Market Place
The world of pharmaceuticals and biotechnology continued to evolve
this year with strategic alliances reshaping industry contours. With mid-size
deals taking centerstage, the growth trajectory appears to be marked by a
balance of both caution and calculated ambition.The deal-making environment was robust in 2023, with over 2,000
unique pharma and biotech deals totaling more than US$ 410 billion, according
to the PharmaCompass database. Last year, there were over 200 mergers and acquisitions (M&As) with transactions exceeding US$ 160 billion in total value. Oncology, infections and infectious diseases, and neurology had emerged as the top three therapeutic areas for deals.PharmaCompass’ analysis indicates that the momentum has been maintained in 2024. As of August 6, the industry had seen over 1,200 unique deals valued at more than US$ 230 billion, including over 120 M&A transactions surpassing US$ 60 billion in aggregate value. While oncology maintains its lead position, neurology and immunology have gained notable traction.The one big difference is that 2024 is yet to witness a mega-deal,
comparable to Pfizer’s US$ 43 billion acquisition of Seagen in 2023 or Amgen’s US$ 27.8 billion Horizon buyout announced in 2022. The largest transaction
thus far has been Novo Nordisk Foundation’s US$ 16.5 billion acquisition of Catalent, a contract development and manufacturing organization (CDMO).This
compilation does not include deals related to acquisition of facilities,
divestment, medical devices, diagnostics and animal health. We have considered
deals announced, irrespective of when these transactions were completed. For a comprehensive overview of CDMO deals and developments
in 2024, please refer to our dedicated roundup.View Pharma & Biotech Acquisitions, Deals & Agreements in 2024 as of Aug. 6 (Free Excel Available) Vertex buys Alpine Immune for US$ 4.9 bn; Gilead’s CymaBay buyout pays off via FDA nodAmongst the biggest acquisitions of 2024 was Vertex Pharmaceuticals’ buyout of Alpine Immune Sciences for US$ 4.9 billion. It granted Vertex access to protein-based immunotherapies, including the promising povetacicept for IgA nephropathy, a serious kidney disease.Gilead Sciences’ acquisition of CymaBay Therapeutics for US$ 4.3 billion in February secured it
access to seladelpar (Livdelzi), an experimental drug that received FDA’s accelerated approval this month for primary biliary cholangitis, a liver disease that affects the bile ducts. Eli Lilly bolstered its presence in
the US$ 26.65 billion inflammatory bowel disease (IBD) market by purchasing Morphic Holding for approximately US$ 3.2 billion in July. Through this deal,
Lilly gained the oral IBD therapy candidate MORF-057, which will offer a more
convenient dosing option compared to injectable drugs currently available in
the market. Lilly sees the IBD space as a way to diversify beyond obesity.Merck expanded its ophthalmology portfolio by acquiring Eyebiotech Limited
for US$ 1.3 billion (plus US$
1.7 billion in milestone payments), obtaining Restoret for diabetic macular edema and neovascular age-related macular degeneration.Japanese drugmaker Ono Pharmaceutical acquired Deciphera Pharmaceuticals for US$ 2.4 billion, gaining Qinlock for
gastrointestinal stromal tumors and vimseltinib for tenosynovial giant cell
tumors. Sanofi targeted rare diseases by
purchasing Inhibrx for up to US$ 2.2 billion. The acquisition gave the French drugmaker access to INBRX-101 for Alpha-1 antitrypsin deficiency, a genetic condition that can cause lung and liver damage.View Pharma & Biotech Acquisitions, Deals & Agreements in 2024 as of Aug. 6 (Free Excel Available) Novartis buys two oncology firms for their assets; J&J, Genmab join ADC bandwagonNovartis has been on a shopping
spree, and has made two significant purchases this year. First, it acquired MorphoSys for € 2.7 billion (US$ 2.9 billion), thereby
adding the promising bone-marrow cancer treatment pelabresib to its pipeline. Second, it
announced the acquisition of Mariana Oncology for US$ 1 billion upfront (plus US$ 750 million in milestone payments), thereby expanding into radioligand
therapies (RLTs) to treat cancers with high unmet need. RLTs take a
targeted approach, delivering radiation to the tumor, while limiting damage to
the surrounding cells.AstraZeneca entered the field of
radioconjugates, which is a promising modality in the treatment of cancer, by
acquiring Fusion Pharmaceuticals for US$ 2.4 billion.In January this year, Johnson & Johnson had announced the acquisition of
antibody-drug-conjugate (ADC) developer Ambrx Biopharma for about US$ 2 billion. With this buyout, J&J has joined the likes of Bristol Myers Squibb, AbbVie and GSK who had entered this
promising field through acquisitions last year.Similarly, Denmark’s Genmab bought ProfoundBio for US$ 1.8 billion in cash, boosting its
oncology portfolio with three next-generation ADC candidates. This includes Rina-S, which recently received FDA’s fast track designation for the treatment of ovarian cancer.View Pharma & Biotech Acquisitions, Deals & Agreements in 2024 as of Aug. 6 (Free Excel Available) Novartis signs multiple
collaborations; GSK, Takeda, AbbVie sign billion-dollar dealsNovartis was not just busy signing M&A deals, it also signed a bevy of collaboration agreements. For instance, Shanghai-based Argo partnered Novartis on two
early-stage RNA interference candidates for cardiovascular diseases,
potentially earning the former up to US$ 4.2 billion plus tiered royalties.Novartis also agreed to pay up to US$ 3 billion (including US$ 150 million
upfront) to Dren Bio to use the latter’s Targeted Myeloid Engager and Phagocytosis platform to develop bispecific antibodies to treat cancer.Moreover, the Swiss drugmaker expanded its peptide discovery
collaboration with Japan-based PeptiDream in a deal worth over US$ 2.71 billion in milestone payments, plus an upfront payment of US$ 180 million. Peptide-drug conjugates (PDCs) are the next generation of targeted therapeutic drugs after ADCs and Novartis is, thus far, the only big pharma with FDA-approved radioligand PDCs. GSK entered a groundbreaking
partnership with Flagship Pioneering, potentially worth over US$ 7 billion, to identify and develop 10
novel drugs and vaccines. The deal, starting with respiratory and immunology
drugs, involves US$ 720 million in upfront and milestone payments for each candidate. This collaboration leverages Flagship’s extensive portfolio of over 40 biopharma companies with drug development capabilities.There were two significant deals in the field of neuroscience.
