IVX Potential ?, page-3

IVX has enormous potential. It has four programmes with a number of future off shoots.
1. Zafirulkast is the one immediately discussed. This is a treatment for acute asthma, mild to moderate. It will compete with cortisosteroids. These have pretty serious side effects but are the current standard of care. Z has already proven safety and efficacy twenty years ago in trials by Zeneca. The trials were abandoned because the product was using CFCs as a propellant and they were banned. Zeneca, despite very considerable expenditure, were unable to develop an alternative formulation that worked. IVX now has a partnership with Hovione, who are experts in this field and most probably would not have signed an agreement unless they had already solved the problem or were very confident that they could. This programme is largely de-risked, serves a very real need and because of the proven safety and demonstrated need, will probably now get a fast track to market from the FDA. The potential market is probably around $6B and this drug has the potential to capture the lion's share of this market. IVX could capture 20% of wholesale selling price. It will probably have a fast track to market.
2. Oral Nadilol is potentially number 2 to market. This is aimed at smoking cessation. Trial results are due any day but should be announced by the end of August. This company always seems to be late with results etc. This is a $3B market. The science behind this drug is impressive and the trial should be successful. The current standard of care is generic together with a drug marketed by Pfizer. They have settled class actions relating to this drug for hundreds of millions of dollars. As far as I can see they cannot continue too long with marketing this drug and fighting off class actions about side effects. So oral Nadilol looks like a sitter for a lucrative deal if the current phase II trial is even moderately successful. 10% of $3B looks like a realistic target for annual royalties.
3. The best long term potential is inhaled Nadilol. Currently IVX has a partnership with 3M to develop an inhaled product for the 3M pressurised metered dose inhaler. This is state of the art technology. I understand that this programme has been successfully completed or is about there. This programme probably has at least eighteen months to market. The current smoking cessation trials will have extensive sputum samples tested which will prove (or otherwise) the safety and efficacy of Nadilol. If the current trials are successful the programme is largely de-risked. The potential market is for COPD, cystic fibrosis and other pulmonary diseases with a potential market of $30B. There is no other drug on the horizon which will actually heal the lining of the lung as Nadilol has been shown to do.
4. Lastly there is Cpn10, the protein which launched this company about 14 years ago. It has been shown as one of five molecular principles that control all inflammation. This gives it the potential to control all auto-immune disease. Of the five hypothesised principles Cpn10 is at least five years ahead of any of the others. Unfortunately this compound has to be manufactured in batches and IVX must now be just about out of drug for any further trials. I would guess that any programme to advance this programme would require at least $10M and that seems a bridge too far in the current circumstances, so the company in its releases has shown this as a partnering opportunity.
The potential is huge, the only problem is the parlous state of finances. Good trial results and access to adequate funds and this will fly.