Oct. 1, 2015 Amarantus to Focus Near-Term Develop
Post# of 30081
Posted On: 03/09/2016 7:21:34 PM
Oct. 1, 2015
Amarantus to Focus Near-Term Development Efforts on Engineered Skin Substitute for Indications in Rare Pediatric Diseases
With the integration of the Cutanogen acquisition now complete, we have unearthed powerful human clinical data that validates the significant potential for the ESS program beyond the areas of adult and pediatric severe burns and into Congenital Giant Hairy Nevus," said Gerald E. Commissiong, President & CEO of Amarantus. "It is important for us to now focus the majority of our resources over the next several months on the ESS program. Upon completion of our review of the long-term longitudinal data, we intend to work closely with the FDA in an effort to establish a shortened clinical development pathway to approval via the RPDD pathway."
"Each approved treatment under the RPDD pathway is entitled to receive a PRV that may be sold to other companies. Two PRVs have been sold in the last 6 months for an aggregate of $595 million to major pharmaceutical companies. The proceeds from the sale of a PRV are in addition to any potential revenues that could be generated from the commercial sales. We believe ESS has the potential for an accelerated regulatory pathway to market in multiple rare and ultra-rare pediatric diseases based on the data we have seen in our preliminary review of the ESS program post-acquisition . Given that the majority of the ESS-related expenses are fixed costs associated with GMP manufacturing, we believe that we gain economies of scale by accelerating the regulatory and clinical development of ESS for the treatment of rare and ultra-rare pediatric diseases."
http://www.amarantus.com/news/press-releases/...efforts-on
March 4, 2015
Amarantus Appoints Brian E. Harvey, MD PhD to Strategic Advisory Board
"I am excited to help Amarantus accelerate regulatory interactions with the FDA for its diverse orphan drug portfolio of products," said Dr. Harvey. "ESS and Eltoprazine are moving into mid and late stage development across several niche indications where the standard of care has not seen any significant innovation in over 50 years. ESS is a product candidate that demands careful, focused clinical and regulatory execution in order to bring this life-saving treatment to market as expeditiously as possible. With respect to Eltoprazine and its recent Orphan designation, Amarantus has an opportunity to redefine the regulatory pathway to approval for Eltoprazine with its recent orphan drug designation, and we intend to engage the regulatory authorities in discussions as it relates to this pathway forward."
"We are very pleased to have attracted Dr. Harvey to our Strategic Advisory Committee to further enhance our already strong regulatory science infrastructure as we prepare to engage the FDA in discussions regarding the pathway forward for the late-stage development of ESS and Eltoprazine," said Gerald E. Commissiong, President & CEO. "As we are rapidly approaching the initiation of the ESS clinical development program with the US Army for the treatment of severe burns, we foresee the burn community strongly advocating for an accelerated approval process to bring this life-saving treatment to market. We want to ensure that we have the experience and infrastructure at the ready to manage various potential scenarios as it relates to ESS."
Cheers
Amarantus to Focus Near-Term Development Efforts on Engineered Skin Substitute for Indications in Rare Pediatric Diseases
With the integration of the Cutanogen acquisition now complete, we have unearthed powerful human clinical data that validates the significant potential for the ESS program beyond the areas of adult and pediatric severe burns and into Congenital Giant Hairy Nevus," said Gerald E. Commissiong, President & CEO of Amarantus. "It is important for us to now focus the majority of our resources over the next several months on the ESS program. Upon completion of our review of the long-term longitudinal data, we intend to work closely with the FDA in an effort to establish a shortened clinical development pathway to approval via the RPDD pathway."
"Each approved treatment under the RPDD pathway is entitled to receive a PRV that may be sold to other companies. Two PRVs have been sold in the last 6 months for an aggregate of $595 million to major pharmaceutical companies. The proceeds from the sale of a PRV are in addition to any potential revenues that could be generated from the commercial sales. We believe ESS has the potential for an accelerated regulatory pathway to market in multiple rare and ultra-rare pediatric diseases based on the data we have seen in our preliminary review of the ESS program post-acquisition . Given that the majority of the ESS-related expenses are fixed costs associated with GMP manufacturing, we believe that we gain economies of scale by accelerating the regulatory and clinical development of ESS for the treatment of rare and ultra-rare pediatric diseases."
http://www.amarantus.com/news/press-releases/...efforts-on
March 4, 2015
Amarantus Appoints Brian E. Harvey, MD PhD to Strategic Advisory Board
"I am excited to help Amarantus accelerate regulatory interactions with the FDA for its diverse orphan drug portfolio of products," said Dr. Harvey. "ESS and Eltoprazine are moving into mid and late stage development across several niche indications where the standard of care has not seen any significant innovation in over 50 years. ESS is a product candidate that demands careful, focused clinical and regulatory execution in order to bring this life-saving treatment to market as expeditiously as possible. With respect to Eltoprazine and its recent Orphan designation, Amarantus has an opportunity to redefine the regulatory pathway to approval for Eltoprazine with its recent orphan drug designation, and we intend to engage the regulatory authorities in discussions as it relates to this pathway forward."
"We are very pleased to have attracted Dr. Harvey to our Strategic Advisory Committee to further enhance our already strong regulatory science infrastructure as we prepare to engage the FDA in discussions regarding the pathway forward for the late-stage development of ESS and Eltoprazine," said Gerald E. Commissiong, President & CEO. "As we are rapidly approaching the initiation of the ESS clinical development program with the US Army for the treatment of severe burns, we foresee the burn community strongly advocating for an accelerated approval process to bring this life-saving treatment to market. We want to ensure that we have the experience and infrastructure at the ready to manage various potential scenarios as it relates to ESS."
Cheers
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