Theobromine-based cough drug close to commercialisation

SEEK, a leading UK privately-owned drug-discovery group, is pleased to announce the establishment of a new joint venture entity with Pernix Therapeutics Holdings Inc, an integrated specialty pharmaceutical company focused primarily on the United States pediatric market. The joint venture will undertake the late-stage development and registration of BC1036, a first-in-class antitussive drug, to address the serious need for an effective, safe, non-opioid treatment for persistent cough. Both parties will also contribute all of their theobromine intellectual property by way of licence or assignment into the joint venture.

Following consultation with a European regulatory authority, the new venture will conduct a single pivotal Phase III trial of BC1036, which is expected to begin in the first half of 2011. This truncated regulatory path is due to the significant historical safety data available for theobromine and the beneficial effect seen in human use to date. The new venture is also in discussions with the US regulatory authorities and expects to be able to confirm the regulatory programme in the US early next year.