Drusolv Therapeutics
Ocustatin™ for early treatment of AMD eye disease
Presenter: John Edwards
Monday, May 13, 2019
Embassy Suites, Chesterbrook, Pennsylvania (directions)
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About
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Drusolv Therapeutics is a clinical-stage drug company based in Philadelphia. It is developing a high-dose oral statin for early intervention in a blinding eye disease called age-related macular degeneration (AMD).
LARGE UNMET NEED:
AMD is the leading cause of blindness in developed countries. It affects 150M people worldwide. This is more than glaucoma and diabetic retinopathy combined, including 1 in 8 people over age 60. Our product, Ocustatin, is aimed at patients who are still in the intermediate stages of the disease and currently have very limited options to prevent progression to late-stage vision loss. This is a $4B per year completely unmet need.
BREAKTHROUGH PRODUCT:
Ocustatin was developed at Harvard University and has been validated in a highly successful proof-of-concept clinical trial. It is based on the strong parallels between atherosclerosis and AMD. Atherosclerosis is characterized by buildup of cholesterol deposits inside artery walls to form plaque. AMD is characterized by accumulation of cholesterol deposits in the retina to form drusen. Drusen has the same composition as plaque. Just as intensive statin therapy dissolves plaque in atherosclerosis, we have demonstrated that it dissolves drusen in AMD. Our proof-of-concept trial showed dramatic efficacy for intermediate AMD patients treated with high-dose oral atorvastatin (generic Lipitor®). Over 40% of the participants had a marked clearance of drusen, with most experiencing essentially complete disappearance. Furthermore, in a five-year follow-up, those who continued treatment had a 75% reduction in progression to late AMD and associated blindness.
COMPETITION & DIFFERENTIATION:
Competition for treatment of intermediate AMD is very limited. The current standard of care is over-the-counter AREDS eye health vitamins that offer modest benefit, and there are at present no prescription drugs for this stage of the disease. In addition, there are only two other candidate drugs targeting intermediate AMD that have ongoing clinical trials. Both are in early development. And unlike oral Ocustatin, both require injections.
3 Major Issues
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- Ocustatin™ is chemically identical to atorvastatin (Lipitor®) but has a unique higher dose. There are at least 10 manufacturers of generic atorvastatin. Is modification of an existing atorvastatin tablet to achieve a new dose (with no other change in formulation) a straightforward process, or are there significant CMC considerations? Is it possible to engage generic manufacturers as strategic partners, for example to get development support in exchange for a favorable supply agreement?
- Drusolv’s goal is to exit via acquisition after a compelling Phase 2 clinical trial. We have identified six recent ophthalmology asset acquisitions after completion of successful Phase 2 trials, with deal values ranging from $95M to $765M. How do we build a case based on these comparables to maximize our valuation?
- We commissioned a market access and reimbursement study for Ocustatin. Payers indicate that they will be receptive to our product until pricing reaches a tipping point of about $300 per month. How do we set a price that optimizes the trade-off between broad payer acceptance and the highest possible revenues?
Program:
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6:30 - Cocktails & Dinner (Cash bar and special 2-entree buffet menu)
7:45 - John Edwards, CEO of Drusolv Therapeutics, will deliver "Elevator" Pitch to the Group
8:00 - A Panel will address three major issues crucial to helping the Company reach the next level.
9:00 - Open discussion: members and guests
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