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: 54754
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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This week, the US Senate cleared the 21st Century Cures bill, touted as the most significant reform in medical treatments. Phispers also brings you news on a court order that reverses a ban on 344 fixed-dose combination drugs in India, a shouting match between head honchos of pharma companies at a healthcare summit, a court order on J&J’s hip implant, and a warning letter to Interquim. US Senate clears Cures Act — the biggest reform on medical treatments On Wednesday, the US Senate passed the landmark 21st
Century Cures Act. The bill had passed the House on November 30 and had advanced through the Senate earlier this week. After the vote, President Barack Obama said he would sign the measure “as soon as it reaches my desk.”The 21st Century Cures Act is a labyrinthine bill
that would bring about significant changes in the way medical treatments are tested and brought to market over the coming decades. The legislation calls for the use of ‘data summaries’ to support the approval of certain drugs for new indications, rather than full clinical trial data. The Cures Act will also allow drug companies to promote off-label uses to insurance companies, allowing them to expand their markets.It includes
ambitious goals to advance biomedical science, and will inject US $ 4.8 billion
into a long-stagnating National Institute of Health budget.Critics call this deregulation, and a wolf in sheep’s clothing. They worry that both science and patients are going to suffer. They have argued the legislation is too friendly to Big Pharma, won’t curb high drug prices and may lead to unsafe treatments being put on the market. Tucked away in the 99-page bill are provisions that are likely to weaken the authority of the FDA as the bill includes language to put forward “real-world evidence” to support the approval of a new indication (or use) for an existing drug.Indian
court quashes ban on fixed dose combination drugs
As the 21st Century Cures Act will take us to an era of ‘inject and see’, the Indian government may want to see if the debate on banning fixed-dose combination (FDC) drugs can be resolved using ‘real-world evidence’. A government order banning 344 FDC drugs was overturned last week when the court was hearing a
plea filed by pharmaceutical companies challenging the March 10, 2016 order
which banned 344 FDC drugs. The ban included several common cough syrups, analgesics (pain killers) and
anti-diabetes combinations.Pharmaceutical companies’ argued that the government’s action had been ad hoc in nature and is not aligned with the procedures mentioned under Section 26A of the Drugs and Cosmetics Act, 1940. They argued that the decision was taken without considering clinical data. And that it was based on an ‘absurd’ claim that there are safer alternatives available in the market today.Pfizer fined US $ 106.5 million in UK for hiking price of epilepsy drug
The Competition and Markets Authority in the UK fined Pfizer a record US $ 106.5 million (GBP
84.2 million) for its role in increasing the cost of an epilepsy drug by a
whopping 2,600 percent. The CMA also fined Flynn Pharma US $ 6.58 million (GBP
5.2 million) for overcharging for phenytoin
sodium capsules.The ruling comes at a time when there is a growing debate both in the US and
Europe about the ethics of price hikes for old off-patent medicines that have
little competition.Pfizer
used to market the (epilepsy) medicine under the brand name Epanutin, but sold the rights to Flynn, a privately owned British company, in September 2012. It was then debranded — i.e. it was no longer subject to price regulation — and the price soared.“The companies deliberately exploited the opportunity offered by debranding to hike up the price for a drug which is relied upon by many thousands of patients,” Philip Marsden, chairman of the CMA’s case decision group, said.“This is the highest fine the CMA has imposed and it sends out a clear message to the sector that we are determined to crack down on such behaviour,” Marsden addedPfizer, Regeneron CEOs get into a shouting match at
healthcare summit
At the Forbes Healthcare Summit held last week, a panel featuring
Gilead CEO
John Milligan, Pfizer CEO Ian Read, incoming Eli Lilly CEO
David Ricks, Astellas Americas President Jim Robinson, and Regeneron CEO
Leonard Schleifer were asked to contemplate on why the pharma industry isn't liked.While the panel discussed middlemen and adding value, Schleifer offered his
own take.“I think you've just seen why our industry isn't liked. You've asked a question why we're not liked, we are a room full of people who are biased to like us, and nobody answered the question why we're not liked,” Schleifer said.“We dispelled of some of it last year, because we blamed it on the extremists, the people who come in, dial up a product that's off patent, raising price ten-fold and they're evil-doers, that's why we're not liked,” he continued. “But the real reason we're not liked, in my opinion, is because we as an industry have used price increases to cover up the gaps in innovation. That's just a fact.”Pfizer’s Read countered this with an often cited statistic that drug costs as a percentage of healthcare expenses haven’t changed in two decades, regardless of price increases.Schleifer’s response: “You’re not entitled to a fraction of the GDP.” What followed was a shouting match, until a member of the panel interjected.