First, Takeda said it is paying Swiss
biotech AC Immune US$ 100 million upfront with potential further payments of US$ 2.1 billion for an exclusive option to license global rights to an Alzheimer’s vaccine and related immunotherapies.Second, AbbVie and clinical stage biotech Gilgamesh Pharmaceuticals joined forces in a deal
potentially worth over US$ 2 billion to develop a new class of psychedelic compounds for psychiatric conditions, combining AbbVie’s psychiatric expertise with Gilgamesh’s innovative neuroplastogen research platform.View Pharma & Biotech Acquisitions, Deals & Agreements in 2024 as of Aug. 6 (Free Excel Available) Our viewDuring this year, companies like Novartis (with US$ 16.8 billion), GSK (US$ 14.5 billion), Sanofi (US$ 11.9 billion), Bristol Myers Squibb (US$ 11.6 billion), and AbbVie (US$ 9.1 billion) have made
substantial investments in acquisitions, collaborations and other forms of
dealmaking.Though the deal-making environment is robust, we notice a shift towards mid-size transactions. Alongside, we notice a growing interest in areas such as ADCs, radiopharmaceuticals, and protein-based immunotherapies, underscoring their growing importance in drug development. There has also been significant interest in silencing RNA (siRNA) therapeutics, highlighting the industry's focus on novel approaches to disease treatment. With the industry focusing on cutting-edge technologies that address unmet medical needs, we feel there is little reason to fret over the size of the deals.
Impressions: 591
https://www.pharmacompass.com/radio-compass-blog/novartis-gsk-sanofi-bms-shell-out-over-us-10-bn-in-dealmaking-as-mid-size-deals-take-centerstage-in-2024
#PharmaFlow by PHARMACOMPASS
22 Aug 2024
Share
The first half of 2024 saw a significant slowdown in approvals of new drugs and biologics by the US Food and Drug Administration (FDA) compared to the same period last year.FDA’s Center for Drug Evaluation
and Research (CDER) approved 21 drugs in H1 2024, reflecting a 19 percent decrease from the 26 approvals granted in H1 2023. Of them, 81 percent (17) were first-in-class drugs (therapies that use a new and unique mechanism of action), while small molecules made up for 67 percent (14) of the total drugs approved.Similarly, the Center for Biologics
Evaluation and Research (CBER) granted approvals to only eight biologics, as compared to 10 in H1 2023.Health Canada also saw a drop in drug approvals as only 10 drugs were okayed in H1 2024, as opposed to 13 approvals in H1 2023.The European Medicines Agency (EMA) saw a marginal rise in drug authorizations at 15 for H1 2024 as compared to 14 approvals in H1 2023. Interestingly, the EMA also saw a surge in pending decisions (applications under review) — from two in H1 2023 to 14 in H1 2024.View New Drug Approvals in H1 2024 with Estimated Sales (Free Excel Available)Merck, Madrigal, Verona bag approvals for breakthrough meds; Lilly’s donanemab okayedThe first half saw some closely watched drugs win regulatory
approvals. FDA approved a breakthrough therapy from Merck — Winrevair (sotatercept) — that treats adults with hypertension caused by the constriction
of arteries in the lungs, known as pulmonary arterial hypertension (PAH).Merck had acquired Winrevair
through its US$ 11.5 billion acquisition of Acceleron Pharma in 2021. The therapy is set
to generate nearly US$ 3 billion in global peak sales by 2028. Another breakthrough therapy approved in H1 2024 is Madrigal’s Rezdiffra (resmetirom), the first FDA-approved treatment for adults with the common fatty liver disease — nonalcoholic steatohepatitis (NASH). Rezdiffra is expected to touch sales of US$ 2.1 billion by 2028.The agency also approved the first maintenance treatment for chronic obstructive pulmonary disease (COPD) in over 20 years — Verona’s Ohtuvayre. The drug has a novel
mechanism of action and is the first inhaled maintenance treatment
for COPD. Approved in June by the FDA, Ohtuvayre is forecast to bring in global
sales of US$ 1.5 billion by 2030.The approval of Eli Lilly’s donanemab was surprisingly delayed, and finally came through on
July 2 after an FDA advisory committee voted unanimously in favor of its
benefits outweighing its risks. To be sold as
Kinsula, the
Alzheimer's drug is estimated to bring in US$ 2.2 billion in sales by 2028.Across the pond, EMA approved Novo Nordisk’s weekly insulin injection Awiqli (insulin icodec). The replacement insulin in Awiqli acts in the same way as the body’s own insulin and helps glucose enter cells from the blood. Meanwhile, FDA rejected this once-a-week insulin
earlier this month and has requested information related to the manufacturing
process.View New Drug Approvals in H1 2024 with Estimated Sales (Free Excel Available) ImmunityBio, Geron, Day One
win approvals for their oncology drugsIn what marks the first approval for ImmunityBio, FDA greenlit Anktiva
(nogapendekin alfa inbakicept-pmln) as part of a combination therapy to treat a type of bladder cancer. Anktiva is a next-generation immunotherapy that creates long-term immunity by activating the so-called natural killer (NK) cells and T-cells. It will compete with Merck’s Keytruda. Anktiva’s yearly sales by 2030 are expected to be around
US$ 1.7 billion.BeiGene’s PD-1 blocker Tevimbra (tislelizumab) got the go-ahead from the FDA as the
treatment for adult patients with unresectable or metastatic esophageal
squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. Tevimbra’s 2028 global sales are forecast to bring in US$ 1.6 billion.FDA signed off on Geron’s Rytelo (imetelstat) for treating transfusion-dependent
anemia in patients with low- to
intermediate-risk myelodysplastic syndromes (MDS), a group of blood cancers. This was Geron’s maiden approval and Rytelo is expected to bring in US$ 1.3 billion by 2030.Day One Biopharmaceuticals’ Ojemda (tovorafenib) was granted FDA’s accelerated approval to treat certain types of pediatric brain
cancer. This is the first FDA approval of a systemic therapy for treating
what is the most common form of childhood brain tumor, including fusions.
Ojemda is forecast to bring in US$ 1 billion in sales by 2030.FDA granted accelerated approval to Amgen’s Imdelltra (tarlatamab-dlle) for adults in advanced stages of small cell lung
cancer (SCLC) that has proven to be hard to treat or has worsened
despite platinum-based chemotherapy. Imdelltra is expected to bring in
annual sales of US$ 975 million by 2030.View New Drug Approvals in H1 2024 with Estimated Sales (Free Excel Available) Infectious disease drugs from
Basilea, Merck, rare disease med from Ipsen bag
approvalsAfter oncology, infections and infectious diseases, and rare
diseases were the two therapeutic areas that saw the second and third most approvals,
respectively. FDA approved Basilea Pharmaceutica’s Zevtera (ceftobiprole medocaril
sodium for injection), an antibiotic for bacterial infections
including multidrug-resistant strains.The US agency also approved Merck’s next-generation vaccine designed to protect adults from pneumococcus bacteria that causes serious illnesses and pneumonia. The jab, known as Capvaxive, helped produce an immune response against all 21 variations (serotypes) of the bacteria that it targeted. These 21 strains account for about 85 percent of invasive pneumococcal disease cases in adults aged 65 and above. FDA also approved Moderna’s mRESVIA, a messenger RNA-based (mRNA) respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and
older from lower respiratory tract disease caused by the syncytial
virus. This is the first non-Covid mRNA vaccine
to be approved in the US.The agency granted accelerated approval to Ipsen’s Iqirvo (elafibranor) to treat primary
biliary cholangitis (PBC), a rare liver disease. This is the first new
medicine approved in nearly a decade for the treatment of PBC. Orchard Therapeutics’ Lenmeldy secured FDA approval to become the first gene therapy in the US for a rare pediatric disorder, known as metachromatic
leukodystrophy (MLD). The debilitating hereditary disease affects the
brain and the nervous system and causes loss of cognitive and motor functions
and early death.View New Drug Approvals in H1 2024 with Estimated Sales (Free Excel Available) Our viewThe increased momentum of drug approvals witnessed after the pandemic appears to have slowed down, but what’s encouraging is the increase in first-in-class therapies, cancer drugs and promising new treatment options for a range of conditions such as PAH, NASH, and COPD.The
second half has already kicked off with the approval of Lilly’s donanemab. And there are several pathbreaking drugs likely to be approved soon, such as Karuna Therapeutics’ schizophrenia drug KarXT and BridgeBio’s heart drug acoramidis. There is every possibility that new drug approvals will spring back up in H2 2024.
