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Debiopharm Group to Acquire Affinium’s Antibiotic Clinical Assets and Platform to Identify and Develop Targeted Antibiotics

February 11, 2014

LAUSANNE, Switzerland, February 11, 2014 /PRNewswire/ –

Debiopharm Group(TM) (Debiopharm), a Swiss-based global biopharmaceutical company
developing prescription drugs that target unmet medical needs as well as companion
diagnostics, and Affinium Pharmaceuticals (Affinium), a Canadian company focusing on the
development of a platform of novel, targeted narrow-spectrum antibacterial therapeutics,
today announced the acquisition by Debiopharm of Affinium’s clinical and preclinical
assets as well as its technology platform.

The clinical assets include AFN-1252, a FabI inhibitor designated by the FDA as a
Qualified Infectious Disease Product (QIDP) which has successfully completed a Phase 2a
study for the treatment of acute bacterial skin and skin structure infections (ABSSSI),
and its prodrug AFN-1720, currently in Phase 1 clinical development. Both compounds are
highly potent agents that are selectively active against all Staphylococcus species and
strains tested thus far (5400 strains) including all known resistant strains such as
methicillin-resistant S. aureus (MRSA) and vancomycin-intermediate S. aureus (VISA). In
clinical trials, AFN-1252 has demonstrated an excellent efficacy, safety and tolerability
profile in over 250 subjects. The possibility to treat staphylococcal infections with a
molecule that allows for an intravenous-oral switch will be a major advance to address
difficult-to-treat infections. Through its expertise of molecular diagnostics, Debiopharm
will develop concomitantly with the clinical trials a diagnostic test that will allow to
select Staphylococcus-infected patients, and increase the success of treatment.

“This acquisition is a strategic choice for Debiopharm and represents a massive
continuing investment in antibiotic development. In September 2013, we entered the
antibiotics arena by signing an agreement with TCG Life Sciences Ltd (India) to develop a
novel class of antibiotics,” said Thierry Mauvernay, Delegate of the Board of Debiopharm
Group. “In 2013, the scientific community has shown that the gut microbiome plays vital
roles in determining how the body responds to challenges as different as malnutrition,
autoimmune diseases and cancer. Thus, as highlighted in the 2013 Science Breakthrough of
the Year, we are convinced that it is crucial to develop innovative targeted antibiotics
which preserve indigenous gut microbiota and overcome resistance to broad-spectrum
antibiotics. Debiopharm intends to make additional investments in this promising field and
become a key player in this therapeutic area and associated diagnostics.”

“The purchase of Affinium’s assets is a unique opportunity to develop a targeted
antibiotic having demonstrated excellent efficacy and safety in clinical trials as well as
the potential to preserve gut flora diversity and thus to prevent acquired resistance. We
are very happy about this achievement and are confident that Affinium’s novel platform
will yield additional, new, first-in-class antibiotics in the near future,” commented
Andres McAllister, Chief Scientific Officer, Debiopharm International SA.

“We are delighted to transfer the subsequent development of Affinium’s clinical lead
antibiotic, AFN-1720, as well as the promising platform in selective antibiotics, to our
colleagues at Debiopharm,” stated Ed Mascioli, MD, CEO of Affinium. “We wish them every
success in bringing AFN-1720 through regulatory approvals to serve the serious medical
needs of an increasing patient population suffering from life-threatening Staphylococcal
infections. We look forward to Debiopharm’s unlocking the very promising potential of the
platform in generating more specific, targeted antibiotics against other serious
infectious pathogens. We are also very pleased that Drs. Nachum Kaplan and Barry Hafkin
will continue with the program’s development. Their collective decades of expertise in
microbiology and infectious diseases as well as with this program will ensure its future
success.”

About AFN-1720 and AFN-1252

AFN-1720 is a prodrug of Affinium’s successful clinical-stage drug, AFN-1252, and
represents a new clinical-stage agent in this novel class of antibiotics. Due to the
unique, staphylococcal-specific activity of AFN-1252, AFN-1720 is expected to preserve the
human gut microbiota resulting in minimal antibiotic-associated side effects, such as
antibiotic-induced diarrhea or C. difficile overgrowth. Clinical data observed to date
strongly support this concept. Additionally, with no resistance pressure on other
bacterial species, the development of multiple drug-resistant organisms like
vancomycin-resistant enterococci (VRE) is unlikely. Oral and IV AFN-1720 formulations are
being developed for clinical use in several serious infections.

About Debiopharm Group(TM)

Debiopharm Group(TM) is a Swiss-based global biopharmaceutical group of 4 companies
active in drug development, GMP manufacturing of proprietary drugs, diagnostics, and
investments.

Debiopharm International SA is focused on the development of prescription drugs that
target unmet medical needs. The company in-licenses, develops and/or co-develops promising
biological and small molecule drug candidates for global registration. The products are
commercialized through out-licensing to pharmaceutical partners to give access to the
largest number of patients worldwide.

For more information about Debiopharm Group(TM), please visit:

http://www.debiopharm.com.

About Affinium Pharmaceuticals

Affinium Pharmaceuticals is a clinical stage biopharmaceutical company focused on
discovery and development of novel anti-infective medicines. The Affinium FASII
antibacterial programs constitute a new antibiotic franchise with the potential for
multiple products targeting the FASII pathway. These programs include a broad base of
long-term intellectual property: issued and pending composition of matter patents on
potent orally available small molecule inhibitors of a new class of antibiotics with a
unique mechanism of action, targeting an underexploited pathway. Affinium’s major
investors include SV Life Science Advisors LLC, Genesys Capital Management, Forward
Ventures, and Ontario Capital Growth Corporation.

For more information about Affinium Pharmaceuticals, please visit:

http://www.afnm.com

        Debiopharm International SA Contact
        Christelle Tur
        Communication Coordinator
        christelle.tur@debiopharm.com
        Tel.: +41(0)21-321-01-11

        Additional Media Contacts
        In London
        Maitland
        Brian Hudspith
        bhudspith@maitland.co.uk
        Tel: +44(0)20-7379-5151

        In New York
        Russo Partners, LLC
        Martina Schwarzkopf, Ph.D.
        Account Executive
        martina.schwarzkopf@russopartnersllc.com
        Tel: +1-212-845-4292

        Affinium Pharmaceuticals Contact
        Ed Mascioli, MD
        Chief Executive Officer
        edmascioli@afnm.com

SOURCE Debiopharm Group


Source: PR Newswire



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