Background  San Diego-based consulting company founded in 2001 by former Dura/Élan executives, with offices also located in the Boulder-Denver area  Managing Partners (Kathleen Heffernan and Vincent Gotz) have broad- based experiences in the pharmaceutical/biotech industry: Big Pharma Specialty Pharma Start-Ups  Experienced in various therapeutic areas including: Respiratory/allergy Dermatology Neurology Oncology Vaccines

Expertise  Kathleen Heffernan, MBA Over 30 years experience in the pharmaceutical industry as a regulatory affairs and quality systems professional  Labeling and promotional activities  Regulatory due diligence for product and company acquisitions  IND, NDA, 505(b)(2) and ANDA processes and requirements  Regulatory complexities associated with drug delivery systems and combination products  FDA requirements for dermatology products, including prescription, OTC and cosmetics

Expertise  Vincent Gotz, MS Pharm, MBA, FCCP Over 25 years experience in pharmaceutical and biomedical companies and 12 years of clinical pharmacy practice, research and academic experiences  Scientific assessments of products and technologies  Due diligence for product, technology and company acquisitions  Identification of partnering opportunities  Licensing/business development  Competitive market analysis  International partnering experiences (Japan and Europe)

Why ProPharmaCon?  We understand the importance of speed and results in a small but rapidly growing organization  We deliver a range of services at competitive rates in a timely fashion  We work to become an integral member of each client’s organization Interim department heads: Regulatory, R&D Committee memberships: Promotional Review, Pipeline, New Product Planning, Patent and Trademark, Product Launch Teams  We have a network of experienced contractors with particular expertise (cGMP audits, vendor selection, quality systems implementation, CE marks, ISO registration, CMC strategy/writing, medical writing, clinical protocol design)

What Makes Us Different?  We have experience in partnered programs over a range of product development (concepts to commercial products) As part of a small organization developing technology and products, we know:  The importance of putting systems in place to provide structure for the growth of the project and the organization  When and how to contract and manage outside services  Alliance management As part of the larger pharma organization, we know:  Product development requires the diligent balance of scope, cost, time  The importance of planning for contingencies, line extensions and next generation products  A Managing Partner of ProPharmaCon has full accountability for the work conducted for a client

How We Work With Clients  We understand that clients need to focus on results  We believe the keys to providing results are: A clear definition of the project’s scope An accurate estimate and management of project cost An ability to manage and measure project progress against clearly established deliverables and timelines  Therefore, the process for working with clients is typically: Conduct introductory meetings to understand project goals and deliverables Provide written estimate of cost and time required to meet deliverables Do the work!

Examples of Projects  Preparation and review of pre-IND package and FDA meeting on oncology product [505(b)(2) submission]  Regulatory strategy and CMC support for several cancer vaccine development projects  Presented dermatology opportunities to clients which were eventually licensed  Identification and assessment of new topical drug delivery systems for a currently marketed product that provides differentiation and proprietary protection  Identification of licensing targets in client’s therapeutic areas  Due diligence on products/technologies being considered for in-licensing in the dermatology, respiratory/allergy and anti- infective areas

Examples of Projects  Successfully concluded a finder’s agreement for new product  Establishment of quality systems and regulatory strategy, as well as the creation of outsourced Call Center (and verification of SOPs) for a new commercial pharmaceutical organization  Development of clinical protocols and preparation of abstracts, slide kits and journal manuscripts  Preparation of presentations for a client’s scientific advisory boards and BOD on development status and new technology opportunities

Clients  Majority of our business is repeat business with the same client We have been working with some clients since ProPharmaCon was founded in 2001  Our new consulting engagements result largely through recommendations from satisfied clients  Select clients are listed on the following slide

Select List of Clients  NexGen Pharma  MabVax Therapeutics  SkinMedica  Bayer Healthcare  Sienna Labs  Adar Science  Somaxon  Pfizer  Adventrx Pharmaceuticals  Avanir Pharmaceuticals  PARI Respiratory Equipment  Windemere Venture Partners  Cadence Pharmaceuticals  Prometheus Therapeutics & Diagnostics  Trius Therapeutics (acquired by Cubist Pharmaceuticals)  Salmedix (acquired by Cephalon)  Xcel Pharmaceuticals (acquired by Valeant Pharmaceuticals)