New peptides for sexual dysfunction: We intend to advance one or more of the peptides we have developed to preclinical toxicology and other studies required by the FDA prior to initiating human clinical trials.
PL-3994 for acute severe asthma: We have planned a proof-of-concept human trial for asthma using a subcutaneously administered formulation of PL-3994, and will submit an Investigational New Drug application to the FDA in the fourth quarter of calendar 2010 for this trial. We also have an inhalation formulation of PL-3994 under development. Depending on financial resources, either or both the proof-of-concept human trial and preclinical inhalation toxicity studies could start as early as the first quarter of calendar 2011.
Active work by Palatin under the collaboration portion of its research collaboration and license agreement with AstraZeneca concluded in January 2010, but we are still providing certain clinical trial related and other services to AstraZeneca. We are eligible for milestone payments totaling up to $145 million, with up to $85 million contingent upon development and regulatory milestones and the balance on achievement of sales targets, plus royalties on sales of approved products. AstraZeneca has responsibility for product commercialization, product discovery and development costs.
Realignment and Workforce Reductions
SOURCE Palatin Technologies, Inc.
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