By Brady Huggett
IDEC Pharmaceuticals Corp. said it can quickly address the issues brought up in the FDA¿s complete review letter concerning IDEC¿s biologics license application for Zevalin, and can do so without further trials.
The company released the news after the market closed Thursday.
¿We believe we can give a complete and comprehensive reply to the matter and do so by mid-July of this year,¿ William Rohn, chief operating officer of IDEC, said in a phone conference and webcast. ¿[The letter] does not request any new clinical trials prior to completion of review. Our dialogue has been positive and productive, and I would characterize their letter in the same light: positive and productive.¿
The FDA requested data in two areas: clinical and chemistry, manufacturing and controls. The chemistry data request is typical, said Elise Wang, an analyst for Salomon Smith Barney International, of New York, and the clinical data is for safety reasons.
¿They wanted imaging data as part of the step behind this therapy ¿ imaging for tumor location and identification of patients that might be at a safety risk,¿ Wang said. ¿The chemistry and manufacturing control information, I think that is fairly standard.¿
Although the request sets IDEC back slightly, Wang said the news wouldn¿t affect the product¿s status too significantly.
¿It does not change our perspective,¿ she said. ¿We anticipate the launch in the first half of next year.¿
Rohn shied away from making any predictions on an approval date, but drove home the point that IDEC would not need to go back to the clinic.
¿Generally, we would characterize it as a safety issue and one of managing patients,¿ he said. ¿They are not asking for any further studies on growth factor. The post-approval study was the only one mentioned, and we are not required to do that before approval.¿
IDEC submitted a biologics license application for Zevalin in early November for the treatment of low-grade, or follicular, relapsed or refractory CD20-positive B-cell non-Hodgkin¿s lymphoma (NHL) and rituximab-refractory follicular NHL. (See BioWorld Today, Nov. 2, 2000.)
Zevalin is a mouse monoclonal antibody targeted against the CD20 antigen found on normal mature B cells and cancerous B cells and is conjugated to a yttrium-90 radioisotope. It¿s administered with Rituxan, IDEC¿s nonradiolabeled chimeric antibody against CD20.
The product is partnered with Schering AG, of Berlin, outside the United States, but IDEC retained rights in the U.S. The deal was estimated to be worth about $47 million to IDEC, including an up-front payment of $13 million, $15 million in development funding and $19.5 million hinged on milestones. As of March 31, IDEC had about $635.9 million in cash, cash equivalents and securities available for sale.
Rituxan is co-marketed in the United States with Genentech Inc., of South San Francisco. It had net sales in the United States of $168 million in the first quarter of 2001, up from $78 million over the same period in 2000.
The company raised $472.7 million through a public offering about two weeks after filing its BLA. It has about 143.4 million shares outstanding. It posted $56.5 million in total revenues for the first quarter of 2001, compared to $27 million for the first quarter of 2001. It had a net income of $20.8 million, or 12 cents per share in 2001¿s first quarter, compared to a net loss of $4.3 million, or 3 cents per share over the same period in 2000.
Rohn said the company would sell the product in two kits ¿ one for imaging and one for therapy. The company has not set a price for the kits but they will be sold separately to allow easier billing in hospitals. But, he said, the FDA has done its part and now the burden of action sits on IDEC¿s shoulders.
¿We have a roadmap of the steps necessary to achieve our goal of Zevalin approval,¿ he said. ¿The task is now with us to respond quickly and comprehensively.¿
IDEC¿s stock (NASDAQ:IDPH) fell $1.38 Thursday before the announcement to close at $52.81.