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`10-K 1 d54155e10vk.htm FORM 10-K
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`Table of Contents
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`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, 2007
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`or
`TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
`ACT OF 1934
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` For the transition period from to
`Commission file number: 000-50447
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`Pharmion Corporation
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`Delaware
`(State or other jurisdiction of
`incorporation or organization)
`2525 28th Street, Suite 200,
`Boulder, Colorado
`(Address of principal executive offices)
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`(Exact name of registrant as specified in its charter)
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`84-1521333
`(I.R.S. Employer
`Identification No.)
`80301
`(Zip Code)
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`
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`720-564-9100
`(Registrant’s telephone number, including area code)
`Securities registered pursuant to Section 12(b) of the Act:
`Title of each class
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`Common Stock, $.001 par value per share
`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 þ No o
`Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act. Yes o No þ
`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 þ 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 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, 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. (Check one):
`Large accelerated filer þ Accelerated filer o Non-accelerated filer o Smaller reporting company o
`(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 Exchange Act). Yes o No þ
`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 of the registrant’s most recently completed second fiscal
`quarter was approximately $886,137,122, based on a closing price of $28.95 per share on June 30, 2007.
`The number of shares outstanding of the registrant’s classes of common stock, as of the latest practicable date.
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`Name of Each Exchange on Which Registered
`Nasdaq Stock Market
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`Class
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`Common Stock, $.001 par value per share
`DOCUMENTS INCORPORATED BY REFERENCE
`Specified portions of the registrant’s definitive Proxy Statement and/or registrant’s amended Form 10-K, which will be filed as required with the Securities and Exchange
`Commission within 120 days after the end of the registrant’s fiscal year ended December 31, 2007, are incorporated by reference into Part III.
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`Outstanding at February 19, 2008
`37,417,987 shares
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`Apotex v. Cellgene - IPR2023-00512
`Petitioner Apotex Exhibit 1012-0001
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`TABLE OF CONTENTS
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`PART I
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` Business
` Risk Factors
` Unresolved Staff Comments
` Properties
` Legal Proceedings
` Submission of Matters to a Vote of Security Holders
` Executive Officers of the Company
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`Item 1.
`Item 1A.
`Item 1B.
`Item 2.
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`Item 3.
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`Item 4.
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`Item 5.
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`Item 6.
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`Item 7.
`Item 7A.
`Item 8.
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`Item 9.
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`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 Financial Data
` Management’s Discussion and Analysis of Financial Condition and Results of Operations
` Quantitative and Qualitative Disclosures About Market Risk
` Financial Statements and Supplementary Data
` Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
` Controls and Procedures
` Other Information
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`PART III
` Directors and Executive Officers of the Registrant 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
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`PART IV
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` Exhibits and Financial Statement Schedules
`Item 15.
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` Employment Agreement
` Form of Amendment to Employment Agreement
` List of Subsidiaries
` Consent of Independent Registered Public Accounting Firm
` Section 302 Certification for President and CEO
` Section 302 Certification of CFO
` Section 906 Certification for President and CEO and CFO
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` Page
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` 1
` 17
` 28
` 28
` 28
` 29
` 29
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` 30
` 31
` 33
` 42
` 42
` 42
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` 45
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`Apotex v. Cellgene - IPR2023-00512
`Petitioner Apotex Exhibit 1012-0002
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`PART I
`Unless the context requires otherwise, references in this report to “Pharmion,” the “Company,” “we,” “us,” and “our” refer to Pharmion Corporation.
`All statements, trend analyses and other information contained in this Form 10-K and the information incorporated by reference which are not historical in
`nature are forward-looking statements within the meaning of the Private-Securities Litigation Reform Act of 1995. These forward-looking statements include, without
`limitation, discussion relative to markets for our products and trends in revenue, gross margins and anticipated expense levels, product development plans and
`anticipated regulatory filings, as well as other statements including words such as “anticipate,” “believe,” “plan,” “estimate,” “expect” and “intend” and other
`similar expressions. All statements regarding our expected financial position and operating results, business strategy, financing plans and forecast trends relating to
`our industry are forward-looking statements. These forward-looking statements are subject to business and economic risks and uncertainties, and our actual results
`of operations may differ materially from those contained in the forward-looking statements for various reasons, including those identified below under “Risk
`Factors” beginning on page 17. Given these risks and uncertainties, you are cautioned not to place undue reliance on forward-looking statements. Although we may
`elect to update these forward-looking statements in the future, we specifically disclaim any obligation to do so, even if our estimates change, except as required under
`federal securities laws and rules and regulations of the U.S. Securities and Exchange Commission (SEC), and readers should not rely on those forward-looking
`statements as representing our views as of any date subsequent to the date of this annual report.
