Acquisitions and spin-offs dominated headlines in 2019 and the tone was set very early with Bristol-Myers Squibb acquiring
New Jersey-based cancer drug company Celgene in a US$ 74 billion deal announced on
January 3, 2019. After factoring
in debt, the deal value ballooned to about US$ 95 billion, which according
to data compiled by Refinitiv, made it the largest healthcare deal on
record.
In the summer, AbbVie Inc,
which sells the world’s best-selling drug Humira, announced its acquisition of Allergan Plc, known for Botox and other cosmetic
treatments, for US$ 63 billion. While the companies are still awaiting
regulatory approval for their deal, with US$ 49 billion in combined 2019
revenues, the merged entity would rank amongst the biggest in the industry.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
The big five by pharmaceutical sales — Pfizer,
Roche, J&J, Novartis and Merck
Pfizer
continued
to lead companies by pharmaceutical sales by reporting annual 2019 revenues of
US$ 51.8 billion, a decrease of US$ 1.9 billion, or 4 percent, compared to
2018. The decline was primarily attributed to the loss of exclusivity of Lyrica in 2019,
which witnessed its sales drop from US$ 5 billion in 2018 to US$ 3.3 billion in
2019.
In 2018, Pfizer’s then incoming CEO Albert Bourla had mentioned that the company did not see the need for any large-scale M&A activity as Pfizer had “the best pipeline” in its history, which needed the company to focus on deploying its capital to keep its pipeline flowing and execute on its drug launches.
Bourla stayed true to his word and barring the acquisition of Array Biopharma for US$ 11.4 billion and a spin-off to merge Upjohn, Pfizer’s off-patent branded and generic established medicines business with
Mylan, there weren’t any other big ticket deals which were announced.
The
Upjohn-Mylan merged entity will be called Viatris and is expected to have 2020
revenues between US$ 19 and US$ 20 billion
and could outpace Teva to
become the largest generic company in the world, in term of revenues.
Novartis, which had
followed Pfizer with the second largest revenues in the pharmaceutical industry
in 2018, reported its first full year earnings after spinning off its Alcon eye
care devices business division that
had US$ 7.15 billion in 2018 sales.
In 2019,
Novartis slipped two spots in the ranking after reporting total sales of US$
47.4 billion and its CEO Vas Narasimhan continued his deal-making spree by buying New
Jersey-headquartered The Medicines Company (MedCo) for US$ 9.7
billion to acquire a late-stage cholesterol-lowering
therapy named inclisiran.
As Takeda Pharmaceutical Co was
busy in 2019 on working to reduce its debt burden incurred due to its US$ 62
billion purchase of Shire Plc, which was announced in 2018, Novartis also purchased
the eye-disease medicine, Xiidra, from the Japanese drugmaker for US$ 5.3 billion.
Novartis’ management also spent a considerable part of 2019 dealing with data-integrity concerns which emerged from its 2018 buyout of AveXis, the
gene-therapy maker Novartis had acquired for US$ 8.7 billion.
The deal gave Novartis rights to Zolgensma,
a novel treatment intended for children less than two years of age with the
most severe form of spinal muscular atrophy (SMA). Priced at US$ 2.1 million,
Zolgensma is currently the world’s most expensive drug.
However,
in a shocking announcement, a month after approving the drug, the US Food and
Drug Administration (FDA) issued a press release on
data accuracy issues as the agency was informed by AveXis that
its personnel had manipulated data which
the FDA used to evaluate product comparability and nonclinical (animal)
pharmacology as part of the biologics license application (BLA), which was
submitted and reviewed by the FDA.
With US$
50.0 billion (CHF 48.5 billion) in annual pharmaceutical sales, Swiss drugmaker
Roche came in at number two position in 2019
as its sales grew 11 percent driven by
its multiple sclerosis medicine Ocrevus, haemophilia drug Hemlibra and cancer medicines Tecentriq and Perjeta.
