Press Release: Destiny Pharma Announces Qualified Infectious Disease Product Designation Granted by US FDA for Novel Antibacterial Product In Development for Prevention of Post-Surgical Staphyloccocal Infections

11th November 2015, Brighton, UKDestiny
Pharma Ltd,
a leading, clinical stage biopharmaceutical companyfocused
on developing and commercialising antibacterial drug products, today
announced that the US Food and Drug Administration (FDA) has granted
Qualified Infectious Disease Product (QIDP) designation to Destiny Pharma’s
lead drug product candidate, XF-73, (Exeporfinium chloride). This is
a novel, synthetic drug with anti-bacterial activity against a broad
range of bacteria. The drug is being developed against the bacteria,
Staphylococcus aureus, including the multi-antibiotic resistant
strain, Methicillin-Resistant Staphylococcus aureus, (MRSA).

The QIDP designation for XF-73 is for the prevention of post-surgical
Staphylococcal infections and there are tens of millions of patients
entering hospitals each year who are at significant risk of contracting
a post-surgical infection because they ‘carry’ this bacteria. Under
the GAIN (Generating Antibiotic Incentives Now) Act, QIDP status confers
FDA priority review, eligibility for fast-track status and an additional
five-year extension of US patent exclusivity when approval is granted.

The FDA grants QIDP designations to drugs intended to treat serious
or life-threatening infections, caused by “qualified pathogens”. These
pathogens include the hospital Superbug, MRSA, one of the leading causes
of post-surgical infections.

Data from four Phase I/IIa studies in Europe has shown that XF-73 is
rapidly bactericidal i.e. reducing the number of bacteria in the nose
quickly. Coupled with the unique property to prevent bacterial resistance
demonstrated in laboratory tests (1), XF-73 promises to be able to prevent
potentially fatal Staphylococcus aureus infections. An approach
which is becoming compromised due to a limited number of antibiotics
and antibiotic resistance. In the USA, a clinical trial of XF-73 is
sponsored and funded by the National Institute of Allergy and Infectious
Diseases (NIAID), part of the National Institutes of Health (NIH), and
is expected to complete shortly.

Dr Bill Love, CEO of Destiny Pharma, commented: “The QIDP designation
is an important milestone in the development of our lead product XF-73
which represents a new approach in hospital infection prevention for
millions of surgical patients. Around the world, governments and global
organisations are calling for new anti-bacterial drugs and are introducing
incentives to reward companies for delivering these products. Tackling
Antibiotic Resistance is on the G7 agenda and industry is starting to
return to this space. XF-73 has a novel bacterial-killing action which
offers the potential of a more comprehensive surgical infection prevention
program.”

For further information please contact:
Hume Brophy
Mary Clark, Eva Haas, Hollie Vile
Tel: +44 20 3440 5813
Email: destinypharma@humebrophy.com

About Destiny Pharma:
Destiny Pharma, a clinical stage biopharmaceutical company, was founded
in 1997. The Company focuses on the R&D of new antimicrobial drugs,
with an emphasis on novel mechanisms of action that seek to address
the global healthcare issue, namely, Antibiotic Resistance. XF-73 is
the Company’s lead drug which has completed 4 Phase I/IIa clinical studies
in the UK/Europe. Through its extensive business network and strategic
partnerships, Destiny Pharma intends to globally commercialise candidates
from the XF Drug platform based on dicationic porphyrins which are differentiated
from traditional antibiotics structurally. XF drug candidates are able
to kill static and growing bacterial cultures, as well as bacteria with
biofilm and may thus see limited resistance development. Non-growing
cultures often become resistant to traditional antibiotics that rely
on the bacteria actively growing to kill them. Additional information
on Destiny Pharma is available at www.destinypharma.com

About infections and hospital admissions:
Infection remains a major complication for hospital admissions. The
most common cause of infection is the bacteria Staphylococcus aureus
(SA), including the antibiotic resistant form, MRSA. Infection prevention
measures including decolonisation of SA/MRSA ahead of surgery in at-risk
patients are now practised in many countries, but the continuing problem
of bacterial resistance prevents the procedure being extended to the
larger number of patients who could benefit. There is an urgent global
need for drugs that can effectively prevent SA infections in patients
without succumbing to bacterial resistance. In the USA alone it is estimated
drug-resistant forms of SA such as MRSA result in 19,000 deaths per
year. The annual cost of Staphylococcus aureus infection in the
US is put at $9.5 billion.

A report in The Lancet 15th October 2015 (2), estimates that between
38 – 51% of bacteria that cause post-surgical infections are resistant
to traditional antibiotics used and that a 30% reduction in current
antibiotic effectiveness could result in 120,000 additional post-surgical
and chemotherapy related infections in the USA alone.

References:
1. David Farrell et al., “Investigation of the potential for
mutational resistance to XF-73, Retapamulin, Mupirocin, Daptomycin,
Fusidic acid & Vancomycin in MRSA isolates during a 55 passage study”.
Antimicrob.Agents & Chemo., (2011), p1177
2. Aude Teillant et al., “Potential burden of antibiotic resistance
on surgery and cancer chemotherapy antibiotic prophylaxis in the USA:
a literature review and modelling study.”, The Lancet Online, 15th Oct
2015. http://dx.doi.org/10.1016/S1473-3099(15)00270-4

Forward Looking Statement:
This press release contains forward-looking statements that are subject
to risks and uncertainties and includes statements that are not historical
facts. Actual results could differ significantly from results discussed.
Destiny Pharma disclaims any intent or obligation to update forward-looking
statements except as required by law.