|By Marketwired .||
|January 29, 2013 01:48 AM EST||
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.
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.
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:
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
Executive Vice President Corporate Development
Tel +33 (0)4 97 24 53 00
D +44 (0)20 7269 7205
M +44 (0)7515 597 858
D +44 (0)20 3077 0458
M +44 (0)7843 080947
D +1 (212) 850 5657
M +1 (917)968 9795
D +1 (212) 850 5761
M +1 (415)706 9155
Bausch + Lomb Contacts
Teresa Gatto Panas
Director Global Pharmaceutical Communications
Tel +1(973) 360-6382
Tel +44 (0)20 8781 5709
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
Containers Expo Blog covers the world of containers, as this lightweight alternative to virtual machines enables developers to work with identical dev environments and stacks. Containers Expo Blog offers top articles, news stories, and blog posts from the world's well-known experts and guarantees better exposure for its authors than any other publication. Bookmark Containers Expo Blog ▸ Here Follow new article posts on Twitter at @ContainersExpo
May. 27, 2015 04:00 PM EDT Reads: 987
The Internet of Things is not new. Historically, smart businesses have used its basic concept of leveraging data to drive better decision making and have capitalized on those insights to realize additional revenue opportunities. So, what has changed to make the Internet of Things one of the hottest topics in tech? In his session at @ThingsExpo, Chris Gray, Director, Embedded and Internet of Things, discussed the underlying factors that are driving the economics of intelligent systems. Discover ...
May. 27, 2015 04:00 PM EDT Reads: 6,379
In their general session at 16th Cloud Expo, Michael Piccininni, Global Account Manager – Cloud SP at EMC Corporation, and Mike Dietze, Regional Director at Windstream Hosted Solutions, will review next generation cloud services, including the Windstream-EMC Tier Storage solutions, and discuss how to increase efficiencies, improve service delivery and enhance corporate cloud solution development. Speaker Bios Michael Piccininni is Global Account Manager – Cloud SP at EMC Corporation. He has b...
May. 27, 2015 03:45 PM EDT Reads: 1,113
SYS-CON Events announced today that O'Reilly Media has been named “Media Sponsor” of SYS-CON's 16th International Cloud Expo®, which will take place on June 9–11, 2015, at the Javits Center in New York City, NY. O'Reilly Media spreads the knowledge of innovators through its books, online services, magazines, and conferences. Since 1978, O'Reilly Media has been a chronicler and catalyst of cutting-edge development, homing in on the technology trends that really matter and spurring their adoption...
May. 27, 2015 03:37 PM EDT Reads: 241
In a recent research, analyst firm IDC found that the average cost of a critical application failure is $500,000 to $1 million per hour and the average total cost of unplanned application downtime is $1.25 billion to $2.5 billion per year for Fortune 1000 companies. In addition to the findings on the cost of the downtime, the research also highlighted best practices for development, testing, application support, infrastructure, and operations teams.
May. 27, 2015 03:30 PM EDT Reads: 1,122
SYS-CON Events announced today that BMC will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. BMC delivers software solutions that help IT transform digital enterprises for the ultimate competitive business advantage. BMC has worked with thousands of leading companies to create and deliver powerful IT management services. From mainframe to cloud to mobile, BMC pairs high-speed digital innovation with robust...
May. 27, 2015 03:30 PM EDT Reads: 583
The OpenStack cloud operating system includes Trove, a database abstraction layer. Rather than applications connecting directly to a specific type of database, they connect to Trove, which in turn connects to one or more specific databases. One target database is Postgres Plus Cloud Database, which includes its own RESTful API. Trove was originally developed around MySQL, whose interfaces are significantly less complicated than those of the Postgres cloud database. In his session at 16th Cloud...
May. 27, 2015 03:15 PM EDT Reads: 1,110
The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long development cycles that produce software that is obsolete at launch. DevOps may be disruptive, but it is essential. The DevOps Summit at Cloud Expo – to be held June 3-5, 2015, at the Javits Center in New York City – will expand the DevOps community, enable a wide...
May. 27, 2015 03:00 PM EDT Reads: 1,890
EMC Corporation on Tuesday announced it has entered into a definitive agreement to acquire privately held Virtustream. When the transaction closes, Virtustream will form EMC’s new managed cloud services business. The acquisition represents a transformational element of EMC’s strategy to help customers move all applications to cloud-based IT environments. With the addition of Virtustream, EMC completes the industry’s most comprehensive hybrid cloud portfolio to support all applications, all workl...
May. 27, 2015 03:00 PM EDT Reads: 753
In her General Session at 15th Cloud Expo, Anne Plese, Senior Consultant, Cloud Product Marketing, at Verizon Enterprise, focused on finding the right mix of renting vs. buying Oracle capacity to scale to meet business demands, and offer validated Oracle database TCO models for Oracle development and testing environments. Anne Plese is a marketing and technology enthusiast/realist with over 19+ years in high tech. At Verizon Enterprise, she focuses on driving growth for the Verizon Cloud platfo...
May. 27, 2015 03:00 PM EDT Reads: 5,344
SYS-CON Events announced today that MetraTech, now part of Ericsson, has been named “Silver Sponsor” of SYS-CON's 16th International Cloud Expo®, which will take place on June 9–11, 2015, at the Javits Center in New York, NY. Ericsson is the driving force behind the Networked Society- a world leader in communications infrastructure, software and services. Some 40% of the world’s mobile traffic runs through networks Ericsson has supplied, serving more than 2.5 billion subscribers.
May. 27, 2015 02:00 PM EDT Reads: 1,258
How does one bridge the gap between traditional enterprise storage infrastructures and the private, hybrid, and public cloud? In his session at 15th Cloud Expo, Dan Pollack, Chief Architect of Storage Operations at AOL Inc., examed the workload differences and required changes to reuse existing knowledge and components when building and using a cloud infrastructure. He also looked into the operational considerations, tool requirements, and behavioral changes required for private cloud storage s...
May. 27, 2015 02:00 PM EDT Reads: 2,662
Software is eating the world. Companies that were not previously in the technology space now find themselves competing with Google and Amazon on speed of innovation. As the innovation cycle accelerates, companies must embrace rapid and constant change to both applications and their infrastructure, and find a way to deliver speed and agility of development without sacrificing reliability or efficiency of operations. In her Day 2 Keynote DevOps Summit, Victoria Livschitz, CEO of Qubell, discussed...
May. 27, 2015 02:00 PM EDT Reads: 5,506
The speed of product development has increased massively in the past 10 years. At the same time our formal secure development and SDL methodologies have fallen behind. This forces product developers to choose between rapid release times and security. In his session at DevOps Summit, Michael Murray, Director of Cyber Security Consulting and Assessment at GE Healthcare, examined the problems and presented some solutions for moving security into the DevOps lifecycle to ensure that we get fast AND ...
May. 27, 2015 02:00 PM EDT Reads: 4,866
The 5th International DevOps Summit, co-located with 17th International Cloud Expo – being held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the...
May. 27, 2015 02:00 PM EDT Reads: 4,025