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Friday, September 7, 2018

Tennessee Blues to stop covering OxyContin


Blue Cross Blue Shield of Tennessee, the largest health insurer in the state, will not cover the addictive OxyContin painkiller next year and instead will cover two alternative pills that are more expensive but deemed less likely to be abused, the Tennessean reports.
Why it matters: The insurer’s decision is a direct response to the state and national opioid epidemic. Most people who misuse painkillers get the drugs through family or friends, not through their own prescriptions, according to federal data.
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Date rape drug test lets women discreetly check for spiked drinks with a few drops


  • Four students from North Carolina State University came up with the idea of a nail polish that could detect date rape drugs.
  • Undercover Colors is finally releasing a test kit for sale to the public starting Thursday.
  • More than half of college sexual assaults occur between August and December and freshman are attacked almost twice as much as other undergraduates.
The start-up that made headlines four years ago for developing a nail polish that would detect date rape drugs is finally releasing a test kit for sale starting Thursday.
Undercover Colors scrapped the nail polish in favor of a gender-neutral small, disposable test to detect whether a drink has been doctored.
The tests, which use just a few drops of liquid, look and operate much like a pregnancy test. They can detect Xanax or its generic alprazolam, Valium (diazepam) and flunitrazepam, also known as Rohypnol, said CEO Barbara Cook. They do not screen for other common date rape drugs, such as GHB or ketamine.
Four classmates at North Carolina State University came up with the idea more than four years ago. The thinking was to give women a way to quickly and discreetly test their drinks at bars and parties with nail polish that changed colors when dipped into drinks laced with date rape drugs. It would take a few years for the science to catch up.
Date rape drugs are used in a fraction of all sexual assaults, but they still can put people in dangerous situations. They’re tasteless and odorless, making them nearly impossible to detect and can make people drowsy or even cause them to black out.
The Undercover tests are small enough to carry in a purse or wallet and can be purchased online for $34.99 for a five-test starter kit or $49.99 for 10 tests.
It takes about a minute to process and looks like a quarter-sized medallion with a foil coating on one side that resembles a miniature pregnancy test when peeled back. Women can either drop the liquid on the test or dunk it into a drink. The readout displays one dark pink line if the drink is bad or two lines if it’s OK.
“We’re focused mostly on getting product out there, and we want to hear the first story of how this helps someone because that will make it all worth it,” said Undercover Colors’ director of research and development, Nick Letourneau, adding that it could eventually display a pattern or a written word like newer pregnancy tests do.
Letourneau said scientists got the nail polish technology to a point where it was working, but executives decided to shelve it in favor of something that could be used more easily by both men and women. Their market research showed surprising demand from men, and not just in the LGBTQ community, he said.
“The technology works,” Cook said. “The form in which that technology was to be delivered is the thing that has evolved over time and to get it it into a form that helps most people in the best way is to begin with is here.”
They also created a stick-on nail, but it isn’t available for public sale yet.
Undercover Colors is timing the release as college students head back to school. The first semester can be a dangerous time. More than half of college sexual assaults occur between August and December, and freshmen are attacked almost twice as much as other undergraduates, according to the Department of Justice. The agency analyzed sexual assaults of female college students from 2014 to 2015, the most recent data available.
“One of the reasons it’s one of the most underreported crime in the freshman year is because women think it’s their fault. And that’s a huge problem,” Cook said.
Private investors, including Mike Hockenberry, Marjorie Kaufman, Liz Pharo and Mark Cuban, have backed Undercover Colors, Cook said. The start-up has not received any institutional investor or venture capital funds.
Undercover Colors' date rape drug test can be attached to a phone.
Source: Undercover Colors
Undercover Colors’ date rape drug test can be attached to a phone.
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Detroit woman says selfies alerted her to stroke, saved her life


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Juanita Branch, 63, noticed her symptoms getting progressively worse with each selfie.

A Michigan woman is crediting a series of selfies she took one morning with helping to save her life after she noticed she was suffering from symptoms of a stroke. Juanita Branch, 63, said that she was planning to upload the pictures to her Facebook on Aug. 13 when she noticed something was off.
“Each one got worse and I’m like, ‘What the heck is going on?’” Branch told Fox 2 Detroit.

Branch, who had suffered a stroke in June 2016, said she saw her face drooping on one side, and that she started losing her balance so she called for an ambulance. Branch told the news outlet that once she got to the hospital her speech had started to go, and that her doctor asked to see the seflies.
Her doctor studied the timestamp on the selfies and realized that there was still time to give her a clot-busting drug to aid her recovery.
“If we give TPA beyond the three-hour mark it could be dangerous,” Dr. Jason Muir told Fox 2 Detroit. “It can cause bleeding in the brain and can be life-threatening.”

