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Wednesday, December 18, 2019

Glaxo’s Benlysta successful in lupus nephritis study

GlaxoSmithKline (GSK +0.3%announces positive results from a Phase 3 clinical trial, BLISS-LN, evaluating Benlysta (belimumab) in patients with active lupus nephritis (LN), kidney inflammation caused by systemic lupus erythematosus (SLE), a condition occurring in up to 60% of SLE sufferers.
The study met the primary endpoint showing a statistically significantly greater proportion of patients treated with Benlysta + standard-of-care (SOC) therapy achieving renal response at week 104 compared to those receiving placebo + SOC (43% vs. 32%, p=0.0311).
Key secondary endpoint was also met.
Complete results will be submitted for presentation at future medical conferences and publication.
The company plans to file regulatory applications in H1 2020.
The FDA approved Benlysta for SLE in May 2011.

Seattle Genetics nabs accelerated review in U.S. for HER2+ breast cancer

The FDA designates Seattle Genetics’ (SGEN +0.1%) tucatinib, combined with Roche’s (OTCQX:RHHBY +0.6%) Herceptin (trastuzumab) and chemo agent capecitabine, a Breakthrough Therapy for the treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including those with brain metastases, who have been treated with trastuzumab, pertuzumab, and T-DM1.
Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.
Tucatinib is a tyrosine kinase inhibitor highly selective for HER2 while avoiding significant inhibition of EGFR (associated with significant toxicities).
The company expects to file a U.S. marketing application next quarter.

Twist Bio down 4% on bearish report

Thinly traded Twist Bioscience (TWST -4.2%) slips on 50% higher volume, a modest 340K shares, in apparent response to a report by The Friendly Bear who sees 50% downside ($13) from yesterday’s close citing potential penalties from an intellectual property theft lawsuit brought by Agilent (A -0.4%) who has a consistent track record of winning this type of case.
Agilent filed a whistleblower complaint with the SEC the day before Twist’s IPO.

Akorn adds to selloff, down 21%

Akorn (AKRX -21.1%) slumps on more than triple normal volume. Shares have sold off more than 32% since Monday when it announced an extension of its standstill agreement with lenders until February 7, 2020, to allow more time for it to evaluate strategic alternatives aimed primarily at addressing litigation-related liabilities. Investors appear wary that it may file for bankruptcy protection.

AbbVie’s Rinvoq OK’d in Europe for rheumatoid arthritis

As expected, the European Commission approves AbbVie’s (ABBV -1%) Rinvoq (upadacitinib) for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis who have not responded adequately to or who are intolerant of one or more disease-modifying anti-rheumatic drugs (DMARDs).
In October, the advisory group CHMP adopted a positive opinion backing approval.

White House releases plan allowing drug imports from Canada

The Trump administration has announced pilot project allowing states and non-federal government entities to import certain medicines from Canada which pays much lower prices under its single-payer system.
Eligible drugs for importation must be approved for sale in Canada and will require retesting and relabeling to ensure quality. Controlled substances, biologics, injectables and high-risk (REMS) medications are excluded.
About a dozen states have expressed a keen interest in sourcing drugs north of the border.
Another provision would allow a domestic drugmaker to import its own product from Canada.
A major hurdle is the Canadian government which has repeatedly stated that its market is too small to accomodate U.S. demand.

Another warning for e-cigarette users that has nothing to do with lung disease

There’s more evidence that e-cigarettes may be bad for your health.
Smoking e-cigarettes increases the risk of heart disease — elevating bad cholesterol, triglycerides and glucose levels, and decreasing blood flow in the heart — and is also associated with coronary vascular dysfunction, according to two separate studies that will be presented at the American Heart Association’s Scientific Sessions, an annual meeting focused on shaping the future of cardiovascular science and medicine, in Philadelphia from Nov. 16 to Nov. 18.
Bad cholesterol was higher in people who only smoked e-cigarettes compared to nonsmokers.
More than 2,000 Americans who use e-cigarettes have become sick since March, many of them teenagers and young adults, and at least 40 people have died. The bulk of the cases occurred in August and September but new cases are still being reported, the Associated Press reported; THC, the psychoactive component in marijuana, was found in most samples tested by the Food and Drug Administration. The Centers for Disease Control and Prevention on Friday identified vitamin E acetate, a chemical added to vaping fluid, as a “very strong culprit of concern” in the illnesses.
“There is no long-term safety data on e-cigarettes,” said Rose Marie Robertson, the American Heart Association’s deputy chief science and medical officer. “However, there are decades of data for the safety of other nicotine replacement therapies.” Bad cholesterol, or low-density lipoproteins, was higher in sole e-cigarette users compared to nonsmokers.
Juul did not respond to a MarketWatch request for comment.
Researchers evaluated healthy adults (ages 21 to 45) without existing cardiovascular disease who were taking no daily medications. The study’s 476 participants included 94 non-smokers, 45 e-cigarette smokers, 52 e-cigarette and tobacco cigarette smokers, and 285 tobacco cigarette smokers. Analysis was adjusted for age, race, sex, and non-smokers, and whether people smoked traditional and/or e-cigarettes.
“The best option is to use FDA-approved methods to aid in smoking cessation, along with behavioral counseling,” said the study’s author Sana Majid, a postdoctoral fellow in vascular biology at the Boston University School of Medicine. The American Heart Association Tobacco Center for Regulatory Science provided research materials for the study, and it was funded by the National Heart, Lung, and Blood Institute and the FDA Center for Tobacco Products.

In a separate study to be released at the same conference this week, researchers analyzed heart blood flow, a measure of coronary vascular function, of 19 young-adult smokers (ages 24 to 32) immediately before and after smoking either e-cigarettes or tobacco cigarettes. They examined coronary vascular function while participants were at rest and after performing a hand-grip exercise to simulate physiologic stress.
These studies could be worrying news for e-cigarette users, especially those who are starting young.
There have been at least half a dozen vaping-related deaths reported in Illinois, Indiana, Kansas, Minnesota and Oregon and, most recently, California. At least 380 cases of the lung illness had been reported in 36 states and the U.S. Virgin Islands as of September, according to the Centers for Disease Control and Prevention.
This could be worrying news for e-cigarette users, especially those who are starting young. Nearly 28% of high schoolers and 11% of middle schoolers this year reported e-cigarette use within the past 30 days, a National Youth Tobacco Survey concluded. More than half of those current e-cigarette users said that Juul was their usual brand, according to the research, which was funded by the FDA and CDC.