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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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AACR Preview Part 5: Late-breaking abstracts TKMR EXEL PCYC IMMU VRTX

04/03/2013

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In this post I will highlight some of the AACR Late-breaker abstracts that I am watching for, mostly related to clinical trial results. The big trials tend to be saved for ASCO in June, but there should be some interesting data nonetheless.

Full coverage:
Introduction
Preview Part 1 (SNTA, ASTX, NVS, INFI)
Preview Part 2
Preview Part 3 (ARRY, ASTX)
Preview Part 4 (ASTX, ARQL, BPAX)

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MNTA and biosimilars: notes from partners and competitors from 4q-2012 earnings

04/03/2013

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This post will summarize highlights from biopharma conference calls - including Novartis, Roche, Baxter, and Sanofi - that are relevant either to Momenta Pharma MNTA specifically, or to the biosimilars space in general.

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AACR Preview part 4: More Astex Pharma ASTX plus ArQule ARQL and BioSante Pharma BPAX

04/01/2013

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BiotechDueDiligence and HSP90 Central will be covering the 2013 AACR Annual Meeting live from Washington DC. This post will focus on abstracts to be presented by Astex Pharmaceuticals ASTX (partnered pipeline - see Parts 1 and 3 for internal ASTX assets), ArQule Inc ARQL, and BioSante Pharma BPAX.

Full coverage:
Introduction
Preview Part 1 (SNTA, ASTX, NVS, INFI)
Preview Part 2
Preview Part 3 (ARRY, ASTX)

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ASTX: Updates from partners' 4q-2012 earnings calls

03/04/2013

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Astex Pharma ASTX has a number of pharmaceutical company partners developing drugs on their behalf. This post will assemble and summarize key updates from this quarter.

DACOGEN: notes from partner and competitor calls can be found in a separate post. Watch for a future post analyzing DACOGEN royalties going forward (Astex guided for a decrease to $55m in 2013 vs $70m in 2012).

(continue reading for additional notes)

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MNTA Momenta Pharma and Biosimilars competition: updates for 3q-2012

12/17/2012

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2012 continues to be an eventful year for Momenta Pharma and their generic drug programs for Lovenox, Copaxone, and undisclosed biosimilars or follow-on biologics (FOBs). Continue reading below for a round up of updates from MNTA's partners and competitors in the space.

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Momenta Pharma $MNTA 1q-2012 partner, competition, and ASCO updates

05/11/2012

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ASCO: 
Momenta will present preclinical data for M402, their heparin-based drug that has just started a phase 1/2 trial in combination with gemcitabine for pancreatic cancer. Abstract will be out May 16th.

m-Enoxaparin (generic LOVENOX):

-no mention of the MNTA-BAX follow-on biologics (FOBs) / biosimilars collaboration on the Baxter quarterly conference call
-no mention of the long lost Teva Pharma $TEVA generic lovenox program on their 1q-2012 conference call.
-no discussion of enoxaparin on Novartis $NVS (Sandoz) 1q-2012 conference call.
-Sanofi $SNY 1q-2012 conference call comments (sorry for poor transcript) from Seeking Alpha and Morningstar has not yet posted one): "On the right side of the chart Lovenox performance even more remarkable, I believe was in €400 million just during the first quarter, a growth of 12%. So it says outside the U.S. where the product more or less never has been patent protected and is undergoing direct competition from [inaudible] many years. I believe [inaudible] inside US Lovenox performed [inaudible] patients mainly but not only due to the fact that we have seen no additional entries of a generic product. But I think it’s fair to say that also we have extreme customer loyalty [inaudible] evidently helped by continued supply problems of our existing competitors."
-Watson Pharma $WPI 1q-2012 conference call excerpts:
"Could you just comment a little bit about generic LOVENOX? How's that product doing for you?" 
"I think it's going all right. We're getting much better supply now. We were building up supply in the beginning. I think where the issue is, just to remind you, we only have the retail part of the business versus the non-retail. There were challenges in the beginning to only sell to the retail because many of our customers supply both retail and non-retail, including the hospitals. I think we have sorted those technical issues out pretty well, and we have steadily getting more market share. I think the prices have gone a little bit lower than we expected. We clearly see that both Sandoz and Sanofi have reacted to the market. But overall, we are quite pleased with where we are with the LOVENOX product."
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Novartis $NVS notes from webcast at Goldman Sachs 6/7/11

07/02/2011

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  • I don't follow big pharma names like Novartis $NVS as closely as I do the smaller companies in the BiotechDueDiligence coverage list, but I enjoy the free flowing format at the Goldman Sachs conference and they are a crucial partner for Momenta Pharma (Click here for MNTA research page) on generic Lovenox and Copaxone products, so I thought I would post a few notes.
  • See the Past Events page for the webcast link- they are still available as of 7/2/11, but I don't know how much longer that will be the case
  • I was hoping to learn about Novartis' perspectives on follow-on biologics (FOBs) aka biosimilars/biogenerics - was covered briefly, and the comments actually slightly increased my perspective on NVS as a potential FOB partner for MNTA
  • See my notes below (these are not a complete transcription by any means, just some highlights):
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