Sigma-Tau

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Sigma-Tau
Private
Industry Pharmaceutical
Founded 1957
Headquarters Pomezia, Italy
Key people
Cavazza Family
Products Medicines
Revenue €697 million (2013)
Number of employees
1919 (2013)
Website www.sigma-tau.it

Sigma-Tau Industrie Farmaceutiche Riunite, referred to as Sigma-Tau, emerges in 1957 from the entrepreneurial initiative of research chemist Claudio Cavazza. During a period in which multinational companies were consolidating their hegemony in the pharmaceutical sector, Claudio Cavazza conceived the idea of an industrial structure in Italy, capable of permanently competing in terms of production while at the same time bringing innovation to the field of research and pharmaceutical experimentation.

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[edit]

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,[1] subsequently receiving another seven. With the discovery in the 1970s of carnitine deficiency syndrome, 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 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 the safeguarding of the results of scientific investigation.

Structure of Sigma-Tau group[edit]

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, 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.

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.

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

  • 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

Incorporated in 1979 as part of the Sigma-Tau Group, Biosint is currently a world-leading producer of L-Carnitine derived by chemical synthesis. The company manufactures and distributes active pharmaceutical ingredients, lactic ferments and nutraceutical products obtained by chemical synthesis and fermentation. Its operations are carried out in full compliance with current good manufacturing practices (cGMP), at establishments approved by FDA and main domestic and international Regulatory Authorities.

  • 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.

  • 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.


Social and environmental responsibilities[edit]

In virtue of the particular nature and social importance of the industrial sector in which it operates, Sigma-Tau considers it fundamentally important to act in absolute respect of ethical principles and existing legislation, and make every effort to reach the highest quality standards. To this end, in 2002 Sigma-Tau adopted a Code of Ethics that clearly defines the behavioural rules and ethical principles that must be adhered to by everyone – employees, consultants, suppliers, clients and stakeholders alike. Open-ended contracts are offered to 99% of employees, in testimony to the policy operated by the company to create stable and lasting relations with its workforce. This aspect is also reflected in the period of employment of staff, which averages around 17 years, highlighting the bond of loyalty and trust formed between the company and its staff. In 1967 Sigma-Tau became equipped with a water conditioning plant. Since 2005, the commitment to reduce impact on the environment in the elimination of solvents in aid of water in many preparations has produced continuing reduction in CO2 emissions that have fallen from 5,932 tons to 5,587 in 2007. Since 2007, Sigma-Tau has begun waste sorting and choosing eco-compatible materials. In the same year, in which Sigma-Tau’s environmental costs amounted to around 600,000 euros, a reduction of 8% in the quantity of industrial wastewater was confirmed.

Humanitarian commitment[edit]

Over the years, Sigma-Tau has developed numerous partnerships, formed with associations and bodies engaged – at national and international level – in projects and activities with a social emphasis, with particular focus on the areas of health and social welfare. The company also provides its medicines free-of-charge to around 40 national and international organizations operating in conflict and post-conflict contexts to support those people stricken by natural disasters and famine. At international level, Sigma-Tau:

At national level:

  • supports various patients’ associations, including l’AGOP (Associazione Genitori Oncologia Pediatrica – Parents’ Association of Paediatric Oncology), based at the Agostino Gemelli University Polyclinic in Rome, which fosters scientific research in the field of paediatric oncology and provides global assistance to sick children and their families;
  • together with AISLA (Associazione Italiana Sclerosi Laterale Amiotrofica – Italian Association of Amyotrophic Lateral Sclerosis) participates in the support of the goals of the association, above all in increasing public awareness of the problems connected to ALS;
  • has for many years supported Destinazione Domani, the popular science journal by AIL, Associazione Italiana contro le Leuecemie, Linfomi e Mieloma – the Italian Association Against Leukaemia, Lymphoma and Myeloma non-profit organization;
  • supports the institutional activities of the Camminare con il Diabete non-profit diabetes association and PerLa - Associazione per l’Andrologia association for andrology;
  • participates in a program of solidarity to support with Associazione Dynamo Camp, each year hosting around 1,000 children affected by serious and chronic diseases from hospitals throughout Italy and abroad for free, at the Cesto del Lupo oasis – a park located in the WWF nature reserve in the Tuscan-Emilian Apennine Mountains. The association works in partnership with the Association of Hole in the Wall Camps which has created 11 structures from the United States to Europe, supporting similar programs in Africa and the rest of the world;
  • collaborates in providing information through Vita, the non-profit weekly magazine which aims to encourage the culture of solidarity and social responsibility, providing its readers with up-to-date, independent analysis of the voluntary sector.

Name[edit]

Sigma and Tau are the two stars that flank Antares at the centre of the Scorpius constellation. Arabs considered the red Antares the heart of the constellation and therefore regarded the bright stars positioned beside it – Sigma Scorpii and Tau Scorpii – as the arteries leading away from the heart, as indicated by the term that describes them both (Al Niyat, meaning the arteries).

References[edit]

  1. ^ Orphan drugs are medicines that are effective in the treatment of certain diseases that are not manufactured or put on the market due to insufficient demand to cover production costs and supply.

External links[edit]