`
` Item 1. Business
` Overview
`Pharmion Corporation is a global pharmaceutical company that acquires, develops and commercializes innovative products for the treatment of hematology
`and oncology patients. We have established our own research, regulatory, development and sales and marketing organizations in the United States (U.S.), the
`European Union (E.U.) and Australia. We have also developed a distributor network to reach the hematology and oncology markets in several additional countries
`throughout Europe, the Middle East and Asia.
`We have established a portfolio of approved products and product candidates focused on the hematology and oncology markets. These include our primary
`commercial products, Vidaza® (azacitidine for injection), which we market and sell as an approved treatment for Myelodysplastic Syndromes (MDS) in the U.S.,
`Switzerland, Israel, the Philippines, Hong Kong, Thailand, Turkey, Argentina, South Korea and Lebanon, and Thalidomide Pharmion 50mg (Thalidomide
`Pharmion), a widely used therapy for the treatment of multiple myeloma and certain other forms of cancer, which we sell on a compassionate use or named patient
`basis in certain countries of Europe. Thalidomide Pharmion is approved in Australia, New Zealand, Turkey, Israel, South Korea, South Africa and Thailand for the
`treatment of multiple myeloma after the failure of standard therapies. In addition, on January 24, 2008, the European Medicines Agency (the EMEA) issued a
`positive opinion recommending the approval of Thalidomide Pharmion in the E.U. for use in combination with melphalan and prednisone as first line treatment for
`patients with untreated multiple myeloma, aged 65 years or older or ineligible for high dose chemotherapy. Together, these two products generated total net sales of
`$247.0 million in 2007, representing 92% of our total net sales in 2007.
`
`Merger Agreement
`On November 18, 2007, we entered into an Agreement and Plan of Merger (the Merger Agreement) by and among the Company, Celgene Corporation, a
`Delaware corporation (Celgene), and Cobalt Acquisition LLC, a Delaware limited liability company and wholly owned subsidiary of Celgene (the Merger Sub).
`Under the terms of the Merger Agreement, Celgene will acquire us by means of a merger in which Pharmion will be merged with and into the Merger Sub (the
`Merger).
`The Merger Agreement provides that, upon consummation of the Merger, each share of our common stock that is issued and outstanding immediately prior to
`the effective time of the Merger (other than shares of our common stock owned by Celgene or its wholly owned subsidiaries or as to which statutory appraisal rights
`are perfected) will be converted into the right to receive (i) that number of shares of Celgene common stock, par value $.01 per share (the Stock Portion) equal to the
`quotient determined by dividing $47.00 by the Measurement Price (as defined below) (the Exchange Ratio); provided, however, that if the Measurement Price is less
`than $56.15, the Exchange Ratio will be 0.8370 and if the Measurement Price is greater than $72.93, the Exchange Ratio will be 0.6445 and (ii) $25.00 in cash,
`without interest. As used herein, “Measurement Price” means the volume weighted average price per share of Celgene common stock (rounded to the nearest cent) on
`The Nasdaq Global Select Market for the 15 consecutive trading days ending on (and including) the third trading day immediately prior to the effective time of the
`Merger.
