PARIS, France—Active Biotech AB and Ipsen have entered intoa broad partnership to co-develop and commercialize Active Biotech'sinvestigational compound Tasquinimod (TASQ). A global Phase III trial of TASQin men with metastatic castrate-resistant prostate cancer (CRPC) was recentlyinitiated by Active Biotech, and patient recruitment has begun.
The ongoing clinical trial, funded by Active Biotech, is aglobal, randomized, double-blind, placebo-controlled Phase III trial inpatients with metastatic CRPC. The aim of the study is to confirm TASQ's effecton the disease, with radiological progression-free survival (PFS) as theprimary endpoint and overall survival as the secondary endpoint. The study willinclude about 1,200 patients in more than 250 clinics.
"This new partnership will broaden the scope of oururo-oncology franchise," says Marc de Garidel, chairman and CEO of Ipsen."Subject to the success of the ongoing Phase III clinical trial for thetreatment of metastatic castrate-resistant prostate cancer and following marketapproval, TASQ will perfectly fit in our current portfolio, alongside thesustained-release formulations of Decapeptyl."
Ipsen has been following the Active Biotech TasquinimodPhase II program with interest, and the two companies' discussions progressedto another stage when the Phase II data were released and the Tasquinimod PhaseIII and regulatory strategies were defined, the company says.
The current plan is to present the Phase III results in 2013and file for approval in 2014.
Tomas Leanderson, president and CEO of Active Biotech, notesthat Ipsen has a proven track record and strong R&D capabilities withinprostate cancer.
"We consider Ipsen an ideal partner for Active Biotech andwith this partnership a powerful development and commercialization strategy forTASQ has been secured," Leanderson says.
TASQ, or ABR-215050, is a drug with a unique mechanism ofaction targeting angiogenesis and immunomodulation. It binds to a moleculecalled S100A9 that is expressed in the white blood cells involved in theregulation of immune responses. S100A9 interacts with two knownpro-inflammatory receptors, Toll like receptor 4 (TLR4), and receptor ofadvanced glycation end products (RAGE), and this interaction is inhibited byTASQ. Upregulation of thrombospondin-1 (TSP1) has been identified as oneimportant component in order to understand and explain the anti-angiogenicmechanism of TASQ treatment of prostate cancer. Under the terms of the agreement, Active Biotech grantsIpsen exclusive rights to commercialize TASQ worldwide, except for North andSouth America and Japan, where Active Biotech retains all commercial andmarketing rights. Asian and Indian clinics will be included in the Phase IIItrials, and Ipsen foresees commercial opportunities for the drug in thesemarkets.
Both companies will co-develop TASQ for the treatment ofcastrate-resistant prostate cancer, with the possibility to develop TASQ inother cancer indications.
"The TASQ mechanism of action is general, so in principle,from a theoretical perspective, the therapy can be used for a large number oftumors," says Göran Forsberg, Active Biotech's vice president of investorrelations and business development. "We have not disclosed when and in whichcancer indication there will be development outside prostate cancer."
Active Biotech is responsible for conducting and funding thePhase III pivotal clinical trial and will receive up to $285 million during thecourse of the agreement. Although the detailed amounts of the milestonespayments cannot be disclosed, an upfront payment of $36 million was paid uponthe signing of the agreement, says Ipsen.
Further payments will depend on the advancement and successof the Phase III clinical trial as well as on the regulatory developments. Oncethe medicine is approved, low-teen royalties on sales will be paid to ActiveBiotech as well as commercial milestones once certain sales thresholds areachieved.
Additional payments are contingent upon achievement ofclinical, regulatory and commercial milestones. In addition, Ipsen will fundand conduct a European supportive study in prostate cancer patients out of itsR&D budget. Future costs to develop TASQ in other cancer indications willbe shared.
