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Saturday, October 31, 2020

Merck sets ultra-high bar with development of Keytruda

  • On Thursday, Sanofi announced an agreement with Merck (NYSE:MRK) under which the latter will supply Keytruda (pembrolizumab) for a mid-stage study evaluating the PD-1 inhibitor with THOR-707, a "not-alpha" interleukin-2 (long-acting version of the immune system-stimulating protein), in a range of cancers.
  • The clinical trial collaboration is the latest addition to a long list of partnerships and studies involving pembrolizumab aimed at expanding its use. Merck's execution has been so effective that it became its top seller in Q1 2018 and accounted for almost 30% of its Q3 2020 revenues ($3,715M/12,551M).
  • In the U.S., Keytruda was first approved in September 2014 for advanced melanoma. 28 subsequent FDA nods have followed in areas like lung, head and neck, bladder, kidney, endometrial and colorectal cancer and several blood malignancies including classical Hodgkin lymphoma.
  • A search in ClinicalTrials.gov showed 1,139 active or planned clinical trials involving pembrolizumab including 137 sponsored by Merck, a subtotal that includes 73 Phase 3s and 41 Phase 2s.
  • From a humble start of $55M in Q4 2014, quarterly sales have grown at a 22.1% compounded clip since then. On a yearly basis, the CAGR has been 153.5% (2020 estimated sales of $14,585M). Even at a more modest quarterly compounded growth rate of 6% (ytd 2020), Keytruda may overtake AbbVie's Humira (adalimumab) as the world's top-selling drug in four or five quarters.
  • The company's impressive accomplishments represent a business school-caliber case study of how to successfully develop a biopharma asset.
  • https://seekingalpha.com/news/3628459-merck-sets-ulta-high-bar-impressive-development-of-keytruda

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