Friday, December 13, 2013

2013 Alliance of the Year Nominee: Roche/Polyphor

It's time for the IN VIVO Blog's Sixth Annual Deal of the Year! competition. This year we're once again presenting awards in three categories to highlight the most interesting and creative deal making solutions of the year. The categories are: M&A of the Year, Alliance of the Year, and Financing of the Year. We'll supply the nominations (about a half dozen in each category throughout over the next week or so) and you, the voting public, will decide the winners (by voting early and often, commencing once we've announced all the nominees). Strap yourselves in, it's The Race for the Roger™.

If catching an early big wave together justifies an alliance nomination then Roche and Polyphor look like contenders. They’re hoping to get a long, lucrative ride using novel science and new US and European regulations aimed at speeding up antibiotic development and approval.

And by choosing Switzerland-based Polyphor’s investigational macrocycle antibiotic POL7080 for development and commercialization, Roche has given notice that it’s back in the antimicrobials space again. For the first time in 30 years. In other words Roche hasn't been interested in developing antibiotics since most of you were old enough to vote -- a development worth honoring with a DOTY nod.

last time Roche developed an antibiotic,
BTTF was in theatres
The pact gives micro-sized Polyphor a big pharma partner to help it punch above its weight. Its three drug candidates, developed using its protein epitope mimetics (PEM) drug discovery technology, are POL7080; POL6326, a CXCR4 antagonist currently in Phase II and ear-marked for several indications; and POL6014, an elastase inhibitor that’s in pre-clinical studies.

Are antibiotic development incentives working? The FDA Safety and Innovation Act aims to prod companies along through the Generating Antibiotic Incentives Now (GAIN) provisions that are intended to spur development of treatments for resistant pathogens. Products receiving the qualified infectious disease product (QIDP) designations are eligible for fast track and priority review, as well as an additional five years of marketing exclusivity upon approval. And new antibacterial drugs could be eligible for a streamlined development program even if they would not be the first approved in a particular disease, according to FDA draft guidance.

Meanwhile, new guidance from the European Medicines Agency means marketing approvals for antibacterials against multi-drug-resistant bugs could be granted in Europe on expanded Phase II clinical trial data.

It’s a regulatory path that multinational Roche and privately-held Polyphor will explore together as Roche, the world’s largest maker of cancer drugs, tries to diversify into other areas.

Under terms of their alliance, announced in November, Roche will pay Polyphor up to CHF 500 million ($548 million) for the experimental antibiotic, which has only just entered Phase II testing. Roche will make an upfront payment of CHF 35 million and milestone payments of up to CHF 465 million to the Swiss biotech.

Roche’s previous legacy in the field of antibacterials involved development of Bactrim (trimethoprim/sulfamethoxazole) in 1969, in collaboration with Wellcome PLC, and Rocephin (ceftriaxone sodium) in 1982.The success of Polyphor's drug would be the first new drug against gram-negative bacteria since the '60s, Polyphor CEO Jean-Pierre Obrecht says.

The two Swiss firms will be targeting the Gram-negative strain Pseudomonas aeruginosa, a bacterium found in hospitals and resistant to many antibiotic treatments, by a novel mode of action. It’s the first of a number of novel antibiotic candidate drugs being assembled by Roche’s pharmaceutical research and early development group pRED, which is now under the new leadership of John Reed.

“We’ve been rebuilding the infectious diseases area in pRED following the restructuring last year and we are now focusing on three areas of unmet medical need. These are hepatitis B, influenza and antibiotics – and this is our first demonstration that we’re back in antibiotics,” Janet Hammond, head of infectious diseases discovery & translational area in Roche pRED, told us when the alliance with Polyphor was announced.

Roche and Polyphor believe the timing of their alliance is good. Other big pharma companies have cut back in the antimicrobial space, including onetime leader Pfizer, which closed its antibiotic R&D center in Connecticut in 2011, as well as Bristol-Myers Squibb Co. and Eli Lilly & Co., leaving only a few players, such as AstraZeneca, GlaxoSmithKline and Merck & Co.

Meanwhile there is rising alarm globally over the lack of new antimicrobials. Roche says P. aeruginosa accounts for one in every 10 hospital-acquired infections in the U.S. and is listed as one of the six most dangerous drug-resistant microbes.

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