Cubist Announces FDA Acceptance of Tedizolid New Drug Application with Priority Review
December 30, 2013 07:30 AM Eastern Standard Time
LEXINGTON, Mass.--(BUSINESS WIRE)--Cubist Pharmaceuticals, Inc. (NASDAQ:CBST) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's New Drug Application (NDA) for its investigational antibiotic tedizolid phosphate (TR-701) with Priority Review. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of June 20, 2014. Cubist is seeking FDA approval of tedizolid for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
"We are pleased to receive NDA acceptance for tedizolid, and look forward to working closely with the Agency on this Priority Review"
Tedizolid phosphate is an oxazolidinone being developed for both intravenous (I.V.) and oral administration for the treatment of serious Gram-positive infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). The NDA submission is based on positive data from two global Phase 3 clinical studies of tedizolid in ABSSSI, which met the primary and secondary endpoints defined by the FDA and the European Medicines Agency (EMA).
Earlier in 2013, the FDA designated tedizolid as a Qualified Infectious Disease Product (QIDP), according to the Generating Antibiotic Incentives Now (GAIN) Act, for its potential indication in ABSSSI. The QIDP designation for tedizolid phosphate has allowed for certain incentives related to the development of new antibiotics, including eligibility for Priority Review and, if tedizolid phosphate is ultimately approved by the FDA, a five year extension of Hatch-Waxman exclusivity.
"We are pleased to receive NDA acceptance for tedizolid, and look forward to working closely with the Agency on this Priority Review," said Steven Gilman, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer of Cubist Pharmaceuticals. "If approved, we expect tedizolid will address the serious public health threat of MRSA and offer a new treatment option for patients with serious skin infections."
During the first half of 2014 Cubist expects to submit a Marketing Authorization Application (MAA) for tedizolid to the EMA in the ABSSSI indication. Cubist is also expecting to submit a New Drug Submission (NDS) to Health Canada in the same timeframe.
Acute bacterial skin and skin structure infections (ABSSSI) are a significant and growing problem throughout the world. ABSSSI are infections that involve deeper tissue or require surgical intervention (e.g., cellulitis, major cutaneous abscesses, and infected wounds) or are associated with a significant underlying disease (e.g., diabetes or systemic immunosuppression) that complicates response to therapy. A variety of pathogens may be identified in ABSSSI but the two most common Gram-positive pathogens are Staphylococcus aureus and Streptococcus pyogenes. The significant increase in the incidence of MRSA hospital-acquired infections, as well as community infections, has resulted in a need for therapy of ABSSSI that is effective against MRSA.
According to the Centers for Disease Control and Prevention (CDC) "Antibiotic resistance threats in the United States, 2013" report, each year more than two million Americans develop infections from antibiotic-resistant bacteria. One of the threats identified by the CDC is methicillin-resistant Staphylococcus aureus (MRSA), which continues to be a clinical and economic burden. Based on CDC data, there are 80,461 severe MRSA infections and 11,285 deaths from MRSA per year. Overall, staph bacteria remain a leading cause of healthcare-associated infections (HAI). The European Centre for Disease Prevention and Control (ECDC) estimates that more than four million EU patients acquire HAI annually, resulting in 37,000 deaths.
About tedizolid phosphate
Cubist added tedizolid phosphate to its pipeline through the acquisition of Trius Therapeutics, completed in September 2013. Cubist submitted a New Drug Application to the FDA for the approval of tedizolid in October 2013. Tedizolid phosphate (also known as TR-701) is a novel oxazolidinone antibiotic drug candidate that is rapidly converted in vivo by phosphatases to the microbiologically active moiety TR-700. TR-700 is a protein synthesis inhibitor that interacts with the 23S ribosomal ribonucleic acid (rRNA) of the bacterial ribosome, thereby preventing the initiation of translation by inhibiting formation of the initiation complex. Tedizolid phosphate is being developed for both I.V. and oral administration in the potential treatment of acute bacterial skin and skin structure infections (ABSSSI). Tedizolid phosphate is also being developed for potential use in nosocomial pneumonia (hospital-acquired bacterial pneumonia [HABP] and ventilator-associated bacterial pneumonia [VABP]). Two Phase 3 studies in ABSSSI demonstrated that tedizolid 200 mg once daily for six days was statistically non-inferior to 10 days of linezolid 600 mg twice daily for the primary efficacy endpoints. Secondary endpoints were also met. In these studies, the adverse event rate was low for both tedizolid and linezolid treated patients. Gastrointestinal adverse events (diarrhea, nausea and vomiting) were the most commonly reported in both treatment groups, with the incidence of these events being lower in patients receiving tedizolid. For more information visit: http://www.cubist.com/products/tedizolid.
