Starboard Acquires Stake in Perrigo- Hedge fund Starboard Value has taken a 4.6% stake in Perrigo (PRGO). The hedge fund is also urging Perrigo to refocus on its core business by selling non-core assets and also exploring other alternatives. The activist fund has criticized PRGO for failing to live up to the performance targets it set. Perrigo issued a statement, saying it would review the letter from the fund and looks forward to having a constructive and productive dialogue.
Amarin’s REDUCE-IT CV Outcomes Study to Continue As Planned- Amarin (AMRN) announced that its cardiovascular (CV) outcomes study, REDUCE-IT, assessing whether Vascepa (icosapent ethyl) reduces CV events in patients with elevated triglyceride levels and other CV risk factors despite being on stabilized statin therapy, will continue as planned. The decision was based on the recommendation of the independent Data Monitoring Committee after its review of the first pre-specified interim efficacy analysis.
Celgene’s Crohn Disease Candidate Shows Encouraging Results in Early-Stage Study- Celgene (CELG) announced interim top-line data from an exploratory study evaluating the effects of its GED-0301 (mongersen) on endoscopic and clinical outcomes in Crohn's disease patients. The data showed positive effects after a 12-week treatment period. he primary endpoint was an assessment of GED-0301 on endoscopic outcomes as measured by the change from baseline in a scale called SES-CD (Simplified Endoscopic Activity Score for Crohn's disease) at Week 12. The results showed endoscopic improvement (at least a 25% improvement from baseline) in a proportion of patients and clinical response and remission across all treatment groups at Week 12.
Geron Tumbles on Uncertainties Over Imet Studies- Geron Corporation (GERN) shares tumbled almost 20% on Monday following an update on two clinical trials being conducted by collaboration partner and licensee Janssen (JNJ) evaluating imetelstat in certain blood disorders. The first trial, IMbark, is a Phase 2 study assessing two dosages of imetelstat (4.7 mg/kg and 9.4 mg/kg) in ~200 patients with intermediate/high risk myelofibrosis (MF) who have relapsed or did not respond to prior treatment with a JAK inhibitor. To date, over 90 subjects have been enrolled in the two arms. The 4.7 mg/kg dose has not demonstrated an acceptable amount of activity so the arm will be closed to further enrollment. Enrollment in the 9.4 mg/kg arm will continue. The minimum number of patients needed for the Week 12 analysis was not met so the analysis will be done on 24-week data instead. Janssen will conduct an additional internal data review in Q2 2017. The second trial, IMerge, evaluating imetelstat in patients with low/intermediate risk myelodysplastic syndromes who have relapsed or failed to respond to an erythropoiesis stimulating agent, will continue unmodified. Janssen will conduct another assessment in Q2 2017.
Foamix Pharma’s FMX103 Succeeds in Mid-Stage Study- Foamix Pharmaceuticals (FOMX) announced that a Phase 2 trial evaluating FMX103 for the treatment of moderate-to-severe papulopustular rosacea (PR) met its primary and secondary endpoints showing a statistically significant reduction in inflammatory lesions compared to vehicle. The primary endpoint was the absolute change from baseline in inflammatory lesion count at Week 12. The mean reductions in lesion count for the 1.5% concentration, 3.0% concentration and vehicle (control) were 21.1, 19.9 and 7.8, respectively (p<0.001). The percent reductions were 61.4%, 55.5% and 29.7%, respectively (p<0.001). Both doses of FMX103 were also statistically significantly better than vehicle in reducing IGA score by two grades and in reaching "clear" (score = 0) or "almost clear" (score = 1) at Week 12 (p<0.01 and p<0.05, respectively).
Eyegate Earns Milestone Payment from Valeant- Eyegate Pharmaceuticals (EYEG) announced that it has earned another milestone payment from Valeant Pharmaceuticals (VRX). The company is eligible to eceive up to $32.5M in milestones under its July 2015 agreement for uveitis. It earned its first milestone in March.
Janssen Files MAA For Single Tablet HIV Regimen- Janssen (JNJ) announced that its European unit Janssen-Cilag International NV has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of a once-daily single-tablet regimen for the treatment of HIV-1 infection in patients at least 12 years old with a minimum body weight of 40 kg. The therapy consists of darunavir 800 mg, cobicistat 150, emtricitabine 200 mg and tenofovir alafenamide (TAF) 10 mg in a single tablet. Darunavir is a protease inhibitor, cobicistat a pharmacokinetic enhancer, emtricitabine a nucleoside reverse transcriptase inhibitor and TAF. Janssen licensed the latter three from Gilead Sciences (GILD) in December 2014 for a single-tablet regimen.