LGND - data from partner Pfizer PFE on Aprela (SERM/estrogen) for menopause from ENDO201211/10/2012 Thanks to a helpful tweet from the Ligand Pharma $LGND corporate twitter handle, I tracked down all of the Endocrine Society annual meeting (ENDO 2012) abstracts related to Aprela - a selective estrogen receptor modulator bazedoxifene (SERM, sold as Viviant/Conbriza) combined with conjugated estrogen. This product is approved in Europe, but the filing of a US new drug application (NDA) with the FDA has been repeatedly delayed, but most recently was guided to occur in 2012. Continue reading here for more details on the data presentations.
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GlaxoSmithKline $GSK and Ligand Pharma $LGND face a late November FDA PDUFA date (priority review) for their sNDA seeking approval of PROMACTA (eltrombopag) for the treatment of HCV-related thrombocytopenia. See below for abstracts accepted for presentation at AASLD 2012 in November. Also check out the first data presentation for Ligand's internal HCV program.
In its acquisition of Metabasis $MBRX, Ligand Pharma $LGND acquired the HepDirect liver-targeting technology. While some of these assets were licensed to Chinese biotech Chiva, some internal R&D remained. We for the first time see data on their guanosine nucleoside prodrug LG-7501 - see complete details below.
Ligand Pharma $LGND has built a business around a large portfolio of partnerships in which other biotech and pharma companies develop drugs at no cost to LGND. The upside to shareholders from any one deal is lower, but the many "shots on goal" and growing royalties from PROMACTA and KYPROLIS offer a lower risk investment opportunity compared to many biotechs.
Continue reading below for a round-up of notes on LGND-partnered programs from a number of partners from 2q-2012 earnings conference calls. ASCO: Ligand and GlaxoSmithKilne $GSK will present early stage data for the use of PROMACTA (eltrombopag) in chemotherapy-induced thrombocytopenia at ASCO 2012 in June. Also, partner Merck will present phase 2 melanoma data for SCH727965. Finally, there will be several presentations from Onyx Pharma $ONXX related to carfilzomib. Abstracts will be released May 16th so stay tuned. First quarter 2012 Partner Updates: Merck $MRK and Baxter $BAX have partnered programs with LGND that were not discussed on their respective 1q-2012 earnings calls. Partner Onyx Pharma $ONXX also has the multiple myeloma drug (which utilizes Ligand Captisol formulation technology) up for a FDA panel review and PDUFA date this summer. I have not seen a 1q-2012 conference call transcript or listened to the webcast, but I don't think there have been any material updates while we wait for those fey FDA events. I speculate that evacetrapib is the undisclosed Eli Lilly $LLY programs slated to enter phase 3 in 2012 that utilizes LGND Captisol technology. As this drug is a member of the troubled CETP inhibitor class, I will carefully monitor to see if this phase 3 program actually begins (and to verify if this is indeed the program partnered with Ligand). With that caveat, here are the relevant excerpts from the conference call: "We anticipate beginning Phase III trial for evacetrapib, our CETP inhibitor" Q: "anything to update us on the timing and design of the evacetrapib studies?" A: "As you know, we communicated our very promising data then in the fall and we are doing extensive planning them for the Phase III trial including interaction with regulators, which we are close to completing. We have also been preparing the CMC material for the trial. So we feel very good about the options we have to start the trial before the end of this year as we have communicated." |
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