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Biologics, or complex drugs that are derived from living organisms, have revolutionized treatment of various conditions such as cancer, autoimmune diseases, and chronic illnesses. In 2023, eight out of 10 of the world’s top-selling drugs were biologics, including Merck’s Keytruda, AbbVie’s Humira, and Sanofi’s Dupixent.Due to their high costs, accessibility of biologics has been a challenge. That’s why biosimilars, or game-changing copycats of biologics that provide highly similar yet more affordable alternatives to established biologics, are becoming popular.The first biosimilar — Sandoz’ Zarxio — was approved by the US Food and Drug Administration (FDA) in 2015. Its reference biologic was Amgen’s Neupogen (filgrastim). Since then, the global market for biosimilars has been growing at an impressive pace — between 2015 and 2020, it grew at a whopping compounded annual growth rate (CAGR) of 78 percent, touching US$ 17.9 billion in size. It is expected to continue growing at a CAGR of 15 percent and reach a size of about US$ 75 billion by 2030.Major
biosimilar players include Amgen, Sandoz, Samsung Bioepis, Pfizer, Biocon Biologics, Celltrion, Stada Arzneimittel, Accord Healthcare, Fresenius Kabi, Coherus Biosciences, Apotex, and Sanofi. The increasing demand for
biosimilars has propelled growth in contract manufacturing. Some of the
leading contract manufacturing organizations (CMOs) and contract development
and manufacturing organizations (CDMOs) that manufacture biosimilars are Polpharma Biologics, Catalent, Pfizer CentreOne, Lonza, Boehringer Ingelheim BioXcellence, Thermo Fisher Scientific, WuXi Biologics, and FUJIFILM Diosynth
Biotechnologies.Access the Interactive Dashboard for Biosimilar Developments (Free Excel)Amgen, Sandoz top list of ‘approved biosimilars’; FDA okays 8 copycats in H1 2024Over
the recent years, regulatory agencies like the FDA
and the European Medicines Agency (EMA) have established rigorous approval pathways for biosimilars.Since 2015, FDA has
approved 53 biosimilars, while the EMA has approved 86 biosimilars. Among the US, European and
Canadian markets, Amgen and Sandoz are tied in the first place
with 13 approved biosimilars each. Samsung Biologics has nine approved
biosimilars, followed by Pfizer with eight and Biocon Biologics with seven. In the first half of this year, FDA set a record by approving eight biosimilars — the highest for H1 of any year. EMA has okayed six biosimilars so far in 2024.In 2023, five biosimilars were approved by the FDA with just one
being okayed in the first half. The year marked the end of exclusivity for Humira after 20 years, in which it
netted a total of US$ 200 billion in sales. AbbVie’s flagship autoimmune drug has a record 10 biosimilars.Johnson & Johnson’s Stelara also lost exclusivity in 2023 and as many as 11
drugmakers hope to bring its biosimilars to the market. Amgen’s Wezlana was the first biosimilar to
Stelara, and it was approved as interchangeable by FDA in October last year.Access the Interactive Dashboard for Biosimilar Developments (Free Excel) FDA approves first
interchangeable biosimilar for Eylea, cuts regulatory feeDeveloping a biosimilar costs both money and time. According to
Pfizer, developing a biosimilar can take five to nine years and cost over US$ 100 million, not including regulatory fees.In October 2023, FDA slashed its fees with the program fee at US$ 177,397, down from US$ 304,162. The application fees for products that require clinical data has been set at US$ 1,018,753, down from US$ 1,746,745. The application fee for products that don’t require clinical data has been set lower — at US$ 509,377 — down from US$ 873,373 set earlier. This reduction in application fee has propelled demand for contract manufacturing of biosimilars.There has also been a rise in approvals of interchangeable
biosimilars this year. Interchangeable biosimilars meet additional requirements
and may be substituted for its reference product by a pharmacist without
consulting the prescriber. This year saw FDA approve the first interchangeable biosimilars for bone cancer
drug denosumab (Prolia and Xgeva) in
Jubbonti and Wyost as well as for eculizumab (Soliris) in Bkemv.In May, FDA approved the first interchangeable biosimilars
for eye drug aflibercept (Eylea) in Opuviz and
Yesafili. Other biosimilars approved in 2024 include Simlandi for adalimumab (Humira), Tyenne for tocilizumab (Actemra), Selarsdi for ustekinumab (Stelara), and Hercessi for trastuzumab (Herceptin).Access the Interactive Dashboard for Biosimilar Developments (Free Excel) Merck’s Keytruda, BMS’ Opdivo, Novartis’ Cosentyx brace for biosimilar competitionHealthcare spending in the US is projected to rise from US$ 4.5
trillion in 2022 to US$ 6 trillion by 2027. While biologics involve just two
percent of prescriptions, they account for 46 percent of all pharmaceutical
spending. In 2022, US$ 252 billion was spent on biologics.Biosimilar-related savings in 2023 were estimated to be US$ 9.4
billion in the US and € 10 billion (US$ 10.68 billion) in Europe. With expensive and widely used drugs like AbbVie’s Humira, J&J’s Stelara, and Regeneron’s Eylea coming under competition, US
savings are projected to reach US$ 181 billion through 2027. Between 2026
and 2032, about 39 blockbusters are set to lose exclusivity in the US and Europe. Merck’s Keytruda (pembrolizumab) was the world’s top-selling drug last year, generating US$ 25 billion in sales. Its patent is set to expire in 2028 with sales expected to drop
19 percent to US$ 27.4 billion in 2029 from US$ 33.7 billion the previous year. Samsung
Bioepis and Amgen initiated phase 3 trials of pembrolizumab in April
and May of this year, respectively.Opdivo (nivolumab), belonging to the same
class of drugs, competes with Keytruda and is also set to lose patent
protection in 2028. It hauled in US$ 10 billion in total global sales in 2023
for Bristol Myers Squibb. The key patents of Novartis’ Cosentyx (secukinumab) are set to expire between
2025 and 2026. Cosentyx saw sales of US$ 5 billion in 2023. Taizhou Mabtech Pharmaceutical and Bio-Thera Solutions are conducting phase 3 trials of secukinumab.Access the Interactive Dashboard for Biosimilar Developments (Free Excel) Our viewWith
over 2 billion people worldwide unable to access life-saving medicines,
biosimilars hold the key to healthcare accessibility. In 2023, a record 13 biosimilars were launched in the market — the highest for a single year. And this included nine much-anticipated biosimilars to AbbVie’s Humira. In April this year, FDA announced a Biosimilars Action Plan to streamline the development of biosimilars. With a sharp focus on biosimilars, we expect more records to be broken in the near term. New launches of biosimilars to drugs like J&J’s Stelara, Regeneron’s Eylea and Merck’s Keytruda will surely help in creating new records.
