MN-166
Posted: Wed Jun 27, 2007 5:38 pm
MediciNova Announces New Strategic Initiative
SAN DIEGO, June 26, 2007 (PRIME NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company that is publicly traded on the Nasdaq Global Market (Nasdaq:MNOV) and the Hercules Market of the Osaka Securities Exchange (Code Number: 4875), today announced that based on recent clinical successes and evaluation of market opportunities, it will focus its resources on development and commercialization of two key assets in its development pipeline, MN-221 and MN-166. MediciNova believes that MN-221, now in Phase IIa clinical testing, has the potential to become the new standard of care for the treatment of severe, acute exacerbations of asthma (status asthmaticus) in emergency facility settings. Data from the Phase IIa trial is expected during the fourth quarter of 2007. MN-166, an oral treatment for multiple sclerosis, demonstrated positive clinical benefits and a superior safety profile after one year of treatment in a two-year randomized, double-blind, placebo-controlled Phase II trial in 297 relapsing multiple sclerosis patients.
Adhering to its strategy to focus investment on key assets such as MN-221 and MN-166, and in order to bring these assets substantially forward towards commercialization, MediciNova will limit its expenditures on other development programs to only those activities necessary to maximize each asset's value, while aggressively pursuing a variety of initiatives to monetize these development programs. As part of this strategy, MediciNova will discontinue development of MN-001 in its current immediate-release formulation. As such, the current Phase III trial of MN-001 in bronchial asthma patients will be stopped. To date, approximately 200 patients have been enrolled in that trial with no reported serious adverse events. The formulation currently being tested requires a multiple dosing per day schedule. Market and competitive analyses point to the desire for a once-a-day therapy for bronchial asthma and, thus, MediciNova will continue its work on developing a once-a-day preparation of MN-001. MediciNova anticipates that this reallocation of resources will provide substantial cash savings over the next 12 months.
"MediciNova's strategy has always been to select and develop product candidates that fill an unmet medical need and offer competitive market advantages. To that end, we have built an attractive pipeline that provides us with multiple opportunities from which to realize value," said Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova, Inc. "In focusing our resources, we are in the enviable position to dedicate investment to two commercially attractive development candidates that we can potentially commercialize on our own with a small, focused sales force, while we simultaneously continue efforts to monetize the remainder of our pipeline through business development initiatives, including potential partnering opportunities. We believe this new strategy will provide even greater value in the realization of our key clinical assets."
SAN DIEGO, June 26, 2007 (PRIME NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company that is publicly traded on the Nasdaq Global Market (Nasdaq:MNOV) and the Hercules Market of the Osaka Securities Exchange (Code Number: 4875), today announced that based on recent clinical successes and evaluation of market opportunities, it will focus its resources on development and commercialization of two key assets in its development pipeline, MN-221 and MN-166. MediciNova believes that MN-221, now in Phase IIa clinical testing, has the potential to become the new standard of care for the treatment of severe, acute exacerbations of asthma (status asthmaticus) in emergency facility settings. Data from the Phase IIa trial is expected during the fourth quarter of 2007. MN-166, an oral treatment for multiple sclerosis, demonstrated positive clinical benefits and a superior safety profile after one year of treatment in a two-year randomized, double-blind, placebo-controlled Phase II trial in 297 relapsing multiple sclerosis patients.
Adhering to its strategy to focus investment on key assets such as MN-221 and MN-166, and in order to bring these assets substantially forward towards commercialization, MediciNova will limit its expenditures on other development programs to only those activities necessary to maximize each asset's value, while aggressively pursuing a variety of initiatives to monetize these development programs. As part of this strategy, MediciNova will discontinue development of MN-001 in its current immediate-release formulation. As such, the current Phase III trial of MN-001 in bronchial asthma patients will be stopped. To date, approximately 200 patients have been enrolled in that trial with no reported serious adverse events. The formulation currently being tested requires a multiple dosing per day schedule. Market and competitive analyses point to the desire for a once-a-day therapy for bronchial asthma and, thus, MediciNova will continue its work on developing a once-a-day preparation of MN-001. MediciNova anticipates that this reallocation of resources will provide substantial cash savings over the next 12 months.
"MediciNova's strategy has always been to select and develop product candidates that fill an unmet medical need and offer competitive market advantages. To that end, we have built an attractive pipeline that provides us with multiple opportunities from which to realize value," said Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova, Inc. "In focusing our resources, we are in the enviable position to dedicate investment to two commercially attractive development candidates that we can potentially commercialize on our own with a small, focused sales force, while we simultaneously continue efforts to monetize the remainder of our pipeline through business development initiatives, including potential partnering opportunities. We believe this new strategy will provide even greater value in the realization of our key clinical assets."