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12:00 AM
 | 
Nov 18, 2013
 |  BioCentury  |  Strategy

Roche's antibiotic return

How regulatory changes lured Roche back to antibiotics

After an almost 15-year absence, Roche's licensing deal for POL7080 from Polyphor Ltd. marks the pharma's return to antibiotics with a focus on multi-drug resistant pathogens.

The pharma believes narrow-spectrum or pathogen-specific activity - once viewed as a poor characteristic for antibiotic drug candidates - is the future of antibiotic development for two reasons.

One is that narrow-spectrum drugs could help prevent cross-resistance. The other is that recent EMA and FDA guidances have made trial designs and timelines for narrow-spectrum antibiotics attractive again.

"Ten to twenty years ago we might be looking at broad-spectrum agents. But now we think narrow activity or single pathogen activity is very much how the therapy area will evolve," said Alex White, Roche's head of partnering for infectious diseases.

On Nov. 4, Roche announced the first of what it expects to be several deals in the space. Polyphor granted the pharma exclusive worldwide rights to POL7080, a synthetic cyclopeptide antibiotic targeting the Pseudomonas LPS-assembly protein (OstA; LptD; Imp). POL7080 is in Phase II testing to treat bacterial infections caused by Pseudomonas aeruginosa.

Polyphor received CHF35 million ($38.3 million) up front and is eligible for up to CHF465 million ($509.2 million) in development, regulatory and commercial milestones, plus tiered double-digit royalties. Polyphor retains an option to co-promote an inhaled formulation in Europe.

POL7080 will supplement an internal preclinical pipeline of multi-drug resistant (MDR) antibiotics that Roche's pRED group started working on about 18 months ago.

White would not disclose the number of programs in development, but he said Roche has made a "significant investment" focused on...

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