Impressions: 1511
https://www.pharmacompass.com/radio-compass-blog/fda-approvals-slump-19-in-h1-2024-nash-copd-pah-get-new-treatment-options
#PharmaFlow by PHARMACOMPASS
25 Jul 2024
Generic drugs play a crucial role in providing access to life-saving drugs at affordable prices. To that end, drugmakers submit Drug Master Files (DMFs) or their ‘recipes for making generics’ to the US Food and Drug Administration (FDA) for review. Of these, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs.PharmaCompass has been reviewing Type II
submissions for several years now. We have noticed that these filings have been
increasing in recent years. There has been a 33.5 percent
increase in Type II DMF submissions since Q1 2018 (when 176 Type II DMFs had
been submitted). However, at 235, the first quarter (Q1) of 2024 saw only a 1.3
percent increase in DMF submissions over Q1 2023. In Q1 2023, DMF submissions
had increased by 21.5 percent (over Q1 2022).Of the 235 Type II submissions received by the FDA in Q1 of this
year, only 35 (or around 15 percent) had their review completed under the Generic Drug User Fee Act (GDUFA). The total number of reviews completed by the US federal agency so far this year is 129.In all, FDA received 353 Type II, III, IV, and V DMF submissions,
compared to 291 in Q1 2023, an increase of 21.3 percent.View FDA DMF Filings in Q1 2024 (Power BI Dashboard, Free Excel Available)DMF submissions from India
dip 1.8%; China witnesses 42% rise in filings As has been the trend, India (dubbed as the pharmacy of the world) and China filed the maximum DMF submissions, with 107 and 101 submissions respectively. However, DMFs filed by Indian companies saw a marginal dip of 1.8 percent in Q1 2024 — in Q1 2023, Indian companies had filed 109 Type II DMFs. Meanwhile, DMF filings by Chinese drugmakers increased 42.2 percent in Q1 2024, up from 71 in Q1 2023.India’s MSN Laboratories was the clear leader with 15 DMF submissions to the FDA, while China’s Sichuan Elixir
Pharmaceutical came a distant second with nine submissions. Indian drugmakers Aurobindo Pharma and Global Calcium (with seven submissions each) were tied at third position. There were two players at the fifth spot — India’s Dr. Reddy’s Laboratories and China’s Zhejiang Jingsheng
Pharmaceutical — as both these drugmakers registered six submissions each.View FDA DMF Filings in Q1 2024 (Power BI Dashboard, Free Excel Available) Diabetes, cancer drugs emerge
as hot molecules in Q1 2024Approved in June 2020, triheptanoin is the first and only FDA-approved treatment for
children and adults with long-chain fatty acid oxidation disorders (LC-FAOD).
At five, triheptanoin saw the maximum DMF filings.
Four of those applications have already been positively reviewed.Anti-diabetic drug sitagliptin phosphate
monohydrate saw four DMF filings. Empagliflozin, the API found in Boehringer Ingelheim and Eli Lilly’s diabetes drug Jardiance, drew three DMF filings in Q1 2024.In the US, Jazz Pharmaceuticals’ Zepzelca (lurbinectedin) is indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC). Three DMF applications were submitted for lurbinectedin. Similarly, ruxolitinib phosphate, used for the treatment of
patients with intermediate or high-risk myelofibrosis, also received three DMF
applications.Semaglutide — the glucagon-like peptide-1 receptor agonist that catapulted Novo Nordisk to the position of the most valuable public company in Europe — received three DMF filings. Semaglutide’s arch rival, tirzepatide, also drew three DMF filings.AstraZeneca’s Brilinta (ticagrelor) plus aspirin is currently approved in
over 115 countries for the prevention of stroke, heart attack, and other events
in adults with acute coronary syndrome (ACS). Ticagrelor received three DMF
submissions. Vonoprazan fumarate, a first-in-class potassium-competitive acid
blocker to treat acid-related diseases, also received three DMF submissions.View FDA DMF Filings in Q1 2024 (Power BI Dashboard, Free Excel Available) Eighteen DMFs filed for first
time in Q1 2024 During the first quarter of this year, 14 drugs saw first time filing of DMFs. Together, these 14 drugs attracted 18 DMF filings with tirzepatide topping the list with three submissions from Chinese companies.The 14 drugs that saw first time filing were clascoterone, capmatinib hydrochloride, niraparib tosylate
monohydrate, vibegron, cabozantinib sulfate,
ruxolitinib hemifumarate, ripretinib, ruxolitinib, ruxolitinib mesylate, tucatinib hemiethanolate, tecovirimat, tirzepatide, tolvaptan povidone, and azilsartan.View FDA DMF Filings in Q1 2024 (Power BI Dashboard, Free Excel Available) Our viewUntil 2020, DMF submissions by Indian companies used to be double those of Chinese and American
firms put together. In 2022, DMF filings from India began to dip, while
submissions by Chinese companies began to rise. In the first half of 2023,
there was a 46.5 percent rise in DMF submissions from China. The gap between
DMF filings by India and China has narrowed down considerably this year. The
reasons behind this phenomenon may be multiple. But it definitely implies that
America will find it increasingly difficult to reduce its reliance on China.
