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Agreements

Date: 2017-03-06

Type of information: Product acquisition

Compound: CTP-656 (D9-ivacaftor ) deuterated ivacaftor

Company: Vertex Pharmaceuticals (USA - MA) Concert Pharmaceuticals (USA - MA)

Therapeutic area: Rare diseases - Genetic diseases - Lung diseases

Type agreement: product acquisition

Action mechanism:

  • CFTR potentiator. CTP-656 is a novel cystic fibrosis transmembrane conductance regulator (CFTR) potentiator that was developed by Concert's novel application of deuterium chemistry to modify ivacaftor. Ivacaftor was discovered by Vertex scientists and is approved in the U.S., Europe, Canada and Australia for people with CF who have specific mutations in the CFTR gene. CTP-656 has the potential to play a key role in future once-daily combination regimens to treat CF.

Disease: cystic fibrosis (CF)

Details:

  • • On July 24, 2017, Concert Pharmaceuticals and Vertex Pharmaceuticals announced that the U.S. Federal Trade Commission has terminated the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act) for the pending sale of CTP-656 and other assets related to the treatment of cystic fibrosis by Concert to Vertex Pharmaceuticals. The expiration of the HSR Act waiting period represents the final regulatory closing condition required to complete the asset purchase. On May 24, 2017 , Concert shareholders approved the authorization of the CTP-656 asset purchase agreement. The transaction is expected to close in the coming days. • On March 6, 2017, Vertex Pharmaceuticals announced that it has signed a definitive asset purchase agreement to acquire CTP-656 from Concert Pharmaceuticals. CTP-656 is an investigational cystic fibrosis transmembrane conductance regulator (CFTR) potentiator that has the potential to be used as part of future once-daily combination regimens of CFTR modulators that treat the underlying cause of cystic fibrosis. Vertex will look forward to exploring once-daily regimens that combine CTP-656 with other potential medicines from its cystic fibrosis pipeline.
  • Concert is currently conducting a Phase 2 study of CTP-656 in people with cystic fibrosis who have gating mutations. As part of the agreement, Vertex will acquire rights to all of Concert's other CF research and preclinical programs.
   

Financial terms:

  • As part of the agreement, Vertex will pay Concert $160 million in cash for all worldwide development and commercialization rights to CTP-656. If CTP-656 is approved as part of a combination regimen to treat CF, Concert could receive up to an additional $90 million in milestones based on regulatory approval in the U.S. and reimbursement in the UK, Germany or France.

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