Printer Friendly
The Free Library
14,634,461 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Positive Opinion For CUBICIN(R) (Daptomycin) Received from European Regulatory Authority; Final EU Approval of Antibiotic Expected in the First Quarter of 2006.


EMERYVILLE, Calif. & LEXINGTON, Mass. -- Chiron Corporation (Nasdaq:CHIR CHIR Chiricahua National Monument (US National Park Service) ) and 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 the Committee for Medicinal Products for Human Use “CHMP” redirects here. For French language Canadian radio station, see CHMP-FM.

CPMP, Committee for Proprietary Medicinal Products, now CHMP Committee for Medicinal Products for Human Use
 (CHMP CHMP Committee for Medicinal Products for Human Use
CHMP Cultural Heritage Management Plan
CHMP Centrale Humanitaire Médico-Pharmaceutique
CHMP Certified Hazardous Materials Practitioner (Institute of Hazardous Materials Managers) 
), the scientific committee of the European Medicines Agency The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. Until 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products.

Roughly parallel to the U.S.
 (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ), has issued a positive opinion recommending approval of Chiron's Marketing Authorization Application (MAA MAA
abbr.
macroaggregated albumin
) for CUBICIN(R) (daptomycin). CUBICIN is an IV antibiotic being evaluated by the EMEA for the treatment of complicated skin and soft-tissue infections (cSSTI) caused by Gram-positive bacteria. The CHMP recommendation for approval is an important step toward bringing this novel antibiotic to the European market. Chiron licensed development and commercialization rights to CUBICIN in the EU from Cubist, which launched CUBICIN in the United States in November 2003.

Gram-positive bacteria are a major cause of problematic infections in many healthcare facilities and institutions. Of particular concern are 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. ), glycopeptide-intermediate S. aureus (GISA GISA Georgia Independent School Association
GISA German Information Security Agency
GISA Genealogiese Instituut van Suid-Afrika (South Africa)
GISA Global Institute for Student Aspirations
) and glycopeptide-resistant enterococci (VRE VRE

vancomycin-resistant enterococcus.

VRE Vancomycin-resistent enterococcus, see there
 or GRE (Generic Routing Encapsulation) A tunneling protocol developed by Cisco that allows network layer packets to contain packets from a different protocol. It is widely used to tunnel protocols inside IP packets for virtual private networks (VPNs). ), particularly E. faecium, which are driving the need for new antibacterial agents.

"The opinion of the CHMP is encouraging news for patients, physicians and healthcare providers in Europe who are increasingly concerned with infections caused by drug-resistant bacteria," said Stephen Dilly dil·ly  
n. pl. dil·lies Slang
One that is remarkable or extraordinary, as in size or quality: had a dilly of a fight.
, M.D., Ph.D., chief medical officer of Chiron BioPharmaceuticals. "We believe that CUBICIN's novel mechanism of action and its convenient once-daily treatment regimen will make it an effective product in addressing this growing threat."

Mike Bonney, President and Chief Executive Officer of Cubist, said: "We are very pleased with this positive opinion from the CHMP. This is a major step toward approval to market CUBICIN in the European Union and reflects the dedicated efforts of the Chiron team, with support from Cubist, in preparing the file for submission and responding quickly to questions from the committee."

The CHMP reviewed clinical data for CUBICIN, which Chiron submitted in its MAA for the product in December 2004. The filing included data from two pivotal Phase 3 clinical trials conducted by Cubist that examined the safety and efficacy of CUBICIN in the treatment of cSSTI. These trials demonstrated that CUBICIN was as effective as standard therapy in this indication.

The positive opinion from the CHMP is the final step before formal approval to market CUBICIN in the 25 member states of the European Union, Iceland, Liechtenstein and Norway. The CHMP is a scientific body that reviews medicinal product applications on their scientific and clinical merit and provides advice on their approval to the European Commission (EC), including recommendations about product labeling. The CHMP has advised Chiron that the committee's opinion will be forwarded to the EC for review. The final decision regarding approval of CUBICIN will be made by the EC and is expected in the first quarter of 2006.