Impressions: 2440
https://www.pharmacompass.com/radio-compass-blog/dmf-submissions-from-china-jump-42-as-india-continues-to-top-list-in-q1-2024
#PharmaFlow by PHARMACOMPASS
23 May 2024
In the intricate world of molecular biology, oligonucleotides stand out as versatile, powerful molecules. Oligonucleotides are essentially short, single strands of DNA or RNA that modulate gene expression. There are various oligonucleotide therapy (ONT) agents (such as antisense, deoxyribozymes, siRNA and CRISPR/Cas) that offer promising therapeutic tools.A variation of gene therapy, oligonucleotide gene therapies (OGTs) are manufactured using synthetic oligonucleotides. These therapies are designed to enter cells. ONTs act like tools that can fine-tune the behavior of certain genetic instructions, and are therefore often designed to treat rare and genetic diseases and cancers. Sometimes, they may be delivered into cells through lipid nanoparticles or adeno-associated viruses (AAV), halting the translation of a specific protein. Oligonucleotides have also revolutionized vaccine development through the creation of nucleic acid vaccines, such as mRNA vaccines.The first oligonucleotide
drug, known as fomivirsen, was approved by the
US Food and Drug Administration (FDA) back in 1998. It was developed by Ionis Pharmaceuticals (then known as Isis Pharmaceuticals), and was approved to treat a rare eye disease. However, ONT approvals have picked up since 2016. Currently, there are 20 oligonucleotide drugs approved by the FDA and the European Medicines
Agency (EMA) and a majority of them treat orphan and rare
diseases.In 2023, FDA approved four ONTs — AstraZeneca-Ionis’ Wainua (eplontersen), Novo Nordisk owned Dicerna Pharmaceuticals’ Rivfloza (nedosiran), Biogen-Ionis’ Qalsody (tofersen) and Iveric Bio’s Izervay (avacincaptad pegol).In 2021, the global ONT market size was estimated to be US$ 18.2 billion. It is expected to increase to US$ 51.4 billion by 2029, growing at a compounded annual rate (CAGR) of 13.85 percent. Similarly, the market for oligonucleotides synthesis (or the process of producing oligonucleotides) was estimated at US$ 7.7 billion globally in 2022
and is expected to grow 11.8 percent CAGR to reach US$ 16.4
billion by 2030. Some of the bigger players in oligonucleotides synthesis are Danaher Corporation, Thermo Fisher Scientific, Merck KGaA, Eurofins, Agilent, Bio-Synthesis, EUROAPI, Eurogentec, STA Pharma, and Bachem.View Our Interactive Dashboard on Oligonucleotide Therapies (Free Excel Available)ONTs address neuro disorders; four ONTs bring in US$ 1.24 bn for AlnylamONTs are widely applied to treat
neurodegenerative diseases, such as Duchenne muscular dystrophy (DMD). Multiple ONTs have been approved in Europe and the US for
DMD, such as Exondys 51 (eteplirsen), Vyondys 53 (golodirsen), and Amondys 45
(casimersen) from Sarepta and NS Pharma’s Viltepso (viltolarsen). Last year, Ionis bagged two approvals in the
space. FDA
approved its Biogen-partnered
therapy Qalsody (tofersen) to treat patients with amyotrophic lateral sclerosis
(ALS). The agency
also approved AstraZeneca and Ionis’ drug Wainua (eplontersen), rendering it as the
first self-administered treatment for a rare nerve damage
disease, known as hereditary transthyretin amyloidosis (ATTR-PN). Analysts
estimate global peak sales for Wainua to come in at US$ 750
million for ATTR-PN alone. The drug is also being
tested for transthyretin-mediated amyloid cardiomyopathy (ATTR-CM), a rare
heart muscle disorder.Alnylam
Pharmaceuticals has also successfully brought four ONTs to market in recent years — Onpattro (patisiran) and
Amvuttra (vutrisiran) for rare
nerve diseases, and Givlaari (givosiran) and Oxlumo (lumasiran). Givlaari has been approved to treat acute hepatic porphyria (a liver enzyme deficiency) while Oxlumo treats primary hyperoxaluria (a disorder characterized by increased urinary oxalate excretion). The four ONTs brought in US$ 1.24
billion for Alnylam in 2023.View Our Interactive Dashboard on Oligonucleotide Therapies (Free Excel Available) Novartis
buys rights to siRNA therapy, GSK bets big on ONT pipeline through dealsAfter Alnylam discovered
inclisiran (Leqvio), Novartis acquired
global rights to the therapy in a US$ 9.7
billion deal. Leqvio was the first
FDA-approved small interfering RNA (siRNA) therapy
for LDL-C (bad cholesterol) reduction. It brought in US$ 355
million for Novartis in 2023.GSK has increasingly
been investing
in its ONT pipeline. The British
pharma has promised over US$ 5 billion in upfront and milestone payments in
multiple deals. In February, GSK exercised
its option to license Elsie Biotechnologies’ discovery platform to find
and develop novel ONTs. GSK has also entered a discovery collaboration with Wave Life Sciences.Last July, Japanese drugmaker Astellas Pharma completed its
approximately US$ 5.9 billion buyout of New
Jersey-headquartered Iveric Bio. Iveric focuses on retinal diseases and the deal gives Astellas drug candidates to treat about 160 million people with eye ailments. Subsequently, in August, Iveric’s Izervay (avacincaptad pegol) was approved by the FDA as a new
treatment for geographic atrophy (GA) secondary to age-related macular
degeneration (AMD).After Novo Nordisk acquired RNAi technology company Dicerna Pharmaceuticals for US$ 3.3 billion in 2021, the latter’s once-monthly RNAi therapy Rivfloza (nedosiran) saw FDA approval last October. Rivfloza was
okayed for children nine years and older to treat a rare genetic condition that affects the kidneys,
known as primary hyperoxaluria type 1 (PH1).View Our Interactive Dashboard on Oligonucleotide Therapies (Free Excel Available) Ionis tees up NDAs for rare
disease treatments after two late-stage trial winsThe industry is looking for cures to a wide spectrum of diseases like cancer (such as melanoma, pancreatic, liver, glioblastoma, breast and ovarian cancer), cystic fibrosis, Alzheimer’s disease, Parkinson’s disease, hepatitis B, asthma, Rett syndrome, non-alcoholic steatohepatitis, and IgA nephropathy through its research on ONTs.In January, Ionis announced late-stage results wherein its
RNA-targeted hereditary angioedema (HAE) candidate, donidalorsen, significantly
reduced the rate of HAE attacks in patients
treated every four weeks and patients treated every eight weeks. The
California-based biotech is readying a new drug application (NDA) to submit to the FDA. HAE is a rare and life-threatening genetic disease that causes unpredictable and frequent severe swelling of the skin, gastrointestinal (GI) tract, upper respiratory system, face and throat. This year, Ionis’ olezarsen was granted fast track designation by
the FDA for the rare genetic disease familial chylomicronemia syndrome (FCS).
