Danish biotech company NatImmune has initiated a phase IIb clinical study with Bamlet Topical Gel for the treatment of skin warts in transplant patients, the company writes in a press release. Bamlet is a protein-lipid based dermalogical candidate drug for the treatment of recalcitrant warts in immuno-suppresed kidney-transplanted patients.
There is no existing drug that is targeted to this patient group and the global market potential is estimated to be USD 500m, according to consultancy firm Defined Health, with the US representing the greatest potential, writes financial daily newspaper Børsen.
Dr. Martin Bonde, CEO of NatImmune says: "We are delighted that our lead product candidate, Bamlet Topical Gel, is entering this phase IIb study. We are dedicated to providing a treatment option for the 75% of organ transplant patients suffering from recalcitrant warts, which today represents an unmet medical need."
Results from the study are expected in H2 2008 and if these are positive, NatImmune plans to find a partner for the product for the European market. "If we obtain positive data, we would like to find a partner in Europe. But in the US, we would like to reserve the opportunity to continue ourselves. Regarding out-licensing in Europe, Leo Pharma is a very interesting player," says Dr. Bonde to Børsen.
Other companies operating in Europe with a focus on dermatology include Stiefel Laboratories, Merz and Almirall. Dr. Bonde says that NatImmune is already talking to several companies, and that there is an interest in the product. "They all cover Europe well, and I would be happy with any one of them as a partner."
NatImmune has cash reserves of approx. DKK 70m (USD 14.9m) for product development, which is sufficient to cover expenses for ongoing projects until the end of 2009, but it is insufficient to start phase III studies with Bamlet. The company is currently in contact with European and American venture funds, and anticipates being able to raise fresh capital.