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`Petitioner Apotex Exhibit 1012-0003
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`In addition, the Merger Agreement provides that, at the effective time of the Merger, each unvested option to purchase shares of Pharmion common stock will
`be converted into an option to acquire such number of shares of Celgene common stock equal to the product (rounded down to the nearest number of whole shares)
`of (i) the number of shares of Pharmion common stock subject to such option immediately prior to the effective time of the Merger and (ii) the Option Exchange
`Ratio (as defined below) at an exercise price per share (rounded up to the nearest whole cent) equal to (A) the exercise price per share of such option immediately
`prior to the effective time of the Merger divided by (B) the Option Exchange Ratio. The Merger Agreement also provides that, at the effective time of the Merger,
`each vested option to purchase shares of Pharmion common stock will be cancelled and will only entitle the holder of such option to receive from Celgene, as soon as
`reasonably practicable after the effective time of the Merger, the consideration (subject to all applicable withholding taxes) such holder would have received if such
`holder had effected a cashless exercise of such vested option immediately prior to the effective time of the Merger and the shares of Pharmion common stock issued
`upon such cashless exercise were converted in the Merger into the consideration to be received by Pharmion stockholders in the Merger described above. As used
`herein, “Option Exchange Ratio” means the fraction having the numerator equal to the per share Merger consideration to be received by Pharmion stockholders
`described above (valuing the Stock Portion at the Measurement Price) and having the denominator equal to the Measurement Price.
`The Merger Agreement contains customary representations, warranties and covenants for a transaction of this type regarding, among other things, our
`corporate organization and capitalization, the accuracy of the reports and financial statements we file under the Securities Exchange Act of 1934, as amended (the
`Exchange Act), the absence of certain changes or events since September 30, 2007, and the receipt of a fairness opinion from our financial advisors regarding the
`consideration to be received by Pharmion stockholders in the Merger. Similarly, Celgene makes representations and warranties regarding, among other things, its
`corporate organization and capitalization and the accuracy of the reports and financial statements it files under the Exchange Act. The consummation of the Merger is
`subject to customary closing conditions, including the adoption of the Merger Agreement by the affirmative vote of stockholders holding a majority of the
`outstanding shares of Pharmion common stock. The Merger Agreement also includes covenants governing, among other things, the Company’s operations outside the
`ordinary course of business prior to the Merger. On January 2, 2008, the thirty-day waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976
`(the HSR Act) expired without the U.S. Federal Trade Commission (FTC) requesting additional information with respect to the Merger. In addition, on January 27,
`2008, the Bundeskartellamt, Germany’s federal cartel office in charge of reviewing the antitrust aspects of mergers and acquisitions, cleared the Merger.
`The Merger Agreement contains termination rights for both Pharmion and Celgene to terminate the Merger Agreement upon the occurrence of certain
`conditions, including: (i) by either party, for failure to consummate the Merger by September 30, 2008 or (ii) by Pharmion in order to enter into an agreement for an
`alternative business combination transaction that constitutes a superior proposal if Pharmion complies with certain notice and other requirements specified in the
`Merger Agreement. The boards of directors of both Pharmion and Celgene have approved the Merger and the Merger Agreement, and Pharmion’s board of directors
`has recommended that our stockholders vote in favor of the Merger. If our board of directors withdraws or modifies its recommendation, or approves or recommends
`a superior proposal, Celgene is entitled to terminate the Merger Agreement and require Pharmion to pay a termination fee of $70 million. In addition, if the Merger
`Agreement is terminated as a result of the Merger having been permanently enjoined for antitrust reasons or if the Merger has not been consummated by September
`30, 2008 as a result of the failure to obtain antitrust clearance and certain other conditions are satisfied, Celgene must pay Pharmion a termination fee of $70 million.
`This description of certain terms of the Merger Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the
`Merger Agreement, a copy of which is attached as Exhibit 2.1 to the Form 8-K filed with the Securities and Exchange Commission (SEC) on November 19, 2007,
`and as Annex A to the Amendment No. 1 to Form S-4 filed with the SEC on February 4, 2008, by Celgene. Except for its status as the contractual document that
`establishes and governs the legal relations among the parties thereto with respect to the transactions described above, the Merger Agreement is not intended to be a
`source of factual, business or operational information about the parties. The assertions embodied in the representations and warranties among the parties to the
`Merger Agreement were made solely for purposes of the contract between the Pharmion, Celgene and the Merger Sub and are subject to important qualifications and
`limitations agreed to by the parties in connection with negotiating the Merger Agreement. Accordingly, you should not rely on the representations and warranties as
`accurate or complete or characterizations of the actual state of facts as of any specified date since they are modified in important part by the underlying disclosure
`schedules which are not filed publicly and which are subject to a contractual standard of materiality different from that generally applicable to stockholders and were
`used for the purpose of allocating risk between the Company, Celgene and the Merger Sub rather than establishing matters as facts.