Last September, olezarsen had met its primary endpoint of reducing abnormally high
levels of triglycerides in a late-stage trial in patients with the metabolic disorder. Currently, there are no
FDA-approved treatments for this condition. If okayed, olezarsen is likely to
bring in US $849 million in sales for Ionis by 2032.In March, FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12 to two in favor of the clinical
benefit/risk profile of imetelstat for the treatment of transfusion-dependent (TD) anemia in certain adult patients with myelodysplastic syndromes. The agency assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 16, 2024, for Geron’s NDA for imetelstat. It is among the most anticipated drug launches this year.View Our Interactive Dashboard on Oligonucleotide Therapies (Free Excel Available) Our viewDeveloping ONTs is a field fraught with challenges, such as toxicity and drug delivery. There are safety concerns as well as concerns around delivering the therapy. However, technological breakthroughs and collaborations between pharma firms and contract research organizations that focus on drug delivery are continuously working towards addressing these challenges. All in all, we foresee exciting times ahead for ONTs.
Impressions: 2983
https://www.pharmacompass.com/radio-compass-blog/fda-approves-four-oligonucleotide-therapies-in-2023-novartis-gsk-novo-bet-big
#PharmaFlow by PHARMACOMPASS
21 Mar 2024
In 2022, when the
US Food and Drug Administration (FDA) was reeling under the impact of the
pandemic, new drug approvals by the agency dropped by 26 percent. But last year, FDA’s new drug approvals rebounded by an impressive 49 percent, with the Center for Drug Evaluation and Research (CDER) approving 55 new drugs in 2023. Of them, 36 percent were considered first-in-class, while small molecules made up for 62 percent of the total drugs approved (i.e. 34). FDA’s Center for Biologics Evaluation and Research (CBER) okayed 19 biologics in 2023 compared to eight in the previous year.The first half of
2023 saw the debut of vaccines for the all-too-common respiratory syncytial
virus (RSV). Among the other notable approvals in H1 was Biogen and Eisai’s
Alzheimer’s drug Leqembi (lecanemab). Out of the total 55 drug approvals, 29
came in H2 2023. This includes Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy that relies on the Nobel Prize-winning CRISPR gene-editing technology. Casgevy has been approved as a treatment for sickle-cell disease (SCD) and β-thalassemia.While FDA witnessed a sharp rise in approvals in 2023, many other drug regulators didn’t. The European Medicines Agency (EMA) granted marketing authorization to 32 novel drugs in 2023, a fall from 33 in 2022. Similarly, Health Canada’s approvals in 2023 decreased to 38, compared to 45 in the previous year.As usual,
oncology topped the list of drug approvals by therapeutic area, at 39 (as
opposed to 35 in 2022). Rare diseases was the second most popular therapeutic
area for drug approvals. With drugmakers clearly paying heed to the unmet needs
of patients suffering from rare diseases, this therapeutic area sprinted from a
9 percent share and the fourth position among new approvals in 2022 to an
impressive 34 percent share in 2023. A quarter of the new drug approvals were
in infectious diseases, followed by immunology (19 percent) and neurology (7
percent).View New Drug Approvals in 2023 with Estimated Sales (Free Excel Available) Casgevy, postpartum depression drug Zurzuvae
emerge as potential blockbustersGene therapy
Casgevy, postpartum depression (PPD) med Zurzuvae, blood cancer med Elrexfio and ulcerative colitis drug Velsipity were some of the prominent approvals of 2023.Britain’s Medicines and Healthcare products Regulatory Agency was the first to okay Casgevy in November as a cure for SCD and β-thalassemia. Soon, the FDA approved it for SCD. In January this year, the American agency also approved it for transfusion-dependent β-thalassemia (TDT). Analysts estimate Casgevy to generate US$ 2.6 billion in peak sales, says Nature. Biogen and Sage’s PPD therapy Zurzuvae became the first and only FDA-approved pill for
the condition that can be life-threatening for both the mother and the child. Global sales of
Zurzuvae are forecast to hit US$ 1.28 billion by 2028.In August, Pfizer’s
Elrexfio (elranatamab) became the first “off-the-shelf” (ready-to-use) therapy in the US for multiple myeloma. The drug provides an option for patients with hard to treat or relapsed blood cancer and is estimated to bring in US$ 861 million in peak sales by 2028, says Nature.Pfizer also
bagged another significant approval in October — its drug Velsipity (etrasimod) was greenlit by the FDA to treat adults with ulcerative colitis, an
inflammatory bowel disease. Peak revenue for Velsipity is expected to come in at US$ 825 million, as per Evaluate.View New Drug Approvals in 2023 with Estimated Sales (Free Excel Available) Astra’s Truqap, GSK’s Ojjaara among top cancer therapies given FDA
nod in H2In November, FDA approved AstraZeneca’s
Truqap (capivasertib) in combination with the Anglo-Swedish drugmaker’s Faslodex (fulvestrant) for treating adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations. Evaluate Pharma forecasts peak Truqap sales to come in at about US$ 690 million.In September, FDA
approved GSK’s
Ojjaara (momelotinib) as the first and only treatment for myelofibrosis with anemia.
Nearly all myelofibrosis patients are estimated to develop anemia over the course of the disease. Ojjaara is taken orally once a
day.Other notable oncology treatments okayed by FDA in H2 2023 include Daiichi’s
Vanflyta (quizartinib) in July to treat an aggressive blood cancer known as acute myeloid leukemia (AML). In August, FDA approved Janssen’s
bispecific antibody Talvey (talquetamab-tgvs)
for difficult-to-treat blood cancer. The agency approved two cancer therapies in November — BMS’ Augtyro (repotrectinib) for ROS1-positive non-small cell lung cancer (NSCLC) and Takeda’s
targeted oral therapy Fruzaqla (fruquintinib) for adult patients with metastatic colorectal cancer (mCRC).View New Drug Approvals in 2023 with Estimated Sales (Free Excel Available) Rare disease drugs Santhera-Catalyst’s Agamree, Novo’s Rivfloza bag approval in H2In October, FDA
approved Santhera Pharmaceuticals and Catalyst Pharma’s Agamree (vamorolone), an oral suspension treatment for Duchenne muscular dystrophy (DMD)
in patients two years of age and older. This makes it the first drug fully approved in both the US and Europe for the muscle
degeneration disorder. Agamree acts in a manner similar to other steroids,
which are the standard of care for the inherited rare disease. However, it
causes fewer side effects.FDA also okayed Novo Nordisk’s
once-a-month injection Rivfloza (nedosiran) in October to treat a rare genetic condition — primary hyperoxaluria type 1 (PH1) — that causes recurring kidney stones.In November, the
agency approved Takeda’s Adzynma (ADAMTS13, recombinant-krhn) as the first treatment for both adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP), a rare genetic blood disorder. Other noteworthy
FDA approvals in H2 2023 for rare blood diseases include Novartis’ Fabhalta and bluebird bio's Lyfgenia. Fabhalta is the first oral monotherapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria, a rare disease that causes symptoms such as hemolytic anemia, hemoglobinuria (excretion of hemoglobin in the urine), fatigue, shortness of breath etc. Lyfgenia is the first cell-based gene therapy for the treatment of SCD in patients 12 years and older. Similarly, another rare disease drug — Regeneron’s Veopoz — bagged FDA approval in August last. Veopoz treats CHAPLE disease, an
ultra-rare disease in which patients have severe gastrointestinal problems.View New Drug Approvals in 2023 with Estimated Sales (Free Excel Available) Our viewAfter a lull in
2022, new drug approvals have finally gathered momentum. The good news is that this year,
several pathbreaking drugs are coming up for approval, such as Madrigal Pharmaceuticals’ resmetirom (the first treatment for NASH with liver fibrosis), Merck’s sotatercept (a treatment for pulmonary arterial hypertension), Lilly’s donanemab for Alzheimer’s disease and Karuna Therapeutics’ drug to treat schizophrenia. Let’s hope 2024 turns out to be an even bigger year for new drug approvals.