The pharma industry surely needs a unified message to send out to the world.
Spain’s Interquim gets FDA warning letter for using dirty equipmentThe latest
company to receive a warning letter from the FDA is Interquim SA of Spain. FDA investigators found the presence of residue in the interior surfaces of non-dedicated drug manufacturing equipment at Interquim that were labeled “clean.” Inadequate
removal of residues from manufacturing equipment during cleaning can lead to
cross-contamination of API subsequently manufactured, using the same equipment.Investigators
also questioned the impact on API quality of the product produced from
equipment whose interior surfaces were discolored even after an equipment
maintenance contractor had previously noted the damage and repaired it.Interquim
is a part of Ferrer, an international group of more than 50 companies with
activities in the pharmaceutical, hospital, diagnostics, fine chemicals, feed
and food sectors. Headquartered in Spain, its products are sold in more than 70
countries. It is a leading manufacturer of APIs like Celecoxib, Imiquimod, Paliperidone Palmitate, Rivaroxaban, Rivastigmine, etc.
Explosion
at excipient manufacturer in India claims two livesAn explosion at a manufacturer of pharmaceutical excipients — Nitika Pharmaceutical Specialities — in India claimed two lives and injured 19 others. While initial news reports claimed a boiler explosion, a
report submitted by the inspector of boilers stated: “The explosion at M/s Nitika Pharmaceuticals Pvt Ltd is not a case of boiler explosion. There is no registered or exempted or unauthorized boiler in the unit. The heat requirement of the factory was being catered to by two thermic fluid heaters installed in the factory.”The local police arrested the company’s senior manager (operations), the senior manager (maintenance) and its managing director, who were later granted bail by the court.
Cannabis cultivation to get boost due to upcoming
approvalsGW Pharmaceuticals, a UK-based company focused on developing medicines from marijuana, plans to expand manufacturing in the UK and boost
cultivation of the cannabis plants it uses to make a treatment for severe epilepsy.The British biotech firm is gearing up to submit Epidiolex — an experimental drug that has shown to be hugely effective in
treating rare and life-threatening forms of childhood epilepsy —with US regulators in the first-half of 2017. Approval could come by early 2018.It was just
last week that PharmaCompass covered the news of the medical cannabis sector managing to comply with pharmaceutical standards for inhalation. Israel’s Teva Pharmaceuticals has partnered with Tel Aviv-based Syqe Medical
to market medical cannabis in Israel for pain management.
Will
Apple launch FDA regulated cardiac monitoring products soon?A
collection of emails obtained by MobiHealthNews, through a Freedom of Information Act request to the FDA,
indicates that since July 2016, Apple has been in discussions with the FDA
about two FDA-regulated products in the cardiac monitoring space.In an
interview with the Telegraph last year, Apple CEO Tim Cook had also
hinted at a regulated medical device from Apple.“We don’t want to put the Watch through the Food and Drug Administration (FDA) process,” he said at the time. “I wouldn’t mind putting something adjacent to the watch through it, but not the watch, because it would hold us back from innovating too much, the cycles are too long. But you can begin to envision other things that might be adjacent to it — maybe an app, maybe something else,” Cook had said.
