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Friday, October 18, 2019

FDA OK’s Foamix topical acne foam

The FDA approves Foamix Pharmaceuticals’ (NASDAQ:FOMX) AMZEEQ (minocycline) topical foam, 4% (formerly FMX101) for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients at least nine years old.
Update: Shares, currently halted, will resume trading at 4:40 pm ET.
https://seekingalpha.com/news/3507048-fda-oks-foamix-topical-acne-foam

FDA OKs Teligent gentamicin cream; shares up 14%

The FDA approves Teligent’s (TLGT +13.7%) Gentamicin Sulfate Cream USP, 0.1%.
Per IQVIA, the U.S. market is ~$15.6M.
https://seekingalpha.com/news/3507037-fda-oks-teligent-gentamicin-cream-shares-14-percent

Foamix shares halted pending news

Nasdaq has suspended trading in Foamix Pharmaceuticals (FOMX -2.5%) pending the release of news. In this case, it pertains to the FDA’s expected decision on its application for acne foam FMX101 today (the actual PDUFA date is Sunday, October 20).
https://seekingalpha.com/news/3507025-foamix-shares-halted-pending-news

Humana sues generic drug makers over alleged price-fixing

Humana (HUM +0.8%) has filed a 610-page complaint in a Philadelphia federal court accusing more than a dozen generic drug makers, including Teva Pharmaceutical Industries (TEVA -2.5%), of conspiring to maintain high prices on 124 generic medicines. The suit claims that Teva “spearheaded” the scheme although it was cog in much larger conspiracy to inflate drug prices.
The supposed peak of collusive activity was the period from July 2013 through January 2015.
Humana also filed a 273-page complaint in a Philadelphia court in August 2018 against generic drug firms so it is unclear how the two differ.
The latest case is: Humana Inc. v. Actavis Elizabeth LLC, 2:19-cv-4862, U.S. District Court, Eastern District of Pennsylvania.
https://seekingalpha.com/news/3507021-humana-sues-generic-drug-makers-alleged-price-fixing

Mirati sets date for closely watched clinical KRAS readout

Mirati Therapeutics is set to reveal the first clinical data on its closely watched KRAS G12C inhibitor MRTX849 Oct. 28. The readout is a key moment in the fairly short history of the drug and Mirati, shares in which have soared in the updraft created by data on Amgen’s rival asset.
San Diego-based Mirati is in the spotlight because of its involvement with KRAS, a cancer target once thought to be undruggable. Amgen ramped up hopes for KRAS inhibitors when it linked its therapy, the first of its kind to enter the clinic, to a 50% response rate in lung cancer patients. Shares in Mirati shot up by almost 50% in the days following the release of the Amgen data.
A subsequent readout from Amgen’s clinical trial tempered expectations somewhat, although that is as much a reflection of how hopes had risen in the run-up to the update as anything. The response rate in the Amgen trial has remained up around 50% as the trial has expanded.
Mirati has grown into a biotech with a $3.4 billion market cap on the back of excitement about KRAS, which Amgen has fueled with its readouts. Now, Mirati is set to provide an early hint as to whether it can live up to that valuation.
Later this month, Mirati will present the first clinical trial data on MRTX849 at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. Dana-Farber Cancer Institute’s Pasi Janne will present the data.
The clinical readout is the most closely watched of several updates Mirati will provide at the event. Janne’s presentation will follow a preclinical update by Mirati Chief Scientific Officer James Christensen, whose presentation is titled “The KRAS G12C Inhibitor, MRTX849, Provides Insight Toward Therapeutic Susceptibility of KRAS Mutant Cancers.”
Mirati is also presenting preclinical data on MRTX849 in two posters, which will cover the discovery of the drug and its use in reconditioning the tumor microenvironment in combination with an anti-PD-1 therapy.
https://www.fiercebiotech.com/biotech/mirati-sets-date-for-closely-watched-clinical-kras-readout

FDA generic approvals hit a new record, but the effort’s not paying off yet

The FDA doesn’t regulate drug prices, but it’s been using one of its most important powers—namely, approving more cheap generics—to drive down costs. And in fiscal 2019, it racked up enough of those approvals to set a new record.
The agency this week said it had cleared 1,171 generics during its 2019 fiscal year, which ended September 30. That smashed its previous record of 971 generic nods, set in fiscal 2018.
And among the latest round of approvals were 125 first-time generics, arguably the most important kind because they set up competition to previously protected—and pricey—branded meds. Those first-time generics included an opioid overdose drug, plus meds to treat breast cancer and pulmonary arterial hypertension, acting commissioner Ned Sharpless said in a statement.
But the onslaught of new approvals hasn’t necessarily delivered big savings, recent research shows. And that’s on top of previous analyses that found a significant number of newly approved copycats hadn’t hit the market months later.
A study published in JAMA this week said the agency’s efforts to bolster generic approvals hasn’t paid off as of the end of last year. Researchers found that while the overall number of generic approvals “increased slightly” from July 2016 to December 2018, the proportion of approvals for meds that faced limited competition or recent shortages remained the same.