Roche’s newly introduced medicines generated US$ 5.53 billion (CHF 5.4 billion) in growth, helping offset the impact of the competition from biosimilars for its three best-selling drugs MabThera/Rituxan, Herceptin and Avastin.
In late 2019, after months of increased
antitrust scrutiny, Roche completed
its US$ 5.1 billion acquisition of Spark Therapeutics to strengthen its presence in
gene therapy.
Last year, J&J reported almost flat worldwide sales of US$ 82.1 billion. J&J’s pharmaceutical division generated US$ 42.20 billion and its medical devices and consumer health divisions brought in US$ 25.96 billion and US$ 13.89 billion respectively.
Since J&J’s consumer health division sells analgesics, digestive health along with beauty and oral care products, the US$ 5.43 billion in consumer health sales from over-the-counter drugs and women’s health products was only used in our assessment of J&J’s total pharmaceutical revenues. With combined pharmaceutical sales of US$ 47.63 billion, J&J made it to number three on our list.
While the sales of products like Stelara, Darzalex, Imbruvica, Invega Sustenna drove J&J’s pharmaceutical business to grow by 4 percent over 2018, the firm had to contend with generic competition against key revenue contributors Remicade and Zytiga.
US-headquartered Merck, which is known as
MSD (short for Merck Sharp & Dohme) outside the United States and
Canada, is set to significantly move up the rankings next year fueled by its
cancer drug Keytruda, which witnessed a 55
percent increase in sales to US$ 11.1 billion.
Merck reported total revenues of US$ 41.75 billion and also
announced it will spin off its women’s health drugs,
biosimilar drugs and older products to create a new pharmaceutical
company with US$ 6.5 billion in annual revenues.
The firm had anticipated 2020 sales between US$ 48.8 billion and US$ 50.3 billion however this week it announced that the coronavirus pandemic will reduce 2020 sales by more than $2 billion.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Humira holds on to remain world’s best-selling drug
AbbVie’s acquisition of Allergan comes as the firm faces the expiration of patent protection for Humira, which brought in a staggering US$ 19.2 billion in sales last year for
the company. AbbVie has failed to successfully acquire or develop a major new
product to replace the sales generated by its flagship drug.
In 2019, Humira’s US revenues increased 8.6 percent to US$ 14.86 billion while internationally, due
to biosimilar competition, the sales dropped 31.1 percent to US$ 4.30 billion.
Bristol Myers Squibb’s Eliquis, which is also marketed by Pfizer, maintained its number two position
and posted total sales of US$ 12.1 billion, a 23 percent increase over 2018.
While Bristol Myers Squibb’s immunotherapy treatment Opdivo, sold in partnership with Ono in Japan, saw sales increase from US$ 7.57 billion to US$ 8.0 billion, the growth paled in comparison to the US$ 3.9
billion revenue increase of Opdivo’s key immunotherapy competitor Merck’s Keytruda.
Keytruda took the number three spot in drug sales that
previously belonged to Celgene’s Revlimid, which witnessed a sales decline from US$ 9.69 billion to US$ 9.4 billion.
Cancer treatment Imbruvica, which is marketed
by J&J and AbbVie, witnessed a 30 percent increase in sales. With US$ 8.1
billion in 2019 revenues, it took the number five position.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Vaccines – Covid-19 turns competitors into partners
This year has been dominated by the single biggest health emergency in years — the novel coronavirus (Covid-19) pandemic. As drugs continue to fail to meet expectations, vaccine development has received a lot of attention.
GSK reported the highest vaccine sales of all drugmakers with
total sales of US$ 8.4 billion (GBP 7.16 billion), a significant portion of its
total sales of US$ 41.8 billion (GBP 33.754 billion).
US-based Merck’s vaccine division also reported a significant increase in sales to US$ 8.0 billion and in 2019 received FDA and EU approval to market its Ebola vaccine Ervebo.
This is the first FDA-authorized vaccine against the deadly virus which causes
hemorrhagic fever and spreads from person to person through direct contact with
body fluids.