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`Petitioner Apotex Exhibit 1012-0004
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`Other Developments
`During 2007, we completed a number of significant corporate milestones, as well as product development and regulatory milestones for several of our product
`candidates. Some of the more notable achievements in 2007 and early 2008 included the following:
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`• The announcement that the U.S. Food and Drug Administration (FDA) had approved our NDA supplement to add intravenous (IV) administration
`instructions to the prescribing information for Vidaza, thereby adding another delivery route to the Vidaza product label;
`• The initiation of a multi-center, open label dose escalation Phase 1 clinical trial of oral azacitidine in patients with MDS and acute myelogenous leukemia
`(AML);
`• The completion of an underwritten public offering of 4,600,000 shares of our common stock at a price to the public of $30 per share;
`• The initiation of a randomized, controlled, international, pivotal Phase 3 clinical trial evaluating amrubicin versus topotecan in the treatment of second line
`small cell lung cancer (SCLC);
`• The presentation of positive results from the Vidaza survival clinical trial, a Phase 3 controlled trial of Vidaza versus conventional care regimens (CCR) in
`the treatment of patients with higher-risk myelodysplastic syndromes (MDS) which demonstrated a statistically significant survival advantage in patients
`receiving Vidaza versus CCR;
`• The initiation of a research collaboration with MethylGene Inc. for the development of novel small molecule inhibitors targeting sirtuins, a separate and
`distinct class of histone deacetylase enzymes implicated in cell survival and death;
`• The submission of an MAA to the EMEA seeking marketing approval of Vidaza for the treatment of patients with higher-risk MDS in the E.U. based on the
`results of the survival trial and acceptance for review by the EMEA under the Accelerated Assessment Procedure; and
`• The announcement by the EMEA that it has issued a positive opinion to recommend approval of Thalidomide Pharmion for use in combination with
`melphalan and prednisone as first line treatment for patients with untreated multiple myeloma, aged 65 years or older or ineligible for high dose
`chemotherapy.
`We believe that Pharmion is uniquely positioned in the field of epigenetics, a promising area of cancer research that examines reversible changes in gene
`regulation and that will remain a primary focus of our research and development activities. Both Vidaza, a deoxyribonucleic acid (DNA) demethylating agent, and
`MGCD0103, an HDAC inhibitor, have demonstrated specific epigenetic effects on the regulation of gene expression. Research indicates that the combination of
`HDAC and DNA methyltransferase inhibitors may act synergistically to reverse tumor suppressor gene silencing and induce apoptosis (programmed cell death) in
`various cancers, and we have initiated clinical studies evaluating Vidaza and MGCD0103 as a combination therapy in hematological cancers. With the initiation of
`our research collaboration program for sirtuin inhibitors in 2007, we now have three active epigenetic anticancer programs at Pharmion. In addition, as research has
`shown that cancer cell resistance to cytotoxic drugs is often mediated by epigenetic mechanisms, we are currently conducting research on combinations of our
`epigenetic therapies, Vidaza and MGCD0103, with cytotoxic drugs.
`We had total net sales of $267.3 million, $238.6 million and $221.2 million in 2007, 2006 and 2005, respectively. Our product sales by geographic region are
`detailed in Note 3 to our consolidated financial statements included in Part II, Item 8 of this Annual Report on Form 10-K.
`We were incorporated in Delaware in 1999 and commenced operations in January 2000. Our principal executive offices are located at 2525 28th Street,
`Boulder, Colorado 80301, and our telephone number is (720) 564-9100. Our website is located at www.pharmion.com. Our annual reports on Form 10-K, quarterly
`reports on Form 10-Q and current reports on Form 8-K, and all amendments to those reports, are available free of charge on the “Investor Relations” section of our
`website as soon as reasonably practicable after we have electronically filed them with, or furnished them to, the Securities and Exchange Commission. The reference
`to our website does not constitute incorporation by reference of the information contained on our website into this Annual Report on Form 10-K. You may read and
`copy any reports, statements or other materials filed by us with the SEC at the SEC’s Public Reference Room at 100 F Street, NE, Washington, DC 20549. Please call
`the SEC at 1-800-SEC-0330 for further information on the operation of the Public Reference Room. The SEC maintains an Internet site that contains reports, proxy
`statements and other information, including those filed by us, at (http://www.sec.gov).
