Programs Skin Lightening

Globally, there is a growing trend for lighter skin in many parts of the world.  Approximately 15% of the world population invests in skin lightening products and the global market is expected to reach US$23 billion by 2020. Asia is currently the largest market, with an estimated US$13 billion spent annually on skin lightening products. This trend includes both men and women as reports have showed that many Indian men also use fairness creams.

Demand for skin lighteners in North America and Europe has also been driven by a desire to reverse sun damage and for the appearance of younger looking skin.  Medical conditions such as hyperpigmentation, melasma, vitiligo and rosacea are also contributing to the demand for safer and more effective skin lightening creams.

There is a recognized need for a safer and more effective skin lightening agent.  The most common skin lightening agent worldwide is hydroquinone. While it is effective, hydroquinone is linked to cancer and has been banned in Europe since 2001.  In the United States, restrictions have been placed on concentration levels of hydroquinone; over-the-counter creams are restricted to no more than 2% hydroquinone and a prescription is required to obtain a maximum 4% hydroquinone concentration. Despite the dangers, restrictions and bans, hydroquinone is still widely used around the world. Other skin lightening agents (e.g. arbutin) have been banned due to their instability and subsequent breakdown into hydroquinone.

Sirona Biochem’s Skin Lightener

Sirona Biochem has developed a skin lightening agent, TFC-1067, which studies prove is safer and more effective than various well-known lighteners. To learn more, please see Sirona’s Skin-Lightening Overview.

The development program is directly supported by the French government. Recognizing the exceptional innovation of Sirona’s subsidiary, TFChem, the French government awarded the laboratory a $1.9M grant in 2011.  The grant is designed to bring the skin lightening program to a commercial-ready stage.  A cosmetic consortium, which includes the University of Rouen and contract research organization, Biogalenys, has also been established to support Sirona’s cosmetic programs.

Several studies have been concluded to demonstrate the effectiveness and stability of Sirona’s depigmenting agents, including TFC-1067. In 2019, the company completed a clinical study in the USA which showed that the compound is more efficacious for creating an even skin tone than the gold standard, hydroquinone.

All studies were completed in accordance with the regulatory methods of the European Centre for the Validation of Alternative Methods (ECVAM) and the Organization for Economic Co-operation and Development (OECD).  No animals were involved in the development and testing of Sirona’s skin lightening compounds.

Commercialization

In September 2019, Sirona announced the formal execution of a non-exclusive licensing agreement with industry leader, Rodan + Fields, for the commercialization of skin lightening compound TFC-1067.  Under the terms of the agreement, Sirona will receive an upfront and milestone payments as well as on-going revenue in return for the manufacture and supply of TFC-1067.

Sirona’s skin lightening compounds remain available for:

  • Licensing Agreements
  • Royalty Agreements
  • Acquisition of our technology
  • Joint ventures

For any additional information please contact Michelle Seltenrich at mseltenrich@sironabiochem.com.

Product Development

While carbohydrate-based molecules offer immense commercial potential, we are focusing on three programs at this time.