Branch is working on physical therapy and preparing to head home, but said that she’s gained a new appreciation for people who take selfies.
“I’m going to stop making fun of people who take selfies,” she told Fox 2 Detroit. “Because that selfie literally did save my life.”
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Zealand Abandons Sanofi Diabetes Drug in $205 Million Deal with Royalty Pharma


Copenhagen-based Zealand Pharma is selling future royalty streams and $85 million in potential commercial milestones for two diabetes drugs, Soliqua/Suliqua and Lyxumia/Adlyxin, to New York-based Royalty Pharma.
Soliqua is a combination of insulin and Zealand’s GLP-1 analog, and sales have been disappointing. Zealand is basically abandoning this area, taking $205 million from Royalty Pharma to invest in a new pipeline, in particular its dasiglucagon, a treatment for congenital hyperinsulinism that’s in Phase III studies.
Royalty Pharma is paying $205 million (U.S.) at the close of the deal. Zealand also indicates it will redeem the outstanding royalty bond of $24.7 million after receiving the funds, which will make it debt free. Zealand will also remain eligible for a $15 million milestone payment from Sanofi,expected in 2020.
“We are grateful for the collaboration with Sanofi, which has been fundamental for our growth during the past 15 years,” said Britt Meelby Jensen, Zealand’s president and chief executive officer, in a statement. “The sale of the future royalties allows us to accelerate our activities to take our own fully-owned product candidates all the way to market, in line with our long-term strategic objectives. These include two leading rare disease programs, glepaglutide for short bowel syndrome and dasiglucagon for congenital hyperinsulinism, each with a Phase III study planned to commence this month.”
This was all forecast in January. Soliqua was launched in January 2017. It came on the market right around the same time Novo Nordisk’s rival combination Xyltophy did. Both are once-daily injections of insulin with a GLP-1 agonist to treat type 2 diabetes in patients who are not managing their blood sugar well on a single-agent therapy. Thomson Reuters conducted a poll and found analyst estimates for Xultophy with sales of $1.2 billion in 2021 and the Sanofi/Zealand product with sales of $550 million in 2021.
PMLive noted at the time, “Much will depend on the reception by big pharmacy benefit managers such as Express Scripts and CVS Health, which have resisted including drugs that offer improved convenience on formularies without steep discounting. And with two competing drugs with similar clinical profiles to play off against each other, negotiations for formulary positions are expected to be tough.”
And apparently, they were. In January 2018, Jensen told Reuters, ”Sanofi has said that this doesn’t live up to their expectations. … They had hoped and believed it would be easier to convince the doctors.”
Soliqua did not meet analysts’ projections or Sanofi’s expectations. In the first nine months of 2017, Sanofi indicated the drug had $21 million in sales, with half of that in the third quarter. Novo Nordisk’s Xultophy had sales of $76.80 million from January to September.
Some of this is likely due to the competition between the two, but also a downward trend in the U.S. market for diabetes-related drug prices. But the overall lackluster sales of Soliqua has caused Zealand to move out of the broad-market arena and partnerships with big pharma to focus on rare diseases and self-marketing.
“Our license agreement with Sanofi has provided Zealand with significant funding since 2003,” stated Mats Blom, executive vice president and chief financial officer of Zealand. “However, since we have neither influence nor visibility over future revenue, the royalty sales provides us with financial certainty. The thorough process on this transaction enabled us to secure the best possible value for Zealand. This is positive for both Zealand and our shareholders.”
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Credit Suisse Joins Consensus To Prescribe Sarepta


The Street has a lot of faith in Sarepta Therapeutics, Inc. SRPT 0.49%. The biotech firm notched its 20th bullish rating Thursday to further neutralize a lone Hold.

The Rating

Credit Suisse analysts Martin Auster, Mark Connolly and Tiago Fauth initiated coverage on Sarepta with an Outperform rating and a $178 price target.

