Date: 2015-02-02
Type of information: Licensing agreement
Compound: AzaSite® (1% azithromycin), BromSite™ (0.075% bromfenac), AzaSite Xtra™ (2% azithromycin)
Company: Nicox (France) InSite Vision (USA - CA)
Therapeutic area: Ophtalmological diseases
Type agreement: licensing development manufacturing production commercialisation
Action mechanism: antibiotic. AzaSite®(azithromycin ophthalmic solution) is a macrolide antibiotic indicated in the U.S. for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following microorganisms: CDC cornyeform group G,* Haemophilus influenzae, Staphylococcus aureus, Streptococcus mitis group, and Streptococcus pneumoniae. Here, azithromycin is formulated with InSite Vision patented DuraSite® drug-delivery technology. AzaSite represents the first ophthalmic application of azithromycin. non-steroidal anti-inflammatory drug. BromSite™(ISV-303) is a low dose (0.075%) bromfenac ophthalmic solution formulated in DuraSite® and is being evaluated for the treatment of inflammation and ocular pain in the post-cataract surgery setting.
Disease: bacterial conjunctivitis, treatment of inflammation and prevention of pain after cataract surgery
Details: * On February 2, 2015, Nicox announced the signature of a license agreement with InSite Vision for the development, manufacture and commercialization of InSite’s innovative ophthalmic therapeutics AzaSite® (1% azithromycin), BromSite™ (0.075% bromfenac) and AzaSite Xtra™ (2% azithromycin). All three products are based on InSite’s proprietary Durasite® drug delivery technology, which is designed to extend the duration of a drug in the eye. The agreement grants Nicox exclusive rights to all three products in Europe, Middle East and Africa. European Marketing Authorization Applications (MAAs) for AzaSite® and BromSite™ are expected to be filed by Q1 2016, with the first launch expected in late 2017. AzaSite® (1% azithromycin) is approved in the US and Canada for the treatment of bacterial conjunctivitis and is marketed in the US by InSite’s licensee Akorn Inc. BromSite™ (0.075% bromfenac) has been developed for the treatment of inflammation and prevention of pain after cataract surgery. Based on positive data from two pivotal phase 3 clinical studies, InSite intends to file a New Drug Application (NDA) with the FDA for BromSite™ in the first quarter of 2015. Nicox is planning to target the same ophthalmic indications in Europe, Middle East and Africa for AzaSite® and BromSite™, which would compete in a market estimated to be worth more than €267 million. The companies are evaluating the most appropriate indication and development path for AzaSite Xtra™ (2% azithromycin), which is at an earlier development stage. Nicox will sponsor and manage the further development required for registration of the products in Europe, Middle East and Africa. No further clinical studies are expected to be required prior to filing for AzaSite® and BromSite™. Nicox will have the rights to use data from the AzaSite® US registration and the BromSite™ studies in regulatory submissions for the approval of these products in the territories covered by the agreement. AzaSite Xtra™ is expected to be a co-development project. A joint collaboration and development committee will oversee the development activities. Both companies may also collaborate on developing additional indications for the products.
Financial terms: Under the terms of the agreement, Nicox will make an upfront payment of $3 million and may make further regulatory and commercial milestone payments up to a total of $13.75 million. The financial terms also include tiered, mid-single-digit to double digit royalties.
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