In October, several pharma companies posted their third quarter (Q3) results. Drugmakers like Pfizer, BMS, Roche, Novartis, Sanofi, Merck and Incyte reported higher-than-expected Q3 earnings, beating analyst expectations.
Despite these healthy results, pharma indices continued on their downward journey that had begun in September. The Nasdaq Biotechnology Index (NBI) dropped 2.6 percent from 4,771.85 to 4,650.07. The SPDR S&P Biotech ETF (XBI) fell 1.6 percent from 98.61 to 97.03, and the S&P Biotechnology Select Industry Index (SPSIBI) decreased 1.9 percent from 7,707.4 to 7,561.29.
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Lundbeck buys Longboard,
AbbVie picks up Aliada, Merck acquires Modifi in US$ 1 bn+ deals
In mergers and acquisitions, Denmark’s Lundbeck agreed to buy
California-based Longboard Pharmaceuticals for US$ 2.6 billion. The acquisition centers
around bexicaserin, a promising phase 3 candidate for rare epilepsies including Dravet syndrome and Lennox-Gastaut syndrome, with Lundbeck projecting potential peak sales of US$ 1.5 billion to US$ 2 billion for this asset.
AbbVie acquired
Boston-based Aliada Therapeutics for US$ 1.4 billion after reportedly outbidding at least three other drugmakers. The acquisition brings innovative blood-brain barrier technology to AbbVie’s portfolio, along with ALIA-1758, a phase 1 compound showing potential as a best-in-class therapy for Alzheimer’s disease. AbbVie also partnered with EvolveImmune Therapeutics in a potential US$ 1.4 billion deal (plus US$ 65 million upfront) to develop next-generation cancer biotherapeutics. The collaboration will leverage EvolveImmune’s innovative T-cell engager platform to create multispecific biologics targeting various oncology indications.
Merck bolstered its
oncology pipeline through the acquisition of Modifi Biosciences in a deal valued up to US$ 1.3 billion. The acquisition targets
novel DNA modification therapeutics for challenging brain tumors, particularly
glioblastomas. Merck also entered into a potential US$ 1.9 billion deal with Mestag Therapeutics to explore fibroblast therapies for inflammatory diseases, leveraging Mestag’s innovative platform.
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Pfizer, Novartis, Biogen sign
molecular glue degrader deals; Astra in US$ 2 bn pact with CSPC
There
were at least three deals signed in October in the molecular glue degrader
technology space. These degraders represent a novel therapeutic approach by
facilitating the degradation of disease-causing proteins that are otherwise
difficult to target with conventional drugs. First, Pfizer partnered Triana Biomedicines in a deal potentially
exceeding US$ 1.5 billion, focusing on cancer
applications. Second, Novartis committed US$ 150 million upfront to Monte Rosa Therapeutics in a deal worth up to US$
2.25 billion. And Biogen tied up with Neomorph, pledging up to US$ 1.45 billion for neurological and
immunological applications.
Among
other deals, AstraZeneca entered into a US$ 2 billion licensing agreement with CSPC Pharmaceutical Group for a novel lipid-lowering
therapy, while Recordati acquired global
rights to Sanofi’s Enjaymo for US$ 825 million upfront, with additional
milestone payments of up to US$ 250 million. The Recordati-Sanofi deal focuses on cold
agglutinin disease (CAD), a rare autoimmune disorder, and includes rights to sutimlimab, the first and only targeted
therapy for CAD patients.
Roche demonstrated its commitment
to gene therapy advancement by expanding its collaboration with Dyno Therapeutics, committing over US$ 1 billion for adeno-associated virus (AAV) vector development, with an upfront payment of US$ 50 million. This expanded partnership builds on their initial 2020 collaboration and aims to accelerate the development of innovative gene therapies for neurological diseases.
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AbbVie wins FDA nod for subcutaneous Parkinson’s drug; Roche med okayed for breast cancer
October
marked significant advances in the treatment of several major diseases. FDA
approved AbbVie’s Vyalev for advanced Parkinson’s disease. This innovative therapy, utilizing foscarbidopa and foslevodopa prodrugs, delivers round-the-clock symptom control through
subcutaneous infusion. The treatment represents a major advancement in managing
motor fluctuations in late-stage patients, with market analysts projecting peak
sales exceeding US$ 2 billion.
In
the oncology space, a historic milestone was reached with FDA’s approval of Vyloy, the world’s first therapy targeting CLDN18.2 proteins in gastric cancer. Developed by Astellas, the drug was approved for
use in combination with chemotherapy for treating advanced gastric or
gastroesophageal junction adenocarcinoma in adults with HER2-negative,
CLDN18.2-positive tumors. This approval validates Astellas’ strategic US$ 1.4 billion acquisition of Ganymed Pharmaceuticals in 2016.
Roche
strengthened its position in breast cancer treatment with the approval of Itovebi, an oral PI3K inhibitor for
first-line treatment of advanced hormone receptor-positive, HER2-negative
breast cancer with PIK3CA mutation. This approval positions Itovebi as a strong
competitor to existing treatments like Novartis' Piqray and AstraZeneca's Truqap, with Roche projecting annual peak sales of US$ 2.3 billion.
Novartis expanded the reach of its leukemia treatment Scemblix through an accelerated approval for newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. This expansion significantly increases the eligible patient population by approximately four times, building on its existing approval as a third-line treatment.
Pfizer expanded its presence in the
respiratory syncytial virus (RSV) market as FDA broadened the approval of Abrysvo to include at
risk adults aged 18 to 50 years, making it the first and only RSV vaccine
authorized for this population. In hematology, Pfizer secured approval for Hympavzi marking its second hemophilia approval in six months. This approval follows the earlier authorization of Pfizer’s one-time gene therapy Beqvez for hemophilia B in April.
Iterum Therapeutics received FDA approval for
its new oral antibiotic, Orlynvah, designed to treat
uncomplicated urinary tract infections (uUTIs) in adult women who have limited
or no alternative oral antibacterial treatment options. This marks the first US
approval for an oral penem antibiotic.
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Gilead withdraws Trodelvy, J&J discontinues late-stage study of its bladder cancer candidate
In a notable development for bladder cancer treatment, Gilead Sciences announced the withdrawal of Trodelvy from the US market after the targeted therapy, which received accelerated FDA approval in 2021 for metastatic urothelial cancer, failed to demonstrate survival benefits in a crucial confirmatory study.
Johnson & Johnson decided to discontinue the
late-stage study of TAR-200, their investigational bladder cancer therapy,
after interim analysis showed no superior benefits compared to standard
chemo-radiation therapy.
In
neurology, Marinus Pharmaceuticals faced disappointment when their phase 3 trial of oral ganaxolone (Ztalmy) failed to meet its primary endpoint in reducing seizures associated with tuberous sclerosis complex (a genetic disorder). Marinus’ stock fell nearly 100 percent in October.
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Our view
The
last quarter was a good one for several drugmakers. Pfizer saw a surge in sales
of its Covid drug Paxlovid to US$ 2.7 billion,
encouraging it to up its guidance for Covid-related sales from US$ 8.5 billion
to US$ 10.5 billion. For BMS, blockbusters like blood
thinner Eliquis and cancer treatment Revlimid continued to bring in
revenue. Merck’s growth was driven by the world’s top-selling drug, Keytruda, which saw revenue jump 17 percent compared to Q3 2023, beating analysts’ estimates.
In a nutshell, the robust Q3 earnings of major pharma companies signals strong industry fundamentals, the volatility in pharma indices notwithstanding.
Access the Pipeline Prospector Dashboard for October 2024 Newsmakers (Free Excel)
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