ImmunoGen Takes Two Hits To Pipeline Promise
By: Hollister H. Hovey, Of DOW JONES NEWSWIRES
NEW YORK -(Dow Jones)- ImmunoGen Inc. officials are placing the burden of explaining the road blocks in trials of two potential cancer drugs on the company's developmental partners.
ImmunoGen Chief Executive Mitchel Sayare said officials from GlaxoSmithKline PLC called the company on Thursday night to tell him Glaxo won't move on to a Phase II trial for cancer-cell-receptor target cantuzumab mertansine under the present terms of the companies' license agreement.
"We heard from (Glaxo) that they have decided they don't want to go forward under the current agreement," Sayare reiterated on a midday conference call Monday with analysts and investors. "The 'why?' has to do with their assessment of this product."
The product, cantuzumab mertansine, is aimed at reducing pancreatic, colorectal and non-small-cell lung tumors. It "was the most advanced of the company's out-licensed products," First Albany Corp. analyst David Webber said.
Then on Friday, ImmunoGen received another disappointing call from a partner, this time from Genentech Inc. . Genentech said it plans to conduct additional preclinical research on another cancer drug, Trastuzumab-DM1, to enable development of an appropriate clinical plan for the product, Sayare said. Trastuzumab-DM1, like cantuzumab mertansine, is a tumor-activated prodrug.
"The Genentech news was significant because the other set of milestones that investors would've been looking for this year is the advance of three drugs into human testing," Webber said. "One of them was supposed to be the Genentech drug. They don't have a new timeline, but it seems unlikely that they'll get it into human testing this year."
As with any molecule, it's necessary to conduct numerous preclinical studies, said Genentech spokeswoman Page Sargisson. "We want to understand the full profile of the molecule," she said. "We want to conduct further studies before making any decisions on timelines."
But reasons for Glaxo's actions remain unclear.
The double whammy sent investors reeling, sending ImmunoGen stock down almost 46% Monday.
While ImmunoGen held the conference call to explain a Monday morning press release that contained the news, Sayare passed the buck onto Glaxo and Genentech, citing confidentiality agreements between ImmunoGen and its partners.
Officials from Glaxo didn't immediately return phone calls seeking comment.
ImmunoGen plans to renegotiate the agreement with GlaxoSmithKline. But if the company finds it is not in its best interest to enter into a revised agreement with GlaxoSmithKline, ImmunoGen said it will get back the rights to cantuzumab mertansine so it can develop and relicense the product as appropriate.
"We need to do what is best with our company and that may not be staying with (Glaxo)," he said. "We're prepared to move forward without them if that is the right path for us."
In November, ImmunoGen and GlaxoSmithKline reported "very favorable" safety data from a 27-patient human clinical trial of cantuzumab mertansine, which included anti-tumor activity in several patients. At that time, ImmunoGen and Genentech reported that Trastuzumab-DM1 caused complete tumor regression in HER2 positive xenograft models in mice.
However, Glaxo's actions show that "in many ways the technology is being questioned here," S.G. Cowan analyst Yaron Werber said. "You wre buying the stock before on specualtion that Glaxo would take (the drug) to Phase II trials and that Genentech would take its drug to clinical trials. Certainly this represents a setback in the validation of the paltform."
In 1999, ImmunoGen and GlaxoSmithKline formed an agreement in which the British pharmaceutical company was to assume full responsibilities for cantuzumab mertansine and get marketing rights after Phase I of the trials. The spokeswoman said ImmunoGen was to receive $41.5 million for upfront and milestone payments, as well as royalties in sales.
To date, Sayare said, ImmunoGen received $11.5 million of the $41.5 million. When the companies signed the agreement in 1999, GlaxoSmithKline acquired a $2.5 million equity stake in ImmunoGen.
The shares have hit a new 52-week low of $2.00, burrowing beneath the last low point of $3.52, hit on June 4 . |
