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Agreements

Date: 2018-10-05

Type of information: Licensing agreement

Compound: lentiviral vectors for ex-vivo gene therapy products in primary immune deficiency disorders and inherited metabolic disorders

Company: Oxford Biomedica (UK) Orchard Therapeutics (UK)

Therapeutic area: Rare diseases - Genetic diseases

Type agreement: collaboration

Action mechanism:

  • gene therapy

Disease: adenosine deaminase severe combined immunodeficiency (ADA-SCID), mucopolysaccharidosis-IIIA (MPS-IIIA or Sanfilippo Syndrome type A), undisclosed follow-on indications.

Details:

  • • On November 29, 2016, Oxford BioMedica announced it has entered into a strategic alliance with Orchard Therapeutics, a biotechnology company dedicated to bringing transformative ex-vivo stem cell based gene therapies to patients with serious and life-threatening orphan diseases. As part of the agreement the group will develop and supply lentiviral vectors used by Orchard for the manufacture of ex-vivo gene therapy products in primary immune deficiency disorders and inherited metabolic disorders, including adenosine deaminase severe combined immunodeficiency (ADA-SCID), mucopolysaccharidosis-IIIA (MPS-IIIA or Sanfilippo Syndrome type A) and undisclosed follow-on indications. Orchard will lead the global clinical development and commercialisation of collaboration programmes in Europe, the United States and in other regions.

Financial terms:

  • Under the terms of the collaboration and licence agreement, Oxford BioMedica will receive a 1.95% equity stake in Orchard and will be entitled to royalties on future sales of products covered by the collaboration. The group will provide process development services and manufacture clinical and commercial GMP-grade lentiviral vectors for Orchard. The process development arrangements include performance-related incentives through which Oxford BioMedica could receive a further 1.95% equity stake in Orchard. The Group has also granted an exclusive intellectual property licence to Orchard for collaboration programmes.

Latest news:

  • • On October 5, 2018, Oxford BioMedica announced additional details of its strategic alliance with Orchard Therapeutics, as disclosed in the public filing by Orchard Therapeutics on a Form F-1 Registration Statement ahead of a planned NASDAQ Initial Public Offering (IPO).
  • In November 2016, Oxford BioMedica entered into a strategic alliance with Orchard Therapeutics for the development of gene therapies for ADA-SCID, MPS-IIIA and certain other diseases (Subsequent Indications). In the agreement, Oxford BioMedica granted to Orchard Therapeutics an exclusive, worldwide license for the research, development and commercialisation of ex vivo gene therapy products for the treatment of ADA-SCID, MPS-IIIA and subsequent Indications. Oxford BioMedica also granted Orchard Therapeutics a non-exclusive, worldwide license for the treatment of certain diseases other than ADA-SCID, MPS-IIIA and Subsequent Indications.
  • As consideration for the licenses granted under the agreement, Oxford BioMedica was issued 735,000 ordinary shares in Orchard Therapeutics. Additional shares were awarded to the group on the achievement of certain milestones, including 188,462 ordinary shares in November 2017 and a further 188,462 ordinary shares in August 2018. Additional ordinary shares will be issued to Oxford BioMedica upon achievement of the remaining milestones.
  • Oxford BioMedica currently owns 1,111,924 shares in Orchard Therapeutics (pre any share capital reorganisation which may be undertaken as part of the IPO process).
  • Additionally, Oxford BioMedica will receive a low single-digit royalty on net sales of licensed products until January 31, 2039. In the event the products are used for compassionate use, these royalties are reduced by a mid-double-digit percentage. Orchard Therapeutics is also required to pay a set monthly fee to Oxford BioMedica in the event the Group’s system for generating stable cell lines is used.

Is general: Yes