12:00 AM
Sep 25, 2006
 |  BioCentury  |  Finance

Ebb & Flow

Amgen (AMGN) has its PDUFA date on Thursday this week for Vectibix panitumumab to treat colorectal cancer. The bellwether last week took steps to clear the path forward for the anti-EGFR antibody by licensing a disputed patent covering EGFR antibodies plus chemotherapy from Yeda Research and Development, the licensing arm of the Weizmann Institute.

Last week's deal came as a U.S. district court ruled that scientists from the Israeli institute were the sole inventors of the IP, invalidating claims of inventorship by a predecessor of sanofi-aventis Group (Euronext:SAN; SNY), Rhone-Poulenc Rorer Inc.

Thus, now armed with the patent, AMGN may be positioned to thwart ImClone (IMCL), which had exclusively licensed the patent. IMCL previously had asserted it could seek royalties or damages from a company selling an anti-EGFR MAb in combination with chemotherapy.

Although the BLA for Vectibix was based on data from a Phase III trial as monotherapy, the antibody is also being studied in multiple ongoing Phase III trials in combination with chemotherapy for the treatment of colorectal cancer.

IMCL maintains the court decision will have no material impact on sales of its Erbitux cetuximab anti-EGFR antibody for colorectal cancer, but buysider Evan McCulloch of Franklin Templeton noted "it appears that Amgen has freedom to operate."

IMCL said it plans to appeal, but also suggested the court's decision to transfer inventorship would invalidate the patent altogether because the Yeda scientists failed to file their own patent application (see "3-Card Monte," A9).

AMGN added $1.12 to $70.89 last week while IMCL fell $1.15 to $29.62.

Soap opera

Meanwhile, financier Carl Icahn joined IMCL's board last week and the discontented shareholder didn't waste any time making his presence felt, issuing a letter in which he asked company Chairman David Kies to resign.

"Given what I consider the sorry record of the Company under your watch, it is time for you to step aside and allow someone else to be elected," Icahn said in his letter. "You have even admitted to me that the board has done a bad job."

The epistle had more bluster than bite, however. The board, which now includes Icahn and two other members that he recommended, last week reelected Kies to the chairman's job.

In an SEC filing, Kies said decisions related to IMCL's business matters "are best made by the full, elected Board, ideally in a face-to-face meeting, and not through a needlessly antagonistic and deliberately public debate that could risk harming the reputation of the Company, undermine employee morale and reduce shareholder value."

Value-added investors

Allosteric modulator specialist Addex went for more than money in last week's CHF40 million ($32 million) series C round, as it says two new corporate investors help validate its story.

New investor SR One led the round, which also included another new investor, Roche Venture Fund. Existing investors, including Sofinnova Partners, Index Ventures, TVM Capital, PolyTechnos Venture-Partners, Bio*One Capital, Renaissance PME and Varuma, also participated. SR One is the venture arm of Glaxo-SmithKline (LSE:GSK; GSK).

"Once you get to having several traditional VC investors, the incremental added value of bringing on another one might be less than bringing investors with a different point of view," CFO Tim Dyer told Ebb & Flow. "SR One and Roche obviously want to make money on their investment, but they also are looking for companies that could be of strategic interest to their pharmaceutical parent companies."

Thus, said Dyer, "we believe that corporate investors bring additional pharma industry validation to our story, in addition to our partnership with Johnson & Johnson."

Addex does not have a deal with either GSK or Roche (SWX:ROCZ). Under a 2005...

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