US-based biotech firm Pfenex has made commercialization deals for its candidate teriparatide biosimilar (PF708) in China and in the US.
Pfenex and China’s NT Pharma Group (NT Pharma) announced on 18 April 2018 an agreement under which Pfenex granted NT Pharma non-exclusive development and exclusive commercialization rights to PF708, a candidate biosimilar of Eli Lilly’s Forteo (teriparatide), in Mainland China, Hong Kong, Singapore, Malaysia and Thailand.
According to the deal, Pfenex received a payment of US$2.5 million upon signing of the agreement and may be eligible to receive additional payments of up to US$22.5 million based on the achievement of certain development, regulatory, and sales-related milestones. Pfenex may also be eligible to receive double-digit royalties on net product sales. NT Pharma will be responsible for any further development required to achieve regulatory approval as well as commercialization activities in the territory.
On 11 June 2018, Pfenex announced that it was entering into an agreement with Alvogen granting Alvogen exclusive rights to commercialize PF708 in the US.
According to the deal, Pfenex will develop and register PF708, while Alvogen will provide additional regulatory and development expertise. Alvogen will assume responsibility for costs related to litigation, commercial manufacturing and supply chain, and commercialization of PF708. Pfenex will receive an upfront payment of US$2.5 million and may be eligible to receive an additional US$25 million in support and regulatory milestone payments. Pfenex may also be eligible to receive a 50% gross profit split on sales if the product is rated as Therapeutic Equivalent (AP) and up to 40% if rated differently.
Pfenex expects to submit a new drug application for PF708 to the US Food and Drug Administration (FDA) in the third quarter of 2018 leading to potential launch in the US in the third quarter of 2019.
Pfenex announced positive results for its phase III PF708-301 study on 12 June 2018. The company says that PF708 ‘showed comparable overall profiles between its biosimilar drug candidate PF708 and Eli Lilly’s teriparatide (Forteo) for osteoporosis’.
The company’s lead product is PF582 is a biosimilar of Roche’s Lucentis (ranibizumab). Their biosimilars pipeline also includes six biosimilars that are being developed as part of a joint venture with Strides Arcolab subsidiary Aguila Biotech [1]. These include biosimilars of multiple sclerosis treatment Betaseron (interferon beta-1b) (PF530), chronic hepatitis B/C treatment Pegasys (peg-interferon alpha-2a) (PF694), peg-interferon beta (PF756), neutropenia treatment Neulasta (peg-filgrastim) (PF529), human growth hormone (PF444) and leukaemia treatment Oncaspar (peg-aspargase) (PF690). Pfenex is also developing a biosimilar of arthritis drug Cimzia (certolizumab-pegol) (PF688) on its own.
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Agila Biotech and Pfenex make biosimilars deal [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 JuL 6]. Available from: www.gabionline.net/Biosimilars/News/Agila-Biotech-and-Pfenex-make-biosimilars-deal
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