NorthWest Biotherapeutics Inc (NWBO)

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Merck makes Temodar. Merck makes Keytruda. Merck was the sponsor of the DCVax-l combo trial with Keytruda. Merck’s former employee went to work for NWBO at the same time NWBO was developing its SAP. He was there when they likely needed matches for their ECA arm, and left once the data locked and likely needed no further matches. He went back to work for Merck. The combination patent, if granted will last until 2035. The DCDirect patent applications, one granted recently, another apparently on its way, it looks like, will also last until about 2035. DCVax-l for GBM, if approved, will have 10 year market exclusivity. Flaskworks, is pumping out patents for automated closed system dendritic manufacturing. DCVax-Direct’s upcoming likely patent grant, not only selects for patient’s best DCs, it can enhance DCs manufactured from patients with otherwise inadequate DCs. Merck is the first, and perhaps only Company that has obtained approval for treating cancers with a genetic tumor trait, no matter where the tumor originated in the body. Seems like a match.

The patent office asked NWBO to choose the specific type of checkpoint inhibitor it intended to use. NWBO chose Monoclonal antibodies against programmed cell death-1 (PD-1). Keytruda is one of those. (So is Nivolumab)

See below:

In late 2019, Merck, a pharmaceutical company that manufactures Temodar (the brand name version of the drug), decided to remove the drug from its patient prescription assistance program (PAP). Pharmaceutical company PAPs allow low-income patients, or patients that are uninsured or underinsured, to receive Temodar at discounted or no cost.

Because there are now a number of generic forms of temozolomide on the market — as well as multiple ways to access prescription drugs contingent on insurance coverage and various health plans’ benefit designs — the impact of this decision on brain tumor patients is not yet fully understood. However, we do know, anecdotally, that some patients now face higher out of pocket costs and some clinician-researchers are worried about the impact on patients’ ability to participate in clinical trials.

Temodar was first approved for the treatment of certain malignant brain tumors in 1999. It was further approved to treat newly diagnosed glioblastoma, and subsequently became part of the standard of care for these patients, in 2005. It is not uncommon for companies that held the original patent on a brand name drug to make the decision to begin reducing their investment in that drug once their period(s) of market exclusivity begins to expire, as lower-cost alternatives begin to cut into sales of the brand name product. In recent years, a number of generic drug makers began producing lower-cost versions of temozolomide.

. https://blog.braintumor.org/press_releases/update-on-patient-prescription-assistance-for-temodar-temozolomide/