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Friday, September 7, 2018

Clock ticking on Teva migraine drug, analyst expresses doubt for approval


Teva executives continue to express confidence the drugmaker’s novel migraine drug will get an FDA nod next week, but with questions lingering about the Celltrion manufacturing plant that will produce it, at least one analyst is writing it off for now.
Teva CEO Kåre Schultz in a meeting earlier this month with analysts at EvercoreISI indicated it was “more likely than not” that fremanezumab, which has already been pushed back three months, would get approved on its Sept.16 PDUFA date, analyst Umer Raffat wrote in a note. But Schultz and other Teva execs acknowledged “it could be approved or not,” Raffat wrote.
Today, with the date a week off, Credit Suisse analyst Vamil Divan is less confident of Celltrion’s ability to get everything wrapped up at the plant than he was when a July reinspection resulted in a Form 483 with eight observations. He told his clients today that it appears issues raised by the FDA about the Celltrion biologics plant are unresolved.
He said Credit Suisse is downgrading its shares to neutral on “what we see as … an unattractive risk/reward ahead of the Sept. 16 FDA Action Date for key pipeline product fremanezumab.” Instead of a fourth-quarter launch of the drug by Teva, Divan is expecting an approval and launch in the the second half of 2019.
“Teva continues to believe fremanezumab will be approved in mid-Sept and expect to launch the product immediately thereafter. However, with the FDA observations made recently at Teva’s partner Celltrion’s manufacturing site still not resolved, we believe an approval within the next 10 days is increasingly unlikely,” Divan wrote to clients Friday. “In addition, we believe expectations on fremanezumab’s commercial potential may be too high given market dynamics in the CGRP space and possibly more attractive offerings from companies such as Amgen/Novartis.”
The FDA reinspected the Celltrion plant in South Korea in July as a follow-up to a warning letter issued earlier in the year. The letter was not directed at the portion of the plant producing the API of Teva’s drug candidate. However, the July visit also served as a preapproval inspection for Teva’s promising migraine drug. It resulted in an FDA Form 483 (PDF) with eight observations.
Celltrion said the citation contained eight “manageable and correctable inspection observations” and that it expects outstanding observations to be lifted soon.
If it is not approved, it will be a disappointing stumble for Schultz, who has received high marks from analysts, particularly for his engineering of a massive restructuring that is slated to cut 14,000 jobs and save $3 billion annually for the Israel-based drug company. The company has said it expects the med “could drive meaningful upside to EBITDA and cash flow for speedier debt repayment”—particularly if it launches this fall.

Pre-Brexit, top UK insulin provider Novo Nordisk plans to double its stockpile


One by one, drugmakers have disclosed plans to prepare for Brexit, which could leave British patients vulnerable to shipping delays and unable to access critical drugs. Novo Nordisk, the largest insulin supplier to the U.K., now says it’ll more than double its stockpile to prepare for the historic move.
Britain is set to leave the European Union in March 2019. By January, Novo Nordisk says it’ll more than double its normal 7-week stockpile to 16 weeks’ worth of insulin. The company supplies more than half of the U.K.’s insulin, according to The Independent. If no deal is established between the U.K. and the European Union, routine shipping and customs between countries could come under long delays.
Novo Nordisk UK Corporate Vice President Pinder Sahota said in a statement that the company’s “first commitment is to ensure that patients treated with our medicines remain unaffected in the event of a ‘no-deal’ Brexit.” The company is “working closely with trade organizations in the UK and the EU to ensure that the interests of our patients are at the forefront of negotiations.”
Additionally, Novo is working with authorities to “ensure continuity of supply, irrespective of the outcome of Brexit negotiations,” Sahota said.
Novo’s fellow insulin maker Sanofi has committed to stockpiling 14 weeks’ worth of drugs to prepare for Brexit fallout. The company also said it’d consider flying flu vaccines into the U.K. because of tight timelines required to deliver the products. If the parties could agree, Sanofi also said it would consider marking trucks to make a fast pass through customs.
Other top players in the pharma industry have been detailing their Brexit plans, as well. Pfizer recently said changes to its supply chain will cost $100 million to ensure supply. British drugmaker GSK has said its Brexit prep work will cost $100 million, while peer AstraZeneca has estimated the bill will be $40 million. Merck, for its part, plans a 6-month drug supply.
Last week, NHS England urged the entire industry to prepare. The agency ordered companies to report by Sept. 10 how they’ll build stockpiles. Officials want at least six weeks’ worth of drug supplies above normal.

