Johnson & Johnson plans to acquire Alios BioPharma for $1.75 billion cash, in a deal that will expand the pharma giant’s viral-disease portfolio with two Phase II drugs and several preclinical compounds, the companies said today.
Alios will be joining J&J’s Janssen Pharmaceutical Companies. The boards of both companies have approved the deal, which is expected to close in the fourth quarter, and is subject to customary closing conditions including clearance under the Hart-Scott-Rodino Antitrust Improvements Act.
Headquartered in South San Francisco, Alios has used its chemical library of nucleoside analogs as well as its own virology-based screening systems to develop therapies for viral infections—including respiratory syncytial virus (RSV), influenza, rhinovirus, and coronavirus.
Alios’ lead compound, AL-8176, is a first-in-class, oral, nucleoside analog that is in Phase IIa studies for the treatment of infants with RSV.
AL-8176 is designed to inhibit the replication of the RSV by acting on the viral polymerase. In vitro studies of the compound have demonstrated potent and highly selective inhibition of both RSV laboratory-adapted A and B strains as well as a range of diverse clinical isolates. AL-8176 also showed multi-log suppression of RSV in an in vivo preclinical model as well as promising results in Phase I.
“We are excited that this acquisition will enable us to explore treatment options for a number of viral infections, including RSV, the last of the major pediatric diseases with no available preventive therapy,” William N. Hait, M.D., Ph.D., Janssen Pharma’s global head, research & development, said in a statement. “AL-8176 complements our existing early stage portfolio for RSV which aims to prevent and treat this disease.”
Also in Phase II trials is ALS-2200/VX-135, an Alios-discovered Hepatitis C virus (HCV) compound being co-developed with Vertex Pharmaceuticals under an up-to-$1.525 billion collaboration launched in 2011.
The potential payments to Alios assumed in part the development of two compounds—ALS-2200 and another oral HCV treatment, the adenosine nucleotide analogue pro-drug ALS-2158—since Vertex paid Alios $60 million upfront for rights to both, and since Alios stood to gain up to $715 million tied to R&D milestones for both. The remaining $750 million was tied to sales milestones on sales of all approved medicines under the collaboration.
But in 2012, Alios and Vertex ended development of ALS-2015, after concluding the drug produced insufficient antiviral activity to warrant proceeding with further clinical studies.
According to Alios’ website, its pipeline has two drugs that have completed IND development—AL-8176 for human metapneumovirus (hMPV) /parainfluenza virus (PIV); and AL-8112 for RSV.
Earlier this month, Alios said it intended to advance into Phase I trials its wholly-owned anti-HCV nucleotide AL-335, a uridine nucleotide analog.
During a September 13 presentation at the American Association for the Study of Liver Diseases (AASLD)/European Association for the Study of the Liver (EASL) 2014 Special Conference on Hepatitis C, held in New York City, Alios released positive preclinical data for AL-335 showing “potent” inhibition of HCV in the cell-based replicon assay across genotypes.
The AL-335 nucleoside triphosphate (NTP) was also shown to be a “potent” inhibitor of the HCV NS5B polymerase, functioning as a chain terminator, and showing high selectivity for the viral polymerase and not human polymerases. In addition, both in cells and in vivo, AL-335 was shown to metabolize, providing “very high” levels of the corresponding AL-335 NTP, which has a long in vivo half-life.
In addition to AL-335, Alios said it is advancing AL-516, a purine nucleotide analog and its second wholly-owned anti-HCV nucleotide, through preclinical development towards human clinical trials in 2015.