Polyphor and Roche Join Efforts to Combat Multidrug-Resistant Bacterial Infections

  Polyphor and Roche Join Efforts to Combat Multidrug-Resistant Bacterial
  Infections

Polyphor licenses investigational antibiotic POL7080 to Roche. POL7080 targets
Pseudomonas species  with a novel mode of action. This “superbug” bacterium is
commonly found in hospitals and has evolved to become resistant to many
antibiotic treatments.

Business Wire

ALLSCHWIL, Switzerland -- November 4, 2013

Polyphor Ltd, a privately held pharmaceutical company, and Roche (SIX: RO,
ROG; OTCQX: RHHBY) announced today that they have entered into an exclusive
worldwide license agreement to develop and commercialize Polyphor’s
investigational macrocycle antibiotic, POL7080, for patients suffering from
bacterial infections caused by Pseudomonas aeruginosa.

Under the terms of the agreement, Roche will make an upfront payment of CHF 35
million to Polyphor as well as payments upon reaching certain development,
regulatory and commercial milestones, potentially up to CHF 465 million. In
addition, Polyphor is entitled to receive tiered double-digit royalties on
product sales. Polyphor will retain the option to co-promote an inhaled
formulation of POL7080 in Europe. The transaction is subject to customary
regulatory clearances including termination of the applicable
Hart-Scott-Rodino waiting period.

Antimicrobial resistance represents a major threat to public health worldwide,
leading to 25,000 deaths and related costs of over €1.5 billion in healthcare
expenses and productivity losses in the European Union alone each year^1.
Pseudomonas aeruginosa accounts for one in every 10 hospital-acquired
infections in the US^2 and is listed as one of the six most dangerous
drug-resistant microbes^3. Over 15% of Pseudomonas aeruginosa isolates were
resistant to at least three classes of antibiotics and close to five percent
were resistant to all five classes under surveillance^4.

POL7080 belongs to a new class of antibiotics that kills Pseudomonas
aeruginosa by a novel mode of action. It has demonstrated clinical safety and
tolerability in a Phase I clinical trial and holds promise for the treatment
of serious and often life-threatening bacterial infections caused by
multi-drug resistant (MDR) Pseudomonas species.

“As part of our Infectious Diseases research strategy we focus on areas of
high unmet medical need, where we feel we can make the most difference for
patients. We are excited to partner with Polyphor as we build a portfolio of
novel antibiotics,” commented Janet Hammond, Head of Infectious Diseases
Discovery & Translational Area in Roche pRED. “As the incidence of
drug-resistant infections is creating an urgent demand for new therapeutic
options, we look forward to adding this potentially important, targeted agent
with a novel mechanism of action to our portfolio of innovative medicines.”

“We are delighted about this license agreement. Roche is an ideal partner for
POL7080, due to its long history of antibiotics development coupled with its
strong scientific, clinical and commercial capabilities. This agreement is
also an important milestone for Polyphor, as it is a further validation of our
macrocycle technologies and rewards more than 10 years of research and
development efforts. We are proud that Roche is building on our discovery and
clinical results to bring this urgently needed product to patients as rapidly
as possible,” said Jean-Pierre Obrecht, CEO and co-founder of Polyphor.

About antimicrobial resistance

Antimicrobial resistance represents a serious and growing threat to human and
animal health worldwide. Resistance can also spread from animals to humans
through the food chain or direct contact. According to the World Health
Organization (WHO), ‘antibiotic resistance is becoming a public health
emergency of yet unknown proportions.’ Meanwhile, new forms of resistance
continue to arise and spread, leaving clinicians with few weapons to bring
infections under control. Yet despite the recognized need for new antibiotics,
the reality is that only two new classes of antibiotics have been brought to
the market in the last three decades.^5

About Pseudomonas species

Pseudomonas is a bacterium commonly found in the environment which can give
rise to serious, life-threatening infections in various types of tissue and
usually occurs in patients in the hospital and/or with weakened immune
systems. A significant proportion of Gram-negative infections are caused by
Pseudomonas species.

Pseudomonas aeruginosa causes urinary tract infections, respiratory system
infections, dermatitis, soft tissue infections, bacteremia, bone and joint
infections, gastrointestinal infections and a variety of systemic infections.
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 almost 50 percent.

Pseudomonas aeruginosa infections are generally treated with antibiotics.
Unfortunately, in hospitalized patients, Pseudomonas infections, like those
caused by many other hospital bacteria, are becoming more difficult to treat
because of increasing antibiotic resistance.

About Polyphor

Polyphor is a Swiss Pharma company focusing on the discovery and development
of macrocycle drugs addressing high unmet medical needs. Macrocycles represent
a new drug class complementary to the classical small molecules and large
biopharmaceuticals. Polyphor leverages its unique and proprietary technologies
to develop its own product portfolio and to pursue licensing and collaboration
opportunities. The company’s lead drug candidates include POL6326, a CXCR4
antagonist, with ongoing and upcoming Phase II clinical trials for stem cell
transplantation, tissue repair and combination treatments in oncology;
POL7080, a highly specific antibiotic with a novel mode of action to treat
Pseudomonas infections (Phase II initiated); and POL6014, an inhaled inhibitor
of neutrophil elastase for the treatment of Alpha-1 Antitrypsin Deficiency,
Cystic Fibrosis, and other lung diseases (ready for IND enabling studies).
Polyphor is a privately held company with about 100 employees, headquartered
in Allschwil, near Basel.

For additional information, please visit www.polyphor.com

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused
healthcare with combined strengths in pharmaceuticals and diagnostics. Roche
is the world’s largest biotech company, with truly differentiated medicines in
oncology, infectious diseases, inflammation, metabolism and neuroscience.
Roche is also the world leader in in vitro diagnostics and tissue-based cancer
diagnostics, and a frontrunner in diabetes management. Roche’s personalized
healthcare strategy aims at providing medicines and diagnostic tools that
enable tangible improvements in the health, quality of life and survival of
patients. In 2012 Roche had over 82,000 employees worldwide and invested over
8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss
francs. Genentech, in the United States, is a wholly owned member of the Roche
Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For
more information, please visit www.roche.com.

^1 Source: ECDC/EMEA joint technical report "The bacterial challenge: time to
react," 2009

^2 Source: US Center for Disease Control and Prevention

^3 Source: Infectious Diseases Society of America

^4 Source: ECDC “Antimicrobial resistance surveillance in Europe” 2011 report

^5 Source: Innovative Medicines Initiative, New IMI Projects to Revitalize
Antibiotic Development, 11 February 2013

Contact:

Polyphor Ltd
Michael Altorfer, Head Corporate Communications
Phone: +41 61 567 16 00
e-mail: PR@polyphor.com
or
Roche Group Media Relation
Alexander Klauser (Head), Silvia Dobry, Daniel Grotzky, Štěpán Kráčala
Phone: +41 61 688 88 88
e-mail: basel.mediaoffice@roche.com
 
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