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Tuesday, January 14, 2020

AbbVie’s Skyrizi tops Cosentyx in head-to-head study

Phase 3 clinical trial comparing AbbVie’s (NYSE:ABBV) Skyrizi (risankizumab) to Novartis’ (NYSE:NVS) Cosentyx (secukinumab) in adults with moderate-to-severe plaque psoriasis showed the former’s superiority.
Specifically, 87% of Skyrizi-treated patients achieved PASI 90 (90% skin clearance) at week 52 versus 57% of those receiving Cosentyx, one of the primary endpoints (p<0.001).
The trial also met the other primary endpoint of non-inferiority to Cosentyx with 74% of Skyrizi patients achieving PASI 90 at week 16 compared to 66% for Cosentyx.
Skyrizi topped Cosentyx on all ranked secondary endpoints as well.
The FDA approved the IL-23 inhibitor for plaque psoriasis in April 2019.
ABBV is down 1% premarket on light volume.

BioLineRx’s Motixafortide an Orphan drug in Europe

BioLineRx (NASDAQ:BLRX) is up 7% premarket after the European Commission granted Orphan Drug Designation to Motixafortide (BL-8040), for the treatment of pancreatic cancer.
Among the benefits of Orphan Drug status in Europe is a 10-year period of market exclusivity for the indication, if approved

Bernie’s ‘Medicare-for-all’ misinformation

Sen. Bernie Sanders has launched a new misinformation campaign on “Medicare-for-all” in advance of this week’s Democratic presidential debate.
Last week, advisers to his campaign released a study trumpeting the supposed savings “Medicare-for-all” would bring. Days prior, Sanders refused to say how much his “Medicare-for-all” plan would cost. “I don’t give a number and I’ll tell you why,” he told the Washington Post. “It’s such a huge number and it’s so complicated that if I gave a number you and 50 other people would go through it and say, ‘Oh . . .”
That number is huge all right — as much as $40 trillion over its first decade, as Sanders himself has admitted. The human costs would be even higher, in the form of lengthy waits for critical care.

Paying for “Medicare-for-all” would require a host of new taxes. Before he “forgot” how much it would cost, Sanders proposed funding his plan with everything from a new 4 percent tax on every American household to a new 7.5 percent payroll tax. He claims Americans would pay less for health care, even with these new taxes.
That’s unlikely. An analysis from Emory University professor Kenneth E. Thorpe found that 70 percent of working, privately insured households would pay more for health insurance under “Medicare-for-all” than they currently do.
To get a sense of the crippling tax burden “Medicare-for-all” would impose on Americans, look to other countries with health care systems where the government is the dominant or sole provider of health coverage. In 2019, the average Canadian family of four paid over $13,000 in taxes just for their health care, according to research from the Fraser Institute, a Vancouver-based think tank.

That health care tax bill has risen more than 65 percent since 1997. For childless couples, the cost of publicly funded health coverage has risen nearly 75 percent in the same period.
“Medicare-for-all” would require an even bigger tax burden than does Canada’s system. Sanders envisions taxpayer-funded coverage of prescription drugs, long-term care, dental and vision care — none of which is covered by our northern neighbor’s single-payer system.
Some 4.5 million people in the United Kingdom were waiting for specialist treatment as of March 2019 — an increase of 40 percent over the last five years.
The average household in the United Kingdom pays over 5,000 pounds a year to fund the National Health System — a 75 percent increase from two decades ago. A pair of British think tanks estimate that every British household will have to shell out an additional 2,000 pounds per year to keep the NHS running as the country ages.
Despite the massive tax increases it would require, advocates say “Medicare-for-all” would lower overall health care costs. A recent study co-authored by advisers to Sanders’ campaign argues that single-payer systems save money by eliminating the administrative costs associated with private insurers. The authors claim the United States would have saved over $600 billion in 2017 alone if it had cut administrative spending to Canadian levels.
But the study doesn’t consider the administrative costs associated with collecting taxes. Under “Medicare-for-all,” those costs would almost certainly increase for government, employers and individual citizens alike.

The study also glosses over the fact that most of the administrative savings generated by “Medicare-for-all” would come from putting hundreds of thousands of people currently employed in the health sector out of work.
And then there’s the disruption “Medicare-for-all” would foist upon patients. Government-dominated systems the world over do not provide unfettered access to free, high-quality health care. They respond to the impossible task of treating an unlimited number of patients with limited resources by rationing care. That results in long wait times.
Some 4.5 million people in the United Kingdom were waiting for specialist treatment as of March 2019 — an increase of 40 percent over the last five years. More than 11 million Britons waited more than three weeks for an appointment with a general practitioner, according to the most recent government data. Nearly 3 percent of the Canadian population was on a wait list for treatment last year.

These wait times add to the cost of “free” health care. Absence and reduced productivity of sick workers cost the United Kingdom around 23 billion pounds each year.
The truth about “Medicare-for-all” is ugly. Americans watching the debate this week must not fall prey to the falsehoods on health care that will no doubt be flowing from the candidates’ mouths.

