EX-99.1 2 a08-4953_1ex99d1.htm EX-99.1

 

EXHIBIT 99.1

 

Contacts:

 

Cubist Pharmaceuticals, Inc.

 

Fleishman-Hillard, Inc.

Eileen C. McIntyre

 

Jonathan R. Potter

Senior Director, Corporate Communications

 

(212) 453-2406

(781) 860-8533

 

potterj@fleishman.com

eileen.mcintyre@cubist.com

 

 

 

CORRECTED CUBIST PATENT NOW RELISTED IN ORANGE BOOK

 

Lexington, MA, February 5 2008 — Cubist Pharmaceuticals, Inc. (NASDAQ:  CBST) announced that the U.S. Food and Drug Administration (FDA) has received today the re-listing application for its U.S. Patent RE 39,071. Patents are considered listed in the Orange Book upon receipt by FDA, and this is one of three patents for daptomycin listed in the Orange Book. We expect that the FDA will publish the re-listed patent information in its next regular Orange Book update.

 

U.S. Patent RE 39,071 covers the pharmaceutical composition of CUBICIN® (daptomycin for injection) and expires in June 2016. On September 11, 2007 Cubist had asked the FDA to de-list the pharmaceutical composition patent from the Orange Book so that it could seek a technical correction. The U.S. Patent and Trademark Office on January 29, 2008 granted a Certificate of Correction for the pharmaceutical composition patent.

 

About the FDA Orange Book

 

The FDA’s Approved Drug Products List with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book, lists all drug products that have been approved by FDA for safety and effectiveness.  The Orange Book also includes information on patents which claim an approved drug product or method of use of the drug product, to facilitate the legal requirement that generic drug applicants include an appropriate certification to each such patent as part of any Abbreviated New Drug Applications (ANDAs) for a generic version of a listed drug.

 

About CUBICIN

 

CUBICIN is currently the only once-daily bactericidal antibiotic approved in the U.S. for the treatment of complicated skin and skin structure infections caused by susceptible strains of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant and methicillin susceptible  strains), Streptococcus pyogenes, S. agalactiae, S. dysgalactiae subsp equisimilis and Enterococcus faecalis (vancomycin-susceptible strains only).  CUBICIN is also approved in the U.S. as therapy for bloodstream infections (bacteremia), including right-sided endocarditis, caused by S. aureus.  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® (daptomycin for injection), the first antibiotic in a new class of anti-infectives called lipopeptides.  The Cubist product pipeline includes pre-clinical



 

programs that address unmet medical need in Gram-positive infections, Gram-negative infections, CDAD (Clostridium difficile-associated diarrhea), and HCV (Hepatitis C infections.)  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 countries where it is not yet approved; (vii) legislative and policy changes in the United States and other jurisdictions where our products are sold that may affect the ease of getting a new product or a new indication approved; (viii)   changes in government reimbursement for our or our competitors’ products; (ix) whether or not third parties may seek to market generic versions of our products by filing Abbreviated New Drug Applications, or ANDAs, with the FDA, and the results of any litigation that we file to defend and/or assert our patents against such generic companies; (x) our ability to conduct successful clinical trials in a timely manner; (xi) the effect that the results of ongoing or future clinical trials of CUBICIN may have on its acceptance in the medical community; (xii)  the ability of our third party manufacturers, including our single source provider of active pharmaceutical ingredient, or API, 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; (xiii) our dependence upon collaborations with our partners and our partners’ ability to execute on development, regulatory and sales expectations in their territories; (xiv) our ability to finance our operations; (xv) the effectiveness of our sales force and our sales force’s ability to access targeted physicians; (xvi) potential costs resulting from product liability or other third party claims; (xvii) our ability to protect our proprietary technologies; (xviii)  our ability to integrate successfully the operations of Illumigen Biosciences, Inc., which we recently acquired,  or any other  business that we may acquire and the potential impact of the acquisition of Illumigen or any other future acquisition on our financial results; (xix) our ability to discover, acquire or in-license drug candidates and develop and achieve commercial success for drug candidates; and (xx) 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 are registered trademarks of Cubist Pharmaceuticals, Inc.

 

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