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Thursday, July 4, 2019

Blood pressure drug linked with increased risk of diverticulosis

This condition causes small bulges or pouches to appear in the lining of the intestine. Particularly affecting the elderly (as many as 65 per cent of over 85s may be affected), diverticulosis can in some cases can lead to a medical emergency if the pouches become infected or burst.
The new early-stage research finding comes from a team of scientists led by Imperial College London, who investigated the effectiveness and side effects of three common blood pressure medications: ACE-inhibitors, beta-blockers and .
High blood pressure affects one in ten adults across the globe, and increases the risk of heart attack and stroke. The most common treatments for high blood pressure are  and medications.
However, despite the three main medications being taken by millions, investigating their potential side effects (as well as studying their effectiveness for treating other diseases), can be difficult and often involves lengthy and expensive clinical trials.
To overcome this problem, the research team, led by Imperial’s School of Public Health, used  to study the effects of the drugs.
By investigating versions of genes that mimic the effects of these drugs, the team were able to study the drugs’ effectiveness—and their potential .
First, the researchers, who published their work in the journal Circulation, identified the proteins targeted by the drugs, and which help lower blood pressure. Next, they analysed genetic data from around 750,000 people and identified the so-called genetic variants that code for these proteins.
The team, who included researchers from LMU Munich, then studied whether these gene variants—which cause increased production of these proteins—were linked to an increased or decreased risk of other diseases.
The good news was that, as expected, these so-called genetic variants (which coded for proteins involved in lowering blood pressure) were linked to lower heart disease and stroke risk.
However after assessing the risk of around 900 different diseases—using data from the UK Biobank study—the team found that the versions of genes related to the effects of a particular type of calcium channel blocker—the non-dihydropyridine class, were linked to an increased the risk of a bowel condition called diverticulosis.
The team compared their findings with further , and supported the potential link with an increased risk of the bowel condition.
The link now needs further investigation with larger trials, explains Dr. Dipender Gill, co-lead author of the research from Imperial’s School of Public Health: “This is the first time that this class of blood pressure drug has been associated with diverticulosis. We’re not sure of the underlying mechanism—although it may relate to effects on the function of intestine muscles, which perform contractions to transport food through the gut.”
Dr. Joanna Tzoulaki, senior author from Imperial’s School of Public Health added: “The study of genetic variants that mimic the effect of drugs is evolving as a powerful concept to help prioritise clinical trials and design clinical trials more likely to be successful”.
Dr. Gill cautions the findings should not change current prescribing guidelines and that people should not stop taking their medication unless first consulting their doctor.
He added: “These findings should not change clinical practice, but instead should act as a catalyst for further research.”

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Journal information: Circulation

Vermont places 92 percent tax on E-cigarettes

A  92 percent tax on electronic cigarettes took effect in Vermont on Monday as the state tries to reduce young people’s use of the devices.
That rate means that e-cigarettes will now cost about the same as combustible cigarettes, CBS News reported.
The e-cigarette tax increase bill was sponsored by State Rep. George Till, who said it will help keep the products out of the hands of young people. “We know the group that is most sensitive to price is teenager,” he told CBS News. “And we know that these companies are going out of their way to get kids addicted.”
Two other measures meant to reduce youth smoking also took effect in Vermont on Monday. One raised the legal age for buying and using cigarettes, e-cigarettes, and tobacco products to 21 from 18, and the other restricts retail and online sales of tobacco and related products, CBS News reported. Just last week, San Francisco became the first U.S. city to ban the sale, distribution, and manufacturing of  products.

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More information: CBS News Article

FDA accepts Insys’ NDA for naloxone nasal spray for opioid overdose

The FDA has accepted Insys Therapeutics’ (NASDAQ:INSY) NDA for its investigational, naloxone nasal spray for the emergency treatment of opioid overdose in both adult and pediatric patients.
A single unit dose spray device delivers 8mg naloxone dose.

Morphosys up on €22M milestone from Glaxo

Morphosys AG (NASDAQ:MOR) is up 4% premarket on light volume on the heels of the launch of licensee GlaxoSmithKline’s late-stage program for rheumatoid arthritis med otilimab.
The dosing of the first patient will trigger a €22M milestone payment from GSK. As a result, MOR is boosting its 2019 guidance for revenue to €65M – 72 from €43M – 50M and EBIT loss of (€105M – 115M) from (€127M – 137M). All other guidance remains as is.

Pfizer may trim Prevnar 13 guidance after panel vote – Cantor

Cantor Fitzgerald’s Louise Chen (Overweight/$53) says Pfizer (NYSE:PFE) may cut its sales guidance for pneumonia vaccine Prevnar 13 after the recent vote by the CDC’s Advisory Committee on Immunization Practices (ACIP) backing a revision of vaccination guidelines for adults over the age of 65.
A poll of primary care docs revealed that 41% do not intend to change their usage of Prevnar 13 despite the vote, however.
The vaccine accounted for 11.3% of the company’s Q1 revenues ($1,486M/13,118).
On another note, Ms. Chen believes that sales of Merck’s (NYSE:MRK) HPV vaccine Gardasil 9 could ramp in patients aged 27 – 45 after the ACIP vote, adding that 26% of primary care physicians will “moderately” increase usage. She rates the stock Overweight with a $95 fair value target.
The Quant rating on PFE is Very Bullish while the SA Authors rating is Bullish.

Jazz Pharma to launch Sunosi next week in U.S.

Jazz Pharmaceuticals (NASDAQ:JAZZ) detailed its U.S. commercial launch plan for Sunosi (solriamfetol) yesterday afternoon via a webcast. The FDA approved the dopamine and norepinephrine reuptake inhibitor in March for the treatment of excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA). Key points:
The product will be available at pharmacies next week. Salesforce will begin calling on healthcare providers next week as well.
61% of the 165K narcolepsy patients in the U.S. are undiagnosed. Most of the diagnosed patients are being treated with stimulants (Schedule II drugs) or wake promoting agents (Schedule IV drugs).
About 12M Americans have been diagnosed with OSA. About 6% are being treated with medications. Almost half with excessive daytime sleepiness fail to respond to medications.
The wholesale price (WAC) is $660 for a 30-day supply of either the 75M mg or 150 mg dose.
Revenue assumptions include an increase in the OSA treatment rate from 6% to mid-teens, low-to-mid-single-digit growth rate in diagnosis and mid-to-high teen market share (all by 2025).
2025 sales target: at least $500M.

Annovis Bio readies IPO

Annovis Bio (ANVS) has filed a preliminary prospectus for an $11.5M IPO.
The Berwyn, PA-based company develops treatments for neurodegenerative disorders like Alzheimer’s (AD) and Parkinson’s (PD) diseases.
Lead candidate is orally administered ANVS-401 which, according to the company, inhibits the synthesis of neurotoxic proteins (amyloid beta, tau and a-synuclein) associated with neurodegeneration. A Phase 2a study in AD patients is ongoing. A Phase 2a in PD patients should launch in Q1 2020. By the end of 2024, it expects to have conducted two pivotal trials in AD and PD and to have filed a U.S. marketing application.
2019 Financials (Q1): Operating Expenses: $186.8K (-1.6%); Net Loss: ($190.9K) (-0.5%); Cash Burn: ($228.7K) (-45.8%).