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Expert Interview

Slingshot members are talking to an expert! The topic is:

Evaluating the Chances of Approval and Market Potential for Alder's (ALDR) ALD403 in Treatment of Chronic Migraines and Frequent Episodic Migraines After Positive Phase 2b Data Readout

Ticker(s): ALDR, AMGN, TEVA

Who's the expert?

Name: Dr Andrew Charles - MD

Institution: UCLA

  • Professor of Neurology and Director of the UCLA Goldberg Migraine and Pain Program.
  • His laboratory investigates basic mechanisms of migraine, with a focus of the identification of new therapies. Research interests include cellular neuroscience, neuropharmacology, and novel treatments for migraine and other headache disorders.
  • Serves as associate editor of the journal Cephalalgia; has served on the Board or Trustees of the International Headache Society, and is presently on the Executive Board of Directors of the American Headache Society.

Interview Questions

Can you describe your experience treating patients, and what current treatment options are being used to prevent migraines? How do your patients respond to current treatment options? 

Added By: pjloria

What are the differences between current approved treatment options, and the CGRP therapies being developed by Alder, Teva, and Amgen?

Added By: pjloria

Are there significant differences in safety or efficacy for products that are already approved, and these products being developed by Alder, Teva, and Amgen? 

Added By: pjloria

What are the differences in terms of costs for CGRP therapies and products currently being used?

Added By: pjloria

Amgen and Alder are currently in Phase III testing, and Teva's TEV-48125 is in Phase II testing. Can you discuss the differences in the designs and standard measures of these trials?

Added By: pjloria

Can you discuss the differences in the safety and efficacy profiles of ALD403, TEV-48125,  and AMG334, and how each drug is administered? Do any of the drugs have an advantage over the others? 

Added By: pjloria

Can you discuss the chances of approval, and timeline for approval, for each drug? 

Added By: pjloria

Following on a Question above, can you elaborate on theoretical potential safety issues of inhibiting CGRP, both receptor and ligand separately?  Have any of these been seen in preclinical studies or in the clinic?  Could any of these be life threatening in humans or would they be expected to be mild and/or reversible.  Have humans been dosed high and long enough to know if long term treatment with CGRPi's has low long term safety risk, or should investors be prepared for potential limitations in duration of use.

Added By: william gerber

Are there any other current theories regarding drivers of migraines besides, or together with, CGRP.  What other potential treatments are in the lab right now.  What are you are excited about?  What targets or mechanisms? How about in the clinic?

Added By: william gerber

Following up on the question of drug administration above, ALDER claims that there is a sizable population that will prefer IV administration over subQ or intramuscular and so they have decided to pursue both subQ and IV forms of their product.  They say 70% of neurologists have an infusion room, so this will be convenient for patients & doctors.  Do you agree that there is value in pursuing IV as well as subQ?

Added By: william gerber

Given that Botox also suppresses local CGRP expression but has a long-standing safety record, do you see these novel therapies being used primarily in a refractory population (given the premium pricing and systemic exposure to CGRP antagonism) or do you see them possibly taking share from Botox-naive patients if the therapies are more efficacious?

Added By: njhaveri

Are there any known important differences between Lilly, Teva and Alder's drugs in molecular structure, CGRP binding domain, binding specificity (i.e. CGRP only or off target binding), PK/PD.  Please compare to Amgen as well if applicable.

Added By: william gerber

Given the current information, which drug do you think has the best chance to dominate the market assuming they all get approved? Which drug do you think you will give to your patients? 

Added By: pjloria

LLY, TEVA, AMGN running trials with thousands of patients- ALDR 600 patients.  Seems like ALDR far behind unless they can get away with smaller trials?

Added By: william gerber

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