ARSTAT Pharmaceuticals
Addressing major unmet needs in women's health
Presenter: Arkady Rubin, PhD
7:30 pm Monday, May 11, 2020 (Online Only)
http://zoom.us/j/116264573 PW: 116264
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About
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ARSTAT Inc. has developed and patented a portfolio of novel pharmaceutical products in women’s health. The company’s major asset is NuvoceptTM – the first and only oral contraceptive specifically formulated for overweight and obese women (about 60% of 10 million US pill users). Nuvocept is developed by a co-inventor of Ortho Tri-Cyclen Lo®, the best-selling oral contraceptive in the US over the past decade.
Addressing a Major Unmet Medical Need and Public Health Issue
Today's oral contraceptives do not work well for women with high BMI due to an increased risk of pregnancy and serious side effects. Reduced efficacy in obese women is confirmed by the FDA seminal meta-analysis and its recent Guidance for industry. Safe and effective pregnancy prevention is of utmost importance to obese women due to maternal and child health hazards, including serious obstetrical complications.
ARSTAT Solution - Nuvocept
This is a multiphasic dosing regimen with the most widely accepted progestin/estrogen combination. Components of this regimen and its hormonal ratio were successfully tested by tens of millions of women. Nuvocept is designed as a highly efficacious and safe option for the targeted high BMI population with up to 3 times fewer pregnancies and a 2- 3-fold reduced risk of serious side effects vs. other brands.
At ARSTAT's pre-IND meeting, the FDA was quick to recognize Nuvocept' unique benefits and, for the first time in the history of regulated contraceptive research, endorsed its dedicated clinical testing in women with high BMI.
3 Major Issues
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- To secure the Nuvocept commercial success, it is critically important to increase the awareness of prescribing OB/GYNs and overweight contraceptive pill users. What would be the recommended course of action both within and outside the scope of the clinical program?
- Nuvocept promises to be a very compelling brand for women with normal weight. Related emphasis may increase the total sales at a price of a somewhat reduced exclusivity status for women with high BMI. What would be the recommended strategy?
- After solidifying its management team, ARSTAT intends to seek R&D funding as a publicly-traded company. In addition to Nuvocept, the IPO may support 2-3 other of its US-patented products that can reach a larger US target market of ~50 million women. What are the advantages or disadvantages to broadening our portfolio?
Program:
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7:00 - "Meet and Greet" on Zoom webcast; talk with other members
7:30 - Arkady Rubin, PhD, Acting CEO of ARTSTAT, will deliver "Elevator" Pitch to the Group
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Reservation is FREE
for this meeting
 Slides
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 Audio
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 Video
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 Webcast
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