Thursday, January 26, 2012

#DDPEvent 2012: Investing and IP Protection for Drug Delivery Companies

Take on the 505b2 Monster and Develop an Optimized Strategy to Ensure Regulatory ApprovalDanchen Gao, Abbott Laboratories
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
Alex Zisson: What have drug delivery companies done to get the attention of Wall Street?  Among other things, they’ve focused on macromolecules, mostly biologics. Macromolecules typically pose tons of risk when it comes to developing them. The numbers show that it is much easier to fully integrate your product and delivery in order to reach their target revenue. Zisson encourages small companies to think outside the box, and provide a very big value added proposition  when it comes to their technologies.

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.

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