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
Share
This week, Phispers brings you news about hefty pay packages at AstraZeneca and Mylan; FDA’s Form 483 observations at three of India’s leading pharma companies and news about changes at a debt-ridden Teva. Plus, there is news on Japanese drug makers Takeda and Otsuka. Read on.
Shareholders protest against AstraZeneca CEO’s pay package
Last week, AstraZeneca suffered a setback from its shareholders in the form of protest over the US$ 17.3 million (£13.4 million) package for its chief executive — Pascal Soriot. In what seemed to be a repeat of a similar episode three years back, nearly 40 percent of investors voted against the pharmaceutical group’s 2016 remuneration report at its annual meet in London. This is about the same percentage of investors who raised objections to remuneration numbers in 2014. Back then, the package in question was to the tune of US$ 4.31 million (£3.34 million), plus potential performance awards of US$ 5.62 million (£4.35 million).
Soriot’s US$ 17.3 million package included a long-term incentive plan and other rewards.
However, the 39 percent vote against AstraZeneca’s 2016 compensation report has no direct consequences. It’s only an advisory.
Mylan chairman’s $97.6 million pay package: Similarly, Mylan chairman’s pay package made headlines this week, after much furor last year over the skyrocketing price of Mylan’s life-saving EpiPens. Mylan chairman, Robert Coury, received a compensation of US$ 97.6 million in 2016. And that doesn’t include an additional US$ 66.3 million in other retirement benefits and payments that Coury received last year as part of a transition from executive chairman to a ‘non-employee chairman role’. Coury will also continue to receive a US$ 1.8 million per year ‘cash retainer’ by virtue of a deal made with Mylan last year.
Big
changes at Teva: Cancer drug portfolio being put on the market
Rumors
about big changes at Teva have been around for quite sometime. But
recently, an earlier report about longtime CFO Eyal Desheh being eased out got
confirmed.
Following
the report about Desheh, there was another Bloomberg report that said the company’s specialty cancer drug portfolio is being put on the
market.
Attributing
to sources, the report said Teva is speaking with
financial advisers about the possible sale of the oncology business, which
includes treatments for leukemia and a slow-growing form of lymphoma.
Teva
acquired the generics business from Allergan for US$ 40.5 billion
last year. This left the company with a heavy debt and underperforming
divisions.
And after the exit of CEO Erez Vigodman more than two months ago, the rumor mills are abuzz with talk of “thousands of job cuts”. There have been reports that 6,000 jobs are being cut, but the company has denied them.
GSK’s new CEO wants bigger launches
British
drug major GlaxoSmithKline's new chief executive — Emma Walmsley (47) — aims to improve returns in drug development, and wants fewer but bigger new medicine launches in the future.
According
to a Reuters report, Walmsley said recently that her priority was the
pharmaceuticals unit, where she wants commercial considerations to be given
greater weight in early investment decisions.
Speaking post the announcement of first-quarter results, Walmsley said: “We’d like to have probably fewer and more focused priorities, to have bigger launches.” According to her, this would involve tough choices and the closure of some research programs.
Novo
to settle probe related to marketing of diabetes
drugs
Novo Nordisk has agreed to settle a probe in the US into the marketing of
its diabetes drugs. According to a whistle-blower lawsuit, Novo
allegedly disguised salespeople as medical educators and paid kickbacks to
persuade doctors to prescribe its medicines, including its diabetes drug Victoza that is covered by
federal health-insurance programs.
These allegations were disclosed when the lawsuit was unsealed by a judge. The investigation dates back to 2011. According to Novo’s 2016 annual report, the investigation focuses on claims of illegal marketing of Novo’s top-selling Victoza diabetes drug and other products.
“We’ve reached an agreement in principle to settle certain claims related to this investigation,” Ken Inchausti, a US-based spokesman for Novo, said.
FDA okays BioMarin’s Brineura; Bayer’s Stivarga approved for liver cancer
Last
week, the US Food and Drug Administration (FDA) gave nod to BioMarin Pharmaceutical Inc’s drug — Brineura. It is a treatment for a rare genetic disorder — a form of Batten disease — that ravages the nervous system and can cause symptoms ranging from seizures to trouble coordinating muscles to vision loss. The disease can affect both adults and children.
The list price of BioMarin’s Brineura is a whopping US $ 702,000. This makes this the second most-expensive drug
after Horizon Pharma’s Ravicti (priced at US $
793,632).
Bayer’s Stivarga gets nod for liver cancer: The
FDA also expanded the approved use of Stivarga (regorafenib)
to include treatment of patients with hepatocellular carcinoma (liver cancer),
who were previously being treated with the drug sorafenib. This is the first FDA-approved treatment for a liver cancer since the approval of
sorafenib in 2007.
Produced
by Bayer, Stivarga is a kinase
inhibitor that works by blocking several enzymes that promote growth of cancer.