The FDA approved 1,832 generics between July 2016 and December 2018, the team found. Of those, about 20% were generics to medicines that faced “limited competition,” or two or fewer generic competitors. Another 39% were generics for drugs that had faced a shortage sometime in the previous five years. Those approval numbers were steady, according to the report.
In all, the “results suggest that there have not yet been noticeable effects of the FDA’s initiatives to expand approvals for generic drugs at risk for price spikes and shortages,” the authors wrote. The work isn’t in vain, though, as the team wrote that “continued attention is needed to foster approval of generic drugs with limited competition and prior shortage.”
The researchers cautioned that their study didn’t consider whether the generics companies actually launched their copycats after winning approval. Kaiser Health News did dig into those numbers, though, looking at the 1,600-plus generics approved from January 2017 through December 2018.
More than 700, or about 43%, of those products hadn’t been launched as of early January, KHN found. Perhaps more importantly, 36% of the first-time generics weren’t yet for sale at that point.

Approving more generics is one of several drug pricing initiatives introduced by former FDA commissioner Scott Gottlieb back in 2017. Others include publishing and regularly updating a list of drugs with limited competition and highlighting alleged “gaming” of regulations by branded drugmakers that can stifle competition.
Despite efforts by the FDA and others to take on high drug prices, U.S. prices remain higher than any other country. President Donald Trump has made the issue a priority, but some of the administration’s efforts have faced setbacks. Gottlieb resigned earlier this year, and the administration walked back its proposal to take on drug rebates after a Congressional Budget Office review. HHS still hopes to force drugmakers to include prices in TV ads.
The FDA is forging ahead with its copycat approvals push, Sharpless said. The agency plans to publish more guidance and meet with generic drugmakers to foster generics development. “We will continue to do all that we can to facilitate a stable, competitive market to increase access to medicines,” Sharpless said.

Why Not Try Free Market Health Care?

I’m often asked if the free market can work in health care. My quick answer is: that’s the only thing that does work.
Show me a health care sector where there is no Medicare, no Blue Cross and no employer and I bet that’s a market that works very well.
Lasik surgery is one example. Patients get a package price and they know what they are going to pay in advance. There are no “surprise medical bills.” As my colleague Devon Herrick has shown, there is price and quality competition here – unlike other health care markets.
Competition works. Over the past decade, the real price of Lasik surgery fell 25%, despite a huge increase in the number of procedures and all manner of technological change – the type of change we are told leads to cost increases everywhere else in medicine.
A similar story can be told about cosmetic surgery – another sector where the third-party payers have no role to play.
What about conventional procedures – like knee and hip replacements? Can the market work there? Where patients pay with their own money, it already is working. Canadian patients routinely come to the United States for these procedures (in order to avoid lengthy waits for surgery in their own country). They get package prices and they pay about the same amount that Medicare pays. That’s about one-half to one fourth of what employer plans typically pay.
By the way, there is nothing the Canadians are doing that you can’t do. There are three requirements: (1) you must be willing to travel, (2) you must pay in advance and (3) you can’t have an insurance company step in after the fact and argue about whether the entire procedure was really necessary.
MediBid is a company that puts patients and doctors together for all manner of procedures. It has created an online competitive market. Patients submit data and their need for a procedure. Providers bid on price. Patients can also check out quality information about the providers.
Then there is the international market for medical tourism. You can shave one-third off the cost of surgical procedures and maybe more by traveling to Health City Cayman Islands. The center posts quality information online (infection rates, readmission rates and mortality rates) and I suspect that their numbers easily beat comparable figures at the hospital nearest you.
It’s also worth noting that most of the cost-saving innovations in health care have emerged outside the third-party payer system – initially catering to people paying with their own money, even if the third-party payers eventually came around.
  • Rx.Com came into existence to compete on price and quality with local pharmacies for patients who bought drugs with out-of-pocket funds.
  • Walk-in clinics emerged for patients who bought primary care with their own health care dollars.
  • Firms like Teladoc began providing phone and email doctor consultations – completely outside the third-party payer system.
If the idea of letting employees participate in a free medical marketplace seems too radical for some employers, I have a more modest suggestion. Liberate primary care.
That is, put two or three thousand dollars in an account for the employee every year and let the employee be completely responsible for all primary care, all diagnostics tests and maybe even all generic drugs.
Who is ready to serve these employees? Walmart, for one. Beginning this month, Sam’s Club is offering customers packages of healthcare services, including discounted dental care, free prescription drugs, and telephone health consultations in Michigan, Pennsylvania and North Carolina.
Also, Walmart has opened its first Health Center in Dallas Georgia, following its business model of “everyday low prices.” A dental cleaning costs $25, a doctor’s visit $40. A test for a urinary-tract infection is $10; a pap smear $50; a vitamin B-12 injection $18; and a flu shot $39.84.
Then there is concierge care. At one time only available to the very rich, a model of what is now called “direct primary care” has been developed by Atlas MD in Wichita and is rapidly spreading across the country.
The cost is $50 a month for an adult and $10 for a child. For that the family gets 24/7 access to a physician (including by phone and email), who provides all the services people traditionally expect from a family doctor. The family also gets access to generic drugs for prices lower than what Medicaid pays.
Ameriflex is a Dallas-based company that helps employers set up a platform for employees to connect with direct primary care doctors – bypassing insurance companies altogether.
A market for primary care is fast developing. Employers are foolish if they don’t take advantage of it.
https://www.forbes.com/sites/johngoodman/2019/10/17/why-not-try-free-market-health-care/#6cfd42625358