Nicox Partners ZERVIATE (TM)in the Gulf and Arab Markets
August 12, 2020 – release at 7:30 am Sophia Antipolis, France Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced the signature of an exclusive license agreement with ITROM Pharmaceutical Group for the registration and commercialization of ZERVIATE (TM)(cetirizine ophthalmic solution), 0.24% for the treatment of ocular itching associated with allergic conjunctivitis in Gulf and Arab markets including the Kingdom of Saudi Arabia, the United Arab Emirates and
Qatar. ITROM is a regional, Dubai-based, internationally recognized pharmaceutical marketing and distribution group of companies specializing in the introduction and representation of breakthrough ophthalmology products since 1999. Gavin Spencer, Chief Business Officer of Nicox, said: “ We are pleased to welcome ITROM as a partner for ZERVIATE as we continue to expand our collaborations globally and increase the value of the ZERVIATE franchise. ITROM has a strong focus in ophthalmology and has successfully
brought other partnered products to the market in the region. They will be able to rely on the U.S. NDA to support their regulatory submission for ZERVIATE and are expected to obtain approvals without the need for further clinical studies. Their broad reach and commercial infrastructure in the region make them an excellent partner for Nicox. ” ITROM is granted exclusive rights to develop and commercialize ZERVIATE in Bahrain, Egypt, Iraq, Jordan, Kuwait, Lebanon, Libya, Oman, Qatar, the Kingdom of Saudi
Arabia, the United Arab Emirates and Yemen. Nicox is eligible to receive 15% royalties on net sales of ZERVIATE in certain key countries, and 10% in other countries. Nicox will also receive a license fee on signature and may receive a future milestone payment upon product launch. ITROM will be responsible, at its own cost, for development and commercialization of ZERVIATE in the countries of the agreement. ZERVIATE is expected to require only the existing approved U.S. New Drug Application (NDA) package to
support approval. About ZERVIATE ZERVIATE (TM)(cetirizine ophthalmic solution), 0.24% is a novel formulation of cetirizine developed and approved for the first time for topical application in the eye for the treatment of ocular itching associated with allergic conjunctivitis. Cetirizine, the active ingredient in ZYRTEC (®), is a second-generation antihistamine (H1 receptor antagonist) that binds competitively to histamine receptor sites. Cetirizine, in approved oral formulations, has a well-characterized
systemic efficacy and safety profile with worldwide exposure resulting from 20 years of oral use. ZERVIATE was developed by Nicox as the first and only formulation of cetirizine for topical application in the eye. ZERVIATE, launched in the United States in March 2020 by Eyevance Pharmaceuticals, Nicox’s exclusive U.S. licensee, is also licensed exclusively to Ocumension Therapeutics in the Chinese and Southeast Asian markets and to Samil Pharmaceutical in South Korea. About Allergic Conjunctivitis
Allergic conjunctivitis occurs when an allergic reaction causes conjunctivitis. Conjunctivitis is an inflammation of the thin layer of tissue that lines the outside of the white surface of the eye and the inner surface of the eyelids. It may affect one or both eyes. The signs and symptoms may include eye redness, excessive watering, itchy burning eyes, discharge, blurred vision and increased sensitivity to light.