Pfizer and Sanofi also reported an increase in their vaccine sales to US$ 6.4
billion and US$ 6.2 billion respectively and the Covid-19 pandemic has recently
pushed drugmakers to move faster than ever before and has also converted
competitors into partners.
In a rare move, drug behemoths — Sanofi and GlaxoSmithKline (GSK) —joined hands to develop a vaccine for the novel coronavirus.
The two companies plan to start human trials
in the second half of this year, and if things go right, they will file
for potential approvals by the second half of 2021.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Our view
Covid-19 has brought the world economy to a grinding halt and shifted the global attention to the pharmaceutical industry’s capability to deliver solutions to address this pandemic.
Our compilation shows that vaccines and drugs
for infectious diseases currently form a tiny fraction of the total sales of
pharmaceutical companies and few drugs against infectious diseases rank high on
the sales list.
This could well explain the limited range of
options currently available to fight Covid-19. With the pandemic currently infecting
over 3 million people spread across more than 200 countries, we can safely
conclude that the scenario in 2020 will change substantially. And so should our
compilation of top drugs for the year.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Impressions: 55100
A review of the Drug Master Files (DMFs) submitted to the United
States Food and Drug Administration (FDA) from October 2016 to March 2017 (the
fourth quarter of 2016 and the first quarter of 2017) indicates an extremely
robust pharmaceutical industry in India. However, the filing make one question
an article we had carried earlier this month on the end of India’s pharma honeymoon.
India filed more than half the DMFs submitted
Indian companies filed more than half (176) of the 345 DMFs
submitted with the FDA. China (60) came a distant second, followed by the
United States (40). While DMF submissions were made from 26 other countries,
the activity levels seen were a far cry from what was seen in India and
China.
In our past compilation for the second and third quarters of 2016,
Macleods Pharmaceuticals (14 DMFs) had pipped MSN Laboratories (13 DMFs) to become the leading filer from
India.
However, in the recent review period, MSN bounced back with 41 DMF
submissions, compared to six for Macleod. Leading Indian pharmaceutical majors
such as Aurobindo,
Sun Pharma, Amneal,
Mylan’s
India operations, Hetero,
Cipla
and Jubilant
had six or more filings each.
Ajinomoto’s
North American operations filed 11 DMFs for various amino acids and led the
submissions for products manufactured in the United States.
Tianjin Weijie Pharmaceutical led the pack from China, with eight DMF
submissions.
Over the review period, a total of 345 submissions were made to the
FDA, almost similar to the 379 DMFs filed during the second and third quarters
of 2016.
Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE!
The next FTF challenges
Since APIs form the building blocks of finished formulations, DMF
submissions give a sneak preview into the next possible first-to-file (FTF)
generic challenges to patented drugs.
In
December 2016, Indian drug major Sun Pharmaceutical Industries
announced it will acquire a branded oncology product, Odomzo,
from Novartis
for an upfront payment of US$ 175 million.
A little over three months after the announcement, MSN Labs filed the first DMF for Odomzo’s active pharmaceutical ingredient (API), sonidegib phosphate. Odomzo was approved by the FDA in July
2015 and is indicated for the treatment of adult patients with locally advanced
basal cell carcinoma.
While patents for Novartis’ drugs Tafinlar
and Mekinist
are not scheduled to expire until 2029, Novartis should prepare for a generic
competitor as DMFs were filed for the APIs used in both drugs by MSN Labs. The
drugs had combined sales in 2016 of US$ 672 million.
Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE!
In addition, MSN Labs also filed the first DMF for nintedanib esylate, the API used in Boehringer Ingelheim’s idiopathic pulmonary fibrosis treatment,
Ofev, and for cabozatinib (S)-malate, the API used by Exelixis for its kidney cancer treatment — Cabometyx.
While in most cases MSN’s DMF is the first one to get filed, in the case of Helsinn’s
Akynzeo,
which is used to prevent chemotherapy-induced nausea and vomiting, Apicore US also filed a DMF along with MSN.
