Welcome!

News Feed Item

Bausch + Lomb Initiates Phase 3 Program for Glaucoma Drug Candidate Licensed From Nicox

SOPHIA ANTIPOLIS, FRANCE and MADISON, NJ -- (Marketwire) -- 01/29/13 --


Bausch + Lomb Initiates Phase 3 Program for Glaucoma Drug Candidate Licensed from Nicox

Bausch + Lomb, the global eye health company, and Nicox S.A. (EURONEXT PARIS: COX) today announced that Bausch + Lomb has initiated its Phase 3 clinical program of latanoprostene bunod (previously known as BOL-303259-X and NCX 116) for the reduction of intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. Latanoprostene bunod is a nitric oxide-donating prostaglandin F2-alpha analog licensed by Nicox to Bausch + Lomb.

This pivotal Phase 3 program includes two separate randomized, multicentre, double-masked, parallel-group clinical studies, APOLLO and LUNAR, designed to compare the efficacy and safety of latanoprostene bunod administered once daily (QD) with timolol maleate 0.5% administered twice daily (BID) in lowering IOP in patients with open-angle glaucoma or ocular hypertension. The primary endpoint of both studies, which will include a combined total of approximately 800 patients, is the reduction in mean IOP measured at specified time points during three months of treatment. The Phase 3 studies are pivotal for U.S. registration and will be conducted in North America and Europe. Additional information about the studies can be found at www.clinicaltrials.gov.

"There is a need for more effective, safer and better tolerated therapies to lower IOP," said Robert N. Weinreb, M.D., chairman & distinguished professor of Ophthalmology, University of California San Diego and director, Shiley Eye Center and Hamilton Glaucoma Center. "The Phase 2b results for latanoprostene bunod were promising, so it is exciting that this potential new therapy is now in pivotal trials."

Bausch + Lomb's decision to proceed with a pivotal Phase 3 program followed positive results with latanoprostene bunod in a Phase 2b trial in 413 patients with elevated IOP due to glaucoma and ocular hypertension. This study showed that latanoprostene bunod consistently lowered IOP in a dose-dependent manner. All four doses tested in the Phase 2b trial showed greater IOP reduction compared with Xalatan® 0.005%, with the differences for two of the four doses reaching more than 1mmHg (statistical significance: p < 0.01).

"Bausch + Lomb believes that latanoprostene bunod has the potential to become an important new treatment option for people suffering from elevated IOP due to glaucoma and ocular hypertension," said Cal Roberts, M.D. executive vice president and chief medical officer, Bausch + Lomb. "We look forward to completing this pivotal research program, and hope to develop an effective new treatment option to benefit physicians and the patients they serve." "Latanoprostene bunod is a nitric oxide-donating compound which was discovered in our Research Laboratories in Milan and is the first Nicox program licensed to a partner to enter into Phase 3," said Michele Garufi, chairman and CEO of Nicox. "We are pleased with Bausch + Lomb's commitment to pursuing this program in an area of significant therapeutic need. The whole Nicox team has contributed to this important milestone which underlines the potential of our research platform in the ophthalmic field."

Nicox and Bausch + Lomb Worldwide Licensing Agreement

In March 2010, Bausch + Lomb signed a worldwide licensing agreement with Nicox for latanoprostene bunod, and made an initial license payment of $10 million. In light of the positive results of the Phase 2b study completed in 2011, Bausch + Lomb made an additional $10 million milestone payment in April 2012 following their decision to pursue further development of latanoprostene bunod. If certain regulatory, commercialization and sales milestones for latanoprostene bunod are met, Nicox stands to receive from Bausch + Lomb additional potential payments which, over time, could total $162.5 million. Nicox will also receive tiered double-digit royalties on the sales of latanoprostene bunod and has the option to co-promote the product in the United States.

About Glaucoma

Glaucoma is a group of eye diseases which can lead to the loss of peripheral vision and eventually total blindness. Glaucoma is frequently linked to abnormally high pressure in the eye (intraocular pressure, IOP), due to blockage or malfunction of the eye's drainage system. Abnormally high IOP does not cause any symptoms itself, however it can lead to optic nerve damage and vision loss if left untreated. Drug therapy is used to reduce IOP and therefore prevent further vision loss, typically through increasing the drainage of intraocular fluid by relaxing certain muscles in the eye. Several large trials have demonstrated that reducing IOP can prevent the progression of glaucoma in both early and late stages of the disease. A significant proportion of patients with elevated IOP require more than one medication to maintain their IOP within target levels, highlighting the need for more effective treatments.

