Sigma-Tau - Structure of Sigma-Tau Group

Structure of Sigma-Tau Group

Sigma-Tau is the main element of a group in which other companies operate, in accordance with the prospects of the corporate development plan.

In 2012, Sigma-Tau group achieved a turnover of 688 million euros, with 2,086 employees and a portfolio of about 100 products marketed in Italy and abroad. Since 1998 it has registered around 300 patents, confirming its status as one of the largest Italian firms with a wholly Italian-owned capital, and a major player in the registration of new molecules and important technological innovations.

Sigma-Tau group is present worldwide with branches in France, Switzerland, the Netherlands, Belgium, Portugal, Germany, United Kingdom and India, as well as manufacturing plants in the United States and Spain. Sigma-Tau’s future lies in the ability to expand its presence in the international scene, mainly through the activation of research collaborations with numerous scientific institutions in America, Europe and Asia. This is the background that in January 2010 brought Sigma-Tau group to acquire the pharmaceutical manufacturing arm of American company Enzon, and more precisely four products for the cure of rare diseases within the field of oncology and the production plant of Indianapolis in Indiana. This was directly taken over by the Sigma-Tau Pharmaceuticals Inc. American branch, with its headquarters at Gaithersburg in Maryland, which is responsible for marketing products acquired on the American market. With continuing commitment, Sigma-Tau became the fourth assignee in the world to obtain an Orphan Drug Designation in the United States in 1984, followed by a further seven. Five new designations have subsequently been requested from the European authorities.

The sigma-tau Group has invested, and continues to invest, a significant part of its revenue into research and development in order to identify innovative therapies to offer treatment also to people affected by rare diseases and/or diseases having a high clinical or social impact. With 290 applications filed from 1998 to 2012. Out of approximately 20 R&D projects in the pipeline are currently focused on the following therapeutic areas: Rare and Neglected Diseases, Oncology, Immuno-oncology, and Biotechnology.

Sigma-Tau in collaboration with the non-profit organization Medicines for Malaria Venture (MMV) has developed a new medicine for the treatment of malaria a fixed combination consisting of dihydroartemisinin and piperaquine, judged to be one of the most effective antimalaria medicines available and the best combination containing artemisinin. The registration dossier was presented on July 3, 2009 in Europe (EMEA)and approved in 2011. The new drug has obtained the registration in Cambodia, Ghana and Tanzania and is started in Burkina Faso, Mozambique and other key African endemic countries.

• Avantgarde - Pomezia

Founded in 1982 and active both in the pharmaceutical market and that of consumer products sold in pharmacies. Avantgarde has developed its business within the dermatological, gynaecological and paediatric sectors; for consumer products the focus is geared to dermocosmetic sector and to oral hygiene with OTC products.

• Biosint - Sermoneta

Established in 1979 as part of Sigma-Tau group, Biosint is the global leader in the production of L-carnitine obtained by chemical synthesis. Since 1995 its production process is the only to have been awarded approval fby U.S. Food and Drug Administration (FDA), having obtained certification for its DASA-ZERT quality system.

• Biofutura - Milan

Biofutura was founded in 2001 with the objective of developing pharmaceutical products in the cure of diseases of the central nervous system and respiratory system. Activity also spread to the development and marketing of products derived from the carnitine biological system.

• Research Centre - Pomezia

Responsible for the research and development of substances active on important areas of treatment including oncology and immunology and on diseases that are rare, neglected and with high social impact.

• Prassis Research Institute - Settimo Milanese

Aimed at the study of innovative approaches to therapy for the treatment of important diseases of the cardiovascular system including hypertension and cardiac insufficiency.

• Tecnogen - Piana di Monte Verna, Caserta

A biotechnological research company in the pharmaceutical field authorized to produce monoclonal antibodies and recombinant proteins for use in clinical trials.

• Sigma-Tau Research Inc. - Gaithersburg, USA

Responsible for the clinical development of Sigma-Tau products in the United States.

• Sigma-Tau Research Switzerland - Mendrisio, CH

A recently established research centre that co-ordinates research and development activity relating to selected products and provides clinical development and chemical analytical expertise.

Over the years Sigma-Tau has formed collaborations both with humanitarian organizations with activities abroad and firms working in Italy, helping to achieve important projects. Furthermore, in response to needs arising from conflict and post-conflict crises and the aftermath of natural disasters, Sigma-Tau provides international co-operation organizations with medicines destined for developing countries. In 1986 the board of Sigma-Tau created a foundation with the aim of promoting and disseminating scientific culture and safeguarding the results of research.