Hill Dermaceuticals, Inc., a privately-held pharmaceutical company based in Sanford, Florida at the Orlando-Sanford Airport, which develops, manufactures and distributes specialty prescription dermatology products, is pleased to announce that Tolak® (fluorouracil) 4% Cream, has been successfully registered in the United Kingdom and in 13 countries within Europe, including France, Germany, Spain, Italy, Belgium, Sweden, Norway, Netherlands, Denmark, Czech Republic, Slovakia, Austria and Portugal. The initial marketing launch will be in Germany.
Tolak® was developed by Hill Dermaceuticals for the treatment of Actinic Keratosis (pre-cancerous lesions) of the face, ears and/or scalp, and received its FDA approval in the fall of 2015, and its Health Canada approval in early 2019.
Tolak will be manufactured for European export exclusively by Hill Dermaceuticals at its Orlando/Sanford Airport facility. Pierre Fabre Derm-Cosmetique, a global player in dermatology and the second largest dermocosmetic company world-wide, has been granted marketing rights in the above-mentioned European countries as well as in other selected world-wide countries
Lavaur (France) and Sanford (USA), March 3, 2017 – Pierre Fabre Dermo-Cosmetique, a global player in dermatology and the second largest dermocosmetic company worldwide, and Hill Dermaceuticals, Inc., a privately-held American pharmaceutical company that specializes in dermatology products, announced today that they have entered into a strategic commercial partnership for TOLAK, a patented prescription dermatologic drug, indicated for the topical treatment of actinic keratosis lesions of the face, ears, and/or scalp.
Under the terms of the agreement, Pierre Fabre Dermo-Cosmétique will be granted an exclusive license for TOLAK in a broad territory through two of its subsidiaries: Pierre Fabre USA for the immediate distribution of TOLAK in the USA, and Pierre Fabre Dermatologie for commercialization in certain other countries (pending local authorization). Pierre Fabre has also acquired the option rights to countries outside the initial licensed territory. Hill Dermaceuticals will retain ownership of the NDA for TOLAK in the USA and will supply the product to Pierre Fabre on an exclusive basis. Pierre Fabre Dermatologie will be responsible for obtaining marketing authorizations outside the USA and will hold any marketing approvals in other countries.
“Pierre Fabre is an ideal partner for Hill Dermaceuticals to help us with the marketing and distribution of this unique patented product and its advancement in the US, Europe and other countries,” said Jerry Roth, CEO of Hill Dermaceuticals. “This collaboration will enable us to expedite future and current development of additional new drugs, and further advance treatment of difficult diseases.”
“With this TOLAK licensing deal, Pierre Fabre Dermo-Cosmétique confirms its strategic goal to develop and commercialize dermatology medicines bridging prescription drugs and dermocosmetics products. We are actually the only company to make this strategic continuity in our competitive environment”, said Eric Ducournau, Pierre Fabre Dermo-Cosmétique CEO.
“This is an important milestone in the history of Pierre Fabre Dermatologie” declared Dr. Jean-Jacques Voisard, Dermatologist and CEO of Pierre Fabre Dermatologie. “Firstly, the acquisition of TOLAK’s international rights is in line with our strategic decision to invest in dermato-oncology, one of our top priority therapeutic areas with pediatric dermatology. Secondly, after having launched HEMANGEOL and DEXERYL in the USA over the last two years, the acquisition of TOLAK’s US rights confirms our determination to become a significant player in medical dermatology in the USA.”
The financial terms of the agreement were not disclosed.
Actinic keratosis, also known as a “solar keratosis,” is a crusty, scaly growth caused by damage from exposure to ultraviolet (UV) radiation. It is the most common type of precancerous skin lesion. In the USA, the prevalence of actinic keratosis in the population is around 16%(1) and is increasing because of sun damage and the aging population. Depending on the nature of the growth and the patient’s age and health, various treatment options are available for actinic keratosis, including topical 5-fluorouracil, which is a form of topical chemotherapy.
This molecule is available in different topical medicines with different dosages and formulations. TOLAK, cream containing 4% fluorouracil, is indicated for the topical treatment of actinic keratosis lesions of the face, ears and /or scalp. It is applied only once daily in an amount sufficient to cover the lesions over the course of 4 weeks. TOLAK is contraindicated during pregnancy and in patients with dihydropyrimidine dehydrogenase (DPD) deficiency. The most common adverse reactions occur at the application site and include erythema, scaling/dryness, crusting, pruritus, stinging/burning, edema, and erosions. For complete product information, please call 1-800-344-5707.
In the US, TOLAK was approved in September 2015 and launched in November 2015; Tolak is not yet approved in the EU or other countries.
Pierre Fabre is a French private pharmaceutical and dermocosmetic company founded in 1962 by Mr. Pierre Fabre. Preliminary revenue in 2016 surpassed €2.28 billion based on sales in over 130 countries. The company is structured around two divisions: Pierre Fabre Pharmaceuticals (ethics, oncology, consumer health care) and Pierre Fabre Dermo-Cosmétique (dermatology, dermocosmetics). In dermocosmetics, its portfolio of 9 brands includes global market-leader, Eau Thermale Avène. Pierre Fabre employs some 13,000 people worldwide and owns subsidiaries in 43 countries. Pierre Fabre allocates about 16% of its pharmaceuticals sales to R&D with a focus on 4 therapeutic areas: oncology, dermatology, central nervous system and consumer health care.
Created in 1983, present in 84 countries where it partners with dermatologists, Pierre Fabre Dermatologie has become a major player in medical dermatology. Its product portfolio covers the management of major dermatological disorders including acne, psoriasis, inflammatory dermatitis, fungal infections, and alopecia. In 2014 Pierre Fabre Dermatologie entered the USA market with the launch of HEMANGEOL® (propranolol hydrochloride) and recently with the launch of DEXERYL®.
Pierre Fabre has a unique shareholding structure that guarantees its continuity and independence. The majority shareholder is the Pierre Fabre Foundation, which is a government-recognized public-interest organization. It has also developed its employee stock ownership plan, and employees thus form the second-largest group of shareholders. This structure is unique in France and is aimed at ensuring the long-term stability of the company’s capital.
To find out more about Pierre Fabre, please go to www.pierre-fabre.com.
Hill Dermaceuticals, Inc., a Florida-based pharmaceutical company, has developed several dermatological products for difficult to treat skin diseases, such as scalp psoriasis and widespread severe atopic dermatitis/eczema in children and adults. The company is also focused on developing advanced treatment for rare skin diseases.
Application site adverse reactions are likely to occur during and for 4 weeks after treatment of actinic keratosis with TOLAK. The most common (incidence > 68%) adverse reactions occur at the application site and include erythema, scaling/dryness, crusting, pruritus, stinging/burning, edema, and erosions. Erythema is observed in 99% of patients with actinic keratosis treated with TOLAK. Eye disorders, including corneal reactions have occurred with topical fluorouracil use. Avoid treatment in the periocular area. Avoid accidental transfer of the drug into eyes and to the periocular area. If accidental exposure occurs, seek medical care. Increased sensitivity to ultraviolet light may occur during and immediately after treatment with TOLAK. Hypersensitivity reactions may occur with TOLAK. TOLAK is contraindicated during pregnancy and in patients with dihydropyrimidine dehydrogenase (DPD) deficiency. Fluorouracil may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception. Increased fluorouracil exposures may occur in DPD deficiency. Discontinue TOLAK if symptoms of fluorouracil systemic toxicity develops. Visit www.TOLAK.com for Full Prescribing Information
(1) Source: Skin Cancer Foundation