Alexza Pharmaceuticals has announced that it will suspend production of Adasuve inhaled loxapine for its partners Ferrer and Teva after the third quarter of 2015 “to reduce Alexza’s underutilized manufacturing capacity, overhead expenses and related costs, while fulfilling the supply requirements of its commercial partners.”
The company says that during the suspension, it “plans to work with its commercial partners to find the most efficient path for future Adasuve manufacturing and assure Adasuve supplies for current and new markets.” Ferrer markets Adasuve in much of Europe, in Latin America and in the Commonwealth of Independent States. Teva markets Adasuve in the US.
As part of a modified agreement, Ferrer will acquire the MAA for Adasuve and will be responsible for pharmacovigilance and post-approval clinical studies in Europe. The company will also get commercial rights to Adasuve in the Middle East, North Africa, Korea, the Philippines, and Thailand. Alexza will forego milestone payments for Ferrer’s first sales in Russia, Brazil and Turkey.
Ferrer will have the option to manufacture Adasuve for its territories and will also have the option to develop additional products using Alexza’s Staccato inhalation platform, including some rights outside of their current territories.
Per the modified agreement with Teva, Teva “will continue to use commercially reasonable efforts to commercialize Adasuve in the US” and will continue paying royalties and milestones; however, its note will not accrue interest during the time that production is suspended.
Alexza President and CEO Thomas B. King commented, “The comprehensive amendments we have completed allow for continued commercialization of Adasuve while providing flexibility to reflect market learnings during the launch of the product. We believe the sales during the global launch of Adasuve do not reflect the clinical benefits Adasuve can convey to patients, and we remain confident in Adasuve long-term commercial prospects. Early feedback from physicians and patients corroborate the positive clinical profile we observed with Adasuve during its clinical development.”
“We believe we are making solid decisions regarding how to run our business for the future and are making strategic changes to our business model. Amending our agreements with Ferrer and Teva will allow us to reduce the costs of producing Adasuve and eliminate the costs associated with some of the EU post-approval commitments, with the overall goal of substantially reducing our cash burn rate,” King added.
Read the Alexza Pharmaceuticals press release.
