Key Developments: Active Biotech AB (ACTI.ST)

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Latest Key Developments (Source: Significant Developments)

Teva Pharmaceutical Industries Ltd and Active Biotech to continue with development of Nerventra for Multiple Sclerosis following confirmation of CHMP Opinion
Friday, 23 May 2014 02:30am EDT 

Teva Pharmaceutical Industries Ltd and Active Biotech:Committee for Medicinal Products for Human Use (CHMP) confirmed Jan. 23, opinion to recommend against approval for treatment of relapsing-remitting multiple sclerosis (RRMS) in European Union (EU) at this time.Both companies remain committed to NERVENTRA (laquinimod) clinical development program for multiple sclerosis (MS) and are focused on evaluating the CHMP feedback to determine potential next steps.To further confirm benefits of NERVENTRA on disability progression, Teva is conducting the CONCERTO trial, MS trial with disability progression as the primary endpoint.Says ongoing CONCERTO trial is third Phase III study in RRMS and explores daily doses of NERVENTRA 0.6 mg and 1.2 mg.In addition, Teva is investigating potential of NERVENTRA in progressive forms of MS.Says first trial for this indication is planned to be initiated soon.  Full Article

Active Biotech AB proposes no dividend for FY 2013
Monday, 14 Apr 2014 02:30am EDT 

Active Biotech AB:Says its board proposes that no dividend be paid for FY 2013.No dividend was paid for FY 2012.  Full Article

Active Biotech says Teva changes clinical development program for laquinimod
Wednesday, 19 Feb 2014 08:00am EST 

Active Biotech AB:Says the company's partner, Teva Pharmaceuticals, has decided not to proceed to the randomization stage of the planned Libretto trial for the treatment of Relapsing Remitting Multiple Sclerosis (RRMS).Says the reason is that the current design is no longer aligned with the regulatory strategy.Says the decision has no impact on other ongoing studies, such as CONCERTO, which are proceeding as planned, or on Teva Pharmaceuticals' plans to initiate clinical studies in Primary Progressive Multiple Sclerosis (PPMS).  Full Article

Teva and Active Biotech to continue development of NERVENTRA despite negative opinion from EMA's CHMP
Friday, 24 Jan 2014 07:03am EST 

Active Biotech AB:Says Teva Pharmaceutical Industries Ltd. and Active Biotech remain committed to the NERVENTRA (laquinimod) clinical development program for multiple sclerosis (MS).Says this statement follows the announcement of a negative opinion for the treatment of relapsing-remitting multiple sclerosis (RRMS) by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).Says CHMP has concluded that the risk-benefit profile of NERVENTRA is not favorable at this time.Says Teva and Active Biotech intend to request a re-examination of the CHMP opinion.  Full Article

Active Biotech AB's Partner Teva Pharmaceutical Industries Ltd Initiates Clinical Trial in Multiple Sclerosis
Monday, 4 Nov 2013 02:30am EST 

Active Biotech AB announced that its partner Teva Pharmaceutical Industries Ltd is to initiate a further clinical trial, LIBRETTO, to evaluate the efficacy, safety and tolerability of two doses of oral laquinimod (0.6 and 1.2 mg/day), compared to interferon beta-1a, in patients with relapsing remitting multiple sclerosis. Primary endpoint of the study will be brain atrophy.  Full Article

Active Biotech AB Receives Tasquinimod Milestone Payment From Ipsen SA For 10TASQ10 Study
Wednesday, 9 Oct 2013 01:36am EDT 

Active Biotech AB and Ipsen SA announced that Active Biotech, under the terms of the co-development and commercialization agreement on the novel candidate drug tasquinimod, has received a milestone payment of EUR12 million from Ipsen. In 2011, Active Biotech and Ipsen entered into a broad partnership for the co- development and commercialization of tasquinimod. Under the terms of the agreement, Active Biotech has granted Ipsen exclusive rights to commercialize tasquinimod worldwide, except for North and South America and Japan, where Active Biotech has retained all commercial and marketing rights. Both companies co-develop tasquinimod for the treatment of metastatic castrate-resistant prostate cancer (mCRPC) and Ipsen is developing tasquinimod also in other cancer indications. Active Biotech is responsible for conducting and funding the Phase III 10TASQ10 pivotal clinical trial and will receive up to EUR200 million (whereof EUR25 million upfront and EUR32 million in milestones have been received so far) upon achievement of clinical, regulatory and commercial milestones. In addition, Ipsen will pay Active Biotech tiered double-digit royalties on all sales of TASQ in Ipsen's territories.  Full Article