...................................

About Bausch + Lomb

Bausch + Lomb is one of the best-known and most respected healthcare companies in the world. Its core businesses include contact lenses and lens care products, ophthalmic surgical devices and instruments, and ophthalmic pharmaceuticals. Founded in 1853, the company is headquartered in Rochester, NY, and employs roughly 11,000 people worldwide. Its products are available in more than 100 countries. More information is available at www.bausch.com.

About Nicox

Nicox (Bloomberg: COX:FP, Reuters: NCOX.PA) is creating a new mid-sized international player in the ophthalmic market by building a diversified portfolio of innovative therapies and diagnostic tools. With a heritage of scientific, business development and commercial expertise, the Nicox team is focused on developing and marketing novel pharmaceuticals and diagnostic devices that can help people to enhance their sight. In the United States, Nicox markets AdenoPlus™, a test for the differential diagnosis of acute conjunctivitis in-licensed from RPS®.

The Company's pipeline includes latanoprostene bunod, a novel drug-candidate based on Nicox's proprietary nitric oxide (NO)-donating R&D platform, developed in collaboration with Bausch + Lomb for the potential treatment of glaucoma and ocular hypertension. Further NO-donating compounds are under development in non-ophthalmic indications, notably through partners, including Merck (known as MSD outside the United States and Canada) and Ferrer.

Nicox S.A. is headquartered in France and is listed on Euronext Paris (Compartment B: Small Caps). For more information please visit www.nicox.com.

...................................

This press release contains certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated in the forward-looking statements.

Risks factors which are likely to have a material effect on Nicox's business are presented in the 4th chapter of the « Document de référence, rapport financier annuel et rapport de gestion 2011 » filed with the French Autorité des Marchés Financiers (AMF) on February 29, 2012 and available on Nicox's website (www.nicox.com) and on the AMF's website www.amf-france.org).

...................................

Bausch + Lomb - Nicox: Phase 3 Program Initiation:

http://hugin.info/143509/R/1673716/544910.pdf

This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients. The owner of this announcement warrants that:

(i) the releases contained herein are protected by copyright and other applicable laws; and

(ii) they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: NICOX via Thomson Reuters ONE

[HUG#1673716]

Nicox Contacts
Nicox
Gavin Spencer
Executive Vice President Corporate Development
Tel +33 (0)4 97 24 53 00
Email Contact

Media Relations
FTI Consulting

Europe
Jonathan Birt
D +44 (0)20 7269 7205
M +44 (0)7515 597 858
Email Contact

Stephanie Cuthbert
D +44 (0)20 3077 0458
M +44 (0)7843 080947
Email Contact

United States
Robert Stanislaro
D +1 (212) 850 5657
M +1 (917)968 9795
Email Contact

Irma Gomez-Dib
D +1 (212) 850 5761
M +1 (415)706 9155
Email Contact

Bausch + Lomb Contacts

US
Teresa Gatto Panas
Director Global Pharmaceutical Communications
Tel +1(973) 360-6382
Email Contact

Europe
Georgina Pinnington
Manager, Communications
Tel +44 (0)20 8781 5709
Email Contact

Nicox S.A.
Drakkar 2 | Bat D | 2405 route des Dolines
CS 10313 | Sophia Antipolis
06560 Valbonne | France
T: +33 (0)4 97 24 53 00
F: +33 (0)4 97 24 53 99