The drug is already approved for treatment of colorectal cancer and
gastrointestinal stromal tumors that are no longer responding to previous
treatments.
What’s in a name? Billions of dollars in tech costs for biosimilars
A
new US FDA guidance on how biological products licensed under the Public Health
Service Act (PHS Act) need to be named is playing havoc with a number of
healthcare organizations.
According to this naming convention, the nonproprietary name designated for “each originator biological product, related biological product, and biosimilar product will be a proper name that is a combination of the core name and a distinguishing suffix that is devoid of meaning and composed of four lowercase letters.”
According
to the healthcare organizations, this step will cost the health care system billions of dollars in technology costs.
According to a healthcare data provider — Wolters Kluwer Health — healthcare organizations (such as hospitals, insurers, and physician practices, as well as government agencies) will “collectively, spend billions of dollars to redesign and reprogram information technology systems to accommodate this new mandate.” The organization mentioned this in a letter to the White House Office of Management Budget.
Decision on relocation of EMA from London likely in October
The
European Union will be taking a decision in October this year on where to relocate the European Medicines Agency (EMA), currently based in London, after Brexit.
According to the Romanian President, Klaus Iohannis, EU leaders met in Brussels last week and talked about the relocation issue “for five minutes”.
The
European Council President Donald Tusk proposed that EU leaders should agree in
June on the criteria to be used for the relocation of the EMA. The final
decision should be taken in fall, Iohannis said.
Takeda’s US $5.2 billion buy begins to pay off; Will Otsuka be next?
Takeda’s US$ 5.2 billion gamble in the form of a
buyout of Ariad paid off recently when the US FDA approved the late-stage cancer
drug brigatinib, that Takeda acquired via this buyout. The FDA has approved
brigatinib for ALK-positive cases of non-small cell lung cancer.
Takeda
had acquired Ariad in January this year. Takeda can now realize its projections of over
US$ 1 billion in annual sales from brigatinib — which will be marketed as Alunbrig. Analysts, however, have predicted US$ 500 million to US$ 800 million in sales for brigatinib.
It
seems Japanese drugmaker Otsuka Pharmaceutical maybe next in line for
receiving pay-offs from its investments. Last year, Ostuka had spent over a billion dollars to partner with Akebia on its experimental anemia drug — Vadadustat — in the US market. But the pact was only a starting point. Last week, Otsuka came back to grab Europe, China, Russia and much of the rest of the world, by paying another US$ 208 million in committed capital.
There is more action at Otsuka. India accounts for about 25 percent of the world’s tuberculosis cases. And Otsuka plans to apply for approval of its TB drug — delamanid — in India within three months, a senior company official said.
FDA Form 483 observations for India’s Aurobindo, Lupin and DRL
Aurobindo
Pharma:
The US FDA recently handed an inspection report (Form 483) with six observations
to major generic drugmaker Aurobindo Pharma.The inspection at Aurobindo Pharma’s Hyderabad facility was
held during April 10 to 18 this year.
The
six observations relate to the company's laboratory system, including a repeat
observation from an inspection the year before.
The company’s “laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures,” the FDA said. And similar to observations we have seen in other recent inspections, FDA investigators found that Aurobindo’s quality control unit did not adequately investigate out-of-specification (OOS) test results.
Lupin: Similarly, Lupin’s Goa facility
also received a form 483 from the US FDA, that
cited three observations related to violation of good manufacturing practices
(GMPs) following an inspection of the site between March 27 and April 7, 2017.
The
FDA observed that Lupin failed to review and
investigate unexplained discrepancy and OOS components of a product batch at
the facility.
“From January 2016 to March 2017, your firm has invalidated several initial out of specification (product) results…You invalidated the initial results without adequate investigation, performed re-testing using new samples and reported the average results of replicate re-tests,” the FDA said in the Form 483.
Similar
problems have been cited in past inspections
at the Goa facility.
Dr. Reddy’s:
Last week, drug major Dr Reddy's Laboratories (DRL) said the US FDA
has issued it a Form 483 with 11 observations after inspecting its manufacturing plant
in Hyderabad.
“The observations by the US FDA are mostly procedural in nature, reflecting the need to improve people capabilities and strengthen documentation and laboratory systems,” Dr Reddy’s said in a statement.
The
audit of the plant was completed last week and the
company said it will address the observations comprehensively and respond to
the regulator within the stipulated time.
Zero
observations for Strides Shasun: Strides Shasun announced that its API
manufacturing facility at Cuddalore (in Tamil Nadu, India) was recently
inspected by US FDA. The company has successfully completed the US FDA
inspection without any Form 483 observations.
