NEW YORK, Apr 24 (Reuters Health) - An inhaleable version of Biogen's interferon beta-1a (Avonex) formulated using Inhale Therapeutic Systems' inhaleable powder technology is entering phase I clinical trials, San Carlos, California-based Inhale Therapeutics announced this week.
Boston-based Biogen will cover research and development costs for the new form of the drug, Inhale said. Biogen also will pay the company for the drug powder and inhalers used in the delivery system and will grant the firm royalties once the product is launched, Inhale reported.
Avonex, which has been shown in clinical trials to slow the progression of physical disability and decrease the frequency of clinical exacerbation in relapsing forms of multiple sclerosis, is currently available only in an intramuscular injectable form.
In addition to providing a painless alternative for existing users of injectable Avonex, an inhaleable drug would likely help to grow the market for MS drugs. The New York City chapter of the National Multiple Sclerosis Society estimates that only about 64% of people with relapsing or remitting MS who might be helped by drug therapy are receiving treatment.
"Many people who could be on the drugs aren't on them, because they just won't inject them.... An inhaleable version would probably increase the number of people willing to try them," a spokesperson for the organization told Reuters Health.
Other marketed drugs with indications similar to those for Avonex, such as Berlex Laboratories' Betaseron (interferon beta-1b) and Teva Pharmaceutical Industries' Copaxone (glatiramer), also must be injected intramuscularly.
Because the drugs are designed for people in the early stages of MS, some patients find the discomfort of injections more unpleasant than the symptoms of the disease itself and opt out of the therapy, the MS society spokesperson said. The injections "can be painful and can cause some bruising," she noted.
"Of course, there are reasons other than the injections that people don't use the drugs," she noted, pointing to side effects, including flu-like symptoms, that can occur with the therapies.
Inhale estimates that approximately 86,000 patients are now on Avonex therapy worldwide. Sales reached $621 million in 1999, up 55% over 1998, the company said.
Inhale is using its Inhance drug delivery platform technology to formulate the new version of Avonex. The technology "combines innovations in powder technology and inhaling devices" to allow large molecule drugs to be inhaled into the deep lung and absorbed into the bloodstream, the company explained.
As previously reported by Reuters Health, Inhance technology is also
being used for an inhaleable insulin product, currently in phase II trials,
which will be marketed by Pfizer.