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The Big Winner With Johnson & Johnson's Recent FDA Approval

By Keith Speights and Brian Orelli, PhD – Jul 23, 2021 at 6:12AM

Key Points

  • The FDA recently approved a subcutaneous version of J&J's blood cancer drug Darzalex.
  • This approval probably won't significantly impact J&J overall due to the company's size and potential cannibalization of sales from the current version of Darzalex.
  • J&J's small partner that contributed key technology for the new Darzalex version could be the big winner.

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J&J's smaller partner could benefit in a big way from the approval of a new version of blood cancer drug Darzalex.

Johnson & Johnson (JNJ 0.61%) already has a blockbuster winner with blood cancer drug Darzalex. The healthcare giant recently picked up a U.S. Food and Drug Administration (FDA) approval for a subcutaneous version of the drug that's more convenient to administer. In this Motley Fool Live video recorded on July 14, Motley Fool contributors Keith Speights and Brian Orelli talk about this approval and the company that could really be the big winner as a result of it.

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Keith Speights: Johnson & Johnson also had some pretty good news recently that was not related to COVID-19. The company received FDA approval for Darzalex Faspro as a second-line treatment of multiple myeloma. Brian, what does this regulatory win mean for Johnson & Johnson?

Brian Orelli: Darzalex Faspro is the subcutaneous version of Darzalex. The original drug is delivered via infusion and now this one can be just injected. The original version is already approved in second-line multiple myeloma.

It's much more convenient obviously for patients to get a shot versus sitting, hooked up to an infusion machine for hours. But I'm not sure it's really going to convince doctors and their patients to go with Darzalex Faspro if they were going to go with Darzalex versus some other drug just because of the convenience. Most patients and doctors are going to pick whatever the best treatment is available, the one that they think will most likely prolong life.

The fact that you can get injected versus sitting, connected to a machine for a few hours, I think most people would take the connected machine for few hours if they thought that was the best treatment. The big winner here could be Halozyme, (HALO 2.41%), I think the ticker there's HALO, which contributed this technology that allows the drug to be given via an injection, Halozyme gets tiered double-digit royalties on sales of Darzalex Faspro. I haven't seen the details about the tier levels for the royalties.

A lot of times those aren't disclosed, but you can imagine that they're getting this approval, can potentially move into the next tier and get a higher royalty, which would obviously benefit the company quite a bit as well as just the added sales will create some royalty for them.

Speights: Yeah. Brian, I'm glad you mentioned the potential impact for Halozyme because as we've said Johnson & Johnson is so big that there's not much good or bad that's going to move the needle for this company all that much.

Even a positive FDA decision like this just isn't going to be huge for Johnson & Johnson, but it could be huge for a smaller company. Again, I'm not familiar with the details of their financial arrangement, but obviously, Halozyme is a lot smaller than Johnson & Johnson. Good news for Halozyme is going to be more likely to move the needle than it would for Johnson & Johnson.

Orelli: Yeah. I think Darzalex is a multi-billion-dollar drug, so it's a pretty big drug for Johnson & Johnson. But I think it's probably mostly just going to shift patients from Darzalex to Darzalex Faspro and that won't absolutely create the much of benefit for Johnson & Johnson.

Speights: Yeah, some cannibalization of sales for the current version of the drug.

Keith Speights has no position in any of the stocks mentioned. The Motley Fool recommends Johnson & Johnson. The Motley Fool has a disclosure policy.

Stocks Mentioned

Johnson & Johnson Stock Quote
Johnson & Johnson
JNJ
$177.17 (0.61%) $1.07
Halozyme Therapeutics Stock Quote
Halozyme Therapeutics
HALO
$57.74 (2.41%) $1.36

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