Altria turns to iQOS in U.S.

Altria (MO +1.1%) is launching its iQOS product in the U.S. with an initial introduction at about 500 stores in the Atlanta area. The company has the rights to sell the product under a licensing agreement with Philip Morris International (PM +1.1%).

Altria hasn’t stated when iQOS will be rolled out across the U.S.

The iQOS device, which heats tobacco but doesn’t burn it, hits the U.S. market with vaping companies like Juul Labs (JUUL) under increasing regulatory scrutiny.

“It’s perfect timing,” notes Piper Jaffray analyst Michael Lavery. “I don’t think they would have expected some consumer uncertainty around vapor coinciding with the launch of Iqos in the U.S.,” he adds.

https://seekingalpha.com/news/3504036-altria-turns-iqos-u-s

DC hospital goes 1 week without running water amid Legionnaires’ threat

Washington, D.C.-based St. Elizabeths Hospital has been without safe water for more than seven days after the discovery of bacterial contamination that could cause Legionnaires’ disease, according to The Washington Post.
During routine water testing, both Pseudomonas and Legionella bacteria were found Sept. 26, forcing the facility shut off all water. The hospital’s patients and staff are currently using bottled water, hand sanitizer and portable showers. As of Oct. 3, none of the state-run facility’s 273 patients have symptoms of Legionnaires’ disease.
“As with any water outage, infectious disease control staff are monitoring closely to address any potential infection risks,” Phyllis Jones, chief of staff of the district’s Department of Behavioral Health, said in a statement to The Washington Post.
Patients are “very distressed” by the situation, especially with flu season approaching, according to Andrea Procaccino, an attorney at the patient advocacy group Disability Rights DC.
“If you’re not able to wash your hands after you go to the bathroom or there’s no running water, it makes it hard to have proper hygiene and sanitation,” she told The Washington Post. “People haven’t taken showers in four or five days.”
The psychiatric hospital will continue to accept patients but lacks a clear timeline of when water will be restored.
https://www.beckershospitalreview.com/quality/dc-hospital-goes-1-week-without-running-water-amid-legionnaires-threat.html

FDA strengthens warning on vaping THC products

The U.S. Food and Drug Administration warns consumers not to use vaping products that include THC, the primary psychoactive ingredient in pot, in an updated consumer alert.

Also warns people not to modify vaping products by adding any substances and tells them not to purchase any vaping products off the street or from other illicit channels.

“At this time, the FDA does not have enough data to identify the cause, or causes, of the lung injuries in these cases,” it said in the statement.

While no one compound or ingredient has emerged as the culprit in the string of lung injuries, “we do know that THC is present in most of the samples being tested,” the FDA said.

The Centers for Disease Control reports 1,080 lung injury cases and 18 deaths associated with using e-cigarette, or vaping products, from 48 states and 1 U.S. territory as of Oct. 1.

Related stocks: Altria (MO +1.3%), Philip Morris (PM +1.3%), British American Tobacco (BTI -0.2%), Gilla (OTCPK:GLLA -12.1%), Vape Holdings (OTCPK:VAPE -25%), Vector Group (VGR +1.7%), Imperial Brands (OTCQX:IMBBY -1.5%), and privately owned Juul (JUUL)

https://seekingalpha.com/news/3504058-fda-strengthens-warning-vaping-thc-products

Gene therapy stocks have taken a beating. Their recovery may be slow

The honeymoon period for gene therapy developers was short-lived. Shares of at least 26 are trading lower now than they were a year ago, amounting to roughly $18 billion in lost market value.
Relief may not come soon, either. Analysts suspect investors aren’t just looking for promising safety and efficacy data anymore; they want to know how companies intend to make money off these treatments. Most don’t have answers to that question yet.
“There’s this phase, not just in gene therapy, but in most companies or technologies, where it’s all exuberance and development,” said Tyler Van Buren, an analyst at Piper Jaffray. “A lot of that can end once rubber hits the road and you have to launch a product.”

