-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, DfX3BCcLukpS7Aywx213S7St9a1Z0RclnbBcqEsC/ikaGTNpzQnAKCssjydQwZjQ bdai+atSQxgH9hPE9CyDcg== 0000950157-04-000303.txt : 20040510 0000950157-04-000303.hdr.sgml : 20040510 20040510155921 ACCESSION NUMBER: 0000950157-04-000303 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20040427 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20040510 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BRISTOL MYERS SQUIBB CO CENTRAL INDEX KEY: 0000014272 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 220790350 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-01136 FILM NUMBER: 04793145 BUSINESS ADDRESS: STREET 1: 345 PARK AVE CITY: NEW YORK STATE: NY ZIP: 10154 BUSINESS PHONE: 2125464000 MAIL ADDRESS: STREET 1: 345 PARK AVE CITY: NEW YORK STATE: NY ZIP: 10154 FORMER COMPANY: FORMER CONFORMED NAME: BRISTOL MYERS CO DATE OF NAME CHANGE: 19891012 8-K 1 form8k.txt CURRENT REPORT =============================================================================== UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report (Date of earliest event reported): April 27, 2004 BRISTOL-MYERS SQUIBB COMPANY (Exact Name of Registrant as Specified in its Charter) Delaware 1-1136 22-079-0350 (State or Other Jurisdiction (Commission File (IRS Employer of Incorporation) Number) Identification Number) 345 Park Avenue New York, NY 10154 (Address of Principal Executive Office) Registrant's telephone number, including area code: (212) 546-4000 =============================================================================== Item 5. OTHER EVENTS On April 27, 2004, the Company entered into a collaboration agreement with Merck & Co., Inc. for worldwide co-development and co-promotion for muraglitazar, the Company's dual PPAR (peroxisome proliferator activated receptor) agonist, currently in Phase III clinical development for use in treating Type 2 diabetes. Under the terms of the agreement, the Company received a $100 million upfront payment in May 2004, and is entitled to receive $275 million in additional payments upon the achievement of certain regulatory milestones. The Company and Merck will jointly develop the clinical and marketing strategy for muraglitazar, share equally in future development and commercialization costs and co-promote the product to physicians on a global basis, with Merck to receive payments based on net sales levels. As announced previously, an NDA for muraglitazar is expected to be submitted to the FDA within the next nine to twelve months for U.S. regulatory approval. In addition, the collaboration includes a back-up compound to muraglitazar, with the same mechanism of action (PPAR), which is anticipated to enter Phase II clinical trials for the treatment of Type 2 diabetes this year. The agreement will expire on a product-by-product and country-by-country basis upon the latest of (i) the expiration of the last to expire Bristol-Myers Squibb patent or patent that is jointly funded in each case with respect to the applicable product in the applicable country, (ii) the expiration of any additional statutory or administrative protections that grant exclusivity with respect to the applicable product in the applicable country, and (iii) the cessation of the sale of the applicable product in the applicable country following first commercial sale of that product in that country. The basic composition of matter patent for muraglitazar in the United States expires in 2020. Patent applications in various countries in the European Union are pending. The Company also may be entitled to additional statutory or administrative protections in the United States and the European Union that would grant exclusivity with respect to muraglitazar beyond 2020. It is not possible to predict the length of market exclusivity for any of the Company's products, including muraglitazar, with certainty because of the complex interaction between patent and regulatory forms of exclusivity, and inherent uncertainties about the enforceability of certain intellectual property rights. Accordingly, the agreement could terminate with respect to muraglitazar prior to the current patent expiration date. In addition, due to the inclusion in the collaboration of the back-up compound and the possibility that the back-up compound will be developed to the point of being a commercially marketed product, the term of the agreement could possibly extend beyond the patent expiration date and exclusivity period relating to muraglitazar. In addition to customary termination provisions for cause, Merck also has the right to terminate the agreement for any reason upon not less than six months prior written notice to the Company. However, this right of termination can be exercised by Merck with respect to any product only during the period between the completion of Phase III clinical trials relating to such product and the time the NDA for such product is filed with the FDA. This right also can be exercised by Merck after the second anniversary of the date of filing of the NDA for such product with the FDA if the product has not been commercially launched in the United States at such time, or, if commercially launched in the United States, after the