Impressions: 1446
https://www.pharmacompass.com/radio-compass-blog/fda-approves-record-eight-biosimilars-in-h1-2024-okays-first-interchangeable-biosimilars-for-eylea
#PharmaFlow by PHARMACOMPASS
27 Jun 2024
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The pharma industry clearly recalibrated itself in 2023, turning its focus away from Covid and onto two of the biggest threats to human health – obesity and cancer. The top lines of the major pharma companies reflect this shift in focus.We
always knew that Pfizer’s record US$ 100 billion revenue for 2022 wasn’t sustainable. Even though Pfizer’s 2023 sales were lower by nearly 42 percent against its 2022 sales, the New York-headquartered drugmaker managed to retain its pole position. The two main reasons behind its ‘top of the charts’ sales of US$ 58.5 billion were Pfizer’s record nine new molecular entity approvals by the US
Food and Drug Administration (FDA) and the launch of its vaccine for
respiratory syncytial virus (RSV).Johnson & Johnson came second with sales of US$ 54.8
billion (excluding its consumer business and MedTech units). AbbVie took bronze despite Humira being subject to biosimilar competition
and Merck maintained its fourth position. Roche nabbed the fifth position from Novartis (which stood sixth). Bristol Myers Squibb maintained its position at seven, as did
AstraZeneca (eighth) and Sanofi (ninth). And Eli Lilly bumped into the tenth spot, knocking out
GSK.View Our Interactive Dashboard on Top Drugs in 2023 by Sales (Free Excel Available)Keytruda, Eliquis, Humira top charts; Novo’s Ozempic debuts top 10 list at number fourMerck’s Keytruda became the number one selling drug in the world, a position that was held
by AbbVie’s Humira for long, and Pfizer’s Comirnaty in the Covid years. This
oncology drug raked in a whopping US$ 25 billion, with sales increasing 19 percent last
year. In fact, Keytruda accounted for 46.7 percent of Merck’s pharmaceutical sales, which grew 3 percent in 2023 to US$ 53.6 billion.At number two was
Pfizer and BMS’ anticoagulant Eliquis — it posted global sales of US$
18.95 billion (marking a
growth of 4
percent on 2022 sales). With
competition from generics, Humira’s sales fell by 32 percent to US$ 14.5 billion. As a result, this
blockbuster anti-rheumatic drug fell to the third rank.The
fourth spot was taken up by Novo Nordisk’s Ozempic, the wonder drug that treats type 2
diabetes. Gilead’s Biktarvy, a med that treats HIV-1, saw sales jump 14 percent — from US$ 10.39 billion posted in 2022 to US$ 11.85 billion last year. This way, Biktarvy emerged as
the fifth largest selling drug of 2023.At
number six was Sanofi and Regeneron’s Dupixent. This allergic diseases med posted
11-figure sales in 2023, netting € 10.72 billion (US$ 11.59 billion) globally, a growth of 34 percent over
2022 numbers.At
number seven was J&J’s biggest blockbuster immunology drug Stelara that raked in US$ 11.3 billion in 2023. Coming a close eighth was Pfizer-BioNTech’s Covid-19 vaccine Comirnaty — its sales fell by over 70 percent to US$ 11.22 billion in 2023. At the ninth spot was Lilly and Boehringer’s diabetes drug Jardiance that saw a 27.7 percent increase in
total global sales at US$ 10.6 billion. And rounding off the list at number 10
is BMS’s Opdivo, a Keytruda rival. Opdivo hauled in US$ 10 billion
in total global sales in 2023, a year-on-year increase of 8 percent.View Our Interactive Dashboard on Top Drugs in 2023 by Sales (Free Excel Available)Driven by diabetes, obesity care meds,
Novo, Lilly post double-digit sales growthDemand
for diabetes and new weight-loss drugs catapulted Novo Nordisk to emerge as the most valuable public
company in Europe. Its net sales zoomed 31 percent to DKK 232.3 billion (US$ 33.75 billion) compared to DKK 177
billion (US$ 25.8 billion) in 2022. Net profit jumped 51 percent to DKK 83.68 billion (US$ 12.51 billion) in 2023 from DKK
55.5 billion (US$ 8.32
billion) in 2022 — the highest annual profit for the Danish drugmaker in over three decades.The
growth was driven by Ozempic, whose sales spiked 60 percent in 2023
to DKK 95.7 billion (US$ 13.91 billion), from DKK 59.8 billion (US$ 8.71 billion) the
year before.Rival
Eli Lilly’s revenue grew 20 percent in 2023 to US$ 34.1 billion from US$ 28.5 billion in 2022. Mounjaro turned out to be a star for the
Indianapolis drugmaker with its sales rocketing 970 percent in 2023 to US$ 5.16 billion. FDA also approved it to treat obesity
under the brand name Zepbound in November, which brought in additional
revenues of US$ 176 million.View Our Interactive Dashboard on Top Drugs in 2023 by Sales (Free Excel Available) GSK’s RSV jab makes strong debut; AbbVie’s immunology drugs post steep growthGSK’s Arexvy was the first RSV vaccine approved by the FDA. It made a strong debut — Arexvy contributed £ 1.2 billion (US$ 1.5 billion) to GSK’s sales in just four months.AbbVie posted another solid financial year.
Though the drop in Humira revenue was offset by two newer
immunology blockbuster drugs, Skyrizi and Rinvoq, the Illinois-headquartered drugmaker
did posted a marginal decrease in revenue of 6.4 percent to US$ 54.3 billion. However, revenue from Skyrizi soared 50 percent to US$ 7.8 billion,
while Rinvoq’s sales increased 57 percent to US$ 4
billion. AbbVie expects a combined US$ 16 billion from Skyrizi (US$ 10.5 billion) and Rinvoq (US$ 5.5 billion) sales in 2024. BMS attributed its 2 percent decrease in
revenue (of US$ 45 billion) to lower sales of Revlimid in the US due to competition from
generics. Sales of the multiple myeloma treatment dropped 39 percent to US$ 6.1
billion. Ophthalmology drug Eylea saw a drop in sales of
4 percent, at US$ 9.21 billion (from US$ 9.65 billion), as competition from Roche’s Vabysmo triggered a price cut by Regeneron. Vabysmo saw sales balloon 324 percent
from CHF 591 million (US$ 685.56 million) to CHF 2.4 billion (US$ 2.78 billion) in 2023.View Our Interactive Dashboard on Top Drugs in 2023 by Sales (Free Excel Available) Our viewAccording
to data analytics company GlobalData, GLP-1 agonist drugs (such as Ozempic and Mounjaro that treat type 2 diabetes) are slated to overtake PD-1 antagonists (such as oncology drugs
Keytruda and Opdivo) as the top-selling drugs on the market
in 2024. It estimates a robust compounded annual growth rate (CAGR) of 19.2
percent from 2023 to 2029 for GLP-1 drugs that seem to have more benefits
besides bringing down blood sugar levels (such as weight management, benefits
to the heart etc).The
market size for GLP-1 is likely to increase to US$ 105 billion by 2029. In
contrast, the data firm projects a CAGR of 4.7 percent in the PD-1 antagonist
market, with its market size projected to be around US$ 51 billion in 2029.
