Aldara gets green light for actinic keratosis

US regulators have given the green light for doctors to prescribe Minnesota-based 3M's Aldara for precancerous skin lesions called actinic keratosis. 3M is also awaiting approval for Aldara's use against a common form of non-melanoma skin cancer, superficial basal cell carcinoma.

3M has been selling Aldara cream, its first product based on that research, since 1997, when it was approved for treatment of genital warts.

Some dermatologists say actinic keratosis -- a condition characterised by rough, red, scaly patches mainly on the face and scalp -- is nearing epidemic proportions. That has many on Wall Street expecting the added prescriptions to spark Aldara sales in the second half of 2004.

Analysts expect sales of Aldara, which comes from a family of molecules known as immune response modifiers, to eventually rise more than three-fold, based on wider use of the drug.

Sales of Aldara already have steadily increased in recent years, as doctors prescribed the cream for conditions other than genital warts caused by a common sexually transmitted disease.

Traditionally, the skin growths have been scraped off or frozen with liquid nitrogen in a dermatologist's office. Aldara cream, however, can be used at home, they noted, and it does not leave scars like those that may result from scraping or freezing.

3M has estimated that genital warts, AK and superficial basal cell carinoma could eventually result in global worldwide sales of up to $600 million.

3M is playing its cards close to the vest when it comes to a follow up to Aldara. The company has said it doesn't intend to ask the US Food and Drug Administration to approve the molecule for anything other than AK, genital warts and superficial basal cell carcinoma.

There's no word on the fate of resiquimod, another immune-response modifier that 3M had hoped would treat herpes. The compound, which the company had planned to develop with Eli Lilly failed to meet the goals of a final or Phase III clinical trial in early 2003.

A hint of things to come may be in a patent filed in February by 3M. The company specifically mentions asthma, another fast-growing worldwide market, and nasal congestion caused by allergies.

Peplin’s skin cancer formulation more effective: CEO

Brisbane based biotechnology Peplin (ASX: PEP) is also developing a topical formulation for skin cancer treatment in partnership with US biotech Allergan.

Earlier this year at a Securities Institute briefing, Peplin chief executive Michael Aldridge said Peplin's treatment had achieved a 95 per cent response rate versus Aldara's 82 per cent for actinic keratosis.

Allergan recently filed two amended IND applications with the FDA for Peplin's PEP005 for indications including actinic keratosis and basal cell carcinoma.

Additional reporting by Renate Krelle