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Saturday, March 9, 2019

Novo Nordisk launches China research accelerator

Novo Nordisk, one of the world`s largest maker of diabetes drugs, announced in Beijingon Wednesday the launch of INNOVO, an innovation platform through which the company seeks to join hands with local academic institutions, bio-tech startups and incubators to accelerate the transformation of scientific research into new drugs and their improvement.
“With the platform, we hope to strengthen innovation through further collaboration. We want to share our in-house expertise with local partners to build a new ecosystem nurturing innovation together,” said Lars Fogh Iversen, senior vice president of Global Research Technologies of Novo Nordisk.
Since setting up its first China office in Beijing 25 years ago, Novo Nordisk has been steadily expanding its local presence, opening a manufacturing plant in Tianjin in 1995, and a research and development (R&D) center in Beijing in 1997, the first multinational pharmaceutical firm to take this step in China.
According to Iversen, the R&D center was playing an important role in the company`s early drug discovery, helping to strengthen its leadership in diabetes care.
“As Beijing is intensifying its efforts to build a national sci-tech innovation center, the establishment of INNOVO will drive innovation with our strong alliances in China to achieve win-win outcomes and benefit patients,” he said.
Innovation accelerator
Novo Nordisk Research Center in China will be in charge of running INNOVO, through which innovative forces from academic institutions to bio-tech startups and incubators will be gathered together to speed up the transformation of science and technology research into drug development and eventually offer protection from chronic diseases like diabetes.
This platform will focus on drug discoveries related to diabetes, obesity, cardiovascular diseases, non-alcoholic steatohepatitis, and chronic kidney diseases, and pursue innovation in key technological areas like protein engineering and preparations, oligonucleotide and stem-cell therapy.
Su Jing, president of the Novo Nordisk Research Center in China, said INNOVO would serve as an innovation accelerator connecting healthcare professionals, academics, and pharmaceutical companies to support drug R&D collaboration in China, and create a global innovation model.

Vertex, NHS talks still stalled

During a House of Commons Health and Social Care Committee witness session on the availability of Vertexs Orkambi and other cystic fibrosis (CF) drugs on the National Health Service (NHS), representatives from NHS England and the UKs pricing regulator National Institute for Health and Care Excellence (NICE) called Vertex an extreme outlier in terms of its engagement with the UKs healthcare authorities and their appraisal processes.
Negotiations between Vertex and NHS representations over Orkambi reached an impasse in July last year and NICEs review of another CF drug, Symkevi, was suspended one month later.
NHSEngland national medical director Professor Stephen Powis said: Unlike other companies who are willing to submit evidence and then work on the processVertex has come at this with a particular price in mind, and they come to try and get those processes modified to meet that price expectation, rather than submit to the process and work for the analysis of the evidence base.
Chief executive of NICE Sir Andrew Dillon stated: It is really unusual to be a position where we simply seem to go round in circles to examine ever more details of NICEs methodology. As if the solution to this problem is redesigning NICE simply to enable the NHS to pay Vertex more money.
In order to unlock the potential of their existing and future treatments for patients with CF in England, it is absolutely essential that the company works with us, Dillon continued. If they do, they will find there are flexibilities in our processes, which will help us all understand the additional value of their treatments and reach a fair price.
NHSEngland claimed that the quickest way to get Orkambi to patients was for Vertex to accept the offer on the table, rather than put pressure on the government to overturn Vertexs patent as called for by the campaign Just Treatment.
The published offer is a payment of 500m over five years for Vertexs entire portfolio of CF drugs, including those developed in the future. John Stewart, NHS England national director of specialised commissioning, noted the flexibility in the organisations offer, and how this is not something that we tend to do.
The offer would cover all existing licensed indications, Kalydeco, Orkambi and Symkevi, and when the future products become licensed, we would immediately reimburse in advance of NICE concluding an appraisal, Stewart said.
At that point, Vertex would be able to submit alternative prices to NICE for the new medications alongside evidence and data that will support and justify a higher price.
However, Stewart clarified for the committee that there has been no movement since June on price from Vertex, and the price offered by Vertex, which is protected by a non-disclosure agreement, is miles away from the NHSs offer.
NHSEngland did reveal that it believes it overpaid for Kalydeco in 2012, and this probably set unhelpful, unrealistic expectations, and it is keen to make sure that the entire Vertex portfolio is priced at a fair and sustainable level going forward.
Vertex explains its position on CF drug pricing
Vertex executives, including CEO Dr Jeffrey Leiden, responded to these allegations by explaining why they could not accept NHS Englands offer.
We have been painted as not being willing to take the offer, I would say differently, we cannot take that offer.
The English offer is around 10,000 per patient per yearIf we accept that offer, that has been made public by the NHS, of course every other country will want that same offer.
If we were to accede to that [in all the countries where Orkambi is available], our total CF revenues wouldbe 850m a year. Unfortunately, that would not allow us to develop the next set of CF medicines, because are spending $1bn just on R&D, so we would go out of business in three to five years.
He noted this would mean the companys development of novel, efficacious triple combination therapies for CF would have to stop.
Leiden also declared that NICEs policies have failed to adapt to progression in life sciences. In 17 countries he claims to have had successful reimbursement agreements, stating that Vertex were able to modify their [the national regulators] assessment to capture the true benefits of these medicines to patients.
He accused the government of walking away from the negotiating table by publicly saying an offer he claims is a 90% discount on the price Vertex offers elsewhere is the last and best offer.
Leiden went on to express hope that his meeting with the Secretary of State for Health and Social Care Matt Hancock next week would get NHS and NICE back to the negotiating table. He said one of the ideas he would be suggesting a similar situation to Scotland where patients have access to the drug at a discounted list price while negotiations are ongoing.

