LEXINGTON, MA, USA I February 27, 2014 I Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that the European Medicines Agency (EMA) has accepted for review the Company’s Marketing Authorization Application (MAA) for its investigational antibiotic tedizolid phosphate. Cubist is seeking approval of tedizolid for the treatment of complicated skin and soft tissue infections (cSSTI), with a decision from the European Commission (EC) expected during the first half of 2015.
Tedizolid is a once daily oxazolidinone being developed for both intravenous (I.V.) and oral administration for the treatment of serious infections caused by certain Gram-positive bacteria, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). The MAA submission is based on positive data from two global Phase 3 clinical studies of tedizolid, which met the primary and secondary endpoints defined by the EMA and U.S. Food and Drug Administration (FDA).
“We are very pleased to receive MAA acceptance for tedizolid and to work with the EMA on this important review process,” said Steve Gilman, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer of Cubist Pharmaceuticals. “As we continue to build out our global infrastructure, this is a significant development in our ongoing mission to advance potential new antibiotics for patients facing serious bacterial infections, such as MRSA, around the world.”
Prior to the EMA acceptance of the MAA, the FDA accepted the Company’s New Drug Application (NDA) for tedizolid with Priority Review and assigned an action date of June 20, 2014. The FDA has asked Cubist to participate in a meeting of its Anti-Infective Drugs Advisory Committee (AIDAC) on March 31, 2014. The AIDAC will review data supporting the Company’s NDA for tedizolid, for which Cubist is seeking approval in acute bacterial skin and skin structure infections (ABSSSI).
Additionally, Cubist expects to submit a New Drug Submission (NDS) to Health Canada during the first half of 2014 in acute bacterial skin and skin structure infections (ABSSSI).
About Serious Skin, Skin Structure and Soft Tissue Infections
Complicated skin and soft tissue infections (cSSTI) and acute bacterial skin and skin structure infections (ABSSSI) are a significant and growing problem throughout the world. These infections 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 cSSTI and ABSSSI but the two most common Gram-positive pathogens are Staphylococcus aureus and Streptococcus pyogenes. The significant increase in the incidence of methicillin-resistant Staphylococcus aureus (MRSA) healthcare-associated infections (HAIs), as well as community infections, has resulted in a need for therapies to address serious skin, skin structure and soft tissue infections that are effective against MRSA.
About MRSA
The European Centre for Disease Prevention and Control (ECDC) estimates that more than four million European Union (EU) patients acquire healthcare-associated infections (HAIs) annually, resulting in 37,000 deaths, and that a large proportion of these deaths are due to the most common multidrug-resistant bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). According to the ECDC, MRSA is still the most commonly identified antimicrobial-resistant pathogen in hospitals in many parts of the world, including Europe, the Americas, North Africa, the Middle-East, and Asia. Data from the Eurosurveillance journal estimates MRSA infections affect more than 150,000 patients annually in the EU. According to the U.S. 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 serious public health threats identified by the CDC is 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 in the U.S. per year.
About tedizolid phosphate
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 is being developed for both I.V. and oral administration in the potential treatment of complicated skin and soft tissue infections (cSSTI) and acute bacterial skin and skin structure infections (ABSSSI). Tedizolid 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, conducted in the U.S., Europe and other regions worldwide, in cSSTI and 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 rates were similar for both tedizolid and linezolid treated patients. Gastrointestinal adverse events (diarrhea, nausea and vomiting) were the most commonly reported in both treatment groups. 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 expects to invest approximately $400M USD in 2014 on antibacterial R&D and approximately 75% of its employee base is focused on the research, development, commercialization and support of antibiotics.
About Cubist
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. Also, connect with Cubist on Twitter @cubistbiopharma and @cubistcareers, LinkedIn, or YouTube.
SOURCE: Cubist Pharmaceuticals
Post Views: 129
LEXINGTON, MA, USA I February 27, 2014 I Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that the European Medicines Agency (EMA) has accepted for review the Company’s Marketing Authorization Application (MAA) for its investigational antibiotic tedizolid phosphate. Cubist is seeking approval of tedizolid for the treatment of complicated skin and soft tissue infections (cSSTI), with a decision from the European Commission (EC) expected during the first half of 2015.
Tedizolid is a once daily oxazolidinone being developed for both intravenous (I.V.) and oral administration for the treatment of serious infections caused by certain Gram-positive bacteria, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). The MAA submission is based on positive data from two global Phase 3 clinical studies of tedizolid, which met the primary and secondary endpoints defined by the EMA and U.S. Food and Drug Administration (FDA).
“We are very pleased to receive MAA acceptance for tedizolid and to work with the EMA on this important review process,” said Steve Gilman, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer of Cubist Pharmaceuticals. “As we continue to build out our global infrastructure, this is a significant development in our ongoing mission to advance potential new antibiotics for patients facing serious bacterial infections, such as MRSA, around the world.”
Prior to the EMA acceptance of the MAA, the FDA accepted the Company’s New Drug Application (NDA) for tedizolid with Priority Review and assigned an action date of June 20, 2014. The FDA has asked Cubist to participate in a meeting of its Anti-Infective Drugs Advisory Committee (AIDAC) on March 31, 2014. The AIDAC will review data supporting the Company’s NDA for tedizolid, for which Cubist is seeking approval in acute bacterial skin and skin structure infections (ABSSSI).
Additionally, Cubist expects to submit a New Drug Submission (NDS) to Health Canada during the first half of 2014 in acute bacterial skin and skin structure infections (ABSSSI).
About Serious Skin, Skin Structure and Soft Tissue Infections
Complicated skin and soft tissue infections (cSSTI) and acute bacterial skin and skin structure infections (ABSSSI) are a significant and growing problem throughout the world. These infections 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 cSSTI and ABSSSI but the two most common Gram-positive pathogens are Staphylococcus aureus and Streptococcus pyogenes. The significant increase in the incidence of methicillin-resistant Staphylococcus aureus (MRSA) healthcare-associated infections (HAIs), as well as community infections, has resulted in a need for therapies to address serious skin, skin structure and soft tissue infections that are effective against MRSA.
About MRSA
The European Centre for Disease Prevention and Control (ECDC) estimates that more than four million European Union (EU) patients acquire healthcare-associated infections (HAIs) annually, resulting in 37,000 deaths, and that a large proportion of these deaths are due to the most common multidrug-resistant bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). According to the ECDC, MRSA is still the most commonly identified antimicrobial-resistant pathogen in hospitals in many parts of the world, including Europe, the Americas, North Africa, the Middle-East, and Asia. Data from the Eurosurveillance journal estimates MRSA infections affect more than 150,000 patients annually in the EU. According to the U.S. 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 serious public health threats identified by the CDC is 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 in the U.S. per year.
About tedizolid phosphate
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 is being developed for both I.V. and oral administration in the potential treatment of complicated skin and soft tissue infections (cSSTI) and acute bacterial skin and skin structure infections (ABSSSI). Tedizolid 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, conducted in the U.S., Europe and other regions worldwide, in cSSTI and 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 rates were similar for both tedizolid and linezolid treated patients. Gastrointestinal adverse events (diarrhea, nausea and vomiting) were the most commonly reported in both treatment groups. 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 expects to invest approximately $400M USD in 2014 on antibacterial R&D and approximately 75% of its employee base is focused on the research, development, commercialization and support of antibiotics.
About Cubist
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. Also, connect with Cubist on Twitter @cubistbiopharma and @cubistcareers, LinkedIn, or YouTube.
SOURCE: Cubist Pharmaceuticals
Post Views: 129
