ImClone Systems Inc.'s drug Erbitux failed to stop lung cancer from worsening in patients with advanced disease, a setback for the company's plan to expand the market for its only product. The shares fell as much as 6.5 percent.
A 600-patient study found that Erbitux combined with chemotherapy didn't halt the progression of lung cancer better than chemotherapy alone, ImClone and its partner on the drug, Bristol-Myers Squibb Co., said today in a statement.
ImClone considers lung cancer the next opportunity for increasing the market for Erbitux, which is approved to treat colon and head and neck tumors. The New York-based company has been boosting research and development related to Erbitux since its takeover by billionaire investor Carl Icahn last October.
``Today's announcement is disappointing for ImClone, as growth opportunities for Erbitux appear in question,'' Geoffrey Meacham, an analyst with JP Morgan Securities in New York, said today in an investment note.
ImClone and its partners plan to continue evaluating Erbitux in lung cancer. Merck KGaA, ImClone's European partner, is expected to release results from a 1,100-patient lung-cancer trial, dubbed FLEX, in the first half of next year. Erbitux generated $1.1 billion in sales last year.
ImClone shares fell $1.69, or 4.7 percent, to $34.21 at 1:22 p.m. New York time in Nasdaq Stock Market composite trading, after touching $33.57.
Shares
ImClone's shares had gained 34 percent this year on optimism the company would find more uses for Erbitux. The company got an additional push from Icahn, who took control of ImClone last October, ousting the company's board and management. Icahn had criticized the board for failing to support the research needed to bolster Erbitux sales.
ImClone is also benefiting from a setback for rival Amgen Inc.'s Vectibix colon-cancer drug, which was pulled from a trial last month after results showed it might be unsafe to use in combination with chemotherapy and Genentech Inc.'s Avastin.
The latest report is the fifth released this year considered key to expanding Erbitux sales. Results have been mixed.
A study made available April 4 of 400 patients with head and neck cancer found that those given Erbitux with chemotherapy as a first-line treatment lived longer than those given chemotherapy alone. Another study, released April 16, found Erbitux, when used alone, extended the lives of colon-cancer patients who had no other treatment options.
Other Studies
In a separate colon-cancer study, Erbitux combined with chemotherapy shrank tumors and kept the disease from worsening, though it didn't improve survival.
On April 10, preliminary results from a long-awaited study in pancreatic cancer found Erbitux combined with chemotherapy failed to help patients live longer than those getting just chemotherapy. The company said it will continue studying Erbitux for this use and in other cancers.
Jim Reddoch, an analyst with Friedman Billings Ramsey & Co. in Arlington, Virginia, said he didn't have high expectations of success for the latest study in lung cancer, though he doesn't discount Erbitux's potential in treating the disease. He expects the FLEX study being conducted by German drugmaker Merck KGaA will be more definitive.
``The FLEX trial is a much bigger trial and a better designed trial,'' Reddoch said today in an interview. ``This study was underpowered and should not be considered the final arbiter in whether or not Erbitux works in lung cancer.''
Erbitux is an antibody designed to interfere with signaling agents in cancer cells that cause them to grow and divide. Erbitux targets a protein known as epidermal growth factor receptor, or EGFR, to block the signal.
Partners
ImClone co-markets Erbitux with New York-based Bristol- Myers in the U.S. and receives about 39 percent of the drug's sales through the partnership. Bristol-Myers shares rose 46 cents, or 1.5 percent, to $32.08 in New York Stock Exchange composite trading.
Shares of Merck KGaA, which co-developed Erbitux and sells it in Europe, fell 1.70 euros, or 1.7 percent, to 99.50 euros in Frankfurt.
``There are no implications for Merck following these study results today,'' Merck KGaA spokesman Gangolf Schrimpf said today in an interview. ``The study design is different, so you can't compare the two.''
source:bloomberg.com
Subscribe to:
Post Comments (Atom)
No comments:
Post a Comment