The year
2020 was an eventful year for the pharmaceutical industry, with several
companies across the world working at a feverish pace to find a treatment or a
vaccine for the raging Covid-19, which has so far taken over 1.79 million lives
worldwide.
With
countries imposing lockdowns and regulators putting on-site inspections on
hold, we were expecting far lower new drug approvals in mid-2020. But our mid-2020 recap published in July, which
looked at new drug approvals by the US Food and Drug Administration (FDA) and European Medical Agency (EMA),
found that the FDA had approved 33 new drugs by the end of June. This put the
approvals within the ballpark of the past two years.
This week, we bring you a roundup of 2020, a tumultuous year when 58 drugs (53 approvals by the Center for Drug Evaluation and Research and 5 by the Center for Biologics Evaluation and Research) bagged FDA’s new drug approvals. While this number is lower than the number of drugs approved in 2018 (62), it is higher than the number for 2019 (54). Out of this, while 23 approvals were in the field of oncology, 9 were for infectious diseases and infections, 8 for genetic diseases, 7 for neurology, 3 for immunology and 2 for gastroenterology.
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A year marked by EUA
With the pandemic raging across the world, emergency use authorizations (EUAs) dominated news headlines in 2020 — the FDA issued 10 EUAs, with the most
prominent being those issued to Pfizer-BioNTech and Moderna for their Covid-19 vaccines.
EMA was busy as well since they issued 75 positive opinions
with Novartis leading
the pack with 8, followed by Pfizer and Sanofi which received 4 each.
The EUAs came with their own set of controversies. In March,
the FDA had issued an EUA “for oral formulations of chloroquine phosphate and hydroxychloroquine sulfate
for the treatment of” Covid-19. However, by June, FDA had revoked the EUA,
as the agency determined that chloroquine and
hydroxychloroquine were not likely to be effective in treating Covid-19 for the
authorized uses in the EUA.
Amongst treatments for Covid-19, in May the FDA
authorized the emergency use of Gilead’s antiviral
drug remdesivir. In our mid-2020 recap, Gilead’s remdesivir was on top of
our list of top-selling drugs after it received an EUA from the FDA.
In October, remdesivir became the first drug to
be approved by the FDA for treatment of Covid-19 patients requiring
hospitalization. While analysts predicted US$ 3.5 billion in revenue in early
October, the future of this drug as a treatment for Covid-19 in hospitalized
patients remains uncertain, especially in wake of results from the World Health
Organization (WHO)-led Solidarity Trial that said Gilead’s remdesivir
had little or no effect on the 28-day mortality or length of hospital
stays for Covid-19 patients. The FDA approved remdesivir for
hospitalized patients a week after the WHO results.
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Gilead US$ 21 billion Immunomedics acquisition
Immunomedics' antibody-drug conjugate (ADC) — Trodelvy (sacituzumab govitecan-hziy) — was approved by the FDA in April this year for the treatment of adult patients with metastatic triple-negative breast cancer who have received at least two prior therapies for the disease. Such tumor types account for 15 to 20 percent of breast cancers. Trodelvy follows remdesivir in our list of FDA approved drugs in 2020 with the highest sales potential. The current forecast for Trodelvy sales is US$ 2.151 billion by 2026.
In
September, Gilead made a big move and acquired biotech company
Immunomedics Inc for US$ 21 billion. The
transaction, which was completed in October, will strengthen Gilead’s cancer portfolio and add another potential blockbuster to it.
Immunomedics
plans to submit a supplemental Biologics License Application (BLA) to support
full approval of Trodelvy in the US over the next quarter. According to a statement, Immunomedics
is also on track to file for regulatory approval of the drug in Europe in the
first half of 2021. Moreover, ongoing studies are also evaluating the potential
of Trodelvy as a treatment for non-small cell lung cancer and other types of
solid tumors.
View New Drug Approvals in 2020 with Estimated Sales (Free Excel Available)
Roche-PTC Therapeutics’ risdiplam bags approval
Following
Troveldy in sales potential for drugs approved by the FDA is Roche and PTC Therapeutics’ drug Evrysdi (risdiplam), the first oral medicine approved for the
rare genetic disease, spinal muscular atrophy, which until four years ago had
no available treatments.
The approval of Evrysdi presents patients and their families with a unique choice between a one-time gene therapy, an RNA-based drug infused three times a year at the doctor’s office and a daily medicine taken at home.
Roche priced the drug by patient weight, with a maximum cost of US$ 340,000 per year — substantially lesser than the competing (and approved) therapies from Biogen and Novartis.
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Vertex’s Kaftrio bags EMA approval
Earlier
this year, PharmaCompass had published its compilation of sales
forecasts for the new drugs approved by the FDA in 2019. The list was led by Vertex’s cystic
fibrosis treatment — Trikafta — which was expected to have sales of US$ 3.935 billion by 2024.