second anniversary of the commercial launch of such product in the United States. With respect to the European Union, Merck can exercise this right of termination after the second anniversary of the commercial launch of such product in the European Union or, if not commercially launched in the European Union, the third anniversary of the commercial launch of the product in the United States. Upon any early termination, the Company will retain control of all rights to muraglitazar. The agreement also provides that, except as described below, for so long as the collaboration between the Company and Merck remains in effect with respect to at least one country in the world, each party and its affiliates will not, and will cause its affiliates not to, advise, assist or encourage others to, directly or indirectly, without the consent of the other party: (i) acquire, announce an intention to acquire, offer or propose to acquire or agree to acquire, directly or indirectly, alone or in concert with others, by purchase, gift or otherwise, any direct or indirect beneficial ownership (within the meaning of Rule 13d-3 under the Securities Exchange Act of 1934, as amended (the "Exchange Act")) or interest in any securities of the other party or any of its affiliates that are entitled to vote for the election of directors of such party or affiliate ("Voting Securities") or direct or indirect rights, warrants or options to acquire, or securities convertible into or exchangeable for, any Voting Securities of the other party or any of its affiliates; (ii) effect or seek, initiate, offer or propose or participate in or assist any other person to effect or seek, initiate, offer or propose any (A) tender or exchange offer, merger, consolidation or other business combination involving the other party or any of its affiliates; or (B) any recapitalization, restructuring, liquidation, dissolution, sale of all or substantially all of its assets or other extraordinary transaction with respect to the other party or any of its affiliates; (iii) make, or in any way participate in, directly or indirectly, alone or in concert with others, any "solicitation" of "proxies" to vote (as such terms are used in the proxy rules of the United States Securities and Exchange Commission promulgated pursuant to Section 14 of the Exchange Act) with respect to the other party or any of its affiliates (whether or not such solicitation is subject to regulation under Regulation 14A promulgated under the Exchange Act) or otherwise solicit any consent or communicate with or seek to advise or influence any person with respect to the voting of such other party's (or its affiliates') Voting Securities; (iv) deposit any Voting Securities of the other party or any of its affiliates into a voting trust or subject any such Voting Securities to any arrangement or agreement with respect to the voting thereof; (v) initiate, propose or otherwise solicit stockholders of the other party or any of its affiliates for the approval of one or more stockholder proposals as described in Rule 14a-8 under the Exchange Act with respect to the other party or any of its affiliates or their bylaws or other constituent documents, or induce or attempt to induce any other person to initiate any such stockholder proposal with respect to the other party or any of its affiliates or their bylaws or other constituent documents; (vi) seek election to or seek to place a representative on the Board of Directors of the other party or any of its affiliates or seek the removal of any member of the Board of Directors of the other party of any of its affiliates; (vii) call or seek to have called any meeting of the stockholders of the other party or any of its affiliates; (viii) request, or take any action to obtain, any list of holders of Voting Securities of the other party or any of its affiliates; (ix) form, join or in any way participate in a "group" (within the meaning of Section 13(d)(3) of the Exchange Act) with respect to any Voting Securities of the other party or any of its affiliates or direct or indirect rights, warrants or options to acquire, or securities convertible into or exchangeable for, any Voting Securities of the other party or any of its affiliates; (x) otherwise act, alone or in concert with others, to seek to control the Board of Directors or influence the management of the other party or any of its affiliates, provided that nothing in this clause (x) shall prevent such party or any affiliate of such party, either acting alone or in concert with others, from taking such action or refraining from taking such action as it believes is required of it under applicable law; or (xi) enter into any agreements, discussions or arrangements with any person other than the Company, Merck or an affiliate of either of them with respect to any of the foregoing; or (xii) seek to waive, amend or modify any of the provisions contained herein (these provisions, collectively, the "Standstill Agreement"). The Standstill Agreement does not prohibit a party or any of its affiliates from acquiring Voting Securities of the other party or any of its affiliates by or through (i) a diversified mutual or pension fund managed by an independent investment