About Cubist's Commitment to Antibiotic R&D
Cubist has a growing commitment to global public health through its leadership in the R&D of antibiotics to treat serious and life-threatening infections caused by a broad range of increasingly resistant bacteria. The Company hopes to deliver at least four new antibiotics in support of the Infectious Diseases Society of America (IDSA) goal of 10 new antibiotics by 2020. Cubist is investing over $300M USD in 2013 on antibacterial R&D and approximately 75% of its employee base is focused on the research, development, commercialization and support of antibiotics.
Cubist Pharmaceuticals, Inc. is a global biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address significant unmet medical needs in the acute care environment. Cubist is headquartered in Lexington, Massachusetts, with a central international office located in Zurich, Switzerland. Additional information can be found at Cubist's web site at www.cubist.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including but not limited to, statements regarding: results from Cubist's Phase 3 clinical studies of tedizolid phosphate; the therapeutic potential of tedizolid phosphate; the anticipated favorable impact resulting from the FDA designating tedizolid phosphate as a QIDP, including if tedizolid phosphate is ultimately approved by the FDA, a five year extension of Hatch-Waxman exclusivity; the expected timing for submitting additional marketing authorization applications to foreign regulatory authorities, including the EMA and Health Canada; our aspirations to achieve a portion of the IDSA's goal of 10 new antibiotics by 2020; and the level of our financial and personnel commitments towards antibiotic research, development and commercialization, are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include, among others: regulatory developments in the United States and foreign countries, including the risk that the FDA and foreign regulatory authorities may not agree with our interpretation of the results from the clinical studies of tedizolid, may not approve on a timely basis or at all, our marketing authorization applications for tedizolid phosphate or may require additional data, analysis, information or further studies that may not be clinically feasible or financially practicable; the review of our NDA may take longer than anticipated due to internal FDA constraints; any marketing approval for tedizolid phosphate may impose significant limitations on its use and additional post-marketing requirements; our ability to successfully commercialize tedizolid phosphate, including as a result of regulatory authorities' decisions regarding labeling and other matters, including adverse side effects, that could affect its availability or commercial potential; competitive risks from current and future therapeutic alternatives to tedizolid phosphate; our ability to maintain and enforce intellectual property protection for tedizolid phosphate; we may not be able to submit additional marketing authorization applications for tedizolid phosphate on our anticipated timelines; additional clinical trials of tedizolid phosphate, including in HABP/VABP, may produce negative or inconclusive results or may not be initiated or conducted in a timely manner; technical difficulties or excessive costs relating to the manufacture or supply of tedizolid phosphate, including our ability to work with our third party contract manufacturers that manufacture and supply tedizolid phosphate on our behalf; we may encounter other unanticipated or unexpected risks with respect to the development or manufacture of tedizolid phosphate; the fact that drug discovery and development is complex, time consuming, expensive and fraught with a high risk of failure; and those additional factors discussed in our most recent annual report on Form 10-K and quarterly report on Form 10-Q filed with the Securities and Exchange Commission. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this document, and we undertake no obligation to update or revise any of these statements.
Cubist Pharmaceuticals, Inc.
Eileen C. McIntyre, 781-860-8533
Vice President, Investor Relations
Jennifer Baird, 781-860-1282
Director of Product Communications