Mylan and Biocon launch Semglee in U.S.

Mylan N.V. (NASDAQ:MYL) and Biocon Biologics India, a subsidiary of Biocon Ltd. (OTC:BCNQY), announce the U.S. launch of Semglee (insulin glargine injection) in vial and pre-filled pen to help control high blood sugar in adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes. It is not recommended for the treatment of diabetic ketoacidosis.

FDA approved Semglee has an identical amino acid sequence to Sanofi’s Lantus.

Mylan is offering Semglee at a wholesale acquisition cost (WAC) of $147.98/package of five 3ml pens and $98.65 per 10ml vial, representing the lowest WAC for any long-acting insulin glargine on the market.

Additionally, Mylan has submitted to the FDA all necessary documentation to request approval of Semglee as a biosimilar to Lantus under the 351(k) pathway and remains confident in seeking an interchangeability designation.

Sanofi’s total IQVIA sales for the 12 months ending June 30 were ~$1.64B for Lantus 100 Units/mL Vial and ~$4.36B for Lantus SoloSTAR Pen.

https://seekingalpha.com/news/3610001-mylan-and-biocon-launch-of-semglee-in-u-s

Amgen Repatha has positive effect in kids with inherited high cholesterol disorder

A Phase 3b clinical trial, HAUSER-RCT, evaluating Amgen’s (NASDAQ:AMGN) Repatha (evolocumab) in pediatric patients aged 10-17 years old with heterozygous familial hypercholesterolemia (HeFH) showed that the addition of the PCSK9 inhibitor to statins and other lipid-lowering therapies significantly reduced LDL-C (“bad” cholesterol) compared to placebo. The data were virtually presented at the European Society of Cardiology Annual Meeting and published in The New England Journal of Medicine. 

The study met the primary endpoint demonstrating a statistically significant 38.3% average relative reduction from baseline in LDL-C compared to control. The absolute mean reduction in LDL-C was 68.6 mg/dL (the eligibility criterion for trial was a minimum of 130 mg/dL).

The FDA approved Repatha five years ago for adults with HeFH.

https://seekingalpha.com/news/3610011-amgens-repatha-shows-positive-effect-in-kids-inherited-high-cholesterol-disorder

Can-Fite on go with mid-stage study of Piclidenoson for COVID-19

The FDA has signed off on a Phase 2 clinical trial evaluating Can-Fite BioPharma’s (NYSEMKT:CANF) lead drug Piclidenoson for the potential treatment of COVID-19.

Enrollment will now proceed with the 40-subject 28-day study.

The primary endpoints are safety, the proportion of patients alive and free of respiratory failure at day 29 and the proportion of patients discharged from the hospital at day 29 without the need for supplemental oxygen.

The stock has been underperforming the Nasdaq Composite this year so positive results should give it a lift.

https://seekingalpha.com/news/3610015-can-fite-on-go-mid-stage-study-of-piclidenoson-for-covidminus-19

Lilly’s Jardiance lowers cardiovascular risk in heart failure patients

Following up on their initial announcement a month ago, Eli Lilly (NYSE:LLY) and commercialization partner Boehringer Ingelheim report full results from the Phase 3 EMPEROR-Reduced study evaluating type 2 diabetes med Jardiance (empagliflozin) in patients with chronic heart failure with reduced ejection fraction with or without diabetes. The data were virtually presented at the European Society of Cardiology Annual Meeting.

The study met the primary endpoint demonstrating a statistically significant 25% relative risk reduction in the composite of cardiovascular (CV) death or hospitalization due to heart failure, when added to standard-of-care treatment, compared to placebo.

The SGLT2 inhibitor has Fast Track status in the U.S. for reducing the risk of CV death and hospitalization in heart failure patients.

https://seekingalpha.com/news/3610027-lillys-jardiance-lowers-cardiovascular-risk-in-heart-failure-patients

BioCryst Pharmaceuticals up on orphan drug tag for BCX9930

BioCryst Pharmaceuticals (NASDAQ:BCRX) +5% as U.S. FDA approves orphan drug designation for its oral Factor D inhibitor, BCX9930, for the treatment of paroxysmal nocturnal hemoglobinuria. Additionally, FDA has also granted fast track designation for BCX9930 in PNH.

Orphan Drug designation qualifies BCX9930 for various development incentives, including tax credits for certain clinical costs, a waiver of the new drug application fee and a designated period of market exclusivity following approval.

https://seekingalpha.com/news/3610031-biocryst-pharmaceuticals-up-12-premarket-on-orphan-drug-tag-for-bcx9930

NGM Bio’s aldafermin shows positive effect in advanced NASH

Thinly traded NGM Biopharmaceuticals (NASDAQ:NGM) perks up 4% premarket on light volume in reaction to final data from Cohort 4 of the 24-week Phase 2 clinical trial evaluating aldafermin 1 mg in patients with nonalcoholic steatohepatitis (NASH). This group consisted of NASH patients with stage 3 (advanced) fibrosis.

30% of these patients receiving aldafermin 1 mg experienced more than a one-stage improvement in fibrosis without worsening of NASH compared to 0% in the control arm.

An analysis of the responders who achieved at least a 30% reduction in liver fat content (LFC) showed that 46% experienced at least on one-stage improvement in fibrosis without worsening of NASH compared to 0% for placebo.

Aldafermin (formerly NGM282) is an engineered variant of a hormone called fibroblast growth factor 19 (FGF19) secreted by the gall bladder that plays a key role protecting the liver.

https://seekingalpha.com/news/3610045-ngm-bios-aldafermin-shows-positive-effect-in-nash-patients-advanced-disease

Vir Biotech rallies on advance of antibody for early treatment of COVID-19

Vir Biotechnology (NASDAQ:VIR) and COVID-19 collaboration partner GlaxoSmithKline (NYSE:GSK) announce the commencement of dosing in a Phase 2/3 clinical trial, COMET-ICE, evaluating VIR-7831 (also known as GSK4182136) for the early treatment of the respiratory infection in patients at high risk of hospitalization.

Preliminary data may be available in Q4. Complete results are expected in Q1 2021. If positive, early access to treatment could happen in H1 2021.

VIR-7831 is a fully human anti-SARS-CoV-2 neutralizing monoclonal antibody that binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (SARS). The companies say that it has been engineered to enhance bioavailability in the lung with an extended half-life which could enable it to work as a prophylactic vaccine in addition to a therapeutic.

https://seekingalpha.com/news/3610062-vir-biotech-rallies-on-advancement-of-anti-sars-covminus-2-antibody-for-early-treatment-of