Ra Pharma to Present at Cowen Conference March 11

Ra Pharmaceuticals, Inc. (RARX) announced that Doug Treco, Ph.D., President and Chief Executive Officer of Ra Pharma, will present at the Cowen 39th Annual Health Care Conference on Monday, March 11, 2019 at 1:30 p.m. E.T. The conference is being held at Boston Marriott Copley Place, Boston, MA.
The presentation will be webcast live and can be accessed by visiting the investor relations section of the Company’s website, www.rapharma.com. A replay of the presentation will also be available and archived on the site for three weeks.

Friday, March 8, 2019

This bull market is 10 years old? Try three months

The birthday party Wall Street is throwing for the bull market’s 10th birthday is a fraud.
The revelers insist that the bull market began on March 9, 2009. Yet that bull market came to an end long ago. If we’re even in a bull market right now — and that is not for sure — an argument can be made that it’s less than three months old.
Consider the semi-official definition of a bear market as a 20% decline in one or more of the major market averages. There have been at least two, and perhaps three, bear markets since 2009. (See accompanying chart.)
The first came in 2011, when between late April and early October several different market averages fell by more than 20%. The second came in the last quarter of 2018, when — once again — several different market averages fell by at least that amount.
The third possibly came between May 2015 and February 2016, when the Russell 2000 index RUT, -0.11%  — though neither the S&P 500 SPX, -0.21%  nor the Dow Jones Industrial DJIA, -0.09%   fell by more than 20%.
To be sure, if you focus on closing values as opposed to intra-day readings, the S&P 500 did not fall by 20% in 2011. But that strikes me as a distinction which makes no difference. Other indices did slide by more than 20%, even on a closing basis. And the granddaddy index of all, the Wilshire 5000 index, which encompasses all publicly-traded stocks, lost more than 20% on a closing basis, even assuming dividends were reinvested.
The 2015-16 decline is admittedly more ambiguous. But it’s worth noting that Ned Davis Research, the quantitative research firm that uses a set of specific and objective criteria for defining a bear market, counts the 2015-16 decline as a bear market. That bear market also is included in the calendar maintained by Jack Schannep, editor of TheDowTheory.com.
(You may recall that last year I wrote a column about the differences between Schannep’s and Ned Davis’ respective calendars. For purposes of this discussion, however, the important thing is that both calendars regard the 2015-16 decline as a bear market.)
Why does the bull market’s age matter? One reason: Some worry that bull markets die of old age. If indeed this bull market began in March 2009, it would be one of the oldest in U.S. stock market history — and, therefore, so the worriers believe, ripe for an early death. In fact, as mentioned above, it’s not even sure we’re in a bull market right now, but if we are it’s just three months old.
Another reason why this discussion matters: It illustrates, once again, the power of collective delusion. If investors can be in denial about recent events as big and significant as bear markets, are there any limits at all to what they can convince themselves to be true?
It’s hard not to be reminded of the classic book on the subject, now almost 200 years old: Charles Mackay’s “Extraordinary Popular Delusions and the Madness of Crowds.” While the current delusion about the age of the bull market may not elevate to the level of those on which Mackay focused — the South Sea Bubble, the Railway Mania of the 1840s, to name two — the same underlying habits of thought are still present.
Humphrey Neill, the father of contrarian analysis, once argued that “when everyone thinks alike, everyone is likely to be wrong.” That’s because the collective group think deadens our critical faculties, and in the process we overlook things that are otherwise utterly obvious.
So have a piece of bull-market birthday cake. But don’t kid yourself that this bull is 10 years old.

