Here's what BOTA bought for 16 million up front

as described in the abstracts of the 2013 Eurogin conference (see below comments).

It's good to see some movement, but the questions are all pretty obvious:

* the phase 2a was in 24 subjects of which  16 received the drug. While the statistical power wasn't formally sought, the differences with control were better but weren't huge. A lot of money for a compound tested in16 patients; and

* HPV subtypes 6 & 11 will gradually but definitely reduce in incidence and prevalence due to Gardasil and Cervarix vaccines, especially if countries vaccinate their boys as well as girls.

The market hasn't responded well so far. Cash is the Biota SP's best friend, and they just snubbed him.

*************************************************************************

SS 15-5
SAFETY, PHARMACOKINETICS AND EFFICACY PHASE II-A STUDY OF AP611074, A HPV-SPECIFIC TREATMENT
FOR ANOGENITAL WARTS:

Fouéré S1, Marchitelli C2, Tatti S3, Galimberti R2, Halioua B4, Dupin N5, Françon P6, Compère D6, Yaniv M7, Thierry F7,8,
Botchan M9, Blumenfeld M6 & Chosidow O10.
1STD Clinic, Hôp. St Louis, Paris, France; 2 Depts of Gynecology and Dermatology, Hospital Italiano, Buenos Aires, Argentina; 3 IADT, Buenos Aires, Argentina; 4STD
Clinic, Institut Alfred Fournier, Paris, France; 5Dept of Dermatology, Hôp. Cochin, Paris, France; 6Anaconda Pharma, Villejuif, France; 7Institut Pasteur, Paris, France;
8IMBaStar, Singapore; 9Dept Biochemistry and Mol Biol, UC Berkeley, USA ; 10Dept Dermatology, AP-HP, Hop. Henri Mondor, and UPEC, all in Créteil, France

Objectives: AP611074 is a new chemical drug that selectively inhibits the interaction of E1 and E2 proteins of HPV 6 and 11, and thus blocks HPV DNA replication. In
this study, we aimed to obtain proof-of-concept study of AP611074 in the topical treatment of anogenital warts (condyloma) related to HPV 6 or 11 infection.
Methods: We performed a phase IIa double-blind randomized clinical trial study to assess the safety, tolerability, efficacy and pharmacokinetics of twice daily repeated
applications of AP611074 5% gel during 42 days on the anogenital lesions of condyloma patients. Twenty-four patients (both males and females) were included and randomized
2:1 (AP611074 vs excipient). The study was multicentric and conducted between February 2012 and July 2013 in four clinical centers located in Paris, France
and Buenos Aires, Argentina. Main inclusion criteria were: male or female patient aged between 18 and 55 years ; BMI between 18 and 30 kg/m2 ; external condylomas,
1-15 lesions, non-confluent and individually isolated ; total lesion surface smaller than 5 cmÇ, and individual lesion surface smaller than 1 cmÇ ; lesions should be
easily measured by the Investigator using a “French Catheter Scale”. Safety, PK and efficacy evaluated by Investigators every week until the end of sudy visit. After completing
the 42 days treatment, patients were observed 14 days post-treatment. Non responder subjects underwent a biopsy of 1-2 lesions at end of study (EOS) visit to
assess if remaining lesions contain HPV6 and/or HPV11. The efficacy objective was assessed after 6 weeks of treatment through primary efficacy end point of complete
clearance rate, secondary efficacy end points of partial clearance and overall response rate, and an additional exploratory analysis of the reduction of the total condyloma
baseline area.
Results: AP611074 topical treatment was shown to be safe with low systemic exposure and was well tolerated as shown by high patient compliance and lack of adverse
events.
Plasma concentrations of AP611074 were very low, steady state was rapidly achieved, no drug accumulation was observed over the 6 week-treatment and no drug was
quantifiable 2 weeks after stopping the treatment.
Efficacy end points showed complete clearance rates of 13% (CI95%: 4-36%), partial clearance of 44% (CI95%: 23-67%), and overall response of 56% (CI95%: 33-77%) in
the FAS population while in the PP population, these rates increased to 20% (CI 95%:6-51%), 50% (CI95%:24-76%) and 70% (CI95%:40-89%), respectively. As expected,
due to the very low power of the trial (<10%), no differences were observed in the primary and secondary efficacy end points in the intergroup comparison.
When the condyloma area was analyzed after 6 weeks of treatment, a 65% reduction of the baseline lesion area was observed in the AP611074-treated patients. This
reduction was statistically significant (p=0.020) when before/after treatment areas were compared intragroup.
Conclusions: AP611074 showed elevated rates of complete and partial clearance and overall response, as well as statistically significant reduction of the baseline lesion
area. The clinical effect that has been observed in this first trial of 6 weeks duration needs to be further investigated in larger adequately powered efficacy and safety
studies of longer duration.
AP611074 is the first drug candidate designed to block HPV replication to enter clinical development, and one of the first examples to show that Protein-Protein

and krensavage too

Krensavage a little late on reporting its buy..

That's another specialist bio fund, and one that likes to buy companies rather than drug prospects.

Read all about it

The new positions in Biota were published today (for transactions in the quarter ending 31 December).

Many funds had either significantly sold down or completely sold out of Biota in that quarter, explaining the large chunky sales.

BlackRock and JP Morgan were the heaviest sellers.

In their place 2 or 3 specialist biotech funds have emerged as holders: RA Capital, Senzar Asset Management and to a smaller extent a new fund Venbio.

Further, East Hill emerged from its hibernation and bought another 400,000 taking it to just under 10% of the company.

Baker Bros and a couple of others held their nerve. Broadfin is still there, but didn't buy more.

And why not I guess: the stock is at cash backing, so hopefully it has hit the bottom. Unlike some biotechs with no cash, where the bottom can be very deep and distant.

One small thing that emerges are the number of links to Vertex: Landon Clay, RA Capital, and a couple of other smaller links.

The BIO CEO presentation was interesting. Not so much for the presentation, but for the questions. Biota management get to field very few questions publicly. Joe Patti was forced to acknowledge a key issue in the company's strategy for vapendavir. If they keep ignoring it, it won't go away.

Vap might prove to be effective, in asthmatics with proven HRV infection. Let's say it is, for the sake of argument. 

The subset of proven HRV to clinically enrolled HRV might be as low as 40%. OK. When the drug goes to the FDA itself and its subcommittees, it's plausible, maybe even likely, that the FDA might say two things:

1. That any level of adverse effect is unacceptable (see plecoranil) given many people without HRV might take it and/or

2. That it's not reasonable to treat the 60% of people with clinical common cold symptoms who don't have HRV to get a response in the 40% who do. This is because HRV is self-limiting. SO, they might approve the drug in proven HRV exacerbations. Which would be fine, if there was a rapid HRV test. Which there isn't yet.

The BARDA contract is nearly disentangled. That became more of an issue than analysing or explaining why they stopped the trial. We have very little information on that.

Relenza and LANI will earn a little more than expected this FY which is great news because the only thing supporting the sp is cash, and the more BOTA burns cash the more the sp will drop.

Finally, no news on LANI. A 10-20 million dollar upfront and a few % royalty is probably all that can be hoped for, but there will be some element of credibility in inking a deal, and the cash will be useful as an addition to a takeover... sometime next year. 

I don't know what East Hill and Broadfin are asking management and the board to do. But settling BARDA, settling LANI, and packaging the cash and royalty streams with vapendavir and RSV might be somebody's idea of a reasonable purchase.