Imiquimod with the brand name Aldara belongs to a group of drugs called immune response modifiers. 3M’s pharmaceuticals division obtained the FDA approval in 1997 as a treatment for external perianal and genital warts and in 2004 for the treatment of superficial basal cell carcinoma. Mild skin irritation, itching, dryness, flaking, scabbing, crusting and redness are the most common Aldara side effects. Aldara cream is also used for melanoma skin cancer.
Approval of Aldara
In 1997: Aldara was approved by the FDA as a treatment for external genital and perianal warts. 3M received the first approval.
In 2004: it was marketed by 3M as a treatment for superficial basal cell carcinoma.
In 2006: 3M sold its pharmaceutical business in America to Graceway and in Europe to Meda AB.
In 2011: the patent on imiquimod expired. Graceway declared bankruptcy and Medicis Pharmaceutical bought its branding and approvals.
In 2015: Imiquimod is available worldwide under many brands.
Indication of Aldara
This patient-applied cream is indicated for the treatment of
- genital warts
- superficial basal cell carcinoma
- actinic keratosis
- melanoma skin cancer
Mechanism of action
The active substance in Aldara cream is called Imiquimod; it is an immune-response modifier that uses the immune system to bring about its effect. When the cream is applied to the skin, it acts locally on the immune system, the body’s natural defenses and trigger the release of cytokines including interferon. Interferon is a protein; it helps to kill the viruses that cause warts or the abnormal cells in the skin that develop into skin cancer or keratoses.
Aldara Cream in the Market
Media has bought exclusive European rights to a new formulation of imiquimod from Graceway Pharmaceuticals. This newly approved formulation in the US and Canada is 3,75% imiquimod topical cream that is indicated for the treatment of actinic keratosis (AK). Today, Meda and also pharmaceutical wholesaler in Turkey market a higher strength (5%) of Aldara in Europe. Sales of this cream were approximately 500 MSEK in 2009 that exceed $360 million. Fougera & Co., a leading specialty pharmaceutical manufacturer, also announced it has received first generic approval from the FDA for Imiquimod Cream 5%; this cream is generically equivalent to Aldara® by Graceway Pharmaceuticals and substitutable for all indications.
Perrigo Company, a leading global healthcare supplier announced it received FDA approval from the FDA to manufacture and market Imiquimod Cream, 5%. They will vertically integrate this product with their own API. This product is the generic equivalent of Graceway Pharmaceuticals Aldara® Cream, 5%, a topical treatment for actinic keratoses on the face or scalp, superficial basal cell carcinoma, and external genital and perianal warts. Wolters Kluwer Health measured that Aldara ® had sales of approximately $382 million prior to generic market formation. Aldara price is around $97 but Turkish pharmaceutical price is different. Dano Health as a pharmaceutical wholesaler in turkey can supply this cream for hospitals and health clinics.