Hawaii-headquartered Allied Patients, Inc. will rely on a network of more than 20 US-based drug development companies to make its products, and plans to outsource clinical trials.
CEO Eduardo Matto – who is personally financing the venture – says the initiative responds to price increases and drug shortages.
“Allied Patients has a unique vantage point and will develop generic medications for old branded medications that are highly needed. We intend to be the new model for the pharmaceutical industry – do right by patients,” he told us.
The firm is currently working on a Phase I programme for a small molecule candidate – Matto did not disclose treatment details – and hopes to eventually move into biologics.
But completing a bioequivalence study within 12 months is the start-up’s initiative objective.
“Too often in the industry, pilot and pivotal bioequivalence studies have to be repeated because of a poor match,” Matto told us.
“Bioequivalence studies account for about 50% of generic development costs, so the study phase is key,” he added.
Matto told us the firm will outsource to US firms only: “The goal is fast development that meets our internal controls and FDA [US Food and Drug Administration] standards.”
“One of our key differences is that I do not work with Indian or Chinese firms,” said Matto, adding: “They have plenty of good development and clinic sites, but I can think of too many examples of unethical behaviour and underperformance by firms in those countries.”