Bluebird bio is having this problem. The Boston biotech’s share price is down 41% from a year ago and 26% since mid-June, when executives said the European launch of its Zynteglo gene therapy would be pushed back from 2019 to 2020.
Mani Faroohar of investment bank SVB Leerink argues the delay has dimmed investor confidence in smaller biotechs working on “transplant” gene therapies like Zynteglo, which treats a blood disorder known as beta-thalassemia by harvesting a patient’s stem cells, engineering them to produce a form of hemoglobin, and infusing them back into patients.
“If the bellwether can’t launch a product that they’ve been spending billions of dollars on over the course of 10 years, how is a $400 million company somewhere going to do it?” Faroohar told BioPharma Dive.
Bluebird isn’t the only gene therapy leader to get knocked recently.
Swiss pharma giant Novartis remains on damage control following a data scandal that, to some extent, tarnished the approval of its Zolgensma gene therapy. Roche’s acquisition of Spark Therapeutics, meanwhile, is taking longer than expected because of antitrust concerns.
Delays to the Spark deal may be having a particularly outsized effect on gene therapy stocks. Signs that the Federal Trade Commission took issue with the pairing, which many analysts assumed would be a sort of “check-the-boxes” acquisition, started to show up in early April.
No gene therapy acquisitions have been announced since, and Faroohar doesn’t expect that to change until buyers have more clarity on what’s holding up Roche. With the deal’s timeline already extended by months, shareholders of other companies might not be willing to wait around for a resolution.
“If you paralyze the acquirers, that makes it very difficult to make a compelling case for a lot of these companies that certainly wouldn’t be able to commercialize their own products without raising a lot of diluted capital,” Faroohar said.
Van Buren sees the Spark deal as a more minor issue, given that gene therapy continues to be one of the hottest areas in drug development. Even so, he acknowledged that it could discourage “natural bidders” from coming to the table, which lowers the probability of certain acquisitions.

Gene therapy co.	Lead therapeutic focus	Stock change, past 52 weeks through Oct. 1
BioMarin Pharmaceutical	Hemophilia	-36% ▼
Sarepta Therapeutics	Duchenne muscular dystrophy	-49% ▼
Bluebird bio	Beta-thalassemia, sickle cell, CALD	-38% ▼
Spark Therapeutics	Eye disease, hemophilia	+80% ▲
Ultragenyx	Rare disease	-45% ▼
CRISPR Therapeutics	Beta-thalassemia, sickle cell	-9% ▼
PTC Therapeutics	AADC deficiency	-31% ▼
Amicus Therapeutics	Batten diesease, CNS	-37% ▼
UniQure	Hemophilia, Huntington’s	+9% ▲
Regenxbio	Retinal diseases, Hunter and Hurler syndromes	-53% ▼
Audentes Therapeutics	Enzyme disorders	-25% ▼
Editas Medicine	Eye disease, beta-thalassemia, sicke cell	-29% ▼
Sangamo Therapeutics	Hemophilia, Fabry, beta-thalassemia, sicke cell	-48% ▼
Homology Medicines	Enzyme, lysosomal disorders	-23% ▼
Intellia Therapeutics	Amyloidosis, AAT deficiency	-56% ▼
Voyager Therapeutics	Parkinson’s, Huntington’s, ALS	-13% ▼
Krystal	Rare skin diseases	+95% ▲
MeiraGTx	Eye disease, Parkinson’s	+16% ▲
Rocket Pharmaceuticals	Danon disease, Fanconi anemia	-52% ▼
Solid Biosciences	Duchenne muscular dystrophy	-79% ▼
Avrobio	Fabry, Gaucher	-46% ▼
Cellectis	Blood cancers	-69% ▼
Prevail Therapeutics	Parkinson’s Gaucher disease	N/A
Adverum Biotechnologies	Eye diseases	-8% ▼
LogicBio Therapeutics	Hemophilia, liver disease	N/A
Axovant	Parkinson’s disease, gangliosidosis	-68% ▼
Mustang Bio	SCID	-43% ▼
Abeona Therapeutics	Skin disease, Sanfilippo syndromes	-82% ▼
AGTC	Eye diseases	-40% ▼
Catalyst Biosciences	Hemophilia B	-57% ▼
Iveric Bio	Eye diseases	-54% ▼
Fibrocell	Skin diseases	+34% ▲
Tocagen	Brain cancer	-96% ▼

