Halozyme pushes to add Merck to its subQ partners
With subcutaneously delivered anti-PD-(L)1 MAbs gaining importance, the coming days could see a major development: Halozyme is to respond to Merck & Co's request to invalidate seven patents covering Halozyme's modified hyaluronidase technology, Mdase. Halozyme claims that its Mdase patents are infringed by Merck's MK-3475A, a SC Keytruda formulation based on modified hyaluronidase technology licensed from Alteogen. Halozyme's chief executive, Helen Torley, revealed at last week's TD Cowen conference that her preferred outcome would be for Merck simply to sign a licence to this IP, but added: "We stand ready and able to take appropriate steps to defend our IP, including lawsuits." After failing with a first-generation tech Merck went to Alteogen for a modified hyaluronidase, and the issue of its IP is hotting up: MK-3475A has now been filed in the US and the EU, with first launches expected this year, Merck revealed at TD Cowen. Still, analysts say the Mdase patents are unusually broad, claiming 95% sequence identity and potentially covering "trillions" of modified hyaluronidases. Evercore ISI's Umer Raffat cites Merck paying a 1% royalty on MK-3475A as a possible outcome, representing a modest amount to the big pharma but a major windfall for Halozyme.
Who is using whose SC technology?
| SC technology | Used by | Status |
|---|---|---|
| Truncated hyaluronidase | ||
| Halozyme's Enhanze (rHyPH20) | Roche for Tecentriq Hybreza (SC atezolizumab) | Approved in US & EU, based on Imscin-001 |
| Bristol Myers Squibb for Opdivo Qvantig (SC nivolumab) | Approved in US, filed in EU, based on Checkmate-67T | |
| Modified hyaluronidase | ||
| Alteogen’s Hybrozyme (berahyaluronidase alfa/ ALT-B4) | Merck & Co’s MK-3475A (SC pembrolizumab) | Filed in US & EU, based on Keynote-D77 |
| Halozyme's Mdase | N/A | Halozyme claims Alteogen’s tech infringes its patents, and has approached Merck requesting payment of a royalty; Merck wants USPTO to invalidate 7 patents, and Halozyme is to issue a formal response to this claim |
| Other | ||
| N/A | Pfizer’s sasanlimab | Being filed after success in Crest trial in non-muscle invasive bladder cancer |
| Undisclosed non-hyaluronidase | Merck & Co’s 1st-gen SC pembrolizumab | Abandoned despite success in Keynote-A86 |
| Undisclosed | AstraZeneca’s SC durvalumab | Abandoned after being tested in ph1 Scope-D1 trial |
Source: OncologyPipeline & company disclosures.
542