Given these projections, we are likely to see more movers and shakers in our
top 10 drug list this year.
Impressions: 3048
https://www.pharmacompass.com/radio-compass-blog/top-pharma-companies-drugs-in-2023-merck-s-keytruda-emerges-as-top-selling-drug-novo-lilly-sales-skyrocket-due-to-glp-1-drugs
#PharmaFlow by PHARMACOMPASS
25 Apr 2024
In 2022, the pandemic continued to bring in a windfall for
pharmaceutical companies manufacturing Covid-19 products, with Pfizer’s total annual sales reaching
a record high by surpassing US$ 100 billion for the first time.AbbVie, despite not having any Covid products
in its portfolio, maintained its second position due to the sales of its blockbuster drug Humira and other medicines. Johnson & Johnson held
onto the third spot, while Merck experienced the most significant
change, climbing to the fourth position from seventh place in the previous
year. AstraZeneca also moved up a spot to the
eighth position. On the other hand, Novartis (fifth), Roche (sixth), BMS (seventh) and Sanofi (ninth) slipped in the rankings,
while GSK (tenth) retained its position.
There were no new entries in the top 10 in terms of pharmaceutical sales.View Our Interactive Dashboard on Top Drugs by Sales in 2022 (Free Excel Available)Pfizer retains top position
as Comirnaty, Paxlovid, together generate over US$ 56 billion In 2022, Pfizer’s Covid-19 products — vaccine Comirnaty and antiviral pill Paxlovid — generated combined sales of US$ 56.7 billion. With a haul of US$ 37.8 billion, Comirnaty comfortably
maintained its position as the top-selling drug for a second year in a row.
Paxlovid brought in US$ 18.9 billion in its first full year on the market, grabbing the number four spot.Moderna’s messenger RNA
Covid vaccine Spikevax generated US$ 18.4 billion in revenues, emerging as the
fifth largest drug by sales in 2022.View Our Interactive Dashboard on Top Drugs by Sales in 2022 (Free Excel Available) AbbVie’s Humira, J&J’s Stelara post impressive growth; BMS face revenue declineAbbVie’s cash cow Humira, the bestselling non-Covid
product in biopharma history, achieved sales of US$ 21.24 billion (partner Eisai reported another US$ 370 million) in 2022. While Humira brought in approximately 37 percent of the company’s total net revenues of US$ 58 billion in 2022, strong revenues from blood cancer drug Imbruvica, psoriasis treatment Skyrizi and rheumatoid arthritis med Rinvoq also contributed to AbbVie’s strong performance.J&J generated US$ 52.56 billion in 2022
revenues. Its pharmaceutical segment experienced an operational growth of 6.7 percent, driven by impressive
performance of key drugs such as Stelara for inflammatory diseases
and Darzalex for multiple myeloma.
Stelara, which generated US$ 10.2 billion in overall sales last year (a
growth of 6.9 percent), is expected to face
generic competition in the US as its
exclusivity is ending in 2023.BMS’ sales remained relatively
unchanged even though its blockbuster multiple myeloma drug, Revlimid, experienced a 22 percent
revenue decline due to generic competition. While Revlimid still generated
sales of US$ 9.98 billion (partner BeiGene reported another US$ 80 million) in 2022, two other drugs, anticoagulant Eliquis and cancer drug Opdivo performed well. Eliquis
generated US$ 11.8 billion in sales (partner Pfizer reported another US$ 6.5
billion), a 9.2 percent increase over 2021, while Opdivo achieved US$ 8.25 billion in sales (partner Ono Pharmaceuticals reported another US$ 1.05 billion). The drugmaker also introduced new products like Opdualag, Abecma and Reblozyl, which bolstered
its overall sales.View Our Interactive Dashboard on Top Drugs by Sales in 2022 (Free Excel Available)Merck expands use of blockbuster Keytruda; oncology drugs boost Astra’s revenueMerck’s blockbuster cancer drug Keytruda had a remarkable year,
achieving a significant year-on-year growth of 22 percent and generating US$ 20.9 billion in 2022 sales. This success propelled Keytruda to the third position among the top-selling drugs. Keytruda’s continuous expansion into new indications and treatment lines has solidified its position as a leading PD1 inhibitor, and is expected to maintain its momentum in 2023. Additionally, Merck’s Covid-19 pill Lagevrio recorded impressive sales of US$ 5.7 billion in 2022. Overall, at US$ 52 billion, the drugmaker posted spectacular
growth in sales of 22 percent.AstraZeneca also experienced an
impressive growth of 18 percent in 2022 to reach US$ 43 billion in revenue. The
growth was primarily driven by the success of its cancer treatments, with
blockbuster drugs like Tagrisso, Farxiga, Imfinzi, Lynparza playing a vital role. These drugs accounted for 35 percent of AstraZeneca’s overall revenue.View Our Interactive Dashboard on Top Drugs by Sales in 2022 (Free Excel Available)Newer
meds bolster Roche’s growth; Sanofi thrives with DupixentIn 2022, Roche experienced a sales growth of 2 percent at Constant Exchange Rate (CER) to reach CHF 45.55 billion (US$
49.8 billion). The company’s strong pharmaceutical sales were fueled by increasing demand for newer medicines, including Ocrevus (for multiple sclerosis), Hemlibra (for hemophilia A), Vabysmo
(for eye conditions), Evrysdi (for spinal muscular
atrophy) and cancer drug Tecentriq. In 2022, Sanofi recorded global sales of €43 billion (US$ 47.1 billion), representing a 7 percent growth at CER. The French drugmaker’s strong performance was driven by major drugs, particularly Dupixent and its vaccine franchise.
Dupixent brought in impressive sales of €8.3 billion (US$ 9.1 billion), marking a significant 57 percent increase over the previous year. Originally approved by the FDA in 2017 for atopic dermatitis,
Dupixent has expanded its applications to include moderate to severe asthma and
eosinophilic esophagitis, contributing to its continued growth. Sanofi expects
Dupixent to reach €10 billion (US$ 10.7 billion) in sales
in the current year.In July 2022, GlaxoSmithKline changed its name to GSK and demerged its consumer
healthcare business to form Haleon, thereby becoming a fully
focused biopharmaceutical company. The British drugmaker reported a modest 8 percent growth in revenue — at £29.32 billion (US$ 36.15 billion).View Our Interactive Dashboard on Top Drugs by Sales in 2022 (Free Excel Available)Our viewAs the pandemic wanes, 2023 could be a year of transition for many
drugmakers. Companies such as Pfizer, Moderna and AbbVie are implementing
significant changes to their business strategies. Pfizer foresees a substantial
decline in revenue, projecting a sharp drop of 33 percent with the reduced demand for
its Covid-19 products. AbbVie, on the other hand, anticipates a decline in
sales of its cash cow Humira due to increasing competition from biosimilars.
