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In September of 2006, NatImmune acquired the Swedish company Nya HAMLET Pharma AB and thereby the intellectual property on a protein-lipid complex called “HAMLET” (human α-lactalbumin, purified from human breast milk, complexed with oleic acid). Clinical investigations performed with HAMLET shows that when applied topically HAMLET has a strong beneficial effect on cutaneous warts. Also, it has been shown that a liquid formulation of HAMLET instilled in the bladder disintegrates papillomas in bladder cancer patients. Finally, a strong pre-clinical proof-of-concept was obtained for HAMLET in a model for human glioblastoma.

Based on the HAMLET technology, NatImmunes is currently developing three drug candidates in-house:

Our first product candidate is a topical formulation of the α-lactalbumin-lipid complex, called “BAMLET Topical Gel”. For this candidate, bovine milk is used as the source of α-lactalbumin. A clinical phase IIb trial treating immunocompromized patients with recalcitrant cutaneous warts with BAMLET has started in Q1 2008 and is enrolling. Clear clinical unmet needs in skin wart treatment exist in immunocompromized patients, such as transplant and AIDS patients. Better therapeutic options for skin warts in otherwise-healthy patients are also in demand. Trials in patients with genital warts and actinic keratosis are aimed at starting end of 2008. Peak sales for the chosen dermatological ailments are researched to be approx. 500 M USD at peak sales.

The second product candidate is a liquid formulation of BAMLET. This product will be used to treat patients with bladder cancer. NatImmune is planning a dose/escalation clinical phase I/II trial in bladder cancer patients. Today’s market for bladder cancer therapy is approx. USD 350 M.

A third product candidate is rHAMLET. This is a candidate where a recombinant form the human α-lactalbumin is complexed with oleic acid. The candidate will be used in oncology indications starting with glioblastoma multiforma. There is a strong unmet need in this disease and the market potential is estimated to be USD 1 B. NatImmune will establish a commercial production process for recombinant human α-lactalbumin and phase I/II studies in glioblastoma patients could commence in 2008/9. On top of the glioblastoma indication, NatImmune will explore the use of rHAMLET in other life threatening oncology indications where patients may benefit from HAMLET therapy.