Cubist Pharmaceuticals Licenses Rights for Development and Commercialization of CUBICIN in Japan to Merck & Co., Inc.
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- Published on Friday, 23 March 2007 02:00
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LEXINGTON, MA, USA | Mar 22, 2007 | Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that it has entered into a license agreement with Merck & Co., Inc. for the development and commercialization of CUBICIN(R) (daptomycin for injection) in Japan. Merck will develop and commercialize CUBICIN through its wholly-owned subsidiary, Banyu Pharmaceutical Co., Ltd. With this agreement in Japan, Cubist has secured an excellent partner for CUBICIN, its first-in-class lipopeptide antibiotic, and now has a full complement of partners ready to commercialize CUBICIN around the world. Cubist commercializes CUBICIN in the United States.
In exchange for development and commercialization rights in Japan, Merck will pay Cubist $6.0 million cash upfront. An additional $39.5 million in total milestone payments could be paid to Cubist for regulatory and sales achievements. Merck also will pay Cubist an undisclosed price for the supply of CUBICIN vials to be sold in Japan.
"We are pleased to announce this partnership with Merck and its Japanese subsidiary Banyu. Banyu has for many years demonstrated strength in the clinical and regulatory environment in Japan and is an experienced commercialization partner. Banyu has been tremendously successful with the commercialization of TIENAM(R), the first carbapenem antibiotic launched in Japan. We look forward to Banyu moving rapidly forward with development of CUBICIN in Japan and when approved, promoting CUBICIN to the Japanese infectious disease community. MRSA is a serious concern in Japan. CUBICIN will provide a much needed additional therapy for serious infections, including those caused by MRSA," said Mike Bonney, President and CEO of Cubist.
"We are delighted to establish this new collaboration with Cubist, which will both enable us to strengthen our portfolio of products and demonstrate our company's commitment to develop and commercialize innovative medicines that can save lives and improve human health," said Haruhiko Hirate, President and Representative Director of Banyu Pharmaceutical Co., Ltd.
Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment. In the U.S., Cubist markets CUBICIN(R) (daptomycin for injection), the first antibiotic in a new class of antiinfectives called lipopeptides. The Cubist product pipeline includes our lipopeptide program and our natural products screening program. Cubist is headquartered in Lexington, MA. Additional information can be found at Cubist's web site at www.cubist.com.
Cubist Safe Harbor Statement
Statements contained herein that are not historical fact may be forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and such statements are subject to a variety of risks and uncertainties. There are a number of important factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements made by Cubist. These factors include, but are not limited to: (i) the level of acceptance of CUBICIN by physicians, patients, third-party payors and the medical community; (ii) any changes in the current or anticipated market demand or medical need for CUBICIN; (iii) any unexpected adverse events related to CUBICIN, particularly as CUBICIN is used in the treatment of a growing number of patients around the world; (iv) competition in the markets in which we and our partners market CUBICIN, including marketing approvals for new products that will be competitive with CUBICIN; (v) whether the U.S. Food and Drug Administration, or FDA, accepts proposed clinical trial protocols that may be achieved in a timely manner for additional studies of CUBICIN or any other drug candidate we seek to enter into clinical trials; (vi) whether we will receive, and the potential timing of, regulatory approvals or clearances to market CUBICIN in other countries; (vii) legislative and policy changes in the United States and other jurisdiction where our products are sold that may affect the ease of getting a new product or a new indication approved, as well as government reimbursement for our or our competitors' products; (viii) whether or not third parties may seek to market generic versions of our products by filing Abbreviated New Drug Applications with the FDA, and the results of any litigation that we file to defend and/or assert our patents against such generic companies; (ix) our ability to conduct successful clinical trials in a timely manner; (x) the effect that the results of ongoing or future clinical trials of CUBICIN may have on its acceptance in the medical community; (xi) the ability of our third party manufacturers, including our single source provider of active pharmaceutical ingredient to manufacture sufficient quantities of CUBICIN in accordance with Good Manufacturing Practices and other requirements of the regulatory approvals for CUBICIN and at an acceptable cost; (xii) our dependence upon collaborations with our partners and our partners' ability to execute on development, regulatory and sales expectations in their territories; (xiii) our ability to finance our operations; (xiv) the effectiveness of our sales force and our sales force's ability to access targeted physicians; (xv) potential costs resulting from product liability or other third party claims; (xvi) our ability to protect our proprietary technologies; (xvii) our ability to integrate successfully the operations of any business that we may acquire and the potential impact of any future acquisition on our financial results; (xviii) our ability to discover, acquire or in-license drug candidates and develop and achieve commercial success for drug candidates; and (xix) a variety of risks common to our industry, including ongoing regulatory review, public and investment community perception of the industry, legislative or regulatory changes, and our ability to attract and retain talented employees.
Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in Cubist's recent filings with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in such filings.
Cubist and CUBICIN(R) are registered trademarks of Cubist Pharmaceuticals, Inc.
Source: Cubist Pharmaceuticals, Inc.