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Cubist Products & Pipeline

Marketed Products

Product/Clinical Pipeline Portfolio

Product/Product Candidate Indication Phase 1Information Phase 2Information Phase 3Information FilingInformation MarketInformation
CUBICIN®
(daptomycin for injection)
Complicated skin and skin structure infections (cSSSI) and Staphylococcus aureus bacteremia (SAB)*        
DIFICID®
(fidaxomicin)
Clostridium difficile-associated diarrhea (CDAD)*        
ENTEREG®
(alvimopan)
Accelerated GI recovery following surgeries that include partial bowel resection with primary anastomosis*        
SIVEXTRO
(tedizolid phosphate)
Acute bacterial skin and skin structure infections (ABSSSI)*+        
Tedizolid phosphate Hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP)**        
Ceftolozane/tazobactam Complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI)**Λ        
Hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP)**        
Surotomycin Clostridium difficile-associated diarrhea (CDAD)**        
Bevenopran Opioid-induced constipation
(OIC)**
       
CB-618 Beta-lactamase inhibitor**        
* Indications for approved therapies.
** Potential indications sought pending outcome of clinical trials and regulatory approval applications for pipeline candidates.
+ Approved in the U.S. for acute bacterial skin and skin structure infections (ABSSSI); in Europe the Marketing Authorization Application filed for complicated skin and soft tissue infections (cSSTI) is under review.
Λ U.S.: PDUFA December 21, 2014.

Information updated as of June 20, 2014.

Phase 1

Phase 1 includes the initial introduction of an investigational new drug into humans. Phase 1 studies are typically closely monitored and may be conducted in patients or normal volunteer subjects. These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase 1, sufficient information about the drug's pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies. The total number of subjects and patients included in Phase 1 studies varies with the drug, but is generally in the range of 20 to 80. Phase 1 studies also include studies of drug metabolism, structure-activity relationships, and mechanism of action in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes.

Source: FDA’s 21 C.F.R. 312.21(b)

Phase 2

Phase 2 includes the controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. Phase 2 studies are typically well controlled, closely monitored, and conducted in a relatively small number of patients, usually involving no more than several hundred subjects.

Source: FDA’s 21 C.F.R. 312.21(b)

Phase 3

Phase 3 studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. Phase 3 studies usually include from several hundred to several thousand subjects.

Source: FDA’s 21 C.F.R. 312.21(b)

Filing

After completion of Phase 1 to 3 clinical trials, a Company may submit a New Drug Application (NDA) or a Biologic License Application (BLA) to the U.S. Food and Drug Administration (FDA) if the drug candidate is a vaccine or a recombinant protein. After submission, the FDA may accept the submission for review, and prior to potential approval. For Europe, a Marketing Authorization Application (MAA) may be submitted to the European Medicines Agency (EMA).

Market

After completion of Phase 1 to 3 clinical trials, a Company may file for a New Drug Application (NDA), or a Biologic License Application (BLA) if the drug candidate is a vaccine or a recombinant protein. Upon review and final FDA approval for use in the specific disease indication, the Company can launch the drug into the marketplace.