Market Place
This week in Phispers, we look at the growing troubles at Teva. The company plans to divest non-core assets to reduce debt and lay-off 7,000 workers. The FDA approved AbbVie’s Mavyret, a drug that poses considerable challenge to Gilead’s Harvoni and Sovaldi. Meanwhile, Martin Shkreli was found guilty in three out of eight charges; diabetes drug exenatide showed benefit to Parkinson’s disease patients in a study; and in the US, the Senate passed key FDA funding bill.
Teva in dire straits: To lay off 7,000 workers, to sell non-core assets to repay
debt
Teva has been in trouble for quite sometime now. It’s a classic case of a company taking on more debt to spur growth. But it’s fallen into hard times, as three CEOs changed guard this decade.
Last week, the world’s largest manufacturer of generic medicines said it would divest non-core assets to shed a part of its US$ 35 billion debt load. While debt may be historically cheap, it still has to be repaid. And if revenues don’t keep up with payments, the downfall can be rapid for Teva.
Teva had taken on
the debt in order to
dominate all facets of generic drugs, including a US$ 40.5 billion
acquisition of Allergan’s generics business last year. The
Allergan deal added more pressure on drug prices and margins.
Teva also slashed
its earnings goals
for the second time this year. It warned investors it may have to renegotiate
some debt agreements if cash flow worsens. Teva reduced its dividend by 75
percent.
The company also
mentioned that it is in the process of laying off 7,000 workers. Greater competition in the
generic drug business due to increased approvals (of generic drugs) by the US
Food and Drug Administration (USFDA) has led to poor results, the company said.
The continued deterioration of its business environment in Venezuela has made
matters worse.
The plight of Teva
has been worsened due to the leadership crisis — the company has been without a CEO and a CFO for months.
Activist
shareholder Benny
Landa blamed acting CEO Yitzhak Peterburg and the board of directors for leading Teva to disaster. Landa said what is happening in the company is no less than a catastrophe. “I've been saying this for three or four years: the company board of directors is incapable of making big decisions and getting the company back on track,” he said.
Price-gouging Shkreli awaits sentence; found guilty on three out of eight charges
Martin Shkreli — the co-founder of Elea Capital, MSMB Capital, Retrophin and the former CEO of Turing Pharmaceuticals who is more famous for price gouging and for defrauding investors — could spend years in prison due to last week’s investor fraud conviction if the judge focuses on the intended impact of his
crime and on his antics on the social media, say legal experts.
Back
in 2015, Shkreli had raised the price of an infection treatment by 5,000 percent to avoid prison due to an unusual twist to his case — defrauded investors suffered no loss from his crime.
That
could work in Shkreli’s favor, because investor harm is the main factor in determining a sentence for securities fraud in the US. However, a report quotes a law enforcement source as saying that prosecutors will challenge Shkreli's underlying assumption of how to calculate the losses of investors.
While
Shkreli was convicted on three securities fraud and conspiracy counts, he was
acquitted of other charges, including the charge that he conspired to steal US$
11 million in assets from Retrophin.
What’s caught the public eye though is Shkreli’s social media antics. Hours after his conviction, Shkreli declared the mixed verdict by the federal jury on YouTube as an “astounding victory.”
Without showing any sign of remorse, 34-year old Shkreli said: “I’m one of the richest New Yorkers there is, and after today's outcome it's going to stay that way.”
According
to lawyers, such a conduct on social media could backfire at the time of sentencing. “He lacked any remorse, and the judge may avoid appearing lenient when she sentences him,” James Cox, a law professor at Duke University, said.
Diabetes drug exenatide could stop the progress of Parkinson’s disease
In future,
clinicians may be able to stop the progress of Parkinson’s disease with a drug normally used in type 2 diabetes. At present, the drugs used to treat Parkinson’s disease only help in managing the symptoms. They do not prevent brain cells from dying.