www.nicox.com

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
What are the successful IoT innovations from emerging markets? What are the unique challenges and opportunities from these markets? How did the constraints in connectivity among others lead to groundbreaking insights? In her session at @ThingsExpo, Carmen Feliciano, a Principal at AMDG, will answer all these questions and share how you can apply IoT best practices and frameworks from the emerging markets to your own business.
Ask someone to architect an Internet of Things (IoT) solution and you are guaranteed to see a reference to the cloud. This would lead you to believe that IoT requires the cloud to exist. However, there are many IoT use cases where the cloud is not feasible or desirable. In his session at @ThingsExpo, Dave McCarthy, Director of Products at Bsquare Corporation, will discuss the strategies that exist to extend intelligence directly to IoT devices and sensors, freeing them from the constraints of ...
SYS-CON Events announced today the Kubernetes and Google Container Engine Workshop, being held November 3, 2016, in conjunction with @DevOpsSummit at 19th Cloud Expo at the Santa Clara Convention Center in Santa Clara, CA. This workshop led by Sebastian Scheele introduces participants to Kubernetes and Google Container Engine (GKE). Through a combination of instructor-led presentations, demonstrations, and hands-on labs, students learn the key concepts and practices for deploying and maintainin...
You think you know what’s in your data. But do you? Most organizations are now aware of the business intelligence represented by their data. Data science stands to take this to a level you never thought of – literally. The techniques of data science, when used with the capabilities of Big Data technologies, can make connections you had not yet imagined, helping you discover new insights and ask new questions of your data. In his session at @ThingsExpo, Sarbjit Sarkaria, data science team lead ...
Cloud analytics is dramatically altering business intelligence. Some businesses will capitalize on these promising new technologies and gain key insights that’ll help them gain competitive advantage. And others won’t. Whether you’re a business leader, an IT manager, or an analyst, we want to help you and the people you need to influence with a free copy of “Cloud Analytics for Dummies,” the essential guide to this explosive new space for business intelligence.
Extracting business value from Internet of Things (IoT) data doesn’t happen overnight. There are several requirements that must be satisfied, including IoT device enablement, data analysis, real-time detection of complex events and automated orchestration of actions. Unfortunately, too many companies fall short in achieving their business goals by implementing incomplete solutions or not focusing on tangible use cases. In his general session at @ThingsExpo, Dave McCarthy, Director of Products...
Traditional IT, great for stable systems of record, is struggling to cope with newer, agile systems of engagement requirements coming straight from the business. In his session at 18th Cloud Expo, William Morrish, General Manager of Product Sales at Interoute, outlined ways of exploiting new architectures to enable both systems and building them to support your existing platforms, with an eye for the future. Technologies such as Docker and the hyper-convergence of computing, networking and sto...
WebRTC is bringing significant change to the communications landscape that will bridge the worlds of web and telephony, making the Internet the new standard for communications. Cloud9 took the road less traveled and used WebRTC to create a downloadable enterprise-grade communications platform that is changing the communication dynamic in the financial sector. In his session at @ThingsExpo, Leo Papadopoulos, CTO of Cloud9, discussed the importance of WebRTC and how it enables companies to focus...
With an estimated 50 billion devices connected to the Internet by 2020, several industries will begin to expand their capabilities for retaining end point data at the edge to better utilize the range of data types and sheer volume of M2M data generated by the Internet of Things. In his session at @ThingsExpo, Don DeLoach, CEO and President of Infobright, discussed the infrastructures businesses will need to implement to handle this explosion of data by providing specific use cases for filterin...
IoT generates lots of temporal data. But how do you unlock its value? You need to discover patterns that are repeatable in vast quantities of data, understand their meaning, and implement scalable monitoring across multiple data streams in order to monetize the discoveries and insights. Motif discovery and deep learning platforms are emerging to visualize sensor data, to search for patterns and to build application that can monitor real time streams efficiently. In his session at @ThingsExpo, ...
Enterprise networks are complex. Moreover, they were designed and deployed to meet a specific set of business requirements at a specific point in time. But, the adoption of cloud services, new business applications and intensifying security policies, among other factors, require IT organizations to continuously deploy configuration changes. Therefore, enterprises are looking for better ways to automate the management of their networks while still leveraging existing capabilities, optimizing perf...
Internet of @ThingsExpo has announced today that Chris Matthieu has been named tech chair of Internet of @ThingsExpo 2016 Silicon Valley. The 6thInternet of @ThingsExpo will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Early adopters of IoT viewed it mainly as a different term for machine-to-machine connectivity or M2M. This is understandable since a prerequisite for any IoT solution is the ability to collect and aggregate device data, which is most often presented in a dashboard. The problem is that viewing data in a dashboard requires a human to interpret the results and take manual action, which doesn’t scale to the needs of IoT.
When building large, cloud-based applications that operate at a high scale, it’s important to maintain a high availability and resilience to failures. In order to do that, you must be tolerant of failures, even in light of failures in other areas of your application. “Fly two mistakes high” is an old adage in the radio control airplane hobby. It means, fly high enough so that if you make a mistake, you can continue flying with room to still make mistakes. In his session at 18th Cloud Expo, Lee...
Continuous testing helps bridge the gap between developing quickly and maintaining high quality products. But to implement continuous testing, CTOs must take a strategic approach to building a testing infrastructure and toolset that empowers their team to move fast. Download our guide to laying the groundwork for a scalable continuous testing strategy.