Posted by realitytrader > 2013-08-01 19:05 | Report Abuse

Watch this space - new blood on Nasdaq, but 2 products on market and a $231m US Govt Grant to commercialize LANI in the US. Serious upside here.

Posted by Propinvestor88 > 2013-08-02 05:12 | Report Abuse

Biocryst is sky rocketting at the moment on little steam. Why is this one staying hidden with so much better value ???

Posted by miso > 2013-08-02 05:34 | Report Abuse

Australia's loss is a U.S. gain. The Australian Biota management believed PR was unnecessary and the solid science was enough. Good riddance. A smarter U.S. Biota management was long overdue. At last Biota will shine.

Posted by realitytrader > 2013-08-02 12:20 | Report Abuse

Off a $4 base, a near term estimate of $5+ and building towards $12 to $20 around Aug/Sept 2014 when Phase 2 LANI results come in.

Remember that LANI is approved and has already overtaken Tamiflu in Japan (LANI known as Inavir in Japan) as the no 1 Flu drug there. Importantly, the Inavir (LANI) safety profile in Japan is good, so FDA approval is highly probable - combined with a $231m investment from the US Govt, BOTA is a special.

Coming in at this entry point looks good for a minimum 100% upon Phase 2 approval.

Posted by Kangaroo1 > 2013-08-02 20:51 | Report Abuse

New to this message board but a long term holder of Biota in Australia and looking forward to exciting prospects now we have moved to NASDAQ. The Influenza antivirals are obviously the flagship products but also a range of other well advanced products in the pipeline. Currently undervalued.
Regards
Kangaroo

Posted by realitytrader > 2013-08-03 04:14 | Report Abuse

US antiviral stockpiling is legislated to be 25% of the population - we are talking 75 million courses of antivirals @ approx $80 per course. That is $6 billion and the shelf life is typically 5-7 years. The spend averages approx $1 billion per year. The standard seasonal market is also approx $1 billion per year. Pandemics are a wildcard and move the re-purchase window forward.

LANI has the potential for FDA Emergency designation following Phase II results, so this brings LANI potentially into play from late 2014 onwards.

Going on Japan experience, Inavir (aka LANI) is already dominating the market over there.

So 2014 Phase 2 trial results could catapult Biota in tens of multiples if there is a bad flu pandemic season over the next 12 months. In absence of a bad season, we'd only be looking at a 200% rerate, however, as LANI moves through Phase 3, the SP will clearly rise progressively.

A nice breath of fresh air when a new opportunity like this hits Nasdaq. Just need to wait for Brokers/Analysts to be introduced to Biota.

Posted by ugandaoranges > 2013-08-03 19:19 | Report Abuse

Interesting. I understand Tamiflu has a formidable position in this multi billion dollar market?

What competitive advantage would the new LANI have over Tamiflu?

Posted by realitytrader > 2013-08-04 02:06 | Report Abuse

Tamiflu is a 5 day course of tablets.

Laninamivir requires only a single puff (like an asthmatic inhaler) and it is a "one and done" treatment - one puff as soon as diagnosed. There is a deeper advantage to "one and done" in relation to an influenza antiviral treatment - to quote from the original study findings, "Furthermore, individuals with influenza might spread influenza virus from up to 2 days before to approximately 5 days after the onset of symptoms, and children can spread the virus for 10 days or longer. Therefore, continuous suppression of influenza virus replication in influenza patients is important." This makes good sense and therefore, this is an important point when comparing a single puff treatment to a 5 day course of tablets.

Kids also are much more likely to tolerate a single puff versus 5 days of tablets.

Tamiflu is ineffective against some mutations of the Influenza virus.

[when a patient presents him/herself to a doctor with suspected influenza, it is not practical for the doctor to send a blood sample off for testing. Therefore, prescribing Tamiflu is potentially a game of Russian Roulette].

LANI is demonstrated to be effective against the mutations that are resistant to Tamiflu. LANI is already the antiviral of choice of doctors in Japan.

The current FDA Phase 2 LANI Trials are Placebo vs LANI 40mg vs LANI 80mg (1:1:1).

In Japan, Inavir (aka LANI) 40mg proved to be slightly more effective than Tamiflu in head to head comparisons (however, "one and done" makes it a far more advantageous option) and with low side-effects and so this will be the safe fallback option, but there is a chance that LANI 80mg will be even more efficacious (this was not trialled in Japan), so LANI in the US could potentially be more powerful than Inavir in Japan. BTW, LANI at 80mg and even 120mg were safely tolerated in healthy adults during Phase 1 trials.

