PR Newswire/Les Echos/

Press release

Novagali Pharma receives positive Scientific Advice from the European 
Medicines Agency for the Phase III clinical trial of Cyclokat(r) for the 
treatment of Dry Eye Disease

Evry (France), January 5th, 2011: Novagali Pharma (NYSE Euronext Paris:
FR0010915553), a pharmaceutical company that develops innovative ophthalmic
products, today announced that it has received positive Scientific Advice from
the European Medicines Agency (EMA) regarding the Phase III clinical trial of
Cyclokat(r), its proprietary cationic emulsion of Ciclosporin, for the 
treatment of Dry Eye Disease (DED).

Following its review, the EMA has agreed with the design of the proposed final
pivotal Phase III study in patients with severe DED intended to be supportive 
of the Marketing Authorisation Application of Cyclokat(r) .

This multicenter, double masked pivotal study, will involve approximately 250
patients. Novagali Pharma expects to obtain regulatory clearance, to initiate
this study, before the end of H1 2011. Results are expected to become 
available by mid 2012.

Jérôme Martinez, Chief Executive Officer of Novagali Pharma, concludes: " No
effective treatment for dry eye disease is currently marketed in Europe,
leaving a major unsatisfied medical need in 18 million patients(1). In view of
this market opportunity, we choose to focus our efforts on developing our
product Cyclokat(r) in Europe. These efforts have already begun to produce
results as we have now received positive Scientific Advice from the EMA for
the Phase III clinical trial of Cyclokat(r) in the treatment of patients with
severe dry eye disease. This major milestone in the final development phase 
of Cyclokat(r) substantially improves its medical value and attractiveness to
potential partners".

For the US market a similar Phase III clinical trial will be conducted.

About Scientific Advice 
Scientific Advice is a procedure offered by the EMA to stakeholders for
clarification of questions arising during development of medicinal products. 
The scope of Scientific Advice is limited to scientific issues, i.e. to 
quality, non-clinical and clinical aspects of the concerned medicinal product 
not yet unequivocally covered by published scientific guidelines. Scientific 
Advice focuses on development strategies rather than pre-evaluation of data to
support a Marketing Authorization Application. Scientific Advice is legally 
non-binding and is based on the current scientific knowledge which may be 
subject to future changes

About NOVAGALI Pharma (www.novagali.com)
Founded in 2000, Novagali Pharma SA is a pharmaceutical company that develops
ophthalmic innovative products for all segments of the eye. Thanks to its 
three proprietary technology platforms, the Company has an advanced portfolio
of highly innovative products, one of which is already on sale and two of 
which are undergoing phase III clinical trials.
In 2009, Frost & Sullivan recognised Novagali with the Award for Industry
Innovation & Advancement of the Year, for its proprietary emulsion technology
platforms, and Siemens awarded the company the "Health Award" Grand Prix de
l'Innovation for Novasorb(r). In April 2010, Novagali Pharma and its partners
in the Vitrena project obtained EUR9.4 million in funding from Oséo for this
diabetic retinopathy project.
Novagali Pharma carried out a successful IPO in July 2010. This entailed a
EUR22 million capital increase, making it the largest round of fundraising on
the stock market in the biotechnology industry in the first half of 2010 in
France.

(1) Prevalence of Dry Eye for Top 5 EU countries - Datamonitor 2010

Contacts

Novagali                     NewCap.
Geneviève Garrigos           Investor relations
VP RH & Communication        Axelle Vuillermet / Emmanuel Huynh
Tel: +33 (0)6 65 54 60 19    Tel: +33 (0) 1 44 71 94 93
                             E-mail: novagali@newcap.fr

        Novagali Pharma is listed on NYSE Euronext Paris - Compartment C
                     ISIN code: FR0010915553 - Ticker: NOVA
                      
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