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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Recently the USFDA approved Aprecia Pharma’s SPRITAM® levetiracetam – a drug for epilepsy treatment manufactured by 3D
printing. This approval should encourage other players to pursue drug
development with renewed vigor.
Last week saw a revolutionary approval from
the US Food and Drug Administration (USFDA). For the first time, the USFDA
approved a drug manufactured by three dimensional printing
(3DP) – Aprecia Pharmaceuticals received the USFDA approval of epilepsy treatment SPRITAM® levetiracetam. Leveitracetam
was first approved in 1999.
Revolutionary
formulation & rapid delivery system
Aprecia gained the exclusive licence to 3DP technology
from MIT in the late 1980s, and by 2007 it began developing its proprietary ZipDose technology. But SPRITAM is revolutionary, not just because it is 3D printed, but for other reasons as well. SPRITAM® is a porous formulation that rapidly disintegrates with a sip of liquid. The dispersion is significantly superior to a conventional over the counter fast-melt tablet (watch the video: https://www.aprecia.com/zipdose-platform/zipdose-technology.php).
In fact, the drug is designed to dissolve
in the tongue (rather than swallowed as a whole). The patient experience is
enhanced since SPRITAM delivers an extremely high drug load, up to 1,000 mg in
a single dose. No measuring is needed as each dose is individually packaged,
making it easy to carry this treatment on the go.
3D
printers are not even expensive
For those not familiar with 3DP (or
additive manufacturing), it is a process used to make a three-dimensional
object without the use of dies, molds or machining. Instead, additive processes
are used, in which successive layers of material are laid down under computer
control (watch the video: https://www.youtube.com/watch?v=G0EJmBoLq-g).
These objects can often be of virtually any shape or geometry, and are produced
from a 3D model or another electronic data source. A 3D printer is a type of
industrial robot, and can range from small scale consumer models to large
factory units.
Now for the moot question – why are pharmaceutical companies not developing drugs with 3D printing? In fact, 3D printers are inexpensive, and the ingredients used to produce the drugs are the same that are currently being used and there are multiple candidates, other than those Aprecia is working on which would benefit from this technological revolution.
Making 3D printed drugs is really not that complicated or expensive. A recently published paper by researchers at the University College of London (UCL), “Effect
of geometry on drug release from 3D printed tablets” produced different shaped tablets using 3D printing which would be otherwise difficult to produce using traditional methods.
Simple
guide to make 3D printed drugs
The researchers simply purchased water-soluble PVA filament from MakerBot (not currently
available but other
PVA filaments are available on Amazon for under US $ 50), along with widely
used pain reducer and fever reliever, Paracetamol (also known as Acetaminophen)
and salts. They cut the filament into small pieces (approximately 2mm in
length), basically turning the spool of filament into pellets. This was
followed by mixing in the Paracetamol, and extruding the mixture from a Filabot filament extruder (it
costs US $ 949) at 180 degrees C. What came out of the printer was a 3D printed
drug.
PharmaCompass’ potential candidates for 3DP
Staying focused on opportunities where an extremely high drug load – up to 1,000 mg – has to be delivered in a single dose we ran a search on the PharmaCompass
database to find a few potential candidates for 3D printing.
Drug Name
Therapeutic Indication
Aminocaproic
Acid
Bleeding disorder treatment
Sucralfate
Ulcer medication
Cefadroxil
Antibiotic
Colestipol
Hydrochloride
Lipid lowering
Metformin
Hydrochloride
Diabetes
Methenamine
Hippurate
Urinary Tract Antiseptic
Ranolazine
Chronic Angina
Valacyclovir
Hydrochloride
Viral Diseases
Icosapent
Cholesterol reduction
In addition to these products, there are
multiple other possibilities which can get created by producing combination
drugs using 3D printing.
Overcoming
the challenges of slow 3D printing
With nearly three million people in the United States diagnosed with active epilepsy, Aprecia Pharmaceuticals’ revolutionary form of Levetiracetam clearly has a very large market need to address. However, the problem with 3D printing is that it is exceptionally slow when compared with conventional production methods for tablets.
Anticipating the problems, Aprecia
Pharmaceuticals announced on Feb. 23, 2015, that the company will open
a new manufacturing facility in Ohio that will use its powder–liquid three-dimensional printing (3DP) technology.
With plans to invest $25 million in a
190,000-ft2 facility, the new facility will be in addition to the
company's existing manufacturing and R&D facility in New Jersey.
Disrupting
healthcare in 3D
In the healthcare industry, 3D printers are
used by dentists to create
replicas of jaws and teeth as well as some finished dental implants and
orthopedic surgeons have tested them to make customized hip replacements.
In 2012, a two-year-old girl in Illinois,
born without a trachea, received
a windpipe built with her own stem cells.
British scientists have also used 3D
printing to create personalized replica models of cancerous parts of the body
to allow doctors to target tumors more precisely.
Our
View
The current way of consuming tablets can
definitely undergo a serious overhaul. With 3D printing technology rapidly
evolving and already inexpensive, there is little reason for the industry not
to pursue this area of drug development with greater vigor.
In addition, if we can measure our blood sugar levels using diagnostic kits at home, is it unrealistic to imagine a day when we’ll start printing our own medicines in 3D?
Impressions: 4638
https://www.pharmacompass.com/radio-compass-blog/fda-approved-first-3d-printed-drug-is-no-fad-but-a-technology-you-can-easily-develop
#PharmaFlow by PHARMACOMPASS
13 Aug 2015