Although sales forecasts for Bayer’s pulmonary arterial hypertension treatment — Adempas (riociguat) — were lowered as the drug did not get the expected sales start
and planned label expansions did not materialize, this did not stop MSN Labs
from filing the first DMF for this product as well.
Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE!
Another drug which is struggling to meet analyst expectations is Novartis’ Entresto. Once considered “one of the most important products in the company's history” with an expectation to reach US$ 10 billion in peak sales, the drug generated sales of only US$ 170 million in 2016. Regardless, Mylan filed the first DMF for the API.
Another drug where MSN Labs did not file the first DMF was for AstraZeneca’s
ovarian cancer treatment, Lynparza (olaparib).
Alp Pharm Beijing submitted the DMF for the drug which
generated US$ 218 million in sales in 2016 and a figure Bernstein Research
analyst Timothy Anderson forecasts will grow to US$ 684 million by 2020.
The onslaught on Novartis’ portfolio is not limited to only patented products as Lamprene,
a product which has been on the market since 1986, and not had any generic
competitor, had Zhejiang Huahai file a DMF indicating a generic competitor maybe on the horizon
soon.
Mylan’s Sotradecol
has been the only injectable form of sodium tetradecyl sulfate
on the market since 2004. That monopoly may end soon as the FDA completed the
review of a DMF filed for the API early this year.
Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE!
Most actively filed products — vortioxetine hydrobromide and dolutegravir sodium
The most actively filed DMFs, with seven filings each, were those
for Takeda’s
depression drug Trintellix (vortioxetine hydrobromide) and GSK’s HIV treatment dolutegravir sodium.
Johnson & Johnson’s diabetes treatment Invokana (canagliflozin), which recently demonstrated that it
decreased the risk of heart attacks and strokes, while increasing the risk of amputation,
particularly of toes, had six new DMFs filed.
There were also six new DMFs filed for apremilast,
five for darunavir
and four each for dapagliflozin
and rivaroxaban.
Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE!
Filings for new drugs under development
Helsinn is moving ahead with the filing of anamorelin hydrochloride, as it filed DMFs for the API and the 100
mg tablets, a product which was welcomed enthusiastically by oncology experts as it raised hopes to
be a drug for cancer cachexia, the extreme wasting seen at the end stages of
the disease.
But those hopes were recently dashed, as a review of the clinical
data by the European Medicines Agency's Committee for Medicinal Products for
Human Use (CHMP) found only "marginal" effects and recommended that
the product be refused marketing authorization in Europe.
Now it remains to be seen what the FDA’s verdict on this drug will be.
Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE!
AB Science’s Masitinib has been in the news recently as an EMA committee announced the drug, developed for a range of cancers, could not be approved due to “serious failings” in the way clinical studies were conducted.
However, this did not stop Excella GmbH from filing its second DMF for the API.
Multiple sclerosis treatment dimethyl fumarate (Biogen’s Tecfidera) generated
sales of US$ 3.97 billion in 2016 and is projected to achieve US$ 5.56 billion by 2020.
While there are now 28 DMFs filed for dimethyl fumarate, in March
this year Alkermes
announced the initiation of a new phase 3 study
of ALKS 8700, a novel, oral monomethyl fumarate (MMF) prodrug candidate in
development for the treatment of relapsing forms of multiple sclerosis.
It remains to be seen when Alkermes’ product will get approved. However, MSN Labs followed Honour Labs to file the second DMF for this product.
Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE!
A new submission for deslorelin acetate
(an injectable gonadotropin releasing hormone super-agonist) indicates there
maybe a new drug development underway for this age-old peptide as currently
there are no approved drugs in the US.
A similar situation seems to exist for taurolidine,
an antimicrobial that seeks to prevent infections in catheters.
Vasudha Pharma’s filing of cisapride monohydrate comes as a surprise. The product, which
was launched by Janssen for increased motility of the
gastrointestinal tract, was later withdrawn from the US market due to concerns of
fatalities linked to cardiac arrhythmias.
The product, however, continues to be exported from India to
countries like Switzerland, Thailand, Mexico, China and Canada.
Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE!
Our view
The last quarter of 2016 and the first quarter of 2017 clearly
demonstrate an API industry in India and China, which is extremely active with
new product development, regardless of disappointing financial results posted
by major pharma companies and growing concerns over regulatory non-compliances.
Given the market headwinds and increased compliance expectations,
it remains to be seen how many of these DMFs filed actually result in drugs
reaching the market.
Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE!
Impressions: 5969
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: 3246
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: 9365
This week, Phispers takes you through the EpiPen price hike controversy, and the Indian government’s decision not to adopt a bulk drug policy. There is more news pertaining to Teva’s divestitures, GSK’s new drug for HIV treatment and drug recalls by Cadila, Teva and Sagent. A setback to Indian pharma as minister
says govt against bulk drug policy Earlier this year PharmaCompass had highlighted the ‘inconvenient
truth about Chinese drug manufacturing’ – that a serious imbalance exists in the global supply chain with regard to its dependence on China. India had declared 2015 as the Year of the API, under the ‘Make in India ‘programme. A Cabinet note for a bulk drug policy, based on the recommendations of the Katoch committee, had been floated
earlier this year. Such a policy would have helped the Indian
pharmaceutical sector turn into a US $ 200-billion industry by 2030, and
shifted global dependence away from China.However, the plan suffered a setback as the chemical and fertiliser minister Ananth Kumar announced this week that
the government was against
a bulk drug policy. Instead, states will have to come up with “bulk drug parks” which will help boost manufacturing of bulk drugs.This news comes at a time when a Bloomberg
analysis concluded that China
drug sales grow despite safety concerns at home. Around 700 Chinese firms were told by regulators in China to review their pending applications to sell new drugs and voluntarily withdraw those that were false or incomplete. “Within months, about 75 percent had been retracted by the manufacturers or rejected by Chinese officials,” the Bloomberg report said.Currently, India is dependent on China for APIs. More than 75 per cent of India’s bulk drug imports come from China. And there is concern over quality. Mylan CEO blames system for EpiPen price hike,
announces launch of generic versionLast week, Mylan made headlines as its 400 percent price increase of EpiPen auto-injector came under scrutiny. The furor continued,
even as the Mylan CEO Heather Bresch tried her best to justify the price hikes
in an interview, which generated more negative publicity. In the interview, Bresch blamed the healthcare system for the price hike. According to her, the price of US $ 608 for the life-saving EpiPen reflects a system where there are “four or five hands that the product touches and companies that it goes through before it ever gets to that patient at the counter.” This week, Mylan tried to suppress the furor by
announcing it would launch an authorized generic version of EpiPen for half the price of the brand-name product. The identical generic two-pack of EpiPens, expected to launch in several weeks, will have a list price of US $ 300. This is still significantly higher than the price of the auto-injector prior to Mylan’s acquisition of the EpiPen in 2007. In Canada, the twin pack costs US $ 200, in France it is around US $ 100.In the interview, Bresch acknowledged that the high
retail price in the US was used to subsidize the price of EpiPens in Europe, where
they sold at just US $ 100 or US $ 150.Bresch went onto say: “Congress and the leaders of this country need to quit putting their toe in this topic and really fix this — we have an outdated system.”After the interview, pharma bad boy Martin Shkreli defended the price increase while some Americans turned to Canada for cheaper EpiPens. And Senators questioned if the FDA was to blame for the high drug prices. Meanwhile, analysts said the authorized generic
version of EpiPen may actually make more money for Mylan! Aurobindo, Intas in race to buyout UK and Irish
portfolios of TevaLast week, two Indian drug makers – Aurobindo Pharma and Intas Pharmaceuticals – emerged as the final contenders to buyout the UK and Irish portfolios of Teva. These portfolios of the Israeli generics behemoth have been put up for
