Cubist Pharmaceuticals Announces Development Decision On OCTX Program.Business Editors/Health/Medical Writers BIOWIRE2K LEXINGTON, Mass.--(BUSINESS WIRE)--April 29, 2004 Company to Discontinue Investment in Program Cubist Pharmaceuticals, Inc. (Nasdaq: CBST CBST Center for Biophotonics Science and Technology CBST Congregation Beth Simcha Torah (NYC) CBST Complete Binary Search Tree ) today announced that results from human clinical research studies examining the bioavailability bioavailability /bio·avail·a·bil·i·ty/ (bi?o-ah-val?ah-bil´i-te) the degree to which a drug or other substance becomes available to the target tissue after administration. bi·o·a·vail·a·bil·i·ty n. of a variety of oral formulations of ceftriaxone ceftriaxone /cef·tri·ax·one/ (cef?tri-ak´son) a semisynthetic, ß–resistant, third-generation cephalosporin effective against a wide range of gram-positive and gram-negative bacteria, used as the sodium salt. , a broad-spectrum antibiotic, were too variable to confirm therapeutic application of the formulations and did not meet the established threshold of bioavailability. As a result, Cubist will discontinue internal investment in the ceftriaxone formulations, known collectively as OCTX. Michael W. Bonney, President & 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 commented on the news: "While we are certainly disappointed that we will not be advancing OCTX into the clinic, we continue to believe that this technology platform could ultimately result in a commercial product. Over the past several years, our pharmaceutical sciences team has made important advances in increasing the oral bioavailability of an extremely difficult-to-absorb compound. We believe that the efforts made by Cubist on these formulations have added significant value to the program and are hopeful that we will be able to realize a return on our investment in the future. In the meantime Adv. 1. in the meantime - during the intervening time; "meanwhile I will not think about the problem"; "meantime he was attentive to his other interests"; "in the meantime the police were notified" meantime, meanwhile , we have decided that our resources are better spent optimizing the launch of our flagship product Cubicin(TM) (daptomycin for injection) and pursuing potential in-licensing candidates to strengthen our near-term product pipeline." Cubist originally licensed the technology from International Health Management Associates, Inc. (IHMA IHMA International Hologram Manufacturers Association IHMA International Harbour Masters' Association IHMA International Hyperbaric Medical Association IHMA International Health Management Associates, Inc. ) and The University of Utah The University of Utah (also The U or the U of U or the UU), located in Salt Lake City, is the flagship public research university in the state of Utah, and one of 10 institutions that make up the Utah System of Higher Education. in late 2000. In early 2002, Cubist announced the successful completion of studies demonstrating clinically relevant blood levels of ceftriaxone delivered intraduodenally, or directly to the small intestine small intestine Long, narrow, convoluted tube in which most digestion takes place. It extends 22–25 ft (6.7–7.6 m), from the stomach to the large intestine. , in human volunteers. These studies confirmed earlier work performed in both non-human primates and rodents. Since achievement of these results, Cubist scientists have worked to optimize oral dosage formulations, achieving significantly improved bioavailability in animal and humans, but insufficient levels to justify further development and investment by Cubist. About Cubist Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development and commercialization of drugs that meet significant unmet medical needs. Since its founding in 1992, Cubist has been exclusively focused on exploiting business and product opportunities in the antiinfective marketplace. In the U.S., Cubist markets Cubicin(TM) (daptomycin for injection), the first antibiotic in a new class of antiinfectives called lipopeptides, for the indication of complicated skin and skin structure infections caused by Gram-positive bacteria. 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. with activity against both methicillin-susceptible and methicillin-resistant Staphylococcus aureus methicillin-resistant Staphylococcus aureus Methicillin-aminoglycoside resistant Staphylococcus aureus, MRSA An organism with multiple antibiotic resistances–eg, aminoglycosides, chloramphenicol, clindamycin, erythromycin, rifampin, tetracycline, (MSSA MSSA Methicillin-Sensitive Staphylococcus Aureus MSSA Microscopy Society of Southern Africa MSSA Maryland Saltwater Sportfishermen's Association MSSA Military Selective Service Act MSSA Mid-South Sociological Association MSSA Minnesota Social Service Association and MRSA MRSA Methicillin-resistant Staphylococcus aureus. See MARSA. ). Cubist is headquartered in Lexington, MA. 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) the level of acceptance of CUBICIN by physicians, patients, third-party payors, and the medical community generally; (ii) Cubist's ability to continue to develop, secure additional regulatory approvals for, and successfully market, CUBICIN; (iii) Cubist's ability to manufacture CUBICIN on a commercial scale; (iv) commercialization of products that are competitive with CUBICIN; (v) Cubist's ability to further identify, develop, and achieve commercial success for new products and technologies; (vi) Cubist's ability to establish and maintain successful manufacturing, sales and marketing, distribution, and development collaborations; (vii) legislative or regulatory changes adversely affecting Cubist or the biopharmaceutical industry; (viii) Cubist's ability to protect its intellectual property and proprietary technologies; and (ix) Cubist's ability to finance its operations. 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. Cubicin is a trademark of Cubist Pharmaceuticals, Inc. Additional information can be found at Cubist's web site at www.cubist.com |
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