Neurologists Remain Skeptical About The Launch Potential Of Novel Pharmacotherapies In Clinical-Stage Development For The Treatment Of Acute Ischemic Stroke

Through 2021, No New Drug Launches are Expected for the Acute or Post-Acute Treatment of Ischemic Stroke, According to Findings from Decision Resources


November 6, 2012-Burlington, Mass. – Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that, in light of repeated clinical trial failures of investigational treatments, neurologists remain skeptical about the launch potential of pharmacotherapies in clinical-stage development for the acute or post-acute treatment of ischemic stroke. As a result, Decision Resources expects that the market for ischemic stroke therapies will continue to be a graveyard for new product development in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.

According to the Pharmacor advisory service entitled Acute Ischemic Stroke, interviewed neurologists continue to express uncertainty about the probability of success for Lundbeck’s thrombolytic desmoteplase—currently the only novel drug in Phase III development—in its redesigned pivotal clinical trial program. Although Decision Resources does not currently forecast approval of desmoteplase, its approval for use within three-to-nine hours post-stroke onset could represent one of the most important therapeutic achievements in stroke in more than a decade, while expanding the proportion of ischemic stroke patients with access to acute therapy.

The findings also reveal that most interviewed experts convey limited optimism that neuroprotectants will prove effective in the treatment of ischemic stroke, given countless failures among such agents in clinical trials—including the recent discontinuation of D-Pharm’s DP-b99. Instead, interviewed neurologists agree that new directions in neurorestorative therapy to aid in post-stroke recovery offer much-needed avenues for treatment. Although success in this arena is far from certain, numerous companies are investigating novel approaches to stimulate neuroplasticity using growth factors, such as Stem Cell Therapeutics’ NTx-265, or innovative technologies such as PhotoThera’s NeuroThera Laser System. Meanwhile, developers including Aldagen, ReNeuron, SanBio/Teijin and Stemedica have initiated the first human clinical trials of ground-breaking cell-based treatments.

Given the high rate of pipeline attrition in this market, investigators also remain focused on improving the utility of recombinant tissue plasminogen activator (rt-PA; alteplase [Genentech’s Activase, Boehringer Ingelheim’s Actilyse, Kyowa Hakko Kirin’s Activacin, Mitsubishi Tanabe Pharma’s Grtpa]), the current standard of care in acute ischemic stroke, through new research, including the use of advanced imaging to expand the treatment window beyond the currently-accepted 4.5 hours. Meanwhile, novel reperfusion strategies such as Cerevast’s ClotBust ER Sonolysis Headframe System, CoAxia’s NeuroFlo and BrainsGate’s Ischemic Stroke System, offer unique non-pharmacological approaches alongside currently-approved neurothrombectomy devices from companies like Concentric Medical, Penumbra and ev3.

“In recognition of the significant and untapped commercial potential in this arena, a broad and diverse array of innovative treatment strategies is in development for the treatment of ischemic stroke, despite myriad development hurdles,” said Decision Resources Therapeutic Area Director Bethany Kiernan, Ph.D. “However, in the projected absence of new drug launches, growth in drug sales and drug-treatment rates in the acute ischemic stroke market will occur primarily as a result of the gradually increasing use of rt-PA, aided by a modestly expanded treatment window, continued improvements in the delivery of stroke care and rising stroke incidence.”

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