Expanded label for Celgene

Expanded label for Celgene’s REVLIMID cleared in Japan

Dec 21 2015, 08:47 ET | By: Douglas W. House, SA News Editor
The Japanese Ministry of Health, Labour and Welfare approves the use of Celgene’s REVLIMID, in combination with dexamethasone, for the treatment of patients with newly diagnosed multiple myeloma (MM).REVLIMID was cleared in Japan in 2010 for patients with relapsed/refractory MM.

This seems like a fairly big deal for them to me because:

  1. Revlimid is their biggest product and revenue producer
  2. Being approved for initial treatment of multiple myeloma is obviously a MUCH bigger market than being restricted to cases that have already failed other treatments.

So even though this is Japan and not the US, I think it’s a significant win for them.



And here’s another news article on CELG the same day.

Norwegian biotech Bionor Pharma announces successful results from a mid-stage study assessing the combination of its therapeutic vaccine Vacc-4x and Celgene’s HDAC inhibitor Istodax (romidepsin) in controlling reactivated HIV and reducing latent viral reservoir in 17 HIV-infected subjects undergoing antiretroviral therapy.

Latent HIV reservoir was reduced by 40% while viral load remained below the level of detection in almost 65% of patients (n=11/17) despite reservoir reactivation.

Hey Saul,

I’m curious if you got back into this one? It started looking like a deal to me a few weeks ago and I nibbled a bit myself. Albeit a few bucks higher than today’s price but still better than over the summer where I thought it got ahead of itself.
Thanks for sharing


Hi Mike, I did, but it’s my smallest position.

Uncanny how you have a knack for these things Saul.

After the market closed this afternoon, Celgene Corporation (NASDAQ:CELG) announced that they have reached a settlement with Watson Laboratories, Inc., Natco Pharma Ltd. and Arrow International Limited regarding their recent REVLIMID patent litigation. As a part of the settlement, Celgene Corporation (NASDAQ:CELG) will allow for generic lenalidomide to enter the market prior to the April 2027 patent expiration, and has agreed to license their patents to Natco, which will allow them to sell generic lenalidomidein the U.S. starting in 2026, among other benefits. Shares of Celgene Corporation (NASDAQ:CELG) are trading up $8.86 or 7.97% in the after hours, following this news. The stock increased 0.27% or $0.3 during the last trading session, hitting $111.14. About 2.83 million shares traded hands. CELG has declined 5.14% since May 19, 2015 and is downtrending. It has underperformed the S&P500 by 2.88%.