Pierre Fabre And Hill Dermaceuticals Announce A Strategic Commercial Partnership For TOLAK (Fluorouracil) Cream 4% In The USA And Beyond

LAVAUR, France and SANFORD, Florida, March 6, 2017 /PRNewswire/ --

* TOLAK is a patented prescription dermatologic drug developed by Hill Dermaceuticals for the topical treatment of actinic keratosis, a skin disease with increasing prevalence worldwide due to the combined effect of sun damage and population aging.

* Pierre Fabre, a leading pharmaceutical company in dermatology, acquired commercialization rights for TOLAK in the USA and other territories, pending registration.

* Hill Dermaceuticals has chosen Pierre Fabre for its global footprint based on its recognized expertise in dermatology, specifically in the USA.

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 dermocosmetic 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.


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 http://www.TOLAK.com for Full Prescribing Information.

SOURCE Pierre Fabre Dermatologie

Back to news