When Greg Gardiner, PhD, looked closely at Bionaut Pharmaceuticals Inc. last November, he saw a problem right away. The start-up was using the proprietary assay system around which it was founded to search for new uses for systemically administered generic drugs. But it was focused on finding new systemic indications, and therefore was not creating any effective product differentiation, Gardiner explains. "I laughed thinking about a drug company doing anything with those drugs."
Repurposing the Repurposing Business Model
Two recent examples of the difficulties of drug repurposing: Bionaut's ability to find new indications was not sufficient to get a foot in pharma's door without novelty to create barriers to entry to deter fast followers. Sention couldn't generate data fast enough on its L-amphetamine in improving cognitive impairment to counter amphetamine's bad image. (Its second program, even armed with pharma-vetted, baggage-less NCEs in-licensed from Merck, emerged too late to save the company.)
More from Strategy
Aldeyra’s dry eye candidate reproxalap received a second FDA complete response letter, but the firm expressed confidence about refiling quickly based on two ongoing studies.
The challenging US biosimilar market remains a persistent problem, leading the biosimilar developer to reconsider how it invests in the future while pushing for changes.
AstraZeneca remains committed to investing in R&D and alliances in China, where Susan Galbraith, the UK major’s head of oncology R&D, sees innovation eventually reaching parity with the US and Europe.
The US FDA approved anti-CD19 antibody Uplizna, from Amgen’s $27.8bn purchase of Horizon in 2023, for IgG4-related disease – a larger market than its original NMOSD indication.
More from Business
The US FDA approved anti-CD19 antibody Uplizna, from Amgen’s $27.8bn purchase of Horizon in 2023, for IgG4-related disease – a larger market than its original NMOSD indication.
BeiGene’s Phase III ociperlimab joins the list of failed TIGIT inhibitors, as candidates from Roche, Merck & Co. and others have failed late-stage studies.
It might be the beginning of the end for the orphan drugs party but there is still sales growth enjoyment to be had for the sector, whose star performers are now looking increasingly like mainstream drugs.