This
week in Phispers, we bring you the latest twists in the GSK-Gilead rivalry over
HIV drugs. India, which recently banned beef nationwide, plans to now replace
gelatin with cellulose-based capsules. A lawsuit in the US says Mylan may have
overcharged the government US$ 1.27 billion in the form of rebates on EpiPens.
And, there is an update on the opioid crisis. Read on.
After beef, India mulls banning animal-based gelatin capsules
As India deals with the aftermath
of the controversial cattle trade ban, the Health Ministry is reviewing a proposal to replace gelatin capsules with cellulose-based capsules which are of plant origin and are “safe for use” as compared to animal-based gelatin capsules. Various stakeholders, NGOs and consumers have 21 days to weigh the pros and cons of this proposal and respond.
India’s ministry of health and family welfare constituted an expert committee on March 20 this year to address all technical issues pertaining to replacement of gelatin capsules with cellulose-based capsules for encapsulation of drugs.
The Indian government's ban on the
trade of cattle for slaughter threatens US$ 4 billion in annual beef exports and millions of
jobs if the government does not revoke it.
Indian meat traders, under the
aegis of the Qureshi Action Committee and other trade and industry
associations, plan to petition India's Supreme Court to get the government
order revoked.
As Pfizer
hikes price of 91 drugs, Maryland enacts law to curb generic drug price gouging
Last week, we had shared our list of drugs with ‘no patents and no competition’.
While our list provides tremendous opportunities for generic companies in the short-term, we also warned that the FDA’s continued focus on accelerating review of these drugs will require companies to rely on strategies less opportunistic than price gouging, to drive their future business growth.
On
October 1, 2017 Maryland will become the first state in the United States to enact a law prohibiting “price gouging” by generic pharmaceutical manufacturers. The Bill was passed by the Maryland General Assembly on April 20, 2017. On May 26, Maryland Governor Larry Hogan sent a letter to the Speaker of the
House stating that he would allow the bill to become law without his signature.
The move coincides with Pfizer
hiking the price of 91 drugs by an
average of 20 percent so far this year in the United States. This includes
price hikes for its erectile dysfunction treatment, Viagra, and
its pain drug, Lyrica, on
June 1.
There are two essential provisions of the Maryland Bill. First, it prohibits a generic drug manufacturer or wholesale distributor from engaging in price gouging in the sale of an “essential off-patent or generic drug.”
Second,
the Bill authorizes the Maryland Medical Assistance Program (MMAP) to notify
the Maryland Attorney General of a price increase when the Wholesale
Acquisition Cost (WAC) of a prescription drug increases by at least 50 percent
from the WAC within the preceding one-year period. Or, when the price paid by
MMAP would increase by at least 50 percent from the WAC within the preceding
one year period and the WAC for either a 30-day supply or a full course of
treatment exceeds US$ 80.
Mylan may have
received US$ 1.27 billion more in rebate for EpiPens
In
the US, Senate Judiciary Committee Chairman Charles Grassley released a Medicaid
investigator's report which highlighted that Mylan’s EpiPen may have received US$ 1.27 billion more from the rebate program from 2006 through 2016 than what the company was entitled to receive.
The
amount is nearly three times a proposed settlement that the company had
announced in October 2016.
Earlier,
Mylan had said it would return US $465 million
to the government as part of settlement negotiations with the Department of
Justice (DOJ). Talks with the DOJ continue.
Senator Grassley has been involved in a long exchange with Mylan questioning
the significant price-hikes which the company had implemented over the years.
The
EpiPen auto-injector, used to treat allergic reactions, cost US$ 57 a shot when
Mylan purchased it in 2007. However, a series of price increases has raised the cost
to more than US$ 600 for a pair of EpiPens.
Before the price hike controversy hit Mylan, the Epipen generated more than US$ 1 billion in sales and contributed about 40 percent to Mylan’s overall profits.
