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Andrew Goodwin holds a Ph.D. in the cellular and molecular basis of human disease, with research experience in infectious diseases and cancer. After 11 years as an academic scientist I now work on the regulatory side of drug development. Aside from my day job, I operate the websites... More
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BiotechDueDiligence
  • 8 Possible Explanations For BioSante Pharma's 56% Pop 0 comments
    May 22, 2012 5:20 AM | about stocks: ANIP

    Theory 1: BPAX is about to conduct a reverse split, in-license a spectacular specialty pharma portfolio, and generate meaningful shareholder value
    Ha. Had you going there didn't I. Moving on.

    Theory 2: Recent Ceregene data
    BPAX, via its acquisition of Cell Genesys, also inherited a stake in privately held drug developer Ceregene. Ceregene has never run a successful clinical trial, but that hasn't stopped them from reanalyzing and re-announcing data from the same trial repeatedly. Last week Ceregene issued another press release from their failed phase 2 trial of CERE-120 in Parkinson's disease.

    Theory 3: ELESTRIN is flourishing now that Jazz Pharma has acquired the drug
    Oops. BPAX makes zero dollars from ELESTRIN. The paltry couple hundred thousand per quarter flows directly to Antares Pharma $AIS.

    Theory 4: ASCO data
    As I posted earlier, BPAX will present yet more data from their phase 1/2 trial of GVAX prostate cancer vaccine plus YERVOY (ipilimumab). Abstracts were announced May 16th, and this is relatively meaningless data mining via lab experiments of samples from an old trial. Any pop from this event would have come last week, as ASCO abstract release date is well known and is pretty much a national holiday among biotech investors. There will be another chance for stock movement based on this data in early June once the actual presentation at ASCO 2012 has occurred.

    Theory 5: Big news regarding LibiGel has leaked
    True, BPAX will make an announcement in the second quarter with regards to the future of the LibiGel cardiovascular safety study. And they may even be crazy enough to start a new efficacy study that seeks to avoid such a dramatic placebo effect. But no one cares anymore.

    Theory 6: GVAX Pancreatic cancer randomized phase 2 trial
    This one sure seems tempting, doesn't it? As BPAX frequently reminds us, the prestigious medical research institution Johns Hopkins (full disclosure...JHU is also my current employer) is conducting many of the GVAX cancer immunotherapy clinical trials. Today, 5/21/2012, a listing of cancer trials ongoing at Johns Hopkins is updated and includes this phase 2 trial in pancreatic cancer entitled "A Phase 2, Randomized, Multicenter, Open-Label Study of the Efficacy and Immune Response of the Sequential Administration of GVAX Pancreas Vaccine (with Cyclophosphamide) Alone or Followed by CRS-207 in Adults with Metastatic Pancreatic Adenocarcinoma"
    Exciting right? A big boy randomized phase 2 trial of GVAX Pancreas. The only problem is that this trial has been ongoing and recruiting patients since September 2011, as you can see in theClinicalTrials.gov listing. If you are a reader of the BiotechDueDiligence blog, then you have no excuse for being fooled. This trial was discussed in some depth at an October 2011 Cancer Immunotherapy conference in presentations by both BPAX and partner Aduro Biotech (see my notes from the webcast here)

    Theory 7: Mine
    Sometimes things are simpler than they appear. BPAX has been a daytraders stock for months. Last Friday, as the world was apparently coming to an end thanks to Facebook, Greece, and JP Morgan, BPAX traded all the way down to $0.33, roughly equal to net cash levels (access real-time valuation calculations here). Today was a strong day for the broad markets and especially biotechs. The smaller, junkier names seemed to perform best. Some bottom feeders got BioSante stock moving, and momentum plus the above "reasons" kept the pop intact. The fact that BPAX has little or no fundamental value remains unchanged - but only sometimes reflected in the stock price.

    Theory 8: Today's deal in the male testosterone spaceOur good friend and leading bio-skeptic Gekkowire sends along the most plausible explanation for the pop in BPAX stock today. Notice I said explanation, not reason. In short, Auxillium $AUXM and GSK entered into a co-promote agreement for Testim. This might have had some relevance if the Teva-BioSante male testosterone gel (Bio-T-Gel) was going to hit the market anytime soon. Or if BPAX owned any rights with which to make a deal. They don't, so this deal is meaningless except for underscoring the growing overall testosterone market. However, I do think that this news is the most likely explanation for the rapid rise in BPAX share price today - just don't expect it to last too long.

    Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

    Stocks: ANIP
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