Market Place
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: 54752
https://www.pharmacompass.com/radio-compass-blog/top-drugs-and-pharmaceutical-companies-of-2019-by-revenues
#PharmaFlow by PHARMACOMPASS
29 Apr 2020
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Every quarter, PharmaCompass compiles the latest Drug Master Files (DMFs) submitted to the US Food and Drug Administration (FDA). These applications provide an overview of products which active pharmaceutical ingredient (API) manufacturers are investing their resources in and also give a sneak preview into the next possible first-to-file (FoF) generic challenges to patented drugs. Here are the key findings from the compilation for the first
quarter of 2016: Compliance problems
aside, India tops the DMF submissionsIf news about compliance problems faced by pharma companies
in India and China are making you believe that there is a slowdown in these
countries, think again. A total of 190 DMF submissions were made in the first
quarter of 2016, up from 180 in the previous quarter. And over two-thirds of
the submissions were for products from facilities based in either India or
China with more than 100 filings from India alone. Companies that have been on the compliance radar recently – such as Ipca
Laboratories, Emcure
Pharmaceuticals, Minsheng
Group Shaoxing Pharmaceutical and Yincheng Goto – also made submissions to the FDA. Besides these, Qilu
Pharmaceutical, which was in the news recently for the controversy in China
involving school children, also submitted its DMFs this quarter. Teriflunomide leads DMF
race; Carfilzomib is the new molecule on the blockLast quarter, Teriflunomide saw the maximum number of DMF submissions – four. This quarter too, Teriflunomide led the pack with maximum submissions – six. This is an indication that Sanofi’s
multiple sclerosis drug will be subject to severe competition in the coming
future.Amgen acquired Onyx
Pharmaceuticals for US $ 10.4 billion in 2013 primarily to cash in on the potential of Kyprolis
(carfilzomib), a cancer-treatment drug. While analysts had estimated peak sales of US $ 1.6 billion as a result of this acquisition, sales in 2014 turned out to be only US $ 331 million – a fifth of their estimates. However, things looked up in 2015 as Kyprolis brought in US $ 512 million in sales. Amgen needs to quickly capitalize on the opportunity as six more DMFs were submitted this quarter, indicating a severe generic onslaught whenever the drug goes off patent. Enzalutamide has been in news recently as Medivation, the US
cancer drug company that discovered the molecule, has finally become open to a
sell-off after Sanofi offered US $ 9.3 billion to buy the cancer drug
maker. Even as Sanofi tries to acquire Medivation, generic activity is underway
with three more DMF submissions this quarter. MSN Labs leads the FoF
challenges and filingsMSN Laboratories may not be well-known in the Indian pharmaceutical industry, but the company is growing from strength to strength each quarter with its capabilities of developing non-infringing routes for APIs and being one of the first companies to submit DMFs.This quarter, MSN
Laboratories and its subsidiaries submitted 20 DMFs, which is more than 10 percent of all applications filed. MSN’s filings include Apremilast
(Celgene’s Otezla), Bosutinib
(Pfizer’s
Bosulif), Macitentan
(Actelion’s
Opsumit) and Vortioxetine
Hydrobromide (Takeda’s
Brintellix) Innovative filings In
the worksBiotin, a water soluble Vitamin B, is claimed to aid nail and hair growth. If French biotech startup -- Medday Pharmaceuticals – succeeds in its Phase III trials, its lead product MD1003, a pharmaceutical grade
D-Biotin, would improve the lives of patients suffering from progressive
multiple sclerosis (MS).MedDay and DSM Nutritional Products had earlier announced a
partnership and co-investment for manufacturing pharmaceutical grade D-Biotin.
This quarter DSM submitted its DMF for Biotin.Switzerland-based biopharmaceutical company Debiopharm’s
Salvacyl®, Moapar® has been used mainly for the treatment of prostate cancer. Now, armed with a new indication, the three-month formulation of triptorelin – which has been registered in several European countries to treat severe sexual deviation in adult men (for instance, paedophilia) – saw a DMF submission this quarter indicating a potential launch of this product in the US.Dimethyl fumarate (Biogen’s Tecfidera) led
the list of DMF filings last quarter as the brand product generated sales of US
$ 3.64 billion in 2015 and is projected to achieve US $
5.56 billion by 2020. While generic companies have been targeting Dimethyl Fumarate, Hyderabad-headquartered
Honour Labs – a company promoted by Dr B Parthasaradhi Reddy
who is also the promoter of generic major Hetero Drugs – filed a DMF for Monomethyl Fumarate. It would be interesting to see if this minor tweaking in the
molecular structure could lead to a windfall gain for Hetero. Our viewWith drug filings ranging from cannabis extract to amphetamines
to generic paracetamol,
the first quarter of 2016 displayed that the API industry is extremely active
with new product development. You can view the PharmaCompass
compilation of the new DMF filings by clicking here or simply by sending us an
email to get your own Excel version of the new submissions.
Click here to view all the submissions of the first quarter of 2016 (Excel version available) for FREE!
Impressions: 5247
https://www.pharmacompass.com/radio-compass-blog/dmf-submissions-reveal-no-slowdown-in-india-china
#PharmaFlow by PHARMACOMPASS
12 May 2016
