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Friday, June 7, 2019

Drugstores Often Don’t Have Opioid Antidote in Stock

Even though the drug naloxone can be a lifesaving antidote to an opioid overdose, researchers in Philadelphia report that only a third of drugstores in that city carried it.
What’s more, although Pennsylvania’s standing order law for naloxone (common brand name: Narcan) allows pharmacists to dispense the drug without a doctor’s prescription, many pharmacies refused to give the nasal spray without a doctors’ OK, the study authors said.
The intent of the law was to encourage pharmacists to give the drug to anyone who asked for it. The impetus for the law was to try to curb the growing number of deaths from opioid overdoses.
Not implementing these laws puts unnecessary barriers in the way of those who need this medicine most, said study co-author Dima Qato, an associate professor of pharmacy systems, outcomes and policy at the University of Illinois at Chicago College of Pharmacy.
“Efforts to strengthen the implementation of naloxone access laws, including statewide standing orders, which are considered the least restrictive, are warranted,” Qato said in a university news release. “Particularly for pharmacies located in communities with the highest rates of death due to opioid overdose.”
For the study, researchers surveyed Philadelphia drugstores by phone in 2017.
Of the more than 400 drugstores surveyed, only 34% had naloxone available. Chain pharmacies were more likely to stock it than independent ones.
Naloxone was also less likely to be found in minority neighborhoods than in white neighborhoods. It was also not likely to be found in areas with the highest number of drug overdose deaths, the researchers noted.
In addition, of those stores that did stock naloxone, 40% asked for a doctor’s prescription and many would not give the drug to those under 18.
Laws are not enough, according to Qato. “Policies need to be enforced and pharmacies need to be aware of and held accountable for implementing them,” she said.
A new law now requires pharmacies to “stock naloxone and to post a sign notifying shoppers that it is stocked,” said researcher Jenny Guadamuz, also from the University of Illinois.
“Pharmacies can be fined $250 for each day they are not in compliance of the law. Now, the question is, will the city enforce the law?” Guadamuz said.
The report was published online June 7 in the journal JAMA Network Open.
More information
The U.S. National Institute on Drug Abuse has more information on naloxone.
SOURCE: University of Illinois at Chicago, press release, June 7, 2019

Biohaven up 16% on sale hopes

The company has been exploring a sale, and reports that it’s decided not to attend Goldman’s annual healthcare conference next week has animal spirits stirring.
BHVN +16.2%

Rewalk Robotics suits up

Europe and the US approvals of the ReStore device have arrived within a week; now the company must deliver commercially.
US FDA clearance for Rewalk Robotics’ second powered exosuit, ReStore, will have come as a relief to the group’s investors after the troubles that have dogged the company’s first system. The group’s stock closed up 122% yesterday.
Analysts had not expected the approval until the second half, so Rewalk is ahead of schedule. But this is a new kind of technology in an unproven market, and early adoption of the system will be closely watched.
ReStore is designed to help in the rehabilitation of stroke survivors with mobility problems. The battery and motor part of the system is worn on the waist, and transmits power to a fabric leg brace and a foot plate under the shoe. This helps the patient lift their feet and move their legs. It also includes sensors worn on both shoes to enable the movements to be synchronised with the patient’s natural gait.
The system also tracks the patient’s performance, and rehab therapists can analyse the data to monitor improvements, tweaking the settings as necessary.
Commercial strategy
The company says this is the first soft exosuit approved in the US, as indeed it was in Europe when it was CE marked at the end of last month. The device will be priced at $28,900, and the company believes that it will fall into existing gait training reimbursement codes.
In Europe ReStore will cost €28,500 and it is set to be launched this month. Rewalk plans to use its own sales force in Germany and the UK as these two countries have reimbursement policies in place for post-stroke rehabilitation. The group is expected to sign up distributors for France and Italy.
As well as selling the suit outright, the company intends to offer a leasing option, potentially allowing rehabilitation centres to limit their up-front capital investment. Investors will now want to see decent early adoption rates.
The company already sells the ReWalk exoskeleton for personal use by patients with spinal cord injury; it also sells the system to rehabilitation centres. ReWalk Personal reached the US five years ago, but was the subject of FDA warnings and skated close to being withdrawn from market (Rewalk draws the FDA’s ire, March 3, 2016).
Rewalk placed 85 of these systems in 2018, giving total revenues of $6.5m. But sales seem to be falling; in 2017 it had sales of $7.8m from 107 systems. Perhaps ReStore’s market debut will help reverse this apparent decline.