The Thesis

Credit Suisse’s sum-of-the-parts analysis indicates significant upside opportunity for the Duchenne muscular dystrophy combatant.
“Despite high expectations for the DMD gene therapy program, we see room for continued share appreciation as the program develops,” Auster, Connolly and Fauth wrote in a note. “While we expect initial data from all three clinical stage gene therapy programs likely will demonstrate robust dystrophin expression in skeletal muscle, we think SRPT’s first mover advantage and strong initial data sets a high bar and a strong competitive position.”
The analysts expect Sarepta to release DMD gene therapy data in October, with Pfizer Inc. PFE 0.44% and Solid Biosciences Inc SLDB 0.88% following in 2019. The “first mover” is modeled to seize a 50-percent market share in with peak sales near $4 billion and annual recurring revenue of $1.5 billion.
Credit Suisse sees Sarepta’s DMD gene therapy representing $99 per share and PMO and PPMO candidates contributing between $35 and $60.
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New Class of Migraine Drug Creates Four-Way Pharma Development Race


Migraines — a neurological condition often characterized by intense, debilitating headaches — can last anywhere from four to 72 hours, affecting a patient’s quality of life.
Until recently, there was no specific treatment for migraine, although symptom-alleviating options such as beta blockers, antidepressants and even Botox were invariably used by affected individuals. Some of the symptom relievers have concerning side effects, especially on the cardiovascular system.
That changed with the May 17 FDA approval of the migraine drug Aimovig, developed by Novartis AG (ADR) NVS 0.17% andAmgen, Inc. AMGN 0.5%.
Aimovig, a preventative treatment option for migraines, belongs to a class of drugs called calcitonin gene-related peptide — or CGRP — inhibitors and antagonists.
CGRP is a member of the calcitonin family of peptides that exist in humans in two forms: alpha and beta. It is synthesized in neurons in brain as well as the spinal cord and acts as a vasodilator, widening the blood vessels. This makes nerve cells more sensitive to pain, and the peptide is released duing migraine attacks and cluster headaches. making the nerve cells more sensitive to pain. It is released during migraine attacks or cluster headaches.

How CGRP Antagonists Work

CGRP antagonists work by blocking CGRP-receptors. The CGRP monoclonal antibody functions by binding itself to the target molecule or its receptor, thereby inhibiting it and preventing a continued reaction.
cgrpaimovig.png
Infographic courtesy of Amgen.

Amgen, Novartis Win The Race

The Amgen-Novartis combo is the first to bring CGRP-based migraine therapy to market. TheFDA greenlighted Aimovig 70mg or 140mg, chemically erenumab, to be administered as a once-monthly self-injection using Amgen’s SureClick autoinjector.
A late-stage study dubbed LIBERTY that evaluated Aimovig showed that patients taking a 140mg dose had about three times better odds of having their migraine days cut by half or more relative to a placebo.
Aimovig targets the CGRP receptor and not the molecule per se, and is priced at $575 per month, or $6,900 annually.
European Union approval came on July 30.
Aimovig seems to have had a strong offtake since its launch in May, according to Biopharmadrive. Prescriptions for the drug have surged to 10,000, with about 3,000 patients starting on the drug by the 10th week of sales.

Teva Waits In The Wings

Teva Pharmaceutical Industries Ltd (ADR) ADR TEVA 0.92%‘s BLA for fremanezumab is before the FDA.
The original PDUFA date for fremanezumab was extended by three months in May, with the revised date set for Sept. 16. At that time, Teva said there was no additional data request from the FDA.
Apparently, the FDA was unhappy with the manufacturing conditions at one of Teva’s South Korean partners.
Teva discontinued the Phase 3 study of fremanezumab for cluster headaches after a pre-specified futility analysis of the study revealed the primary endpoint might not be met.
Cluster headaches differ from migraines in that the former affects one side of the head and results in intense pain, while the latter causes throbbing pain, with symptoms manifesting as nausea, vomiting and sensitivity to sound and light.
Notwithstanding the hiccup, Teva reportedly is working overtime to bring the drug to pharmacies by mid-September. This is one of the two pipeline candidates the Israeli drug company is banking on to salvage it from the debt burden it is saddled with following its purchase of Allergan plc AGN 0.18%‘s generic unit.
If not by mid-September, Teva hopes to begin commercializing the product candidate before the end of 2018.

Eli Lilly Plays Catch-Up

Eli Lilly And Co LLY 0.62%‘s galcanezumab, a CGRP antagonist targeting the molecule, was found effective in treating patients with episodic and chronic migraines who previously failed to respond to two or more preventive therapies. The findings are based on three Phase 3 studies: EVOLVE-1, EVOLVE-2 and REGAIN.
Eli Lilly expects the FDA to vet its migraine treatment candidate, which is also a once-monthly, self-administered injection, in the third quarter of 2018.

Alder Biopharma Trails Competitors

Alder Biopharmaceuticals Inc ALDR 0.55% is developing eptinezumab, a monoclonal antibody administered via infusion, as opposed to the self-injection mode offered by competitors.
Eptinezumab is being evaluated in multiple, randomized pivotal Phase 3 studies.
Alder announced in top-line data from the PROMISE 1 study in late June that showe the study met the primary endpoint of highly statistically significant reductions in monthly migraine days.

