`Our other sources of revenue consist of royalties we receive from net sales of products related to patents that we licensed (royalty revenues) and revenues
`from our contract manufacturing, product supply and biosimilar arrangements (corporate partner revenues). Summary information about our other sources of
`revenue is set forth in the table below:
`
`(In millions)
`Royalty revenues
`Corporate partner revenues
`
`
`
`
`
`$
`$
`
`2012
`
`
`168.7 $
`43.8 $
`
`2011
`
`
`158.5 $
`57.4 $
`
`2010
`
`137.4
`31.7
`
`Our most significant source of royalty revenue is derived from net worldwide sales of ANGIOMAX, which is licensed to The Medicines Company
`(TMC). TMC markets ANGIOMAX primarily in the U.S. and Europe for use as an anticoagulant in patients undergoing percutaneous coronary intervention.
`For a description of this royalty arrangement, please read the subsection entitled “ Other Revenues - Royalty Revenues” in the “Management's Discussion
`and Analysis of Financial Condition and Results of Operations ” section of this report.
`
`•
`
`2012 Developments
`In March 2012, the U.S. Patent and Trademark Office granted the extension of the term of the principal U.S. patent that covers ANGIOMAX to
`December 15, 2014. Under the terms of our royalty arrangement for ANGIOMAX, TMC is obligated to pay us royalties earned, on a country-by-
`country basis, until the later of (1) twelve years from the date of the first commercial sale of ANGIOMAX in such country or (2) the date upon which the
`product is no longer covered by a licensed patent in such country. The annual royalty rate is reduced by a specified percentage in any country where the
`product is no longer covered by a licensed patent and where sales have been reduced to a certain volume-based market share. TMC began selling
`ANGIOMAX in the U.S. in January 2001.
`
`Research and Development Programs
`A commitment to research is fundamental to our mission at Biogen Idec. Our research and development strategy is to discover and develop first-in-class
`molecules or best-in-class molecules that improve safety or efficacy for unmet medical needs. By applying our expertise in biologics and our growing
`capabilities in small-molecule drug discovery and development, we target specific medical needs where new or better treatments are needed.
`
`We intend to continue committing significant resources to research and development opportunities and business development activity. As part of our
`ongoing research and development efforts, we have devoted significant resources to conducting clinical studies to advance the development of new
`pharmaceutical products and to explore the utility of our existing products in treating disorders beyond those currently approved in their labels. The table
`below highlights our current research and development programs. Drug development involves a high degree of risk and investment, and the status, timing and
`scope of our development programs are subject to change. Important factors that could adversely affect our drug development efforts are discussed in the “ Risk
`Factors” section of this report.
`
`4
`
`MYLAN PHARMS. INC. EXHIBIT 1080 PAGE 8
`
`

