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JP Morgan 2017 - Day 1
January 09, 2017
The 35th annual JP Morgan Healthcare Conference is being held in San Francisco, CA from January 9-12, 2017. 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 Biomedtracker Research Standards.
Below are some key points from today’s company presentations:
- The meeting kicked off with the blockbuster announcement that Takeda will acquire Ariad (ARIA) and its oncology
portfolio for approximately $5.2b. In March 2016, Takeda announced its strategic roadmap where it placed the oncology,
gastroenterology, and central nervous system (CNS) franchises as its top R&D priority moving forward. The acquisition of Ariad reinforces
Takeda’s commitment to its oncology portfolio, as the acquisition brings in multiple pipeline drugs in development for solid tumors.
Specifically, the two major drugs adopted from the acquisition are brigatinib for NSCLC and the already approved Iclusig for ALL and
CML. The acquisition is also aligned with Takeda’s plan announced in 2016 of rearranging R&D, in an endeavor to concentrate its efforts
in the US and Japan, greatly reducing its presence in the UK. This acquisition is a step forward in the company’s restructuring goal to
optimize R&D operations.
- Surprisingly, the new CEO of Biogen (BIIB) spent little time discussing any potential differentiators for
aducanumab in Alzheimer’s disease following the high-profile failure of LLY’s solanezumab. However, he gave guidance for some data
to be presented in the next 12-18 months. In the meantime, the CEO also said to expect the company to take a “calculated risk” to add to
its pipeline but failed to give any additional details or list of any targeted companies.
- Jazz (JAZZ) is expecting to see 5 regulatory submissions and 4 clinical study initiations in 2017 and early 2018. In the near-term, JZP-110 draws interest as the Company expects to see top-line data from the Phase III studies in obstructive sleep apnea and narcolepsy in the first quarter and second quarter of 2017, respectively. If successful, these studies could support an NDA submission by late 2017. Looking farther down the road, the Company’s Xyrem follow on products, JZP-507 and JZP-258, are significant additions to Jazz’s pipeline and could be on the market as early as 2019. Both products contain a substantially lower amount of sodium, which could lead to a decrease in CV comorbidities allowing for a greater patient population.
- The Medicines Company (MDCO) released updated results from the Phase II ORION-1 study of its PCSK9
synthesis inhibitor inclisiran in conjunction with the Company’s presentation at JPM. While numerical results were not provided, the data
were consistent with prior data supporting dosing 2-3 times/year, with no new safety issues. Officials said an additional death in the study
was due to an infected aortic aneurysm and not considered drug-related (the study is not yet unblinded, but the majority of patients are
on inclisiran). Details from the study will be presented at the ACC conference. MDCO also announced the initiation of ORION-2 (in
Homozygous Familial Hypercholesterolemia) and the ORION-3 extension study versus AMGN's Repatha.
- Celgene (CELG) considers ozanimod one of their next blockbuster drugs in their pipeline with pivotal Phase III
data from the SUNBEAM and RADIANCE studies in the first half of 2017. Positive results will allow Celgene to file an NDA by the end of
2017, with a second indication for ulcerative colitis in 2018 and Crohn's disease 2019 and beyond.
- BioMarin (BMRN) announced updated results from the Phase I/II study of BMN 270 which showed continual
progress since previous results reported at the International Congress of the World Federation of Hemophilia (WFH) in July 2016. To
date, 6 out of the 7 patients have continued to have Factor VIII levels above 50 and are within the normal alanine aminotransferase ALT
range with mean annualized bleeding rate and Factor VIII infusions dropping 91 and 98 percent, respectively.
- Incyte (INCY) provided a roadmap for its main revenue driver, Jakafi. Specifically, officials seemed excited about
advancing its development for GvHD and essential thrombocytopenia. Baricitinib will be the next revenue driver, according the the CEO,
with a focus on psoriatic arthritis. IDO inhibitors have also been a new target class of intense interest, and the company’s epacadostat
appears to be advancing strongly. Positive new data from the Phase I/II ECHO-202 combination study with Keytruda (MRK) in solid
tumors were released with the meeting, and development will advance to Phase III in bladder, head & neck, NSCLC, and renal cell
cancer in addition to the already Phase III melanoma indication. New data are anticipated at ASCO 2017. Data collection is ongoing for
DLBCL and MSI-high colorectal cancer and future studies in those indications has not been decided. In ovarian and triple-negative
breast cancer, there are no current Phase III plans as data does not justify moving forward at this point in time. Finally, the company
initiated a collaboration with Merus to develop bispecific antibodies.
- Regeneron (REGN) announced upcoming milestones for its IL-4/IL-13 antibody Dupixent for the treatment of
allergic disorders. Regeneron believes it has found the “control point” for a variety of allergic diseases and that this drug can be
expanded to indications including food allergies. To date, there has been significant efficacy data presented from the Phase III SOLO 1
and 2 trials in atopic dermatitis with top-line data in other indications including esophagitis and asthma expected by the end of the year.
An FDA action date has been set for the BLA in atopic dermatitis at the end of the first quarter of 2017, and Regeneron expects to submit
regulatory filings in asthma by the end of the year. Throughout the presentation, the CEO expressed the most optimism towards the
direction of Dupixent as a promising first-in-class treatment, if approved, for this significant unmet need.
- Insys (INSY) announced its plans to expand its current drugs Subsys and Syndros in multiple new indications and
applications. For its Subsys product, the Company plans on initiating trials to manage pain in patients undergoing bone marrow biopsies,
changes in burn dressing, and for anticipated pain in a radiotherapy setting. For Syndros, a trial for the treatment of agitation in
Alzheimer's disease is planned in the second half of 2017, pending FDA feedback.
- In an update on Repatha, Amgen (AMGN) officials said while 75% of prescriptions are still being rejected by payers, if all had been filled for the class, the market would already be over $1 billion. Cardiovascular outcomes data for Repatha at this year's ACC conference in March should bolster their case for clinical guidelines changes and easier reimbursement, though advances in the market will likely depend on a label change. In Repatha's patent case, where last week a court granted a surprise permanent injunction that would effectively remove competitor Praluent (SNY, REGN) from the market unless there is a settlement, the court has just extended the time for the injunction to go into effect pending appeal to 45 days. AMGN officials understandably did not comment on their willingness to settle.
For our disclosures, please read the Biomedtracker Research Standards.
| Disease Group Covered: |
Allergy
Autoimmune/immunology Cardiovascular Dermatology Endocrine Hematology Infectious Disease Metabolic Neurology Oncology Ophthalmology Psychiatry Renal Respiratory Urology |
| Indications Covered: |
Dysmenorrhea
Female Sexual Arousal Disorder |
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