In Parkinson’s, the brain is progressively damaged and the cells that produce the hormone dopamine are lost. Legendary boxer Muhammad Ali had died last year at the age of 74 after battling for years with Parkinson’s disease.
In the trial, half
the patients were given
the diabetes drug exenatide and the rest were given a placebo (dummy treatment). All the patients stayed on their usual medication. Those on just their usual medication declined over 48 weeks of treatment. But those given exenatide were stable. And three months after the experimental treatment stopped, those who had been taking exenatide were still better off.
Exenatide,
derived from the saliva of Gila monster, is a glucagon-like peptide-1 (GLP-1)
agonist. It treats type 2 diabetes by mimicking the hormone GLP-1, which
triggers insulin secretion.
According to University College London (UCL) researchers, Parkinson’s patients treated with exenatide did
better on movement tests than patients who received a placebo. If they can prove the drug changes the disease itself, it could transform the way we treat Parkinson’s.
Though the UCL team is “excited”, it has urged caution as any
long-term benefit is uncertain and the drug needs more testing.
FDA approves AbbVie’s Mavyret — a drug that cures Hepatitis C in eight weeks
Last
week, the USFDA approved the first-ever drug that can treat all six major strains of hepatitis C (or HCV) in just eight weeks — AbbVie’s Mavyret. For competitors like Gilead, Mavyret spells bad news. Mavyret is
also being considered a ‘steal’ in the world of HCV drugs, with a price tag of US$ 26,400 for an eight-week treatment course. In comparison, Gilead’s Harvoni costs about US$ 63,000 for eight weeks, though the
discounts bring the net price down to US$ 30,000.
Gilead also has its own ‘pan-genotype’ hepatitis C medicine, Epclusa, in addition to its blockbuster HCV drugs
Sovaldi and Harvoni, that have been at the centre of a
controversy around their steep prices.
With
a combination of two new direct-acting antivirals — glecaprevir and pibrentasvir — Mavyret treats adult Hepatitis C patients with genotype 1 through 6 who don’t have cirrhosis or with mild cirrhosis, or those who are on dialysis. According to the FDA, it’s the first pan-genotypic HCV drug with an eight-week treatment duration. Other options cure the disease in 12 weeks or longer.
J&J’s Invokana is CVS Caremark’s preferred diabetes drug
Close on the heels of Express Scripts’ 2018 formulary release, rival pharmacy benefit management (PBM) giant CVS Caremark has published its own list of drugs that are in,
and those that are out. Express
Scripts Holding is the largest PBM organization in the US.
In
the SGLT2 class of drugs to treat diabetes, CVS
removed Eli Lilly and Boehringer Ingelheim’s Jardiance and added Johnson & Johnson’s
Invokana as a preferred option. This, despite the fact that Invokana came with an
increased risk for amputations in a cardiovascular outcomes study finished
earlier this year.
A Boehringer Ingelheim spokesperson said the company is “very disappointed” with the formulary move “and the potential treatment disruption” and the impact this could have on patients. This decision restricts treatment options for patients who could benefit from Jardiance’s life-saving cardiovascular benefit, the spokesperson added.
CVS removed 17
drugs in 10 classes, with Merck’s Zetia, Daiichi
Sankyo’s Benicar and Teva’s Nuvigil among them. Despite the removals, the company expects 99.76
percent of members will be able to keep using their current treatments.
US Senate overwhelmingly passes reauthorization of FDA’s user fees
In the US last week, Senators voted overwhelmingly to pass a key Food and Drug Administration (FDA) funding bill. The bill is now with President Trump, for his approval.
The Senate passed a five-year reauthorization of the FDA’s user fees in a 94-1 vote, with only Senator Bernie Sanders voting against the measure. The move is in major contrast to the recent rancor surrounding the Senate’s efforts to repeal ObamaCare.
The
funding reauthorizations are based on recommendations from industry groups.
This bill renews FDA’s authority to collect fees from the prescription drug and medical device industries. Together, they account for 25 percent of all FDA funding; and should amount to around US$ 8-9 billion over the next five years.