SEC files suit against Opko Health, Phil Frost alleging ‘pump and dump’ schemes

In a lawsuit filed in the U.S. District Court for the Southern District of New York, the SEC alleged that Barry Honig, Phillip Frost, OPKO Health, and other defendants engaged in “pump-and-dump” schemes that enriched the defendants and “left retail investors holding virtually worthless shares.” Honig was the primary strategist, calling upon other defendants to buy or sell stock, arrange for the issuance of shares, negotiate transactions, or engage in promotional activity, the SEC lawsuit claims.

Nightstar target upped by Leerink


Thinly traded Nightstar Therapeutics (NITE +8.4%) is up on almost double normal volume, albeit on turnover of only 198K shares. Earlier today, Leerink’s Joseph Schwartz raised his fair value target to $30 (40% upside) from $25.
The company develops gene therapies to treat retinal disorders. Lead candidate NSR-REP1 is in Phase 3 development for choroideremia, an inherited condition characterized by progressive vision loss. The initial symptom is night blindness, usually occurring in early childhood.

Departure of Portola’s CCO is a ‘clear positive,’ says Citi


Citi analyst Yigal Nochomovitz said the resignation of Portola Pharmaceuticals’ CCO is a “clear positive” and is not much of a surprise given his lack of experience in commercial operations. The analyst believes Portola can now substantially re-shape top-level management with a new COO with the right operational experience ahead of both the Andexxa and Bevyxxa launches. Norchomovitz rates Portola Pharmaceuticals a Buy with a $50 price target.

College 529 plans could be used to pay off student loans in new tax legislation


  • Homeschooling, apprenticeship fees — and, most notably, student loans, could all be paid for with 529 plans.
  • “Anything that provides families with more flexibility in how they use 529 plans would be beneficial,” said Mark Kantrowitz, the publisher of SavingForCollege.com.
The first round of tax cuts that went into effect this year allowed people to dig into their 529 plans before college to pay for kindergarten through 12th grade private school tuition.
Now, in the second round of tax changes, the list of things the tax-advantaged education accounts can be used for might grow longer still.
Homeschooling, apprenticeship fees — and, most notably, student loans, could all be paid for with 529 plans, according to an updated version of what will be included in the so-called Tax Reform 2.0 provided on Thursday to Republicans by the House Ways and Means Committee.
“Anything that provides families with more flexibility in how they use 529 plans would be beneficial,” said Mark Kantrowitz, the publisher of SavingForCollege.com.
The change is likely to increase awareness about the accounts, he said. The advantages of the plans are notable: If you start saving at your child’s birth, Kantrowtiz said, about a third of the college goal will come from earnings. However, less than one-third of people understand their purpose.
Grandparents saving for their grandchildren’s education could especially benefit, Kantrowitz said.
Currently, a parent’s 529 plan has a minimal impact on their child’s financial aid eligibility, whereas grandparents’ accounts can have a serious one. To workaround that drawback, grandparents could now wait to use their 529 plans until their grandchildren are out of school and in debt. (More than 70 percent of graduates carry student loans.)
Still, the policy’s benefits will be inconsequential, said Steven Bloom, director of government relations for the American Council on Education.
Most people deplete their 529 plans by the time their child is finished with college and so there would be no money left over for them to cover their student debt anyway, Bloom said.
And, he added, “If you’re wealthy enough to have a lot in your 529, you’re probably not going to have student loans.”
There are ways that tax policy can provide relief to the millions of Americans with student debt, he said, such as adding incentives for employers to help their workers with their loans. However, this proposal, “makes it looks like you’re trying to solve a problem,” he said, “when you’re not really solving it.”
Fewer than 1 in 5 children under the age of 18 have a 529 plan, according to SavingforCollege.com. Half of those who do make more than $150,000.

