01 March 2010
SPECIALIST pharmaceutical company Auralis is utilising the manufacturing services of UK-based SCM Pharma for the supply of its new product Buccolam™ that is currently going through a paediatric clinical trial.
Auralis focuses on introducing medicines that address currently unmet medical needs, with Buccolam being designed to help treat childhood epilepsy. The company is partnering with SCM Pharma as its diverse product supply needs fit well with the contract manufacturing organisation’s (CMO) licenses and small-medium scale fill/finish service offerings.
To support Auralis’ preparation for submission, the specialist CMO has conducted a feasibility study, scale-up batches and is also carrying out a two year stability study. SCM Pharma has also recently completed the manufacture of process validation batches in preparation for the product’s marketing authorisation.
Buccolam is an oromucosal (buccal) solution of midazolam hydrochloride, which is placed in the space between the gums and the cheek to effect absorption directly into the bloodstream, enabling more rapid treatment of the patient. 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.
Auralis has jointly developed the product with paediatric healthcare company Therakind, looking at the rapid treatment of children suffering from acute epileptic seizures.
Auralis Director, Andy Sneddon, said: "We are committed to introducing new medicines for patients, including children, whose medical conditions cannot be adequately addressed by currently available products.
"SCM Pharma has a superb manufacturing facility and is a well-suited partner to support Auralis given they can supply us the product to distribute in an unlicensed form alongside the clinical trial supply. In addition, they are also able to assist us with scaling-up as we prepare for commercialisation of the product,” added Mr Sneddon.
Sterile fill/finish specialist SCM Pharma works on various product presentations across a number of therapeutic areas including cancer, rheumatoid arthritis, dermatitis, needle-free injection technology and sexual health. Around half of the projects undertaken by the company are novel or bespoke and generally require a high level of technical expertise and facilities.
Shirley Dann, managing director at SCM Pharma, said: “We are working closely with the team at Auralis in order to help them be first to market with their innovative product. Our role in the project involves filling, packaging, labelling and delivering the patient-ready dosage forms to the clinical trial sites in Europe.
The EMEA (the European Medicines Agency) agreed the Paediatric Investigation Plan (“PIP”) for Buccolam™ last year. The clinical trial involves 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.
The liquid product is pre-filled in syringes at varying dosage strengths to meet the needs of the wide age range and as the product is preservative-free and is being manufactured within SCM Pharma’s grade C cleanroom facilities.
Assisting pharma, biotech, medical device and other healthcare institutions such as hospitals and universities, SCM Pharma has specialist expertise is being able to sterile manufacture and/or aseptically process radio-labelled compounds, highly potent products, biologicals and fill drug device combinations.
The company offers sterile and non-sterile contract GMP production services to assist clients progressing their innovative drug products or medical devices through clinical trials. With an emphasis on hazardous and difficult new products, SCM Pharma also provides other customers with a commercial supply of licensed products requiring ongoing small-medium scale volumes.
Auralis is an innovative specialist pharmaceutical company with a clearly defined product development strategy focused upon three key therapeutic franchise areas; critical care, paediatrics and addiction.
ENDS
Media contact:
Raman Sehgal
SCM Pharma
01661 838 186
ramans@scm-pharma.com
