By Kim Coghill
Immunex Corp. Friday said the FDA approved Novantrone as the first therapy for secondary progressive multiple sclerosis.
Novantrone now can be used for reducing neurologic disability and the frequency of clinical relapses in patients with secondary progressive, progressive relapsing or worsening relapsing-remitting MS.
"For patients who don't have their disease adequately controlled and are worsening and need new hope, this is good news," said Tim Warner, director of corporate communications for Seattle-based Immunex. "The 140,000-plus patients who fall into this category had nothing before Novantrone was approved today."
Immunex will launch Novantrone immediately. The company's 100-member sales force will begin selling to health care workers in the neurology and MS fields, Warner said.
The company's stock (NASDAQ:IMNX) closed Friday at $42, up $4.375, or 12 percent.
Fariba Ghodsian, managing director of Roth Capital Partners in Los Angeles, said the company's stock remains neutral. "I think the price is reasonably valued given the recent warnings from the European regulatory agencies and in the U.S. on side effects of Enbrel."
Immunex issued a warning last week advising prescribers to use caution in considering the use of Enbrel in patients with pre-existing or recent-onset central nervous system demyelinating disorders. Enbrel, the company's flagship product, is indicated for rheumatoid arthritis.
"The stock pretty much already included FDA approval," Ghodsian said. "They received panel recommendation a few months ago and typically the FDA follows the panel. It was very much anticipated that they would get final approval."
Novantrone has been on the market in the U.S. since 1987 for the treatment of acute myelogenous leukemia. In 1997, the company received approval to expand the label to include the treatment of the pain associated with prostate cancer. Because the drug suppresses the activity of T cells, B cells and macrophages, Immunex began exploring the drug's utility in controlling MS. (See BioWorld Today, Jan. 31, 2000.)
The company filed for expanded labeling for Novantrone for the treatment of patients with worsening MS in June 1999 and it was unanimously recommended for approval by the FDA's Peripheral and Central Nervous System Drugs Advisory Panel in January. (See BioWorld Today, Jan. 31, 2000.)
Warner said there are other drugs on the market that are commonly used for MS, but none of them is labeled for the secondary stage.
"Using this drug, patients will find themselves in more control and more able to have an improved quality of life," he said. "These are patients who are walking with a cane or in a wheelchair or having trouble with vision or motion. The patients in our studies have improved symptoms and more ability to control their motor functions and have an improved quality of life."
MS is a chronic, debilitating autoimmune disease affecting the central nervous system that can take different forms. As many as 350,000 people in the U.S. suffer from MS. The severity of the disease ranges from a relapsing-remitting form, characterized by episodes of disability followed by relatively normal functioning, to a relentlessly progressive disability. Half of all people diagnosed with relapsing-remitting MS will see their disease progress to secondary progressive MS within 10 years.
The FDA approval followed a 24-month Phase III clinical trial in which Novantrone, at a dose of 12 mg/m2, was administered by short IV infusion once every three months. The trial demonstrated that Novantrone had a statistically significant impact on prolonging time to first treated relapse and on delaying disability progression in patients with secondary progressive or progressive relapsing MS. There also was a significant reduction in the mean number of treated relapses. There was a significant reduction in the number of Novantrone patients who had new MS lesions seen on magnetic resonance imaging.
Warner said patients treated with Novantrone may develop serious heart problems and thus should be regularly tested for their heart's ability to pump blood. He said because of this, there is a limit on the total lifetime amount a person can consume.
According to a prepared statement by Immunex, the total amount is about eight to 12 doses over two to three years. The company also warns that patients and their doctors should carefully keep track of how much Novantrone is administered. The drug also can increase the potential for infection, and pregnant women or women who are trying to conceive or breastfeeding should not take the drug.