Replies to post #250742 on Biotech Values

[DewDiligence]

The FDA moved BMY’s PDUFA date for subcutaneous Opdivo two months earlier in what is apparently a correction of a clerical error by the FDA. The new PDUFA date is 12/29/24 rather than 2/28/25.

Explanation: By treating BMY’s filing as an sBLA rather than an original BLA, an FDA standard review is 10 months rather than 12 months. In an sBLA—but not an original BLA—the approximately 2 months from the applicant’s submission to the FDA’s acceptance of the submission is counted as part of the total 10-month review period. The rationale for this review being an sBLA (rather than an original BLA) is that the FDA previously approved both Opdivo and HALO’s hyaluronidase excipient.

https://news.bms.com/news/corporate-financial/2024/Bristol-Myers-Squibb-Announces-Updated-Action-Date-by-the-U.S.-Food-and-Drug-Administration-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx (5/21/24 PR)

https://news.bms.com/news/corporate-financial/2024/U.S.-Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-Application-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx (5/6/24 PR)

[DewDiligence]

HALO sues MRK for patent infringement wrt subcutaneous Keytruda:

https://www.prnewswire.com/news-releases/halozyme-sues-merck-for-patent-infringement-over-subcutaneous-keytruda-formulation-302437331.html

Halozyme believes the subcutaneous formulation of Merck's cancer medicine, Keytruda, infringes multiple patents that Halozyme filed beginning in 2011 to protect its groundbreaking MDASE subcutaneous delivery technology. Subcutaneous (SC) Keytruda has completed phase 3 clinical testing and Merck has publicly commented on its intention to launch the SC product in 2025. Merck has used Halozyme's technology to develop SC Keytruda without Halozyme's permission.

… None of the MDASE patent rights which Halozyme is seeking to enforce in this suit relate to the Company's ENHANZE licensing program. The MDASE patents are not licensed to any of Halozyme's licensees. Therefore, the outcome of this dispute will not impact ENHANZE, the ability of any licensee to use ENHANZE, or revenues Halozyme receives from ENHANZE licensees.