FDA clears new BioCardia catheter

The FDA grants 501(k) clearance to BioCardia’s (OTCQB:BCDA) Morph DNA deflectable guide catheter used to guide the Helix Biotherapeutic Delivery System during CardiAMP cell therapy delivery in the heart. The company says Morph DNA enables navigation within the heart’s chambers without building up torque.
Shares down 5% premarket on average volume.

Foamix Pharma’s Amzeeq on preferred list at Express Scripts

Foamix Pharmaceuticals (NASDAQ:FOMX) is up 5% premarket on light volume in reaction to its announcement that acne med Amzeeq (minocycline) topical foam, 4% is now on Express Scripts’ National Preferred, Flex and Basic commercial formularies.
The list price of Amzeeq is $485 per 30 gm canister, a price point that the company says is lower on a per-unit basis than current brand leaders in the prescription acne market.

Amgen CEO expects 25% of growth to come from Asia in next decade

Biotechnology giant Amgen Inc expects up to a quarter of its growth to come from Asia over the next decade, Chief Executive Officer Robert Bradway told Reuters.
The forecast marks a shift for 40-year-old Amgen, which still relies on the U.S. market for more than 75% of its sales, 30 years after it won U.S. marketing approval for its first drug, red-blood-cell-booster Epogen.”China and Japan are the second and third largest markets in our industry,” Bradway said in an interview on Monday on the sidelines of the JP Morgan healthcare conference in San Francisco. “In the case of China, it is a rapidly growing market. … Japan has an aging population and we expect that will be a growth market for us.”
Amgen, based in Thousand Oaks, California, late last year acquired a 20.5% stake in Beijing-based BeiGene Ltd in a deal to expand its presence in China.
In Japan, Amgen expects by the second quarter of this year to dissolve its current joint venture with Astellas Pharma Inc and begin for the first time to operate an independent marketing unit in that country.
Bradway said the Astellas venture is a model for what Amgen aims to do with BeiGene – “work on a basket of drugs together, then after a period of time, the rights would return to us.” Under the deal, BeiGene can retain rights to one of Amgen’s cancer products.
Bradway said Amgen drugs such as osteoporosis treatments Prolia and Evenity as well as potent cholesterol fighter Repatha are tailor-made for aging populations.
“Where there are therapies available to prevent disease, it makes sense for society to identify people who are at risk,” Bradway said. “The alternative is to fix that which is broken.”
Amgen, which is facing more U.S. competition for older biotechnology drugs for which “biosimilar” versions are becoming available, needs new sources of growth.
Bradway said Amgen will announce its 2020 financial outlook on Jan. 30, when it presents fourth-quarter 2019 results. He said the company is unlikely to return to its previous pattern of issuing five-year financial plans, due in part to “a much more uncertain environment.”
In addition to biosimilar competition, pharmaceutical companies are grappling with backlash from politicians and consumers to the industry’s practice of routinely hiking list prices, and then giving some of that money back to health insurers in return for preferential reimbursement terms.
For 2019, Amgen forecast that its global net sales prices would drop by a rate in the mid-single digits.
Bradway said Amgen continues to see growth in Europe, where product sales volumes are increasing by rates in the high-single-digits or low-double-digits.

As in most European countries, the governments of both Japan and China negotiate prices for pharmaceuticals paid for by state-operated health plans.
Bradway said Amgen does not currently have any of its drugs authorized for coverage on China’s National Reimbursement Drug List, but the company does plan to apply to have drugs like Repatha and leukemia treatment Blincyto approved for inclusion.

7 of the Top 20 Pharma Companies Adopt Veeva Vault Study Startup

Leading companies are using advanced study start-up application to speed clinical trials
Accelerating study start-up is a top priority among leading life sciences companies. With this shift underway, an increasing number of organizations are selecting Vault Study Startup from Veeva Systems (NYSE:VEEV) to improve clinical trial efficiency and speed time to site activation. Seven of the top 20 largest global pharmaceutical companies are adopting Vault Study Startup to bring together start-up activities and processes in a single, easy-to-use modern cloud application.
“Study start-up is the clinical area with the most potential to improve overall trial efficiency because of a heavy reliance on manual processes and legacy standalone systems,” said Ashley Davidson, director of Veeva Vault Study Startup. “Customers are using Veeva Vault Study Startup to modernize their start-up operations and get trials up and running much faster.”
Veeva Vault Study Startup is an advanced application that eliminates manual processes to speed cycle times and trial execution. Sponsors can find the right site faster by automating and streamlining site identification, feasibility, and selection. Companies can also prioritize and assign tasks such as site contracting and budgeting throughout their study portfolio – an area that accounts for most of the cycle time during study start-up.1
Vault Study Startup is part of Veeva’s unified suite of clinical operations applications, enabling sponsors and CROs to seamlessly share information and documents across CTMS, eTMF, and study start-up for better collaboration and increased efficiency throughout the study lifecycle.
To learn how Vault Study Startup is helping companies speed time to site activation, watch the on-demand webinar at veeva.com/StudyStartupWebinar.