The strong rebuke by the FDA and its Oncologic Drugs Advisory Committee (ODAC) to ASTX's attempt to gain approval for DACOGEN (decitabine) for elderly AML patients raised significant doubts as to whether the drug will gain approval in this indication in the US or Europe. If not, increased attention will shift to the rest of the company's pipeline. The slide deck from the companies joint analyst and investor R&D day in April 2011 is a good place to start. Find these presentations below and as always get more details on the ASTX research pages. Look forward to additional analysis of these programs here at BiotechDueDiligence and for Chimera Research Group subscribers.
On 2/14/2012 Karo Bio (Stockholm $KARO; OTC $KARBF.PK) announced the termination of their eprotirome program for dyslipidemia after discovering long-term safety issues in preclinical studies.
This eliminates a competitor for ISIS (KYNAMRO aka mipomersen) and AEGR.
The company had planned to spin off their preclinical research and development operations, but since that is all they have now, those plans have been scrapped. Does anyone have any comment about these programs? See embedded slide deck below if interested.
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You may have noticed the news stories this morning announcing a patent litigation settlement between Mylan/Pfizer (the makers of the branded Epi-Pen epinephrine product) and Intelliject/Sanofi.
Intelliject and SNY received tentative FDA approval for their 505(b)(2) application for e-cue, a novel epinephrine delivery device in July 2011. This agreement will allow this competing product to enter the market in November 2012.
Antares $AIS and Teva are developing a generic epi-pen and have filed an ANDA. Pfizer (originally King Pharma $KG) filed patent infringement lawsuits (based on more recently issued patents around a "next-generation" autoinjector) against Teva/AIS and Intelliject/SNY. The consolidated trial was scheduled to begin this week, but now will only involve TEVA/AIS vs PFE.
What does the settlement mean for AIS? Keep in mind that TEVA and AIS are seeking approval for a generic (ANDA pathway) device that closely resembles the branded product, while the Intelliject auto-injector is vastly different (link). Therefore the degree to which the two products potentially infringe on the branded epi-pen is dramatically different.
Certainly a settlement between PFE and TEVA/AIS is still possible, but one shouldn't read much into the terms (especially negotiated launch date) in the settlement announced today as an example. For now, the trial is underway and we will await further developments. Launch of the epi-pen or another Teva-partnered injector product is a crucial milestone on the path to profitability for Antares Pharma that has been repeatedly delayed.
To make the best use of my efforts, I've decided to stop maintaining a comprehensive catalyst calendar here on the BiotechDueDiligence site. The information that I have published on the Upcoming Events will continue to be available going forward in a number of different ways:
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