ERBITUX Approved in Japan for Colorectal Cancer
ImClone Systems Incorporated (NASDAQ: IMCL) is seeing a slight gain this morning after the company announced that ERBITUX(R) has received final marketing authorization in Japan to treat patients with advanced or metastatic colorectal cancer (mCRC).
ERBITUX will be used to treat Japanese patients with epidermal growth factor receptor (EGFR)-positive, curatively unresectable (inoperable), advanced or recurrent CRC, and has the use of ERBITUX plus irinotecan in second and further lines of mCRC. ERBITUX is now the first ever EGFR-targeted monoclonal antibody to receive marketing authorization in Japan.
Bristol-Myers Squibb (NYSE: BMY) has been Imclone’s commercialization partner. We would also note that Merck KGAA (the German Merck, not U.S.) was also in the pact that was sent in for approval back in 2007.
We have seen minimal trading so far, but as of 8:45 AM EST we have seen 1,000 shares trade and shares are indicated up over 0.5% at $41.50. Its 52-week range is $30.34 to $49.18 and it trades an average daily volume of about 1.8 million shares.
Jon Ogg
July 16, 2008
Regeneron Feels Cancer Setback (REGN)
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) has provided an update on its clinical development program for aflibercept, which includes results from a Phase 2 study in advanced ovarian cancer. The drug is under development with Sanofi-Aventis (NYSE: SNY).
Unfortunately, this study failed to meet its primary endpoint of achieving a base of 5% response based on certain criteria in two dosage strengths. These results were from an independent review committee. The higher dosage of aflibercept achieved a 4.5% response, but the lower dose generated a mere 0.9% response.
The companies are still evaluating their next steps to take in the advanced ovarian cancer indication, although this response rate is low enough that you have to wonder if the entire program for this indication will be shelved so it can concentrate on the other indications.
The companies are still evaluating aflibercept as a chemotherapy combination potential treatment in four late-stage studies to evaluate the treatment of prostate, pancreatic, colorectal, and non-small cell lung cancers.
Regeneron still has more than ample cash and liquidity to keep funding its existing trials and existing programs. With $826 million total liquidity as of last quarter (cash, equivalents, long-term investments) and total liabilities of $470 million, the company even has enough dough to look for new opportunities.
Shares of Regeneron are down 14% at $18.40 and the 52-week trading range is $13.55 to $25.25. If this was the only program and if there was less liquidity, the drop would have been far worse.
Jon Ogg
May 21, 2008