15 Oct 2009 07:00
THERAKIND PRODUCT UPDATE
Clinical Trial of Paediatric Epilepsy Treatment
IPSO Ventures plc ("IPSO"), the creator of commercial value from technology, is pleased to report that its portfolio company, Therakind Limited ("Therakind"), has announced the start of a paediatric clinical trial of a new product, Buccolamtm, designed for the rapid treatment of children suffering from acute epileptic seizures.
Buccolamtm, which has been jointly developed with another specialist pharmaceutical company, is an oromucosal (buccal) solution of midazolam hydrochloride. It is placed in the space between the patient's gums and the cheek to effect absorption directly into the bloodstream, enabling more rapid treatment. Buccal midazolam is already being used routinely in the treatment of acute seizures in children both in the UK and Europe, but in an unlicensed form.
The European Medicines Agency ("EMEA") agreed the Paediatric Investigational Plan for Buccolamtm earlier this year and the clinical trial, sponsored by Therakind, is being conducted in Germany. The study will involve up to 75 children aged between 3 months and 18 years and the objective is to gather the necessary clinical data for an application to the EMEA for a paediatric licence across Europe.
Nick Rodgers, CEO of IPSO, said: "Buccolamtm is Therakind's first product and starting this trial represents a significant milestone for the company. Combining Therakind's considerable regulatory and clinical development expertise with 3rd party product marketing and distribution capability has proved very worthwhile. We believe co-development will prove to be a highly effective approach for Therakind's product ideas in the neglected field of paediatric medicines."
Therakind is continuing to expand its customer base and generate revenues. It is currently assisting three other companies with the evaluation and development of a number of paediatric therapeutics.
Further information, please contact:
| IPSO Ventures plc: Simon Hunt, Chairman Nick Rodgers, Chief Executive | Tel: 020 7921 2990 simon@ipsoventures.com nick@ipsoventures.com |
| Website details: | www.ipsoventures.com www.therakind.com |
| Ambrian Partners Limited Samantha Harrison | Tel: 020 7634 4700 samantha.harrison@ambrian.com |
| Rawlings Financial PR Limited Catriona Valentine | Tel: 01653 618 016 catriona@rawlingsfinancial.co.uk |
NOTES TO EDITORS
IPSO:
IPSO creates commercial value from technology and its business model is entirely demand driven. It works closely with its industrial collaborators to identify the demand for new, innovative technologies and then, through its strong relationships with research institutions, sources technologies which could meet those needs. Much of this technology requires considerable further work by IPSO before it can be sold to industry as a developed product. IPSO creates businesses and provides expertise, strategic direction, human and seed capital, as well as corporate finance advice.
For industrial collaborators, IPSO provides a mechanism to identify and develop technologies which could be of significant value to their businesses, and removes the risk to them of acquiring raw, unproven and undeveloped technology.
For research institutions, IPSO provides greater certainty that their technology will find commercial success.
THERAKIND LIMITED
Therakind is a paediatric healthcare company with strong drug formulation, clinical development and regulatory capabilities. Focusing on paediatric medicine, the company has the expertise to develop a product from idea through to regulatory approval. The company identifies niche areas of unmet medical needs and works with other drug development companies on a collaborative basis.
Therakind was created in 2006 in collaboration between Intellectual Property ("IP") commercialiser, IPSO Ventures, and the School of Pharmacy, London University to address the significant unmet need for paediatric drugs. The School of Pharmacy is the only research department in the UK focusing on this area.
Therakind's dedicated team brings a wealth of experience in:
| paediatric drug evaluation, formulation, and drug delivery; | |
| clinical and regulatory strategy; | |
| clinical study design, management, analysis, and reporting; | |
| interacting with Health Authorities and obtaining scientific advice; and | |
| securing approvals for Paediatric Investigation Plans ("PIPs"), clinical trial and marketing authorisations. |
In addition, Therakind has a network of highly competent and professional paediatric specialists in the UK and Europe with considerable experience of treating children.
Why paediatrics?
The paediatric drug market has, in the past, been largely ignored by pharmaceutical companies since their products have been routinely used "off label" by clinicians treating children. Estimates vary, but the paediatric drug market would appear to represent between 15% and 25% of the overall drug market. EU and US regulators have sought to address the lack of licensed paediatric medicines through legislation which, in the EU, is both a "carrot" and "stick" offering added market protection for drugs, but with the threat of delays to adult approvals if there is no paediatric plan.
Shareholders
The shareholders of Therakind include the School of Pharmacy, UCL Business plc, Great Ormond Street Hospital, IPSO Ventures and Prof. Ian Wong.