These drugmakers are turning to innovative therapies, new indications,
cost-cutting measures, acquisitions and partnerships to restrict the
anticipated drop in revenues and ensure sustained growth.Barring these drugmakers, several other big players shared
positive growth in the first quarter of 2023. While analysts predict Keytruda
and Dupixent to continue their strong growth, there is optimism surrounding diabetes and obesity drugs,
with Novo Nordisk’s Wegovy experiencing unprecedented
demand. Eli Lilly is also anticipating the US
approval of Mounjaro for obesity later this year.
All in all, we anticipate more changes in our list of top companies and drugs
for 2023!
Impressions: 5298
https://www.pharmacompass.com/radio-compass-blog/top-pharma-companies-and-drugs-in-2022-pfizer-breaks-us-100-billion-barrier-abbvie-s-humira-retains-second-spot
#PharmaFlow by PHARMACOMPASS
01 Jun 2023
Every year, the list of top pharmaceutical products and companies by sales sees some churn. But the year 2021 was a lot different — it saw the pharma industry landscape change dramatically. It was a
year when the industry was busy developing vaccines and therapies so that the
world could recover from the Covid-19 pandemic. And this resulted in many
drugmakers raking in billions of dollars in sales.
As a result,
the top company of 2020 in terms
of pharmaceutical sales — Roche — slipped to the number five spot, while Pfizer, which was at number eight in 2020 after
spinning off its generic business, moved up to the number one slot.
The year
proved to be a good one for pharmaceutical companies.
Interestingly, last year none of the top 20 pharmaceutical companies saw a decline in
their revenue.
View Our Interactive Dashboard on Top Drugs by Sales in 2021 (Free Excel Available)
Pfizer’s Comirnaty steals the show
The
company that reaped the maximum gains from its Covid vaccine was Pfizer.
Comirnaty (tozinameran) was the top selling pharmaceutical
product of 2021, posting global revenues of US$ 36.8 billion. This
messenger-RNA Covid-19 vaccine, developed along with its German partner BioNTech, catapulted Pfizer to the slot of the top company by sales in 2021. Pfizer’s global topline grew from US$ 41.7 billion in 2020 to US$ 81.3 billion in 2021.
In
2020, Pfizer was at
number eight, behind Roche, Novartis, GSK, AbbVie, J&J, Merck and BMS. In 2021, it took a lead of billions of dollars on all these companies. The second largest drug company by sales — AbbVie — was way down at US$ 56.1 billion in global revenues. In fact, Comirnaty has
become the fastest-selling drug in the history of the pharmaceutical
industry.
Back in
December 2020, when both Comirnaty and Moderna’s Spikevax had bagged the US Food and Drug Administration’s emergency use authorization (EUA), there was a lot of uncertainty around how the promised doses would be delivered across the world. But both Comirnaty and Spikevax have proven to be a resounding success. Spikevax emerged as the third largest selling pharmaceutical product of 2021, bringing in US$ 17.7 billion for Moderna.
Analysts
expect both Pfizer-BioNTech and Moderna to sell even more vaccines in
2022. The reasons are manifold. First, SARS-CoV-2 is able to mutate often, and
is unlikely to be eradicated in the near future, creating a need for booster
shots. Second, the younger age groups are still to get vaccinated.
Along with
Comirnaty, Pfizer is battling Covid-19 with its antiviral pill, Paxlovid. Though the sales of Paxlovid have nosedived of late, Pfizer expects
Comirnaty and Paxlovid to help the New York-headquartered drug behemoth achieve US$ 100 billion
in 2022 revenues.
View Our Interactive Dashboard on Top Drugs by Sales in 2021 (Free Excel Available)
AbbVie
moves up, sans Covid product; Roche slips to number five
With no
Covid-19 related products, AbbVie did fairly well in 2021 — it moved up from the number four spot in 2020 to number two position, thanks to its Allergan acquisition, cash cow Humira (adalimumab), the continued success of its
cancer drug Imbruvica (ibrutinib) and an increase in sale of its psoriasis treatment Skyrizi (risankizumab) by a whopping 85 percent in 2021. Humira brought in sales of US$ 21.2 billion for AbbVie in 2021. However, things may change soon, with biosimilars of Humira slated to enter the market in 2023. The years 2022 and 2023 are likely to be transition years for AbbVie, as it works to build the market for its Humira successors — Rinvoq and Skyrizi.
Roche
emerged as a big loser in 2021, as several copycats of its blockbuster drugs
hit the market. Copycats to Roche’s three blockbuster cancer drugs—Avastin, Herceptin and Rituxan—eroded US$ 4.9 billion (CHF 4.73 billion) from the company’s sales in 2021. A large chunk
of growth for Roche came from its multiple sclerosis med Ocrevus, hemophilia drug Hemlibra, inflammatory disease therapy Actemra and PD-L1 inhibitor Tecentriq. The pandemic resulted in
lower-than-expected sales of Ocrevus (ocrelizumab) due to fears around its
immunosuppressive effects.
Like Roche, Novartis also slipped last year. It fell from
number two in 2020 to the number four slot in 2021. Essentially, Novartis is
struggling with a relatively lackluster pipeline. It had sold its 33 percent stake in Roche last
year for US$ 20.7 billion. It plans to use that sum for acquisitions in order
to beef up its pipeline. The Swiss drugmaker has also drawn up a restructuring
plan that includes layoffs of thousands of employees.
Before the
pandemic, Merck’s Keytruda was touted as the drug that would overtake
Humira at the top in 2024. The checkpoint inhibitor has continued to grow
impressively, adding new indications and treatment lines. Keytruda is now used
in close to 40 indications. With US$ 17.2 billion in sales, Keytruda emerged as
the fourth largest selling drug of 2022.
Overall
though, Merck slipped from number six to the number eight slot. This was due to
the fact that Merck had spun out its women’s
health, biosimilars and established brands businesses into Organon. However, its Covid-19 antiviral pill — Molnupiravir — was able to compensate for the lost revenue. Though the FDA is yet to grant the drug a full approval (it bagged an EUA in December 2021), advance sales agreements helped it rack up US$ 952 million in sales in the fourth quarter.
View Our Interactive Dashboard on Top Drugs by Sales in 2021 (Free Excel Available)
BMS moves
up with Eliquis, Revlimid; J&J lands at number three
Bristol Myers Squibb (BMS) moved up from number seven in 2020 to number six, thanks to two of its drugs that made it to top 10 — anticoagulant Eliquis at number five and oncology drug Revlimid at number six. However, Revlimid will soon face competition — four generic companies now have the approval to sell their versions of Revlimid (lenalidomide) after March 2022. Revlimid
sales are expected to drop from US$ 12.9 billion to just US$ 2.06 billion in
2026.
BMS posted
US$ 46.4 billion in global revenues, a nine percent increase from US$ 42.5
billion reported in 2020. In immuno-oncology, Opdivo
brought in US$ 7.52
billion in sales, while Yervoy drew in sales of US$ 2 billion
(an increase of 20 percent).