Impressions: 4132
https://www.pharmacompass.com/radio-compass-blog/big-changes-at-teva-fda-approves-one-of-the-world-s-costliest-drugs
#PharmaFlow by PHARMACOMPASS
04 May 2017
This week, PharmaCompass brings you a compilation of the Drug Master Files (DMFs) updates at the US Food and Drug Administration (FDA) over the past two quarters. These applications provide an overview of the products active pharmaceutical ingredient (API) manufacturers are investing in. And, they also give a sneak preview into the next possible first-to-file (FTF) generic challenges to patented drugs.
Here are some key findings from our compilation of the FDA’s DMF updates over the second and third quarter of 2016, details of which were provided in July and October:
India leads
the pack, as the number of filings remain the same
Over the period, there were a total of 379 updates of DMFs at the FDA. This number
indicates a pace in filings that is nearly the same as the previous quarters.
We had seen 180 DMFs updates in the last quarter (Q4) of 2015 and 190 in the first quarter (Q1) of 2016.
During the last
two quarters, the DMF updates were led by Indian companies, such as Macleods Pharmaceuticals (14 DMFs), MSN Labs (13 DMFs), Hetero
(12 DMFs), Lupin (9 DMFs), Cipla and Biophore. The other prominent companies were Mylan and Teva.
Companies
with compliance issues stay away
Unlike previous
quarters, where
companies with compliance problems continued to submit DMFs, the last two
quarters were slightly different, since companies like Zhejiang Hisun and Ipca
Laboratories did not submit DMFs.
However,
Emcure Pharmaceuticals — whose Pune facility was inspected by
the FDA last year and a warning letter was issued to the company for violations of current good manufacturing practices (cGMPs) in March this year — submitted one DMF (for Phytonadione)
While
China shut down antibiotic manufacturing in the Shijiazhuang
city, raising concerns about the global supply chain’s dependence on China, Sinopharm Weiqida Datong
Pharmaceutical, located about 300 kilometers away from Shijiazhuang, filed DMFs for the key building blocks of antibiotic manufacturing — 6-APA and 7-ACA.
Once
again, this filing reinforces the dependence of global
antibiotic manufacturing on China.
Click here to view all the updates of the second and third quarter of 2016 (Excel version available) for FREE!
Imminent FTF challenges
The
FTF challenges to Alvimopan Dihydrate (Merck’s Entereg), Apremilast (Celgene’s Otezla), Bosutinib (Pfizer’s Bosulib), Daclatasvir
Dihydrochloride (Bristol-Myer
Squibb’s Daklinza), Elvitegravir (an ingredient in Gilead’s Vitekta,
Stribild, Genvoya), Ibrutinib (AbbVie’s
Imbruvica), Ospemifene (Shionogi’s Osphena), Perampanel (Eisai’s Fycompa), Pomalidomide (Celgene’s Pomalyst), Regorafenib (Bayer’s Stivarga), Tofacitinib (Pfizer’s Xeljanz) and
Vortioxetine
Hydrobromide (Takeda’s Trintellix) seem to be imminent in
view of the recent filings of DMFs.
Roche’s 2014 acquisition of
InterMune for US $ 8.3 billion to gain rights to Esbriet (pirfenidone)
is likely to come under attack as three more DMFs were submitted during the
period under review.
The ink wasn’t dry on the deal papers of Pfizer’s US $1 4 billion acquisition of Medivation in August this year, when two more companies — Watson Pharma (now Allergan) and Scinopharm — submitted filings for Enzalutamide, the product for
which Pfizer paid all that money. This takes the total number of US submissions
for this product to seven.
Apixaban and Canagliflozin are most actively filed products
The most actively updated DMFs in the past six months were for the APIs of Bristol-Myer Squibb’s new-age anticoagulant Eliquis (Apixaban)
and Johnson & Johnson’s diabetes treatment Invokana (Canagliflozin). Sixteen DMFs were submitted for Apixaban along with nine for
Canagliflozin.
Products
like Dimethyl Fumarate and Teriflunomide — which were the
most frequently filed DMFs in our previous reports — continued to see vigorous filing activity.
Synbias Pharma made a submission
for Nelarabine, the only
submission for a Novartis product that was approved in 2005
and for which the only listed patent is expiring in June 2017. Similarly DSM’s submission of Dexpanthenol is the only DMF
listed for a product used in a variety of injectable and intravenous solution
products.
Established
pharmaceutical companies like Quimica Sintetica and Piramal Healthcare made submissions for products — Benznidazole and Norprostol — which are currently not approved in the United States, indicating the possibility of development projects being underway.
Our view
With drug filings ranging from multiple FTFs to cannabis derivatives,
updates over the two quarters have shown that regardless of the compliance
news, activity in the API industry is extremely robust.
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 updates of the second and third quarter of 2016 (Excel version available) for FREE!
Impressions: 4465
https://www.pharmacompass.com/radio-compass-blog/us-dmf-filings-indicate-a-robust-api-industry-with-multiple-first-to-file-challenges
#PharmaFlow by PHARMACOMPASS
08 Dec 2016
