Some false info being posted on this board. Info re OX1 as far as I am aware have not disclosed what triggers milestone payments and Orphan may well be applied for after phase 1 completed.
NEW YORK, Sept. 30, 2011 (GLOBE NEWSWIRE) -- Intellect Neurosciences, Inc. (OTCBB:ILNS) announced today that Intellect has granted an exclusive License to ViroPharma Incorporated (Nasdaq:VPHM) regarding certain of Intellect's licensed patents and patent applications related to Intellect's clinical stage drug candidate, OX1, a multimodal, metal-binding, extremely potent antioxidant molecule, which has been demonstrated to protect nerve cells from highly oxidizing neurotoxins. ViroPharma plans to develop and commercialize OX1 as a treatment of Friedreich's Ataxia and possibly other diseases for which OX1 may qualify for orphan drug designation.
Under the terms of the Exclusive License Agreement, Intellect has agreed to transfer to ViroPharma all of Intellect's intellectual property rights, data and know-how related to its OX1 research and development program. In return, ViroPharma has agreed to pay a $6.5 million up-front licensing fee and will pay additional milestones based upon defined events. The maximum of these milestone payments assuming successful advancement to market could amount to $120 million. In addition, ViroPharma will pay a tiered royalty of up to a maximum of low double digits based on annual net sales.
From Annual report, re seeking Orphan designation;
OX1, FA and "Orphan Drugs"
In 2011, we redirected the focus of the OX1 program from Alzheimer's disease to FA. Research suggests that the symptoms
associated with FA are the result of oxidative stress caused by the abnormal accumulation of iron1,2. The Company recognized that OX1's ability to neutralize ROS could be an effective agent to reduce oxidative stress in FA, thereby eliminating the symptoms of FA and increasing both quality of life and longevity in affected individuals.
The Orphan Drug Act provides for granting special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor and satisfaction of certain mandated criteria. In the United States, the Rare Diseases Act of 2002 defines rare disease according to prevalence, specifically "any disease or condition that affects less than 200,000 people in the United States" or about 1 in 1,500 people. Generally, orphan status allows for reduced hurdles and time to regulatory approval, tax credits during development, market exclusivity even after patent expiration (10 years in U.S. and 7 years in Europe) and premium drug prices. We believe it is likely that the FDA would designate FA as an orphan disease and OX1 as an "orphan drug" that could qualify for beneficial treatment, including exclusivity beyond expiration of the OX1 patents in 2019.
Recent Development Progress
In February 2013, ViroPharma filed an investigational new drug application ("IND") to permit initiation of a single ascending dose Phase 1 study to evaluate the safety, tolerability and PK/PD of OX1 (renamed by ViroPharma as "VP 20629") in subjects with FA. The study commenced in the United States in August 2013 and is expected to be completed in November 2014. Details of the study, entitled "A Phase 1, Randomized, Double-blind, Placebo-controlled, Multicenter, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral VP 20629 in Adult Subjects with Friedreich's Ataxia" may be found at: www.clinicaltrials.gov; identifier NCT01898884.
Although there can be no assurance, we anticipate that following completion of the Phase 1 study in November 2014, Shire will review the safety of VP 20629 and its possible effect on plasma/urine biomarkers of oxidative stress and thereby decide whether to move to Phase 2. Indication of positive biomarker effects could result in a decision by Shire to seek Orphan Drug designation for VP 20629. We have no ability to control Shire's decision as to whether to seek such designation.
