Fixed-Combination Drugs New Business Models Drive Profits, Patent Protection

Held Dec. 16, 2009

When does 1+1 = 3 ... 4 ... 5 ... or even more? When a creative pharmaceutical manufacturer successfully combines two existing patents to create what amounts to a new Rx.

But FDCs do not come without hurdles. To be successful, FDCs must overcome:

  • Formulation challenges — Will the combination continue to maintain accepted chemistry and safety profiles?
  • FDA regulatory requirements — Despite combining two previously approved APIs the FDA is still closely examining new drug applications. The EMEA requires confirmatory clinical trials.
  • Patent/exclusivity feasibility
  • Pricing and reimbursement — Can a premium price be obtained for FDCs? How will payers evaluate product?
  • Rebates and contracting concerns — Are current contracts sufficient to address unique issues presented by FDCs?
  • Government price reporting — Will health reform provisions relating to “new formulations” be relevant to FDCs?

Sign up now for an all-new webinar from FDAnews on overcoming hurdles to FDC development. Here’s a taste of what you’ll learn in just 90 profit-building minutes:

  • Key questions to ask before you start FDC development
  • Important implications of drug patent law
  • Possibility of new chemical entity exclusivity from the FDA
  • How to evaluate legal implications of product pricing strategies
  • Avoiding unintended consequences of various standard commercial contract provisions with respect to FDCs
  • Compliance considerations, including government price reporting and antitrust
  • Possible impact of health reform proposals on development strategy

We make it easy to learn. Seminars on the web mean no airplanes or hotel rooms in strange cities. They also spell total interactivity. Got questions? Send them in via email. You’ll have your answers before you log off.

Bring along your staff too — in fact, bring everyone in the company who might benefit from participating. We make it easy with one low registration fee per site, regardless of how many participants log on from that site.

As R&D pipelines shrink and the patent cliff draws nearer, FDCs hold out hope for reaching untapped patient segments, protecting existing branded business, and challenging rivals with drugs in the same class.

  • Regulatory/legislative affairs
  • Corporate/general/outside counsel
  • Compliance officers
  • Clinical and medical directors
  • Product lifecycle managers
  • Business development officers
  • Executive management
  • Medical affairs

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Kathleen A. Peterson is a senior associate in the Health Care and Life Sciences Practice at Epstein Becker & Green, in the firm's Washington, D.C. office, where she practices in the Pharmaceutical Industry Health Regulatory Practice Group. Ms. Peterson has provided health regulatory counsel to a range of industry clients, including pharmaceutical and biological manufacturers, distributors, PBMs, managed care organizations, specialty pharmacies, medical education companies, GPOs and investment firms.

Ms. Peterson's experience includes: reviewing and analyzing the impact of state and federal legislative developments, including health reform; counseling regarding government drug pricing calculations; analyzing contracting, reimbursement and fraud and abuse issues in connection with federal and state healthcare programs (including Medicare Part D, Medicare Part B, and Medicaid); counseling regarding marketing practices, rebate contracting practices, grants, coupon programs, consulting relationships, CME programs, medical communications, drug importation, repackaging, drug sampling, state marketing and price disclosure laws, false claims, kickbacks and inducements; coordinating responses to government investigations and inquiries, as well as conducting internal compliance reviews; implementing corporate compliance programs and performing compliance training at both the field and management levels; advising on various FDA regulatory issues, including DDMAC compliance, Phase IV trials and REMS.

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