The
fee helps speed
up the approval of new drugs and devices. This funding reauthorization of FDA’s user fee comes about a month before the current user fee agreement expires.
The White House hasn’t said if it will sign the user fee bill. In a statement of administrative policy issued in July after the bill passed the House, the White House expressed concern with some minor provisions, though it did not threaten a veto.
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#PharmaFlow by PHARMACOMPASS
10 Aug 2017
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GSK, Google form first bioelectronics firm; 11 generic companies benefit from the Teva Allergan deal
This week,
Phispers brings to you the details of the bioelectronics firm formed by GSK and
Google. There is also news on companies like Teva, Takeda, Jinan Jinda and Eli
Lilly, besides two other news snippets pertaining to the FDA -- while the first
one pertains to generic approvals, the other one relates to an additional black
box warning on a few antibiotics. GSK and Google
join hands to form first bioelectronics startupGlaxoSmithKline and Google’s parent company – Alphabet – have joined hands to create a new company that is focused on fighting diseases by targeting electrical signals in the human body. This way, GSK and Alphabet’s life sciences unit – known as Verily Life Sciences – will be jump-starting a new field of medicine known as bioelectronics.Verily Life
Sciences and GSK will together contribute US $ 715.12
million
over seven years to the startup Galvani Bioelectronics. The startup will develop
miniature electronic implants for the treatment of asthma, diabetes and other
chronic conditions. The
implantable devices developed by Galvani, which is owned 55 percent by GSK and
45 percent by Verily, can modify electrical nerve signals. The aim is to
modulate irregular or altered impulses that occur in many illnesses.The
new company
will be based at GSK’s Stevenage research center north of London, with a second research hub in South San Francisco.The announcement comes just weeks after GSK had said it was going to use Apple’s HealthKit to conduct clinical trials.Three years ago, GSK had first unveiled its ambitions in bioelectronics in the journal – Nature. Bioelectronic remedies attach battery-powered implants the size of a grain of rice (or even smaller) to individual nerves to correct faulty electrical signals between the nervous system and the body’s organs.GSK believes altering these nerve signals could open up the airways of asthma patients, reduce inflammation in the gut from Crohn’s disease and treat patients with a range of other chronic ailments such as arthritis. So far, the implants have only been tested on animals but the aim is to produce treatments that will supplement or replace drugs that often come with side-effects.GSK
has been working on bioelectronic medicines since 2012 in a push to develop new
patentable treatments, since its Advair respiratory treatment faces competition
from generic versions. It has invested US $50 million in a venture capital fund
for bioelectronics and provided funding to scientists working in the field. Teva divests 79
products to 11 generic players to close Allergan dealTeva
Pharmaceutical Industries – the world’s largest generics drug company – won a US
anti-trust approval to purchase Allergan's generics
business, after agreeing to divest 79 generic drugs to rival firms. This was arrived
at to settle Federal
Trade Commission (FTC) charges that its proposed US $ 40.5 billion acquisition of Allergan’s generic pharmaceutical business would be anti-competitive. The remedy requires Teva to divest the drug portfolio to 11 firms, and marks the largest drug divestiture order in a FTC pharmaceutical merger case.The Teva-Allergan deal, which was announced in July 2015, solidifies Teva’s position as the world's largest maker of generics while freeing Allergan to focus on branded drugs.The
companies that
have acquired
the divested products are Mayne Pharma
Group, Impax
Laboratories, Dr Reddy’s Laboratories, Sagent
Pharmaceuticals, Cipla Limited, Zydus Worldwide
DMCC, Mikah Pharma, Perrigo Pharma
International, Aurobindo
Pharma USA,
Prasco and 3M Company. Eli Lilly CEO
steps down; company under probe by US Justice Department Eli Lilly CEO John
Lechleiter has stepped down after steering the pharma company through long R&D droughts. The company’s president David Ricks will move up to the top spot. And after a brief spell as executive chairman, Lechleiter will leave the company next spring.Lechleiter