Market Opportunity For CGRP Antagonists

Amgen, with its first-mover advantage, certainly has its nose ahead of the pack. Estimates byGlobalData, a data and analytics company, show that Aimovig is likely to be the market leader in Europe, with estimated sales of $325 million in the region by 2026.
This new class of drugs is estimated to have a market potential of $4.5 billion in 2020, which is forecast to grow to $6.9 billion in 2025, according to Investor’s Business Daily, which quoted Leerink estimates.
CRGP antagonists, which boast a multibillion-dollar opportunity, could initially be  the domain of early movers, although analysts believe there’s room for all four pioneers to thrive and grow.
FDA approvals for the remaining three products could be de-risking events for the respective pharma companies. It remains to be seen if these can emerge from the FDA process unscathed to take advantage of a major market opportunity.
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Lilly’s New PET Scan Offers Another Tool for Studying Alzheimer’s


There are two primary mechanisms believed to cause the loss of memory and cognition in Alzheimer’s disease. The first is the accumulation of beta-amyloid in the brain. This occurs early on in the disease and is the focus of much of the research into preventing and treating the disease. The second is the accumulation of another type of protein tangles called tau. This tends to occur later on in the disease.
Eli Lilly and Company and its wholly-owned subsidiary Avid Radiopharmaceuticals, announced the successful Phase III trial of a Positron Emission Tomography (PET) imaging agent, flortaucipr F 18, in identifying tau in the brains of late-stage Alzheimer’s patients.
PET scans are imaging tests that utilize special dyes containing radioactive tracers. The tracers are swallowed, inhaled or injected into a vein, depending on the part of the body being studied. Specific organs or tissues absorb the tracer. The tracer gathers in areas of higher chemical activity. PET scans are typically used to measure blood flow, oxygen use, the body’s sugar metabolism and other active functions.
In the Lilly and Avid study, dubbed A16, 156 end-of-life patients with dementia, mild cognitive impairment or normal brain function received flortaucipir PET imaging. Then, 67 of the patients were studied postmortem. The trial met pre-specified endpoints with flortaucipir showing statistically significant sensitivity and specificity for identifying tau pathology of Braak Stage V/VI. This is a pathological staging scale for tau neurofibrillary tangles.
The imaging agent also demonstrated statistically significant sensitivity and specificity for total Alzheimer’s disease neuropathologic change, which combined both tau and amyloid plaque densities. This was based on the National Institute on Aging and Alzheimer’s Association (NIA-AA) neuropathology criteria.
Lilly and Avid plan to release more data in October at the Clinical Trials on Alzheimer’s Disease meeting held in Barcelona, Spain. They are in discussions with the U.S. Food and Drug Administration (FDA) about the next steps for regulatory approval.
“These encouraging results are a major advance in our ability to image the pathology of Alzheimer’s disease,” said Mark Mintun, vice president of Lilly’s pain and neurodegeneration research and development, in a statement. “We hope this and other advances in the field can help speed development of treatments, as well as provide more diagnostic information for doctors taking care of patients suspected of having Alzheimer’s.”
Alzheimer’s disease and most other forms of dementia are diagnosed through clinical symptoms, for example, forgetfulness and confusion. There are, however, several types of dementia besides Alzheimer’s disease, such as Lewy body dementia, frontotemporal dementia, and vascular dementia. Alzheimer’s accounts for 60 to 80 percent of dementias.
There have been some advances in using biomarkers, such as the genetic marker ApoE, and imaging studies. However, ApoE doesn’t diagnose Alzheimer’s, but is sometimes linked to higher risk of the disease. This PET scan imaging modality appears to be one more tool to be used in investigating Alzheimer’s and other dementias, but not necessarily for diagnosing it. It may also be useful for tracking the progression of the disease.
Interestingly, in 2017, the findings of a four-year study of PET scans in the brains of 4,000 Medicare patients with mild cognitive impairment (MCI) or dementia, was presented at the Alzheimer’s Association International Conference in London, reported The Washington Post.The study intends to evaluate more than 18,000 people, but the results were presented on the first 4,000. The Post wrote, “Among 4,000 people tested so far in the Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) study, researchers from the Memory and Aging Center at the University of California at San Francisco found that just 54.3 percent of MCI patients and 70.5 percent of dementia patients had the plaques. A positive test for amyloid does not mean someone has Alzheimer’s, though its presence precedes the disease and increases the risk of progression. But a negative test definitively means a person does not have it.”
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