Pfenex Inc., a clinical stage biotech company based in San Diego, California, has announced execution of an agreement with Hospira Inc. (Illinois) to exclusively develop and commercialise Pfenex’s biosimilar candidate (PF582) for Genentech’s Lucentis. In conjunction with Pfenex, Hospira Inc., one of the world’s leading providers of injectable drugs and infusion technologies, aims to make a significant impact in Genentech’s multi-billion dollar anti-VEGF revenues. In an announcement by Pfenenx, the company stated that it will receive an upfront payment of $51 million following antitrust approval of the transaction and, over the next 5+ years, will be eligible to receive a combination of “development and sales-based milestone payments up to an additional $291 million”. The deal is also understood to include tiered double-digit royalties on net sales of the biosimilar product while both companies will share the cost of phase 3 equivalence trials. Hospira will take responsibility for the manufacturing and commercialization of the product.
Biosimilars have become a highly attractive field for many of the large pharma companies hoping to piggy-back on lucrative opportunities, without the requirement of decades of R&D or deep war chests of cash generally associated with the market development of biologics. However, the road to revenues is seldom direct and while R&D timelines and costs may not be as great as for the initial innovator, challenges remain in terms of regulatory and manufacturing hurdles, in addition to navigating patent restrictions. Biologics, by definition, are considerably more complicated than small molecules, especially in terms of supply chain issues and reproducible manufacture. Regulatory agencies need to be convinced in respect of equivalence and consistency from batch to batch. As many such biologic candidates are produced in cells even the most minor of perturbations can cause significant modifications in the final “product” and therein lies a considerable proportion of the challenge. In addition, many of the current lucrative biologics are seldom covered by a single patent, many are protected by a series of use and manufacturing patents, often with varying expiration dates and complex inter-dependencies that can be used by innovators to extend market protection. Nevertheless the prize is always attractive with a recent RAND Corporation report suggesting that biosimilars could save in excess of $44 billion in US healthcare costs by 2024.
Commenting on the Pfenex – Hospira agreement Bertrand Liang, CEO of Pfenex stated, “We are extremely pleased to announce our collaboration with Hospira, a recognized world leader in biosimilars. This collaboration further validates the product development strength and capability of Pfenex as we continue to advance our pipeline of biosimilar candidates.” Similarly, Sumant Ramachandra, M.D., Ph.D., and Chief Scientific Officer of Hospira stated, “We look forward to working closely with the Pfenex team to offer patients, physicians and healthcare systems a more affordable treatment option for retinal diseases.” Pfenex is currently running a, “Pilot Phase 1/2, Double Blind, Parallel Group, Controlled Study of the Safety, Tolerability and Preliminary Efficacy Evaluation of Intravitreally Administered Pfenex Ranibizumab Biosimilar Versus Lucentis for the Treatment of Neovascular AMD”. The study, scheduled to complete in December 2015, will have eligible participants receive either PF582 or Lucentis, by injection into one eye on study Day 1, 28 and 56 with visits conducted on Day 2, 7, 14 80 and at 6 and 12 month intervals. The primary outcome will be to evaluate the safety and tolerability of PF582, compared to that of Lucentis in patients with neovascular AMD.