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Amryt Pharma - good news completes talks with FDA and EMA: BUY

By HotStockRockets | Tuesday 7 March 2017


Disclosure: Financial Investigative Media Limited, which is not owned by Tom Winnifrith but by a trust for his dependants, owns shares in companies mentioned in this article. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from ShareProphets). I have no business relationship with any company whose stock is mentioned in this article.


Amryt (AMYT) has announced that it has completed of discussions with the Food and Drug Administration, the US FDA,  and European Medicines Agency regarding the design of its pivotal phase 3 clinical trial for AP101 as a potential treatment for Epidermolysis Bullosa. The global market for a treatment for EB is, according to Amryt, worth £1.3 billion.

Amryt can now start Phase 3 - the final trials of its drug at the end of this month. Amryt has also agreed to conduct some further non-clinical studies in parallel with this phase 3 study. INC Research has been appointed as the contract research organisation for the phase 3 study, and approximately 30 clinical trial sites in 15 countries have already been pre-qualified.

A total of 164 evaluable patients will be treated for a 90 day blinded period. The proportion of patients with completely healed target wounds within 45 days will be evaluated as the primary endpoint. Secondary endpoints include the time to achieve wound healing and changes in pain and pruritus (itch). So we will, hopefefully, start getting a very exciting - given the size of the market - newsflow within weeks.

At 19p mid ( up 4% today) the company is still capitalised at just under £40 million. It has a cashed up balance sheet and debt in place to fund trials and it has now bought in product which is already generating cash. That really de-risks this play and the current market cap does not discount the potential of a drug now on phase three looking to tackle such a vast market.

Now on a roll we are ahead on this share tip but still, at up to 20p, buy with a target to sell of 27p.

This article first appeared on HotStockRockets - its always paying customers first.  If you missed out on this red hot share tip, fear not! To catch our next red hot share tip  out on Wednesday 8 March (TOMORROW)  at 11AM, for just £5, go HERE

PS. Broker Beaufort has today issued a note on the stock which is below. The underline is ours!

The pharmaceutical company focused on best-in-class treatments for rare and orphan diseases, yesterday announced the completion of discussions with the Food and Drug Administration (‘FDA’) and European Medicines Agency (‘EMA’) regarding the design of its pivotal phase 3 clinical trial for AP101. This molecule is a potential treatment for Epidermolysis Bullosa (‘EB’). EB is a rare genetic skin disorder that leads to exceptionally fragile skin and children with the disorder are often referred to as “Butterfly Children”. The global market for a treatment in EB is estimated to be in excess of EUR 1.3 billion.

With regulatory authority discussions now completed with FDA and EMA and the design of the clinical trial established, Amryt is on track to commence the phase 3 trial at the end of March. Amryt has also agreed to conduct some further non-clinical studies in parallel with this phase 3 study. INC Research has been appointed as the contract research organisation for the phase 3 study, and approximately 30 clinical trial sites in 15 countries have already been pre-qualified. Adult and paediatric patients with EB will be enrolled into a randomised double blind placebo controlled trial.

A total of 164 evaluable patients will be treated for a 90-day blinded period. The proportion of patients with completely healed target wounds within 45 days will be evaluated as the primary endpoint. Secondary endpoints include the time to achieve wound healing and changes in pain and pruritus (or itch). An important component of the phase 3 study is an independent data monitoring committee that will conduct an un-blinded interim efficacy analysis after 50% enrolment. The potential outcomes of this interim analysis include continuation of the study unchanged, discontinuation of the study for futility, or an increase in the number of patients in the study to preserve adequate statistical power. 

Our view: This is very positive news! Reaching this critical development milestone is an important step forward for Amryt. AP101 received marketing approval for the treatment of partial-thickness wounds from the European Commission in January 2016. But agreement with the regulatory authorities for its phase 3 study in EB was a precursor to commencing its pivotal study, which it now expect will enrol its first patients in the coming weeks. There remains substantial unmet need for drugs which can address the symptoms and significant progress can now be made toward a potential treatment this review.

Working with INC Research, Amryt believes an adaptive approach to study sample size will help to ensure that it achieves a reliable assessment of the potential benefit of this new skin healing treatment for the orphan designated disease. Having patent grants in the US and in Europe, as well as other territories including Japan, Canada and Australia, the Board estimates its global EB market opportunity to be in excess of EUR 1.3 billion.

Amryt's other earlier stage product, AP102, is focused on developing novel, next generation somatostatin analogue peptide medicines for patients with rare neuroendocrine diseases, where there is also a high unmet medical need, including acromegaly and Cushing's disease. AP102 was recently granted orphan designation in the US in acromegaly by the FDA.

While it is true that the London equity markets have few other ‘rare diseases’ focussed development groups against which Amryt might be compared, the clear tax and development advantages offered has created a complete sub-sector of such companies listed on the US’s NASDAQ. Elementary comparison amongst these of their respective clinical development suggests a significant and unwarranted valuation gap. Beaufort retains its Speculative Buy recommendation on Amryt Pharma plc.

 



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