J&J’s pharma division brought in US$ 52.1 billion in revenues
last year, an increase of 14 percent over its revenues of US$ 45.6 billion
posted in 2020. Drugs like Darzalex (for multiple myeloma), Stelara and its Covid-19 vaccine brought in growth during 2021,
helping J&J move up from number five to the number three slot. J&J’s Covid-19 vaccine brought in US$ 2.4 billion in
sales.
View Our Interactive Dashboard on Top Drugs by Sales in 2021 (Free Excel Available)
GSK bags
approval for shingles vaccine; Takeda suffers setbacks
GlaxoSmithKline (GSK) slipped four places — from number three in 2020 to number seven in 2021. Though GSK did not have a drug in the top 10, sales of GSK and Vir Biotechnology’s Covid-19 antibody treatment
sotrovimab helped produce a seven percent increase in its 2021 revenue. The British drugmaker also bagged a critical FDA approval — its vaccine to prevent shingles (herpes zoster), Shingrix, bagged the agency’s nod in July. GSK hopes to double the sales of Shingrix by 2026.
GSK is also undergoing a major transformation, and plans to demerge its consumer health unit this year. The unit generated revenues of £9.6 billion (US$ 13 billion) last year, and GSK sees the demerger as a necessary step to fuel growth through the development of new vaccines and specialty medicines.
Sanofi managed to retain its ninth slot, even as
its global turnover increased from US$ 39.3 billion (Euro 36.04 billion) to US$
41.6 billion (Euro 37.76 billion). It snapped up Kymab, Tidal Therapeutics, Translate Bio, Kadmon Holdings, Origimm Biotechnology and Amunix in deals that bolstered its presence in immunology, immuno-oncology and vaccines. Dealmaking is on the French drugmaker’s menu for 2022 and beyond, Sanofi’s CFO said at this year’s virtual JP Morgan Healthcare Conference.
AstraZeneca’s global revenues grew from US$ 26.6 billion in 2020 to US$ 37.4 billion in 2021. However, its rank fell from nine in 2020 to 10 in 2021.
AstraZeneca
wrapped up the US$ 39 billion acquisition of Alexion in July 2021. Alexion’s rare disease franchise—led by C5 inhibitors Soliris and Ultomiris—added an extra US$ 3.1 billion to Astra’s top line last year.
Takeda suffered several clinical and regulatory setbacks in 2021, which it labeled as an “inflection year.” For Gilead, sales of its Covid-19 antiviral Veklury brought in US$ 5.6 billion last year,
helping its revenues grow by 11 percent.
View Our Interactive Dashboard on Top Drugs by Sales in 2021 (Free Excel Available)
Our view
If anything,
the pandemic has taught us that change is the only constant. It has also taught
us that products can become blockbusters in a matter of a few months.
The industry
landscape continues to change. On the one hand, we are seeing people scrambling
to get Covid vaccines and booster shots, on the other hand, the FDA has limited the use of monoclonal antibodies, such as Eli Lilly’s bamlanivimab and etesevimab and
Regeneron’s REGEN-COV (casirivimab and
imdevimab), in treating Covid caused by the Omicron variant. The FDA has also pulled the authorization
granted to GSK and Vir Biotechnology’s antibody therapy this month,
citing data that suggested it was unlikely to be effective against the dominant
Omicron sub-variant.
And last
week, there was news that demand for Pfizer’s
antiviral pill Paxlovid has remained unexpectedly low. The supply
of Paxlovid, which reduced hospitalizations or deaths in high-risk patients by
around 90 percent in a clinical trial, has far outstripped demand in many
countries like the US, the UK and South Korea.
Though Pfizer is hopeful of crossing US$ 100 billion in revenue this
year, much depends on how the pandemic pans out and what new research has to
say about the novel coronavirus. A lot will change once the pandemic becomes endemic.
The first four months of 2022 tell us that vaccines like Comirnaty and Spikevax
will continue to perform well.
But two years down the line, our charts could look very different.
Impressions: 8047
https://www.pharmacompass.com/radio-compass-blog/top-pharma-companies-drugs-in-2021-covid-vaccines-pills-cause-churn-in-list
#PharmaFlow by PHARMACOMPASS
28 Apr 2022
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: 55009
https://www.pharmacompass.com/radio-compass-blog/top-drugs-and-pharmaceutical-companies-of-2019-by-revenues
#PharmaFlow by PHARMACOMPASS
29 Apr 2020
The year 2018 was a landmark year for the US Food and Drug Administration (FDA) as the agency approved a record number of novel drugs. FDA approved 62 novel drugs in 2018, out of which 34 were orphan drugs. FDA’s Center for Drug Evaluation & Research (CDER) approved 59 drugs while the other three were approved by the Center for Biologics
Evaluation and Research (CBER).
In a speech towards the end of the year, FDA Commissioner Scott Gottlieb said: “Far more important than the overall quantity of approvals however is the quality of the new drugs”. He went on to add that some “of [the] previous records were set in years when there were a lot of drugs that critics bemoaned were me-too medicines,” or novel chemical entities that addressed the same common, therapeutic targets.
In 2018, FDA reversed three earlier drug
rejections, approved the first cannabis-based drug, allowed the first ever RNA interference drug to market
and gave the green light to Loxo Oncology/Bayer’s Vitrakvi (larotrectinib)
which became the second anti-cancer drug (after Merck’s Keytruda)
to bag an approval that treats cancer based on a biomarker across different
types of tumors rather than the location in the body where the tumor
originated.
Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018
Gilead’s Biktarvy tops our list for sales potential
PharmaCompass
compiled the peak sales estimates of the new drugs approved in 2018 and in our
compilation, Gilead’s antiretroviral treatment for HIV — Biktarvy — topped the charts with an estimated sales potential of almost US$ 5.3 billion followed by Vertex’s cystic fibrosis drug Symdeko
that is expected to bring in US$ 2.75 billion.
Alexion’s Ultomiris,
Abbvie’s Orilissa,
Novartis’ Lutathera
and J&J’s Erleada
are all expected to bring in more than US$ 2 billion for their companies at
their peaks.
Although Loxo’s cancer drug, with an estimated US$ 860 million in peak sales, did not make it to the list of top 15 drugs in
2018 by sales potential, the company got purchased
by Eli Lilly earlier this month for US$ 8 billion.
Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018
Pfizer won four approvals, Shire won three
For 2018, Pfizer
led the approvals with four drugs that got the green light, followed by Shire with
three drugs. Companies like AstraZeneca,
Array Biopharma, Alynlam and Paratek Pharmaceuticals each won two drug approvals. Merck
also had two approvals which were in cooperation with other companies.
Amgen, Teva
and Eli Lilly got their CGRP inhibitors for migraine prevention approved within
a few months of each other.
Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018
First cannabis-based drug bagged approval
Last year, FDA also approved
Epidiolex (cannabidiol or CBD) oral solution for the
treatment of seizures associated with two rare and severe forms of epilepsy — Lennox-Gastaut syndrome and Dravet syndrome.
CBD is a chemical component of the Cannabis sativa plant, more commonly
known as marijuana. And Epidiolex is the first marijuana-based drug to be
approved in the US for epilepsy. It is produced by GW Pharmaceuticals.
Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018
CBD does not cause intoxication. It is one of
the hundreds of molecules found in marijuana and has been cited by scientists
as a potential treatment for mental health issues.
2018 saw the launch of one-dose flu cure from
Shionogi
In March 2018, Shionogi & Co Ltd.’s Xofluza — a pathbreaking drug that cures flu with just one dose — was approved in Japan. The drug is a treatment for influenza A and influenza B.
In October, the US Food and Drug Administration (FDA) also approved Xofluza (baloxavir marboxil).
Xofluza is the first new antiviral flu treatment with a novel mechanism of
action approved by the FDA in nearly 20 years.
Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018
The single dose feature gives Xofluza an edge
over other neuraminidase inhibitors like Tamiflu and Relenza. For example, Tamiflu typically requires two
doses each day for five days. Therefore, there are nine more doses of Tamiflu
required, as compared to the single-dose Xofluza.
Shionogi aims to double the global market for flu treatment
with Xofluza.
“While the global market of flu drug is said to be about US$ 1 billion to US$ 1.5 billion, we want to expand it to around US$ 3 billion,” Shionogi CEO Isao Teshirogi said last year.
Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018
Though the FDA approval for Xofluza has
been granted to Shionogi, Genentech (a member of the Roche Group
which marketed Tamiflu, which is now a generic) will be marketing the
medication in the US.
Industry
gets far lower returns from its drug launches
Gottlieb used Twitter to promote the progress of FDA’s review cycle. “In 2018, CDER met its PDUFA goal for 100 percent of the novel drugs approved – 95 percent of which on the first cycle – reflecting our efficiency in getting new therapies to patients quickly,” he tweeted.
Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018
A ‘cycle’ is the time from when CDER accepts an application for a new drug until the agency decides whether to approve it or not.
However, the record number of approvals doesn’t present the complete picture for the pharmaceutical industry. A study published in December by Deloitte
highlighted that the industry is getting far lower average returns from its
drug launches than ever before. While the costs to bring a drug to market
have almost doubled in eight years to over US$ 2 billion, peak sales
forecasts have halved to a little over US$ 400 million, the study said.
Drug discovery reviews in the scientific publication Nature reached a similar conclusion. “Projected peak annual sales for new therapeutic drugs (NTDs) approved in 2018 total US$ 45 billion — lower than 2017’s US$ 58 billion — and the value of the average peak sales per product has continued to trend down to only US$ 720 million per drug in 2018, the lowest figure in almost a decade,” the publication said.
“The decline is driven both by fewer blockbusters at the top end, as well as a proliferation of very small products at the bottom end. We believe the underlying driver of both these trends — more approvals but smaller markets per approval — is better understanding of biology fostering precision medicine,” it added.
Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018
Our view
After suffering brutal losses towards the end of 2018, wherein biotech was among the US stock market’s most oversold sectors and saw a decline of nearly 10 percent, this year the biotech sector has got off to the best start since 2012.
Drug companies are continuing to innovate more
targeted therapies, and Chinese companies are investing in developing new
drugs.
While the industry expects to see a lot more
mergers and acquisitions in 2019, where smaller biotech companies get acquired
by major pharmaceutical corporations, it is unlikely that the general trend of
companies bagging more approvals for targeted therapies with a smaller peak sales
potential is going to reverse anytime soon.
Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018
Impressions: 7095
https://www.pharmacompass.com/radio-compass-blog/sales-forecast-of-fda-s-novel-drugs-approvals-in-2018
#PharmaFlow by PHARMACOMPASS
17 Jan 2019
In August, the biotech boom of 2018 continued unabated and the Wall
Street Journal reported that investment banks have lured top biotech
analysts with guaranteed pay packages of US$ 3 million or more.
At this time of the year, equity analysts who assess companies and
write reports that help investors gauge prospects and
interpret news will certainly have their hands full as investments into pharma
and biotech companies continue to grow at a rapid pace.
Leading the pack
in August was US-based Emergent BioSolutions which made two acquisitions to
stay on track of its growth plan to achieve US$ 1 billion in revenue by
2020.
While European
businesses have had a long-established practice of taking off during the months of July or August, last month two German startups — Affimed NV and Mologen AG — announced big ticket deals which could result in multi-billion dollar payouts. And
Hong Kong continued its efforts to lure overseas-listed firms to conduct
secondary share offerings in the financial hub.
Click here to view the major deals in August 2018 (FREE Excel version available)
Emergent
BioSolutions’ billion-dollar shopping spree
In a deal
valued up to US$
735 million, consisting of an upfront payment of US$ 635 million and up to US$ 100 million in cash for potential
sales-based milestones, Emergent Biosolutions acquired Adapt Pharma to access its flagship product Narcan (naloxone Hydrochlroride) Nasal Spray — the first and only US Food and Drug Administration (FDA) approved nasal form of naloxone for the
emergency treatment of a known or suspected opioid overdose.
The acquisition is designed to
help Emergent expand its presence within the public health threats market
to respond to the opioid crisis, which has been declared a public health
emergency by the US government.
Click here to view the major deals in August 2018 (FREE Excel version available)
Narcan is often carried by police officers and medical teams and was approved in 2015. Earlier
this year, the US Surgeon General released a public health advisory urging more
Americans to carry naloxone.
The
purchase of Adapt Pharma is expected to generate revenues of US$ 200
million to US$ 220 million and to be accretive to adjusted net income and
EBITDA in 2019.
Just weeks earlier, Emergent
announced an all-cash US$ 270 million acquisition of specialty vaccines company PaxVax. The
acquisition will add two revenue-generating FDA-licensed vaccines that
protect against cholera and typhoid fever to Emergent’s vaccine portfolio. These vaccines
are expected
to generate revenues of US$ 70 million to US$ 90 million in 2019.
Click here to view the major deals in August 2018 (FREE Excel version available)
Novo bags new diabetes technology by acquiring Bristol univ spinout — Ziylo
Novo Nordisk acquired full rights to Ziylo’s early-stage glucose binding molecules in a staged acquisition with a potential deal value that could exceed US$ 800 million. The acquisition will give Novo Nordisk full rights to Ziylo’s glucose binding molecule platform to develop glucose responsive insulin molecules.
Ziylo is a University of Bristol spin-out company based out of the Unit DX science incubator in Bristol, UK. Ziylo has been pioneering the use of its platform technology — synthetic glucose binding molecules — for therapeutic and diagnostic applications.
Click here to view the major deals in August 2018 (FREE Excel version available)
Ziylo’s glucose binding molecules are synthetic molecules that exhibit an unprecedented selectivity to glucose in complex environments such as blood.
The development of glucose
responsive insulin molecules is a key strategic area for Novo Nordisk, as it
wants to develop this safer and more effective (next generation of insulin)
therapy.
A glucose responsive insulin would
help eliminate the risk of hypoglycaemia (deficiency of glucose in the blood
stream), which is the main risk associated with insulin therapy and one of the
main barriers to achieving optimal glucose control. Such an insulin molecule
could also lead to better metabolic control.