CDC is launching its first investigation into e-scooter injuries

The Centers for Disease Control and Prevention (CDC) is starting to take a look at accidents related to electric scooters, according to CNBC. The ongoing study, launched at the request of health and transportation officials in Austin, Texas, comes as increased scrutiny has been paid to the number of injuries that occur on the shareable devices. The CDC confirmed to Engadget that it is conducting the study.
The study is being overseen by Jeff Taylor, the manager of the Epidemiology and Disease Surveillance Unit with Austin Public Health. He’s joined by three epidemiologists from the CDC who will focus on severe injuries that occurred to e-scooter riders in Austin. The study has already completed the data collection process and is now being summarized for a final report.
Preliminary observations from the study found that the vast majority of injuries — 98 percent of them — happen to riders who aren’t wearing helmets. Nearly half of all riders involved in accidents had a blood-alcohol level above the legal limit and 52 percent tested positive for use of an illicit substance. Taylor noted that while many people believe accidents occur at night, they happen at all hours of the day. They also rarely involve another vehicle.
Electric scooter injuries have been the subject of a number of recent studies, including a Consumer Reports investigation that found there were at least 1,500 people treated for scooter-involved injuries in the US over the last year. Still, companies like Lime and Bird have rapidly expanded their presence in major cities in the US, Canada and the UK. Engadget reached out to Lime and Bird to find out if either company is cooperating with the study. We will update this story if we hear back.

