NOVA Novo Nordisk

Regulatory News:

Novagali Pharma (Paris:NOVA), a pharmaceutical company that develops and markets innovative ophthalmic products, today announces its revenue for the first nine months of 2011.

Third-quarter and 9-month revenue to September 30th, 2011

In thousands of euros - IFRS*   Q3 2011   Q3 2010   9 months 2011   9 months 2010 Sales   199   160   568   396 Research contracts and licence revenue 0 10 0 10 Subsidies, public funding and research tax credit   437   443   1 454   862 Total revenue   636   613   2,022   1,268

* Unaudited

Quarterly revenues

In thousands of euros - IFRS*   Q3 2011   Q2 2011   Q1 2011   Q3 2010   Q2 2010   Q1 2010 Sales   199   238   131   160   129   107 Research contracts and licence revenue 0 0 0 10 0 0 Subsidies, public funding and research tax credit   437   639   379   443   211   208 Total revenue   636   877   510   613   340   315

* Unaudited

For the 3rd quarter of 2011, Novagali Pharma’s earnings, reflecting sales of Cationorm®, totalled €199k, up more than 24% compared to the 3rd quarter of 2010. This pursuance in sales growth is associated with the upramping of sales in countries where the product was already marketed. Total revenue was €636k over the quarter, a slight increase of 3.8%.

Over the first nine months of 2011, total revenue was up more than 59% at €2.0m, compared to €1.3m over the same period of 2010. This growth was the result of a 43.4% increase in Cationorm® sales and a 68.7% increase in “Subsidies, public funding and research tax credit” to €1.4m over the period. The latter notably includes the first payments of the OSEO ISI operating subsidy, for €190k, relative to the launch of the VITRENA project concerning diabetic retinopathy.

Milestones and recent events

• Clinical developments
  • Positive results for the phase II clinical trial carried out in the United States regarding the efficiency and innocuousness of Catioprost® amongst patients with concomitant glaucoma and eye surface problems (September 2011). The trial achieved its objectives by revealing a reduction in intraocular pressure and an improvement in the signs and symptoms of OSD (ocular surface disease) compared to the Travatan Z® control group.
• Commercial developments:
  • The required authorisations have been granted for the marketing of Cationorm® in the United Arab Emirates and the launch of the product in Saudi Arabia.
• Majority stake for Santen Pharmaceutical Co., Ltd.
  • On October 11th, 2011, Japanese pharmaceutical leader Santen Pharmaceutical Co., Ltd. and Novagali Pharma announced Santen’s acquisition of 50.55% of Novagali Pharma’s capital.
  • As a result of this acquisition, Santen will soon table a mandatory takeover bid with the AMF for the remaining shares and securities it does not yet hold. This offer would be followed by the delisting of the remaining Novagali Pharma shares, assuming that Santen holds at least 95% of Novagali Pharma’s capital and voting rights after the takeover offer.

Outlook

• Cationorm®: the launch of the product in the United States and Saudi Arabia is currently being prepared. Cationorm® will also be available in a multi-dose bottle with no preservatives. Furthermore, the Company is involved in discussions regarding the product’s launch in other countries, notably in Europe.
• Cyclokat®: the recruitment of patients for the phase III confirmatory trial in Europe is continuing, with results expected in mid-2012.

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®. Novagali Pharma carried out a successful IPO in July 2010 enabling the Company to raise €22 million.

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

Disclaimer

This press release contains forward-looking statements. Although Novagali Pharma considers these statements to be based on reasonable assumptions, they could be affected by risks and uncertainties causing actual results to differ significantly from these forward-looking statements. For details of the risks and uncertainties that could potentially affect Novagali Pharma’s results, financial situation, performances or achievements and thus result in a variation in these figures compared to the forward-looking statements contained in this document, please refer to the Risk Factors section of the Document de Base source document registered with the French Autorité des Marches Financiers (“AMF”) under number R. 11-021 on April 29th, 2011 and available on the AMF (http://www.amf-france.org) and Novagali Pharma (www.novagali.com) websites.

This press release and the information contained herein do not constitute an offer to sell or subscribe to, or a solicitation of an offer to buy or subscribe to, shares in Novagali Pharma in any country.