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Re: Fred Kadiddlehopper post# 10068

Tuesday, 04/01/2025 6:15:39 PM

Tuesday, April 01, 2025 6:15:39 PM

Post# of 11392
"The multiple myeloma therapy, which brought in $11.7B net sales for J&J (JNJ) in 2024 ahead of its loss of market exclusivity in two years,..." The article is from Seeking Alpha. This may not affect Halo, though.

"Genmab (GMAB) ADRs traded lower on Tuesday after Bernstein downgraded the Danish biotech to Underperform from Market Perform, arguing that its stock has yet to fully reflect the upcoming patent cliff for the company’s blood cancer therapy Darzalex, marketed with J&J (JNJ).

The multiple myeloma therapy, which brought in $11.7B net sales for J&J (JNJ) in 2024 ahead of its loss of market exclusivity in two years, can lead to a threefold drop in GMAB’s group revenue in 2030-2040 under his base case, Bernstein analyst Justin Smith wrote.

Despite disappointing news about JNJ’s decision to opt out of HexaBody-CD38, a potential successor to Darzalex, Genmab (GMAB) shares have yet to fully discount the impact from the upcoming patent cliff, Smith added, citing his base case 2025–2029 EPS estimates for GMAB."

According to AI overview:
Darzalex (daratumumab) faces a loss of market exclusivity, with its patents expiring in 2027 in the US and 2026 in the EU, potentially leading to biosimilar competition.
Here's a more detailed breakdown:
Patent Expiration:
Darzalex's key US patents are set to expire in 2027.
The drug's patents are protected until 2026 in both the US and EU.
However, several other patents extend its exclusive protection until 2035.
Orphan Drug Exclusivity:
Darzalex has regular MP and ODE for the treatment of multiple myeloma, both of which will expire in May 2026.
Potential for Biosimilars:
The expiration of Darzalex's patents could pave the way for biosimilar versions of the drug to enter the market.
Darzalex Faspro:
Darzalex Faspro, a subcutaneous formulation of Darzalex, also has patents that are set to expire in 2035.
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