adviser or pension plan established for the benefit of the employees of such party or its affiliates, (ii) any employee benefit plan of such party or any of its affiliates or (iii) any stock portfolios not controlled by such party or any of its affiliates that invest in the other party or any of its affiliates among other companies; provided that such party or any of its affiliates does not, directly or indirectly, request the trustee or administrator or investment adviser of such fund, plan or portfolio to acquire such Voting Securities and provided that no such fund, plan or portfolio acquires more than five percent (5%) of any class of Voting Securities of such other party or any of its affiliates. Further, the Standstill Agreement does not prevent any party or any of its affiliates from acquiring securities of another pharmaceutical or biotechnology company or other person that beneficially owns any securities of the other party or any of its affiliates. The provisions in the Standstill Agreement will be suspended solely to permit a party and its affiliates (collectively the "Acquiring Party") to: (i) take any of the actions described above to the extent the other party or any of its affiliates specifically invites the Acquiring Party to take such actions or (ii) to compete in an Acquisition Transaction (as defined below) with respect to the other party or any of its affiliates if such Acquisition Transaction shall have been publicly proposed by the other party or any of its affiliates or by a person unaffiliated with the Acquiring Party and accepted or approved by the other party or its affiliate, or if rejected or not approved by the other party and its affiliates, pursued on a unilateral basis pursuant to a tender or exchange offer and/or a proxy solicitation, or if the other party or its affiliate shall have entered into an agreement in principle or definitive agreement providing for such Acquisition Transaction. "Acquisition Transaction" means (A) any direct or indirect divestiture or sale by a party or any of its affiliates of assets representing thirty-five percent (35%) or more of the market capitalization of a party or of thirty-five percent (35%) or more of the Voting Securities of or equity interest in such party or any of its subsidiaries, or (B) any tender offer or exchange offer that if consummated would result in any person or group beneficially owning thirty-five percent (35%) or more of any class of Voting Securities of such party or affiliate, or (C) any merger, consolidation, business combination, recapitalization or similar transaction involving such party or any of its affiliates representing thirty-five percent (35%) or more of the market capitalization of such party or of thirty-five percent (35%) or more of the Voting Securities of or equity interest in such party or any of its subsidiaries." Incorporated by reference in its entirety is a press release issued by the Registrant on April 28, 2004, attached as Exhibit 99, announcing the co-development and co-promotion agreement with Merck & Co., Inc. Item 7(c). EXHIBITS Exhibit 99 - Press release dated April 28, 2004 announcing the co-development and co-promotion agreement with Merck & Co., Inc. SIGNATURE Under the requirements of the Securities Exchange Act of 1934, the Registrant has caused this report to be signed on its behalf by the undersigned hereunto duly authorized. BRISTOL-MYERS SQUIBB COMPANY By: /s/ Sandra Leung ------------------------------------- Sandra Leung Secretary Dated: May 10, 2004 EXHIBIT INDEX Exhibit Number Description -------------------------------------------------------------- 99 Press release dated April 28, 2004 regarding Registrant's Co-Development and Co-Promotion Agreement with Merck & Co., Inc. EX-99.1 2 ex99-1.txt PRESS RELEASE Exhibit 99 BRISTOL-MYERS SQUIBB AND MERCK ANNOUNCE GLOBAL DEVELOPMENT AND COMMERCIALIZATION ALLIANCE FOR MURAGLITAZAR, A NOVEL COMPOUND FOR DIABETES NEW YORK, NEW YORK and WHITEHOUSE STATION, NEW JERSEY (April 28, 2004) -- Bristol-Myers Squibb Company (NYSE: BMY) and Merck & Co., Inc. (NYSE:MRK) today announced that they have entered into a global collaborative agreement for muraglitazar, Bristol-Myers Squibb's dual PPAR (peroxisome proliferator-activated receptor) agonist, currently in Phase III clinical development for use in treating both blood glucose and lipid abnormalities in patients with type 2 diabetes. Under the terms of the agreement, Bristol-Myers Squibb will receive a $100 million upfront payment and $275 million in additional payments based upon the achievement of certain regulatory milestones. Bristol-Myers Squibb and Merck will jointly develop the clinical and marketing strategy for muraglitazar and share equally in future development and commercialization costs. Both companies will co-promote the product to physicians on a global basis, and Merck will receive payments based on net sales levels. In addition, Merck received rights to development and commercialization for a back-up compound to muraglitazar, which is entering Phase II clinical trials for the treatment of diabetes. Further details of the agreement were not disclosed. "This collaboration with Merck reflects our new corporate strategy, which