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Weekend Biotech Reading List

05/17/2013

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And the Award for Clinical Futility Goes To
Derek Lowe (In the Pipeline)

Are Biosimilars Ethical?
David Williams (Health Business Blog)

ASCO 2013 Highlights PD-1 and PD-L1 Immunotherapy
Sally Church (Pharma Strategy Blog)

Orphans Find a Home
Lisa Jarvis (Chemical & Engineering News)

US Would See Clinical Trials Reporting Transparency Under New Legislation
Alexander Gaffney (Regulatory Focus)
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STEM MACK TSPT MAXY MSTX: Investor Relations Q&A posted

05/17/2013

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A new set of May 2013 investor relations (IR) questions and responses from biotechs provided by Mike O'Neill has been posted, covering financials and upcoming catalysts for each biotech stock. 

This round of responses features StemCells Inc STEM, Transcept Pharma TSPT, Merrimack Pharma MACK, Maxygen MAXY, and Mast Therapeutics MSTX.

Check out the complete index of all IR Questions and Answers if you missed the previous editions - now covering >70 biotech and pharmaceutical companies!
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Weekend Biotech Reading List

05/09/2013

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We The People vs. The Pharmaceutical Industry
Bernard Munos (Forbes)

Is Glyphosate Poisoning Everyone?
Derek Lowe (In the Pipeline)

FDA Patient Network
Doing my contractual duty...a new patient-focused web portal from FDA which has been getting good reviews so far

Deciphering the 10-K
The Financialist (hat tip to Josh Brown, one of the best follows on all of Twitter)

PhD Biopharma CEOs: Better, Bolder, Or Occasionally Lucky?
David Shaywitz (Forbes)

Lessons For Drug Development From The Aveo Buzzsaw
Luke Timmerman (Xconomy)

FDA: From Risk Aversion to Approval Activism
Ben Comer (PharmExec Blog)

4 Behavioral Biases And How To Avoid Them
Investopedia

How can Merck look itself in the mirror?
Josh Bloom (Medical Progress Today)
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ASCO 2013: PI3K inhibitor clinical trials data presentations

05/06/2013

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It is that time again.... the annual meeting of the American Society of Clinical Oncology (ASCO) is just around the corner in early June. Abstracts will be released May 15th, so we will begin to feature key presentations both here at BiotechDueDiligence and at HSP90 Central.

Featured in this post are the phosphatidylinositol-3-kinase (or PI3K) inhibitors. Featured drugs include IPI-145 (Infinity Pharmaceuticals $INFI, BYL719 and BKM120 (Novartis $NVS), idelalisib (a.k.a. GS-1101, CAL-101; Gilead Sciences $GILD via Calistoga Pharma), and SAR245409 (Sanofi $SNY). Thanks to @zDonShimoda for compiling this list and allowing me to share it with you. You can find similar compilations related to ALK and HSP90 inhibitors.

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ISIS NBY BLRX IMMU SSH - Investor Relations Responses Posted

05/03/2013

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A new set of recent investor relations (IR) questions and responses from biotechs provided by Mike O'Neill has been posted, covering financials and upcoming catalysts for each biotech stock. 

This round of responses features Isis Pharmaceuticals $ISIS, NovaBay Pharmaceuticals $NBY, BioLineRx $BLRX, Immunomedics $IMMU, and Sunshine Heart Inc $SSH.

Check out the complete index of all IR Questions and Answers if you missed the previous editions - now covering >70 biotech and pharmaceutical companies!
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LGND: highlights from partner Onyx Pharma year-end 2012 earnings call re KYPROLIS (carfilzomib)

05/01/2013

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A major contributor to the strength in the shares of Ligand Pharma LGND over the past several quarters has been attributable to their single-digit royalty on sales on the multiple myeloma drug KYPROLIS (carfilzomib) from partner Onyx Pharmaceuticals ONXX. This post captures highlights and discussion regarding this drug from the recent ONXX earnings conference call.

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SPPI: Spectrum Pharma 4q-2012 earnings notes part 2

05/01/2013

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The first part of my summary of news and notes from Spectrum Pharma's year-end earnings conference call focused on apaziquone, the bladder cancer drug that missed in phase 3 and was recently returned by partner Allergan. You can read SPPI Part 1 here.

Part 2 will cover other highlights, particularly regarding Fusilev and Zevalin. Of course all of these comments should be taken with a grain of salt given the bombshell press release SPPI released a couple weeks later. In some cases the change in commentary in such a short period of time is very difficult to reconcile.

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SRPT ISIS GSK: key presentations at Cold Spring Harbor RNA conference

05/01/2013

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RNA and Oligonucleotide Therapeutics
April 10 - 13, 2013
Cold Spring Harbor Laboratory (CSHL)
Conference homepage link

Organizers:
Ryszard Kole, Sarepta Therapeutics 
Adrian Krainer, Cold Spring Harbor Laboratory
Art Krieg, RaNA Therapeutics
Bruce Sullenger, Duke University

There was a great deal of discussion around this conference, and particularly the data presentation by GSK/Prosensa for their Duchenne Muscular Dystrophy DMD drug drisapersen. This drug is of course the key competitor to eteplirsen from Sarepta Therapeutics SRPT. Key links and info are archived in this post.

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Weekend Biotech Reading List

04/26/2013

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The Devil is in the Details: What BioPharma Press Releases Don’t Say
Stewart Lyman (Xconomy)

Doctors Denounce Cancer Drug Prices of $100,000 a Year
New York Times

Data Submitted Before 2010 shouldn't be Used to Approve Biosimilars, Group Says
Alex Gaffney (Regulatory Focus)
This fight may seem far-fetched but I don't see it going away anytime soon.

An Open Letter To The PhRMA CEO On Pharma's Image
John LaMattina (Forbes)

From Assets to Zen: Building Successful Drug Hunting Relationships
John Mendlein (Xconomy)

ASCO 2013: it's coming...the annual American Society of Clinical Oncology meeting that is. Check back for much more coverage here at BiotechDueDiligence and HSP90 Central in the weeks to come (the first two preview posts are live now over on the HSP90 Central blog). So far, presentations titles have been released, but not fulltext abstracts with the actual data. You can search for presentations related to you favorite stock or drug using the ASCO13 iPlanner.
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ISIS: Quick Notes from Roche Huntington's Disease Webcast

04/24/2013

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On April 8, 2013, Isis Pharma and Roche announced a new alliance around treating Huntington's Disease with an antisense approach to target huntingtin (HTT). Here are the quick highlights from the webcast (no slide deck):
•  $30m upfront and typical Isis option deal with total of $362m milestones
•  Royalties are tiered and double digit but stay below 20%
•  Initial approach to target wild-type and mutant HTT but could also try to target just mutant form in subset of patients
•  Still early preclinical stage, have not yet selected a development candidate for IND enabling studies
•  Would not commit to phase 1 timeline (late 2014?)
•  As of now Isis only gains access to Roche brain shuttle technology for the HTT target.
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