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`Our Products
`The following table summarizes our principal products and the status of development for each:
`Product
` Vidaza® (azacitidine for injection)
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`Worldwide
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`Territory
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`Disease/Indication
`MDS, other hematological
`malignancies and solid tumors
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`Thalidomide Pharmion 50mg
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`•
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`Status
`NDA supplement for IV
`administration approved by U.S.
`FDA in January 2007;
`Positive results from MDS Phase 3
`survival study announced in 2007;
`European MAA submitted in
`January 2008, to be reviewed under
`the Accelerated Assessment
`Procedure;
`Compassionate use and named
`patient sales ongoing in Europe;
`Approved in the U.S., Switzerland,
`Israel, the Philippines, Hong Kong,
`Thailand, Turkey, Argentina, South
`Korea and Lebanon.
`European MAA for untreated
`multiple myeloma recommended
`for approval by the EMEA in
`January 2008;
`Compassionate use and named
`patient sales ongoing in Europe;
`Approved in Australia, New
`Zealand, South Korea, Turkey,
`Israel, South Africa and Thailand.
`Initiated Phase 3 study in second
`line SCLC initiated in October
`2007;
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`• Phase 2 studies in SCLC ongoing.
`•
`European MAA for 2nd line HRPC
`submitted in second quarter 2007;
`Several Phase 1 and Phase 2 single
`agent and combination studies
`ongoing in hematological and solid
`tumors.
`Investigational New Drug
`application (IND) active in January
`2007;
`Multi-center, dose escalation Phase
`1 clinical trial initiated in April
`2007.
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`•
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`•
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`•
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`•
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`•
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`•
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`Amrubicin
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`Satraplatin
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`MGCD0103
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`Oral azacitidine
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`Multiple myeloma
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`All countries outside of North
`America and certain Asian countries
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`Small cell lung cancer; metastatic
`breast cancer
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`Second line hormone refractory
`prostate cancer (HRPC)
`Hematological malignancies, solid
`tumors
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`Hematological malignancies, solid
`tumors
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`North America and Europe
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`Europe, Turkey, Middle East,
`Australia and New Zealand
`North America, Europe, the Middle
`East and certain other countries
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`Worldwide
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`Petitioner Apotex Exhibit 1012-0006
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`The primary products in our current portfolio include the following compounds:
`Vidaza (azacitidine for injection) is a pyrimidine nucleoside analog that has been shown to reverse the effects of DNA hypermethylation and promote
`subsequent gene re-expression. We were granted an exclusive worldwide license to Vidaza by Pharmacia & Upjohn Company, now part of Pfizer, Inc., in June 2001.
`In 2004, we received full approval from the FDA for the treatment for all subtypes of MDS, a bone marrow disease that affects the production of blood cells. This
`was the FDA’s first approval of a treatment for MDS and Vidaza was the first demethylating agent to be approved by the agency. We launched Vidaza for commercial
`sale in the U.S. in July 2004. Vidaza has been granted orphan drug designation by the FDA, which entitles the drug to market exclusivity for MDS in the
`U.S. through May 2011. In January 2007, we announced that the FDA had approved our NDA supplement that expands the approved label to add IV administration
`instructions to the Vidaza prescribing information. IV administration provides an alternative administration method to the previously approved subcutaneous delivery
`of Vidaza.
`In 2007, net sales of Vidaza were $165.3 million, which represented approximately 62% of our total net sales for 2007, compared with $142.2 million in 2006,
`or approximately 60% of our total net sales for 2006, and $125.6 million in 2005, or approximately 57% of total net sales for 2005.
`In August 2007, we announced top line results from our multi-institutional, international, randomized Phase 3 clinical trial examining the effect of Vidaza on
`the survival of higher-risk MDS patients as compared to treatment with various conventional care regimens, including best supportive care alone, low-dose
`cytarabine plus best supportive care or standard chemotherapy plus best supportive care (CCR). In the primary endpoint analysis, Vidaza treatment was associated
`with a median survival of 24.4 months versus 15 months for those receiving CCR treatment, an improvement of 9.4 months with a stratified log-rank p-value of
`0.0001. The hazard ratio describing this treatment effect was 0.58 (95 percent confidence interval of 0.43 to 0.77). Two-year survival rates were 50.8 percent versus
`26.2 percent for patients receiving Vidaza versus CCR (p<0.0001). The median number of treatment cycles was nine for Vidaza. The survival benefits of Vidaza were
`consistent regardless of the CCR treatment option used in the control arm. Data and analysis from this clinical trial data were presented at the American Society of
`Hematology annual meeting in December 2007.
