Sol-Gel Technologies Ltd. shares SLGL, +13.16% soared 9.5% in premarket trade Monday, after the company said that two late-stage trials of a treatment for papulopustular rosacea produced positive results. The Israeli company said the trials evaluating Epsolay(R) microencapsulated benzoyl peroxide cream, 5%, made with the company’s proprietary microencapsulation technology, met its main goals. Epsolay showed statistically significant improvement in both primary endpoints of the number of patients achjieving “clear” or “almost clear” in the Investigator Global Assessment (IGA) and absolute mean reduction from baseline in inflammatory lesion count, the company said in a statement. Papulopustular rosacea is a chronic inflammatory skin disorder that affects nearly 5 million Americans. Symptoms include redness on the cheeks, nose, chin or forehead and over time, it can cause pimples, burning, stinging, dry skin, plagues and skin thickening. Shares have gained 51.5% in 2019, while the S&P 500 SPX, -0.60% has gained 19.3%
Monday, July 8, 2019
U.S. looks to extradite Chinese researcher in GSK trade secrets case
The U.S. wants Switzerland to hand over a Chinese scientist accused of helping his sister steal trade secrets from GlaxoSmithKline, Reuters reported on Monday. Gongda Xue allegedly received those secrets from his sister, conducted tests at his workplace in Basel and sent the results to associates in China.
Swiss authorities arrested Xue in May and are keeping him in custody while they mull the extradition request, Reuters reported. He is fighting extradition and considered a potential flight risk, according to a Swiss Federal Criminal Court Verdict.
Xue’s sister, Yu Xue, worked at GSK’s R&D unit in Pennsylvania from 2006 to 2016, when charges were brought and the Big Pharma fired her. She pleaded guilty last August to attempting to steal confidential research and funnel it to accomplices in China.
Yu Xue sent her own research and that of other GSK scientists to her personal email address, as well as to associates who founded Nanjing, China-based Renopharma, the Department of Justice said in a statement at the time. She did so between Jan. 1, 2012 and Dec. 28, 2015, according to the complaint.
The indictment, brought in January 2016, also implicated Yu Xue’s twin sister, Tian Xue, who was accused of hiding advances paid by Renopharma to Yu Xue.
As for where their brother fits in, Gongda Xue allegedly received trade secrets from Yu Xue relating to “involved antibodies that bind to tumor cells and kill them,” Reuters reported. He performed tests at Friedrich Miescher Institute for Biomedical Research, where he worked until 2014, and then passed results on to conspirators in China.
“Gongda Xue knowing received, bought, and possessed a trade secret belonging to GSK…knowing it to have been stolen…with the intent to convert that trade secret…to the economic benefit of someone other than GSK,” said one U.S. charge, according to Reuters.
BioLife Solutions to acquire SAVSU Technologies
BioLife Solutions (BLFS +1.5%) exercised its option to acquire the remaining 56% stake in privately held SAVSU Technologies in exchange for 1.1M BioLife shares.
The acquisition broadens BioLife’s bioproduction tools portfolio and increases its footprint and engagement level in its customers’ cell and gene therapy manufacturing, storage and distribution workflows.
The company will revise its financial outlook during Q2 2019 earnings call, scheduled on August 8, 2019
Bayer’s Xarelto successful in pediatric study
Results from a Phase 3 clinical trial, EINSTEIN-Jr., evaluating a body weight-adjusted 20 mg equivalent dose of Bayer’s (OTCPK:BAYRY) blood thinner XARELTO (rivaroxaban) in children from birth to age 17 for the prevention of recurrent venous thromboembolism (VTE) showed comparable efficacy and safety to studies in adults. The data were presented at the International Society on Thrombosis and Hemostasis Congress in Melbourne.
Only 1.2% (n=4/335) of treated children experienced recurrent VTE compared to 3.0% (n=5/165) in those receiving standard-of-care (SOC) treatment (heparin alone or with a vitamin K antagonist).
The rate of clinically relevant bleeding in the treatment group was 3.0% (n=10/335) versus 1.9% (n=3/158) in the SOC arm.
A marketing application in Europe for the expanded use is next up.
ViiV launches U.S. study on implementing monthly HIV treatment
ViiV Healthcare commences a U.S.-based study, CUSTOMIZE, aimed at identifying and assessing the best ways to implement a once-monthly injectable treatment for HIV infection into clinical practice. The goal is to find the most practical and efficient ways to manage monthly treatment.
In April, ViiV submitted its marketing application to the FDA seeking approval for its once-monthly two-drug HIV regimen of cabotegravir and Janssen’s rilpivirine. The agency’s action date under Priority Review status is December 29.
ViiV Healthcare is the HIV-focused joint venture between GlaxoSmithKline (GSK -0.5%), Pfizer (PFE -1.3%) and Shionogi (OTCPK:SGIOY -3.1%).
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