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News breaking: 2018-01-09

Novaliq sticht dochteronderneming in de Verenigde Staten in Cambridge, Massachusetts, voor versterkte aanwezigheid op groeiende Amerikaanse oogheelkundemarkt

Organisatie in de Verenigde Staten komt onder leiding van Bernhard Günther, oprichter en CIO van Novaliq

HEIDELBERG, Duitsland–(BUSINESS WIRE)– Novaliq GmbH, een gespecialiseerd farmaceutisch bedrijf met een revolutionair platform voor medicijntoediening dat slecht oplosbare geneesmiddelen verandert in effectieve oogheelkundige therapieën, heeft vandaag de oprichting van een nieuwe dochteronderneming bekendgemaakt, Novaliq Inc. Het nieuwe bedrijf vestigt zich in Cambridge in de Amerikaanse staat Massachusetts.

Als opkomende pionier in oogheelkunde voert Novaliq momenteel twee vergevorderde onderzoeken uit in de Verenigde Staten:

1. Fase 2b/3 van het onderzoek ESSENCE  (NCT 03292809) is een cruciaal gerandomiseerd, dubbel gemaskeerd, vehikel-gecontroleerd onderzoek in meerdere centra voor een beoordeling van de veiligheid, effectiviteit en verdraagbaarheid van topische CyclASol® voor de behandeling van droge ogen. CyclASol® vertoonde in Fase 2 in de Verenigde Staten een betere effectiviteit en verdraagbaarheid in vergelijking met Restasis™ dat als goudstandaard geldt.

2. Het klinische onderzoek SEECASE van Novaliq (NCT 03333057) is een gerandomiseerd, dubbel gemaskeerd, met saline gecontroleerd tweedefaseonderzoek in meerdere centra voor de beoordeling van de effecten van NOV03 in twee verschillende doseringen op symptomen van evoparotieve droge ogen. NOV03 is mogelijk het eerste medicijn tegen droge ogen dat functiestoornissen aan de klieren van Meibom en droge ogen door verdamping aanpakt.

 

Novaliq Establishes U.S. Subsidiary in Cambridge, Massachusetts to Strengthen Its Presence in the Growing U.S. Eye Care Market

U.S. Organization will be headed by Novaliq’s founder and current CIO, Bernhard Günther

HEIDELBERG, Germany–(BUSINESS WIRE)– Novaliq GmbH, a specialty pharmaceutical company with a disruptive drug delivery platform that transforms poorly soluble drugs into effective therapeutics for ophthalmology, today announced the formation of its new subsidiary, Novaliq Inc., which will be located in Cambridge, Massachusetts, U.S.

As an emerging leader in the field of ophthalmology, Novaliq is currently pursuing two late-stage clinical trials in the United States:

Novaliq’s ESSENCE phase 2b/3 clinical trial (NCT 03292809) is a pivotal randomized, double-masked, vehicle-controlled, multi-center trial, designed to evaluate the safety, efficacy and tolerability of topical CyclASol® for the treatment of dry eye disease (DED). CyclASol® has demonstrated better efficacy and tolerability versus current gold-standard Restasis™ in a US Phase 2 trial.

Novaliq’s SEECASE clinical trial (NCT 03333057) is a phase 2, multi-center, randomized, double-masked, saline-controlled study to evaluate the effect of NOV03 at two different dosing regimens on the signs and symptoms of evaporative DED. NOV03 is potentially the first DED drug treatment addressing Meibomian gland dysfunction (MGD) and evaporative-caused DED.

The new Cambridge-based office will be headed by Novaliq’s founder and current chief innovation officer (CIO), Bernhard Günther. Mr. Günther will build the new U.S. organization to leverage the advantages and the potential of the water-free EyeSol® drug delivery technology and innovative products in the U.S. Novaliq Inc. is a 100% subsidiary of Novaliq GmbH.

“Over the past two years, Novaliq has gained significant momentum,” says Mr. Günther. “With the opening of our new U.S. subsidiary, we can better serve the important and growing U.S. eye care market. I am excited to take on this new challenge and to lead the internationalization of the Novaliq group.”

“As a leader in DED with first and best-in-class products, we see our role in redefining how this disease is treated,” says Christian Roesky, PhD, CEO of Novaliq GmbH. “In the U.S., more than 16 million patients are diagnosed with DED; however, only approximately 10 percent are being treated. This significant gap is a clear indication that new DED therapies are needed. A strong presence in the United States will assist us to better serve this vital pharma market.”

About Novaliq – Founded in 2007, Novaliq GmbH is a Heidelberg-based specialty pharmaceutical company focused on ophthalmology. Its mission is to transform poorly soluble drugs into effective ocular therapeutics for both the front and the back of the eye. Novaliq’s proprietary EyeSol® technology enhances the topical bio-availability, stability and safety of traditionally insoluble or unstable drugs improving the delivery, efficacy and convenience of treatments for ocular surface diseases, including dry eye through preservative-free and multi-dose formulations. Novaliq has developed a tiered and long-term sustainable dry eye family of truly differentiated products that addresses the different needs of dry eye patients. The company’s most advanced products are NovaTears® with CE-approval marketed under the brand name EvoTears® in Europe, and NovaTears®+Omega-3, which was just recently CE-approved in Europe. CyclASol®, a second-generation prescription drug, is currently in pivotal phase of clinical development. More on www.novaliq.com

View source version on businesswire.com: http://www.businesswire.com/news/home/20180108006259/en/

Contacts

For US:

Michael O’Rourke + 1 813 323 1438

Strategic Consultant

mrourke@novaliq.com

or

For EU/Asia:

Heidrun Kirsch + 49 6221 50259 243

VP Marketing

hkirsch@novaliq.com

 

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