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Agreements

Date: 2014-09-11

Type of information: Milestone

Compound: BGB-290

Company: Merck KGaA, Merck Serono (Germany) BeiGene (China)

Therapeutic area: Cancer - Oncology

Type agreement: development licensing commercialisation

Action mechanism: poly ADP ribose polymerase PARP inhibitor/PARP inhibitor. BGB-290 is an oral, selective and potent inhibitor of poly (ADP-ribose) polymerase (PARP), an enzyme family which is involved in a number of cellular processes, including DNA repair and programmed cell death.

Disease:

Details:

  • • On November 13, 2013, Merck Serono, the biopharmaceutical division of Merck, has announced that a global licensing, co-development, and commercialization agreement for BeiGene-290 has been signed with BeiGene, a biotech research and development company in Beijing, China. The compound, which is a potent poly (ADP-ribose) polymerase (PARP) inhibitor for the treatment of cancer, is currently in preclinical development and is expected to enter clinical development next year. This is the second collaboration agreement between the two companies this year. BeiGene is a Chinese novel R&D oncology company focusing on discovering, developing and commercializing innovative oncology therapeutics. With a team of around 150 scientists and staff, its pipeline is comprised of novel oral small molecules and monoclonal antibodies for cancer. BeiGene Ltd. is a Cayman Islands exempted company that is an investor in and collaborator with BeiGene (Beijing).

Financial terms:

  • Under the terms of the collaboration, BeiGene will be responsible for the development and commercialization of BeiGene-290 in China, and Merck will be responsible for the development and commercialization of BeiGene-290 for the rest of the world. BeiGene will receive an undisclosed upfront payment and is eligible to receive further payments of up to € 170 million (US$ 232 million) for the achievement of clinical development and potential commercial milestones in both the People’s Republic of China and rest of the world, as well as royalties on net sales.

Latest news:

  • • On September 11, 2014, BeiGene announced the achievement of a clinical milestone in the company’s collaboration with Merck Serono for BGB-290, an investigational poly (ADP-ribose) polymerase (PARP) inhibitor candidate currently in Phase 1 development. The milestone triggers a $ 9 million payment from Merck to BeiGene. In July 2014, BeiGene announced the enrollment of the first patient in a Phase 1 study of BGB-290 to assess safety, tolerability and pharmacokinetic properties of the candidate as a single agent. The enrollment of the fifth patient triggered this milestone payment. This Phase 1 multicenter, open-label, dose escalation clinical trial of BGB-290 is designed to assess the safety, tolerability and pharmacokinetic properties of BGB-290 as a single agent. Key objectives in the study include determining maximum tolerated dose, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of BGB-290. Disease-specific expansion cohorts will be enrolled at the maximally-tolerated or biologically-relevant dose.

Is general: Yes