Just before selling itself to
Novo, Ziylo spun out a new company
dubbed Carbometrics to develop the diagnostics and glucose monitoring
applications of its technology. Carbometrics is now the new home for all Ziylo
researchers. Through a research collaboration with Novo Nordisk, Carbometrics
will assist with ongoing optimization of glucose binding molecules for use in
glucose responsive insulin molecules.
Click here to view the major deals in August 2018 (FREE Excel version available)
Novo Nordisk has a strong presence in the diabetes care market with a global value market share of 27 percent. In the total insulin market, Novo’s global value market share is 46 percent; and in the modern and new-generation insulin market, it is 45 percent.
The European
discovery outfit at Evotec also announced a tie up with Novo Nordisk to build early-stage pipeline drugs
for diabetes, obesity drugs, and also diseases like NASH (non-alcoholic fatty
liver disease), cardiovascular diseases and diabetic kidney disease. The
scientists at Evotec will build a preclinical pipeline of small molecules
primarily concentrating on diabetes and obesity.
While the
financial details of the alliance are not known, it is clear that Evotec is
adding a major partnership on top of a string of deals with companies
like Celgene, Bayer and Sanofi, as well as a number of smaller
biotech firms.
Click here to view the major deals in August 2018 (FREE Excel version available)
German cancer
startups announce big ticket deals
Last month, Genentech, a member of the Roche group, announced it will pay German clinical stage biopharmaceutical company — Affimed — US$ 96 million upfront. It also committed to funding, thereby making Affimed eligible for up to an additional US$ 5.0 billion in revenues which includes milestone payments, and royalties on sales.
The German start up is focused on
discovering and developing highly targeted cancer immunotherapies that harness
the power of innate and adaptive immunity (NK and T cells).
Affimed will apply its proprietary Redirected Optimized Cell Killing (ROCK®) platform, which enables the generation of both NK cell and T cell-engaging antibodies, to discover and advance innate immune cell engager-based immunotherapeutics of interest to Genentech.
Click here to view the major deals in August 2018 (FREE Excel version available)
In June, at the European
Hematology Association, Affimed shared data of its lead candidate AFM13 in combination with
Keytruda (Pembrolizumab)
in patients with Relapsed/Refractory
Hodgkin Lymphoma. Assessment of 18 patients treated at the highest AFM13 dose
showed best overall response rate (ORR) of 89 percent (16/18 patients).
Another German company Mologen AG announced a deal with Oncologie which could generate
payouts of over US$ 1.16 billion (€1 billion) towards the development of its lead compound — lefitolimod.
In the near-term, Mologen would receive US$ 26.63 million (€23 million) to conduct the phase III Impala trial and build on the promising data from a phase II trial as a maintenance
therapy after first-line induction chemotherapy in patients with metastatic
colorectal cancer. Impala is a randomized phase III study in patients with
metastatic colorectal carcinoma.
In the field of
active immunotherapies, great hopes are riding on substances that bind to very
specific receptors, known as toll-like receptors (TLR). These receptors are
part of the innate defense system. Through activation of the immune system,
they are able to facilitate the recognition of tumor-associated antigens.
Click here to view the major deals in August 2018 (FREE Excel version available)
Many years of
research work have shown that toll-like receptor 9 (TLR9) plays a particularly
important role in the fight against cancer. Substances that activate TLR9 are
referred to as TLR9 agonists and form the main focus of global research and
development activities.
Lefitolimod
is regarded as the best-in-class TLR9 agonist.
Under new listing rules, Hong Kong stages second biotech IPO
Chinese cancer drug developer BeiGene, which debuted to a US$ 158 million public offering on the Nasdaq back in 2016, had its secondary IPO on the Hong Kong stock exchange last month.
As part of an effort to attract
secondary listings, Hong Kong is implementing new and more lenient rules for
drugmakers that are still in the earliest stages of the clinical trial process
without any products on the market.
BeiGene is only
the second to launch an IPO under the new regime and the US$ 903 million raised during the dual listing improves its exposure to
investors in Asia while being close to the mainland China market.
Click here to view the major deals in August 2018 (FREE Excel version available)
BeiGene intends to use net proceeds from the offering for clinical trials, preparation for registration filings, and for the launch and commercialization of its core product candidates — zanubrutinib, tislelizumab, and pamiparib.
Under the revised rules, Ascletis Pharma was the first early-stage biotechnology company to be listed on the Hong Kong Stock Exchange (HKEX) in July 2018. After the new rules were put in place
in Hong Kong, more than 10 biotech companies, mostly Chinese, announced plans
to list in Hong Kong. Some have also dropped plans to launch IPOs in the US in
favor of the Hong Kong exchange.
Click here to view the major deals in August 2018 (FREE Excel version available)
The overall IPO range sought by
BeiGene was reportedly between US$ 908 million and US$ 1.07 billion
and one of the reasons given for the biotech falling short of its target was the
vaccine scandal in China which has been making headlines and may have hurt
investor confidence.
Currently New York-based Nasdaq is
the biggest center for biotech listings, with US$ 2.4 billion worth of such
shares sold last year, according to the data provided by Thomson Reuters.
Click here to view the major deals in August 2018 (FREE Excel version available)
Our view
The first half of 2018 witnessed a spate of M&A activity in
the pharmaceutical and biotech space with the industry witnessing some of the
biggest deals from companies like Takeda, Celgene and Sanofi. In addition, healthcare startup funding
from venture capital firms reached US$ 15 billion, which is 70 percent higher
than the corresponding figure for last year.
Click here to view the major deals in August 2018 (FREE Excel version available)
While July and
August were comparatively slow months for activity, we expect a significant
ramp up of deal-making in the coming months.
Keep
track of all that is happening with PharmaCompass’ compilation of Top Pharma & Biotech Deals — PharmaFlow.
Click here to view the major deals in August 2018 (FREE Excel version available)
Impressions: 2569
https://www.pharmacompass.com/radio-compass-blog/top-pharma-biotech-deals-investments-m-as-in-august-2018
#PharmaFlow by PHARMACOMPASS
13 Sep 2018
As April 2018 breezed past with news of Novartis’ US$ 8.7 billion buyout of AveXis, May set the temperatures soaring with one of the largest pharma acquisitions in recent years.
Japanese drugmaker Takeda Pharmaceutical agreed to buy British drugmaker Shire for US$ 62 billion (£45.3 billion) in the biggest pharma M&A deal of the year.
In a month that witnessed extensive deal making, Eli Lilly announced its commitment to spend over US$ 2.2 billion to acquire immuno-oncology companies — ARMO Biosciences and AurKa Pharma, while Genentech signed a deal worth US$ 969 million with Lodo Therapeutics to discover novel molecules with therapeutic potential against multiple disease-related targets of interest to Genentech.
AstraZeneca was also busy last month as it expanded its collaboration with the UK-based Bicycle Therapeutics by signing a wide-ranging deal to develop novel small molecule medicines for respiratory, cardiovascular and metabolic diseases.
