PharmaTher Holdings Ltd., a known speciality life sciences company dedicated to unveiling the therapeutic capabilities of ketamine for neuropsychiatric disorders, has confirmed its closing of the existing declared sale of its Abbreviated New Drug Application (ANDA#217858) for Ketamine Hydrochloride Injection USP to a known sterile-injectables pharmaceutical company.
On the closing of the sale, the PharmaTher was credited with confidential upfront cash payments. With this payment, the company has also been qualified to receive additional profit payments based on the profit-sharing payments and heavy effective sales. As per the previously signed agreement, the payment will be credited to PharmaTher for seven years following its first marketing sale. Overall, the transaction delivers the capability to create above US$25 million by time entitle to commercial performance.
The sale has encouraged and powered PharmaTher’s focus on the commercialisation and establishment of the trademarked long-acting injectable (LAI) ketamine program. The program has reached its advanced stage under the option-to-license and exclusive assessment partnership with Oakwood Laboratories, LLC.
The Chief Executive Officer and Chairman of PharmaTher, Fabio Chianelli, said, “The closing of the ANDA sale represents the beginning of PharmaTher’s next chapter. We have transitioned a familiar generic asset to a long-term upside and non-dilutive capital. With this closing, we are back to concentrate on forming a classified long-acting ketamine authorisation for neuropsychiatric disorders.”
The LAI ketamine program accelerates Oakwood’s microsphere-related sustained-release robust technology. The technology is engineered to allow intramuscular or subcutaneous administration with the help of a balanced drug launch for weeks to months. The company plans to take a 505(b)(2) regulatory pathway with a primary focus on peaked volume neuropsychiatric indications like major depressive disorder (MDD), Parkinson’s disease and treatment-resistant depression (TRD).
Mr Chianelli added, “We think that the long-acting ketamine is a genuine and natural evolution of the latest ketamine treatment model. A minimal, frequent and convenient injectable alternative holds the true capability to mitigate clinical burden, expand access and improve adherence while protecting ketamine’s continuous antidepressant benefits.”
PharmaTher has listed down its milestones with its crystal clear catalyst-expensive plan that is expected to reach the achievement stage in the coming quarters. The company's priority is to modernise the CMC activities and formulation in partnership with Oakwood to contribute to the clinical-grade supply. Furthermore, there are more prioritised lists to be focused on after the achievement of this closing.
Mansi Kadam is a market research writer with over 3 years of experience analyzing trends in the healthcare industry. At Towards Healthcare, she covers innovations in medical sector, sustainability initiatives, and the evolving regulatory landscape.
