About Novelix

Novelix Pharmaceuticals, Inc. (Novelix), a Delaware corporation, is a private,  biotechnology company committed to developing innovative, proprietary, dermatology products with large market potential to treat serious skin diseases. The company’s main focus is the development of NVX-207, a novel, topical drug candidate with the potential to significantly enhance the treatment of actinic keratosis (AK), external genital warts (EGW) and basal cell carcinoma (BCC). Topical therapy is used in only about 25% of these patients due to the severe inflammation and irritation of available topical products. Other procedural treatment options for each of these indications (cryotherapy and photodynamic therapy) have significant limitations — they are painful, suffer from high recurrence rates and/or poor cosmetic outcomes, do not treat emerging lesions, or require significant physician training and capital equipment. The medical treatment costs for each of these indications exceeds $1billion in the US (total medical costs 2004-$4.2 billion).  

While NVX-207 has the potential to be active in all of these indications, the initial indication will be in the largest of these three markets, AK. AK is a pre-cancerous skin condition with the potential to advance into squamous cell carcinoma; it is characterized by hyperkeratotic lesions as a result of prolonged sun exposure and is the skin disease most frequently diagnosed by US dermatologists, affecting more than 11% of the US population. Physicians and patients are seeking a safe and effective topical treatment that provides high efficacy rates, treats emerging lesions, and has a low irritation profile.

Over the next 18 months, Novelix intends to conduct a 48 patient safety and efficacy study in Australia with a highly reputable CRO, thereby achieving clinical “proof of concept” in AK patients and creating an inflection point in shareholder value. Several large dermatology companies (including GSK/Stiefel, Allergan, Valeant, Galderma and Novartis) have expressed interest in licensing NVX-207 when the company completes this clinical development stage. A recent transaction demonstrates the interest in new therapies in AK markets - LEO Pharma of Denmark acquired Peplin for $287.5 million in cash to gain access to PEP005, a natural product, without composition of matter patent protection, in early Phase 3 development for AK.

Novelix has selected the NVX-207 program for further development.