Will Takeda-Shire’s US$ 62 billion deal go through?
Japanese drug maker Takeda Pharmaceutical Limited
clinched Ireland-based Shire for a hefty price tag
of US$ 62 billion (£46 billion).
Together, they have almost
made
it to the league of the 10 largest drug companies.
Takeda’s first non-Japanese CEO, Christophe Weber, envisions the new entity as a global pharmaceutical giant with its roots in Japan, along with becoming a leader in gastroenterology, neuroscience, oncology and rare diseases.
The transaction has
been approved by the boards of both the companies. It is expected to close in
the first half of 2019.
Click here to view the major deals in May 2018 (FREE Excel
version available)
Upon closing of the
transaction, Takeda shareholders will own approximately 50 percent of the
combined group.
However, Takeda’s board faces stiff
opposition from a group of shareholders who say the buyout will shrink the value of Takeda’s shares.
The small groupof Takeda shareholders comprising the drug maker’s ex-employees has achieved sizable support in its opposition to the company’s deal.
This 130-member group comprising ex-Takeda employees holds one percent of the drug maker’s shares and needs to secure a third of shareholder votes. The group also includes members of the founding Takeda family which holds about 10 percent of Takeda shares, as reported on Nikkan Yakugyo, a Japanese daily.
Click here to view the major deals in May 2018 (FREE Excel
version available)
Reuters reported earlier this week that Takeda “will hold the shareholder meeting later this year or early next year to approve an issue of new stock to help fund the Shire deal, making it a de facto vote on the deal itself.”
This rebel group of shareholders is “working steadily to increase support” for blocking the deal among domestic retail investors and overseas institutional investors who own 25 percent and 35 percent of Takeda shares respectively, Reuters noted.
Last year, this shareholder group had tried preventing the appointment of outgoing Chairman Yasuchika Hasegawa to an advisory position at the company. The proposal stood defeated at the company’s annual general meeting then, since it had gained only 30.5 percent of votes.
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After discovering
drugs from soil, Lodo rakes in almost US$ 1 billion from Genentech
Lodo Therapeutics Corporation,
a drug discovery and development company focused on identifying bioactive
natural compounds directly from soil bacteria, announced it had formed a strategic drug discovery
collaboration with Genentech, a member of the Roche Group.
The Genentech
collaboration has Lodo receiving an undisclosed upfront payment and becoming
eligible to receive research, development and commercialization milestone
payments of up to US$ 969 million.
In addition, Lodo is
eligible to receive tiered-royalties on sales of certain products resulting
from the collaboration.
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Two months before the Genentech deal was announced, Lodo published its discovery of a new class of antibiotics called “malacidins” in the journal Nature Microbiology.
Malacidins,
discovered from soil, attack an essential part of the bacterial cell wall in a
unique way compared to other existing calcium-dependent antibiotics. They annihilate several
bacterial diseases that are resistant to most existing antibiotics, including
the superbug MRSA.
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Experts say this
approach offers fresh hope in the antibiotics arms race and may be able to reduce the time and cost of drug
discovery.
Dr Sean Brady's team at New York’s Rockefeller University — the researcher whose vision inspired the founding of Lodo Therapeutics — has devised a gene sequencing technique that can analyze more than 1,000 soil samples which became the basis for the company’s genome mining platform.
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Eli Lilly strengthens its oncology portfolio as it goes on a buying spree
Eli Lilly announced it was bolstering its immuno-oncology
portfolio by acquiring ARMO BioSciences for US$ 1.6 billion in cash — just a few months after ARMO’s successful IPO debut on Nasdaq.
This US$ 1.6 billion transaction brings to Lilly’s table ARMO’s lead immuno-oncology asset, pegilodecakin, which is being studied
in multiple tumor types.
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While pegilodecakin is a valuable phase 3 asset, the reason for the billion-dollar price tag is its potential use in combination treatments
with Merck’s Keytruda and BMS’ Opdivo.
The successful combination of pegilodecakin with Keytruda and
Opdivo can potentially expand the blockbuster market for the drugs by turning
non-responders into responders.
ARMO has tested pegilodecakin in combination with both Keytruda and Opdivo, but could
combine it with its own anti-PD-1 antibody in the long term.
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The biotech bagged US$ 67 million in August to bankroll the pegilodecakin
program, and to move its anti-PD-1 antibody into the clinic.
An Evaluate Pharma report,
published a year ago, examined the explosion in the number of
clinical trials using anti-PD-1 and anti-PD-L1 antibodies combined with other
therapeutic approaches. The report states that the number of combined use
clinical trials had shot up from 215 to 765.
Just four days after the US$ 1.6 billion all-cash
transaction, Lilly announced it is paying US$ 110 million upfront and another US$ 465 million in milestones to buy Montreal-based AurKa Pharma.
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At the center of this deal is AK-01, an Aurora kinase A inhibitor that Lilly discovered years ago, which was sold off to TVM Capital Life Science in 2016. Aurora A kinase is a master regulator of mitotic progression, and disrupting it can play a role in preventing tumor progression through various pathways. As such it now fits Lilly’s sweet spot and the cancer team wants it back in their pipeline.
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AstraZeneca expands collaboration with UK-based Bicycle Therapeutics
Last month, AstraZeneca and Cambridge-based Bicycle
Therapeutics announced they
have expanded their 2016 collaboration to develop a novel class of small
molecule medicines for treating respiratory, cardiovascular and metabolic
diseases.
The companies said the
alliance could be worth more than US$ 1 billion for Bicycle, if all planned
programs reach the market.
Bicycle Therapeutics is focused on identifying Bicycles, the company’s proprietary bicyclic
peptides that resemble
injectable antibody drugs. These are essentially small molecules that possibly
can be given as pills.
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The company states on its website — ‘Bicycles address therapeutic needs unreachable with any other existing modality’. Their small size and exquisite tumor targeting quality delivers rapid tumor penetration and retention while clearance rates and routes can be tuned to minimize exposure of healthy tissue and toxicities.
Our view
While the drug pricing debate continues to rage on in the
United States, Evaluate Pharma recently published its World Drug Forecast
report which predicts that prescription drug sales will grow to US$ 1.2
trillion in 2024 at a compound annual growth rate of 6.4 percent over the next
seven years.
Recently, the Gates Foundation opened its not-for-profit venture and French companies like Servier and Ipsen
announced the launch of their operations in Boston. Being a pharma hub with
small startups, large drug makers, incubator sites and large-biotech focused
research institutes, we expect more deals to take place in Boston over the
coming months, especially post the BIO convention.
PharmaCompass’ compilation of Top Pharma & Biotech Deals — PharmaFlow — is your way of keeping track of all that is happening.
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Impressions: 2700
https://www.pharmacompass.com/radio-compass-blog/pharma-biotech-deals-investments-and-m-as-in-may-2018
#PharmaFlow by PHARMACOMPASS
14 Jun 2018