Impressions: 2961
https://www.pharmacompass.com/radio-compass-blog/fda-approvals-rise-49-in-2023-crispr-s-gene-editing-therapy-sees-light-of-day
#PharmaFlow by PHARMACOMPASS
01 Feb 2024
Every week,
PharmaCompass compiles important developments in the world of pharmaceuticals
and brings a compilation to you in the form of Phispers. Of the hundreds of
stories we carried in 2023, here are the top 10 stories, including some trends
and updates.I. Pfizer buys Seagen for US$ 43 billion to
bolster its oncology portfolioIn March, Pfizer said it is acquiring cancer treatment specialist Seagen for US$ 43 billion. Seagen is a pioneer in antibody-drug conjugates
(ADCs), or drugs that work like “guided missiles” to destroy cancer cells while sparing healthy cells. Another important deal in the field of ADCs took place in December when AbbVie picked up ImmunoGen for US$ 10.1 billion, giving it access to Elahere (mirvetuximab soravtansine-gynx), an ADC approved for platinum-resistant ovarian
cancer. Elahere is expected to achieve blockbuster status by 2030. II.
Merck, BMS, trade bodies, sue US government over IRA negotiationsIn June, Merck filed a lawsuit against the US government seeking to block Medicare from negotiating lower
prescription drug prices under the Inflation Reduction Act (IRA). Days later,
the US Chamber of Commerce, one of the most influential trade groups in the US, filed a separate lawsuit, arguing
that the negotiations violated drugmakers’ constitutional rights and granted
excessive control over prices to the government. They were joined by Bristol Myers Squibb (BMS) and lobby group PhRMA. Drugmakers and
the Biden administration appeared to be at each other’s throats. In December, the White House identified 48 drugs whose prices spiked faster than inflation in Q4.
These drugs may be subject to rebates starting January 2024. Biden
Administration also announced it is setting a new “march-in” policy that allows the government to seize medicine patents held by drugmakers for therapies whose
development was taxpayer-funded, if it believes they are not “reasonably available and affordable.”III. US, UK approve Lilly’s Mounjaro for weight management; to be
sold as ZepboundIn November, drug
regulators in the US and the United Kingdom approved Eli Lilly's Mounjaro (tirzepatide) for weight management, to be sold under the brand name Zepbound. The drug will pose strong competition
to Novo Nordisk’s Wegovy in a market that's expected to reach US$ 100 billion by the end of
the decade.IV. Novo, Lilly plan capacity expansions for
weight loss drugsBoth Novo Nordisk and Eli Lilly announced expanding their manufacturing capacities in
order to capitalize on the burgeoning market for weight loss drugs. Novo is
investing over DKK 42 billion (US$ 6 billion) in Kalundborg (Denmark), US$ 2.3 billion to expand its site in Chartres (France) and over € 2 billion (US$ 2.18 billion) in Dublin (Ireland) to boost production of its blockbuster diabetes
and weight-loss drugs, including Ozempic and Wegovy (both semaglutide). Similarly, Eli Lilly had announced a US$ 2.5 billion manufacturing facility in Germany in November to address the demand for its new obesity and diabetes therapies.V. FDA finds violations at Global Pharma’s eye drops plant in India; issues Form
483In April, FDA
found several violations in manufacturing processes and sterilization methods
used by India-based Global Pharma for its EzriCare Artificial Tears Eye Drop, which has been linked to
68 cases of eye infection in the US, including eight cases of vision loss and three deaths.VI. ‘Intas India staff tore documents, threw acid to destroy evidence’, notes FDAIn January, FDA
issued a Form 483 with 11 observations to Intas Pharma’s
drug manufacturing facility in Ahmedabad (Gujarat, India). A team of three FDA
drug regulators conducted an inspection of the manufacturing facility from
November 22 to December 2, 2022. The 36-page report issued by the FDA has alleged that employees at the
facility had destroyed documents related to manufacturing practices by tearing
them into pieces and disposing them inside the quality control lab and scrap
areas. Acid was used to destroy evidence, notes FDA.VII. GSK overtakes Pfizer in bagging first FDA
approval for RSV vaccineIn May, FDA
approved GSK’s
respiratory syncytial virus (RSV) vaccine for people aged 60 and above. Arexvy is the first RSV vaccine to be approved in the US
for the common condition that can be fatal for the elderly. Later that month,
Pfizer’s RSV vaccine Abrysvo also got approved. In July, Sanofi-AstraZeneca’s
RSV antibody therapy, Beyfortus (nirsevimab-alip), received approval from the FDA. It is a long-acting treatment that can be given
once per season. The approval is specifically developed for newborns and
infants.VIII. UK authorizes gene therapy Casgevy for
blood disorders, US follows suit In November, Britain’s Medicines and Healthcare products Regulatory Agency was first off the block in authorizing CRISPR Therapeutics and Vertex Pharmaceuticals’ Casgevy, a therapy that seeks to cure two blood disorders — sickle-cell disease (SCD) and β-thalassemia. The therapy is based on gene editing technology that had won its scientists the Nobel Prize in Chemistry in 2020.Less than a month
later, FDA not only approved Casgevy (exagamglogene autotemcel) for SCD, but also approved bluebird bio’s
Lyfgenia (lovotibeglogene autotemcel) for the treatment of SCD in patients aged
12 and older who have a history of vaso-occlusive events (when tissues become
deprived of oxygen).IX. Leqembi becomes first med to bag full
approval to treat Alzheimer’sEisai and Biogen’s Alzheimer’s drug Leqembi (lecanemab) had won FDA’s accelerated approval in January. It treats patients who are in the earliest
stages of the neurodegenerative disease. In July, it became the first treatment to receive full FDA approval to treat the condition.X. Bayer’s experimental anticoagulant fails late-stage
trialOne of the
biggest disappointments from clinical trials came when a major late-stage trial for Bayer’s experimental anticoagulant asundexian had to be discontinued due to its inadequate effectiveness. Bayer had expectations in excess of € 5 billion (US$ 5.5 billion) from this drug.
