BioMedTracker's JPM Drug News: Day 2
This article was originally published in Scrip
Every day of the 34th annual JP Morgan Healthcare Conference in San Francisco, analysts from BioMedTracker – an affiliate of Scrip Intelligence – produce a report detailing the drug events and catalysts that are announced or updated at the meeting. See below for the highlights, and click on the link at the bottom for a complimentary copy of the full report.
Key Points – Day 2
?The second day of JPM saw several large companies providing fairly general overviews. Bristol-Myers Squibb (BMY) focused on the continued expansion of its immune-oncology franchise led by guidance for the continued development of Opdivo across tumor types, including a foray into DLBCL. Sanofi (SNY) suggested a transformative year 2016 as the company works to maintain its diabetes franchise and gain a small foothold in oncology, likely through acquisitions. Finally, GlaxoSmithKline (GSK) disclosed plans to submit regulatory filings for Benlysta SC for lupus in 2016.
?Astellas (4503:JP) presented new data from its Japanese lung cancer study of ASP8273, its entrant into the next generation of EGFR inhibitors. ASP8273 trails Tagrisso (AZN), which has already been FDA approved, and rociletinib (CLVS), for which an NDA has already been filed.
?CureVac provided guidance for its prostate cancer drug, CV9104. The company announced that top-line data would likely be available in 2016.
?Immunogen (IMGN) suggested that its highly anticipated data for mirvetuximab in ovarian cancer would likely be presented at the 2016 ASCO. The company also said IMGN779 from its new class of DNA alkylating agents would enter Phase I clinical study for AML in 1H2016.
?Acadia (ACAD) expects to report first results from its Phase II study of Nuplazid in Alzheimer's disease during the second half of 2016.
?For its cardiovascular franchise, Amgen (AMGN) reiterated important catalysts for Repatha in the second half of 2016, which should demonstrate that its LDL-c lowering does improve atherosclerosis and CV events: top-line data from both the cardiovascular outcomes study and the IVUS coronary imaging study. Officials view the latter as a complementary differentiating factor. AMGN's presentation had Rx data showing Repatha and competitor Praluent are currently running neck and neck, but with only about 400 total Rxs per week each. AMGN officials hope payer utilization management criteria will change with positive results from the outcomes study. REGN/SNY are expecting interim analyses in Praluent's cardiovascular outcomes study in 2016, with a futility analysis at 50% of events and, in H2, a futility/overwhelming efficacy analysis at 75% of events. If those are negative, the final results are expected in H2 2017, per SNY's presentation at the conference (REGN's presentation will come tomorrow, but they already released the slides). In heart failure, AMGN officials were excited about the prospects for omecamtiv, but still need to go through several hurdles for a decision on Phase III.
?Amicus (FOLD) had new, patient-level data on migalastat's impact on diarrhea in Fabry disease, showing more clearly the larger separation at higher levels of baseline symptoms, though the number of placebo patients in the higher baseline group was small. The company expects to submit answers to the day-150 EMA questions shortly, with a CHMP opinion continued to be expected early 2016. It still needs to meet with the FDA later this quarter to determine on a regulatory pathway (because of mixed data). For its epidermolysis bullosa drug, Zorblisa, acquired with Scioderm, the company noted the Phase III was powered for a difference on target wound healing of ~17%. It just barely saw that degree of difference in the small Phase IIb in the ITT population (19%), but there was a substantially larger difference in the evaluable population (41%). It is also selecting patients with larger and more chronic wounds to improve the chances for a positive study. The Phase III trial is approximately half enrolled, and officials extended the estimate for top-line data to H2 2016.
?On the diabetes front, Lilly (LLY) expects positive cardiovascular outcomes data from SGLT2 inhibitor Jardiance to be added to its label in the US and EU in 2016. Data for the Phase IIIb MARLINA study of DPP4 inhibitor Tradjenta in patients with albuminuria is also expected, but will likely just be released as the data are presented at a medical meeting. Sanofi announced plans to start Phase III trials in Q4 for a couple of diabetes drugs it licensed in November 2015, SGLT2 inhibitor sotagliflozin (which also has SGLT1 properties) and GLP1 agonist efpeglenatide. However, these compounds are late to the game and it is unclear if they are differentiated enough to have much impact.
To download a complimentary copy of BioMedTracker's full 42-page Day 2 report, click here.