After a year when
drug approvals by the US Food and Drug Administration
(FDA) slipped to the lowest since 2016, the first half of 2023 (H1 2023) saw a
62.5 percent growth in drug approvals by the Center for Drug Evaluation and Research (CDER) as compared with the same period last year. FDA’s CDER approved 26 new drugs
in 2023, up from 16 in H1 2022. Approvals of biologics by the FDA surpassed full-year totals for many of the past 20 years. Nine new biologics were approved by FDA’s Center for Biologics Evaluation and Research (CBER) in H1 2023, as against just eight
for 2022.While FDA approved more drugs, authorizations by the European Medicines Agency (EMA) also increased but drug approvals by Health Canada dipped by approximately 50 percent. In the first half of 2023, EMA authorized 14 drugs, as opposed to 10 in H1 2022. Similarly, Health Canada approved 13 drugs against 25 in H1 2022.Among the
promising drugs approved in H1 2023 are Biogen and Eisai’s Alzheimer’s drug Leqembi (lecanemab), Astellas Pharma’s drug for hot flashes (associated with
menopause) Veozah, AbbVie and Genmab’s blood cancer drug Epkinly and, GSK and Pfizer’s RSV vaccines Arexvy and Abrysvo, respectively.View New Drug Approvals in first half of 2023 with Estimated Sales (Free Excel Available)GSK, Pfizer’s RSV vaccines to generate over US$ 1 billion by 2028The highlight of H1 2023 has been the approval of vaccines for respiratory syncytial virus (RSV), a contagious virus that causes infections of the respiratory tract, and can cause severe illness in older adults and infants. In May 2023, FDA approved GSK’s Arexvy, respiratory syncytial virus (RSV) vaccine for people aged 60 and older, making it the first vaccine approved in the US that protects against the disease. The drug is expected to generate US$ 1.73 billion in peak sales by 2028.Weeks later, the agency approved Pfizer’s Abrysvo, another RSV vaccine for older adults. The vaccine is expected to be available
in the third quarter of 2023. In late August, Pfizer also bagged an FDA nod for
use of Abrysvo to prevent RSV in infants by vaccinating pregnant women. The
drug is expected to generate US$ 1.31 billion in peak sales by 2028.View New Drug Approvals in first half of 2023 with Estimated Sales (Free Excel Available) Leqembi, Veozah, Epkinly likely to join ‘over US$ 1 billion club’ by 2028In March, the US health regulator suggested stricter trials for accelerated approval of cancer drugs. The proposed recommendation followed criticism over the approval of Biogen and Eisai’s Alzheimer’s treatment Aduhelm through this pathway in June 2021.Contrary to this
stand though, FDA had approved another Alzheimer’s drug from Biogen and Eisai — Leqembi (lecanemab) — through the same pathway in January 2023. Leqembi is an amyloid beta-directed antibody indicated for the treatment of Alzheimer’s disease. The drug is expected to generate US$ 1.9 billion in peak sales by 2028. Later in July, FDA expanded the accelerated approval of lecanemab to a traditional approval for early-stage Alzheimer’s disease.The US regulator
approved several potential blockbuster drugs during the month of May. It
granted full approval to Pfizer’s Covid-19 oral antiviral pill Paxlovid (nirmatrelvir and ritonavir) during the month, which had been
granted an emergency use authorization during the heydays of the pandemic. Paxlovid is the first oral antiviral pill for Covid-19. With the pandemic behind us, Paxlovid’s sales have been waning, though it is still projected to yield approximately US$ 5.5 billion in sales by 2028.The other
important drug approved in May is Japanese drugmaker Astellas Pharma’s oral drug Veozah (fezolinetant) for the treatment of moderate to severe vasomotor symptoms (VMS), or hot flashes associated with menopause. The drug will cost US$ 550 for a month’s supply. Veozah is expected to generate US$ 1.9 billion in sales by 2028.FDA also granted
accelerated approval to AbbVie and Genmab’s blood cancer therapy Epkinly (Epcoritamab-Bysp) in May. It
has bagged approval to treat patients with diffuse large B-cell lymphoma
(DLBCL), and is likely to emerge as a US$ 1.1 billion product.View New Drug Approvals in first half of 2023 with Estimated Sales (Free Excel Available) Sarepta, Biomarin’s gene therapies bag FDA nod; Lilly’s Jaypirca okayed for lymphomaIn June, FDA
approved Sarepta’s Elevidys and Biomarin’s Roctavian. Elevidys bagged accelerated approval in Duchenne muscular dystrophy (DMD)
patients aged four to five years. This is the first gene therapy approved by
the FDA for the treatment of certain patients with DMD. Elevidys is expected to
generate US$ 3.36 billion in peak sales by 2028.BioMarin’s one-time gene therapy – Roctavian – has been approved by the FDA to treat severe hemophilia A, a
rare bleeding disorder. Priced at US$ 2.9 million, Roctavian is the first gene
replacement therapy to be approved for the condition. Roctavian is expected to
generate US$ 1.43 billion in peak sales by 2028. This approval follows another
approval granted in November 2022 for the first gene therapy to treat adults with hemophilia B — CSL Behring and uniQure’s Hemgenix.In January, Lilly’s Jaypirca (pirtobrutinib) bagged FDA nod, thereby becoming the first and only non-covalent, BTK Inhibitor for the
treatment of adult patients with relapsed mantle cell lymphoma which did not
respond to other BTK Inhibitors. Jaypirca is expected to generate US$ 0.91
billion in peak sales by 2028.In March, FDA approved Pfizer’s Zavzpret (zavegepant) as the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine. Zavzpret is expected to generate US$ 0.649 billion in peak sales by 2028.Another important FDA approval was granted to GSK’s drug Jesduvroq — it is now the first oral treatment for anemia caused by chronic kidney disease in adults who have been on dialysis for at least four months.View New Drug Approvals in first half of 2023 with Estimated Sales (Free Excel Available) FDA rejects Lilly’s donanemab, Alvotech/Teva’s Humira biosimilarIn January, when
the FDA had approved Leqembi, the agency had rejected Eli Lilly’s bid for an accelerated approval pathway for its experimental Alzheimer’s disease drug donanemab. The agency had cited a lack of participants who received continuous treatment with donanemab for at least 12 months as the reason for its decision. However, Lilly
announced positive late-stage trial
results on donanemab in July — it slowed cognitive decline by 35 percent compared to a placebo in a late-stage trial. An FDA decision on the drug is likely around 2023-end or in early 2024.Similarly, FDA turned down Lilly’s mirikizumab for the treatment of ulcerative colitis. The agency also rejected a BLA for Eli Lilly’s ulcerative colitis drug mirikizumab over manufacturing concerns. Besides these, FDA also rejected Alvotech/Teva’s Humira biosimilar — AVT02 — for a second time this year.View New Drug Approvals in first half of 2023 with Estimated Sales (Free Excel Available) Our viewAfter the
pandemic, business is back to normal at the FDA. The number of CDER approvals
in the first half of this year are approximately 70 percent of the approvals in
2022. We anticipate more approvals in the upcoming months. If the FDA sustains
this pace, approvals this year could potentially double those of the previous
years.
Impressions: 3409
Over the last five years, a
lot has changed for Pfizer Inc, one of the world’s leading pharmaceutical companies based on pharma sales revenue. From entering into an agreement with German biotechnology company BioNTech SE in August 2018 for joint research
and development of mRNA-based influenza vaccines to merging its off-patent
branded and generic drug business, known as Upjohn, with Mylan to form Viatris and launching
Covid-19 vaccine Comirnaty and antiviral drug Paxlovid during the pandemic,
the New York-headquartered pharma giant has witnessed substantial
transformation in the recent past.The launch of Covid products was
undoubtedly the biggest event for the 174-year-old drugmaker, propelling it to the number 1 slot in 2021 with a turnover of US$ 81.3 billion, surpassing competitors such as AbbVie, Johnson & Johnson, Novartis, Roche, Bristol Myers Squibb, Merck, and several others. In 2022, Pfizer further consolidated its position, with revenues exceeding US$ 100 billion, largely due to the success of its Covid products. This success of Covid products filled Pfizer’s coffers, allowing it to expand through the acquisition of smaller companies. Pfizer’s new brand identity and logo,
unveiled in 2021, signaled the company's shift from "commerce to science".Pfizer commercially operates through two segments — Biopharma, or its innovative science-based biopharmaceutical business that posted revenues worth US$ 98.98 billion in 2022, and Pfizer CentreOne (PC1),
a global contract development and manufacturing organization as well as a
leading supplier of specialty active pharmaceutical ingredients (APIs) with US$ 1.3 billion in 2022 revenues.Pfizer’s core therapeutic areas are inflammation and immunology, internal medicine, oncology, rare diseases, vaccines and anti-infectives.View our Dashboard to know more about Pfizer's Drugs in Development (Free Excel)Pfizer in acquisition overdrive: Buys Seagen for US$ 43 bn, Biohaven for
US$ 11.6 bnPfizer has been utilizing its
war chest generated during the pandemic in acquiring companies that would help
grow the business when Covid is behind us and its other best-selling drugs
(such as Ibrance, Vyndaqel/Vyndamax, Xeljanz and Xtandi) face expiration of patents. In November 2021, Pfizer snapped
up Trillium Therapeutics for US$ 2.22 billion. Trillium is a
clinical stage immuno-oncology company developing innovative therapies for the
treatment of cancer. In March 2022, Pfizer acquired
Arena Pharmaceuticals for US$ 6.7 billion, a company that
develops novel therapies to treat immune-inflammatory ailments. Then, in Oct 2022 it completed the US$ 11.6 billion buyout of migraine specialist Biohaven. This brought Biohaven’s leading oral migraine drug in the US – Nurtec ODT (rimegepant) – into Pfizer’s fold. In June 2022, Pfizer completed the acquisition of ReViral Limited, gaining access to
its experimental drugs used to combat respiratory syncytial virus (RSV)
infections. In October, Pfizer paid US$ 5.4 billion for blood disorder
drugmaker Global Blood Therapeutics (GBT). Through this buyout, Pfizer has added GBT’s approved drug, Oxbryta, along with two other sickle cell medicines – GBT601 and inclacumab (both in mid- to late-stage testing) – to its portfolio.And this month, Pfizer
announced it will acquire Seattle-based cancer specialist Seagen for US$ 43 billion, its biggest acquisition in the recent past. “We are not buying the golden eggs,” Albert Bourla, CEO of Pfizer, said post the announcement. “We are acquiring the goose that is laying the golden eggs.”The Pfizer-Seagen deal is
also the largest biopharma acquisition since 2019, when BMS bought Celgene for US$ 74 billion. Seagen is a leader
in antibody-drug conjugate (ADC) technology. This deal will bring four
commercial medicines (Adcetris, Padcev, Tukysa and Tivdak) and a deep pipeline of ADC candidates to Pfizer’s fold.Seagen is likely to post US$
2.2 billion in revenues this year, which is expected to grow to over
US$ 10 billion (risk-adjusted) by 2030. Earlier this year, Bourla had said the company has planned to use its “extraordinary firepower” to buy products that will deliver US$ 25 billion in
incremental revenue by 2030. While Seagen will
bring in US$ 10 billion, another US$ 10.5 billion will come from Arena,
Biohaven, GBT and ReViral.View our Dashboard to know more about Pfizer's Drugs in Development (Free Excel) Diminishing demand for Covid products, expiring patents to drag turnover
downPfizer’s turnover has nearly doubled since 2018, when it was at US$ 53.6 billion. In July 2019,
Pfizer had announced the plan to combine
Upjohn with Mylan to form a new company — Viatris. With the separation of the Upjohn business and the formation of a consumer healthcare joint venture with GSK in 2019, Pfizer
transformed into a more focused player in innovative medicines and vaccines.
However, this restructuring measure also
led to a drop in its turnover to US$ 51.8 billion in 2019 and to US$ 41.9 billion in 2020. From the number three slot in 2018 (behind J&J and Roche), Pfizer’s ranking fell to eight in 2020.
However, Covid turned its fortunes yet again and its turnover increased to US$
81.3 billion in 2021.When we split Pfizer’s 2022 revenues of US$ 100.3 billion, we notice that its
portfolio has 10 products with sales greater
than US$ 1 billion. These include the Covid-19 vaccine Comirnaty with US$ 37.8
billion in revenues, Paxlovid with US$ 18.9 billion, anticoagulant Eliquis with US$ 6.5
billion, and the Prevnar family of pneumococcal vaccines with US$ 6.3 billion
in revenues. Pfizer's partner BMS recorded sales of US$ 11.8 billion for Eliquis in 2022.With a drop in Covid cases,
demand for Comirnaty and Paxlovid has decreased significantly. In 2023,
Comirnaty’s revenue is likely to drop 64 percent to around US$ 13.5 billion, and Paxlovid’s revenue is likely to plummet by around 58 percent to around US$ 8 billion.Pfizer expects its 2023
revenues to be between US$ 67 billion and US$ 71 billion, reflecting an
operational decline of over 30 percent. However, when we exclude the revenues
of Covid products, we are likely to see a growth in revenues of around 7 to 9 percent, coming primarily from new product launches, recently acquired products and Pfizer’s in-line portfolio.“Pfizer expects 2024 sales of Covid products to stabilize, then starting in 2025 and continuing in
2026 and beyond, it expects to see an increase in Covid-19 vaccination rates, assuming the successful development and approval of a Covid-flu combination product,” said Bourla. Last December, Pfizer and BioNTech received fast track designation from the US Food and Drug Administration (FDA) for their mRNA-based combination vaccine candidate for influenza and Covid-19, which aims to help prevent two respiratory diseases with a single injection.View our Dashboard to know more about Pfizer's Drugs in Development (Free Excel) Stars in Pfizer’s pipeline — RSV, pneumococcal and meningococcal vaccinesIn 2022, Pfizer spent US$ 11.4 billion in research and development, up 12 percent from its R&D spend in 2021. It has a power-packed pipeline with 110 programs, including 72 new molecular entities. Out of the 110 programs, 33 are in oncology, 23 in inflammation and immunology, 19 in vaccines, 15 in internal medicines, 12 in rare diseases and eight in anti-infectives.However, the stars in Pfizer’s pipeline are its vaccine candidates. Pfizer’s RSV vaccine candidate RSVpreF is being developed for pregnant women (to help protect their babies from RSV after birth) and individuals 60 years of age or older for the prevention of lower respiratory tract disease caused by RSV. The vaccine recently received support from the FDA's advisory committee, and a decision on its use for older adults is expected by May 2023.The agency has also granted
priority review to the maternal RSV vaccine, with an action date of August
2023. If approved, it would be the first vaccine for pregnant women
to help protect against the complications of RSV disease in infants from birth
through six months.Recently, FDA also designated
Prevnar 20 for priority review in children aged six weeks through 17 years. Six months ago, Merck’s Vaxneuvance had received pediatric approval. The Merck vaccine defends against 15 serotypes, as compared to 13 strains covered by Pfizer’s Prevnar. However, Merck’s edge could be short-lived as Prevnar’s next-generation vaccine protects against 20 serotypes. The US regulatory agency has also accepted the BLA (biologics license application) review of Pfizer’s pentavalent meningococcal vaccine candidate — MenABCWY — in adolescents with the PDUFA date of October 2023. Moreover, the
company has announced positive top-line results from a phase 3 study of
its hemophilia B gene therapy candidate, fidanacogene elaparvovec.Besides this vaccines and
therapies, FDA is going to decide on several other Pfizer drugs in 2023, such
as ritlecitinib for alopecia,
elranatamab for multiple myeloma, etrasimod for ulcerative
colitis, and Abrilada, a biosimilar of AbbVie’s blockbuster Humira (adalimumab).View our Dashboard to know more about Pfizer's Drugs in Development (Free Excel) Our viewAs of today, the sweet spot of US$ 100.3 billion in 2022 revenues posted by Pfizer surely looks like a one-off. Though the drug behemoth’s vaccine pipeline looks promising, its shopping list reflects a huge reliance on oncology for future growth.While only time can tell which of those bets will work and which won’t, it looks like Pfizer has capitalized on the lead the pandemic granted it to race ahead of competition.(All financial and drug pipeline-related information has been taken from the Pfizer website.)
Impressions: 2707
The pandemic years haven’t been great for dealmaking. Our analysis of top 10 biopharma M&A transactions shows that after a blockbuster 2019, when the combined value of top 10 biopharma M&A transactions had hit US$ 207 billion, M&A activity decreased in the next two pandemic years, with the combined value of top 10 deals dropping to US$ 97 billion in 2020 and to US$ 53 billion in 2021.In 2022, the combined value of the top 10 M&A transactions reached US$ 69 billion. However, our analysis shows that total M&As increased only marginally — from US$ 93.6 billion in 2021 to US$ 98.7 billion in 2022. In fact, the total M&As by upfront cash dropped from US$ 77.6 billion to US$ 76.3 billion. Our data does not include deals in medical devices, diagnostics and animal health.Industry watchers had predicted 2022 to be the year of M&As, as Big Pharma were expected to spend the booty amassed during the pandemic on acquisitions. But record inflation, a looming recession, the ongoing Russia-Ukraine war, volatile stock markets and some regulatory moves (such as the US Inflation Reduction Act) deterred companies from loosening their purse strings.The result was another
lackluster year for M&As. The top 10 M&A deals in 2022, selected based on upfront cash paid,
include Amgen’s Horizon takeover (US$ 27.8 billion), Pfizer’s purchase of Biohaven (US$ 11.6 billion) and Global Blood Therapeutics (US$ 5.4 billion), and BMS’ purchase of Turning Point Therapeutics (US$ 4.1 billion).View Top 100 Pharma & Biotech Deals in 2022 by Deal Size (Free Excel Available)Amgen buys Horizon in 2022’s biggest deal; picks up ChemoCentryx for US$ 3.7 bnThe year began on a sluggish note with M&A activity picking up in the second half. The biggest deal of the year — Amgen’s acquisition of Horizon Therapeutics — came in December.Last November, Horizon Therapeutics had said it
had drawn
buyout interest from players like Amgen, Sanofi and Johnson
& Johnson. Just weeks before Christmas, Amgen announced its US$ 27.8 billion takeover of Horizon. The Irish firm develops medicines for rare autoimmune and severe inflammatory diseases mostly sold in the US. Once complete, the deal will give Amgen access to Horizon’s two best-selling drugs – thyroid eye disease drug Tepezza and gout
treatment Krystexxa. Owing to the Amgen-Horizon deal, the rare
diseases therapeutic area attracted the highest amount of M&As (by deal
size). The second largest was neurology, with Pfizer taking over Biohaven and UCB
Pharma acquiring Zogenix.In August, Amgen had picked up Californian
biotech ChemoCentryx for US$ 3.7
billion to help broaden its portfolio of inflammation and kidney drugs. The deal brought ChemoCentryx’s potential blockbuster treatment for inflammatory disorders — Tavneos (avacopan) — into Amgen’s fold, along with three early-stage drug candidates that target ulcerative colitis, skin conditions and cancer.View Top 100 Pharma & Biotech Deals in 2022 by Deal Size (Free Excel Available) Pfizer acquires Biohaven for US$ 11.6 bn, Global Blood Therapeutics for
US$ 5.4 bnThe pandemic brought huge
revenue gains for Pfizer and the drug
behemoth decided to use the cash by cherry-picking companies that would
strengthen its portfolio. In May, Pfizer notched up New Haven-based Biohaven
Pharmaceuticals for US$ 11.6 billion. The deal gave
Pfizer the rights to Nurtec ODT, a leading oral migraine drug in the US and a potential blockbuster. Biohaven has six other migraine drugs in development and Pfizer expects them to top US$ 6 billion in annual sales. Biohaven is Pfizer’s largest purchase since 2016, when it bought Medivation for US$ 14 billion.Later in the year, Pfizer
acquired blood disorder drugmaker Global Blood Therapeutics (GBT) for US$ 5.4 billion with the intention of expanding its sickle cell disease portfolio. Through this buyout, Pfizer has added GBT’s approved drug, Oxbryta, along with two other sickle cell medicines – GBT601 and inclacumab (both in mid- to late-stage testing) – into its portfolio. Pfizer expects all these blood disorder drugs to contribute US$ 3 billion in peak sales.View Top 100 Pharma & Biotech Deals in 2022 by Deal Size (Free Excel Available) BMS buys Turning Point for its oncology pipeline; Takeda acquires Nimbus
LakshmiIn June, Bristol Myers Squibb acquired California-based drug developer Turning Point Therapeutics for an upfront
cash amount of US$ 4.1 billion to bolster its cancer drug pipeline. The deal gives BMS access to Turning Point’s star candidate, repotrectinib, in trials to treat non-small cell lung cancer (NSCLC) along with other advanced solid tumors. BMS expects repotrectinib to be approved in the US in the second half of 2023 and become a standard-of-care therapy for certain patients with NSCLC.In December, Takeda Pharmaceutical acquired US-based Nimbus
Lakshmi, a subsidiary of Nimbus Therapeutics that works
on TYK2 programs, for US$ 4 billion in upfront payment. Through the deal, Takeda won Nimbus’ experimental psoriasis drug TAK-279. Takeda will make two milestone payments of US$ 1 billion each to Nimbus if TAK-279 achieves annual net sales of US$ 4 billion and US$ 5 billion.View Top 100 Pharma & Biotech Deals in 2022 by Deal Size (Free Excel Available) GSK enters pneumococcal vaccine race with Affinivax deal; UCB buys ZogenixGSK – one of the world’s largest vaccine makers by sales – is set to compete for a share of the lucrative pneumococcal vaccine market with its purchase of Affinivax for a potential US$ 3.3 billion. Through the deal, the British drugmaker has gained access to the Boston-based biopharma’s 24-valent pneumococcal vaccine candidate, along with its vaccine development technology platform MAPS (Multiple Antigen Presenting System) and other assets. GSK believes the vaccine candidate will help it challenge market leader Pfizer’s blockbuster Prevnar range of vaccines.GSK also paid US$ 1.9 billion for American drug
developer Sierra Oncology and gained access to the latter’s targeted therapies for the treatment of rare forms of cancer. Sierra’s lead candidate momelotinib is being developed to address the unmet medical needs of anemic myelofibrosis patients. GSK believes the drug will work better at treating anemia than the currently approved JAK inhibitors on the market. FDA will decide on the drug’s approval by June 2023.Belgian biopharma UCB paid US$ 1.9 billion for Zogenix, expanding its
portfolio of treatments for specific and rare forms of epilepsy drugs. The
acquisition will help UCB deepen its foothold in the epilepsy market, adding to
its existing line of four products, including Vimpat and Briviact.View Top 100 Pharma & Biotech Deals in 2022 by Deal Size (Free Excel Available) Merck inks deal with Kelun Biotech; Regeneron buys rights to Sanofi’s cancer drugSeveral drugmakers announced
collaborations where milestone payments took precedence over upfront payments.
In one such deal, Merck entered into a
potential US$ 9.3 billion licensing and collaboration agreement with China’s Kelun Biotech that will give it
rights to seven early-stage antibody-drug conjugate candidates against oncology targets. Merck paid a relatively small sum
of US$ 175 million upfront to Kelun as
part of the deal.After partnering with Sanofi for seven years, Regeneron Pharmaceuticals
acquired the global rights to cancer drug Libtayo from the French
drugmaker for an upfront payment of US$ 900 million. Regeneron paid another US$ 100 million to Sanofi after FDA
approved the drug as a first-line treatment for adult patients with advanced
NSCLC (to be administered in combination with platinum-based chemotherapy). As
part of the deal, Sanofi will receive a royalty of 11 percent on worldwide net
sales of Libtayo and will get another potential US$ 100 million in
sales-related milestone payments over the next two years.View Top 100 Pharma & Biotech Deals in 2022 by Deal Size (Free Excel Available) Biocon acquires Viatris’ biosim business; Biogen sells stake in Samsung Bioepis Biocon Biologics, a subsidiary of Indian drugmaker Biocon, acquired US-based Viatris’ biosimilars business for US$ 3.34 billion. The deal expanded Biocon’s biosimilar portfolio of 20 treatments – including 11 that were with Viatris – by adding therapies for treating diabetes, tumors and autoimmune diseases. According to Biocon, Viatris’ biosimilar portfolio is expected to generate over US$ 1 billion in 2023.Samsung Biologics shelled out US$ 2.3 billion to take over partner
Biogen’s stake in Samsung Bioepis, which the duo had
set up in 2012 to develop and manufacture biosimilars. Biogen, however,
retained the commercial rights to both Byooviz (a biosimilar of Novartis’ eye drug Lucentis) and the investigational candidate SB15 (a biosimilar of Regeneron’s Eylea) along with the
biosimilars of Enbrel, Humira and Remicade.View Top 100 Pharma & Biotech Deals in 2022 by Deal Size (Free Excel Available) Our viewGlobally, M&As slowed down substantially across all industries in 2022 as companies confronted challenges such as rising interest rates, a pullback in leveraged finance, bond-market jitters and the possibility of a recession. According to Refinitiv, the total value of deals announced globally fell 37 percent last year — the biggest year-over-year percentage drop since 2001.Going by these statistics, the pharmaceutical industry didn’t fare badly. In its latest ‘Pharmaceutical & life sciences: US Deals 2023 outlook’ report, PricewaterhouseCoopers has predicted a more active 2023, with “M&As to more closely resemble prior years” with a total deal value in the US$ 225 billion to US$ 275 billion range across all sub-sectors.The new year has begun on a
positive note, with three M&A deals worth over US$ 4 billion being announced at last month’s JP Morgan Healthcare Conference. A series of patent expirations are going to put global
prescription sales at risk through 2026. Therefore, it seems plausible that the recent momentum in M&A activities will continue throughout 2023.
Impressions: 3555
This week, AbbVie’s Humira (adalimumab) saw its 20-year exclusive
run come to an end in the United States as Amgen launched its copycat — Amjevita. This is just the start of
the onslaught of Humira copycats, as seven other biosimilars are due to be
launched this year.In a press statement, Amgen said
Amjevita (40 mg) is available in the US at a list price (wholesale acquisition
cost) 55 percent below the current Humira list price. According to a Reuters report, Humira’s US list price is US$ 6,922 per month. The biosimilar is also available at a list price 5 percent below the current Humira list price.“Amgen’s goal is to provide broad access for patients by offering two options to health plans and pharmacy benefit managers,” the company said.Blockbuster that’s brought in US$ 200 billion so farHumira had bagged the US Food and Drug Administration’s approval in 2002. Back in those days, it was a part of Abbott. The drug had been developed
by a division of BASF Pharma, known as Knoll
Pharmaceuticals. Abbott had acquired Humira through its purchase
of Knoll in March 2001. In 2013, Abbott completed the separation of its research-based drugs business into an independent biopharmaceutical company — AbbVie.Humira is a tumor necrosis factor (TNF) blocker indicated for inflammatory diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis. From 2012 to 2020, Humira was
the world’s top selling drug. In 2012, it ousted Pfizer’s cholesterol drug Lipitor from the number one
spot. AbbVie reported Humira revenues of US$ 19.2 billion in 2019 and US$ 19.8 billion
in 2020. The drug brought in US$ 2.7 billion for AbbVie in 2021. However, that year, it lost its top-selling drug status to Pfizer’s Covid-19 vaccine Comirnaty.Since its approval in December 2002, Humira has brought in over
US$ 200 billion for AbbVie. Last year alone, the drug had delivered sales of US$ 15.6 billion until September 30, accounting for approximately 36 percent of AbbVie’s total net revenues. It is still a top-seller among non-Covid drugs.Humira’s controversial patent thicketThe original patent that covers Humira expired in 2016. Post that, FDA approved eight biosimilars for Humira. These are Amgen’s Amjevita (approved in 2016), Boehringer Ingelheim’s Cyltezo (2017), Sandoz’s Hyrimoz (2018), Samsung Bioepis’ Hadlima (2019), Pfizer’s Abrilada (2019), Viatris’ (earlier Mylan) Hulio (2020),
Coherus BioSciences’ Yusimry (2021) and Fresenius Kabi USA’s Idacio (2022).At present, Cyltezo is the only FDA-approved interchangeable biosimilar, giving it an edge over others since it can be substituted for Humira without a doctor's advice. However, this advantage may be short-lived. FDA is reviewing applications for interchangeability of Abrilada, Pfizer's approved product, and AVT02, Alvotech’s biosimilar under review. FDA is
expected to announce its decision on AVT02 in April.Even though Amjevita was approved in 2016, it wasn’t launched in the US as AbbVie used a strategy known as a “patent thicket” wherein the company applies for multiple patents in addition to the original one. Post that, AbbVie faced class action and
antitrust lawsuits from grocery workers’ union and welfare-benefit plans. In 2019, welfare-benefit plans that pay for Humira sued AbbVie in Chicago federal court, alleging its patent collection created an illegal monopoly by scaring off potential competitors.In June last year, a bipartisan group of US senators asked the US
Patent and Trademark Office to look into curbing the patent thicket. However,
in September, a US appeals court ruled that AbbVie’s use of a patent thicket did not unlawfully block competition. Humira’s last patent will expire in 2037.Our viewPost the launch of Amjevita, several
analysts have talked about how cost savings due to the launch of biosimilars
are expected to be limited given the complicated system of insurance, middle
men and rebates in the US.According to a March 2021 report brought out by the National Bureau of Economic Research, “competitive forces yield important price reductions as the number of competitors increase.”With each biosimilar entry, weighted average price ratios can fall anywhere between four and 10 percentage points, the report adds. Often,
the originator drops its price. In Europe, AbbVie had offered up to 80 percent discounts in November 2018, a month after Humira went off patent. It will be interesting to see how AbbVie counters the onslaught of biosimilars in the US.
Impressions: 1502
We usher in 2023 with the key highlights of the US Food and Drug Administration’s December 2022 list of Off-Patent, Off-Exclusivity (OPOE) Drugs with No Approved Generics. With this list, the FDA hopes to bolster competitiveness
in the generics market.The OPOE list gets updated every six months. Such updates are a part of FDA’s initiative to improve transparency and encourage the development and submission of abbreviated new drug applications (ANDAs) in markets with little competition.Since 2017, the FDA has been publishing the OPOE list of drugs without an approved generic. For a year now, the FDA has been publishing two versions of the OPOE list — one for prescription drug products and one for over-the-counter (OTC) drug products that are approved and marketed under a new drug approval (NDA).View FDA's 2022 List of Off-Patent and Off-Exclusivity Drugs (Free Excel)Four
new applications added to Dec 2022 list; 96 first generics approved last yearWhile the FDA’s June 2022 list of OPOE Drugs with No Approved Generics had 98 new applications for prescription drugs, the December 2022 list saw a sharp decline — only four new applications were added during this period. We had witnessed a similar trend in 2021 — the December 2021 list had only 16 new applications as
opposed to 35 new applications in the June 2021 list.The four new applications were for diclofenamide (a drug to treat glaucoma), ephedrine sulfate (a drug used to treat asthma and
heart failure that also acts as a central nervous system stimulant), meloxicam (an arthritis drug) and pemetrexed (a chemotherapy medication). In
May 2022, the FDA approved the first generics for pemetrexed injection
developed by several companies, including Accord Healthcare, Fresenius Kabi, Apotex, Qilu Pharmaceutical, Biocon, Dr. Reddy’s Laboratories and
Zydus, to treat non-small cell lung cancer (NSCLC) and mesothelioma. Almost one-third of the prescription products – 184 out of 505 – are drug products delivered as injectables, and 68 entries are for oral solid dosage forms (such as tablets, capsules and modified release forms).In the June 2022 list, a total of 60 OTC
drug products were listed. This time too, the same number of OTC drug products
figured in the OPOE list. These include antiseptic agent chlorhexidine gluconate,
non-steroidal anti-inflammatory drug ibuprofen, anti-allergy drug loratadine and painkiller acetaminophen. Of these, 19 are delivered as
oral solid dosage forms (such as
tablets, capsules and modified release forms).In 2022, the FDA approved 96 first generics. This is slightly higher than
the 93 approved by the agency in 2021.As the name suggests, “first generics” are the first approvals handed by the FDA to manufacturers to market a generic product in the United States. The agency considers first generics to be important to public health, and prioritizes review of these submissions.View FDA's 2022 List of Off-Patent and Off-Exclusivity Drugs (Free Excel)AbbVie’s Humira, Novartis’ Entresto to finally face generic competitionAbbVie is facing one of the steepest patent cliffs in the industry’s history, with Humira slated to face the onslaught
of eight biosimilars this year. The blockbuster drug had generated US$ 21.2 billion in 2021. Amgen’s Humira biosimilar – Amjevita – will hit the market this month. The other Humira
biosimilars that will be launched this year include Abrilada (Pfizer), Cyltezo (Boehringer), Hadlima (Samsung Bioepis), Hyrimoz (Sandoz), Hulio (Viatris) and Yusimry (Coherus BioSciences). In mid-December, Fresenius Kabi became the latest
company to win US approval for its Humira copycat — Idacio.Novartis’ heart failure drug Entresto will also go off patent this month. The blockbuster drug had generated US$ 3.5 billion in 2021.View FDA's 2022 List of Off-Patent and Off-Exclusivity Drugs (Free Excel)Our viewIn our previous OPOE drug listing, we had talked about FDA’s intent to bring down drug prices, with the agency putting 98 new applications of prescription drugs in the OPOE list for June 2022. That intent has only become stronger with the US Patent and Trademark Office (USPTO) and the FDA joining hands to promote
competition. The two bodies are working towards improving the patent system in an effort to stop its misuse through “patent thickets”, “evergreening” and “product-hopping”. With this clear intent to lower drug prices in the US, the OPOE lists for 2023 and beyond are likely to get more interesting. For now, all eyes are set on what generic competition will do to blockbusters like AbbVie’s Humira and Novartis’ Entresto.
Impressions: 2698
Nearly every
year, drugmakers ring in the new year with drug price increases in the US. This
year too, prices of over 450 prescription
medicines increased by an average of around 5 percent at the start of January.
This, when high drug prices have been one of the biggest political issues in
the US over the last few years.
PharmaCompass decided to usher in 2022 with a review of the US Medicare Part D Prescription Drug data recently released by the Centers for Medicare and Medicaid Services (CMS) for calendar year 2019. Using the available data, we have developed our own dashboard to show recent trends in consumption of prescription drugs. With this analysis, we hope our readers will get a better understanding of the world’s largest market for pharmaceuticals, as also a fix on where it may be headed.
View US Medicare Part D 2019 Drug Spending (Free Excel Available)
Rising healthcare, drug spends in US
Over the
last several years, we have repeatedly heard political leaders in the US
complain about high drug prices. Yet, drug prices and healthcare spends have
risen unabated.
America’s National Health Expenditure Accounts (NHEA) includes annual expenditures on healthcare goods and services, public health activities, the net cost of health insurance, and investment related to healthcare. In 2019, America’s national health expenditure (NHE) grew by 4.6 percent to US$ 3.8
trillion, accounting for 17.7 percent of the gross domestic product (GDP).
During the year, prescription drug spend increased by 5.7
percent to US$ 369.7 billion. In comparison, Medicare spend grew 6.7
percent to US$ 799.4 billion.
President
Joe Biden recently stressed on the need to cap the prices of essential drugs,
and said that the average American pays the highest prices for prescription
drugs anywhere in the world. Americans pay 10 times as much as other countries for life-saving insulin — the top selling prescription drug covered by the Part D program.
Pharma
companies, on the other hand, have vehemently argued against any price cuts in
the US, saying price cuts would hinder drug research and development for all
diseases.
View US Medicare Part D 2019 Drug Spending (Free Excel Available)
Patented drugs account for 80.3 percent of total Part D spend
Medicare is the US federal government’s program that
provides health insurance to most people who are 65 years
or older. Medicare’s Part D plan provides outpatient drug coverage through private
insurance companies that have contracts with the federal government. Eligible
people have to choose and enroll in a private prescription drug plan for Part D
coverage. Medicare Part B, on the other hand, covers a wide variety of
medically necessary outpatient services and some preventative services.
Prescription
drug coverage under Part D reached US$ 183 billion in 2019 — a growth of around 9 percent over 2018, when spending was US$ 168 billion. Spending
on patented drugs in 2019 accounted for around US$ 147 billion or 80.3 percent
of the total spend for the year. Generic drugs made up for the remaining 19.7
percent (approximately US$ 36 billion). In 2018, generic drugs worth US$ 35.8
billion were sold under Part D, accounting for 21 percent of the total spend
under the program.
View US Medicare Part D 2019 Drug Spending (Free Excel Available)
Eliquis ranks highest on Medicare’s brand drug spend
Under Part
D, endocrinology and oncology were the two therapeutic areas that generated
maximum revenue for pharma companies, driving home sales of over US$ 31.8
billion and US$ 23.5 billion, respectively. Neurology drugs generated sales of
around US$ 22.9 billion.
Among branded
drugs, Bristol Myers Squibb’s anticoagulant Eliquis (apixaban) was the most selling drug in 2019 under Part D, notching up about US$ 7.3 billion in sales — a rise of US$ 2.3 billion or 46 percent over 2018.
Celgene’s cancer drug Revlimid (lenalidomide) roped in US$ 4.7 billion (up
by 14.6 percent), while another anticoagulant drug Xarelto (rivaroxaban) by Janssen Pharma — a unit of Johnson & Johnson — fetched US$ 4.1 billion (up 20.6 percent) in sales through Part D. AbbVie’s anti-rheumatic drug Humira and Sanofi’s diabetes drug Lantus saw sales of around US$ 3.7 billion each
under the program.
Amongst
generics, the largest selling drug under Part D (by dosage units) was metformin (diabetes), followed by gabapentin (seizure), PEG3350 with
electrolyte (gastroenterology), metoprolol (hypertension) and atorvastatin (cholesterol). In 2019, the
overall dosage units sold also jumped higher by 2.25 billion units to 111.35
billion.
The sales
ranking of Part D does bare some similarities with the global ranking of
highest selling drugs. In 2020, Humira had retained its position as the highest
selling drug in the world, generating sales of US$ 20.4 billion. Both
Eliquis and Revlimid had retained their ranking as the third and fourth most
selling drugs, bringing home US$ 14.1 billion and US$ 12.1 billion in global
sales in 2020.
View US Medicare Part D 2019 Drug Spending (Free Excel Available)
Medicare’s inability to negotiate prices costs American taxpayers billions of dollars
Over the
years, drug companies have used Medicare’s
inability to negotiate prices under Part D to increase the prices of their
drugs significantly and rip off huge profits, a three-year-long US House
Oversight Committee investigation has revealed.
US taxpayers could have saved over US$ 25 billion in five years if the prices of just seven drugs — Humira, Imbruvica, Sensipar, Enbrel, Lantus, NovoLog and Lyrica — were negotiated by Medicare. Another US$ 16.7 billion could have been saved between
2011 and 2017 on insulin products manufactured by Eli Lilly, Novo Nordisk and Sanofi, which control 90 percent of the insulin market in the US, the committee’s report revealed.
Elsewhere in
the world, the same drugmakers are bending over backwards to get into medical
insurance programs. For instance, China reported that several international
pharma firms, many of them headquartered in the US, slashed the prices of their
drugs by up to 94 percent to get into the country’s national medical insurance coverage.
In the US — which accounted for around 46 percent of the global share of drugs in 2020 — senior citizens may have to pay more for medicines as the government announced a large hike in Medicare premiums for 2022
if an expensive Alzheimer’s drug, Aduhelm, is included in the list.
In order to
ensure inclusion in Medicare, Biogen slashed the price of Aduhelm by half — from US$ 56,000 to US$ 28,200 — just weeks before a crucial meeting called by the CMS. Clearly, this has set a precedent in an industry which is known for rampant price hikes and rarely for any price cuts. This could also be put forth as an example of what Medicare could achieve if it receives negotiation rights.
View US Medicare Part D 2019 Drug Spending (Free Excel Available)
Our view
President
Biden's Build Back Better legislation,
which the House passed last month, is up for vote in the Senate. The
legislation contains provisions that would allow Medicare to negotiate the
prices of some expensive drugs, penalize drugmakers who raise prices faster
than inflation and cap out-of-pocket costs for insulin at US$ 35 per month.
However, chances of the bill being passed in its present form are slim.
Even if the
Senate passes the bill, Medicare would be able to negotiate the prices of only 10 prescription drugs and insulin products in 2025.
The number would increase over the years, reaching 100 in six years, and hence
forth grow by 20 drugs a year.
It seems like 2022 won’t be the last year when January 1 will be braced with price hikes in the US by drugmakers. Looks like they will continue to make hay while the sun shines.
View US Medicare Part D 2019 Drug Spending (Free Excel Available)
Impressions: 2622
Acquisitions and spin-offs dominated headlines in 2019 and the tone was set very early with Bristol-Myers Squibb acquiring
New Jersey-based cancer drug company Celgene in a US$ 74 billion deal announced on
January 3, 2019. After factoring
in debt, the deal value ballooned to about US$ 95 billion, which according
to data compiled by Refinitiv, made it the largest healthcare deal on
record.
In the summer, AbbVie Inc,
which sells the world’s best-selling drug Humira, announced its acquisition of Allergan Plc, known for Botox and other cosmetic
treatments, for US$ 63 billion. While the companies are still awaiting
regulatory approval for their deal, with US$ 49 billion in combined 2019
revenues, the merged entity would rank amongst the biggest in the industry.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
The big five by pharmaceutical sales — Pfizer,
Roche, J&J, Novartis and Merck
Pfizer
continued
to lead companies by pharmaceutical sales by reporting annual 2019 revenues of
US$ 51.8 billion, a decrease of US$ 1.9 billion, or 4 percent, compared to
2018. The decline was primarily attributed to the loss of exclusivity of Lyrica in 2019,
which witnessed its sales drop from US$ 5 billion in 2018 to US$ 3.3 billion in
2019.
In 2018, Pfizer’s then incoming CEO Albert Bourla had mentioned that the company did not see the need for any large-scale M&A activity as Pfizer had “the best pipeline” in its history, which needed the company to focus on deploying its capital to keep its pipeline flowing and execute on its drug launches.
Bourla stayed true to his word and barring the acquisition of Array Biopharma for US$ 11.4 billion and a spin-off to merge Upjohn, Pfizer’s off-patent branded and generic established medicines business with
Mylan, there weren’t any other big ticket deals which were announced.
The
Upjohn-Mylan merged entity will be called Viatris and is expected to have 2020
revenues between US$ 19 and US$ 20 billion
and could outpace Teva to
become the largest generic company in the world, in term of revenues.
Novartis, which had
followed Pfizer with the second largest revenues in the pharmaceutical industry
in 2018, reported its first full year earnings after spinning off its Alcon eye
care devices business division that
had US$ 7.15 billion in 2018 sales.
In 2019,
Novartis slipped two spots in the ranking after reporting total sales of US$
47.4 billion and its CEO Vas Narasimhan continued his deal-making spree by buying New
Jersey-headquartered The Medicines Company (MedCo) for US$ 9.7
billion to acquire a late-stage cholesterol-lowering
therapy named inclisiran.
As Takeda Pharmaceutical Co was
busy in 2019 on working to reduce its debt burden incurred due to its US$ 62
billion purchase of Shire Plc, which was announced in 2018, Novartis also purchased
the eye-disease medicine, Xiidra, from the Japanese drugmaker for US$ 5.3 billion.
Novartis’ management also spent a considerable part of 2019 dealing with data-integrity concerns which emerged from its 2018 buyout of AveXis, the
gene-therapy maker Novartis had acquired for US$ 8.7 billion.
The deal gave Novartis rights to Zolgensma,
a novel treatment intended for children less than two years of age with the
most severe form of spinal muscular atrophy (SMA). Priced at US$ 2.1 million,
Zolgensma is currently the world’s most expensive drug.
However,
in a shocking announcement, a month after approving the drug, the US Food and
Drug Administration (FDA) issued a press release on
data accuracy issues as the agency was informed by AveXis that
its personnel had manipulated data which
the FDA used to evaluate product comparability and nonclinical (animal)
pharmacology as part of the biologics license application (BLA), which was
submitted and reviewed by the FDA.
With US$
50.0 billion (CHF 48.5 billion) in annual pharmaceutical sales, Swiss drugmaker
Roche came in at number two position in 2019
as its sales grew 11 percent driven by
its multiple sclerosis medicine Ocrevus, haemophilia drug Hemlibra and cancer medicines Tecentriq and Perjeta.
Roche’s newly introduced medicines generated US$ 5.53 billion (CHF 5.4 billion) in growth, helping offset the impact of the competition from biosimilars for its three best-selling drugs MabThera/Rituxan, Herceptin and Avastin.
In late 2019, after months of increased
antitrust scrutiny, Roche completed
its US$ 5.1 billion acquisition of Spark Therapeutics to strengthen its presence in
gene therapy.
Last year, J&J reported almost flat worldwide sales of US$ 82.1 billion. J&J’s pharmaceutical division generated US$ 42.20 billion and its medical devices and consumer health divisions brought in US$ 25.96 billion and US$ 13.89 billion respectively.
Since J&J’s consumer health division sells analgesics, digestive health along with beauty and oral care products, the US$ 5.43 billion in consumer health sales from over-the-counter drugs and women’s health products was only used in our assessment of J&J’s total pharmaceutical revenues. With combined pharmaceutical sales of US$ 47.63 billion, J&J made it to number three on our list.
While the sales of products like Stelara, Darzalex, Imbruvica, Invega Sustenna drove J&J’s pharmaceutical business to grow by 4 percent over 2018, the firm had to contend with generic competition against key revenue contributors Remicade and Zytiga.
US-headquartered Merck, which is known as
MSD (short for Merck Sharp & Dohme) outside the United States and
Canada, is set to significantly move up the rankings next year fueled by its
cancer drug Keytruda, which witnessed a 55
percent increase in sales to US$ 11.1 billion.
Merck reported total revenues of US$ 41.75 billion and also
announced it will spin off its women’s health drugs,
biosimilar drugs and older products to create a new pharmaceutical
company with US$ 6.5 billion in annual revenues.
The firm had anticipated 2020 sales between US$ 48.8 billion and US$ 50.3 billion however this week it announced that the coronavirus pandemic will reduce 2020 sales by more than $2 billion.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Humira holds on to remain world’s best-selling drug
AbbVie’s acquisition of Allergan comes as the firm faces the expiration of patent protection for Humira, which brought in a staggering US$ 19.2 billion in sales last year for
the company. AbbVie has failed to successfully acquire or develop a major new
product to replace the sales generated by its flagship drug.
In 2019, Humira’s US revenues increased 8.6 percent to US$ 14.86 billion while internationally, due
to biosimilar competition, the sales dropped 31.1 percent to US$ 4.30 billion.
Bristol Myers Squibb’s Eliquis, which is also marketed by Pfizer, maintained its number two position
and posted total sales of US$ 12.1 billion, a 23 percent increase over 2018.
While Bristol Myers Squibb’s immunotherapy treatment Opdivo, sold in partnership with Ono in Japan, saw sales increase from US$ 7.57 billion to US$ 8.0 billion, the growth paled in comparison to the US$ 3.9
billion revenue increase of Opdivo’s key immunotherapy competitor Merck’s Keytruda.
Keytruda took the number three spot in drug sales that
previously belonged to Celgene’s Revlimid, which witnessed a sales decline from US$ 9.69 billion to US$ 9.4 billion.
Cancer treatment Imbruvica, which is marketed
by J&J and AbbVie, witnessed a 30 percent increase in sales. With US$ 8.1
billion in 2019 revenues, it took the number five position.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Vaccines – Covid-19 turns competitors into partners
This year has been dominated by the single biggest health emergency in years — the novel coronavirus (Covid-19) pandemic. As drugs continue to fail to meet expectations, vaccine development has received a lot of attention.
GSK reported the highest vaccine sales of all drugmakers with
total sales of US$ 8.4 billion (GBP 7.16 billion), a significant portion of its
total sales of US$ 41.8 billion (GBP 33.754 billion).
US-based Merck’s vaccine division also reported a significant increase in sales to US$ 8.0 billion and in 2019 received FDA and EU approval to market its Ebola vaccine Ervebo.
This is the first FDA-authorized vaccine against the deadly virus which causes
hemorrhagic fever and spreads from person to person through direct contact with
body fluids.
Pfizer and Sanofi also reported an increase in their vaccine sales to US$ 6.4
billion and US$ 6.2 billion respectively and the Covid-19 pandemic has recently
pushed drugmakers to move faster than ever before and has also converted
competitors into partners.
In a rare move, drug behemoths — Sanofi and GlaxoSmithKline (GSK) —joined hands to develop a vaccine for the novel coronavirus.
The two companies plan to start human trials
in the second half of this year, and if things go right, they will file
for potential approvals by the second half of 2021.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Our view
Covid-19 has brought the world economy to a grinding halt and shifted the global attention to the pharmaceutical industry’s capability to deliver solutions to address this pandemic.
Our compilation shows that vaccines and drugs
for infectious diseases currently form a tiny fraction of the total sales of
pharmaceutical companies and few drugs against infectious diseases rank high on
the sales list.
This could well explain the limited range of
options currently available to fight Covid-19. With the pandemic currently infecting
over 3 million people spread across more than 200 countries, we can safely
conclude that the scenario in 2020 will change substantially. And so should our
compilation of top drugs for the year.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Impressions: 54752
The US Food and Drug Administration’s (FDA) momentum of new drug approvals dropped marginally in 2019 — while 62 novel drugs were approved in 2018, 54 were approved in 2019. FDA’s Center for Drug Evaluation and Research (CDER) approved 48 drugs while another six were approved by the Center for Biologics Evaluation and
Research (CBER).
Novartis dominated new drug approvals as CDER approved five of its new drugs across five different therapeutic areas. But then, it also made headlines when the FDA raised data accuracy issues over the Swiss drugmaker’s gene therapy — Zolgensma — which sent the company into a crisis
management mode.
View FDA’s New Drug Approvals in 2019 with estimated sales (Free Excel Available)
The gene therapy drug
came into the fold of Novartis in April 2018 through the US$ 8.7 billion acquisition of Illinois-based AveXis Inc.
Zolgensma — the world’s most expensive drug — was approved as a one-time treatment for spinal muscular atrophy (SMA) in May 2019.
However, in March 2019, Novartis learnt of manipulation in the raw data derived
from a mice assay used at the time to test Zolgensma samples, but only alerted the FDA in June — about a month after the drug gained US approval.
Post that, Novartis came under fire from US lawmakers who said the company should have informed the regulators about the data irregularities before the drug’s approval in May, instead of waiting to conclude an internal investigation.
Novartis’ other approvals were brolucizumab (for treatment of macular
degeneration), siponimod (to treat multiple sclerosis), alpelisib (breast cancer), crizanlizumab (sickle
cell disease) and triclabendazole (fascioliasis, a tropical disease).
View FDA’s New Drug Approvals in 2019 with estimated sales (Free Excel Available)
Vertex’s Trikafta leads in estimated sales potential
At PharmaCompass,
we compiled the sales forecasts for the new drugs approved by the FDA in 2019. Vertex’s cystic fibrosis treatment — Trikafta — with expected sales of US$ 3.935 billion by 2024, leads our list.
Trikafta is a combination of ivacaftor, tezacaftor and elexacaftor. Vertex already has three cystic fibrosis drugs on the market — Kalydeco (a standalone ivacaftor treatment), Symdeko (a combination of ivacaftor and tezacaftor) and Orkambi (which contains ivacaftor and lumacaftor).
Trikafta’s stellar clinical data made the FDA approve the drug within three months of Vertex’s application filing and five months before FDA’s action date.
Abbvie’s Humira, the top-selling drug in the world, is beginning to face generic competition in certain parts of the world and two new drug approvals in 2019 — Skyrizi (risankizumab for
plaque psoriasis) and Rinvoq (upadacitinib for rheumatoid arthritis) — are critical to AbbVie's plans to
grow beyond Humira. The two drugs are expected to contribute over US$ 5.5 billion by 2024 to AbbVie’s top-line.
In April, AstraZeneca struck a deal worth US$ 6.9 billion with Japanese drug major
Daiichi Sankyo, to jointly develop and commercialize the antibody drug conjugate cancer therapy —trastuzumab deruxtecan. The
breast cancer treatment won FDA approval in December and analysts forecast
sales of US$ 2.5 billion by 2024 with some believing that the drug could
achieve US$ 7 billion in peak sales.
View FDA’s New Drug Approvals in 2019 with estimated sales (Free Excel Available)
The rise of new drugs from Asia
While Daiichi won the FDA nod for its cancer treatment — Turalio (pexidartinib) — new drugs from established Japanese drug makers like Shionogi, Kyowa Kirin and Eisai also bagged the American agency’s approval.
Shionogi’s novel antibiotic — Fetroja (cefiderocol) — got approved for complicated urinary tract infections while Kyowa won the nod for its Parkinson’s treatment — Nourianz (istradefylline). Eisai’s insomnia drug — Dayvigo (lemborexant) — was one of the last drugs approved in the year and is expected to generate sales of US$ 329 million.
View FDA’s New Drug Approvals in 2019 with estimated sales (Free Excel Available)
In 2019, the FDA also
approved new drugs from China and Korea. Zanubrutinib (branded
as Brukinsa) developed by Chinese biotech BeiGene won accelerated approval for adult patients with mantle cell lymphoma (MCL) — a typically aggressive and rare form of blood cancer.
This was followed, almost immediately, by news that the agency approved a new treatment for partial-onset seizures in adults. The drug — cenobamate — will be sold as Xcopri by SK Life Science,
the US subsidiary of the massive Korean conglomerate SK Group. Xcopri will
provide another therapeutic option to patients with epilepsy. This approval
marked the first time a Korean company independently took a compound from the
stage of discovery to FDA approval.
Xcopri is SK Life Science’s first commercial product and wraps a decade of quiet growth from SK Life Science, which has been developing its presence in the pharmaceutical industry.
The company plans to hire a salesforce to support the drug’s launch, which is expected to generate over US$ 1.5 billion in sales.
View FDA’s New Drug Approvals in 2019 with estimated sales (Free Excel Available)
Sanofi’s controversial dengue vaccine, cast-off drug get approved
The FDA very narrowly approved Sanofi’s controversial dengue vaccine — Dengvaxia. The vaccine, which took 20 years to develop, got embroiled in a controversy when in 2017, Sanofi disclosed that Dengvaxia could increase the risk of severe dengue in children who had never been exposed to the virus.
In Philippines, 800,000 school-age children had been vaccinated against dengue, the world’s fastest growing infectious disease.
The year 2019
had begun with Bristol-Myers Squibb (BMS) and Celgene announcing their US$ 74 billion mega-merger. As the firms worked through the year to get the merger approved, the FDA signed off on Celgene’s myelofibrosis drug Inrebic
(fedratinib).
Inrebic — the once-daily oral drug — is the first new treatment in nearly a decade approved to treat myelofibrosis. The story of Inrebic’s rise from the dead is a major success for Celgene,
which picked up the drug as a part of a US$ 1.1 billion acquisition of Impact
Biomedicines in January 2018. Before that, Inrebic had passed through multiple
hands.
Fedratinib was a flop
for Sanofi as patients began to develop a dangerous neurological
condition tied to vitamin B deficiency called Wernicke’s encephalopathy. As a result, the FDA put a clinical hold on it in 2013 and Sanofi ultimately shelved the effort.
Executives
at BMS have said the drug is among a group of potential blockbusters at
Celgene.
View FDA’s New Drug Approvals in 2019 with estimated sales (Free Excel Available)
Our view
With over 40 companies from across the world getting new
drugs approved in 2019 across 17 therapeutic areas, the horizon for new drug
development across the globe continues to widen.
Although 2018 was a landmark year for approvals, given all
the development activity underway, the day is not far when this record too will get beaten. And
2020 could well witness that day!
View FDA’s New Drug Approvals in 2019 with estimated sales (Free Excel Available)
Impressions: 14509
This week, PharmaCompass reviews the recently released data of the Medicare Part D Prescription Drug Program in the United States for calendar year 2017.
The US market is the world’s largest and most important pharmaceutical market, accounting around 45 percent of the global share of drugs, and was valued at US$ 466 billion in 2017.
View Our Interactive Dashboard on Medicare Part D 2017 Spending (Free Excel Available)
What is Medicare?
Medicare is the federal health insurance program in the US which covered 58.4 million people in 2017 — 49.5 million aged 65 and older, and 8.9 million disabled.
The National Health Expenditure (NHE) in the US grew 3.9 percent to US$ 3.5 trillion in 2017 and accounted for 17.9 percent of the gross domestic product
(GDP). As a result, Medicare spending grew 4.2 percent to US$ 705.9 billion in
2017, or 20 percent of the total NHE.
Prescription
drug spending in the US increased to US$ 333.4 billion in 2017 while prescription drug coverage under the Medicare program,
known as Medicare Part D, reached US$ 151.6 billion in 2017, a little less than half of the total prescription
drug spending in the United States.
View Our Interactive Dashboard on Medicare Part D 2017 Spending (Free Excel Available)
Why has Medicare been in news?
The Medicare Part D drug benefit is delivered by private drug plans, which are mostly chosen by the program’s participants. Under Part D, drug prices are determined primarily through negotiations between Part D plans and providers (such as pharmacies and drug manufacturers). A key factor that helps Part D plans lower drug costs are rebate payments that the plans negotiate with drug manufacturers.
With drug pricing debate raging in the
United States, these rebate payments have come under a lot of scrutiny.
View Our Interactive Dashboard on Medicare Part D 2017 Spending (Free Excel Available)
During the hearing of Big Pharma executives summoned by the Senate
Financing Committee last month, Sanofi’s CEO Olivier Brandicourt detailed a chart showing Sanofi and Genzyme's US sales from 2018, explaining how as much as 55 percent of Sanofi’s gross sales were given back to payers as rebates.
The chart showed how out of Sanofi’s US$ 21.6 billion in gross sales in 2018, US$ 4.5 billion was given back in mandatory rebates to government payers and US$ 7.3 billion in discretionary rebates.
Earlier this month, the Trump administration
unveiled a budget that would reduce spending in Medicare as
well as Medicaid by hundreds of billions of dollars compared to the current
law.
View Our Interactive Dashboard on Medicare Part D 2017 Spending (Free Excel Available)
What are the insights available from the
2017 US Medicare Part D data?
The Medicare Drug Spending dashboards were updated earlier this month to include data for 2017, providing more
data and transparency to better identify trends and track consumption and price
changes over time.
Using the available data, PharmaCompass has developed its own dashboard to show
recent trends in consumption of prescription drugs under Medicare D. Our
dashboard also helps identify drugs with limited to no competition.
The data reveals that while almost 60 percent of the Medicare spend (nearly US$ 90 billion) is for drugs with only one manufacturer, i.e. mostly patented drugs, there is another US$ 12 billion spend on drugs which have only two manufacturers. The next highest spend — of US$ 4 billion — is on drugs with as many as five manufacturers.
This clearly indicates that if the market
can support up to five manufacturers for established products, increased
generic competition will significantly help Medicare reduce its Part D
prescription drug spending.
View Our Interactive Dashboard on Medicare Part D 2017 Spending (Free Excel Available)
Medicare’s highest spend was on Insulin Glargine (US$ 4.7 billion) followed by patented
drugs Celgene’s Revlimid (lenalidomide), Bristol-Myers Squibb’s Eliquis (apixaban), Merck’s Januvia (sitagliptin phosphate) and AbbVie’s Humira (adalimumab).
