Date: 2014-07-17
Type of information: Licensing agreement
Compound: Sjö™ laboratory test
Company: Nicox (France) Immco Diagnostics (USA)
Therapeutic area: Autoimmune diseases - Ophtalmological diseases
Type agreement: commercialisation
Action mechanism: The development of this new diagnostic test is based on the discovery of novel antibodies in Sjögren’s Syndrome by researchers at the University at Buffalo and Immco Diagnostics, Inc.: SP-1 (salivary gland protein-1), CA-6 (carbonic anhydrase-6) and PSP (parotid secretory protein). Traditional tests use ANA, Ro, La and RF antibodies which have significant limitations of sensitivity and/or specificity and are associated with later-stage disease. During studies, these novel antibodies were found in 45% of patients meeting the criteria for Sjögren’s Syndrome who lacked the traditional antibodies for Ro or La. In patients diagnosed with idiopathic xerostomia and xerophthalmia for less than two years, 76% had antibodies to SP-1 and/or CA-6 while only 31% had antibodies to Ro or La3 The new laboratory test developed by Immco is a sensitive and specific diagnostic test combining these biomarkers (SP-1, CA-6, PSP) and the traditional markers (ANA, Ro, La, RF). This breakthrough test can aid in diagnosing Sjögren’s Syndrome at an earlier stage compared to traditional methods therefore significantly improving management of the disease. The test was approved by the appropriate US regulatory authorities in 2013, and is already available to doctors across North America.
Disease: Sjögren’s Syndrome
Details: * On June 19, 2013, Nicox has announced that it has entered into an exclusive agreement with Immco Diagnostics Inc, a leader in autoimmune diagnostic products and services, to promote a proprietary laboratory test targeted at early detection and diagnosis of Sjögren’s Syndrome to eye care professionals in North America. Under the terms of the agreement, Immco will grant Nicox the exclusive rights to promote the laboratory test to eye care practitioners in North America (US, Canada, Puerto Rico, Mexico). Nicox will be responsible for all marketing activities, while Immco will carry out the test in its CLIA-approved laboratory in Buffalo, NY, and be responsible for regulatory activities and reimbursement. Nicox will receive a majority share of revenue generated from eye care practitioners and no upfront or milestones payments will be made by Nicox. Nicox also has a nine month option to negotiate an agreement to promote the test in the rest of the world. During this period, Immco and Nicox are planning to study and evaluate the feasibility and implementation steps for the test in other markets, including Europe.Nicox has significant experience within the ocular surface disease space and ophthalmic diagnostic markets, and recently built its own commercial organization in the US. The Company intends to expand its existing sales organization to maximize the opportunity with this new test alongside AdenoPlus®, the first and only CLIA-waived point-of-care diagnostic test that aids in the differential diagnosis of acute conjunctivitis, and other point-of-care diagnostic tests.
Financial terms:
Latest news: * On July 17, 2014, Nicox announced that it has acquired the extension of the rights to market Sjö™, an advanced diagnostic panel for early detection of Sjögren’s syndrome, to all healthcare practitioners in North America. This builds on the June 2013 agreement with Immco Diagnostics Inc. to promote Sjö™ to eye care specialists in the U.S, Canada,
Mexico and Puerto Rico. Sjö™ was launched by Nicox’s subsidiary, Nicox Inc., in select US markets in November 2013, with a full national roll out of the product now underway. Under the terms of the expanded agreement , Nicox will be responsible for all marketing activities using its existing team, while Immco will carry out the test in its CLIA-approved laboratory in Buffalo, NY,
and be responsible for regulatory activities and reimbursement. The financial terms for Nicox remain unchanged
