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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https://www.pharmacompass.com/radio-compass-blog/teva-to-sell-assets-to-reduce-debt-lay-off-7-000-workers-shkreli-awaits-sentence
#PharmaFlow by PHARMACOMPASS
10 Aug 2017
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This week, Phispers tells us why David Hung’s taking charge as CEO of Axovant could signal the revival of an Alzheimer’s compound shelved by GSK. While, the FDA has extended compliance date for submitting DMFs in electronic format, there are also indications that there will be more FDA inspections in India. Plus, there is news on companies like Fresenius, Stada, Ajanta Pharma, Merck and Teva. Read on.
FDA
extends compliance date for electronic DMF submissions to May, 2018
On April
7, the US Food and Drug Administration (FDA) announced it is extending the compliance date for submitting DMFs in Electronic Common Technical Document (eCTD)
format to May 5, 2018.
“DMF submissions that are not submitted in eCTD format after this date will be rejected,” the FDA website said.
“Presentations on submitting in eCTD format created prior to April 7, 2017 will have the incorrect compliance date for DMFs,” it added. Electronic submissions of Drug Master Files (DMFs) were supposed to become mandatory from May 5, 2017.
The
news coincides with the US Senate’s confirmation hearing for Scott Gottlieb, on April 7. Gottlieb was President Trump’s nominee to be the next Commissioner of the FDA.
Gottlieb was with the FDA when the regulator launched its Pharmaceutical cGMPs for the 21st Century initiative. Out of five guidance documents
listed as part of this initiative, only one has been finalized.
With
Gottlieb heading back, Ajaz Hussain, (former FDA deputy office director and
president of the National Institute for Pharmaceutical Technology and
Education of NIPTE), Vadim Gurvich (executive
director of NIPTE) and Peter J. Pitts (president of the Center for Medicine in
the Public Interest and a former FDA associate commissioner) shared their
perspective on how Trump and the FDA can create a pharmaceutical manufacturing renaissance in a blog posted on Morning Consult.
Axovant appoints new CEO and revives ghosts of GSK’s billion dollar mistake
After
selling Medivation to Pfizer for US $ 14 billion and
exiting with US $ 354 million for himself, David Hung is now the CEO of Axovant, the company which we wrote about two years ago, as we asked the question — Did a 29-year old show GSK that it made a billion dollar mistake?
Back in December 2014,Vivek Ramaswamy, CEO and Founder of Roivant Neurosciences and Axovant, had bought an old Alzheimer’s drug that GSK had dropped for US $ 5 million. In October 2014, Roivant had spun off a subsidiary by the name of Axovant, which then bought the GSK drug. GSK had shelved the compound — 5HT6 — after testing it in 13 trials and on 1,250 patients.
Six months after purchasing the compound from GSK, and
without doing any clinical development, the drug resulted in the biggest
biotech IPO ever for Axovant, which got valued at US $ 2 billion. Since then,
Ramaswamy has been setting up more companies.
Throughout, Ramaswamy has recruited high-profile executives to run his companies. And who could be more high profile than Hung? The stock market cheered his appointment — Axovant’s stock was up 28 percent
earlier this week after Hung was announced its CEO.
Axovant is looking for positive data that GSK had gathered for its 5HT6 Alzheimer’s drug. And a number of senior players in the industry say Axovant has a decent shot at taking the successful dose back into the clinic. With Hung joining, it seems the drug discarded by GSK does indeed have merit.
Fresenius
in talks to buy Akorn; Stada sold for US $5.6 billion
Fresenius SE said
it is in talks to buy US generic drugmaker - Akorn Inc.
Though discussions are underway, there is no certainty of a deal, Fresenius
said. A spokeswoman for Akorn
declined to comment.
The CEO of Fresenius, Stephan Sturm, who took charge in July 2016, has been expanding the group’s global reach through acquisitions. Last year, the company bought Spanish hospital group IDC Salud Holding SLU, also known as Quironsalud, for US $ 6.11 billion (Euro 5.76 billion) in the company’s largest-ever acquisition.