In October 2003, Chiron and Cubist completed a license agreement for the development and commercialization of CUBICIN in Western and Eastern Europe, Australia, New Zealand, India, and certain Central American, South American and Middle Eastern countries. Under the terms of the agreement, Chiron is responsible for regulatory filings in those territories.

About CUBICIN(R) (Daptomycin Powder for Solution for Infusion)

CUBICIN is the first of a new class of antibiotics called cyclic lipopeptides. Its mechanism of action, distinct from any other antibiotic, involves binding to the cell membrane of Gram-positive bacteria, causing depolarization depolarization /de·po·lar·iza·tion/ (de-po?lahr-i-za´shun)
1. the process or act of neutralizing polarity.

2. in electrophysiology, reversal of the resting potential in excitable cell membranes when stimulated.
 and leading to inhibition of protein, DNA DNA: see nucleic acid.
DNA
 or deoxyribonucleic acid

One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes.
 and RNA RNA: see nucleic acid.
RNA
 in full ribonucleic acid

One of the two main types of nucleic acid (the other being DNA), which functions in cellular protein synthesis in all living cells and replaces DNA as the carrier of genetic
 synthesis. This results in bacterial cell death.

Two randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
, controlled clinical trials studied the efficacy and safety of 4mg/kg once daily CUBICIN in complicated skin and soft-tissue infections in adults compared to vancomycin or semi-synthetic penicillins. In both of these studies, CUBICIN was shown to be as effective as the comparator agents. CUBICIN has been shown to be effective clinically in complicated skin and soft-tissue infections caused by the following organisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus dysgalactiae subsp equisimilis and Streptococcus pyogenes.

For subjects who received CUBICIN in clinical trials, the adverse reactions most frequently reported were headache, nausea, vomiting, diarrhea, muscle pain, fungal infections, rash, infusion site reaction, increased Creatine creatine /cre·a·tine/ (kre´ah-tin) an amino acid occurring in vertebrate tissues, particularly in muscle; phosphorylated creatine is an important storage form of high-energy phosphate.  phosphokinase (CPK CPK creatine kinase.

CPK

creatine phosphokinase.
) and abnormal liver enzymes Alanine aminotransferase (ALT), Aspartate aminotransferase (AST (AST Computer, Irvine, CA) A PC manufacturer founded in 1980 by Albert Wong, Safi Quershey and Tom Yuen (A, S and T). It offered a complete line of PCs that sold through its dealer channel. ) and Alkaline phosphatase (ALP).

CUBICIN was approved for the treatment of complicated skin and skin-structure infections by the U.S. Food and Drug Administration in September 2003. CUBICIN is also approved for use in Israel and Argentina.

About Chiron

Chiron delivers innovative and valuable products to protect human health by advancing pioneering science across the landscape of biotechnology. The company works to deliver on the limitless promise of science and make a positive difference in people's lives. For more information about Chiron, please visit www.chiron.com.

About Cubist

Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development and commercialization of antiinfective 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. 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 (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) in complicated skin and skin structure infections. For full U.S. prescribing information, visit www.cubicin.com. The Company has announced that its Phase 3 Staphylococcus aureus (S. aureus) endocarditis endocarditis (ĕn'dōkärdī`tĭs), bacterial or fungal infection of the endocardium (inner lining of the heart) that can be either acute or subacute.  and bacteremia trial of CUBICIN(R) (daptomycin for injection) at 6 mg/kg once daily met its primary endpoints of non-inferiority in the intent-to-treat (ITT) and per protocol (PP) populations. Cubist has filed a supplemental New Drug Application (sNDA) seeking priority review for approval to add S. aureus bacteremia with known or suspected endocarditis to the indication statement for CUBICIN. Cubist's pipeline includes HepeX-B(TM), a monoclonal antibody biologic being evaluated to determine its potential for the prevention of infection by the Hepatitis B virus (HBV HBV hepatitis B virus.

