Scope
Reference
DAC
Description
This procurement if for active and placebo capsule manufacture for the LAMDARCT Clinical Trial .
Contract 1. Active and placebo capsule manufacture for the LAMDARCT Clinical Trial
Supplier
Contract value
- £416,789.25 excluding VAT
- £500,147.10 including VAT
Above the relevant threshold
Earliest date the contract will be signed
1 October 2025
Contract dates (estimated)
- 1 November 2025 to 1 November 2029
- 4 years, 1 day
Main procurement category
Goods
CPV classifications
- 33600000 - Pharmaceutical products
Contract locations
- UKN - Northern Ireland
Other information
Conflicts assessment prepared/revised
Yes
Procedure
Procedure type
Direct award
Direct award justification
Prototypes and development
Schedule 5, (2) The public contract concerns the production of a prototype, or supply of other novel goods or services, for the purpose of (c) other research, experiment, study or development.
Age-related macular degeneration (AMD) is a leading cause of visual loss. There are two main forms of AMD: dry and wet. The current wet AMD treatment is intravitreal antiVEGF injections, repeated every 4-12 weeks. Due to the cost of the medication, the route and frequency of administration, this treatment is a significant burden on the NHS budget.An additional treatment option for wet AMD is L-dopa. L-dopa is a widely available drug (used in treatment of Parkinson's), typically in the form of Carbidopa-L-Dopa. It is taken as an oral tablet and is significantly cheaper than the antiVEGF injections.
The study will be a placebo-controlled clinical trial. Eligible patients will be randomised to receive either 100mg L-DOPA+25mg carbidopa or placebo twice a day, for 24 months, in addition to the current standard of care to determine if this is a more cost-effective and easier-to-administer treatment regime than the current standard of care.
To 'blind' this clinical trial (to reduce bias) requires the development and manufacture of over encapsulated 100mg L-DOPA+25mg carbidopa tablets and development and manufacture of matching placebo capsules. The expertise required to develop and manufacture these capsules in the quantity required for this trial requires outsourcing to a manufacturer licensed by the MHRA possessing the necessary technical expertise.
Supplier
ALMAC CLINICAL SERVICES LIMITED
- Companies House: NI041905
- Public Procurement Organisation Number: PRCD-2287-GMQG
Almac House
Craigavon
BT63 5QD
United Kingdom
Email: csrfinotifcations@almacgroup.com
Website: http://ww.almacgroup.com
Region: UKN07 - Armagh City, Banbridge and Craigavon
Small or medium-sized enterprise (SME): No
Voluntary, community or social enterprise (VCSE): No
Contract 1. Active and placebo capsule manufacture for the LAMDARCT Clinical Trial
Contracting authority
Belfast Health & Social Care Trust
- Public Procurement Organisation Number: PLQJ-5727-JCLR
Trust Headquarters, 2nd Floor, Non Clinical Support Building, Royal Victoria Hospital
Belfast
BT12 6BA
United Kingdom
Region: UKN06 - Belfast
Organisation type: Public authority - central government
Devolved regulations that apply: Northern Ireland