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: 55099
This week, Phispers brings you two tales
of alleged misuse of information involving former employees of Teva and
AstraZeneca. Latin America is presenting more challenges for pharma MNCs,
especially with Brazil under recession. Meanwhile, FDA is investing US$ 500
million under the Cures Act, passed by the Obama Administration in December
last year. And Eli Lilly has won a long-drawn patent dispute against Actavis
over its cancer best-seller.
Teva sues ex-exec romantically involved with Apotex’s CEO
Last week, Teva filed a lawsuit against its ex-employee Barinder Sandhu who was Senior Director, Regulatory Affairs, US Generics at Teva USA, until her termination in October, 2016.
Also named in the lawsuit is Jeremy Desai, who is President and CEO of Teva’s direct competitor — Apotex, a Canada-headquartered drug firm.
Teva has claimed that Sandhu breached her confidentiality agreement by sharing trade secrets and other confidential information to benefit Apotex’s own competitive product development.
According to the lawsuit, Sandhu “emailed Teva USA documents containing trade secrets and other confidential information, many specifically marked ‘Confidential’, to Desai at his Apotex email account.”
She also allegedly sent information to her personal email account, in violation of Teva USA’s policies, used USB flash drives on her work-issued computer laptop and used a cloud-based drive to share “hundreds of Teva USA documents”.
The information shared by Sandhu relates to a project whose identity has been concealed in the lawsuit as ‘Product X’. Teva claims that Desai and/or Apotex used the “misappropriated information to gain a competitive advantage over Teva USA”.
According to the complaint, Apotex employees openly discussed Teva USA’s trade secrets and other confidential information related to ‘Product X’ and participated in roundtable discussions in an effort to advance Apotex’s potential market position of its competing generic product.
The lawsuit mentions that in the summer of 2016, Teva USA learned through a former Apotex employee that Sandhu had provided Desai with a copy of highly confidential correspondence from the FDA to Teva USA known as a Complete Response Letter (“CRL”).
This letter from the FDA provided comment on an application for ‘Product X’, which was circulated amongst Apotex employees.
After accusing former protege of info misuse, is AstraZeneca’s CEO leaving to take the top job at Teva?
There was more news last week, pertaining to the potential misuse of confidential information — AstraZeneca accused former executive
Luke Miels of misusing confidential information and documents to win
the top pharma job at GlaxoSmithKline.
According to court
documents obtained by the Times, Miels
alleged that Pascal Soriot, AstraZeneca CEO and Miels’ former mentor, took Miels' decision to resign and join GSK very personally and “sought to threaten and punish” him by enforcing a 12-month notice period.
AstraZeneca, on the other hand, alleged that Miels, who was paid US$ 1.67 million (£1.3 million) last year, “had access to information that was confidential beyond his 12-month notice period” that would damage Astra if it was obtained by a competitor.
Miels’ lawyers responded by stating that AstraZeneca was in no position to complain about him using AstraZeneca’s documents in his job negotiations since AstraZeneca had shared confidential information with Soriot before he left Roche to become Astra’s CEO.
The
story may take another unexpected twist as Israeli news reports say that AstraZeneca CEO Pascal Soriot has agreed to take the top job at
Teva. Soriot is expected to earn twice as much as Teva’s previous CEO and receive a bonus upon signing the contract, estimated at about $20 million.
Pfizer bows out with sale of Teuto in
Brazil
Not long ago, Brazil
was one of the hottest emerging markets for
drugs, and big pharma were lining up to cash in on this opportunity. Today, Brazil is in the midst of a historic recession that
has dampened drug demand.
Back in 2010, when
the going was good, Pfizer had struck a US$ 240 million deal for a 40 percent stake in the Brazilian generic drug firm — Laboratório Teuto Brasileiro. But the joint venture never really took off. And recently, Pfizer has accepted a payment of 1 Brazilian Real — or US$ 0.30 — to relinquish its stake to the heirs of Laboratório Teuto’s founder.
For nearly a year, Pfizer had been trying to offload Teuto. A spokesperson for Pfizer said: “Since 2010, both companies have worked together to improve access to medicines in Brazil.” However, Pfizer arrived at this decision as a result of a “desire to focus resources on ensuring the success of its existing portfolio and pipeline.”