`

`Table of Contents
`
`Therapeutic Area
`Neurology
`
`
`
`
`
`
`
`
`
`Hemophilia
`
`
`Immunology
`
`
`Other
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Product Candidate
`TECFIDERA (BG-12)
`
`Peginterferon beta-1a
`
`Daclizumab
`TYSABRI
`Anti-LINGO
`
`BIIB037
`ISIS - SMNRx
`Neublastin
`
`Factor IX
`
`Factor VIII
`
`STX-100
`Anti-TWEAK
`Anti-CD40 Ligand
`
`GA101
`GA101
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Targeted Indications
`MS
`
`MS
`
`MS
`Secondary-progressive MS
`Optic Neuritis
`MS
`Alzheimer’s disease
`Spinal muscular atrophy
`Neuropathic pain
`
`Hemophilia B
`
`Hemophilia A
`
`Idiopathic pulmonary fibrosis
`Lupus nephritis
`General lupus
`
`Chronic lymphocytic leukemia
`Non-Hodgkin’s lymphoma
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Status
`Marketing applications submitted and
`under regulatory review
`Expect to submit marketing applications
`by mid - 2013
`Phase 3
`Phase 3
`Phase 2
`Phase 1
`Phase 1
`Phase 1b/2a
`Phase 1
`
`U.S. BLA submitted and under
`regulatory review
`Expect to submit U.S. BLA in 1H 2013
`
`Phase 2
`Phase 2
`Phase 1
`
`Phase 3
`Phase 3
`
`Late Stage Product Candidates
`Additional information about our late stage product candidates is set forth below.
`
`TECFIDERA (BG-12)
`In February 2012, we submitted a New Drug Application to the FDA for marketing approval of TECFIDERA, our oral small molecule candidate for the
`treatment of MS. The regulatory submission was based on TECFIDERA's comprehensive development program, in which TECFIDERA demonstrated
`significant reductions in MS disease activity coupled with favorable safety and tolerability in the Phase 3 DEFINE and CONFIRM studies. The FDA accepted
`our application for TECFIDERA and granted us a standard review timeline. In October 2012, we announced that the FDA extended the initial PDUFA date for
`its review of our application by three months, which is a standard extension period. The extended PDUFA target date is in late March 2013. The FDA has
`indicated that the extension of the PDUFA date is needed to allow additional time for review of our application. The agency has not asked for additional
`studies.
`
`In March 2012, we submitted a Marketing Authorisation Application for TECFIDERA to the EMA. The EMA has validated our application for review
`of TECFIDERA in the E.U. We have submitted additional regulatory applications for TECFIDERA in Australia, Canada and Switzerland.
`
`We acquired TECFIDERA as part of our acquisition of Fumapharm AG in 2006. For more information about this acquisition and associated milestone
`obligations, please read the subsection entitled “ Contractual Obligations and Off-Balance Sheet Arrangements-Contingent Consideration ” in the
`“Management's Discussion and Analysis of Financial Condition and Results of Operations ” section of this report.
`
`Peginterferon beta-1a
`Peginterferon beta-1a (Peginterferon) is designed to prolong the effects and reduce the dosing frequency of interferon beta-1a. The FDA has granted
`Peginterferon fast track status, which may result in priority review.
`
`In January 2013, we released the primary efficacy analysis and safety data from our Phase 3 study, ADVANCE. Results support Peginterferon as a
`potential treatment dosed every two weeks or every four weeks for relapsing-remitting MS. The primary endpoint of ADVANCE, annualized relapse rate at one
`year, was met for both the two-week and four-week dosing regimens. Results showed that Peginterferon also met the secondary endpoints of risk of 12-week
`confirmed disability progression, proportion of patients who relapsed and magnetic resonance imaging assessments for both dose regimens. We plan to submit
`marketing applications for Peginterferon in the U.S. and E.U. by mid - 2013.
`
`5
`
`MYLAN PHARMS. INC. EXHIBIT 1080 PAGE 9
`
`

`

`Table of Contents
`
`Daclizumab
`Daclizumab is a monoclonal antibody that is being tested in relapsing MS. In May 2010, we began patient enrollment in a Phase 3 study of daclizumab
`in relapsing MS, known as DECIDE, evaluating the efficacy and safety of daclizumab compared to interferon beta-1a (AVONEX). The DECIDE study is
`designed to have a two year endpoint and is expected to involve approximately 1,800 patients.
`
`In August 2011, we announced positive results from SELECT, a global, registrational Phase 2b study designed to evaluate daclizumab in relapsing MS
`over one year. Results showed that daclizumab, administered subcutaneously once every four weeks, met primary and key secondary study endpoints,
`compared to placebo.
`
`We collaborate with AbbVie Biotherapuetics, Inc., a subsidiary of AbbVie, Inc. on the development and commercialization of daclizumab. For
`information about this collaboration, please read Note 21, Collaborative and Other Relationships to our consolidated financial statements included in this
`report.
`
`TYSABRI (SPMS)
`As part of our efforts with Elan to identify additional applications for TYSABRI, in September 2011 we began patient enrollment in a Phase 3b study of
`TYSABRI in secondary progressive MS, known as ASCEND. The study is designed to have an endpoint of approximately two years and involve
`approximately 850 patients. Secondary progressive MS is characterized by a steady progression of nerve damage, symptoms and disability.
`
`Long-Lasting Recombinant Factors VIII and IX
`In October 2012, we announced positive top-line results from the Phase 3 study, known as A-LONG, investigating our long-lasting recombinant Factor
`VIII-Fc fusion protein in hemophilia A, a rare inherited disorder which inhibits blood coagulation. We plan to submit a Biologics License Application to the
`FDA for our long-lasting Factor VIII product candidate in the first half of 2013.
`
`We submitted a Biologics License Application to the FDA for marketing approval of our long-lasting recombinant Factor IX-Fc fusion protein in
`hemophilia B, a rare inherited disorder which inhibits blood coagulation, in the fourth quarter of 2012. The regulatory submission was based on the positive
`to