Market Place
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".
Impressions: 3177
https://www.pharmacompass.com/radio-compass-blog/after-beef-india-may-ban-gelatin-capsules-gsk-gilead-s-hiv-race-heats-up
#PharmaFlow by PHARMACOMPASS
08 Jun 2017
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Global
pharmaceutical companies are increasingly focusing on the development of new
biologics. In fact, in 2016, nine out of the top
15 pharmaceutical drugs by sales were of biologic origin. This makes us wonder
what the future holds for manufacturers specializing in drugs that originate
from chemical synthesis.
This
week, PharmaCompass continued its analysis of the top pharma drugs by
sales to evaluate the drugs that registered large sales growth in 2016.
Click here to Access All the 2016 Data (Excel version available) for FREE!
Please
note that these are not the top-selling drugs, but are the top 10 drugs that
registered the maximum growth in global sales over 2015.
Interestingly, things didn’t appear that bad for drugs originating from chemical synthesis — while the top two drugs on the list were biologics, the remaining originated from chemical synthesis.
Here’s a list of drugs that witnessed the largest sales growth in 2016:
1. Opdivo (nivolumab) – Bristol-Myers Squibb
2016
sales: US$ 3,774 million
2015 sales:
US$ 942 million
Sales
growth: US$ 2,832 million
First
approved in 2014, Bristol-Myers Squibb’s Opdivo and Merck’s Keytruda — also known as checkpoint inhibitors — continued to stay on track to be among the top 20 best-selling drugs in the world by 2020. They represent the hot new field of immunotherapy and are known to have given 90-year old Jimmy Carter (former President of the United States) hope in his fight against cancer.
With
a sales growth of US$ 2.832 billion, Opdivo registered the highest sales growth
of any single drug in 2016. However, Bristol-Myers Squibb received a nasty
surprise last year when Opdivo did not demonstrate the desired slowdown in the
progress of advanced lung cancer in a trial, as compared to conventional
chemotherapy.
While Bristol-Myers’ stock price plunged on this news, Merck announced that not only did Keytruda succeed in a clinical trial as an initial treatment for advanced non-small cell lung cancer, but patients actually lived longer. Although Keytruda did not make it to our list of top 10 drugs by sales growth in 2016, it did register a sales increase of US$ 836 million, as its sales grew from US$ 566 million to US$ 1,402 million.
Click here to Access All the 2016 Data (Excel version available) for FREE!
2. Humira (adalimumab) – AbbVie
2016
sales: US$ 16,078 million
2015
sales: US$ 14,012 million
Sales
growth: US$ 2,066 million
Abbvie’s Humira (adalimumab)
juggernaut continued as it not only remained the best-selling drug in the
world, but also added another US$ 2 billion to its 2015 sales by generating
record sales of US $16.078 billion in 2016.
Last
year, the US Food and Drug Administration (FDA) approved Amgen’s Amjevita™ (adalimumab – atto) — a biosimilar of Humira®. Therefore, it remains to be seen if Humira will be able to sustain the momentum. Amjevita was approved for treating adults with a variety of medical conditions ranging from rheumatoid arthritis, plaque psoriasis, to ulcerative colitis.
3. Epclusa (sofosbuvir and velpatasvir) – Gilead
2016
sales: US$ 1,752 million (new launch)
Gilead’s third sofosbuvir-based regimen — Epclusa (sofosbuvir and velpatasvir) was approved by the US FDA in June 2016. It is the first and only all-oral, pan-genotypic single tablet regimen for chronic Hepatitis C virus infection. While Epclusa registered an impressive start, Gilead's other two sofosbuvir-based treatments — Sovaldi (sofosbuvir) and Harvoni (sofosbuvir and lepidasvir) — saw their combined sales decline by almost US$ 6 billion.
Click here to Access All the 2016 Data (Excel version available) for FREE!
4. Imbruvica (ibrutinib) — Johnson & Johnson / AbbVie
2016
sales: US$ 3,083 million
2015
sales: US$ 1,443 million
Sales
growth: US$ 1,640 million
Abbvie’s 2015 US$ 21 billion buy of Pharmacyclics seems to be paying off.
The Pharmacyclics buy was a way to get access to Imbruvica (ibrutinib), a cancer drug which
is co-marketed with Johnson & Johnson. It generated sales of US$ 3.083 billion in 2016. Imbruvica works by blocking a specific protein called Bruton’s tyrosine kinase (BTK). In December 2011, Johnson & Johnson said it would pay Pharmacyclics as much as US$ 975 million to fund getting the drug to market in exchange for half the profits generated globally.
5. Eliquis (apixaban) -
Bristol-Myers Squibb / Pfizer
2016
sales: US$ 3,342 million
2015
sales: US$ 1,860 million
Sales
growth: US$ 1,483 million
Although
apixaban was the third-to-market
novel oral anticoagulant (NOAC), which is co-promoted by Pfizer and Bristol-Myers Squibb as Eliquis, it continues to unseat Johnson & Johnson’s Xarelto (rivaroxaban) as the leader in its
class based on total prescriptions. Rivaroxaban's total 2016 sales were US$
5.392 billion.
