Herantis Pharma’s Phase 2 Dry Eye study recruitment completed ahead of schedule

Herantis Pharma's Phase 2 Dry Eye study recruitment completed ahead of schedule
Herantis Pharma Plc
Company release 11 March 2015 at 10:00 am

Herantis  Pharma Plc has  completed patient recruitment  in its Phase 2 clinical
study ahead of schedule. Also the number of recruited patients exceeded targets:
A  total of 161 patients were  randomized in the study  compared to the targeted
150 patients.  The randomized  patients will  receive 4 weeks  of treatment with
either  placebo eye drops  or either of  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

This  study  is  conducted  in  the  USA  by  Ora,  Inc.,  the  world's  leading
independent,  full-service ophthalmic clinical  research and product development

"The  study  has  proceeded  extremely  well",  appreciates Pekka Simula, CEO of
Herantis.  "Thanks to our seamless long-time collaboration and the experience of
Ora  in this  field the  patient recruitment  exceeded our  expectations both in
terms  of schedule  and the  number of  patients randomized.  A higher number of
patients  means stronger  statistical significance  of the  results, which  is a
critical factor in this business."

"This  is a data  driven industry", reminds  Burkhard Blank, MD, Herantis' Chief
Medical  Officer. "We really look  forward to the results  of this study as they
will  eventually tell us whether our cis-UCA Eye Drops work for the treatment of
Dry Eye, as we have a reason to believe based on preclinical efficacy data."

Herantis Pharma intends to publish top-line data of the Phase 2 study during the
second  quarter  of  2015. The  company  had  previously estimated that top-line
results  would be announced by  September 2015. If the results  of the study are
positive  the company  aims to  proceed toward  commercialization of cis-UCA Eye
Drops  for instance by  negotiating a commercialization  agreement with a global
pharmaceutical company.

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

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, to simulate 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®. The reported sales of Restasis® in 2014 exceeded 1
billion US dollars.

About drug development

Drug  development projects can usually be divided in two stages: The preclinical
stage,  and the clinical stage involving  human subjects. The clinical stage 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.