Cubist Pharmaceuticals Licenses Rights for Development and Commercialization of CUBICIN in China to AstraZeneca.LEXINGTON, Mass. -- Cubist Pharmaceuticals, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : CBST CBST Center for Biophotonics Science and Technology CBST Congregation Beth Simcha Torah (NYC) CBST Complete Binary Search Tree ) today announced that it has entered into a license agreement with AstraZeneca for the development and commercialization of CUBICIN([R]) (daptomycin for injection) in China and certain other countries in Asia, the Middle East and Africa not covered not covered Health care adjective Referring to a procedure, test or other health service to which a policy holder or insurance beneficiary is not entitled under the terms of the policy or payment system–eg, Medicare. Cf Covered. by existing CUBICIN international partnering agreements. The agreement does not include Japan, which is yet to be partnered. In exchange for development and commercialization rights, AstraZeneca has agreed to pay Cubist $10.25 million cash upfront. In addition, Cubist will receive payments on reaching regulatory and sales milestones. AstraZeneca will pay Cubist an undisclosed price for the supply of CUBICIN vials to be sold in the licensed territory. "This agreement is another important milestone for Cubist in our efforts to fully commercialize our first in class cyclic lipopeptide, CUBICIN"said Mike Bonney, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Cubist. "China is a very important growth market for pharmaceuticals, in particular antibiotics such as CUBICIN. We are looking forward to our alliance with AstraZeneca, which has a long term presence and a rich history of success in China." "As the leading ethical pharmaceutical company in China, AstraZeneca is strongly committed to investing in new and innovative products for China" said Bruno Angelici, Executive Vice President, International Sales and Marketing Organization (ISMO ISMO Isosorbide-5-Mononitrate ISMO Information Systems Management Office ISMO Information Systems Missions Order ISMO Implicit Space Mapping Optimization ISMO Information Systems Management Order ISMO Intensive Support Mutual Obligation (job search) ) of AstraZeneca PLC. "We believe CUBICIN will address an area of significant unmet need, and will bring a novel antibiotic to patients with serious infections, in an area where resistance to existing antibiotics is increasing. We are committed to working with the local medical community and regulatory agencies to ensure these products are used appropriately to benefit Chinese patients." About CUBICIN([R]) (daptomycin for injection) CUBICIN is currently the only once-daily bactericidal bactericidal /bac·te·ri·ci·dal/ (bak-ter?i-si´d'l) destructive to bacteria. Bactericidal An agent that destroys bacteria (e.g. antibiotic approved in the U.S. indicated for the treatment of complicated skin and skin structure infections caused by susceptible strains of the following Gram-positive microorganisms: Staphylococcus aureus Staphylococcus au·re·us n. A bacterium that causes furunculosis, pyemia, osteomyelitis, suppuration of wounds, and food poisoning. Staphylococcus aureus Staphylococcus pyogenes (including methicillin-resistant strains), Streptococcus pyogenes Streptococcus py·og·e·nes n. A bacterium that causes the formation of pus or of fatal septicemias. Streptococcus pyogenes A common bacterium that causes strep throat and can also cause tonsillitis. , S. agalactiae, S. dysgalactiae subsp equisimilis and Enterococcus faecalis Enterococcus faecalis is a Gram-positive commensal bacterium inhabiting the gastrointestinal tracts of humans and other mammals.[1] Like other species in the genus Enterococcus, E. (vancomycin-susceptible strains only). CUBICIN is also approved in the U.S. as therapy for blood stream infections including right sided endocarditis endocarditis (ĕn'dōkärdī`tĭs), bacterial or fungal infection of the endocardium (inner lining of the heart) that can be either acute or subacute. , caused by S. aureus The aureus (pl. aurei) was a gold coin of ancient Rome valued at 25 silver denarii. The aureus was regularly issued from the 1st century BC to the beginning of the 4th century AD, when it was replaced by the solidus. . CUBICIN is not indicated for the treatment of pneumonia. Most adverse events reported in clinical trials were mild to moderate in intensity. The most common were anemia, constipation, diarrhea, nausea, vomiting, injection site reactions, and headache. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CUBICIN, CUBICIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria susceptible to CUBICIN. For full prescribing information, visit www.cubicin.com. About Cubist 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. About AstraZeneca China AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $23.95 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca China has its headquarters in Shanghai, with branch offices in more than 20 cities across China. For more information please visit: www.astrazeneca.com.cn Cubist Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. 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) whether we will receive, and the potential timing and scope of, regulatory approvals or clearances to market CUBICIN in other countries pursuant to our currently planned filings and any filings we determine to make in the future, which filings are subject to approval by the applicable regulatory agency or agencies, regardless of our confidence in the results of the clinical trials supporting such filings; (ii)the level of acceptance of CUBICIN by physicians, patients, third party payors and the medical community; (iii)any changes in the current or anticipated market demand or medical need for CUBICIN; (iv)competition in the markets in which we and our partners market CUBICIN; (v)whether the U.S. Food and Drug Administration, or FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. , accepts proposed clinical trial protocols A Clinical Trial Protocol is a document that describes the objective(s), design, methodology, statistical considerations, and organization of a clinical trial. The protocol usually also gives the background and reason the trial is being conducted, but these could be provided in that may be achieved in a timely manner for additional studies of CUBICIN or any other drug candidate that we seek to enter into clinical trials; (vi) our ability to conduct successful clinical trials in a timely manner; (vii) the ability of our third party manufacturers, including our single source provider of API, to manufacture sufficient quantities of CUBICIN in accordance with current Good Manufacturing Practices Good Manufacturing Practice or GMP (also referred to as 'cGMP' or 'current Good Manufacturing Practice') is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods and pharmaceutical products. and other requirements of the regulatory approvals for CUBICIN and at an acceptable cost; (viii) our dependence upon collaborations with our partners; (ix) our ability to finance our operations; (x) the effectiveness of our sales force; (xi) potential costs resulting from product liability or other third party claims; (xii) our ability to protect our proprietary technologies; (xiii) our ability to integrate successfully the operations of any business we may acquire and the potential impact of any future acquisition on our financial results; (xiv) our ability to discover, acquire or in-license drug candidates and develop and achieve commercial success for drug candidates; and (xv) a variety of risks common to our industry, including ongoing regulatory review, litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc intellectual property, and legislative or regulatory changes. 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 are registered trademarks of Cubist Pharmaceuticals, Inc. |
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