Novartis confirms its leadership in ophthalmology by entering a new therapy area. Acquisition of Encore Vision, Inc. to add first-in-class disease modifying topical treatment for presbyopia patients to the Novartis ophthalmology pipeline in an area of high unmet medical need and high prevalence
Presbyopia is an age-related loss of near distance vision affecting approximately 80% of people over the age of 45; characterized by a progressive inability to focus on objects nearby, making everyday activities such as reading challenging; current therapies only provide optical correction without addressing cause of vision loss
Basel, December 20, 2016- Novartis announced today that it has entered into a definitive agreement for the acquisition of Encore Vision, Inc., a privately-held company in Fort Worth, Texas, USA, focused on the development of a novel treatment in presbyopia. This acquisition would add a first-in-class disease modifying topical treatment for presbyopia to the Novartis ophthalmology pipeline, providing a potentially disruptive innovation to patients in a new therapeutic area of high unmet need and high prevalence. The transaction is subject to customary closing conditions, including regulatory approval. The financial details of this transaction are not disclosed.
"There is a large need for innovative, effective and safe treatment options for people with presbyopia, and there is currently no disease-modifying treatment available at all," said Vasant Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis. "Novartis confirms its leadership in ophthalmology by entering another new therapy area. The addition of this topical disease modifying treatment to our portfolio, if successful, will provide affected people with a new option to improve and maintain their vision and quality of life."
Encore Vision's lead investigational product, EV06, is a first-in-class topical treatment for presbyopia. Presbyopia is a common age-related loss of near distance vision characterized by a progressive inability to focus on objects nearby, making everyday activities - such as reading - challenging. It is estimated that more than 80% of adults over the age of 45 develop presbyopia; currently there are no safe, effective and well-tolerated topical treatments available that could stop progression of or even reverse this condition.
In a phase I/II masked, placebo-controlled proof of concept study, 50 patients were treated daily for 90 days with topical EV06 and 25 patients with placebo. EV06 showed a statistical significant difference to placebo in distant corrected near vision at all time points measured (from day 8); at day 90, 82% of participants treated with EV06 had 20/40 near vision (or 0.30 LogMAR) versus 48% in the placebo group. Near vision of 20/40 allows for majority of near vision tasks in most people.
About Novartis Ophthalmology Novartis is the leading ophthalmology company, with therapies that treat both front and back of the eye conditions, including retina diseases, glaucoma, dry eye and other external eye diseases. In 2016, Novartis combined its retina medicines business with the Alcon pharmaceuticals business, now operating as one Ophthalmology franchise under Novartis Pharmaceuticals.
Disclaimer The foregoing release contains forward-looking statements that can be identified by words such as "pipeline," "entering," "to add," "agreement for the acquisition," "would," "potentially," "subject to customary closing conditions," "potential," "will," or similar terms, or by express or implied discussions regarding potential completion of the announced acquisition of Encore Vision, or regarding potential marketing approvals for EV06, or regarding potential future revenues from EV06 and the other products in the Novartis ophthalmology portfolio. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the proposed acquisition will be completed in the expected form or within the expected time frame or at all. Nor can there be any guarantee that Novartis will be able to realize any of the potential strategic benefits, synergies or opportunities as a result of the acquisition. Neither can there be any guarantee that EV06 will be submitted or approved for sale in any market, or at any particular time. Nor can there be any guarantee that EV06 or the other compound in the Novartis ophthalmology portfolio will be commercially successful in the future. In particular, management's expectations regarding EV06 could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally, including an unexpected failure to obtain necessary government approvals for the acquisition of Encore Vision, or unexpected delays in obtaining such approvals; the potential that any other closing conditions for acquisition of Encore Vision might not be met; the potential that the strategic benefits, synergies or opportunities expected from the acquisition of Encore Vision may not be realized or may take longer to realize than expected; the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; competition in general; global trends toward health care cost containment, including ongoing pricing pressures; unexpected safety, quality or manufacturing issues, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Novartis Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2015, the Group achieved net sales of USD 49.4 billion, while R&D throughout the Group amounted to approximately USD 8.9 billion (USD 8.7 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 118,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world. For more information, please visit http://www.novartis.com.
References  Brien A. Holden et al., Global Vision Impairment due to Uncorrected Presbyopia (Arch Ophthalmol. 2008;126(12):1731-1739).  Yuliya Bababekova et al., Font Size and Viewing Distance of Handheld Smart Phones (Bababekhova et al 2011)