J&J to pay over US $1 billion in Pinnacle
hip implants caseLast week, a
federal jury in Dallas ordered Johnson
& Johnson and its unit DePuy Orthopaedics to pay more than US $ 1
billion to six plaintiffs who said they were injured by the Pinnacle hip implants.According to the jurors, the metal-on-metal Pinnacle hip implants were
defectively designed. And both companies failed to warn consumers about the
risks. J&J and DePuy have been hit with nearly 8,400 lawsuits over the
devices.However, verdicts of such size are often lowered by courts. In July, the
judge presiding over this case reduced a US $ 500 million verdict in an earlier
Pinnacle implant case to US $ 151 million by citing a Texas state law that
limits punitive damages awards.
Impressions: 2066
https://www.pharmacompass.com/radio-compass-blog/record-fine-levied-on-pfizer-for-hiking-drug-price-us-senate-clears-biggest-drug-approval-reform
#PharmaFlow by PHARMACOMPASS
08 Dec 2016
Each year,
the US Food and Drug Administration (FDA) approve hundreds
of new medications. A small subset of approvals, classified as novel drugs, are considered to
be truly innovative products that often help advance clinical care.
In 2015, the
FDA approved 45 novel drugs, an all-time record high. PharmaCompass has compiled a list of novel drugs approved by the FDA in 2015.The FDA also approved new dosage forms of existing products in the market (email us if you would like a copy), like the 3D printed version of anti-epilepsy drug, Spritam (Levetiracetam).
This week, PharmaCompass focuses on the new dosage
forms of existing drugs that got approved last year.
Modified blockbusters
Improving the delivery form of a blockbuster drug is something that not only helps patients but often successfully extends the patent life of the cash-generating drugs for Big Pharma. Here are some blockbuster drugs that saw their modified versions being launched in 2015:
Jadenu (deferasirox): With
almost a billion dollars in revenues in 2015, Exjade (deferasirox) was approved in 2005 as a
tablet for use in a suspension. Novartis, the innovator,
got approval in March 2015
for Jadenu, a once-daily oral tablet. Jadenu (deferasirox), a new formulation
of Exjade, is the only once-daily oral tablet for iron chelation. Jadenu has
simplified daily treatment administration for patients with chronic iron
overload.
Nexium
24HR (esomeprazole magnesium): Also
known as the Purple Pill, Nexium – Astra
Zeneca’s blockbuster drug for acid reflux that generated annual sales in America of more than US $ 3 billion – went generic in 2015. In order to extend Nexium’s market, Pfizer and AstraZeneca came together to promote an over-the-counter (OTC) version of Nexium. A capsule version of OTC Nexium was approved in 2014 and is known as
Nexium 24HR. Last year, the FDA granted approval to the tablet form of the
drug.
Iressa
(gefitinib): AstraZeneca re-introduced Iressa in
the US market in 2015. The
FDA had approved Gefitinib in May 2003 for non-small cell lung cancer. Approved
as a third-line therapy, in 2010 the FDA requested AstraZeneca to voluntarily withdraw Iressa tablets
from the market, as post-marketing studies had failed
to verify and confirm clinical benefit. Iressa (gefitinib) is now back in the US as a first-line therapy for a type of lung cancer. However, the patent protection is limited – only one listed patent in the Orange Book which expires next year, and five US Drug Master Files already submitted.
Onivyde (irinotecan): Liposomal formulation of anti-cancer
drugs have been in vogue for some time. Merrimack Pharmaceuticals got its novel encapsulation of Irinotecan in a liposomal formulation approved for the
treatment of patients with metastatic pancreatic cancer, sold under the brand
name Onivyde.
Vivlodex (meloxicam): In October 2015, the FDA approved 5 mg and 10 mg (administered once daily) doses of Vivlodex™ (meloxicam) capsules, a nonsteroidal anti-inflammatory drug (NSAID) used for the management of osteoarthritis pain. The previously approved doses for meloxicam capsules were 7.5mg and 15mg. Vivlodex uses a proprietary SoluMatrix Fine Particle Technology™, which contains meloxicam as submicron particles that are approximately 10 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution.
