ITALFARMACO S.p.A.

Core Business and Operations

The primary function of ITALFARMACO S.p.A. is the entire lifecycle of pharmaceutical products, encompassing research, development, production, and global marketing of both branded prescription ("ethical") and non-prescription (over-the-counter) products. The company is dedicated to improving patient health and well-being through innovative solutions for disease prevention, management, and cure, while adhering to the highest quality standards in the manufacturing of its medicinal specialties.

The Group's operations are distinctly segmented into two major areas:

1. Pharmaceuticals: This arm focuses on developing and commercializing drugs across a wide range of therapeutic areas, with a particular emphasis on high-therapeutic-content products. The pharmaceutical research and development efforts are primarily oriented towards the cardiovascular area and diseases associated with disorders of the immuno-oncologic system. The company actively pursues product portfolio expansion through increased R&D investment in established areas and strategic commercial partnerships.
2. Fine Chemicals and Active Pharmaceutical Ingredients (APIs): Through its chemical-industry arm, primarily the subsidiary Chemi S.p.A. (and Italfarmaco Chemical in Brazil), the Group is a major manufacturer of active ingredients for the pharmaceutical industry. Chemi S.p.A. is noted for its expertise in producing complex molecules, including the synthesis of APIs, and holds advanced technologies in the fields of phospholipids, peptides, and the chemistry of chiral products, exporting a significant portion of its production to international markets like the USA, Japan, and the EU.

Products and Services

ITALFARMACO S.p.A. offers a comprehensive portfolio of pharmaceutical products and a complete service spectrum encompassing drug discovery and manufacturing.

Therapeutic Areas and Key Products

The company's commercialized products and R&D pipeline are structured around several key therapeutic areas:

• Rare Diseases: A growing and priority focus area for the Group is the development of innovative treatments for specialty and rare diseases, addressing significant unmet medical needs.
  • Duchenne Muscular Dystrophy (DMD): A major commitment includes programs for DMD, a severe genetic disorder. A notable example is the product Givinostat, an investigational therapy for this condition.
  • Neurodegenerative Disorders: The rare disease pipeline also includes programs for conditions such as Amyotrophic Lateral Sclerosis (ALS) and Becker muscular dystrophy.
  • Other Rare Blood Disorders: The portfolio also includes programs for conditions like polycythaemia vera.
• Cardiovascular: Products for the treatment and management of heart and circulatory system diseases.
• Immuno-Oncology: Products targeting the immune system and cancer-related disorders.
• Gynecology and Women's Health: This is a strong area of specialization, focusing on the health of women and children.
  • The Natalben product range is a clear example, offering healthcare products designed for various stages of the reproductive life cycle, including pre-conception, pregnancy, and breastfeeding.
• Neurology: Treatments for various disorders of the nervous system.
• Musculoskeletal and Bone Metabolism: Products for conditions like osteoporosis and orthopaedic issues.
• Other Specialties: The company is also involved in Dermatology, Respiratory Care, and other general medicine areas.

Manufacturing and Production Services

ITALFARMACO Group maintains modern, sophisticated industrial plants that oversee the entire drug creation process, ensuring quality and supply. The manufacturing network is geographically dispersed to support its multinational presence:

• Milan, Italy: Manufacturing of preparations for injection (injectables) and solid oral products.
• Madrid, Spain: Manufacturing unit for liquid oral products.
• Frosinone, Italy: Production of chemical-pharmaceutical products (APIs).
• Barcelona, Spain: Manufacturing of semi-solid products.
• Camaçari / Salvador de Bahia, Brazil: Production of chemical-pharmaceutical products (APIs).
• Santiago de Chile, Chile: Manufacturing of liquid oral products.

The company's commitment to research and its comprehensive, vertically integrated structure???from API synthesis to the marketing of finished pharmaceutical and over-the-counter products???positions ITALFARMACO as a key player in the Italian and international pharmaceutical sector.