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: 55103
Insofar as pharma M&As are concerned, 2018 is turning out to be a milestone year with more than US$ 170 billion invested in the first quarter alone. While March saw a steep climb in deal values with the Cigna-Express Scripts US$ 67 billion acquisition, April remained significant for Novartis’ renewed interests in gene therapy — the Swiss pharma giant acquired AveXis, a clinical-stage gene therapy company, for US$ 8.7 billion.
Novartis retains focus on gene
therapy with US$ 8.7 billion AveXis buyout
In a bid to secure its leadership position in gene therapy,
Novartis struck a deal to acquire
Illinois-based AveXis, a
clinical-stage gene therapy company working to develop treatments of rare and
life-threatening neurological genetic diseases.
AveXis’ lead pipeline candidate is a neurology-targeted treatment based on virus-mediated gene therapy — AVXS-101. It has the potential to be the first one-time gene replacement therapy for spinal muscular atrophy (SMA), a disease which results in early death or lifelong disability with considerable healthcare costs.
“What was remarkable and what we consider transformative – and frankly all the experts in the SMA field also feel the same – is that we had 100 percent survival of the children at 13.6 months of age, and 100 percent survival of the children at 20 months of age,” Sukumar Nagendran, the chief medical officer of AveXis said in an interview with SMA News Today.
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In addition, AVXS-101 has attained the Breakthrough Therapy
Designation in the US and the Sakigake
Designation in Japan.
Moreover, this therapy, which is currently in Clinical Phase 3 development,
also has access into the PRIority MEdicines (PRIME) scheme in the EU.Novartis
CEO Vas Narasimhan said recently the patient population for SMA was
23,500 people in established markets. A filing with the US Food and Drug
Administration (FDA) for AVXS-101 is expected in the second half of 2018 and
approval and launch in the US is expected in 2019.
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P&G acquires Merck KGaA’s consumer healthcare business
Proctor & Gamble, one of the world’s largest personal care goods manufacturer, announced in mid-April that it has agreed to buy Merck KGaA’s consumer health unit for US$ 4 billion (€3.4 billion). This was just weeks after GlaxoSmithKline
announced its buyout of Novartis’ consumer healthcare joint venture
for US$ 13 billion.
Priced at US$ 4.2 billion, the deal enables P&G to expand its
successful consumer healthcare business by adding a fast-growing portfolio of
differentiated, physician-supported brands across a broad geographic footprint.
P&G now has better access to the Asian and
Latin American markets, and an enhanced product portfolio that includes vitamin
brands like Femibion, Neurobion and Seven Seas. It also provides P&G with
leadership in consumer healthcare, complementing its existing portfolio that
includes brands like Vicks, Metamucil, Pepto-Bismol,
Crest and Oral-B.
According to Reuters, the purchase price for Merck’s business suggests the German consumer healthcare conglomerate climbed down from price demands of as much as US$ 4.71 billion (€4 billion), which may have deterred initial suitors such as Nestle.
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Ionis is flush with cash as it bags deals with Biogen and AstraZeneca
Carlsbad, California-based drug maker, Ionis Pharmaceuticals, which successfully brought Spinraza (nusinersen)
to clinic, earned US$ 1 billion in cash from Biogen as the
two companies expanded their research collaboration on neurological diseases.
Biogen announced
in April this year that the transaction builds
upon the collaboration that produced Spinraza as well as two antisense
drug candidates currently in the clinic, with the potential to
advance up to seven more drug candidates to the
clinic within the next two years.
Biogen’s announcement came less than two weeks after AstraZeneca
paid Ionis a US$ 30 million license fee for its potential treatment for nonalcoholic steatohepatitis (NASH) where the inhibition target
is undisclosed.
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Ionis stands to receive up to US$ 300 million in
additional development and regulatory milestone payments, as well as tiered
royalties from sales of the drug.Speaking about the development, Brett P. Monia, CEO and senior vice president of Antisense Drug Discovery at Ionis Pharmaceuticals said: “AstraZeneca has played a strategic role in advancing this program forward by providing both preclinical and development expertise in NASH that has contributed to the rapid advance of this drug into development. We look forward to AstraZeneca moving this program swiftly into clinical testing and ultimately to the market.”
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Rise in immuno-oncology deals
Shire announced it was selling its oncology business to
French company Servier for US$ 2.4 billion, whilst Takeda said it was
considering an acquisition bid for Shire.
Servier has obtained the rights to Shire’s
presently marketed chemotherapy agent, Oncaspar, and pancreatic cancer treatment, Onivyde. Additionally, Shire’s pipeline of immuno-oncology assets (including Calaspargase Pegol under priority review) are all part of the offerings that were made during the divestment to Servier.
For Servier,
the acquisition of Shire’s oncology franchise enables it to establish a stronger “commercial presence in the US as well as the ex-US territories where Servier is already present,” Olivier Laureau, President of the Servier Group, said.
Two dedicated cancer immunotherapy companies — Allogene Therapeutics and Cellectis — together announced a joint asset contribution agreement
involving select allogeneic CAR-T
programs from Pfizer’s
oncology portfolio for a massive US$ 2.8 billion. This deal also landed Allogene US$ 300 million in funding and Pfizer a 25 percent stake
in the company.
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The immune-oncology collaboration provides Allogene exclusive rights to develop 16 preclinical assets including UCART19 — a CAR T-cell product jointly developed by Servier and Pfizer that Pfizer had earlier licensed from Cellectis and Servier.
Cellectis’ CAR-T platform provides an allogeneic approach of using engineered T-cells from healthy donors, which makes T-cell therapy more accessible to cancer patients. This is distinct from autologous approaches that require the patient’s own T-cells for targeting tumor cells.
Early last month, Boehringer Ingelheim and OSE Immunotherapeutics entered into an immuno-oncology collaboration to develop OSE-172 — a novel antibody targeting myeloid lineage cells.
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While this highlights Boehringer Ingelheim’s strategy to strengthen its core pillar of cancer immunology, Paris-based OSE stands to receive approximately US$ 1.2 billion (€1.1 billion) upon reaching pre-specified development, commercialization and sales milestones, plus royalties on worldwide net sales.
Our view
Deals by major pharmaceutical companies during the month of April
continued to be driven by their focus on gene therapy and immuno-oncology.
While companies like Novartis, Biogen, AstraZeneca and Boehringer-Ingelheim are betting
big on drugs that are still
in development, others like Proctor & Gamble, Servier and Takeda
have chosen to acquire proven assets that will immediately contribute to their
sales.
All eyes are set on Pfizer,
which is exploring a sale of its consumer healthcare business. However, the
pharma major has seen potential suitors drop out and during an earnings call a few weeks ago, its
chairman Ian Read ruled out a transformative deal.
“I don’t see that we need a transformative deal or see one at an appropriate value,” Read had said. Even if the Pfizer deal does not prove to be transformative, the M&A deals in the first few months of 2018 surely indicate that the world of pharmaceuticals is transforming at a fast pace.
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Impressions: 3302