ReGen Therapeutics is poised for the first launch of its Colostrinin neutraceutical for early stage cognitive decline, with the signing of a licensing agreement with Metagenics in North America.
The UK-based biotech's trademarked Colostrinin complex is derived from ovine and bovine colostrum (the first milk produced by a mammal after giving birth). In addition to launching Colostirin itself as a nutraceutical, the company is also developing a pharmaceutical preparation based on the peptides within it, for the treatment of Alheimer's disease.
A spokesperson for the company confirmed that an introduction through Metagenics make Colostrinin available for the first time, anywhere in the world. ReGen is hoping that it will come to market in early 2007, but it is dependent on completion of toxicology testing, regulatory filings and due diligience on bulk manufacturing facilities in South Dakota.
Percy Lomax, ReGen executive chairman and CEO said: "This agreement with Metagenics is of great significance to ReGen in that it recognises the commercial potential of Colostrinin in the North American nutraceutical market."
The spokesperson told NutraIngredients.com that although the company is looking at other countries, the US represents 50 to 60 per cent of the world market. "We wants to get this one under our belt first."
Last Ausust a US patent was granted covers the use of Colostrinin, its constituent peptides and analogues to promote cytokine induction.
ReGen has previously said it is also discussing Colostrinin with a potential partner in Japan.
Alzheimer's disease is the most common form of dementia and currently affects over 13 million people worldwide. The direct and indirect cost of Alzheimer care is over $100 billion (€ 81 billion) in the US alone. The direct cost of Alzheimer care in the UK is estimated at £15 billion (€ 22 billion).
The agreement with Metagenics will give it the exclusive right to market the nutraceutical in the US through health care practitioners, as well as the option to extend into retail channels within six months.
Metagenic reaches a pool of 30,000 healthcare practitioners in the US.
When it was revealed at the beginning of this month that discussions with a US partner were at an advanced stage, shares in ReGen jumped 50 per cent. Yesterday they closed at £1.38.
Last September ReGen presented preliminary evidence of an anti-ageing effect from Colostrinin at the 21st International Conference of Alzheimer's Disease International taking place in Istanbul.
Researchers saw that the product increased the lifespan of cells isolated from mice predisposed to premature ageing and therefore, death, when they tested its impact on the mitochondria of cells isolated from strains of senescence-prone (SAMP1) and senescence-resistant (SAMR1) mice.
While cells from SAMP1 mice produce more reactive oxygen species (ROS), exhibit severe mitochondrial dysfunction, and have a decreased lifespan compared to the cells from SAMR1 mice, adding Colostrinin significantly decreased ROS levels, normalized mitochondrial function and increased the lifespan to levels similar to those in SAMR1 cells.
Continuous low levels of oxidative damage to cells, caused by ROS, play a key role in age-associated neurodegenerative diseases such as Alzheimer's, Parkinson's disease and other disorders of the central nervous system.
A double-blind, placebo-controlled trial on 106 people with mild to moderate Alzheimer's disease, published in 2004, found that after 15 weeks of taking the product in tablet form, around 40 per cent of the patients were stabilised or had an improved overall response in tests on cognitive function.