Impressions: 2295
https://www.pharmacompass.com/radio-compass-blog/pfizer-s-buyout-of-seagen-drugmakers-suing-us-govt-obesity-drugs-make-it-to-top-10-phispers-of-2023
#PharmaFlow by PHARMACOMPASS
18 Jan 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: 5387
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: 8103
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
Last
year, the pandemic impacted everyone’s life in one way or the other. It turned
the limelight on to the pharmaceutical industry, which stepped up efforts to
deliver treatments and vaccines for Covid-19. It was a year of challenges for
the drug
industry as it struggled to supply existing drugs and treat emergencies
amid disruptions in the way business was conducted the world over.
Unlike previous years when the top five drug companies largely remained unchanged, 2020 saw several movers and shakers. The acquisition of Allergan by AbbVie helped it enter the ‘top five’ list, while companies like Pfizer and Merck got edged out. Despite a 2 percent increase in revenues, Pfizer dropping out
of the top five was not a complete surprise as it spun-off its
Upjohn unit. The unit merged with Mylan to create Viatris, an entity
with over US $10 billion in revenues.
View Our Interactive Dashboard on Top drugs by sales in 2020 (Free Excel Available)
Roche emerges as top drug company by global sales
The
top five list of global pharmaceutical companies by sales in
2020 was quite a mix of surprises. While Swiss major Roche topped the
ranking of global drug companies by pharmaceutical sales (with global revenues
of US$ 49.6 billion or CHF 44.532 billion), it also witnessed a sales decline
of 8 percent, which was partially an outcome of the Swiss franc gaining against
most currencies during the pandemic. Overall, competition from biosimilars and the Covid-19 pandemic had a negative impact on Roche’s
pharmaceutical sales in 2020. However, it witnessed strong sales growth
of newly launched medicines like Tecentriq, Hemlibra, Ocrevus, Perjeta and Kadcyla, which
helped in offsetting the CHF 5 billion (US$ 5.53 billion) impact of competition
from biosimilars.
At
the
second position was Swiss drugmaker Novartis, whose global sales (at US$ 48.7 billion) were marginally lower than Roche’s. Unlike the numero uno, Novartis’ pharmaceutical sales grew 4 percent, driven by cardiology drug Entresto that witnessed a 44 percent increase in revenues. While its
oncology unit and Sandoz’s biosimilars business also posted an increase in sales, Covid-19 negatively impacted demand, particularly for the company’s ophthalmology and dermatology operations and the retail operations of Sandoz. The year also saw Novartis’ gene therapy
Zolgensma, the world’s costliest drug, reach nearly US$ 1
billion in sales.
As
the British pound became a lot stronger against the US dollar, GlaxoSmithKline Plc (GSK) witnessed a 3 percent increase in sales in constant currency terms and saw its group sales (£ 34.1 billion or US$ 47.27 billion) take the number three spot in US dollar terms. Strong sales performances
from key growth drivers in HIV, respiratory, oncology and consumer healthcare
offset disruptions from Covid-19. GSK’s consumer healthcare division reported over £10 billion (US$ 13.91 billion) in sales and the firm is on track to create new standalone biopharma and consumer healthcare companies in 2022.
View Our Interactive Dashboard on Top drugs by sales in 2020 (Free Excel Available)
AbbVie’s international Humira sales
drop 13.6% due to biosimilars
AbbVie reported worldwide revenues of US$ 45.8
billion, an increase of 38 percent versus the previous year. This included US$ 10.3
billion in revenues from the Allergan acquisition,
growth in the immunology portfolio, and the continued strength of Humira in the US as
well as revenue growth from Imbruvica and Venclexta. Humira, the
best-selling drug since 2012, continued to dominate with US$ 19.83 billion in
sales, an increase of 3.5 percent as compared to 2019. While the
international sales of Humira dropped 13.6 percent due to competition from biosimilars, in the US sales increased as Humira is protected from biosimilar competition until 2023.
J&J’s
pharmaceutical division delivered a strong performance as its pharmaceutical
sales grew 8 percent to US$ 45.6 billion and contributed more than the combined sales of its other two units — consumer health and medical devices. This sales growth was largely attributed to primary operational drivers including Imbruvica and Stelara, which were
among the top 10 drugs by sales in 2020. J&J and AbbVie have an equal share
in the profits (and losses) from the sales of Imbruvica, which witnessed a
double digit increase in sales to US$ 9.4 billion. Similarly, J&J’s Stelara
reached US$ 8.0 billion in sales. J&J’s overall revenues grew by just 0.6 percent
to US$ 82.6 billion (including sales from its consumer health and medical
devices divisions). It will be interesting to see what J&J’s 2021
revenues look like as it benefits from the sales of its single-dose Covid-19
vaccine.
View Our Interactive Dashboard on Top drugs by sales in 2020 (Free Excel Available)
Merck’s Keytruda on its way to becoming world’s best-seller
With AbbVie’s Humira beginning to face generic competition, Merck’s oncology
drug Keytruda continued to go from strength to strength posting a sales growth of 30
percent. Keytruda delivered more than US$ 14.4 billion in sales, almost a third
of the firm’s US$ 43 billion revenue. It’s only a matter of time before Keytruda becomes the world’s best-selling drug.
Bristol Myers Squibb (BMS)
reported worldwide revenues of US$ 42.5
billion in 2020. BMS’ products Revlimid and Eliquis reported
significant growth last year, and followed Humira and Keytruda in terms of sales. Eliquis, which is also promoted by Pfizer in some geographies,
had total sales of US$ 14.1 billion while Revlimid posted over US$ 12 billion
in sales. Revlimid, which BMS picked up through its acquisition
of Celgene, will face
limited generic competition sometime after March 2022. Furthermore, while BMS’ oncology
treatment Opdivo’s sales (US$
7.2 billion) declined by 3 percent compared to 2019, it remained one of the top selling drugs in 2020 (US$
7.9 billion) with a small portion of sales coming from Ono Pharma in Japan.
Sanofi reported
approximately US$ 43.6 billion (€36 billion) in net sales
for 2020, which rose by 3.3 percent at constant exchange rates even as some of
its flagship products’ sales declined due to generic and
biosimilar competition. Solid performances from Dupixent, vaccines and its
specialty care global business unit across all geographies, more than offset
lower sales.
In
the case of Gilead, while
products like Biktarvy in its HIV
portfolio witnessed a growth of over 50 percent to more than US$ 6 billion,
it was Gilead’s treatment for Covid-19 — remdesivir — promoted under the brand Veklury which went from no sales in 2019 to US$ 2.81 billion in sales in 2020.
View Our Interactive Dashboard on Top drugs by sales in 2020 (Free Excel Available)
Our view
The
human health business of many companies was negatively impacted by the Covid-19
pandemic. However, operating expenses saw a reduction due to lower promotional
and selling costs, as well as lower R&D expenses.