has been the company's CEO since April 1, 2008, and the chairman of its board
of directors since January 1, 2009.The
announcement has come at a time when Eli Lilly has been asked by the
Justice Department to disclose information on relationships with pharmacy benefits
managers (PBMs), the companies that negotiate prices and set reimbursement
conditions.It
has not been clear what exactly the department of justice is looking for. In
the past, drug makers such as Novartis and AstraZeneca have agreed to
pay fines and penalties to settle allegations pertaining to PBMs. FDA continues
to race ahead with generic approvals The
American regulator has reduced its pile of ANDA (abbreviated new drug
applications) by about 500
applications in the first six months of 2016. The FDA has also approved 315 more ANDAs over the same time period and has sent 66 more complete response letters — or rejections — to drug makers.This
news comes after Bloomberg reported
last month that the FDA has become ‘something of a bogeyman’ for India’s stock markets by approving generic drug applications from India at a record place. Similarly, PharmaCompass
had reported last week that Indian
companies have been fixing compliance issues. China’s Jinan Jinda fails another EDQM inspection; compliance troubles in Denmark In
regulatory news from across the world, Jinan Jinda, a Chinese API
manufacturer that had failed an inspection by Italian regulators in June 2015,
had more bad news awaiting it a year on. In
a June 2016
re-inspection, this time by the Spanish Health Authority, the regulator maintained the ‘facilities non-compliance standing’ since two critical observations were made and the corrections from the previous inspection “were found as not having been implemented in a satisfactory way”. And critical deficiencies were found on raw data.In
the June 2015 inspection, the critical observation was related to an unofficial
and non-controlled storage area containing mainly raw materials and finished
products which had been made
inaccessible to inspectors as the door had been removed and replaced with a panel fixed with
screws to the wall.Meanwhile,
the FDA issued an untitled letter (dated July 15, 2016) to Danish allergy
immunotherapy company ALK-Abelló (ALK) over manufacturing and quality control issues at its Horsholm, Denmark facility. The letter comes after a 12-day inspection of the facility in March 2016. During the inspection, the FDA had cited ALK for four “significant deviations” from cGMP requirements. Another black
box warning added to antibiotics like Cipro and LevaquinThe
FDA has upgraded
warnings on
certain antibiotics, such as Johnson & Johnson’s Levaquin, Bayer’s Cipro
extended-release tablets and Merck’s Avelox. The FDA had
added a black box warning in 2008 about the increased risk of tendinitis in
which the tissue connecting muscle to bone becomes inflamed. In
May this year, the FDA had advised restricting the use of fluoroquinolone antibiotic for certain uncomplicated
infections and had warned about the disabling side-effects of the drug.The new warning talks about long-term risks to the drugs’ current black box warning. The agency also advised using the drugs only for serious infections. Manufacturers of fluoroquinolone have faced thousands of lawsuits from patients who claim that their injuries were caused by the drugs. J&J alone faced 3,400 lawsuits over Levaquin’s links to tendon problems and has also settled many of those cases. Takeda to
overhaul R&D, downsize operations in the UKTakeda Pharmaceutical of Japan has
said it plans to build a new pipeline of drugs. It plans to revamp its
research operations at the cost of around US $ 727 million.. The
company also plans to close some of its R&D operations in the UK. Takeda is
beginning the first ‘consultation stage’ of the layoff process in the UK, which hosts a pre-clinical R&D operation in Cambridge as well as a development center headquarter with facilities in the UK, Switzerland and Denmark.Under the revamp, Takeda’s R&D activities will be concentrated in Japan and the US, the 235-year old drug company said in a statement. Takeda plans to now focus on the three therapeutic areas of oncology, gastroenterology and the central nervous system.“We need to first build new capabilities and embrace new ways of working,” Andy Plump, Takeda’s chief medical and scientific officer, said in the statement.
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#PharmaFlow by PHARMACOMPASS
04 Aug 2016