A strategy beyond positive readouts

The gene therapy field evolved rapidly over the last decade and, by 2025, the Food and Drug Administration expects to clear for market 10 to 20 cell or gene therapy products annually.
Investor sentiment is shifting with the times. As Bluebird, Novartis and Spark Therapeutics proved these treatments can move through the clinic and gain regulatory approval, investors became increasingly interested in marketing and manufacturing strategies — even for drugs in early development.
“For so long, [gene therapy companies] didn’t really trade on, ‘What’s my margin structure going to be? What’s my distribution method? How do I realize attractive pricing in Europe versus Japan versus the U.S.?'” Faroohar said.
Now, investor awareness “about some of these very nuanced commercial questions is catching up.”
One of their biggest commercial concerns revolves around insurance coverage, since the U.S. insurance system wasn’t designed to handle incredibly expensive, potentially one-time treatments like Zolgensma, which Novartis offers at $2.1 million through a five-year installment plan.
Another commercial sticking point has been manufacturing. Bluebird, for example, pinned Zynteglo’s slower launch on tweaks the company was making to the therapy’s production process.
Ensuring consistent and quality manufacturing will likely be a challenge for others too. PwC proposes in a new report that the growing interest in gene therapy will lead to greater competition for the time and resources of contract manufacturers working in the space. The competition could, in turn, result in higher costs or supply constraints, and may force companies to invest more in their own manufacturing — a development seen with projects begun by Novartis, Pfizer, Sarepta and Bluebird.
“The days of 100% outsourcing and letting somebody else deal with it — I don’t see that being the standard model,” said Karen Young, U.S. Pharmaceutical and Life Sciences Leader at PwC.
The industry, however, is still getting acclimated to the small-scale, highly personalized, logistically daunting processes required for cell and gene therapy production. Building in-house capabilities and a team with the technical know-how to run them would likely be an expensive, time-consuming endeavor.
These challenges are, of course, predicated on a gene therapy having positive clinical data. On that measure, analysts have observed investors becoming harder to impress.
https://www.biopharmadive.com/news/gene-therapy-stocks-investor-concerns-marketing-manufacturing/564112/

FDA accepts filing for DBV Tech’s peanut allergy treatment

DBV Technologies (DBVT +2.8%) says the Food and Drug Administration has accepted the Biologics License Application for its Viaskin peanut immunotherapy for the treatment of peanut-allergic children aged 4-11; shares are halted.

If approved, Viaskin Peanut would be the first and only epicutaneous immunotherapy indicated for the potentially life-threatening condition in children.

DBV says the FDA plans to hold an advisory committee meeting to discuss the application, with a target action date of Aug. 5, 2020.

https://seekingalpha.com/news/3504026-fda-accepts-bla-filing-dbv-techs-peanut-allergy-treatment

SmileDirect says ‘no factual basis’ in allegations against it

SmileDirectClub (SDC +5.1%) responds to statements made by some dental trade organizations and allegations in a lawsuit filed in Nashville federal court that question the safety and legitimacy of the company’s teledentistry platform.

“There is no factual basis nor scientific or medical justification in these allegations to substantiate the false claims made about our model and the state-licensed doctors in our affiliated network,” the company said in a statement.

It blames the allegations on anticompetitive campaigns and notes that previous complaints filed with state dental boards and federal government institutions by dental trade organization and others “have gone nowhere.”

