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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.
 
 
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.
 
 
A bit early this week and back after a brief hiatus, but here is another installment of the BiotechDueDiligence weekend biotech reading list.

 
 
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 Inovio Pharmaceuticals INO, Prima Biomed PBMD, QLT Inc QLTI, Immunocell ICCC, and Tesaro Inc TSRO.

Check out the complete index of all IR Questions and Answers if you missed the previous editions (covering >60 biotech and pharmaceutical companies)

 
 
This post features recent comments from a couple of competitors to Optimer Pharmaceuticals $OPTR in the Clostridium difficile associated diarrhea (C. difficile or CDAD) market.

For prior coverage, start with the OPTR and CBST stock research pages, click on the blog archives for either company, or use the site search box at the top of the page.

 
 
This post will highlight comments on the Sanofi $SNY year-end 2012 conference call relevant to Isis Pharmaceuticals $ISIS, partner for the development and commercialization of KYNAMRO (mipomersen) for familial homozygous hypercholesterolemia.

 
 
This post features comments from the Teva Pharmaceuticals $TEVA year-end 2012 earnings conference call that are relevant to companies covered here at BiotechDueDiligence.

As usual the discussion centers COPAXONE for multiple sclerosis, which Momenta Pharmaceutical $MNTA and partner Sandoz (Novartis $NVS) are seeking approval for a generic version of.

Related coverage:
MNTA and biosimilars - notes from other biotech/pharma conference calls
Other blog posts related to TEVA and MNTA

(continued)

 
 
This post will highlight updates provided on the Merck $MRK 4q-2012 earnings conference call related to the MK-8931 BACE inhibitor program partnered with Ligand Pharma LGND for Alzheimer's Disease.

Additional coverage:
Info from Merck R&D presentation about MK-8931
MK-8931 data presented at 2012 AAIC conference
Links of interest regarding drug discovery against the BACE target
Merck announces phase 2/3 plans for MK-8931

 
 
This afternoon, investors, patient advocates, and the cancer research community get their first glimpse at clinical data from an RNAi therapeutic targeting polo-like kinase 1 (PLK1), in development by Tekmira Pharmaceuticals $TKMR. Preliminary phase 1 safety and efficacy data are being presented by Dr. Ramesh Ramanathan at the American Association for Cancer Research (AACR) Annual Meeting in Washington, DC.

 
 
Orphan Diseases: Rare Rivalry
Tanya Lewis - Medical Marketing and Media (h/t @bradloncar)
On AEGR Juxtapid (lomitapide) and SNY ISIS Kynamro (mipomersen) in homozygous familial hypercholesterolemia.

Gilead Sciences Building on HIV, Becoming Cancer [and inflammation] Drug Force
Luke Timmerman (Xconomy)

Novartis, Gleevec, and Indian patents? An odd trifecta for a big news story, here are some details from various perspectives...
Novartis press release
New York Time article
In the Pipeline blog (Derek Lowe)

SEC’s New Social Media Guidance: Sensible, Fair, Inevitable
Brad Loncar (Xconomy)

Myths In The Pricing Of New Drugs
John LaMattina (Forbes)

Biosimilars are not similar enough: a proposal for true "biogenerics"
Drug Baron blog
Calls for mandatory licensing of production info after an exclusivity period as alternative to current biosimilar pathways.

Fewer ODAC Meetings? It's not your imagination!
Peggy Eastman (Oncology Times) with comments from Richard Pazdur

Leading Health-care Organizations Issue Guideline Recommendations for Molecular Testing and Targeted Therapies
The ASCO Post
New recommendation: ALL advanced lung adenocarcinoma patients should be screened for EGFR and ALK mutations.