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By PharmaCompass
2023-09-07
Impressions: 3370
After a buoyant July, when all the three pharma indices inched up by 2 percent, August proved to be a downer. While the Nasdaq Biotechnology index (NBI) was up 1 percent, at US$ 4,150.80 (against US$ 4,129.98 in July), the SPDR S&P Biotech ETF index was down by 4 percent, at US$ 80.15 (against US$ 84.29 in July) and the S&P Biotechnology Select Industry Index (SPSIBI) was down by 5 percent, at US$ 6,161.27 (against US$ 6,544.43 in July).
Many drugmakers, such as Eli Lilly, Novo Nordisk, Amgen, Regeneron, Pfizer and Bayer, announced their Q2 results last month.
August was a lackluster month for deals. Only one deal over US$ 1 billion got reported last month — Novo Nordisk’s acquisition of Inversago Pharma, a privately held obesity drugmaker, for up to US$ 1.08 billion. This buyout will broaden Novo’s blockbuster weight loss portfolio.
Access the Pipeline Prospector Dashboard for August 2023 Newsmakers (Free Excel)
Lilly, Novo, Amgen, Regeneron post stock market gains due to upbeat Q2 results
Several drugmakers posted an increase in Q2 revenues. Eli Lilly (stock up 22 percent in August) posted a 28 percent increase in its revenues for the quarter — at US$ 8.31 billion, up from US$ 6.48 billion in Q2 2022. This growth was driven by drugs such as Mounjaro (a diabetes med) that brought in US$ 979.7 million, Verzenio (a breast cancer drug) whose sales increased 57 percent at US$ 926.8 million, Jardiance (a diabetes med) with revenues of US$ 668.3 million and psoriasis therapy Taltz that brought in US$ 703.9 million.
Lilly posted some gains in clinical trials as well. Its oncology drug Retevmo (selpercatinib) demonstrated superior progression-free survival in phase 3 clinical trial compared to other approved multikinase inhibitors as an initial treatment for patients with a type of advanced or metastatic Rearranged during Transfection (RET) medullary thyroid cancer.
Novo Nordisk (up 15 percent) posted sales growth of 30 percent on a constant exchange rates (CER) basis in the first half of 2023 to DKK 107.66 billion (US$ 15.49 billion). There was much good news on its weight loss med Wegovy (semaglutide 2.4 mg) — it met its primary goal of preventing major cardiovascular events by reporting a 20 percent drop in the risk of cardiovascular death, heart attack, or stroke in overweight and obese patients. In another phase 3 study, Wegovy reduced symptoms and physical limitations in patients with obesity and heart failure with preserved ejection fraction as compared to placebo.
Amgen (up 10 percent) reported strong Q2 results, with a 6 percent increase in revenue — at US$ 7.0 billion, compared to US$ 6.6 billion in Q2 2022. The growth was driven by its osteoporosis drug Evenity (US$ 281 million), leukemia drug Blincyto (US$ 206 million), cholesterol-lowering medicine Repatha (US$ 424 million) and Humira biosimilar Amjevita (US$ 150 million).
Another gainer was Regeneron (stock up 12 percent) — its Q2 revenues increased by 11 percent over Q2 2022 to touch US$ 3.16 billion. Moreover, the company secured two FDA approvals last month. One, its drug Veopoz (pozelimab) bagged approval to treat an ultra rare disease, known as CHAPLE disease, in both adults and pediatric patients. Two, FDA okayed Regeneron’s Eylea HD (aflibercept) injection 8 mg — a higher dose version of Eylea 2 mg. Developed in collaboration with Bayer, Eylea HD is the first and only treatment approved in wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR) for immediate dosing at eight-week and up to 16-week intervals following three initial monthly doses.
Gilead (stock up 1 percent) saw its Q2 revenue increase by 5 percent — to US$ 6.6 billion, as opposed to US$ 6.3 billion in Q2 2022. Growth was driven by its HIV drug portfolio that brought in US$ 4.6 billion.
Access the Pipeline Prospector Dashboard for August 2023 Newsmakers (Free Excel)
Pfizer reports 54% drop in Q2 revenues; BMS, Astra resolve patent lawsuits
Among the big stock market losers in August were Pfizer (-3 percent), Roche (-5 percent), AstraZeneca (-4 percent) and Bayer (-6 percent). Pfizer reported a 54 percent drop in its Q2 revenues, at US$ 12.73 billion against US$ 27.74 billion in Q2 2022, owing to reduced sales of its Covid-19 products Comirnaty and Paxlovid.
But negative news ran deeper than just the Q2 results. The drug behemoth removed several phase 1 and mid-stage candidates from its pipeline, including a phase 1 respiratory syncytial virus (RSV) infection candidate, two phase 2 assets including an oral obesity and diabetes candidate and a pneumococcal vaccine, along with an atopic dermatitis drug. In clinical trials, a heart drug from BridgeBio — acoramidis — showed better results than Pfizer’s approved drug Vyndamax (tafamidis) in transthyretin amyloid cardiomyopathy, a rare heart disease. To make matters worse, GSK sued Pfizer in a US court alleging that Pfizer’s RSV vaccine Abrysvo violates GSK’s patent rights in its rival RSV shot Arexvy.
However, there was some good news too — FDA granted accelerated approval to Pfizer’s Elrexfio (elranatamab) for the treatment of relapsed or refractory multiple myeloma and approved its RSV vaccine Abrysvo for use in infants through active immunization of pregnant women.
Bayer’s group turnover was down 8.2 percent to €11.04 billion (US$ 11.94 billion) in Q2 2023, from US$ 13.6 billion in Q2 2022. The group’s pharmaceutical sales were down from €4.81 billion (US$ 5.16 billion) in Q2 2022 to €4.55 billion (US$ 4.88 billion) in Q2 2023.
In March 2022, Bristol Myers Squibb (BMS) had sued AstraZeneca over infringement of Opdivo patents. In January this year, BMS sued Astra yet again for infringing on its Yervoy patents. In three separate lawsuits, BMS had complained that Astra’s drugs, Imfinzi and Imjudo, infringed patents on BMS’ therapies, Opdivo and Yervoy.
But last month, BMS and Astra resolved patent infringement lawsuits. According to news reports, AstraZeneca has agreed to pay BMS and Ono Pharmaceutical US$ 510 million to resolve these lawsuits. Astra’s stock was down 4 percent in August.
However, there was some positive news for AstraZeneca — the US Centers for Disease Control and Prevention (CDC) advisory committee on immunization practices unanimously recommended the use of Sanofi and Astra’s antibody, nirsevimab, to prevent RSV in infants and toddlers.
Access the Pipeline Prospector Dashboard for August 2023 Newsmakers (Free Excel)
Our view
Our Pipeline Prospector in July had ended with the caveat that even though the indices have ended the month on a stronger footing, August could be different. Though this is the second consecutive year when the markets have remained volatile, what gives us hope are the innovative drugs in the pipelines of various drugmakers — both big and small.
Access the Pipeline Prospector Dashboard for August 2023 Newsmakers (Free Excel)
Pharma & Biotech Newsmakers in August 2023
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Image Credit : Pharma & Biotech Newsmakers in August 2023 by PharmaCompass license under CC BY 2.0
“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”
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