NABI BIOPHARMACEUTICALS : NVP

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15 juin 2011 •13:24

Neurovive Pharmaceutical (NVP)
Cotée à Stockholm

NeuroVive – a presentation with estimated stock
potential

http://www.zerohedge.com/forum/swedish-small-cap-biotech


Neuro Vive Pharmaceutical, NVP.ST, is a Swedish drug developing company which in April 2011 entered an external French Phase III clinical study with their promising cyclosporin-A-based formulation and drug candidate CicloMulsion, just over a year after NeuroVive had completed its own Phase I trial. The Phase III trial is almost free for NeuroVive since the company is only sponsoring the study with CicloMulsion and
placebo.

http://www.neurovive.com/press/2011/110419_First_Heart_Attack_Patien t_Treated_with_NeuroVives_CicloMulsion.php

The Phase III study will enroll 1,000 patients with the aim to investigate the efficacy of CicloMulsion in cardiac cell protection after myocardial infarction before PCI treatment to prevent reperfusion injury which otherwise occurs when the blood flow is restored to the heart. A promising French external combined Phase I / II study was completed in 2008.

http://www.nejm.org/doi/full/10.1056/NEJMoa071142#t=article

The NeuroVive CEO has been quoted as saying that the results of the Phase III study is expected within 22-26 months, which implies that a potential market entry in Europe may occur around 2014 or 2015 if the study is successful. The world market for drugs against reperfusion injury is very big since many million people suffer from acute myocardial infarction annually, and many of these patients are undergoing PCI treatment. There are currently no effective drugs available for this multibillion-dollar market. CicloMulsion is now the first promising drug candidate against reperfusion injury that is known to have commenced Phase III trials. Thus a potential CicloMulsion licensee, probably a Big Pharma company, could get an important so-called first-mover advantage in the market, even if the cyclosporin-A-formulation patent cannot not be renewed after 2012. An analyst of the Swedish independent financial company Redeye has estimated that the first drug against reperfusion injury that enters the world market could have a revenue peak of USD 2 billion just counting the seven biggest markets by country.



Research also indicates a big Orphan Drug Designation-protected market potential for NeuroVive in traumatic brain injury (TBI). En external promising combined phase I / II trial in the USA has previously been completed
successfully.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2770729/

NeuroVi ve will begin its own traumatic brain injury combined Phase IIb / III trial planned for the last quarter of 2011 or first quarter of 2012 with their drug candidate
NeuroSTAT.

http://www.neurovive.com/press/2011/110303_NeuroVive_and_the_Europ ean_Brain_Injury_Consortium_Sign_TBI_Clinical_Trial_Collaboration.php

There is is an estimate that around 10 million people worldwide suffer from TBI annually. The market potential only in Europe and in USA is estimated by NeuroVive to be worth over USD 1 billion. There are no effective neuroprotective drugs on the market today. NeuroVive will probably look for a partner to co-finance this study or a licensee to pay expenses until a possible market introduction.



NeuroVive if successful in the Phase III and Phase IIb/III clinical trials has a potential to achieve a royalty based profit before tax of around SEK 500 million (corresponding to over USD 80 million) within 5 or 6 years, which could be compared to the company market value of less than SEK 580 million (less than USD 100 million) in May 5, 2011 at the closing stock price of SEK 36.2 (There are 14.94 million shares and no warrant or option dilution).



The statistically estimated probability for success in the forthcoming clinical trials is relatively high in Phase III and IIb / III, or roughly estimated at 65-70 % as a standard assumption for such advanced trials after the two promising Phase I/II external clinical trials. Some other Swedish pharmaceutical companies with ongoing Phase III trials recently had market values about 6-7 times higher, Diamyd and Medivir, although these have more advanced Phase III trials and also have other interesting projects with great potential in Phase II.

Judging from a Redeye interview with the NeuroVive CEO in April, 2011 the clinical research portfolio could be interpreted to look something like this in 2013 if the company can fulfill its plans :

Reperfusion Injury in the late stage of Phase III or registering

TBI in fairly late stage of combined Phase IIb / III

Status epilepticus in Phase II or combined Phase II / III

Stroke in Phase II (or possibly Phase II / III)

Then within two years the pipeline may be roughly on par with that of Diamyd and Medivir in early 2011 which would correspond to a NeuroVive stock price of around SEK 250 and a two year over 6-fold stock potential from now. The world market potential for drugs for all these four deseases together is estimated to be worth around USD 16 billion and there are no drugs available today. This is an enormous sum for NeuroVive with a market capital of around USD 0.1 billion and it represents a huge potential for NeuroVive if successful.

NeuroVive has a scientific strength regarding the mechanism of cyclosporin-A (CsA) which now is well researched and understood including the mitochondria based nerve cell and cardiac cell protection mechanism after a large number of their own and external pre-clinical and clinical trials. In addition, the side effects has since long ago been well known due to the fact that CsA has been a drug for decades as immunosuppressant in organ transplantation. Furthermore in neuroprotection and cardiac protection CsA is administered for a much shorter time and therefore the risk for a backlash due to unknown adverse effects should be relatively low.

NeuroVive's shares are listed on the Swedish trading platform AktieTorget