Kalydeco (ivacaftor): A cystic fibrosis drug from Vertex Pharmaceuticals – Kalydeco – has been making headlines
because of its high price (more than US $ 300,000 a year). Price concerns
aside, 2015 saw the launch of a pediatric version of the drug as a ‘weight-based oral granule formulation of Kalydeco that can be mixed in soft foods or liquids’.
Extended release versions
Many of
the approvals granted by the FDA last year were to extended release
formulations (a pill formulated so that the drug is released slowly) of
existing drugs.
Kremers Urban’s
extended release version of Methylphenidate
capsules made headlines last year because of a reclassification of the drug by
the FDA. Under the new classification rating, methylphenidate hydrochloride extended-release tablets can be prescribed but may
not be automatically substituted for J&J’s reference drug Concerta (methylphenidate hydrochloride). Kremers Urban was almost sold last year. But due to this reclassification, investors aborted their US $ 1.53 billion buyout. Kremers Urban was later acquired by Lannett Company Inc.
In
addition, extended-release versions of Aspirin, Carbidopa/Levodopa, Paliperidone Palmitate, Tacrolimus
and Morphine Sulphate also received green signals for a market launch.
First generic opportunities
Last year, PharmaCompass
shared the names of some drugs which had no generic competition and were also
not protected by patents. (Read: “Litigation Free, first generic opportunities list”).
Deferiprone (a drug that chelates iron and is
used to treat iron overload in thalassemia major) met the criteria. But it still
has no generic competitor and is now available as a new dosage form.
Amedra Pharmaceuticals, now owned by Impax Laboratories, has enjoyed the rights to sell Albendazole tablets for almost two decades
without generic competition in the US. Albendazole is a medication used for the
treatment of a variety of parasitic worm infestations. In 2015, patients were
provided access to chewable tablets of Albendazole.
New combinations at work
The FDA also approved
multiple combination drugs where the individual active ingredients had been brought
to market previously.
Most of the combination drugs
approved belong to major pharma players like Novartis, Novo Nordisk, Bristol Myers etc.
Boehringer’s diabetes treatments – Jardiance (empagliflozin) – approved in 2014 and
Tradjenta (linagliptin) approved in 2011, were
combined and the combination drug product Glyxambi was approved in 2015. Another
combination of empagliflozin, with metformin – Synjardy – was also approved in August last
year.
Lesser known companies also
got combination drugs approved. UK-based
development company Vernalis got approval for its cold-cough treatment, Tuzistra XR – an extended release suspension of codeine polistirex and chlorpheniramine
polistirex.
Similarly, US-based biopharmaceutical startup, Spriaso LLC, also
working in the cold and cough therapeutic area, got an extended release tablet
containing codeine phosphate and chlorpheniramine maleate approved.
Symplmed, a company which is
developing various forms of Perindopril, got approval for Prestalia (a
combination of perindopril arginine and amlodipine besylate) for the
treatment of hypertension.
Our view
Each year, the FDA approves several
pharmaceutical drugs in order to improve patient care; and often versions of
these drugs are marketed and distributed across the globe.
PharmaCompass’ list of drugs approved in 2015 is now available – just email us for your copy.
Accelerate your drug development
PharmaCompass has also launched
the Drug Development Assistance tool on its platform.
Simply search for the drug or the active ingredient of your interest, click on the Drug Development icon on the left menu bar and you can see the inactive ingredients used to formulate
the various drug products approved in the United States.
Impressions: 5419
https://www.pharmacompass.com/radio-compass-blog/fda-s-drug-approvals-in-2015-novel-drugs-new-versions-of-existing-drugs
#PharmaFlow by PHARMACOMPASS
14 Jan 2016