sale to comply with the European anti-trust regulations.Both Aurobindo and Intas put
up binding offers of around US $ 1 billion, along with firm financing
commitments, The Economic Times
reported. Last year, Teva had acquired
Allergan Plc’s generic business for US $ 40.5 billion. Teva
is selling assets as part of a broader divestiture process to comply with the
anti-trust regulations for this acquisition.In order to comply with
these regulations, Teva has already sold 80 products in the US to drug makers
like Dr Reddy’s, Sagent, Cipla, Zydus Cadila, Aurobindo, Impax and Perrigo. Glaxo plans to shake up HIV treatment with new drugGlaxoSmithKline plans to capsize the decade-old strategy for treating HIV. Executives at GSK are hoping that the company’s latest HIV pill is powerful enough to suppress the virus, with the help of just one more drug. The drug – Dolutegravir – belongs to a class of HIV drugs known as integrase inhibitors that rapidly reduces the level of virus in the blood. It has already been approved for use as part of traditional triple therapy and hasn’t reported cases of the virus developing resistance to dolutegravir in patients who are new to the treatment.Since the mid-1990s, the treatment of HIV – a virus that causes AIDS – hasn’t changed much. In the mid-1990s, a new class of antiretroviral drugs were introduced. One drug from the new class, along with two other drugs from an earlier class, hindered the virus from developing resistance. This three-drug regimen has been the standard approach for treating HIV for the last two decades.Dolutegravir, according to GSK CEO Andrew Witty, would
be the game changer because taking fewer drugs will lead to fewer side effects.GSK’s majority-owned HIV business – ViiV Healthcare – is undergoing the long process of proving the efficacy of the Dolutegravir. Pfizer and Japan’s Shionogi & Co hold minority shares
in ViiV Healthcare. Japanese wholesaler arrested for illegally selling drugs to Chinese
touristsHidenobu Zaima, president of Tokyo-based drug wholesaler – Biken Pharmacy, was arrested along with four others, on the suspicion of illegally selling
large quantities of prescription drugs to Chinese tourists and violating the
Pharmaceutical and Medical Device Law.Zaima is believed to have sold about 291,000 products
to a Chinese broker for US $ 147,000 between September 2015 and May 2016. Chinese tourists often buy prescription and
over-the-counter products in other countries, such as Japan and Hong Kong,
where they can be cheaper. They also believe that drugs bought in these
countries would be of better quality. Teva, Cadila and Sagent recall drugsThis was a week of drug recalls in the US. Teva issued
a recall of antibiotics for the second time
this year. This time the recall pertained to amoxicillin manufactured at a plant in Canada. The
company is recalling 53,000 bottles of the drug manufactured by Teva Canada Limited in Toronto.Earlier this year, Teva had recalled amikacin sulfate manufactured at its
facility in Hungary due to the potential for the presence of glass particulate.
Meanwhile, India’s Cadila Healthcare recalled 26 batches (or 223,776 bottles)
of an antidepressant -- venlafaxine HCL ER capsules – as well as nine lots for which the company did not specify the bottle count. These drugs were manufactured at the company’s plant in Ahmedabad. The drugs failed dissolution specifications when retained samples were tested. Venlafaxine is used to treat major depressive disorder, anxiety and panic disorder.Similarly,
Sagent Pharmaceuticals recalled one lot of oxacillin for injection manufactured by India-based Astral SteriTech. The action was taken after a customer
complained that small, dark particulate matter was found in the solution after
it was reconstituted. The foreign matter found in the vials was identified as iron oxide.
Impressions: 3859
The year 2015 has gone down
in history as a record year for mergers and acquisitions in the pharmaceutical
and biotech space with deals worth US $ 300 billion being announced. The highlight
of the year was the Pfizer-Allergan mega-merger – the biggest-ever pharma transaction worth more than US $ 160 billion.
Pharma Letter tracked transactions
through the year and found the number of deals exceeding US $1 billion at 30 in
2015, as compared to 26 in 2014 and 20 in 2013. In all, a total of 166 M&A
deals were announced in 2015 (out of which some are yet to be completed),
compared to 137 in 2014.