Active Biotech AB and Teva Pharmaceutical Industries Ltd Announce Post-Hoc Analyses of Phase III ALLEGRO and BRAVO Studies
Friday, 4 Oct 2013 09:30am EDT 

Active Biotech AB and Teva Pharmaceutical Industries Ltd. announced the presentation of post-hoc analyses of the Phase III ALLEGRO and BRAVO studies supporting that once-daily, oral laquinimod may have an effect on both inflammation and the broader underlying mechanisms associated with disease progression in relapsing-remitting multiple sclerosis. Results from the post-hoc subgroup analysis of pooled data from the Phase III double-blind ALLEGRO and BRAVO studies showed there were some patients who experienced disease progression without experiencing a relapse during the studies. Regardless of treatment arm and despite relapse status, 12% of patients studied experienced disability progression after two years; of those patients who progressed, approximately one-third did not experience a relapse. Results specific to treatment with laquinimod showed that both relapsing and relapse-free patients treated with laquinimod experienced less disease progression than those treated with placebo. Overall, laquinimod reduced three-month confirmed disability progression by 26.7% in relapsing patients (P=0.058) and 38.9% in relapse-free patients (P=0.036) compared to placebo.  Full Article

Active Biotech AB and Teva Pharmaceutical Industries Ltd Publish Pre-Planned Analysis of Phase III ALLEGRO Study
Tuesday, 1 Oct 2013 08:00am EDT 

Active Biotech AB and Teva Pharmaceutical Industries Ltd. announced the publication of a pre-planned analysis of the Phase III ALLEGRO study demonstrating that once-daily oral laquinimod provides a beneficial impact on brain tissue damage, one of destructive aspects of multiple sclerosis. The results showed that when compared with placebo, patients treated with laquinimod experienced decreased rates in brain tissue damage shown by various MRI markers. Specifically, patients receiving laquinimod showed decreased rates of white matter (WM), grey matter (GM) and thalamic atrophy; developed fewer permanent black holes (PBH); and accumulated less damage in normal appearing brain tissue (NABT), WM and GM, when compared to patients receiving placebo. A third Phase III laquinimod trial, CONCERTO, is evaluating two doses of the investigational product (0.6mg and 1.2mg) in approximately 1,800 patients for up to 24 months. The primary outcome measure is the time to confirmed disability progression as measured by the EDSS. The study will also examine the impact of laquinimod on endpoints such as percent change in brain volume, as well as other clinical and MRI markers of disease activity.  Full Article

Active Biotech AB to Present Further Analysis Supporting Effect of ANYARA in Biomarker Defined Subgroup
Thursday, 12 Sep 2013 04:00am EDT 

Active Biotech AB announced that a biomarker trend analysis of overall survival (OS) and Progression Free Survival (PFS) from the ANYARA Phase II/III study in renal cell cancer will be presented at the scientific conference European Cancer Congress 2013 (ECCO-ESMO-ESTRO) held in Amsterdam, the Netherlands, September 27 - October 1. The detailed analysis gives further support to the previous findings that low baseline levels of pre-formed antibodies against ANYARA or low levels of the cytokine IL-6, independently predict anti-tumor efficacy after ANYARA+IFN-alpha treatment. The results also highlight the potential role of IL-6 as a predictive factor for the outcome of immunotherapy of cancer in general. The analysis showed clear trends of increased OS (decreasing Hazard Ratios, HRs) in patients with decreasing IL-6 and anti-ANYARA antibodies. Similar trends were seen for PFS HRs.  Full Article

Active Biotech AB and Teva Pharmaceutical Industries Ltd Announce Positive Results from Phase IIa Study of Laquinimod in Active Lupus Nephritis
Wednesday, 12 Jun 2013 08:00am EDT 

Active Biotech AB and Teva Pharmaceutical Industries Ltd. announce the results of a Phase IIa study of oral laquinimod designed to assess safety, tolerability and clinical efficacy in patients with active lupus nephritis. Treatment with laquinimod provided an additive effect in improving renal function when combined with current standard of care for active lupus nephritis (mycophenolate mofetil and corticosteroids), compared with standard of care alone. Results provide rationale for further studies of laquinimod in active lupus nephritis to confirm the safety and efficacy profile observed in this study. The data will be presented during the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology in Madrid, 12-15 June, 2013 as part of the late-breaking news session.  Full Article

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