Product licences received for Aviticol® and Colecalciferol 800 IU and 1000 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 received UK marketing authorisations (product licenses) for two new strengths of Vitamin D capsules from from the Medicines and Healthcare products Regulatory Agency ("MHRA").
The two new strengths, 800 IU capsules and 1000 IU capsules, are in both branded (Aviticol® ) and generic (Colecalciferol) versions, giving a total of four new licensed products. The 1000 IU capsule represents the first unlicensed to licensed development of its type to be made available 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.
Vitamin D is essential for skeletal growth and bone health and severe deficiency can result in rickets among children and osteomalacia among children and adults. There is a wide range of uses for Vitamin D and recent research has found that lower levels of Vitamin D have also been linked with a higher risk of cancer4. Quantum is building a branded product range that services this fast growing area of treatment. Currently the NHS prescribes the equivalent of 1.2 million 30 capsule packs of 800 IU per annum met by licensed pharmaceuticals and nutritionals and 160,000 30 capsule packs of 1000 IU per annum fulfilled by specials and nutritionals. As a result of government health guidelines, there is increasing use of Vitamin D supplements in at-risk groups, which include infants and children, pregnant and breastfeeding women, people over 65 years of age and those who have low or no exposure to sunlight5.
Andrew Scaife, Chief Executive of Quantum Pharma Plc, commented: “We are delighted to receive licences for these two new strengths of our Vitamin D range in both branded and generic presentations. Vitamin D deficiency is a growing market in which we are seeking to become a significant player through our commitment to developing a broad product range.”
“The 1000 IU strength is of particular interest as it represents the first unlicensed to licensed product development of its type to be made available in the UK and demonstrates our pipeline moving into delivery. The 800 IU complements and adds to our portfolio of different strengths of UK licensed Vitamin D capsules.”
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 Serum 25-Hydroxyvitamin D Concentrations >40 ng/ ml are associated with >65% Lower Cancer Risk: Pooled Analysis of Randomized Trial and Prospective Cohort Study. This can be viewed at: http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0152441
5 A Pulse analysis of official figures show that GP prescriptions for Vitamin D have risen steadily year on year from 14 million items in 2012, to 20 million items in 2015. The cost to the NHS has shot up accordingly, from a stable cost of around £4.8 million a month before 2012 to £7.1 million in the latest figures from November 2015. The total NHS spend on Vitamin D in 2015 was around £85 million. (Source: Pulse, 31 March 2016)
Posted by: Quantum Webmaster on 12th April 2016