Pfizer’s exit follows challenging acquisition experiences by Sanofi and Teva in Latin America.
Eli Lilly wins patent dispute against
Actavis over its best-selling cancer drug
Last week, Eli Lilly won a long-drawn patent dispute
with Actavis after the UK Supreme Court ruled that the generic drugmaker's versions of Lilly's top-selling cancer drug — Alimta — directly infringes on certain Lilly patents in Britain, France, Italy and Spain.
The generic version
of Alimta (pemetrexed)
is now owned by Teva,
after it bought Allergan's generic business — Actavis — in August last year.
Alimta is Lilly's
top-selling oncology treatment. It generated sales of US$ 2.3 billion last
year.
This decision
reportedly applies to about US$ 300 million worth of annual sales.
Merck’s purchase of Sigma Aldrich under EU scanner
The European
Commission has raised objections to the purchase
of Sigma Aldrich by German drugmaker Merck. In a Statement of Objections sent out to Merck and Sigma-Aldrich, the Commission alleged that these companies breached EU merger rules. The companies could face a fine equivalent to 1 percent of the combined firm’s annual revenue, the Commission said.
According to the
Commission, when Merck and Sigma-Aldrich disclosed their merger plan in 2015 they did not share details of a project “with relevance for certain laboratory chemicals at the core of the Commission’s analysis.”
The Commission
said the project was being developed by one of the parts of the Sigma business
that was acquired by Honeywell in October 2015. The technology
developed as a result of the project was subsequently licensed to Honeywell,
the Commission added.
“Honeywell now has the technology it should have received with the divested business. However, this happened with a delay of almost one year and only because the Commission was subsequently made aware of the issue by a third party,” the Commission said.
FDA to invest US$ 500 million innovation
fund under Cures Act
Last week, the FDA
laid out its plans of
investing the US$ 500 million innovation fund earmarked in the 21st Century
Cures Act, passed last year under the Obama Administration. The fund will be
spent from this year, until 2025, and is subject to annual appropriations from
the US Congress.
Scott Gottlieb, FDA’s Commissioner, in a blog post, said the agency’s plans for investing the innovation fund are steps that will both improve public health (by facilitating biomedical innovation) and reduce drug costs (by cutting the burden of unnecessary regulation).
FDA’s plans for the innovation fund include allocating US$ 25.8 million to advance patient-focused drug development, and US$ 95.3 million to regulatory science initiatives, including qualification of drug development tools such as biomarkers. It also plans to streamline the regulation of targeted drugs for rare diseases, and to award grants to advance continuous manufacturing technology. The largest expenditure from the innovation fund — US$ 168.2 million — is earmarked for FDA’s initiatives designed to improve the collection of evidence about safety and efficacy.
“FDA’s headway in pursuing the opportunities enabled by Cures illustrates the agency’s enthusiasm and commitment to the law—both its letter and its spirit,” Gottlieb said in his blog.
Did Gilead use Chinese API claiming it came from an approved
South Korean manufacturer?
The United States
Court of Appeals for the Ninth Circuit reversed a federal judge’s 2015 ruling in the Gilead Sciences’ case. The US drugmaker is back in court to defend accusations that it made false statements about complying with federal regulations on HIV drugs.
There were allegations that Gilead had netted billions of dollars in government purchases, and that it had fired a whistleblower — a senior employee who spoke against the company’s illicit conduct.
The ex-employees claim that Gilead used a company called Synthetics China to produce unapproved emtricitabine, at unregistered facilities, to
save money.
For almost one and a half years, beginning in 2007, Gilead imported emtricitabine
API from Synthetics China to use in its finished drugs, claiming that the API
had come from its approved South Korean manufacturer.
Emtricitabine is used by Gilead to produce several HIV
drugs, such as Atripla, Emtriva and Truvada.
The Ninth Circuit three-judge appeals panel held that former Gilead employees Jeff and Sherilyn Campie had adequately pleaded that Gilead’s conduct opened it to liability under the False Claims Act (FCA). In 2008 and 2009, the government paid more than US$ 5 billion for the HIV drugs, the court held.
Impressions: 8789
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: 3245
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: 9364
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: 57120