Bausch + Lomb Initiates Phase 3 Program for Glaucoma Drug Candidate Licensed From Nicox
January 29, 2013 - Sophia Antipolis, France And Madison, NJ
Bausch + Lomb Initiates Phase 3 Program for Glaucoma Drug CandidateLicensedfrom Nicox
Bausch + Lomb, the global eye health company, and Nicox S.A.(EURONEXT PARIS: COX) today announced that Bausch + Lomb hasinitiated its Phase 3clinical program of latanoprostene bunod (previously known asBOL-303259-X andNCX 116) for the reduction of intraocular pressure (IOP) in patientswithglaucoma or ocular hypertension. Latanoprostene bunod is a nitricoxide-donatingprostaglandin 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 tocompare the efficacy and safety of latanoprostene bunod administered oncedaily(QD) with timolol maleate 0.5% administered twice daily (BID) in loweringIOP inpatients with open-angle glaucoma or ocular hypertension. The primaryendpointof both studies, which will include a combined total of approximately800patients, is the reduction in mean IOP measured at specified time pointsduringthree months of treatment. The Phase 3 studies are pivotal for U.S.registrationand will be conducted in North America and Europe. Additional informationaboutthe studies can be found at www.clinicaltrials.gov.
"There is a need for more effective, safer and better toleratedtherapies tolower IOP," said Robert N. Weinreb, M.D., chairman & distinguishedprofessor ofOphthalmology, University of California San Diego and director,Shiley EyeCenter and Hamilton Glaucoma Center. "The Phase 2b results forlatanoprostenebunod were promising, so it is exciting that this potential newtherapy isnow in pivotal trials."
Bausch + Lomb's decision to proceed with a pivotal Phase 3 programfollowedpositive results with latanoprostene bunod in a Phase 2b trial in 413patientswith elevated IOP due to glaucoma and ocular hypertension. This studyshowedthat latanoprostene bunod consistently lowered IOP in a dose-dependentmanner.All four doses tested in the Phase 2b trial showed greater IOPreductioncompared with Xalatan® 0.005%, with the differences for two of thefour dosesreaching more than 1mmHg (statistical significance: p < 0.01).
"Bausch + Lomb believes that latanoprostene bunod has the potential tobecome animportant new treatment option for people suffering from elevated IOPdue toglaucoma and ocular hypertension," said Cal Roberts, M.D. executivevicepresident and chief medical officer, Bausch + Lomb. "We lookforward tocompleting this pivotal research program, and hope to develop aneffective newtreatment option to benefit physicians and the patients they serve.""Latanoprostene bunod is a nitric oxide-donating compound which wasdiscoveredin our Research Laboratories in Milan and is the first Nicox programlicensed toa partner to enter into Phase 3," said Michele Garufi, chairman andCEO ofNicox. "We are pleased with Bausch + Lomb's commitment to pursuing thisprogramin an area of significant therapeutic need. The whole Nicox team hascontributedto this important milestone which underlines the potential of ourresearchplatform in the ophthalmic field."
Nicox and Bausch + Lomb Worldwide Licensing Agreement
In March 2010, Bausch + Lomb signed a worldwide licensing agreement withNicoxfor latanoprostene bunod, and made an initial license payment of $10million. Inlight of the positive results of the Phase 2b study completed in 2011,Bausch +Lomb made an additional $10 million milestone payment in April 2012followingtheir decision to pursue further development of latanoprostene bunod. Ifcertainregulatory, commercialization and sales milestones for latanoprostenebunod aremet, Nicox stands to receive from Bausch + Lomb additional potentialpaymentswhich, over time, could total $162.5 million. Nicox will also receivetiereddouble-digit royalties on the sales of latanoprostene bunod and has theoptionto co-promote the product in the United States.
Glaucoma is a group of eye diseases which can lead to the loss ofperipheralvision and eventually total blindness. Glaucoma is frequentlylinked toabnormally high pressure in the eye (intraocular pressure, IOP), due toblockageor malfunction of the eye's drainage system. Abnormally high IOP does notcauseany symptoms itself, however it can lead to optic nerve damage and visionlossif left untreated. Drug therapy is used to reduce IOP and thereforepreventfurther vision loss, typically through increasing the drainage ofintraocularfluid by relaxing certain muscles in the eye. Several large trialshavedemonstrated that reducing IOP can prevent the progression of glaucoma inbothearly and late stages of the disease. A significant proportion of patientswithelevated IOP require more than one medication to maintain their IOPwithintarget levels, highlighting the need for more effective treatments.
About Bausch + Lomb
Bausch + Lomb is one of the best-known and most respected healthcarecompaniesin the world. Its core businesses include contact lenses and lens careproducts,ophthalmic surgical devices and instruments, and ophthalmicpharmaceuticals.Founded in 1853, the company is headquartered in Rochester, NY, andemploysroughly 11,000 people worldwide. Its products are available in more than100countries. More information is available at www.bausch.com.
Nicox (Bloomberg: COX:FP, Reuters: NCOX.PA) is creating a newmid-sizedinternational player in the ophthalmic market by building adiversifiedportfolio of innovative therapies and diagnostic tools. With aheritage ofscientific, business development and commercial expertise, the Nicoxteam isfocused on developing and marketing novel pharmaceuticals and diagnosticdevicesthat can help people to enhance their sight. In the United States, NicoxmarketsAdenoPlus, a test for the differential diagnosis of acuteconjunctivitisin-licensed from RPS®.
The Company's pipeline includes latanoprostene bunod, a noveldrug-candidatebased on Nicox's proprietary nitric oxide (NO)-donating R&D platform,developedin collaboration with Bausch + Lomb for the potential treatment ofglaucoma andocular hypertension. Further NO-donating compounds are under development innon-ophthalmic indications, notably through partners, including Merck(known as MSDoutside 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 visitwww.nicox.com.
This press release contains certain forward-looking statements.Although theCompany believes its expectations are based on reasonable assumptions,theseforward-looking statements are subject to numerous risks anduncertainties,which could cause actual results to differ materially from thoseanticipated inthe forward-looking statements.
Risks factors which are likely to have a material effect on Nicox'sbusiness arepresented in the 4th chapter of the « Document deréférence, rapport financierannuel et rapport de gestion 2011 » filed with the FrenchAutorité des MarchésFinanciers (AMF) on February 29, 2012 and available on Nicox'swebsite(www.nicox.com) and on the AMF's website www.amf-france.org).
Bausch + Lomb - Nicox: Phase 3 Program Initiation:
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