Novocellus

Novocellus Ltd (In vitro fertilisation - 92% holding)

Novocellus has developed a patent protected system, EmbryoSure®, for selecting embryos likely to lead to a successful pregnancy. This is expected to lead to a 25% increase in the clinical pregnancy rate for IVF as well as a reduction in health risks for the mother and baby.

Novocellus has a corporate partnership with ORIGIO a/s to fund and manage the final trials process and take responsibility for the product going forward. ORIGIO supplies around one in five of the global market for IVF culture medium and is ideally placed to ensure that EmbryoSure® is widely adopted giving Novocellus access to the largest IVF customer base in the world. ORIGIO has the right to license the EmbryoSure IP in exchange for milestone payments and a royalty on future net sales.

Worldwide there are over 1.5 million cycles of IVF annually. A single cycle of IVF costs between £4,000 and £8,000 in a UK private clinic. ORIGIO believes that EmbryoSure will be widely adopted and will justify a premium price.

With successful trials and product launch, Novocellus will receive up to £4.5 million in milestone payments and a 25% royalty on net sales of EmbryoSure products for the life of the patents, and an additional 12 months thereafter, which is expected to be 2028. Novocellus offers the potential for a very substantial upside to ANGLE with only limited investment risk.

If the EmbryoSure® trials are successful, the royalty potential for Novocellus if the product is adopted across all of ORIGIO's existing customer base is in excess of £25 million per annum.

Background

Novocellus was set up by ANGLE plc, under its Progeny® programme, to develop and commercialise patented technology based on the research of Professor Henry Leese at the University of York. The technology, Amino Acid Profiling (AAP), is a quantitative, non-invasive method for selecting those embryos that are most likely to lead to a successful pregnancy and live birth. The product will be marketed as EmbryoSure™ and we expect its use to uplift overall pregnancy rates in IVF by at least 25%.

The Clinical Need

Infertility is a growing problem driven by environmental and lifestyle changes. This has led an increasing number of couples to seek infertility treatment, the best known of which is in vitro fertilisation or IVF. Current clinical practice in IVF relies on subjective methods of assessing embryo 'quality' and this has often resulted in low live birth rates (ca 20%). A consequence has been multiple embryo transfers, in an attempt to increase the pregnancy rate, leading to a high incidence of multiple births. This is significant in terms of increased risk to mother and a higher incidence of peri-natal mortality and birth defects.

These problems are being addressed through the increasing use of elective single embryo transfer (eSET), but this has led to an overall reduction in pregnancy rate per IVF cycle. Against this background, the global IVF clinical community has a serious unmet need for a more effective method of embryo assessment, if they are to offer success rates comparable to, or better than, those for multiple embryo transfer.

The Market Opportunity

It is estimated that there are over 1.5 million cycles of IVF carried out globally, a figure that is growing at more than 4% a year. This represents a potential global market opportunity for EmbryoSure® of $1.5 billion by per annum by the end of the patent life.

Adoption of EmbryoSure® will be driven by the need of patients, healthcare providers and clinicians for a higher degree of certainty that the embryos being transferred are likely to lead to a successful pregnancy. This is particularly true for eSET and the increasing trend towards its use will be a significant driver of future revenue growth.

The Novocellus Solution

EmbryoSure® involves measuring the turnover of natural amino acids by the embryo in its first 24 hours of development. This is done by analysing changes in the amino acid content of the medium in which the embryo has been cultured.

In practice, a small sample (2µl) of the spent culture medium is analysed using our patented technology. The output of the test is an Embryo Viability Score, based on AAP and standard morphological grading. This score is used by the embryologist to determine which embryo(s) are likely to result in a successful pregnancy. The selected embryo(s) can then either be transferred immediately or frozen for future use.

To test the clinical utility of the technology, i.e. "proof of principle", EmbryoSure® has already been evaluated in two pilot clinical studies at hospitals in the UK. These showed a significant correlation between the amino acid profiles, clinical pregnancy and live births.

Based on the pilot studies, it was concluded that AAP would be of value in predicting which embryos would be most likely to lead to a successful pregnancy and should result in at least 25% uplift in the clinical pregnancy rate.

Current Status

ORIGIO is currently undertaking clinical trials for EmbryoSure®.

There are two elements to the trials. Firstly, "retrospective" trials where the benefit of EmbryoSure® is assessed by considering what would have happened to the pregnancy success rate had EmbryoSure® been deployed. Secondly "prospective" trials where EmbryoSure® is used to select embryos for transfer and the effect on pregnancy success rate is measured.

The retrospective study is in progress with a target completion in mid-year 2013. European regulatory approval CE marking of the culture medium and preparation of the analysis module will be initiated as soon as positive retrospective study interim results are obtained.

As soon as positive results are obtained from the full retrospective study, CE marking of the culture medium is complete and an analysis module is ready, ORIGIO will launch EmbryoSure® in the UK market, currently estimated to be mid-year 2014.