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Biotech Catalyst Play: BiondVax Pharmaceuticals Ltd (ADR) (NASDAQ:BVXV)

Biotech Catalyst Play: BiondVax Pharmaceuticals Ltd (ADR) (NASDAQ:BVXV)
Written by
Chris Sandburg
Published on
June 21, 2017
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Influenza is a big problem both domestically in the US and globally. There's a massive infrastructure in place to try and combat human infection all over the world, spearheaded by the World Health Organization (WHO), it's not as comprehensive as many believe.There are countless and ever-evolving strains of influenza in current and future existence. We don't know what type or strain is going to prove most prevalent year after year, so every year the WHO publishes a best guess, and companies get to work producing stockpiles for four different strains – two type A and two type B.Estimates suggest that this best guess method results in around 40% seroprotection (that's 40% of al those who receive a vaccine becoming immune to the prevalent strain) in a good year, and considerably lower on a so-called 'mismatch' year, which is when the WHO gets it wrong.BiondVax Pharmaceuticals Ltd (ADR) (NASDAQ:BVXV) is trying to overcome this issue.The company has developed a vaccine called M-001, which it's billing as the first universal flu vaccine. Currently, the SOC vaccines take a bit of a particular strain of the flu virus and introduce it to the immune system. The immune system creates antibodies against said strain and – if the individual is then infected – the antibodies are ready to go after infected cells.With M-001, BiondVax has taken what's called peptide technology, which is a technology already used in things like immunotherapy but that – as yet – is relatively underused in the vaccination space; especially as regards to prophylaxis (preventative) vaccinations. It allows a single vaccine to present a range of peptides that mimic antigens across a whole spectrum of influenza strains.When administered, the vaccine (this is the theory, at least) will induce the creation of antibodies that are primed to attack a wide range of influenza strain types as and when they infect the individual in question.So why are we discussing all this now?The company collected some pretty convincing early stage data and is currently investigating the safety and efficacy of M-001 as part of a phase IIb study in Europe. Well, we say currently investigating, that's not entirely correct; the trial is complete but results are yet to hit press.As per this release, the company expects to have the numbers in the hands of markets during the first half of 2017. That leaves less than two weeks for publication. When they hit press, and assuming they replicate the clinical benefit inferred by the early stage data, this one's really going to run.Why?Because of the size of the potential market for an asset like this.The company is going after what's called a seasonal primer vaccine approval first. In the US alone primer dosing was given to 135 million individuals in the US last year. Price point comes in at between $8 (discounted) to $28. That's a market potential (at a midpoint price) of $200 million at 33% penetration – something that we would assume is easily achievable if the company can prove the multi-strain efficacy.Beyond that, management wants to seek approval for pandemic primer, which basically means it will be on the stockpile-add list and create the vaccine to sell to the government. This is a $240 million opportunity in the US based on a $12 price point and a critical workforce proportion of circa 15%.The end goal is to get this vaccine approved as a standalone vaccine. Analysts estimate that, for a drug like this, there's $700 million worth of revenues at peak sales.So this is why this upcoming data release is so important – because it opens the door to a range of phase III studies, each of which will set up specifically to target one of the above three market indications.As mentioned, then, the numbers should hit press over the next two weeks at the outside. If we see clinical benefit (basically defined as comparable to SOC), this company's going to run.We will be updating our subscribers as soon as we know more. For the latest updates on BVXV, sign up below!

Image courtesy of NHS Employers via Flickr

Disclosure: We have no position in BVXV and have not been compensated for this article.

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