There are positive results from Achillion Pharmaceuticals (NASDAQ:ACHN) phase IIa study of an all-oral triple combination of AL-335. Odalasvir, which is also christened ACH-3102 is in common use in the treatment of genotype 1 chronic hepatitis C virus (HCV) infection. It is used alongside Johnson & Johnson’s (NYSE:JNJ)Olysio (simeprevir).
It is just over a year now since Johnson & Johnson took over Achillion’s HCV portfolio since the agreement that took place in June 2015. The agreement gave J&J exclusive rights to enlarge and commercialize one or more of Achillion’s lead HCV candidates including ACH-3102, ACH-3422 and sovaprevir.
The three candidates, AL-335, odalasvir and Olysio have different mandates. AL-335 is a nucleotide-based HCV NS5B polymerase inhibitor. odalasvir and Olysio are an HCV NS5A inhibitor and an HCV NS3/4A protease inhibitor respectively. The notable results from the all-oral combination regimens, containing odalasvir, AL-335 did not give any signs of serious adverse events. However, their pharmacokinetics, efficacy and safety were under the determination of the phase 2a study.
What does Achillion’s collaboration with Johnson & Johnson mean?
It is perhaps one of the many signs of expansion for Johnson & Johnson whose expertise in development and commercialization capabilities has evolved over time. On the other hand, it would also boost Achillion’s development, regulatory and sales milestone payments through the $1.1 billion or more that the company will receive. This will be followed by tiered royalties in the mid teens to low twenties on any future worldwide sales.
Meanwhile, Janssen, a JNJ subsidiary, seems to have been encouraged by the interim results of the Phase II study. It is now putting together plans to instigate an overall Phase IIb study on both treatment-naïve and treatment-experienced patients who are suffering from genotypes 1–6 HCV. It will also incorporate patients with or without cirrhosis.