Pittsburgh nonprofit plans OTC naloxone aided by OxyContin maker Purdue


The maker of OxyContin is giving more than $3 million to a Pittsburgh-based nonprofit to expedite the development of an over-the-counter form of the naloxone nasal spray, the so-called overdose antidote.
The $3.42 million grant from Stamford, Conn.’s Purdue Pharma to Harm Reduction Therapeutics in Pittsburgh was announced Wednesday as part of the pharmaceutical giant’s push to combat side effects of the opioid epidemic — the seeds of which were planted by Purdue itself.
“Purdue is committed to advancing patient care and public safety,” Craig Landau, president and CEO of Purdue Pharma, said in a statement. “While naloxone accessibility cannot be seen as a single solution, it must be part of our collective actions.”
In a phone call with The Incline, Harm Reduction Therapeutics’ CEO Michael Hufford called the Purdue grant the first piece in a puzzle that, once complete, will make naloxone more accessible and more affordable. Hufford said the Purdue grant will help Harm Reduction Therapeutics get its New Drug Application submitted to the U.S. Food and Drug Administration.
“The FDA approved naloxone in 1971, and it’s been off-patent since ‘85,” said Hufford, who obtained his Ph.D. from Pitt. “But as the opioid crisis unfolded, the cost of naloxone substantially increased. Meanwhile, the cost of heroin has continued to go down, and the purity of heroin has continued to go up.”
Hufford added, “[Naloxone] itself costs less than a dollar to save a life, yet the retail price for intranasal forms of naloxone is over $100 and for intramuscular forms it’s over $4,500. And I saw that as unconscionable.”
Hufford said he also saw an opportunity to help naloxone go over the counter while addressing cost and access simultaneously. Hufford said you address access by taking the drug over the counter and cost by selling it as a nonprofit “at the lowest possible price.”
Beyond the Purdue grant and the FDA approval process, Hufford said money will need to be raised by Harm Reduction Therapeutics for outreach, manufacturing and awareness campaigns. That manufacturing campaign will be relatively limited, at least by big pharma standards, and dependent on the success of those fundraising efforts.
“Our goal is to have an initial run in excess of a million units,” Hufford said. “But the total need for naloxone is in the many millions of units a year, although it’s hard to get good numbers on that.”
He continued: “There are glass vials of naloxone that sit in every ER in the U.S. and on pharmacy shelves in every hospital. We’re not going after that market. Our market is two-fold: 1. To get it in the hands of consumers like any other over-the-counter product, and 2. Trying to address the needs of first responders and municipalities who have been breaking the bank trying to afford naloxone.”
In Middletown, Ohio, for example, a member of city council last year proposed withholding naloxone from repeat overdose victims citing the cost and the strain on emergency services, according to the Washington Post. In Pennsylvania, Gov. Tom Wolf announced $5 million included in the 2017-18 budget to provide naloxone to first responders. Wolf and Physician General Dr. Rachel Levine also issued a standing order in 2015 making naloxone available over the counter at pharmacies here, but that order didn’t directly address the price point.
How much Harm Reduction Therapeutics would sell its over-the-counter naloxone spray for is yet to be determined and dependent on the amount of money it raises from grantors like Purdue, but Hufford said it will be a “fraction of the price of current products.”
Hufford said Harm Reduction Therapeutics is in talks with “dozens of philanthropies and high network folks” in its search for funders, adding of Purdue’s $3.42 million grant, “We would love to see this be the first of multiple contributions.”
He also addressed the elephant in the room, so to speak: Was he comfortable taking money from Purdue?
The corporation fueled the opioid crisis by lying to patients and doctors about the risks of addictive products like OxyContin and by targeting vulnerable populations, all while raking in huge profits. It’s paid millions in settlements, and in 2007 agreed to pay a $600 million penaltyfor misbranding OxyContin and misrepresenting associated risks. In February, Purdue said it would stop marketing OxyContin to doctors, CNN reported at the time.
Purdue is one of a number of big pharmaceutical companies being sued for its hand in creating the opioid crisis. A number of states have sued Purdue, in particular, accusing the company of deceptive marketing of its prescription painkillers. There have also been lawsuits filed by local governments and municipalities, including Pittsburgh and Allegheny County. According to the Tampa Bay Times, the number of lawsuits against the industry being overseen by a federal judge topped 1,000.
But Hufford said he welcomes Purdue’s investment in life-saving treatments like naloxone now.
“I would answer this question with a favorite quote of mine from Mary Lasker who formed the American Cancer Society and Planned Parenthood and who was a very famous philanthropist. She said, ‘Money is frozen energy, and you unfreeze it when you pay people to work.’ And that’s how I see investment capital. It is frozen energy, and what we need at the end of the day isn’t good wishes, what we need is capital, and so we’re pleased and grateful to Purdue for this. […] I think this is the direction things should be going.”
The Incline posed a similar question to Purdue: Was it too little too late for the company to now become concerned with the impacts and consequences of the opioid epidemic, and was the Harm Reduction Therapeutics grant all just a PR move?
In an email, Purdue spokesperson Robert Josephson wrote, “In response to critics, we share their concerns about the opioid crisis and are committed to working collaboratively with all stakeholders to help stem the tide of this public health crisis.”
He added, “It is a bit hypocritical to demand that the pharmaceutical industry step up and help address the opioid crisis and then criticize such important public health efforts. […] We have long supported access to naloxone and have funded such initiatives in the past. Since 2014, we have partnered with the National Sheriffs’ Association on training and access to naloxone. This program is credited with saving approximately 275 lives to date, and Purdue has provided $850k.”
More than 72,000 Americans died from drug overdoses in 2017, including illicit drugs and prescription opioids, according to the CDC. That’s a two-fold increase over the last decade.
In Allegheny County, there were 737 drug overdose deaths recorded in 2017 alone, according to data provided by the county. It was the highest number here in a 10-year-period that saw 3,800 fatal overdoses in total.