A US public company based in San Diego, Pfenex Inc. (NYSE MKT: PFNX) has announced that is has regained commercial rights to a biosimilar of Lucentis, PF582. The rights were returned to Pfenex Inc from Pfizer Inc which had purchased Hospira Inc., the licensee of the ophthalmic biosimilar who had obtained rights to the drug in February 2015. According to Pfenex Inc, Pfizer’s decision to terminate its interest in the Lucentis biosimilar was based on a “strategic review of the current therapeutic focus of its biosimilar pipeline.” At the same time, Pfenex has reported that the biosimilar has met the primary endpoint of its safety study in a Phase I/II trial for the treatment of AMD.
Pfenex, a clinical stage biotech company in California, with significant investment in the biosimilar space, is understood to have completed a study of 25 VEGF-inhibitor naïve patients with AMD, all of who received 3 monthly intravitreal injections of either PF582 or Lucentis. The primary endpoint was safety and tolerability of PF582 compared to Lucentis, in respect of which the company reported no meaningful differences in intra-ocular pressure, BCVA or CRT between PF582 and Lucentis at any of the timepoints measured. In addition, no local or systemic adverse events or safety or tolerability findings were reported in the population studied. Commenting on the milestone, Bertrand C. Liang, CEO of Pfenex stated, “we will consider strategic options for PF582 following the expeditious transition of the full development program back to Pfenex. Pfenex’s development capabilities, leveraging our Pfenex Expression Technology® platform, has allowed us to advance a diverse portfolio of product candidates, including PF582″
Biosimilars have become a highly attractive field for many of the large pharma companies with designs 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 RAND Corporation report suggesting that biosimilars could save in excess of $44 billion in US healthcare costs by 2024.