`Based on the results of this clinical trial, we submitted an MAA to the EMEA in January 2008 seeking marketing approval of Vidaza for the treatment of
`patients with higher-risk MDS in the E.U. In February 2008, the EMEA informed us that it had accepted our MAA for review and that it intends to review the
`application under the Accelerated Assessment Procedure. The Accelerated Assessment Procedure is granted for medicinal products that are expected to be of major
`public health interest, particularly from the point of view of therapeutic innovation. Accelerated Assessment reduces the time limit for the Committee for Medicinal
`Products for Human Use to give an opinion from 210 days to 150 days, although at any time during the MAA evaluation, the Committee may decide to continue the
`assessment under standard centralized procedure timelines. We began named patient and compassionate use sales of Vidaza in the fourth quarter of 2005 in the E.U.
`The EMEA granted Vidaza orphan medicinal product designation, which, if our MAA for Vidaza is approved, and the criteria for orphan designation continue to be
`met, would entitle Vidaza to ten years of market exclusivity from the date of MAA approval for the MDS indication in the E.U.
`We are also exploring Vidaza’s potential effectiveness in treating other cancers associated with hypermethylation. A significant number of ongoing Phase 2
`studies examining the use of Vidaza as a single agent or in combination with other cancer therapies have been initiated by us and independent clinical investigators in
`AML and other hematological cancers as well as certain solid tumors.
`Thalidomide Pharmion 50mg (thalidomide) is an oral immunomodulatory and anti-angiogenic agent. We obtained commercialization rights to thalidomide
`from Celgene Corporation (Celgene) for all countries outside of North America and certain Asian markets in November 2001. Thalidomide has become a standard of
`care for the treatment of multiple myeloma, a cancer of the plasma cells in the bone marrow, and there is a substantial body of data that demonstrates its benefit as a
`first line treatment of this disease. We began selling thalidomide in Europe on a compassionate use or named patient basis under a comprehensive risk management
`program in the third quarter of 2003. Currently, we have an active MAA filed with the EMEA seeking full regulatory approval for this drug in the E.U. However,
`until we receive a marketing authorization, we will not be permitted to market Thalidomide Pharmion in Europe. To date, Thalidomide Pharmion has been approved
`as a treatment for relapsed and refractory multiple myeloma in Australia, New Zealand, Turkey, Israel, South Korea, Thailand and South Africa. In 2007, net sales of
`Thalidomide Pharmion were $81.7 million, which represented approximately 31% of our total net sales for 2007, compared with $77.5 million, or 32% of our total
`net sales for 2006, and $79.4 million in 2005, or approximately 36% of total net sales for 2005.
`In January 2008, we announced that the EMEA had issued a positive opinion recommending the approval of Thalidomide Pharmion for use in combination
`with melphalan and prednisone as first line treatment for patients with untreated multiple myeloma, aged 65 years or older or ineligible for high dose chemotherapy.
`Our MAA was submitted to the EMEA in
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`Apotex v. Cellgene - IPR2023-00512
`Petitioner Apotex Exhibit 1012-0007
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`January 2007 and was accepted for review by the agency in March 2007. The EMEA’s Committee for Medicinal Products for Human Use (CHMP) reviewed the
`application, and its positive opinion will be forwarded to the European Commission, which generally follows, but is not obligated to follow, the recommendation of
`the CHMP, and issues final marketing approval within two to three months. If ratified by the European Commission, a single marketing authorization would be
`granted to Pharmion to market Thalidomide Pharmion for first line multiple myeloma in the 27 member states of the E.U., as well as Norway and Iceland.
`Our MAA was based upon a clinical data package comprised of several studies, including the Intergroupe Francophone du Myelome (IFM 99-06) clinical trial.
`The three-arm study conducted by IFM demonstrated the superiority of melphalan/prednisone plus thalidomide (MPT) over standard therapy of
`melphalan/prednisone (MP) alone or a combination of chemotherapies (vincristine/adriamycin/dexame