This
year, as Covid vaccines from Pfizer, Moderna, J&J and AstraZeneca are rolled out in more
countries across the world, they are expected to ring in significant
revenue contributions for these companies. For instance, Pfizer recently announced
that it expects US$ 26 billion in revenues from the sale of its vaccine
in 2021. Similarly, Moderna said it expects US$ 19.2 billion in sales from its Covid-19 vaccine this
year.
Given this scenario, the order of the top drug companies and the sales contribution of various drugs will change significantly in 2021. It seems likely that Pfizer’s vaccine will become the best-selling product by sales in 2021 and the American drugmaker will be back among the top five in the global drug companies by sales list.
View Our Interactive Dashboard on Top drugs by sales in 2020 (Free Excel Available)
Impressions: 13450
https://www.pharmacompass.com/radio-compass-blog/top-drugs-and-pharma-companies-by-sales-in-2020
#PharmaFlow by PHARMACOMPASS
13 May 2021
In 2016, M&A deals
fell drastically in both numbers and value. One key reason was the falling
through of the Pfizer-Allergan mega merger due to America’s crack down on inversion deals.
The year 2015 went down in
history as a record year for mergers and acquisitions (M&As) in the
pharmaceutical and biotech space, when deals worth US $ 300 billion were
announced.
The
highlight of 2015 was the mega-merger announced between US drugmaker Pfizer and
Ireland-based Allergan – the biggest-ever pharma transaction that
was worth more than US$ 160 billion.
2016 saw Pfizer and Allergan walk away from their US$ 160 billion merger when the new US
Treasury rules cracked down on inversion deals that were encouraging US
companies to move overseas to cut taxes.
The merger would have allowed
New York-based Pfizer to cut its tax bill by an estimated US$ 1 billion
annually by domiciling in Ireland, where tax rates are lower.
M&A deals dip by 20
percent in 2016
Although the Pfizer-Allergan
mega-merger did not go through, The Pharma Letter tracked transactions through the year and noted that although “worldwide merger and acquisition activity in the pharmaceutical and biotechnology sector in 2016 was plentiful”, the numbers and values were “well down” on those seen in the previous two years.
The number of transactions announced in 2016 was 130, compared to 166 M&A deals in 2015 – which was a record year – and 137 in 2014, says The Pharma Letter.
Values of the top 10 deals
drop to a third
The other crucial fact about
M&A deals in 2016 was that transactions that exceeded the US$ 1 billion
mark were down to just 23 in 2016, as against 30 in 2015 and 26 in 2014.
The Pharma Letter quotes a
KPMG report published earlier this year which notes that the total value of the
top 10 completed deals in the first half of 2016 amounted to US $ 67.2 billion
as opposed to US $190.4 billion in first-half 2015.
Sanofi-Actelion — the deal that wasn’t
Sanofi made headlines, not for the acquisitions it made, but for the ones it wasn’t able to close.
Late last year, the French
pharma giant was widely identified as the big player that managed to push Johnson & Johnson away from negotiations with Actelion only to lose its US$ 30 billion bid to J&J even though it would have delivered “approximately equivalent value to Actelion’s shareholders”.
The Actelion loss came after Sanofi was out bid by Pfizer for Medivation.
Pfizer agreed to buy the US
cancer drug company for US$ 14 billion in cash, adding its blockbuster prostate
cancer drug Xtandi to
the company's growing oncology roster.
Additionally, Pfizer acquired Anacor for US$ 5.2 billion to add an eczema gel to its portfolio.
Bayer’s US$ 66 billion takeover
The biggest deal announced in
2016 was Bayer’s US$ 66 billion takeover of the US seeds company Monsanto after months of wrangling. It was the German drug and crop-chemical company’s third offer that clinched the deal, which is also known to be the largest all-cash deal on record.
This signature
deal has disrupted the agribusiness sector, which in recent years has been
involved in a consolidation race largely triggered by factors such as shifting
weather patterns, intense competition in grain exports and a souring global
farm economy.
Top pharma companies by sales
Bayer’s acquisition of Monsanto makes the ranking of top pharmaceutical companies consistently complicated since Bayer will generate more sales from its crop
science and high-tech polymer division than from the sale of prescription
drugs.
Should divisions like
diagnostics, animal health, vaccines, consumer health be counted while
determining the size of a pharmaceutical company?
In a volatile global world,
where wild exchange rate fluctuations play their own major role in determining
the size of organizations, this week PharmaCompass
shares the revenues, as presented in the 2016 annual reports of top 15
companies, so that you can draw your own conclusions on the top drug companies
of the world.
Company Name
Currency
Pharma
Consumer Health
Medical Devices/ Diagnostics
Vaccines
Animal Health
Other Revenues
Total Sales
1
Pfizer
USD
41,600
3,407
6,071
1,746
52,824
2
Novartis
USD
48,518
48,518
3
Roche
CHF
41,047
11,589
52,636
4
Merck & Co.
USD
29,360
5,791
3,478
1,178
39,807
5
GlaxoSmithKline
GBP
16,104
7,193
4,592
27,889
6
Johnson & Johnson
USD
33,464
13,307
25,119
71,890
7
Sanofi
EUR
22,932
3,330
4,577
2,708
274
33,821
8
Gilead
USD
29,953
437
30,390
9
Abbvie
USD
25,560
78
25,638
10
Bayer
EUR
16,420
6,037
1,523
22,789
46,769
11
Amgen
USD
21,892
1,099
22,991
12
Astrazeneca
USD
21,319
1,683
23,002
13
Teva
USD
20,664
1,239
21,903
14
Eli Lilly
USD
18,064
3,158
21,222
15
Bristol-Myers Squibb
USD
17,702
1,725
19,427
Sales figures are reported in millions.
Currency exchange rate used CHF: 0.99 USD/ EUR: 1.06 USD / GBP: 1.25 USD
Ranking methodology
When it came to ranking
companies, based on their total sales, we at PharmaCompass did
not face any challenges while including the sales of prescription drugs along
with those of vaccines.
But matters got a little
complicated when we got down to ranking consumer health divisions.
For instance, while we have
included consumer health divisions of companies like Sanofi, GSK and
Bayer, which primarily sell OTC drug products (such as brands like Allegra, Voltaren and Aleve), we have excluded those of companies like Johnson
& Johnson, given their focus on baby and beauty products.
Such a demarcation — based on the focus of the company — will always be a matter of debate.
Similarly, revenue generated
from the sale of medical devices/diagnostics as well as revenues of animal health divisions were not included in our rankings.
In the case of companies like Bayer, whose Covestro’s division has over US$ 10 billion in sales from customer industries such as automotive, construction, electrical and electronics, and furniture, such sales were accounted for in ‘other revenues’.
Our table highlights the sales
revenue of various divisions of companies in order to bring more clarity into the
figures which were included in our rankings.
Impressions: 13665
https://www.pharmacompass.com/radio-compass-blog/top-15-pharmaceutical-companies-by-drug-sales-in-2016
#PharmaFlow by PHARMACOMPASS
02 Mar 2017
