Biopharma Week in Review
We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&A. Eli Lilly and Company (LLY) received FDA approval for donanemab (Kisunla) in early Alzheimer’s, which was largely expected following unanimous support from the June AdComm and multiple delays. The cost of Kisunla is $32K/year, which is at a premium to Leqembi (Biogen, Inc. [BIIB]/Eisai Co. Ltd. [ESAIY]) at $26.5K/year, but total cost per patient should be lower for Kisunla, as treatment can be stopped with amyloid clearance. Kisunla has a dosing advantage (Q4W versus Q2W) and showed better efficacy, but Leqembi had better safety, with lower ARIA rates. Both require IV infusions, which pose logistical issues. Novo Nordisk A/S (NVO) and Eli Lilly and Company (LLY) faced criticism for high prices of their obesity drugs in an op-ed co-authored by President Biden and Senator Sanders. Political headline risk is nothing new for the biopharma industry, but passing broad drug pricing reform has been challenging for the government. The obesity drugmakers saw added pressure from a JAMA published study showing potentially higher risk (4-8x) for a rare vision loss condition, NAION, with semaglutide (Ozempic/Wegovy). LLY was up 1% and NVO was flat last week. Roche Holding AG (RHHBY) will halt tiragolumab (anti-TIGIT) Phase 2/3 SKYSCRAPER-06 study in 1L nSq NSCLC due to worse outcomes in primary PFS (HR=1.27) and interim OS (HR= 1.33) analyses versus the comparator group. This latest tira dataset continues the rollercoaster for TIGIT developers, which have seen two prior tira Phase 3 failures (SKY-01 and -02) and one success (SKY-08). Final OS data for SKY-01 is expected in 2H24, which may change sentiment for TIGIT again. TIGIT competitors include MRK, GILD/RCUS, AZN/CGEN, MREO, and ITOS. RHHBY was down 2% on Friday. Longboard Pharmaceuticals, Inc. (LBPH) received FDA Breakthrough Therapy designation for bexicaserin (LP352) in seizures associated with developmental and epileptic encephalopathies (DEE). Breakthrough designation typically enables an accelerated development and regulatory path for highly promising drugs in serious, underserved diseases. LBPH was up 14% last Monday. NRSN, PCRX, ARDX, and RNAC news on page 2.
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