Company Overview of Auven Therapeutics Management L.L.L.P
Auven Therapeutics Management L.L.L.P formerly known as Celtic Therapeutics Holdings L.P. is a private equity firm specializing in acquiring and investing in proprietary therapeutic product candidates (small-molecules and biologics), drug development, and complementary technologies. The firm also invests in developing mid-stage pharmaceutical programs. It acquires ownership of clinical-stage therapeutic assets and potential new products, primarily mid-stage development programs, with all their associated intellectual property and proprietary preclinical and clinical data. Auven Therapeutics Management L.L.L.P was founded in 2007 and is based in Saint Thomas, Virgin Islands, with additional o...
6501 Redhook Plaza
Saint Thomas, VI 00802
Founded in 2007
Key Executives for Auven Therapeutics Management L.L.L.P
Co-Founder and Co-Managing General Partner
Co-Founder and Co-Managing General Partner
Managing Director, Chief Legal Officer, and Chief Administrative Officer
Partner and Managing Director of Investments and Business Development, U.S.
Partner of European Origination and Managing Director of Investments and Business Development, Europe
Compensation as of Fiscal Year 2016.
Auven Therapeutics Management L.L.L.P Key Developments
Auven Therapeutics Announces Completion of Enrollment in Confirmatory Phase 3 Clinical Trial of Seciera (OTX-101) for the Treatment of Dry Eye Disease
Aug 22 16
Auven Therapeutics announced that it has completed patient enrollment in the Phase 3 confirmatory study of Seciera (OTX-101), a novel patented nanomicellar formulation of cyclosporine for the treatment of dry eye disease. The multi-center, randomized, double-blind, placebo-controlled, two-arm, Phase 3 confirmatory trial enrolled 747 patients with confirmed dry eye disease at 47 investigational sites in the U.S. The trial is designed to confirm the significant, clinically meaningful increase in the signs of dry eye disease demonstrated in the previous Phase 2b/3 study. The primary efficacy endpoint is percent of patients with 10mm improvement in tear production (as measured by the Schirmer’s test) compared to placebo. Secondary endpoints include significant reduction in signs of ocular surface inflammation, as measured by conjunctival and corneal staining. In the previous Phase 2b/3 study, Seciera demonstrated robust statistical superiority over placebo-vehicle for the co-primary efficacy endpoint of change from baseline at week 12 in conjunctival lissamine green staining, and in analyses of tear production and fluorescein corneal staining. It also demonstrated excellent safety, comfort and tolerability profiles compared to placebo-vehicle, with more than 90% of patients in all groups completing the 12-week study.
Auven Therapeutics Announces Initiation of Confirmatory Phase 3 Clinical Trial of Seciera (OTX-101) for the Treatment of Dry Eye Disease
Mar 3 16
Auven Therapeutics announced the first patient has been dosed in its Phase 3 confirmatory study of Seciera (OTX-101), a novel patented nanomicellar formulation of cyclosporine for the treatment of dry eye disease. Following several consultations with the U.S. Food and Drug Administration (FDA), this Phase 3 trial has been designed to confirm the significant, clinically meaningful increase in tear production (as measured by the Schirmer’s test) that was demonstrated in the previous Phase 2b/3 study. The large reduction in signs of ocular surface inflammation compared to placebo-vehicle seen in the Phase 2b/3 study will be one of several secondary endpoints in the Phase 3 study. Approximately 700 patients will be enrolled at 51 U.S. trial sites. Auven has commissioned an independent commercial assessment of Seciera including key opinion leader and third-party payor interviews. Auven believes that Seciera will be prescribed for the treatment of moderate to severe dry eye disease by a substantial portion of ophthalmologists and should achieve peak global sales in excess of $1 billion per year.
Auven Therapeutics and Bellus Health Announce Completion of Pivotal Phase 3 Confirmatory Trial of KIACTA for the Treatment of Orphan Disease AA Amyloidosis
Jan 21 16
Auven Therapeutics and BELLUS Health Inc. announced the completion of the KIACTA (eprodisate) Phase 3 confirmatory study for the treatment of AA amyloidosis. Top-line results are expected to be announced in second quarter of 2016 after all remaining patients have completed final study visits, all queries have been resolved based on input from study sites and the database has been locked.
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