Launch of Ergocalciferol 50,000 IU capsules
Quantum Pharma Plc (AIM: QP.), the growing, service-led niche pharmaceutical manufacturer, developer and supplier to the health and care sectors, is pleased to announce that Colonis Pharma Limited1 (“Colonis”) has now received approval to launch Ergocalciferol 50,000 IU capsules in the UK, an important extension to Quantum Pharma’s existing Vitamin D product portfolio.
The 50,000 IU capsule represents the first unlicensed to licensed development for this product in the UK and will be launched by way of ‘cease and desist’ notices2, which will mean equivalent unlicensed medicines (“specials”3) will no longer be able to be supplied.
Ergocalciferol is a form of Vitamin D that is produced from natural non-animal sources. It is the main form of oral Vitamin D used in the United States and an important source globally. The product is indicated for the prevention and treatment of Vitamin D deficiency in adults, which NICE estimated in 2014 affects approximately 10 million UK adults.
The number of GP prescriptions for Vitamin D rose steadily year on year from 2012 to 2014, from 14 million items to 20 million items4. The monthly cost to the NHS of fulfilling these prescriptions increased commensurately, from around £4.8 million before 2012 to £7.1 million in the latest figures from November 20154. The total annual NHS spend on Vitamin D in 2015 was around £85 million4.
Quantum now has UK marketing authorisations for seven licensed products across four different strengths of Vitamin D products in a combination of branded and generic versions. The seven licensed Vitamin D products are: Aviticol® 800 IU, Colecalciferol 800 IU, Aviticol® 1000 IU, Colecalciferol 1000 IU, Aviticol® 20,000 IU, Colecalciferol 20,000 IU and Ergocalciferol 50,000 IU capsules.
Andrew Scaife, Chief Executive of Quantum Pharma Plc, commented: “We are pleased to announce the upcoming launch of Ergocalciferol 50,000 IU capsules which represents the first licensed presentation of this product in the UK. This marks further progress in our strategy to deliver unlicensed to licensed and other niche products to the market.
“This product completes our existing portfolio of licensed Vitamin D products and means that we can now offer a range across four different strengths of this essential vitamin. We look forward to continuing to successfully deliver further products from our development pipeline.”
Vitamin D deficiency in the UK is estimated to affect 12 million people (around 1 in 5 adults and around 1 in 6 children per NICE 2014 estimates, applied to ONS mid 2014 population estimates). Vitamin D (a fat-soluble vitamin) is required for the proper absorption of calcium and phosphorus from the intestinal tract. It is required for normal growth and development of bones and teeth, protection against muscle weakness, and regulation of the heart. Vitamin D enhances immunity, helps prevent hypocalcemia, osteomalacia, rickets, and osteoporosis, and is required for proper thyroid function and blood clotting. The main natural source of Vitamin D is from sunlight. At risk groups include children, the elderly, pregnant women and people who have dark skin types.
1. Colonis is the product development business in the Group’s Niche Pharmaceuticals division which takes niche pharmaceutical products including specials through the regulatory pathway to achieve marketing authorisation (product licence) and/or regulated product (medical device) status.
2. Cease and desist - MHRA guidance note 14 (May 2014) states, ‘An unlicensed medicinal product should not be supplied where an equivalent licensed medicinal product can meet the special needs of the patient.’ Unlicensed medicines may only be supplied by importers or specials manufacturers against valid special clinical needs of a patient. This requires that there is no authorised equivalent licensed medicinal product available on the national market. Once a medicine has been granted a licence and stock is available to satisfy orders, all importers and suppliers of unlicensed medicines or specials must stop supplying that medicine as an import or a special and all prescribers should prescribe the licensed version and pharmacies should source the licensed product from a licence holder.
3. Special - a special is an unlicensed medicine which is prescribed to a patient when the licensed form of a drug does not meet their specific clinical need, or when there is no licensed form of drug available on the market suitable to treat their condition. Specials are requested and prescribed for treatment by appropriately qualified doctors under their own authority.
4. Pulse Study, 31 March 2016
Posted by: Quantum Webmaster on 19th April 2016