Jeffrey A. Wolfson, Haynes & Boone, LL
What does it take to start a 505b(2) Company?
-Make sure you know how to access your market, have physician detailing and how much payors will pay for reimbursement.
IP Considerations – Rights needs to be protected beyond FDA. Intellectual property is more than just patents – trademarks register with patients.
Challenges with patent system for 505b(2):
-Narrow patent protection – new indications, combination products and broad formulations are ways to reach patent protection. Patent extensions are only valid once per product.
FIRESIDE CHAT: Walk Down Wall Street—Analyze the Economy's Effects on Pharma and Drug Delivery and Predict Future Trends
Moderator: Alex Zisson, Thomas McNerney & Partners
Brett Zbar, Aisling Capital
Scott Henry, Roth Capital Partners
|Alex Zisson, Thomas McNerney & Partners|
Scott Henry: There are four variables to covering a company according to investors: relationship, credibility, business model, investment appeal. What can a company do to increase their coverage chances? In order to get on the radar screen of the investors. Companies should get to know analysts and bankers and develop relationships, gain credibility, business model should not be highly risky and investment appeal by telling the story when times are good.
Zbar: What do investors look at when looking to invest? Team technology products (focus on commercial potential), focus on products (clinical development and regulatory) , IP review, and exit strategies. They also examine where the technology is already being used, as a way to leverage the power of the product. Investors focus has been on the reimbursement environment. Investors do like drug delivery companies
Small companies spend a lot of time trying to find a contact to make connections to Wall Street types. These Wall Street Professionals encourage these companies to make the time to have a meeting to discuss the opportunity, because everyone is a potential client. They also want to see some early stage data on the performance of the new potential drug delivery method.