November 30, 2015
By Alex Keown, BioSpace.com Breaking News Staff
BASEL, Switzerland – Roche has dropped plans to develop its investigational antibiotic RG7929/POL7080 for the treatment of “superbug” infections, Reuters reported Sunday night.
The decision ends a two-year partnership with Swiss-pharmaceutical company Polyphor to develop the superbug killer. A Roche spokesperson told Reuters the company will “discontinue its involvement in the clinical development of the investigational antibiotic RG7929/POL7080 for the treatment of patients with severe Pseudomonas aeruginosa infections and will return the asset to Polyphor.”
Pseudomonas is a bacterium commonly found in the environment which can give rise to serious and often life-threatening infections in various types of tissue. These infections usually occur in patients in the hospital and/or with weakened immune systems. Any Pseudomonas infection represents a serious problem in immuno-suppressed patients with cancer, AIDS, and severe burns or in patients suffering from chronic infections such as Cystic Fibrosis. The case fatality rate in some of these patient groups is close to 50 percent.
Polyphor will continue to develop the superbug antibiotic on its own, Reuters said. RG7929/POL7080 is currently in Phase II clinical trials. In preclinical studies, POL7080 was shown to be “highly active on a broad panel of clinical isolates including multi-drug resistant Pseudomonas bacteria with outstanding in vivo efficacy in septicemia, lung and thigh infection models,” Polyphor said on its website. In 2014, the U.S. Food and Drug Administration (FDA) designated POL7080 as a Qualified Infectious Disease Product for the treatment of Ventilator-Associated Bacterial Pneumonia caused by Pseudomonas aeruginosa. The designation provides certain incentives for the development of new antibiotics including priority review, eligibility for fast-track status and a five-year extension of market exclusivity in the U.S. if the product is approved.
The Swiss newspaper NZZ am Sonntag called Roche’s decision a “major setback” for Polyphor. The decision is also worrisome to some Swiss healthcare workers, who reported an increasing number of bacterial spores resistant to antibiotics, the paper reported.
Superbugs are disease-causing bacteria that have become resistant to most antibiotic treatments. The most dangerous superbugs include Streptococcus pneumoniae, Clostridium difficile (also called C. diff), Campylobacter, gonorrhoeae, salmonella and Methicillin-resistant Staphylococcus aureus (MRSA). According to a report issued by the U.S. Centers for Disease Control and Prevention (CDC), approximately 2 million people in the United States develop antibiotic-resistant infections annually. Of those, there are about 23,000 related deaths.
The Roche spokesperson told Reuters that superbugs are serious threats to public health and Roche would “continue to focus on this unmet medical need as part of its infectious disease research and development strategy.”
Roche and Polyphor entered into a development agreement for RG7929/POL7080 in 2013. Under terms of the deal, Roche had agreed to pay Polyphor up to $485.3 million for rights to the product. Roche’s closed at $33.49 on Friday.
Roche’s termination of its deal with Polyphor follows the company’s decision to vacate four manufacturing sites in the United States and Europe, displacing approximately 1,200 employees as part of a restructuring effort for the manufacturing of its small molecule products. The move comes as Swiss-based Roche addresses what it called the “underutilization” of its portfolio of medicines. Roche said the affected sites are in Florence, S.C. in the United States, Clarecastle in Ireland, Leganes in Spain and Segrate in Italy. In order to evade job loss, Roche said it will look for divestment opportunities, as opposed to immediately planning to close the sites. Roche said the restructuring effort will begin in 2016 and continue through 2021.
Roche is in the process of presenting data about three highly anticipated drugs to treat multiple sclerosis, cancer and hemophilia. The highly anticipated drugs ocrelizumab for MS, atezolizumab for cancer, and ACE-910 for hemophilia, have the potential for combined sales of $5 billion, according to a Thomson Reuters Cortellis forecast. The breakdown for that would be $1.051 billion for ocrelizumab, $3.188 billion for atezolziumab and $721 million for ACE-910.