Akorn could complement Fresenius’ Kabi medicines division, which specializes in intravenous drugs, and accounts for about a fifth of the company’s revenue.
Stada sell-off: Stada Arzneimittel AG has been sold to Bain Capital and Cinven for US
$ 5.6 billion (Euros 5.3 billion), after
a long-fought takeover contest. The sell-off will give the equity firms
control of one of the last independent generic-drug businesses in Europe.
The
deal would give buyers access to German and Russian markets for OTC and copycat
medicines. It marks another step in the consolidation of the generics
industry.
FDA inspections in India to rise, says Edelweiss Securities
India’s pharmaceutical sector is the largest supplier of drugs to the US. However, “quality issues are an ongoing challenge for the Indian pharmaceutical industry,” Mary Lou Valdez, FDA’s associate commissioner for international programs wrote in a blog.
Of the 42 warning letters sent out by FDA’s office of manufacturing quality last year, about one-fifth (9) were addressed to Indian facilities. The number could rise over the next three years as the FDA would inspect 190 facilities that it could not inspect in the past five years, wrote Edelweiss Securities.
FDA inspections in India and China have doubled since 2012.
This has led to a spurt in warning letters as well.
GSK to withdraw 600,000 inhalers; no observations for Ajanta
GSK would be voluntarily recalling close to 600,000 Ventolin asthma
inhalers across the US, says the FDA. The recall is due to a leak observed in
some of the products.
The exact number of inhalers to be recalled, as reported by the FDA, is 593,088. These were produced in GSK’s Zebulon, North Carolina manufacturing facility. This is the second time in just over a year that the plant has faced problems with leaking inhalers.
Ajanta Pharma: On Monday this week,
shares of India-based Ajanta Pharma soared by over
5 percent in intraday trading as investors cheered the fact that no observations were issued during a regulatory
inspection at its unit.
“Our formulation facility at Dahej (in Gujarat) was inspected by US Food and Drug Administration (FDA) from April 3 to April 7, 2017. At the end of the inspection, no Form 483 was issued to us,” Ajanta Pharma said in a notification to the stock exchanges.
FDA delivers a blow to Merck’s Januvia marketing plan
In 2015, Merck had come out with a massive 14,724-patient study where the data demonstrated that Type 2 diabetes patients could take its flagship DPP-4 drug — Januvia — without increasing their risk for cardio complications. DPP-4 inhibitors work by blocking the action of DPP-4, an enzyme which destroys the hormone incretin.
Merck wanted to use the
findings of this survey in a label to help distinguish themselves from
same-class rivals like Onglyza, which has risks.
However, the FDA recently nixed the idea, handing the pharma giant a complete response letter
(CRL).
The CRL covered Merck’s blockbuster Januvia as well as its combos with metformin. However, Merck says it
is reviewing the letter and will discuss next steps with the FDA.
Teva’s US $ 3.5 billion buy pays off with FDA approval of Austedo
Last week, the FDA gave its nod for Teva’s promising drug deutetrabenazine, after
putting it on hold ten months back due to certain suspicions regarding some
metabolites found in patients.
Teva had paid US $ 3.5
billion to acquire Auspex two years back. Teva’s deutetrabenazine is the
first deuterated drug to bag
an FDA approval.
A
deuterated drug is a drug where hydrogen has
been replaced by deuterium. A simple swap of six hydrogens with deuterium in an existing drug, Xenazine® (tetrabenzaine), resulted in an improved version of the drug, called deutetrabenzaine
or SD-809 (which had been developed by Auspex).
The
drug will be sold as Austedo. Due to the presence of deuterium, the drug breaks down more slowly in patients. This way physicians can give the drug less
often and at lower doses and still manage great results. The drug is designed
to regulate the levels of dopamine in
the brain.
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https://www.pharmacompass.com/radio-compass-blog/ghosts-of-gsk-s-billion-dollar-mistake-return-new-date-for-electronic-submissions-of-dmfs
#PharmaFlow by PHARMACOMPASS
13 Apr 2017