Assn Of American Physicians & Surgeons ‘Strongly Opposes’ Mandatory Vaccines

Tensions are high regarding vaccines lately.
Due to a measles outbreak in the United States, frightened people are pushing an agenda to take an important medical decision out of the hands of parents. They’re calling for federally mandated vaccines. They’re calling for the shaming of parents who have chosen not to vaccinate their children.
The hysteria is running high, fueled by fear and memes.
Whether you opt to vaccinate or not to vaccinate, I think we can agree we all want what’s best for our children.
The Association of American Physicians and Surgeons opposes federally mandated vaccines.
An important letter was presented last week to the Senate subcommittee that is discussing federal laws that force parents to vaccinate their children. The statement below is from The Association of American Physicians and Surgeons, and they have come out strongly in opposition to the possibility of federally mandated vaccines.
No matter what your opinion is on vaccinating children, please read this.
To: Oversight and Investigations Subcommittee, House Energy and Commerce Committee
Senate Committee on Health, Education, Labor and Pensions
Re: Statement federal vaccine mandates
Feb. 26, 2019
The Association of American Physicians and Surgeons (AAPS) strongly opposes federal interference in medical decisions, including mandated vaccines. After being fully informed of the risks and benefits of a medical procedure, patients have the right to reject or accept that procedure. The regulation of medical practice is a state function, not a federal one. Governmental preemption of patients’ or parents’ decisions about accepting drugs or other medical interventions is a serious intrusion into individual liberty, autonomy, and parental decisions about child-rearing.
A public health threat is the rationale for the policy on mandatory vaccines. But how much of a threat is required to justify forcing people to accept government-imposed risks? Regulators may intervene to protect the public against a one-in-one million risk of a threat such as cancer from an involuntary exposure to a toxin, or-one-in 100,000 risk from a voluntary (e.g. occupational) exposure. What is the risk of death, cancer, or crippling complication from a vaccine? There are no rigorous safety studies of sufficient power to rule out a much lower risk of complications, even one in 10,000, for vaccines. Such studies would require an adequate number of subjects, a long duration (years, not days), an unvaccinated control group (“placebo” must be truly inactive such as saline, not the adjuvant or everything-but-the-intended-antigen), and consideration of all adverse health events (including neurodevelopment disorders).
Vaccines are necessarily risky, as recognized by the U.S. Supreme Court and by Congress. The Vaccine Injury Compensation Program has paid some $4 billion in damages, and high hurdles must be surmounted to collect compensation. The damage may be so devastating that most people would prefer restored function to a multimillion-dollar damage award.
The smallpox vaccine is so dangerous that you can’t get it now, despite the weaponization of smallpox. Rabies vaccine is given only after a suspected exposure or to high-risk persons such as veterinarians. The whole-cell pertussis vaccine was withdrawn from the U.S. market, a decade later than from the Japanese market, because of reports of severe permanent brain damage. The acellular vaccine that replaced it is evidently safer, though somewhat less effective.
The risk: benefit ratio varies with the frequency and severity of disease, vaccine safety, and individual patient factors. These must be evaluated by patient and physician, not imposed by a government agency.
Measles is the much-publicized threat used to push for mandates, and is probably the worst threat among the vaccine-preventable illnesses because it is so highly contagious. There are occasional outbreaks, generally starting with an infected individual coming from somewhere outside the U.S. The majority, but by no means all the people who catch the measles have not been vaccinated. Almost all make a full recovery, with robust, life-long immunity. The last measles death in the U.S. occurred in 2015, according to the Centers for Disease Control and Prevention(CDC). Are potential measles complications including death in persons who cannot be vaccinated due to immune deficiency a justification for revoking the rights of all Americans and establishing a precedent for still greater restrictions on our right to give—or withhold—consent to medical interventions? Clearly not.
Many serious complications have followed MMR vaccination, and are listed in the manufacturers’ package insert, though a causal relationship may not have been proved. According to a 2012 report by the Cochrane Collaboration, “The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate” (cited by the National Vaccine Information Center).
Mandate advocates often assert a need for a 95% immunization rate to achieve herd immunity. However, Mary Holland and Chase Zachary of NYU School of Law argue, in the Oregon Law Review, that because complete herd immunity and measles eradication are unachievable, the better goal is for herd effect and disease control. The best outcome would result, they argue, from informed consent, more open communication, and market-based approaches.
Even disregarding adverse vaccine effects, the results of near-universal vaccination have not been completely positive. Measles, when it does occur, is four to five times worse than in pre-vaccination times, according to Lancet Infectious Diseases, because of the changed age distribution: more adults, whose vaccine-based immunity waned, and more infants, who no longer receive passive immunity from their naturally immune mother to protect them during their most vulnerable period.
Measles is a vexing problem, and more complete, forced vaccination will likely not solve it. Better public health measures—earlier detection, contact tracing, and isolation; a more effective, safer vaccine; or an effective treatment are all needed. Meanwhile, those who choose not to vaccinate now might do so in an outbreak, or they can be isolated. Immunosuppressed patients might choose isolation in any event because vaccinated people can also possibly transmit measles even if not sick themselves.
Issues that Congress must consider:
Manufacturers are virtually immune from product liability, so the incentive to develop safer products is much diminished. Manufacturers may even refuse to make available a product believed to be safer, such as monovalent measles vaccine in preference to MMR (measles-mumps-rubella). Consumer refusal is the only incentive to do better.
There are enormous conflicts of interest involving lucrative relationships with vaccine purveyors.
Research into possible vaccine adverse effects is being quashed, as is dissent by professionals.
There are many theoretical mechanisms for adverse effects from vaccines, especially in children with developing brains and immune systems. Note the devastating effects of Zika or rubella virus on developing humans, even though adults may have mild or asymptomatic infections. Many vaccines contain live viruses intended to cause a mild infection. Children’s brains are developing rapidly—any interference with the complex developmental symphony could be ruinous.
Vaccines are neither 100% safe nor 100% effective. Nor are they the only available means to control the spread of disease.
AAPS believes that liberty rights are unalienable. Patients and parents have the right to refuse vaccination, although potentially contagious persons can be restricted in their movements (e.g. as with Ebola), as needed to protect others against a clear and present danger. Unvaccinated persons with no exposure to a disease and no evidence of a disease are not a clear or present danger.
AAPS represents thousands of physicians in all specialties nationwide. It was founded in 1943 to protect private medicine and the patient-physician relationship.
Respectfully yours,
Jane M. Orient, M.D., Executive Director
Association of American Physicians and Surgeons
Regardless of our opinions on vaccines, we all want to do what is best for our children.

Hospital chain Ardent Health discloses ’18 financials before estimated $400M IPO

Ardent Health Partners, an LBO’d operator of 30 acute care hospitals, reported financial results for the year end December 31, 2018, in an amendment filed with the SEC on Wednesday. It originally filed with the SEC to raise up to $100 million in an initial public offering. However, the deal size is likely a placeholder for an IPO that we estimate could raise as much as $400 million. The offering is a combination of primary and secondary shares.
Ardent Health Partners was founded in 1993 and booked $4.2 billion in sales for the 12 months ended December 31, 2018. The Nashville, TN-based company plans to list on the NYSE under the symbol ARDT. Barclays, Citi, J.P. Morgan, BofA Merrill Lynch, Credit Suisse, Goldman Sachs and RBC Capital Markets are the joint bookrunners on the deal.