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A message to all readers as BiotechDueDiligence turns 2 years old!

1/30/2013

To my readers,

This week marks the two-year anniversary of the BiotechDueDiligence website and my @BioDueDiligence Twitter feed. Back then I was a post-doc with a hobby-sized brokerage account, a laptop full of SEC filings, spreadsheets, slide decks, and journal articles plus a few notebooks of illegible notes from webcasts and telephone conversations. I thought I would use a website to organize my thoughts on various biotech stocks, and if a few other people found it useful, so much the better. I had no expectations, but the journey from that day to where I am now would have blown away any aspirations I could have had.

Despite changing day jobs twice, becoming a father, and losing some hair since then, I am still pretty much that same guy who would happily spend any day researching and talking about all things biotech with anyone and everyone within "earshot" of my voice, tweets, blog entries, or websites.

(Continue reading after the jump)

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New Feature: Mike O'Neill's "Investor Relations Questions"

1/28/2013

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I am very excited to announce a new feature for BiotechDueDiligence readers. Fellow biotech enthusiast Mike O'Neill (be sure to follow him on Twitter @MikeOinSATX) has graciously agreed to archive his biotech investor relations questions ("IRQs") and answers here on the website.

What are the "IRQs"? Mike starts his due diligence on any biotech stock by asking their IR department the same five questions.

Continue reading for a brief introduction to Mike's philosophy and the key topics about which he asks each and every biotech company on his watch list:

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CELG CELGZ THLD CRIS: Selected ASCO GI Abstracts

1/23/2013

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The 2013 ASCO Gastrointestinal Cancers Symposium (ASCO GI 2013) is set to take place January 24-26, 2013. So far the most buzz has been around the release of successful (but perhaps not as stupendous as some thought) phase 3 pancreatic cancer data for ABRAXANE from Celgene CELG.

The CELG data, Abraxane's likely FDA approval for pancreatic cancer (NDA anticipate 1h-2013), and the future sales of Abraxane are all key to the value of the CELGZ contingent value right (CVR) issued as part of the Abraxis buyout. Find all the CELGZ financial details here.

Continue reading below for the Celgene abstract as well as a couple of others from Threshold Pharma THLD (phase 2 pancreatic cancer data for TH-302 - not sure if anything new here, please let me know in the comments section if so) and Curis CRIS (another unsuccessful clinical trial of ERIVEDGE/vismodegib) in an indication other than basal cell carcinoma/BCC).

You can search all ASCO GI 2013 abstracts here.

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LLY: BACE inhibitor Alzheimer's disease data at #AAN13

1/18/2013

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Eli Lilly (click here for all LLY-related content on BiotechDueDiligence) will present phase 1 data on their BACE inhibitor LY2886721 (in development for Alzheimer's disease) at the annual meeting of the American Academy of Neurology (#AAN13) on March 18, 2013. Continue reading below for the fulltext abstract.

LY2886721 has a number of competitors, including MK-8931 from Merck MRK and Ligand Pharma LGND. As you'll see in the data below, the Lilly drug is inferior to MK-8931 in terms of the reduction of CSF levels of AB1-40 (alpha-beta 1-40) peptide after 14 days of treatment (maximum decline of 74% vs. 94%). Of course we have a long way to go before we have any idea if either drug will be effective in treating Alzheimer's disease.

Click here for data from four abstracts on MK-8931 presented at the 2012 AAIC meeting (see where the 94% figure came from...)

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ISIS BIIB: Isis Pharma and Biogen Spinal Muscular Atrophy data at AAN 2013

1/18/2013

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Isis Pharma stock (click here for index of all ISIS content on BiotechDueDiligence) has been on fire ever since the positive buzz and commentary about early signs of clinical benefit surrounding their early stage antisense program for the devastating childhood disease of spinal muscular atrophy (SMA). The drug, targeting the splicing of the SMN gene, is partnered with Biogen $BIIB and is in phase 1/2 development.

Early-stage clinical trial data for ISIS-SMNrx will be presented at the American Academy of Neurology (#AAN13) annual meeting on March 20, 2013. Continue reading below for the fulltext abstract of the data to be presented. Investors, patients, and the medical community will all be hoping for greater details at the actual platform presentation.

Oh, and don't forget that ISIS and Sanofi/Genzyme $SNY have an upcoming FDA PDUFA date for KYNAMRO (mipomersen) for homozygous familial hypercholesterolemia. Competitor Aegerion Pharma AEGR recently won FDA approval for JUXTAPID (lomitapide), but ISIS was rejected by the EU and faced greater criticism from a November FDA panel, leading to greater concern about mipomersen's prospects for approval.

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<<Previous

A message to all readers as BiotechDueDiligence turns 2 years old!

New Feature: Mike O'Neill's "Investor Relations Questions"

CELG CELGZ THLD CRIS: Selected ASCO GI Abstracts

LLY: BACE inhibitor Alzheimer's disease data at #AAN13

ISIS BIIB: Isis Pharma and Biogen Spinal Muscular Atrophy data at AAN 2013

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