Cubist Pharmaceuticals Launches Cidecin Compassionate Use Program.Business Editors/Health/Medical Writers BIOWIRE2K LEXINGTON, Mass.--(BUSINESS WIRE)--April 8, 2003 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 the availability of a Compassionate Use compassionate use Pharmacology The use of an agent to treat Pts for whom conventional therapies have failed, or for whom no other drug exists; CU refers to the use of an agent on humanitarian grounds before it has received regulatory–FDA–approval Protocol for its investigational antibiotic Cidecin(R) (daptomycin for injection). The Compassionate Use Protocol is designed to treat patients with Gram positive bacterial infections that are resistant to currently available antibiotics, or who are refractory to, intolerant of, or contraindicated to receive currently available therapies. A New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for CIDECIN is currently under priority review with the U.S. Food & Drug Administration (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. ) for the treatment of complicated skin and skin structure infections caused by Gram-positive bacteria. Scott M. Rocklage, Ph.D., Chairman & 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: "Compassionate Use Protocols are part of an effort by the FDA and the pharmaceutical industry to make investigational drugs available during the later stages of clinical development for the treatment of serious or life-threatening diseases. We are very pleased to be initiating this protocol to allow those in need access to CIDECIN." For more information, please contact PPD (1) (Parallel Presence Detect) The method used by earlier SIMM memory modules to communicate their capacity to the computer. A binary number coming from a parallel set of pins was read by the system, with each pin representing one bit. Contrast with SPD. Development, the contract research organization that is managing the Compassionate Use Protocol on behalf of Cubist, by telephone at 888-327-8630. About Cubist Cubist Pharmaceuticals, Inc. is focused on becoming a global leader in the research, development and commercialization of novel pharmaceuticals to combat serious and life-threatening infections. Cubist has submitted a New Drug Application (NDA) with the U.S. Food & Drug Administration (FDA) for Cidecin(R) (daptomycin for injection) for the treatment of complicated skin and skin structure infections (cSSSI) and is conducting an additional Phase 3 study in the treatment of infective endocarditis/bacteremia. The CIDECIN NDA is currently under review at FDA under priority review status. Cubist has broadened its pipeline to include multiple pre-clinical drug candidates, including an oral version 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. (OCTX), a broad-spectrum cephalosporin cephalosporin (sĕf'əlōspôr`ĭn), any of a group of more than 20 antibiotics derived from species of fungi of the genus Cephalosporium and closely related chemically to penicillin. Cephalosporins, e.g. antibiotic, and CAB-175, a next generation cephalosporin antibiotic with demonstrated in vitro activity against 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, (MRSA MRSA Methicillin-resistant Staphylococcus aureus. See MARSA. ). Cubist is headquartered in Lexington, MA. Cubist Safeharbor 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, that 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 the Company. These factors include, but are not limited to: (i) the Company's ability to successfully complete product research and development, including pre-clinical and clinical studies and commercialization; (ii) the Company's ability to obtain required governmental approvals; (iii) the Company's ability to attract and/or maintain manufacturing, sales, distribution and marketing partners; (iv) the Company's ability to develop and commercialize its products before its competitors; and (v) the Company's ability to finance its operations. Additional factors that would cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in the Company's filings with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in the Company's recent SEC filings. Cidecin(R) is a registered trademark of Cubist Pharmaceuticals, Inc. Additional information can be found at the Company's web site at www.cubist.com |
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion