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FDA reports 62.5% growth in new drug approvals in H1 2023; Health Canada sees drop

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.

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31 Aug 2023

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Company Tracker: Pfizer turns to acquisitions as Covid products’ sales nosedive

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.)

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23 Mar 2023

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Top 100 pharma & biotech deals in 2022

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.

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23 Feb 2023

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Amgen ends Humira’s 20-year reign in US with Amjevita launch

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.

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02 Feb 2023

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FDA’s list of off-patent drugs suggests higher approvals of first generics in 2022

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.

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05 Jan 2023

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America’s drug price hike conundrum in backdrop of 2019 Medicare Part D data

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)

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06 Jan 2022

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Top drugs and pharmaceutical companies of 2019 by revenues

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)

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29 Apr 2020

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Novartis leads in new drug approvals; Vertex’s cystic fibrosis med holds highest sales potential

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)

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31 Dec 2019

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US market offers niche opportunities, reveals manufacturer sales data from Medicare Part D

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)

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28 Mar 2019

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Top drugs by sales in 2017: Who sold the blockbuster drugs?

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!

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29 Mar 2018

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