Roche strengthens hand in antibiotics and cancer

Roche has entered into an agreement with Meiji Seika Pharma and Fedora to develop and market a novel antibiotic treatment, which is currently in phase I trials.

The deal is another indicator of the revived interest in antibiotic development from big pharma, and follows Merck’s $9.5 billion bid for US biotech Cubist in December.

OP0595 is a beta-lactamase inhibitor, which works by restoring or strengthening the activity of beta-lactam antibiotics. Combining it with a beta-lactam antibiotic targets severe infections caused by Enterobacteriaceae, including multi-drug-resistant strains.

Under the deal, which is potentially worth up to $750 million, Roche gains worldwide rights for development and commercialisation with the exception of Japan, where Meiji will retain sole rights.

Roche has a legacy in antibiotic development and this addition “has the potential for an expanded spectrum against multi-drug resistant bacteria and could be a much-needed option for patients suffering from difficult-to-treat infections,” according to Janet Hammond, head of Infectious Diseases for Roche Pharma Research and Early Development (pRED).

Christopher Micetich, founder and CEO of Fedora said he had seen “truly impressive” bacterial eradication in highly resistant strains generated by combination of this beta-lactamase inhibitor with existing beta-lactam antibiotics: “The properties of OP0595 and its ability to be combined with new or existing beta-lactam antibiotics promise a significant advance in the battle against increasing multi-drug-resistant bacteria,” he commented.

The beta-lactam class includes penicillins, cephalosporins, monobactams and carbapenems, which constitute an estimated 65 per cent of global antibiotic sales. However, rising bacterial resistance is caused by beta-lactamase enzymes which render the antibiotics increasingly ineffective. Beta-lactamase inhibitors are administered in combination with beta-lactam antibiotics to restore or extend their ability to treat bacterial infections caused by beta-lactamase producing, antibiotic-resistant bacteria.

In the US, the Centers for Disease Control (CDC) estimates that more than two million patients are affected by drug-resistant infections each year, with direct healthcare costs as high as $20 billion.

Roche collaborates on personalised cancer drugs

Roche is also set to work with Foundation Medicine Inc (FMI) to develop personalised medicines for cancer, using FMI’s molecular information and genomic analysis to identify and develop novel treatments.

The deal sees Roche investing R&D funding of $150 million or more for a minimum of five years and contributing its expertise in oncology. FMI will continue to operate independently, focusing on developing genomic profile tests for cancer immunotherapies and continuous blood-based monitoring.

FMI’s molecular information is used to characterise a tumour that is matched with approved targeted therapy options and novel treatments under development. Understanding the comprehensive genomic profile of a cancer patient’s disease will enable better personalised solutions to optimise treatment outcomes.

“We believe that putting molecular information at the centre of cancer care will help transform the delivery of care for patients and speed the pace of drug discovery and development,” said Dr Michael Pellini, President and CEO of FMI.

Roche will have access to FMI’s molecular information platform to standardise clinical trial testing, enabling it to compare clinical trial results for R&D purposes, and ultimately in the clinic.

The venture is expected to support the development of combination therapies, novel targets, more accurate patient population identification and inclusion in clinical trials, as well as next generation companion diagnostics.

On the commercial side, Roche will obtain rights ex-US (under the FMI brand) to existing FMI products, as well as to future co-developed products. In the US, Roche’s medical education team will provide information to pathologists.

Three Roche representatives will join FMI’s board when the deal completes, which is likely to be in the second quarter of 2015.


Antibiotics back in vogue as Merck cuts $9.5 billion deal for Cubist

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