Blog & Resources Camargo Blog July 3rd, 2008

Hospira Expands Into 505(b)(2) Development

Hospira, best known as a generic injectable pharmaceutical company, is going to start developing a transdermal product. Yesterday (7/2/2008), Altea Therapeutics announced a partnership with Hospira for the development and commercialization of an undisclosed product. Altea is best known for its transdermal delivery system. You can see where this business deal is going. Hospira many injectables, many of which can be switched to transdermal patches. As quoted in the press release, “[t]his agreement further validates the development of the Altea Therapeutics transdermal patch technology for drugs that previously were administered by needle injection or infusion, including water-soluble proteins, carbohydrates, and small drugs” said Dr. Eric Tomlinson, PhD, DSc, President and CEO of Altea Therapeutics. Hospira provides funding, development studies and commercialization, while Altea provides the technology platform. Sweet deal.

Generally, for any transdermal approval you need 3-4 Phase 1 studies; a bridging pK study, an irritation, sensitization, washing and sunscreen studies The need for pre-clinical and clinical safety and efficacy studies depends on the drug product and the delivery system.

We believe that there will be more announcements of generic companies getting into 505(b)(2) developments. The competition in generics is fierce and the resurgence of authorized generics by Prasco Laboratories is causing several generic companies to look at other channels for revenue. We have seen some stumbles. The 505(b)(2) process is not just a modified 505j nor a 505(b)(1). Pre-IND meetings have not given the companies clarity. The major reason for pre-IND disappointments is that the pre-IND submissions are deficient. They don’t include all of the needed evaluation of safety and efficacy, nor do they contain sufficient detail on the proposed development program. They also don’t know what the current approval requirements are. Also, it appears that some companies are just jumping in without a full understanding of what products to develop. Growing pains, to be sure.

Categories: 505(b)(2) Development

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