Leadiant Biosciences, formerly known as Sigma-Tau Industrie Farmaceutiche Riunite, was founded in 1957 by research chemist Claudio Cavazza.
In 2018 Leadiant Biosciences has come under fire for creating a monopoly for CDCA and unnecessarily increasing the price by a factor of 335.
Construction began in 1964 of an industrial facility in Pomezia equipped with state-of-the-art automatic production machinery to provide steady employment for 64 people. The choice of Pomezia for its headquarters created one of the first industrialization and urban development initiatives in an area of Central-southern Italy that had previously been mainly devoted to agriculture. With the creation and launch of the Rekord B12 vitamin complex in September 1966 – an antiasthenic medicine that soon spread within the field of restorative infantile therapies – Sigma-Tau definitively asserted itself as a pharmaceutical manufacturer in Italy and abroad.
From the 1970s to today
From the 1970s onwards, Sigma-Tau focused on experimenting with new medicines for rare diseases – a commitment that in 1984 would cause it to become the fourth largest pharmaceutical company in the world and assignee in the United States of an Orphan Drug Designation, subsequently receiving another seven. With the discovery in the 1970s of Carnitine deficiency syndromes, an illness with a fatal outcome, Sigma-Tau focused the investigative efforts of its laboratories on research into a molecule capable of opposing the disease. This was to bring about the creation of L-carnitine, one of the few Italian pharmaceutical products widely received outside Italy, and which was recognized by the United States in 1984 for its value as a life-saving medicine. The chemical and biologic pharmacology study of carnitine, a substance of natural origin, enabled a greater understanding of its efficacy in correcting the biochemical and metabolic defects at the base of numerous other pathologies.
Fondazione Sigma-Tau was created in 1986 as a charitable organization with the aim of developing research, promoting scientific and cultural progress, and safeguarding the results of scientific investigation.
Structure of Sigma-Tau group
The Sigma-Tau Group achieved a corporate turnover of 697 million euro in 2013, employs a workforce of 1,919 and possesses a portfolio of more than 100 products marketed in Italy and abroad, with regards to the following therapeutic areas: Cardiometabolic disorders, Orthopedic and Rheumatologic diseases, Broncho-Pneumology, Infectology, Oncology, Neurology, Gastroenterology, Dermatology, Urology and Gynecology, Malaria and Rare Diseases. The Group is a leader in the nutraceutics industry and produces supplements of high scientific interest. Its product range also includes high-end dermocosmetics lines, as well as oral and personal care products. Since 1998 it has filed 297 patents confirming itself, among the national Italian owned, as a major player in the registration of new molecules or important technological innovations. The Sigma-Tau Group has headquarters in Pomezia (Rome, Italy), and subsidiaries in France, Switzerland, Belgium, the Netherlands, Germany, UK, and India, and with production plant in Italy as well as in Spain and US (Indianapolis). The ability to expand its presence on the international stage, mainly through the activation of collaborative research with numerous scientific institutions in America, Europe and Asia, is the key to Sigma-Tau's future. Since the pioneering studies conducted by its founder Claudio Cavazza, Sigma-Tau has always proved to be a groundbreaker in the discovery of drugs for rare and orphan diseases: for instance, Carnitine for the treatment of primary or secondary “specific deficiencies” was the second product ever to obtain the designation as “orphan drug” by the US FDA. Leveraging this background, the company has confirmed its commitment to developing drugs with orphan indications over the years and has acquired Enzon's “speciality pharma” portfolio. With eight products for the treatment of rare and neglected diseases, today Sigma-Tau is a pharmaceutic player acting in the forefront in the treatment of Rare Diseases. The goal of its recently created Global Rare Disease Business Unit is to contribute to the progresses in the knowledge, diagnosis and treatment of Rare Diseases.