This week, PharmaCompass
brings you a compilation of the top drugs of 2015 by sales revenue and growth.
Sofosbuvir – the outright winner of 2015
2015 was the year of Sofosbuvir – the revolutionary active ingredient used for the treatment of hepatitis. Together, through the sale of drugs Harvoni and
Sovaldi, Sofosbuvir brought in sales of almost US $ 19 billion.
The PharmaCompass prediction
that Harvoni (a combination of Ledipasvir and Sofosbuvir; and used for the treatment
of infectious diseases like hepatitis and HIV) would become the best-selling
drug ever in 2015 fell slightly short of expectations as its sales of US $ 13.864
billion were marginally less than AbbVie’s rheumatoid arthritis treatment – Humira.
Humira retained its place as the best-selling drug with US $
14.012 billion in sales in 2015. However, with sales growth of US $ 11.737
billion in a single year, Harvoni is poised to become the best-selling drug by
the end of 2016.
Top 20 Drugs by Sales
Here is PharmaCompass’ compilation of the best-selling drugs of 2015. This is based on information
extracted from annual reports and US Securities and Exchange Commission (SEC) filings
of major pharmaceutical companies.
If you would like your own copy of all the information we’ve collected, email us at support@pharmacompass.com and we’ll send you an Excel version.
Click here to access all
the 2015 data (Excel version available) for FREE!
Product
Active Ingredient
Main Therapeutic Indication
Company
2014 Revenue in Millions
(USD)
2015 Revenue in Millions
(USD)
2015 Sales Difference
Millions (USD)
1
Humira
Adalimumab
Immunology (Organ Transplant, Arthritis etc.)
AbbVie
12,543
14,012
1,469
2
Harvoni
Ledipasvir
and Sofosbuvir
Infectious Diseases (HIV, Hepatitis etc.)
Gilead
Sciences
2,127
13,864
11,737
3
Enbrel
Etanercept
Immunology (Organ Transplant, Arthritis etc.)
Amgen / Pfizer
4,688
8,697
4009
4
Remicade
Infliximab
Immunology (Organ Transplant, Arthritis etc.)
Johnson
& Johnson / Merck
6,868
8,355
1487
5
MabThera/Rituxan
Rituximab
Oncology
Roche
5,659
7,115
1,456
6
Lantus
Insulin Glargine
Diabetes
Sanofi
6,978
7,029
51
7
Avastin
Bevacizumab
Oncology
Roche
6,481
6,751
270
8
Herceptin
Trastuzumab
Oncology
Roche
6,338
6,603
265
9
Revlimid
Lenalidomide
Blood Related Disorders
Celgene
Corpoartion
4,980
5,801
821
10
Sovaldi
Sofosbuvir
Infectious Diseases (HIV, Hepatitis etc.)
Gilead
Sciences
10,283
5,276
(5,007)
11
Seretide / Advair
Salmeterol
Respiratory Disorders
GlaxoSmithKline
6,005
5,227
(778)
12
Crestor
Rosuvastatin
Calcium
Cardiovascular
AstraZeneca
5,512
5,017
(495)
13
Lyrica
Pregabalin
Neuroscience and Mental Health
Pfizer
Inc.
5,168
4,839
(329)
14
Neulasta
Pegfilgrastim
Blood Related Disorders
Amgen
4,596
4,715
119
15
Gleevec / Glivec
Imatinib
Oncology
Novartis
4,746
4,658
(88)
16
Xarelto
Rivaroxaban
Anticoagulants
Bayer / Johnson
& Johnson
3,369
4,345
976
17
Copaxone
Glatiramer
Neuroscience and Mental Health
Teva
4,237
4,023
(214)
18
Januvia
Sitagliptin
Diabetes
Merck
& Co
3,931
3,863
(68)
19
Abilify
Aripiprazole
Neuroscience and Mental Health
Bristol-Myers
Squibb/ Otsuka
Holdings
6,485
3,804
(2681)
20
Tecfidera
Dimethyl
Fumarate
Neuroscience and Mental Health
Biogen
2,909
3,638
729
Click here to access all
the 2015 data (Excel version available) for FREE!
