NicOx says compound shows promising preclinical results, prompts new development deal with Pfizer

By E. Janene Geiss

Philadelphia, March 2 - NicOx SA announced Thursday that it has achieved "very encouraging" preclinical results in its collaboration with Pfizer Inc., which is focused on the development of more effective treatments for glaucoma using NicOx' proprietary nitric oxide-donating technology.

The NicOx compound proved to be significantly more effective than the reference drug in a validated in vivo model of abnormally high intraocular pressure (pressure within the eye) and was superior to the reference drug in two other validated models, according to a company news release.

NicOx also announced Thursday that it has signed what it termed a major new agreement. which grants Pfizer exclusive rights to use its technology across the entire field of ophthalmology.

With the new agreement, Pfizer will make payments of €23 million in the first year of the collaboration, of which €15 million will be in the form of an equity investment in NicOx, officials said.

Additionally, NicOx may receive total potential milestones in excess of €300 million in the ophthalmology field and royalties on each resulting marketed product.

NicOx said it has granted Pfizer the exclusive right to apply its nitric oxide-donating technology in a drug discovery research program covering the entire field of ophthalmology.

In return, Pfizer will make an upfront payment of €8 million and NicOx will receive €3 million in research funding on each anniversary of the agreement for the duration of the research program, officials said.

Pfizer said it also will make a €15 million equity investment in NicOx, at a 4.9% premium to the company's share price at the time of purchase. This equity purchase is subject to NicOx shareholder approval and will take place during 2006.

Pfizer said it has the option to obtain an exclusive worldwide license to develop and commercialize compounds resulting from the research program in the field of ophthalmology.

Payments could top €300 million

The agreement provides for total potential milestone payments in excess of €300 million in the ophthalmology field, of which €102 million would arise from the successful full development and launch of the first program compound.

In case the companies identify a potential indication outside of ophthalmology for a compound developed within the joint research program, Pfizer said it shall have first option on its development and commercialization.

NicOx said it would then be eligible to receive additional potential milestone payments of up to €194.3 million if this option were exercised.

Pfizer said it will make royalty payments in line with industry standards on all marketed products that result from the collaboration. The two companies will conduct the research program under the management of a joint steering committee and Pfizer will manage and fund the subsequent clinical development of selected compounds, officials said.

Large potential market

It is estimated that more than 3 million people in the United States suffer from glaucoma and 120,000 are believed to have lost their vision as a result of the disease.

"We find the preclinical results produced by the joint Pfizer-NicOx team extremely interesting, as they indicate that nitric oxide-donation can significantly improve the control of intraocular pressure. This is important, as research suggests that the greater the pressure reduction you achieve, the slower a patient's disease will progress toward vision loss and blindness," Ennio Ongini, vice president of research at NicOx, said in the release.

In the first in vivo model, raised intraocular pressure was induced transiently, followed by treatment with either vehicle, the NicOx compound, or the reference drug. Mean peak intraocular pressure occurred between 60 and 90 minutes and the NicOx compound demonstrated a significantly lower intraocular pressure profile in terms of an under the curve analysis, compared to the reference drug and vehicle, officials said.

In a second in vivo disease model, the NicOx compound achieved a maximum mean decrease in intraocular pressure of 12.8 mmHg at 4 hours post dose and was superior to the reference drug. The NicOx compound also was significantly better than vehicle at all time points in this model.

In a third in vivo model, the NicOx compound achieved a maximum mean decrease of 9.2 mmHg 2 hours after the first dose, which was significantly better than vehicle and superior to the reference drug.

There is experimental evidence that nitric oxide may play a role in controlling intraocular pressure through specific mechanisms, including relaxation of the ciliary muscles and other structures which allow fluid to drain from the eye.

In November, NicOx announced that Pfizer selected a development candidate and exercised its option to acquire an exclusive worldwide license to the proprietary compounds covered by this current agreement, which was originally signed in August 2004.

Some payments received

To date, NicOx has received €4 million from Pfizer in connection with this agreement and stands to receive an additional €33 million, plus royalties, if the collaboration results in the successful commercial development of a product. These sums would be in addition to the upfront payments, research funding, potential milestones and royalties due under the new agreement with Pfizer.

NicOx is a Sophia-Antipolis, France, product-driven biopharmaceutical company dedicated to the development of nitric oxide-donating drugs to meet unmet medical needs. NicOx is targeting the therapeutic areas of inflammatory and cardio-metabolic diseases.

New York-based Pfizer develops prescription medicines for humans and animals.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.