Date: 2012-09-10
Type of information: R&D agreement
Compound: improved blood factors (TheraPEG™ Factor IX, TheraPEG™ Factor VIII, TheraPEG™ Factor VIIa)
Company: PolyTherics (UK) Pro Bono Bio (UK)
Therapeutic area: Hematological diseases - Genetic diseases - Rare diseases
Type agreement: R&D
licensing
development
commercialisation
Action mechanism:
Disease:
Details: * On May 29, 2012, Pro Bono Bio and PolyTherics, a provider of solutions for the development of better biopharmaceuticals, have announced progress on their haematology alliance to produce longer-acting versions of blood factor proteins. The lead programme, for the development of TheraPEG™ Factor IX, has shown good technical and scientific progress and the parties have extended their agreement to actively pursue the development of a further blood factor product, TheraPEG™ Factor VIIa. In addition, encouraged by the results achieved with these two programmes they have embarked on a feasibility study to assess the potential of a TheraPEG™ Factor VIII product.
The Parties have recently signed an exclusive global licence agreement to develop and commercialise a PEGylated version of blood factor VIIa, which again uses the PolyTherics’ site-specific TheraPEG™ conjugation technology. This product has successfully completed preclinical pharmacology studies and the TheraPEG™ PEGylation process is now being transferred to enable PBB’s biomanufacturing affiliate to produce material for further development.
In addition to the two licence agreements, the Parties have signed an exclusive option agreement to develop a PEGylated form of blood factor VIII under a feasibility programme. The option agreement includes a pre-agreed exclusive global licence for TheraPEG™ Factor VIII.
Financial terms: PolyTherics is due to receive further development and regulatory milestones as well as royalties on future worldwide product sales under the terms of the TheraPEG™ licence agreements for Factor IX and Factor VIIa. Clinical development of both products is expected to be initiated within the next 18-24 months.
Latest news: * On September 10, 2012, Pro Bono Bio Group and PolyTherics have announced further progress on their haematology alliance to produce longer-acting versions of blood factor proteins. Following their May agreement, PBB and PolyTherics undertook a feasibility programme to evaluate the use of PolyTherics’ TheraPEG™ technology to develop a unique long-acting PEGylated form of Factor VIII (“TheraPEG™ FVIII”) for the treatment of Haemophilia A. The successful conclusion of this programme has led PBB to exercise an option to take an exclusive, global licence to use TheraPEG™ technology to develop and commercialise a TheraPEG™-FVIII product that will be longer acting than the FVIII products currently in use.
The exercise of the option and signing of the licence has triggered an undisclosed milestone payment to PolyTherics. Under the terms of the licence PolyTherics is also due to receive further development and regulatory milestones as well as royalties on future worldwide product sales. PBB already has exclusive, global licences to use TheraPEG™ technology to develop and commercialise long-acting forms of Factor IX (for the treatment of Haemophilia B, “HB”) and Factor VIIa (for the treatment of HA or HB in patients with an immune response to FVIII or FIX respectively, and also for use in trauma situations). The new licence to develop and commercialise TheraPEG™ FVIII completes this suite of the most important therapeutic blood factors.