VTV’s diabetes reinvention gains some ground

After crashing on a late-stage Alzheimer’s failure last year VTV Therapeutics has taken a small step forward in type 1 diabetes.
VTV Therapeutics looked dead and buried after the Alzheimer’s project azeliragon flopped in its pivotal study last year, but the company’s reinvention as a diabetes drug developer gained some ground today.
Still, VTV still has a long way to go. Data from a phase II trial of the group’s oral glucokinase activator TTP399 in type 1 diabetes look promising, but the results so far are in just a handful of patients, and it might take more to convince the markets.
VTV’s shares initially opened up 14% today, but these gains had soon faded, perhaps as investors took the opportunity to sell on the news. And the company’s current market cap of $84m is well off what it was before the azeliragon blowup (VTV pivots to diabetes after Alzheimer’s flop, 10 April 2018).
Insulin add-on
If VTV does get TTP399 to market in type 1 disease, it is likely to have little competition – insulin is the only option for these patients, and they often still struggle to keep glucose levels under control.
The Simplici-T1 trial tests TTP399 on top of insulin. Its primary endpoint is 12-week change in glycated haemoglobin, or HbA1c, a measure of blood sugar levels.
The first part of the study found a mean 0.6% reduction in HbA1c in eight patients receiving TTP399, versus a 0.1% rise in the 11 given placebo; the difference was significant, with a p value of 0.03.
VTV hopes to replicate these results in part two of the study, in a broader population; results are due in the first quarter of 2020.
TTP399 also reported positive data from a phase II trial in type 2 diabetes in 2016, but things have gone quiet since, which led Bernstein analysts to suggest a lack of enthusiasm at VTV for this indication.
The type 2 space is much more crowded, which could explain any reluctance from the company to move forward here.
The only other glucokinase activator in active development, according to EvaluatePharma, is Hua Medicine’s dorzagliatin, also known as HMS5552, which is in phase III trials in China. The company has said it will look to partner the project outside the country after the pivotal data report in the second half of this year.
Other glucokinase activators have been discontinued owing to lack of efficacy and side effects including hypoglycaemia and liver steatosis.
VTV has another mid-stage candidate in the form of its small-molecule GLP1 agonist TPP273, for type 2 diabetes; however, even if this progresses it could have a hard time competing against Novo Nordisk’s oral semaglutide.
And, remarkably, VTV has not given up on azeliragon, with plans to start a phase II trial in mild Alzheimer’s and type 2 diabetes this month.
TTP399 looks at present to be the group’s best shot at success, but it still has a lot to prove.
VTV’S PIPELINE
ProjectDescriptionIndicationStatus
TTP399Glucokinase activatorType 1 & 2 diabetesPhase II
TPP273Oral GLP-1 receptor agonistType 2 diabetesPhase II
AzeliragonRage antagonistMild AD and type 2 diabetesPhase II imminent
HPP737PDE 4 inhibitorCOPDPhase I
HPP593/REN001*PPAR-delta agonistMitochondrial diseasesPhase I
UnnamedNrf2/Bach1 modulatorUndisclosedPhase I
*Licensed to Reneo Pharmaceuticals. Source: EvaluatePharma & company website.

Germany’s Stada buys six of GSK’s consumer brands, eyes further deals

Private equity-backed generic drugmaker Stada said on Friday it would buy six consumer healthcare products from British drugmaker GlaxoSmithKline to bolster its presence in Europe.

The price tag for the mainly Europe-focused brand portfolio, which include itch relief cream Eurax, antiseptic cream Savlon and Tixylix cough liquids, was in the high double digit million pound range, according to a person close to the deal.
Stada declined to comment on the price.
GSK is streamlining its product offering as it prepares to fold its consumer business into a joint venture with Pfizer by the second half of this year, creating a market leader that will primarily look to the United States and China for growth.
Stada CEO Peter Goldschmidt said the company, which will fold the brands into its British Thornton & Ross unit, would bring to bear its knowledge of complex European healthcare markets that some global players are lacking, also with a view to future deals or alliances.
“We have a strong presence in almost all the European countries, there are not many companies where that is the case. For companies in, say, the United States, India or China that are looking for a European partner we are the go-to partner,” the CEO told Reuters.
The German company, majority owned by buyout firms Bain and Cinven since 2017, reported adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) of just over 500 million euros last year on sales of 2.3 billion euros.

Gene editors rally on Vertex/Crispr deal

CRISPR/Cas9 gene editors Intellia Therapeutics (NTLA +4.6%) and Editas Medicine (EDIT +8.4%) are enjoying a spike in demand after Vertex Pharmaceuticals in-licensed the technology from CRISPR Therapeutics (CRSP+15%) to develop gene therapies for Duchenne muscular dystrophy and myotonic dystrophy Type 1.

Lilly petitions Supreme Court to protect Cialis BPH patent

FiercePharma reports that Eli Lilly (LLY +1%) has petitioned the Supreme Court to reconsider a lower court decision invalidating a Cialis (tadalafil) patent for benign prostatic hyperplasia or BPH (enlarged prostate).
The patent was invalidated after being challenged by an entity in Germany that Lilly calls “shadowy.”
The company is hoping that SCOTUS will agree to hear the case (and reverse the decision) which may stem the continued erosion in sales. In Q1, for example, Cialis sales were down 38% to $308.2M. In Q1 2017, sales were $533.6M (-7.5%).