Drugs with limited to no competition can be
identified using the dashboard by sorting for drugs with few
manufacturers.
Information is also provided on drug uses
and clinical indications, thereby enabling comparison between different
medications for a given condition.
View Our Interactive Dashboard on Medicare Part D 2017 Spending (Free Excel Available)
Impressions: 4699
The year 2017 was a landmark year for pharmaceutical
industries in the US and Europe, with a sharp increase in the number of new molecular entities (NMEs) being approved in both geographies.
The US Food
and Drug Administration (USFDA) approved 46 NMEs in 2017, the second highest
since 1996 when 53 NMEs were approved. In Europe, the European Medicines Agency
(EMA) approved 35 drugs with a new active substance, up from 27 in 2016.
Sales for most major pharmaceutical
companies continued to grow in 2017. Earnings forecasts for 2018 have been raised due to the recent US tax reform that has
generated investor hopes for accelerated dividend growth and share buyback
plans.
This week, PharmaCompass brings
you a compilation of the top drugs of 2017 by sales revenue.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
Top-sellers: Humira races ahead, despite launch of biosimilars; Enbrel a distant second
There wasn’t any upheaval
at the top of the pharma drug sales charts. AbbVie’s anti-TNF (tumor necrosis factor) giant
Humira (adalimumab), which is approved to treat
psoriasis and rheumatoid arthritis, added
almost another US $3 billion to its 2016 sales and posted nearly US $19 billion in revenues.
Last year, AbbVie’s raised expectations for Humira’s earnings to reach US $21 billion in global sales by 2020. The
company believes this drug will continue to be a significant cash contributor
until 2025 and the US $21 billion sales forecast
by 2020 is about US $3 billion higher than its expectation two years ago.
In 2016, the US Food and Drug Administration
(FDA) approved Amgen’s Amjevita (adalimumab-atto) — a biosimilar of Humira. And in 2017, another Humira biosimilar — Boehringer Ingelheim’s Cyltezo
(adalimumab-adbm) — received approval from the FDA and European authorities.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
Enbrel (etanercept),
the longest-used biologic medicine for the treatment of rheumatism around the
world, was the second best-selling drug with US $8.262 billion in 2017 sales.
The sales of the drug were down from US $9.366 billion in
2016 owing to lower selling prices and increased
competition, which in turn hurt demand.
Since it was first approved in the United States in 1998,
Enbrel has been approved in over 100 countries and the drug is promoted by Amgen,
Pfizer
and Takeda
in different geographies.
Novartis’ biosimilar copy of Enbrel, which got approved by the FDA in August
2016 for the treatment of patients with
rheumatoid arthritis (RA), plaque psoriasis, ankylosing spondylitis (AS) and
other diseases is still not on the market because of a patent-protection
challenge from Amgen.
Amgen is arguing in the US federal court
that its drug has patent protection until 2029.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
Fast-growing drugs: Eylea and Revlimid bring
fortunes for Regeneron and Celgene
Regeneron’s
flagship eye treatment, Eylea (aflibercept) which is marketed by Bayer outside the United States, added another US $1 billion in
annual sales last year to record US $8.260 billion in total sales. Eylea net
sales grew 11 percent year-on-year in the US and 19 percent year-over-year
outside the US.
The company believes much of the recent
growth in the US was driven by demographic trends with an aging population as
well as an overall increase in the prevalence of diabetes.
These demographic trends are expected to
continue in the coming years, providing an opportunity for continued growth.
Eylea sales alone contribute 63 percent to Regeneron’s total sales.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
Celgene’s
Revlimid
(lenalidomide)
— a thalidomide derivative introduced in 2004 as an immunomodulatory agent for the treatment of various cancers such as multiple myeloma — brought in an additional US $1.2 billion in 2017 sales and had total revenues of US $8.187 billion.
Revlimid continues to contribute more than 60 percent to the company’s total sales of US $13 billion.
Celgene received a setback this month as the
USFDA refused to consider Celgene’s
application for ozanimod, an experimental
treatment for relapsing multiple sclerosis. The treatment was being seen as a
key to the company’s fortunes as Celgene had
said ozanimod is worth US $4 billion to
US $6
billion a year in peak sales.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
Gilead’s Hepatitis C franchise enters free fall
Gilead Sciences’ blockbuster hepatitis C drugs franchise that includes Sovaldi and Harvoni continue to feel the
competitive heat as they registered US $9.137
billion in 2017 sales, down from US $14.834
billion the previous year.
While reporting 2017 results, Gilead provided guidance for
2018 and said its sales of Hepatitis C drugs could fall
further to US $3.5 billion - US $4 billion. At their peak in 2015, Gilead’s Sovaldi and Harvoni had together generated
US $19.1 billion in sales.
One of the major reasons for this drop is AbbVie’s launch of its new treatment Mavyret
at a deep price discount to the competition. AbbVie
also claims to have the shortest treatment course at eight weeks, compared with
12 weeks or longer for other treatments.
AbbVie reported US $1.274 billion in Hepatitis C drug sales
in 2017, down from US $1.522 billion in 2016.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
Novartis’ Gleevec, Merck’s cardiovascular drugs, GSK’s Advair face generic heat
Novartis’ Gleevec (imatinib), which had at one point become the best-selling drug for Novartis and had brought in US $3.323 billion for the company in 2016, started facing generic competition last year and the anti-cancer drug lost US $1.380 billion in sales to bring in ‘only’ US $1.943 billion last year.
The US patents of Merck’s cardiovascular drugs — Zetia (Ezetimibe)
and Vytorin (Ezetimibe
and Simvastatin) — expired in April 2017. In May 2010, Merck and Glenmark
Pharmaceuticals entered into an agreement that allowed Glenmark to launch
a generic version of Zetia in late 2016. The drugs
that had combined sales of US $3.701
billion in 2016 felt the generic heat in 2017 and the sales were US
$1.606 billion lower at US $2.095
billion.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
GSK’s Advair, which was expected
to encounter generic competition in 2017, continued to breathe easy as the FDA
found deficiencies in the applications of Hikma, Mylan and Sandoz.
All three failed to get the FDA nod for their generic versions of Advair, a drug used in the management of asthma and chronic obstructive pulmonary disease that generated sales worth US $4.431 billion (£3.130 billion) in 2017.
Top 15 drugs by sales
Here is PharmaCompass’ compilation
of the best-selling drugs of 2017. This is based on information extracted from
annual reports and US Securities and Exchange Commission (SEC) filings of major
pharmaceutical companies.
If you would like your own copy of all the information we’ve collected, email us at support@pharmacompass.com and we’ll send you an Excel version.
Click here to access all the 2017 data (Excel
version available) for FREE!
S. No.
Company / Companies
Product Name
Active Ingredient
Main Therapeutic Indication
2017 Revenue in Millions (USD)
1
AbbVie Inc., Eisai
Humira®
Adalimumab
Immunology (Organ Transplant, Arthritis etc.)
18,946
2
Amgen, Pfizer Inc., Takeda
Enbrel®
Etanercept
Immunology (Organ Transplant, Arthritis etc.)
8,262
3
Regeneron, Bayer
Eylea
Aflibercept
Ophthalmology
8,260
4
Celgene
Revlimid
Lenalidomide
Oncology
8,187
5
Roche
MabThera®/Rituxan®
Rituximab
Oncology
7,831
6
Johnson & Johnson, Merck, Mitsubishi Tanabe
Remicade®
Infliximab
Autoimmune Disorders
7,784
7
Roche
Herceptin®
Trastuzumab
Oncology
7,435
8
Bristol-Myers Squibb, Pfizer Inc.
Eliquis®
Apixaban
Cardiovascular Diseases
7,395
9
Roche
Avastin®
Bevacizumab
Oncology
7,089
10
Bayer, Johnson & Johnson
XareltoTM
Rivaroxaban
Cardiovascular Diseases
6,590
11
Bristol Myers Squibb, Ono Pharmaceutical
Opdivo
Nivolumab
Oncology
5,815
12
Sanofi
Lantus
Insulin Glargine
Diabetes
5,731
13
Pfizer Inc.
Prevnar 13/Prevenar 13
Pneumococcal 7-Valent Conjugate
Anti-bacterial
5,601
14
Pfizer Inc., Eisai
Lyrica
Pregabalin
Neurological/Mental Disorders
5,318
15
Amgen, Kyowa Hakko Kirin
Neulasta®
Pegfilgrastim
Blood Disorders
4,553
Sign up, stay ahead
In order to stay informed, and receive
industry updates along with our data compilations, do sign up for the PharmaCompass Newsletter and
you will receive updated information as it becomes available along with a lot
more industry analysis.
Click here to Access All
the 2017 Data (Excel version available) for FREE!
Impressions: 58408