Agreements

Date: 2017-12-10

Type of information: Termination of an agreement

Compound: simeprevir

Company: Medivir (Sweden) Janssen Pharmaceuticals, a J&J company (USA - NJ)

Therapeutic area: Infectious diseases

Type agreement:

Action mechanism:

direct-acting antiviral agent/protease inhibitor/RNA polymerase (NS3A) inhibitor. Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir.

Disease: hepatitis C

Details:

• On November 30, 2004, Medivir announced that it has signed a license and research collaboration agreement on hepatitis C with Tibotec Pharmaceuticals, a subsidiary of Johnson & Johnson. The goal of the research collaboration is to discover and develop orally active protease inhibitors of the NS3/4A protease of HCV. Medivir has developed a novel series of potent HCV NS3/4A protease inhibitors. These HCV inhibitors exhibit antiviral properties in a cell-based assay and have drug-like properties. Tibotec will be responsible for the global clinical development of these compounds and has acquired exclusive, worldwide marketing rights, except for in the Nordic countries, which have been retained by Medivir. The product will be commercialized in the non-Nordic countries by the Tibotec, Ortho-Biotech or Janssen Cilag operating companies of Johnson & Johnson.

Financial terms:

Under the terms of the agreement, Tibotec will make an upfront payment of €6.5 million and, based on successful achievement of pre-specified scientific, clinical and regulatory milestones, payments of up to €62 million. In addition, upon reaching a specific clinical milestone, Medivir has the right to receive a product that achieves certain predefined commercial criteria for marketing in the Nordic region or an additional payment. Medivir will receive royalties on product sales. The agreement also includes research funding.

Latest news:

• On December 10, 2017, Medivir announced that Janssen Pharmaceuticals has decided to terminate the license that it holds for simeprevir due to Janssen’s assessment of market demand. The termination of the license will become effective in June 2018 and Medivir will continue to receive royalties on any remaining sales of Olysio®/Sovriad® (simeprevir) that Janssen will make until that time. Medivir will seek to identify potential commercialization partners for specific territories where it believes there may be a market opportunity. Medivir’s royalty on the global sales of simeprevir in the first three quarters of 2017 were SEK 13.7M, SEK 7.7M, and SEK 4.1M respectively.