Roche to re-enter antibiotics market…again

Roche could restart its antibiotic development activities if a superbug busting drug candidate being developed by new partner Polyphor fulfils its early clinical promise.

The Swiss drug giant paid Polyphor CHF35m ($38m) for exclusive worldwide rights to the macrocycle antibiotic, Pol7080, which is being developed as a treatment for hospital-acquired Pseudomonas aeruginosa infection.

Roche spokesman Luke Willats told in-Pharmatechnologist.com that: “POL7080 is in Phase II clinical trials. A Phase I clinical trial in healthy volunteers in Europe has successfully demonstrated the clinical safety and tolerability of POL7080. All primary study objectives were achieved in this trial."

He added that: “Phase II studies previously initiated will be completed by Polyphor. Roche will assume full responsibility for remaining development and commercialisation.”

So...subsidiaries don't count?

Roche stopped developing antibiotics when it abandoned anti-infectives research in 1999 (page 68) as it moved to reshape its R&D activities.

However, despite what has been widely reported, the new license does not mark Roche’s return to the antibiotics development field. In February, the firm’s subsidiary Genentech entered into an R&D collaboration with RQx in a project focused on an antibiotic to combat multi-drug resistant gram negative bugs.

Nevertheless, a second deal in the field of antibiotics could indicate Roche has changed its view of the revenue potential offered by anti-infectives, so in-Pharmatechnologist.com asked Willats what prompted the agreement.

He said that: “This license agreement complements the Roche pRED portfolio by adding antibiotics to the current focus areas in virology: Hepatitis B and influenza.

It reinforces pRED’s strong commitment to infectious diseases, particularly for areas of high unmet medical need. As one of the leading causes of antibiotic-resistant infections, Pseudomonas is a good starting point for Roche pRED.” 

Polyphor could earn as much as CHF465m from the deal, based on certain development, regulatory and commercial milestones, is entitled to receive tiered double-digit royalties on product sales.