will build long-term growth by focusing on critical disease areas such as diabetes and will optimize the value of all of our assets," said Peter R. Dolan, chairman and chief executive officer, Bristol-Myers Squibb. "As we move forward in implementing this new strategy, Bristol-Myers Squibb will center our efforts on reaching specialists and high prescribing primary care physicians. The company will also selectively develop strategic partnerships, such as this one, that enable us to realize the full potential of our promising pipeline." Muraglitazar was discovered and developed by Bristol-Myers Squibb as part of an intensive internal research program to deliver innovative medicines for patients with type 2 diabetes. The dual PPAR agonist works by targeting both alpha and gamma PPAR receptors and, as a result of this dual agonist activity, muraglitazar is being tested to potentially provide both blood sugar control and improved lipid management in patients with type 2 diabetes. As announced previously, muraglitazar is expected to be submitted within the next 9-12 months for U.S. regulatory approval. If approved, muraglitazar has the potential to be the first of the novel class of drugs known as dual PPAR agonists to be approved for marketing in the U.S. "We are very proud to be working with Bristol-Myers Squibb as their partner for the development and commercialization of muraglitazar, which has the potential to represent a true advance in the treatment of type 2 diabetes," said Raymond V. Gilmartin, chairman, president and chief executive officer, Merck. "We believe that the combined scientific and marketing talents of our two companies will help advance this potential new medicine. "Through the discussions that have already taken place between our two teams, we believe that this will be a productive relationship. This partnership is consistent with Merck's strategy to develop external alliances that complement our substantial internal research effort," Gilmartin added. Type 2 diabetes, often known as adult-onset diabetes, occurs when the body does not produce enough insulin to normally regulate blood sugar levels or when the body develops resistance to the effects of insulin. Type 2 diabetes is a growing public health problem that today affects 17 million adult Americans and is now the sixth leading cause of death in this country, according to the U.S. Centers for Disease Control (CDC). The condition is associated with older age, obesity, a family history of diabetes and physical inactivity. Worldwide, type 2 diabetes affects an estimated 40 million people in major pharmaceutical markets today, a number that is expected to more than double to 90 million people by 2015. "Bristol-Myers Squibb and Merck are well established as leaders in the fields of type 2 diabetes and cardiovascular medicine," Dolan said. "This collaboration will enable Bristol-Myers Squibb and Merck to leverage the breadth of R&D and commercial capabilities and resources in both type 2 diabetes and cardiology to realize the full potential of muraglitazar. We are excited about this partnership and we are dedicated to combining our extensive resources to advance the development and commercialization of muraglitazar as a potential new treatment option for the millions of patients around the world with type 2 diabetes." ABOUT BRISTOL-MYERS SQUIBB Bristol-Myers Squibb is a global pharmaceutical and related healthcare products company whose mission is to extend and enhance human life. Visit Bristol-Myers Squibb on the World Wide Web at www.bms.com ABOUT MERCK Merck & Co., Inc., which operates in many countries as Merck Sharp & Dohme, is a global research-driven pharmaceutical products company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health, directly and through its joint ventures. Visit Merck on the World Wide Web at www.merck.com BRISTOL-MYERS SQUIBB FORWARD-LOOKING STATEMENT This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve significant risks and uncertainties that may cause results to differ materially from those set forth in the statements. Among other risks, there can be no guarantee that the product described in this release will receive regulatory approval, or that it will prove to be commercially successful. This and other risk factors are discussed in the company's 2003 Annual Report on Form 10K and in the company's periodic reports on Form 10-Q. We undertake no obligation to publicly 3 update any forward-looking statement, whether as a result of new information, future events, or otherwise. MERCK FORWARD-LOOKING STATEMENT This press release contains 'for ward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements include statements regarding product development. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect the Company's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2003, and in its periodic reports on Form 10-Q and Form 8-K (if any) which Merck incorporates by reference. For more information, contact: Merck - Janet Skidmore, Media, 908-423-3046; Mark Stejbach, Investors, 908-423-5185; or Bristol-Myers Squibb - Bonnie Jacobs, Media, 609-252-4089; John Elicker, Investors, 212-546-3775 Article Date: 04/28/2004 -----END PRIVACY-ENHANCED MESSAGE-----