Trikafta
is a combination of ivacaftor, tezacaftor and elexacaftor and its
stellar clinical data made the FDA approve the drug within three months of
Vertex’s application
filing and five months before FDA’s action date.
In
June 2020, EMA’s CHMP adopted a positive opinion, recommending the granting of a marketing authorization for
Vertex’s
combination, which will be marketed as Kaftrio.
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A year
of multiple setbacks
Not everything went smoothly in 2020. In fact, the year saw several setbacks — almost 44 drugs were not granted approval by the FDA. Bristol Myers Squibb was one such company that
received setbacks. As part of Bristol’s US$ 74 billion acquisition of Celgene, the New
York-headquartered drug company offered Celgene shareholders Contingent Value Rights or
CVRs. But to realize the US$ 9-a piece payment, approvals for three
ex-Celgene drugs must meet their pre-specified deadlines.
While in March, the FDA approved Bristol’s ozanimod, a sphingosine-1-phosphate receptor agonist for the treatment of relapsing multiple sclerosis, well ahead of the December 31, 2020 deadline, in May, Bristol Myers Squibb and bluebird bio, Inc announced
that they have received a Refusal to File letter from FDA regarding the Biologics License Application (BLA) for their CAR-T therapy — idecabtagene vicleucel
(ide-cel) — for patients with heavily pre-treated relapsed and refractory multiple myeloma, which was submitted in March 2020. Upon preliminary review, the FDA
determined that the Chemistry, Manufacturing and Control (CMC) module of the
BLA requires further details to complete the review.
This was
followed by Bristol Myers announcing that the FDA has extended the action date
by three months for the BLA for lisocabtagene maraleucel (liso-cel), a
CD19-directed CAR-T therapy for the treatment of adults with relapsed or
refractory (R/R) large B-cell lymphoma after at least two prior therapies. The
FDA had then set the new Prescription Drug User Fee Act (PDUFA) action date as
November 16, 2020. However, on that day, FDA informed the company that its
review of the BLA for liso-cel will not be completed by November 16.
The FDA
approval of liso-cel by December 31, 2020 is one of the required remaining
milestones of the CVRs issued upon the close of the Celgene acquisition in the
fourth quarter of 2019. The other is FDA approval of ide-cel by March 31, 2021.
FDA declines approval to Novartis’ inclisiran: Recently, there was news that
the FDA declined to approve Swiss drugmaker Novartis AG’s lipid-lowering therapy, inclisiran (branded as Leqvio). The drug came to Novartis' fold through the
US$ 9.7 billion acquisition of The Medicines Company last year. The drug has been cleared by the European Commission.
In a statement, Novartis said the
FDA has not raised any concerns
related to the efficacy or safety of inclisiran. The complete
response letter (CRL) is due to unresolved facility inspection-related
conditions. No onsite inspection was conducted by the FDA, the company said.
View New Drug Approvals in 2020 with Estimated Sales (Free Excel Available)
Our
view
Like the
drug companies, regulators across the world also worked at a frenetic pace in
order to accelerate EUAs and drug approvals, especially for treatments and
vaccines for Covid-19.
Apart from
Covid-19, the year saw wider adoption and
approvals for cell and gene therapies along with approvals of several innovative medicines like relugolix (the first
oral gonadotropin-releasing hormone receptor antagonist for the treatment of
adult patients with advanced prostate cancer), berotralstat
the first oral once daily plasma kallikrein inhibitor to prevent attacks of
hereditary angioedema in adults and pediatric patients 12 years and older,
lumasiran (an HAO1-directed small interfering
ribonucleic acid indicated for the treatment of primary hyperoxaluria type 1 to lower urinary oxalate levels in pediatric and adult
patients) and osilodrostat for the treatment of adults with Cushing’s disease).
Moreover, there were several interesting ‘non-Covid’ medical breakthroughs that took place during 2020. One such breakthrough is a single pill that combines four medications meant to
lower blood pressure and cholesterol and aspirin that was found to cut the risk
of heart disease.
While the agility shown by pharma companies and regulators was
undoubtedly quite impressive, with many countries granting EUA to vaccines for
Covid-19, the ongoing pandemic did put mankind in a bind for several months.
And if the words of the WHO director general Tedros
Adhanom Ghebreyesus are to be believed, the
coronavirus crisis will not be the last pandemic and attempts to improve human health are “doomed” without tackling climate change and animal welfare.
If that really proves to be the case, the pharma industry has a lot to learn from this pandemic, and science has a lot to demonstrate if mankind is to emerge unscathed from such adversities.
View New Drug Approvals in 2020 with Estimated Sales (Free Excel Available)
Impressions: 6875
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: 54764