Eyes on Clinical Trial Data, Supply Upgrades, and Patent Litigation

The news this week was full of "Ups-n-Downs." We've had eyes on many and thought we'd share a few here. What surprises did you see with clinical trial data results, M&A, Patent litigation, or more?

➕ Regeneron and Sanofi score in their second phase 3 study with Dupixent, the first monoclonal antibody treatment for COPD with type 2 inflammation in more than a decade. In the US only, nearly 300 000 patients are being treated for this potentially fatal condition.

The study, known as NOTUS, demonstrated a 34% reduction in COPD patient exacerbations that needed additional treatment, compared to placebo (p-value of 0.0002). Dupixent induced an improvement of lung function with an average of 139 mL from baseline at week 12, compared to 57mL in the placebo (p-value of 0.0001), which was sustained throughout the 52 weeks. The rate of adverse events, such as headache, COVID-19, and nasopharyngitis, were 67% for Dupixent and 66% for the placebo group.

Regeneron and Sanofi plan an end-of-the-year FDA submission together with results from the phase 3 BOREAS trial, which paved the way for Dupixent’s classification as a breakthrough therapy. Dupixent is currently being reviewed by EMA’ as a therapy for COPD patients with type 2 inflammation.

Itepekimab, an IL-33 inhibitor, is next in line for Regeneron and Sanofi’s COPD pipeline, due for a readout in 2025. Unlike Dupixent, IL-4, and IL-13 inhibitors, itepekimab inhibits IL-33 pathways, targeting former smokers who make up 70% of the COPD population. Read more here and here.

➖ Bayer’s asundexian trial OCEANIC-AF failed due to inferior efficacy last week, followed by a second setback as a Missouri jury ordered Bayer to pay out $1.56 billion over claims that their weedkiller Roundup caused cancer. Bill Anderson, Bayer’s CEO, claims its strategic options remain intact but may possibly become a little tighter. As a result, Bayer’s share price fell 17.5% at the beginning of this week.

The blood thinner Asundexian (factor Xia inhibitor) no longer poses a threat to Pfizer and Bristol Myers Squibb’s Eliquis for stroke prevention in patients with atrial Fibrillation. Bayer does plan to continue development in stroke prevention in patients >65 – though it is a smaller opportunity. Those two events, coupled with Xarelto’s upcoming loss of exclusivity, are a meaningful negative to the company, as Bayer continues to drive efforts in new drug development to aid recovery. Read more here and here.

🏢 Two new Sandoz antibiotic and biosimilar facilities opened recently to satisfy EU demand for the supply and development of antimicrobial resistance medicines: Kundl in Austria, for the production of penicillin and a center for biosimilar development in Holzkirchen, Germany. Sandoz received a EUR 50m grant from the Austrian federal government as an additional financial contribution for the development, for a final investment of EUR 150m for the company’s new facilities. An additional investment of EUR 25m has been made by Sandoz in Germany to realize its vision of becoming a global hub for the development of biosimilars.

The beginning of 2023 saw increased drug shortages across Europe due to high rates of respiratory infections, together with an ongoing production insufficiency. Antimicrobial resistance is one of the top global public health threats, and penicillin still dominates the treatment. Read more here and here.

⚖️ The EPO ruled Moderna’s European COVID-19 vaccine patent invalid. The patent listed in the European Patent Register protects ‘respiratory virus vaccines. The listing notes the following opposers to the patents: BioNTech, Pfizer, and Sanofi.

Moderna is currently seeking compensation from BioNTech and Pfizer for infringement on this patent, but BioNTech states Moderna’s insufficiency in all 100 auxiliary requests failed to keep the patent in an amended form. This victory for BioNTech will come under fire as Moderna appeals the ruling. Read more here, here, and here.

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