HBV
abbr.
hepatitis B virus
) in liver transplant patients, and research efforts focused on novel members of the lipopeptide class of molecules and on natural products discovery. Cubist is headquartered in Lexington, MA.

Chiron Forward-Looking Statement

This news release contains forward-looking statements, including statements regarding European regulatory approval of CUBICIN and expected timing for such approval, that involve risks and uncertainties and are subject to change. Forward-looking statements often address our expected future performance and often contain words such as "expects," "anticipates," "intends," "plans," "believes," "seeks" or "will." A discussion of the company's operations and financial condition, including factors that may affect its business and future prospects that could cause actual results and developments to differ materially from those expressed or implied by forward-looking statements, is contained in documents the company has filed with the SEC, including the Form 10-K for the year ended December 31, 2004, and the Form 10-Q for the quarter ended September 30, 2005, and will be contained in all subsequent periodic filings made with the SEC. These documents identify important factors that could cause the company's actual performance to differ from current expectations, including the outcome of clinical trials, regulatory review and approvals, competition, manufacturing capabilities, intellectual property protections and defenses and marketing effectiveness. In particular, there can be no assurance that Chiron will receive approval to market CUBICIN in Europe in the first quarter of 2006 or ever.

Chiron does not undertake an obligation to update the forward-looking information the company is giving today.

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 generally; (ii) Cubist's ability to continue to develop, secure additional regulatory approvals for, and successfully market, CUBICIN; (iii) Cubist's expectations regarding our ability to continue to manufacture sufficient quantities of CUBICIN in accordance with current Good Manufacturing Practices; (iv) commercialization of products that are competitive with CUBICIN; (v) Cubist's ability to discover or in-license drug candidates; (vi) Cubist's ability to successfully develop drug candidates in its pipeline, including HepeX-B; (vii) Cubist's ability to successfully commercialize any product or technology developed by Cubist; (viii) Cubist's ability to establish and maintain successful manufacturing, sales and marketing, distribution, and development collaborations; (ix) legislative or regulatory changes adversely affecting Cubist or the biopharmaceutical industry; (x) Cubist's expectations regarding the future market demand and medical need for CUBICIN; (xi) Cubist's ability to protect its intellectual property and proprietary technologies; and (xii) 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. Cubist is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

NOTE: Cubist and CUBICIN are registered trademarks of Cubist Pharmaceuticals Inc.; HepeX-B is a trademark of XTL Biopharmaceuticals Ltd.
COPYRIGHT 2005 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Geographic Code:1USA
Date:Nov 17, 2005
Words:1541
Previous Article:AmerisourceBergen to Host Investor Day in New York.
Next Article:Central Garden & Pet Wins ''Editors' Choice'' Award from Pet Product News; Super Pet ''Critter Trail Off To School'' Wins Pet Product News Editors'...
Topics:



Related Articles
Cubist Pharmaceuticals and Gilead Sciences Announce European Commercialization Agreement for Investigational Antibacterial Agent Cidecin.
Will Avilamycin Convert Ziracine into Zerocine?(Brief Article)
LILLY'S TERIPARATIDE GETS POSITIVE OPINION FROM EUROPEAN CPMP.
Cubist Pharmaceuticals and Chiron Corporation Announce CUBICIN International Commercialization Agreement.
Cubist Pharmaceuticals and Chiron Corporation Announce Plans to File for European Regulatory Approval of Cubicin --Daptomycin for Injection-- by...
Chiron and Cubist Pharmaceuticals Announce the Filing for EU Regulatory Approval to Market Cubicin -Daptomycin for Injection-.
Cubicin(R) Granted Marketing Approval in Europe; First-in-Class Antibiotic Approved for Treatment of Complicated Skin and Soft-Tissue Infections;...
Airline Finance News - Europe.
Travel Security Update.
CHMP ADOPTS POSITIVE OPINION FOR ALEXION'S SOLIRIS IN EUROPE.

Terms of use | Copyright © 2009 Farlex, Inc. | Feedback | For webmasters | Submit articles