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JP Morgan 2016 - Day 1
January 11, 2016
The 34th annual JP Morgan Healthcare Conference is being held in San Francisco, CA from January 11-14, 2016. A list of events and
catalysts that were announced or updated at the conference today is included in this report.
Below are some key points from today’s company presentations:
For our disclosures, please read the BioMed Tracker Research Standards.
Below are some key points from today’s company presentations:
- Drug pricing has received a lot of negative press, so at the opening luncheon, it was interesting to hear JPM Chairman and CEO, Jaime Dimon suggest that nothing would really change with a new administration. He did add, however, that a new administration could address tax policy that would affect acquisitions that effectively move companies overseas like the recent Pfizer-Allergan deal.
- Medivation (MDVN) disclosed a new SREBP inhibitor, MDV4463, that has reached clinical development. The SREBP inhibitor is still being evaluated for safety but could eventually be developed for NASH, hyperlipidemia, diabetes, obesity, and metabolic syndrome. MDVN also suggested that its PD-1 inhibitor pidilizumab (which was acquired from Curetech) is likely not primarily a PD-1 inhibitor. Its MOA for efficacy is in fact not fully understood by the company, although the company is fully pursuing DLBCL as its fastest path towards regulatory approval. Finally, look forward to continued evaluation of Medivation’s lead drug, Xtandi (enzalutamide) as it expands its potential therapeutic use including data from PLATO evaluating treatment through rising PSA levels in 2H2016.
- Incyte (INCY) announced a collaboration to evaluate the combination of INCB39110, a JAK1 inhibitor, with Tagrisso (osimertinib), AZN’s recently-approved EGFR inhibitor. The company also indicated that it was moving both an anti-GITR and ANTI-LSD1 drug into clinical development in 1H2016. The company also reiterated that it was moving forward with its INCB50465 PI3K-delta inhibitor instead of its similar INCB40093 drug.
- Biomarin (BMRN) reported numerically positive, albeit preliminary, data from an uncontrolled Phase II trial of reveglucosidase alfa in late-onset Pompe's disease. The company needs to meet with regulators to discuss what will be needed for Phase III/registration.
- The Medicines Company (MDCO) announced initiation of its Phase II ORION-1 study, as expected, evaluating quarterly and bi-annual dosing in patients with elevated LDL-c and atherosclerotic cardiovascular disease (ASCVD) or risk equivalents. Completion is expected by the end of 2016. If successful, the regimens would be more convenient than biweekly and monthly dosing for current competitors. The company has also started dosing its proof-of-concept intravascular ultrasound (IVUS) study, MILANO-PILOT, for MDCO- 216, a synthetic HDL. The first interim analysis is projected for the first half of 2016.
- Vertex (VRTX) recently began clinical development of two next generation correctors, VX-152 and VX-440, being studied in triple combination with VX-661 and ivacaftor for up to 14 days in Phase I. Safety results are expected mid-2016, such that Phase II studies could start in the second half of 2016. Based on preclinical results, these drugs are expected to substantially improve treatment and provide treatment for heterozygous F508del patients, as well.
- Ionis (IONS) presented a new analysis of data from its trial of nusinersen in infants with SMA, showing markedly improved ventilation-free survival compared to a matched natural history cohort. Officials noted the number of patients over 2 years of age with nusinersen, with a couple at least 3 years old, was unprecedented. Officials also pointed to improvements in children with SMA, with 3 non-ambulatory patients who were able to walk with treatment. Phase III trials are underway, with results expected early 2017, but officials noted they are in discussions with regulators on bringing the drug to market as quickly as possible for infants.
- Coherus BioSciences (CHRS) and Baxalta (BXLT) announced positive top-line results for its etanercept biosimilar, CHS-0214, in rheumatoid arthritis, though details were not provided. The data follows on the heels of similar top-line data for psoriasis last November. An MAA filing is expected in the second half of 2016, but the company did not give an update on US plans.
- United Therapeutics (UTHR) noted Medtronic had answered questions from the FDA regarding their Synchromed II implantable pump for Remodulin, and has a PMA approval expected in March. As a result, UTHR filed an SNDA for Remodulin in December, with a 10-month time frame, though UTHR is working to accelerate that. The pump has significant convenience advantage over current pumps, which are worn externally.
For our disclosures, please read the BioMed Tracker Research Standards.
| Disease Group Covered: |
Autoimmune/immunology
Cardiovascular Dermatology Endocrine Gastroenterology (Non Inflammatory Bowel Disease) Hematology Infectious Disease Metabolic Neurology Oncology Ophthalmology Psychiatry Renal Respiratory Rheumatology (Non Autoimmune) |
| Indications Covered: | Dysmenorrhea |
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