A year of record FDA approvals
2015 was also the
year when the US Food and Drug Administration (FDA) approved 45 novel drugs, another
all-time record high. In January this year, PharmaCompass had compiled a list of novel drugs approved by the FDA in 2015. We also extensively covered the new dosage forms of existing drugs approved in 2015. Do go through the article published on January 14, 2016, for more information.
PharmaCompass’ compilation of sales forecasts of novel drugs indicated a significant
variation in estimates. However, in our view, drugs that
saw highest sales growth in 2015 are likely to do well this year as well.
Top 20 drugs by sales growth (in USD, millions)
Product
Active Ingredient
Main Therapeutic Indication
2014 Revenue in Millions
(USD)
2015 Revenue in Millions
(USD)
2015 Sales Difference
Millions (USD)
1
Harvoni
Ledipasvir
and Sofosbuvir
Infectious Diseases (HIV, Hepatitis etc.)
2,127
13,864
11,737
2
Viekira Pak
Ombitasvir/Paritaprevir/Ritonavir
Infectious Diseases (HIV, Hepatitis etc.)
48
1,639
1,591
3
Humira
Adalimumab
Immunology (Organ Transplant, Arthritis etc.)
12,543
14,012
1,469
4
Hepatits C Franchise
Daclatasvir and Asunaprevir
Infectious Diseases (HIV, Hepatitis etc.)
256
1,603
1,347
5
Imbruvica
Ibrutinib
Chronic lymphocytic leukemia
200
1,443
1,243
6
Cubicin
Daptomycin
Anti-bacterial
25
1,127
1,102
7
Eliquis
Apixaban
Anticoagulants
774
1,860
1,086
8
Triumeq
Abacavir, Dolutegravir and Lamivudine
Infectious Diseases (HIV, Hepatitis etc.)
-
1,037
1,037
9
Xarelto
Rivaroxaban
Anticoagulants
3,369
4,345
976
10
Opdivo
Nivolumab
Oncology
6
942
936
11
Revlimid
Lenalidomide
Blood Related Disorders
4,980
5,801
821
12
Tecfidera
Dimethyl
Fumarate
Neuroscience and Mental Health
2,909
3,638
729
13
Xtandi
Enzalutamide
Oncology
480
1,207
727
14
Ibrance
Palbociclib
Oncology
-
723
723
15
Invokana / Invokamet
Canagliflozin
Type 2 diabetes
586
1,308
722
16
Victoza
Liraglutide
Diabetes
2,014
2,704
690
17
Stribild
Cobicistat, Elvitegravir, Emtricitabine and Tenofovir
Disoproxil Fumarate
Infectious Diseases (HIV, Hepatitis etc.)
1,197
1,825
628
18
Levemir
Insulin
Diabetes
2,133
2,745
612
19
Votrient
Pazopanib
Oncology
565
565
20
Perjeta
Pertuzumab
Oncology
927
1459
532
Hepatitis C products, which had three
of the four highest sales growths in 2015, clearly show the impact these
revolutionary treatments will have on the global healthcare landscape in time
to come. Cancer immunotherapy treatments, a new generation of blood thinners
and novel diabetes treatments were some of the others which demonstrated stellar
growth in 2015.
Vaccines from Pfizer and Sanofi also displayed tremendous sales growth although they
have not been included in the compilation of drugs.
Click here to access all
the 2015 data (Excel version available) for FREE!
Sign Up, Stay Ahead
While some companies like Boehringer and Valeant are yet to release their annual reports. In order to
stay informed, 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 2015 data (Excel version available) for FREE!
CORRECTION, April 12, 2016: An earlier version of this compilation
did not account for cases where the same drug is sold by multiple companies
(e.g. Enbrel, Remicade, Xarelto etc.). As an outcome, a re-ranking of the Top
20 Drugs by Sales and Sales Growth has been done.
Impressions: 57124