Previously: SmileDirectClub -4.2% after cautious mention by Hindenburg (Oct. 4)

https://seekingalpha.com/news/3504045-smiledirect-says-no-factual-basis-allegations

Short Courses of Antibiotics Can Cause Big Problems for Dental Patients

Some dental patients who were inappropriately given antibiotics prior to procedures suffered adverse events potentially connected to the drugs, such as anaphylaxis and Clostridioides difficile infection, researchers said here.
Of patients inappropriately prescribed antibiotic prophylaxis prior to a dental procedure, almost 4% had adverse events ranging from new allergies and emergency department visits to anaphylaxis and C. difficile infection, reported Alan Gross, PharmD, of the University of Illinois at Chicago (UIC).
Dentists prescribe 10% of antibiotics in the U.S., and are the largest specialty prescriber, said co-author Katie Suda, PharmD, of UIC College of Pharmacy, speaking at a press conference at the IDWeek meeting, with joint sponsorship by the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, the Society for Healthcare Epidemiology of America (SHEA), and the HIV Medicine Association.
To put that into perspective, she added, pediatricians and internists prescribe 10%-12% of all antibiotics in the U.S.
“[We need] awareness of other providers out there that need to be pulled into the fold and have an awareness as part of stewardship,” Thomas Talbot, MD, of SHEA, told MedPage Today. “The layers of the onion of stewardship need to broaden out and there are undoubtedly other clinicians similar to this that we need to identify and help … understand stewardship.”
This was a follow-up analysis to a prior study on inappropriate antibiotic prescribing, which found that over 80% of antibiotic prescriptions for prophylaxis prior to dental visits were unnecessary.
Suda pointed to data from the CDC, which found that antibiotic prescribing among dentists has remained stable, while prescribing among physicians has declined. In fact, she noted that their study found that clindamycin was the most likely to be overprescribed. Dentists are the top prescriber of clindamycin, which is associated with the highest risk for C difficile infection, she said.
“Dentists are a very unique prescriber group. Not only are they pressured to prescribe antibiotics from their patients, but from other clinicians,” Suda said at the press conference.
And in some cases, those guidelines may be outdated. She said that orthopedic surgeons used to recommend one dose of antibiotics prior to a dental visit if the patient had a prosthetic joint, such as a prosthetic knee, but those guidelines have changed.
The American Heart Association guidelines have also narrowed over time, Suda said, with fewer patients with cardiac conditions now indicated to receive an antibiotic prior to a dental visit. These guidelines now apply to patients with cardiac conditions considered to be at the highest risk of adverse outcomes if the patient gets infective endocarditis, such as those with prosthetic heart valves, and generally for “invasive dental procedures.”
“This study illustrates the perception that antibiotics are fairly benign, even if it’s just one dose,” Talbot said at the press conference. “We need to have those conversations … [that] it’s not a harmless decision to give antibiotic prophylaxis for just one dose; there can be some consequences.”
Study Details

Gross and colleagues examined data from 2011 to 2015 of patients with dental visits linked to medical and prescription claims. In this study, researchers looked at unnecessary antibiotic prophylaxis — defined as antibiotic prophylaxis in patients who both did not undergo a procedure that manipulated the gingiva/tooth periapex and did not have an appropriate cardiac diagnosis.
Of the 168,420 dental visits with antibiotic prophylaxis, 136,177 were unnecessary, and of those, 3.8% of unnecessary prescriptions were associated with an antibiotic-related adverse event. The most common adverse events were new allergies (2.9%) and emergency department visits (1.2%).
The researchers also specifically looked at clindamycin versus azithromycin. Suda noted that in their previous study, clindamycin was most likely to be overprescribed and was associated with a 34% increased risk of a serious adverse drug event versus amoxicillin.
Suda noted that their data was a “conservative estimate,” because the study only measured patients where patients sought healthcare, and didn’t include adverse events such as nausea or diarrhea, nor did it include drug/drug interactions.
“If patients have adverse events, they’re not going back to the dentist — they’re seeing their primary care provider or going to the emergency department,” she noted. “Dentists never see those adverse outcomes … but we should try to provide dentists with more streamlined access to a patient’s medical information. Very few dental offices have that available to them.”

Gross and Sudha disclosed no conflicts of interest.
One co-author disclosed support from BioK+.

last updated 10.04.2019

• Primary Source

  IDWeek

  Source Reference: Gross AE, et al “SHEA Featured Oral Abstract: Serious Antibiotic-Related Adverse Effects Following Unnecessary Dental Prophylaxis in the United States” IDWeek 2019; Abstract 1895.

https://www.medpagetoday.com/meetingcoverage/idweek/82556