While Pfizer’s reports its sales as part of Alliance revenues, and exact sales are not known, Bristol-Myers Squibb results alone put Eliquis in the top 10 list. Generics are hot on their tail as, last month, Pfizer and Bristol-Myers’ filed suits against 16 generic makers to uphold their patents for apixaban.
6. Genvoya (elvitegravir,
cobicistat, emtricitabine, tenofovir alafenamide) — Gilead
2016
sales: US$ 1,484 million
2015
sales: US$ 45 million
Sales
growth: US$ 1,439 million
Genvoya has been the most
successful HIV treatment launch since the introduction of Atripla (the first
single-tablet regimen launched a decade ago). Gilead is the dominant HIV
player in the US market and has the top three most-prescribed HIV regimens in
the US.
Genvoya
adds Tenofovir Alafenamide (TAF) to already known
treatments. TAF based drugs have demonstrated a better safety profile. They
would also allow Gilead to maintain its dominance in the HIV market.
Click here to Access All the 2016 Data (Excel version available) for FREE!
7. Ibrance (palbociclib) — Pfizer
2016
sales: US$ 2,135 million
2015
sales: US$ 723 million
Sales
growth: US$ 1,412 million
Discovered
in Pfizer laboratories and approved by the US
FDA in February 2015, Ibrance is used in combination
with Letrozole as a first-line
treatment of postmenopausal women with estrogen receptor-positive, human
epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast
cancer.
8. Triumeq (abacavir,
dolutegravir, lamivudine) – GlaxoSmithKline
2016
sales:US$ 2,151 million
2015
sales: US$ 905 million
Sales
growth: US$ 1,246 million
GlaxoSmithKline's HIV drugs business — ViiV Healthcare — has been enjoying sales growth with the introduction of Triumeq ® in its portfolio. While GSK is the major shareholder in ViiV Healthcare, Pfizer and Shionogi also have a stake. Triumeq® is the company’s first fixed-dose combination tablet for a once-daily single pill regimen that combines dolutegravir, an integrase inhibitor, with the nucleoside reverse transcriptase inhibitors — abacavir and lamivudine.
9. Revlimid (lenalidomide) – Celgene
2016
sales: US$ 6,974 million
2015
sales: US$ 5,801 million
Sales
growth: US$ 1,173 million
Celgene’s Revlimid (lenalidomide) — a thalidomide-derivative introduced in 2004 as an immunomodulatory agent for the treatment of various cancers such as multiple myeloma — brought in US$ 5.8 billion in 2015, and grew another 20 percent this year, to US $6.974 billion. Revlimid now contributes more than 60 percent to Celgene's total sales of US$ 11.229 billion.
10. Xarelto (rivaroxaban) – Johnson & Johnson (US) and Bayer
2016
sales: US$ 5,392 million
2015
sales: US$ 4,255 million
Sales
growth: US$ 1,137 million
Bayer’s Xarelto, which is promoted by Johnson & Johnson in the United States, provided patients with an alternative to the old-guard therapy — warfarin. While rivaroxaban is competing with other
novel oral anticoagulants (NOAC) like Eliquis (apixaban) and Pradaxa (dabigatran), rivaroxaban has the
class lead in indications.
Xarelto
recently posted positive results in a large-scale Phase 3 study —COMPASS, involving 27,402 patients, that assessed the effect of the
blood thinner in preventing major adverse cardiac events (MACE).
The
trial was stopped a year early
on the advice of an independent Data Monitoring Committee, after the primary
endpoint of prevention of MACE (which includes cardiovascular death, myocardial
infarction and stroke) reached its pre-specified criteria for superiority over aspirin.
Click here to Access All the 2016 Data (Excel version available) for FREE!
Our
view
In QuintilesIMS Institute’s new annual drug spending report, analysts have forecasted that
over the coming five years the industry should continue to receive 40 to 45 new
drug approvals every year.
A quarter of all the drugs in late-stage development are now
focused on oncology. The rate of oncology drug development has hit such a
rapid pace that new drugs are superseding old ones in a matter of a few years.
It’s clear that this compilation will see radical changes next year. However, with eight out of the 10 fastest-selling drugs coming from chemical synthesis, traditional generic manufacturers still have a lot of opportunities to explore.
Sign up,
stay ahead
In order to stay informed,
and receive industry updates along with our data compilations, do sign up for
the PharmaCompass Newsletter and you will receive updated information as
it becomes available along with a lot more industry analysis.
Click here to Access All the 2016 Data (Excel version available) for FREE!
Impressions: 9289
https://www.pharmacompass.com/radio-compass-blog/chemical-entities-shine-in-the-top-10-fastest-growing-drugs-of-2016
#PharmaFlow by PHARMACOMPASS
17 May 2017