GSK, Gilead’s HIV contest heats up, as GSK goes for priority review
Two
of the top 10 fastest growing drugs in 2016 were those used to treat HIV. GlaxoSmithKline’s Triumeq (abacavir,
dolutegravir, lamivudine) and Gilead’s Genvoya (elvitegravir,
cobicistat, emtricitabine, tenofovir alafenamide), both generated a
sales growth in excess of US$ 1 billion.
For
a long time, Gilead dominated the HIV market. But GSK fought back recently. In
an effort to stay ahead in the game, GSK used a priority review voucher,
for which it paid US$ 130 million, to shave four months off its application approval process.
ViiV Healthcare, the global specialist
HIV company majority-owned by GSK, with Pfizer Inc and Shionogi Limited as its shareholders,
announced regulatory submissions to the European Medicines Agency (EMA) and US
Food and Drug Administration (FDA) for the first HIV maintenance regimen
single-tablet, which comprises of only two medicines. The two-drug regimen
contains dolutegravir (Tivicay, ViiV
Healthcare) and rilpivirine (Edurant,
Janssen Sciences Ireland UC).
However,
don’t count Gilead out. In four late-stage studies, the US company's new drug
bictegravir was found to be as effective as GSK's established dolutegravir,
which has been the cornerstone of the British group's growing HIV business in
recent years.
This
year, Gilead plans to apply for regulatory approval to sell its combination of
bictegravir and emtricitabine/tenofovir alafenamide
(FTC/TAF), with a submission in the US in the second quarter and in Europe in
the third quarter.
If
Gilead uses a priority voucher at the US FDA, it could launch in the US market
in the first quarter of 2018, industry analysts said.
Mallinckrodt
explores divestment of its generics business
Mallinckrodt Plc plans to sell off its generic drug unit in a deal that could fetch the company around US$ 2 billion. The move would also help the specialty
pharmaceutical maker shift towards higher-margin branded drugs.
Mallinckrodt's generics unit has
seen its sales plummeting, in part because some of its products include
opiate-based pain killers, which have fallen out of favor with doctors due to
their addictive potential.
The divestment would complete the company’s gradual shift away from its original focus on generic drugs and nuclear imaging towards branded specialty pharmaceuticals, which now make up for bulk of its revenues.
Between 2015 and 2016,
Mallinckrodt's generic drug sales declined around 18 percent, to just over US$
1 billion. During the same period, sales of branded specialty drugs increased
by around US$ 2.3 billion.
The England-based Mallinckrodt has reportedly hired investment bank Credit Suisse
Group AG to run a sale process for the unit.
Canadian researchers trace
the origins of the opioid crisis, as Ohio sues drug makers
Last week, the state of Ohio in
the US sued five major drug manufacturers, accusing them of misrepresenting the risks of prescription
opioid painkillers that have fueled a skyrocketing drug addiction epidemic.
Opioid drugs, including
prescription painkillers and heroin, killed more than 33,000 people in the
United States in 2015, more than any year on record, according to the US
Centers for Disease Control and Prevention.
Canadian researchers have traced
the origins of the current opioid crisis to a letter published in the New England Journal of Medicine (NEJM) in 1980,
which stated that opioids were not addictive. The original letter
titled ‘Addiction Rare in Patients Treated with Narcotics’, was just a
paragraph long.
The lone evidence the letter cited
was an anecdote that out of 11,882 hospitalized patients treated with
narcotics, only four patients with no history of addiction became addicted.
The journal's prestige helped fuel
this misguided belief. The letter was cited over 600 times, usually to argue
that opioids were not addictive.
Last week, the NEJM published an unusual warning for readers about the 1980 letter.
The editor's note on the original letter in the NEJM reads,
"For reasons of public health, readers should be aware that this letter
has been 'heavily and uncritically cited' as evidence that addiction is rare
with opioid therapy."
The five companies
Ohio sued were Purdue Pharma LP, Johnson & Johnson's Janssen Pharmaceuticals Inc unit, a unit of Endo International Plc, Teva Pharmaceutical Industries Ltd's Cephalon unit and Allergan Plc".
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