Updated Manufacturing and Importation Authorisation
Solural Pharma ApS receives an updated Manufacturing and Importation Authorisation No. 30108 by the Danish Health and Medicines Authority expanding its manufacturing capabilities from oral products to also include topical products and primary and secondary packaging of Investigational Medicinal Products.
Solural Pharma gets a European patent
The European Patent office has announced a decision to grant Solural Pharma a European patent “Solid Oral Dosage Form of Testosterone Derivative.”
Ascelia Pharma AB acquires Oncoral Pharma ApS
Ascelia Pharma AB acquires Oncoral Pharma ApS and its novel tablet based proprietary formulation of the chemotherapeutic agent, irinotecan, which today is only available as an intravenous infusion product.
Solural Pharma will continue to support Ascelia Pharma with chemistry manufacturing and control services.
Solural US patent issued
The United States Patent and Trademark office has issued the Solural patent “Solid Oral Dosage Form of Testosterone Derivative”.
First human dosing in combination with oral capicitabine tablet
Oncoral Pharma ApS initiates first human dosing on Herlev Hospital using a proprietary oral Irinotecan tablet product developed by Solural Pharma in combination therapy with oral capicitabine tablet in adult patients with solid tumors.
Oncoral Pharma ApS gets an Innobooster grant
The Danish Innovation Fund has granted Oncoral Pharma ApS 497.310 DKK as an Innobooster grant to support an open label phase I study to show that their proprietary oral irinotecan tablet product can be taken together with oral capecitabine tablet as a new, safe and effective tablet based treatment to be taken at home.
Exclusive license agreement
Solural Pharma ApS enters into an exclusive license agreement with Dyna Therapeutics Co., Ltd, Korea to develop and commercialize SOL-804 for treatment of metastatic castration resistant prostate cancer. SOL-804 is based on the proprietary Solural Lymphatic Targeting Technology.
First human dosing initiated by Oncoral Pharma
Oncoral Pharma ApS initiates first human dosing on Herlev Hospital using a proprietary oral irinotecan product developed by Solural Pharma
Certificate of GMP Compliance of a Manufacturer
Solural Pharma ApS receives Certificate of GMP Compliance of a Manufacturer issued by the Danish Health and Medicines Authority
Grant to develop a new innovative product
The Danish Innovation Fund has granted Solural Pharma 1.5 mio DKK for together with Contera Pharma ApS (part of Bukwang Pharmaceuticals Co Ltd) , Dr. Sandra Klein, the University of Greifswald and Erweka Gmbh, to develop a new innovative product for the treatment of Morning Akinesia in Parkinson Patients.
First human dosing
Solural Pharma initiates first human dosing on the SOL-924 new product formulation developed by Solural Pharma ApS. The project is being developed in partnership with an undisclosed major US partner.
Grant to support human testing
Herlev Hospital has received a grant from the Danish Cancer Society of 1 mio DKK to support human testing of the Oncoral Pharma oral irinotecan product
Exclusive licensing agreement
Solural Pharma ApS enters into an exclusive licensing agreement with an undisclosed US partner on the development of a new proprietary product developed by Solural Pharma.
Oncoral Pharma ApS and Herlev Hospital receives a grant from the Advanced Technology Foundation for developing an oral treatment of an existing intravenous chemotheraphy.
Solural Pharma ApS spin-out technology and together with Østjysk Innovation A/S form a new company Oncoral Pharma ApS with the purpose to develop a new tablet treatment of an existing intravenous chemotheraphy.
Solural Pharma ApS enters into a Master Service Agreement with a major US Pharmaceutical company on the development of a new oral treatment within hormone disorders.
The company has moved to new and larger facilities at Energivej 42 in Ballerup, 20 km from Copenhagen.
The company has signed a Letter of Intent with a partner for the development of an oral oncology product intended for metronomic dosing.
The company has filed its first patent application for a European patent.
Solural Pharma is formally registered at Erhvervs og Selskabsstyrelsen to become inaugurated
as Solural Pharma ApS. The company was founded and will initially be managed by Ann Fullerton and Peter G Nielsen.
The company has its premises at Kanalholmen 8-12, Hvidovre, Copenhagen, Denmark, where we also
have access to laboratory and GMP pilot facilities.