Through much of 2023, markets remained volatile, with pharma indices managing to inch up only in some months. November bucked the trend — the Nasdaq Biotechnology Index (NBI) rose by 4 percent at 3,902.97 after an 8 percent drop in October. The SPDR S&P Biotech ETF index (XBI) spiked 12 percent to 75.52, compared to a drop of 12 percent in October. And the S&P Biotechnology Select Industry Index (SPSIBI) gained 12 percent to 5,882.09 after plunging 9 percent in October.The indices mirrored the bullish activity witnessed in the US stock markets, with the S&P 500 rebounding 8.92 percent in November. Importantly, healthcare stocks outperformed all 11 major sectors of the S&P 500.The month witnessed another significant deal in the
antibody-drug conjugates (ADCs) space after Pfizer acquired Seagen in March for US$ 43 billion. As November drew to a close, AbbVie picked up ImmunoGen for US$ 10.1 billion, including its first-in-class
ADC, Elahere, approved for platinum-resistant
ovarian cancer (wherein patients relapse within six months of receiving platinum-based
chemotherapy). ADCs are
fast-growing, innovative biopharmaceutical products that target cancer cells, while protecting the healthy cells.In other big
news, the United Kingdom became the first country to grant regulatory approval to a
medical treatment involving the revolutionary CRISPR gene editing tool. And the
month also saw several drugmakers announce their third quarter (Q3) results.Access the Pipeline Prospector Dashboard for November 2023 Newsmakers (Free Excel) Astra
joins obesity med jamboree with Eccogene deal; Lilly, Novo ride GLP-1 waveNovember was a good month for Eli Lilly (stock up by 7 percent) as both
the US Food and Drug Administration (FDA) and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) approved its weight-loss injection
Zepbound (tirzepatide). Moreover, the drugmaker’s Q3 revenue increased by an impressive 37 percent, driven by the growth of its GLP-1 diabetes treatment
Mounjaro (tirzepatide) and breast cancer drug Verzenio (abemaciclib).The other drugmaker that rode on the popularity of GLP-1
meds is Novo Nordisk (up by 4 percent). The Danish
drugmaker posted a rise in sales of 29 percent in the first nine months of 2023.
Its diabetes and obesity care meds saw a gain of 36 percent, bringing in DKK
153.8 billion (US$ 20.6 billion) for Novo in the first nine months of 2023. Out
of this, the GLP-1 meds (Saxenda, Ozempic, Rybelsus, Wegovy) contributed DKK 30.4 billion (or US$ 4.1 billion). The company also plans to expand its manufacturing
capacities with an investment of over DKK 42 billion (US$ 6 billion) in Kalundborg
(Denmark), and an additional investment of DKK 16 billion (US$ 2.3 billion) at its
Chartres (France) facility to capitalize on the burgeoning market for weight
loss drugs. Its weight loss med Wegovy has also shown heart protection benefits in a phase 3 trial.Not wanting to
miss out on the bourgeoning market for weight loss drugs (estimated to reach an
annual market size of US$ 100 billion by
2030), AstraZeneca (up by 2 percent) has entered into an
exclusive license agreement worth US$ 2 billion with Chinese biopharma Eccogene for its investigational treatment
ECC5004 for obesity, type-2 diabetes, and other cardio-metabolic conditions.
The company has reported a 5 percent rise in its Q3 revenues (at US$ 11 billion), fueled by good performances in oncology, cardiovascular renal management, and rare diseases.Access the Pipeline Prospector Dashboard for November 2023 Newsmakers (Free Excel) GSK’s RSV jab nears US$ 1 bn in sales; Novartis, Sanofi post positive
trial updatesLaunched in early
May 2023, GSK’s (stock up by 3 percent) RSV vaccine, Arexvy, has made an impressive debut. GSK’s Q3 results show that its total sales increased by 10 percent, fueled by a 33 percent surge in vaccine sales. This includes £0.8 billion (US$ 0.97 billion) from sales of its shingles vaccine (Shingrix) and £0.7 billion (US$ 0.85 billion) from sales of Arexvy. In its first year of launch, Arexvy sales are poised to cross £1 billion (US$ 1.26 billion).In crucial phase 3 trials, Novartis’ (up by 4 percent) highly selective, oral Bruton’s tyrosine kinase (BTK) inhibitor remibrutinib showed clinically significant results in treating chronic spontaneous urticaria (CSU). Currently, H1-antihistamines are the only recourse for people plagued by chronic hives.Sanofi (up by 2 percent) also made
trial gains as its blockbuster drug Dupixent (dupilumab) showed “overwhelming positive efficacy” in a second, large phase 3 trial undertaken to test it as a cure for chronic obstructive pulmonary disease (COPD). Sanofi now plans to seek FDA approval to expand its
use for COPD. If approved, Dupixent will be the first biologic to treat the
disease.Access the Pipeline Prospector Dashboard for November 2023 Newsmakers (Free Excel) UK okays CRISPR therapy for thalassemia, Madrigal’s NASH drug posts trial gainsIn a world first, the UK’s MHRA has given the go-ahead for
CRISPR Therapeutics (up by 61 percent) and Vertex Pharmaceuticals’ (down by 4 percent) gene therapy Casgevy for patients aged 12 and above to cure the genetic conditions — β-thalassemia and sickle-cell disease (SCD). This renders it the first treatment ever that uses the gene-editing tool CRISPR, whose inventors won the 2020 Nobel Prize.Large-cap Alnylam (up by 8 percent) achieved
robust Q3 commercial results, reporting US$ 313 million in revenue, driven by the successful launch of Amvuttra, a rare heart disease drug.Mid-cap Madrigal (up by 53 percent) announced
positive data from a late-stage trial demonstrating broad treatment
effects of resmetirom on nonalcoholic steatohepatitis (NASH) with liver fibrosis. It is the only investigational therapy for NASH that has achieved both fibrosis improvement and NASH resolution primary endpoints in a phase 3 trial. Among small-cap companies, FDA approved SpringWorks Therapeutics’ (up
by 42 percent) Ogsiveo (nirogacestat) for adults suffering from rare
desmoid tumors, rendering it the first approved treatment for
the non-cancerous condition.Among losers, Bayer (down by 22 percent) scrapped a significant late-stage trial assessing the efficacy
of a new anti-clotting drug, asundexian, compared to Eliquis (apixaban) in patients with atrial fibrillation at risk of a stroke. The drugmaker had hoped asundexian would generate revenues in excess of €5 billion (US$ 5.5 billion) and compensate for the drop in revenues of its blood thinner Xarelto, set to lose protection from key
European patents in 2026. Bayer
also voluntarily recalled a single lot of
its cancer drug Vitrakvi due to microbial contamination.Access the Pipeline Prospector Dashboard for November 2023 Newsmakers (Free Excel) Our
viewIn the US, the Federal Reserve left interest rates unchanged in its meeting in November. This has raised
investor expectations, and hopes of inflation cooling down this winter.However, given the rise in bankruptcy filings,
layoffs, weaker availability of finance to small and medium-sized businesses
and larger concerns of a slowdown in the global economy, we would exercise
caution before putting inflationary and other economic concerns to rest.Access the Pipeline Prospector Dashboard for November 2023 Newsmakers (Free Excel)
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