Herantis Pharma has initiated Phase 2 study with Cis-UCA Eye Drops in Patients with Dry Eye Syndrome, results expected in Q3/2015

Herantis Pharma Plc.
Company release 7 January 2015 at 9:00 am

Herantis  Pharma Plc. has initiated its  Phase 2 clinical study with Cis-UCA Eye
Drops in patients with Dry Eye Syndrome. In the study, 150 patients with Dry Eye
Syndrome  will be randomized to receive 4 weeks of treatment with either placebo
eye  drops or two different strengths of cis-UCA Eye Drops. The objective of the
study is to compare the safety and efficacy of Cis-UCA Eye Drops to placebo, for
the treatment of the signs and symptoms of Dry Eye Syndrome.

This  study  will  be  conducted  in  the  USA by Ora, Inc., the world's leading
independent,  full-service ophthalmic clinical  research and product development
firm,  who has worked  with Herantis on  cis-UCA development for  the past three
years,  including  supporting  requirements  for  clinical supply manufacturing,
preclinical efficacy screening and regulatory guidance and interface.

"Cis-UCA  development program  has progressed  well thanks  to a  great team and
strong  commitment in  the project  by the  involved parties", appreciates Pekka
Simula, CEO of Herantis Pharma. "While the rate of patient recruitment is always
difficult  to estimate, our partner Ora,  Inc. has developed an efficient system
to  study dry eye  that directly combats  the variability, such  as slow patient
recruitment,  seen in these studies.   We now believe that  we can announce top-
line data from the study already by September 2015."

"An  estimated 45 million  patients in  the USA  and Europe  suffer from Dry Eye
Syndrome",  adds Burkhard  Blank, MD,  Chief Medical  Officer of  Herantis. "The
currently  available symptomatic treatments do  not provide sufficient relief in
the  inflammation related to most patients with Dry Eye Syndrome, where only one
prescription drug has been approved by the FDA in the USA and none in the EU. We
believe  that Cis-UCA Eye Drops  have the potential to  provide an effective and
safe treatment for many patients affected by Dry Eye Syndrome who do not benefit
from the existing drugs."

Herantis  Pharma aims to publish top-line data of the Phase 2 study by September
2015. The  company  had  previously  estimated  that  top-line  results would be
announced by the end of 2015.

Further information:

Herantis Pharma Plc., Pekka Simula, CEO, telephone: +358 40 7300 445
Company web site: www.herantis.com
Certified Advisor: UB Capital Oy, telephone: +358 9 2538 0225

About Dry Eye Syndrome

Dry  Eye  Syndrome  (Keratoconjunctivitis  sicca)  is  the  most common cause of
irritation  in  the  eye.  Typical  subjective symptoms include dryness, burning
sensation,  pain, redness, and feeling of dirt in the eye. A severe or prolonged
Dry  Eye Syndrome may lead to complications causing damage to the surface of the
eye  and impaired vision. Dry Eye Syndrome  is expected to become more prevalent
with  the  aging  population  and  with  increasing  use of computers and mobile
devices.

About Cis-UCA Eye Drops

Cis-UCA Eye Drops is an ophthalmic solution indicated for the treatment of the
signs and symptoms of Dry Eye Syndrome. Cis-urocanic acid (Cis-UCA), the active
product ingredient of Cis-UCA Eye Drops, is an endogenous small molecule
component of human and animal skin. It is constantly present in the human body
and has been identified as a locally acting anti-inflammatory agent, which also
reduces free radicals.

Cis-UCA Eye Drops has previously been investigated in an experimental model of
dry eye in the mouse, conducted by Ora to simulate the CAE clinical model being
used in the Phase 2 clinical study. The results indicate that 1% Cis-UCA Eye
Drops is efficacious in reducing corneal fluorescein staining in the model and
performs better than the clinical comparator, Restasis®.

About drug development

Drug  development projects can  usually be divided  in clear phases: Preclinical
phase,  and clinical phase  involving human subjects.  The clinical phase can be
further  broken  in  three  formal  phases.  Phase 1 clinical studies assess the
safety of a drug candidate in human subjects. In Phase 2, the optimal dosing and
possible  efficacy in the treatment of a particular disease is studied. Phase 3
studies  finally aim to establish a statistical  proof of safety and efficacy of
the  drug candidate  in typically  hundreds or  thousands of patients for market
approval.  Drug  development  can  take  10-15 years  from the first preclinical
studies to market approval.

About Herantis Pharma Plc.

Herantis  Pharma  Plc.  is  a  pharmaceutical  company  specialised  in new drug
research and development. The company focuses on diseases with an unmet clinical
need.  These diseases include for example dry eye syndrome, Parkinson's disease,
and  secondary lymphedema. We believe  our drugs are the  first or best in their
class  and have  the potential  to change  treatment strategies of diseases. The
shares of Herantis Pharma Plc. are listed on the First North Finland marketplace
run by NASDAQ Helsinki stock exchange.