Prophylaxis also becomes an interesting and easy option, at least for certain types of personnel (for example, govt/army personnel). The Japanese version (Inavir) is expected to be approved for prophylaxis by the end of this year.

I've been waiting for Biota ($BOTA) to finally trade on Nasdaq and at the current SP, it is not yet on the radar of any/many analysts. Once it comes into range, I have no doubt it will fly. Therefore, a buy at the current SP is a steal IMO.

Posted by miso > 2013-08-04 02:24 | Report Abuse

The simple answer,

"A single inhalation of laninamivir octanoate is effective for the treatment of seasonal influenza, including that caused by oseltamivir-resistant virus in adults."

laninamivir = LANI
oseltamivir = Tamiflu


The long answer,

Source,
http://cid.oxfordjournals.org/content/51/10/1167.full.pdf

Posted by miso > 2013-08-04 03:58 | Report Abuse

An I a science nerd (retired microbiologist)? Yes I am.


Two neuraminidase (NA) inhibitors, zanamivir (Relenza) and oseltamivir phosphate (Tamiflu), have been licensed for use for the treatment and prophylaxis of influenza. We have reported on laninamivir (code name, R-125489), a novel neuraminidase inhibitor, and have discovered that the laninamivir prodrug CS-8958 worked as a long-acting neuraminidase inhibitor in a mouse influenza virus infection model when it is intranasally administered. In this study, CS-8958 was administered just once 7 days before infection and showed significant efficacy in vivo. The efficacy of a single administration of CS-8958 after viral infection was then compared with that of repeated administrations of oseltamivir phosphate or zanamivir in mice and ferrets. CS-8958 showed efficacy superior or similar to the efficacies of the two licensed NA inhibitors. CS-8958 also significantly reduced the titers of an oseltamivir-resistant H1N1 virus with a neuraminidase H274Y substitution in a mouse infection model. These results suggest that since CS-8958 is characteristically long lasting in the lungs, it may be ideal for the prophylaxis and treatment of influenza.

Source: http://www.ncbi.nlm.nih.gov/pubmed/20047917

CS-8958 = LANI

Posted by Autosime > 2013-08-04 22:19 | Report Abuse

Amazingly low Enterprise value for current revenue streams, 231m Barda contract and future revenue.

Not often you find a company where key customer ( US Govt ) funds trials and development and the company maintains all the upside.

I expect institutional support to gain momentum following recent roadshows and a big rerate to follow

Posted by squizy > 2013-08-05 08:49 | Report Abuse

G'day USA... I am long term holder of Biota Bota ....which has just landed on your shores by way of reverse takeover... Seriously amazing opportunity for switched on investors ...as Biota is chasing a big stake of the flu pandemic and seasonal markets with its Laninamivir which is in stage 2 clinical testing for USA & rest of world markets (but already approved in japan) yep already approved in Japan!!! and it's outselling competitors in Japan...including Tamiflu... and they are being funded by Uncle Sam (BARDA Grant...to the tune of $231m ... just to test and get this product to the market... naturally once it's approved by FDA)
But the most EXITING part of this is that LANI is pretty much derisked as not only is it on the market in Japan, butit has been prescribed to over a million patients... whats not to Love about BOTA it's a smart bet on a sure thing... gotta love that.
The Journey begins >>> join us.

Posted by realitytrader > 2013-08-05 10:18 | Report Abuse

Keep watching the volume

Posted by squizy > 2013-08-05 11:21 | Report Abuse

Hi realitytrader I cannot see anything happening short term on volume as this is such a tightly held stock ... Plenty of well educated holders that are aware of this stocks intrinsic value... At these prices availability will remain scarce... However as demand increases supply could loosen up I guess...
Soon the lights will turn on and this stock opportunity will be recognised.
But do your own research as I am not an analyst or financial advisor...

Posted by realitytrader > 2013-08-05 11:40 | Report Abuse

Hi Squizy - will be interesting to watch and agree that it is tightly held (many will be holding till at least Phase 2 LANI results are released) , but as brokers get briefed and in turn initiate coverage, we could see nice steady price movement even on low but steadily increasing volume.

I'll simply be watching Historical Prices each day, with Aug 1st as my starting point and look for those steady volume increments.

Keep in touch.

Posted by Propinvestor88 > 2013-08-05 18:42 | Report Abuse

Cheap as chips folks!. For all those revenue generating assets, and yet the market only value Biota Inc at about US$118 million. Noting that US$70 million available in cash, the market enterprise value of Biota is only about US$48 million. Just simply incredible value for this one when you compare with its peer Biocryst.