Research and Development

Angelini has more than 50 years of research and development experience in the pharmaceutical sector, as demonstrated by the full development of a number of drugs.

Angelini research

Two of them, the topical anti-inflammatory benzydamine and the antidepressant trazodone, are worldwide distributed and commercialized in more than 60 Countries. Angelini in-licensed the fluoroquinolone prulifloxacin in the ‘90, and carried out its full preclinical and clinical development in Europe, following the registration and commercializing the product in several European countries. More recently, Angelini strengthened the efforts in the anti-infective area by in-licensing dalbavancin, a semi-synthetic second-generation lipoglycopeptide antibiotic, in use for the treatment of ABSSSI (acute bacterial skin and skin-structure infections). Last year, the first ever in Europe combination of paracetamol and ibuprofen entered the Angelini portfolio.

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Innovation and dynamic pipeline

Innovation
The Innovation activities are implemented in the RR&D Division (Research, Regulatory & Development), where the R&D, the Regulatory Affairs, and the Business Development work together to increase and maintain the high level of innovation, aimed to ensure a sustainable Company portfolio. To this end, the R&D is further divided into R&D WEP (Well Established Products) and R&D NPP (New Pharma Products), allowing the most effective effort in the different activities: research for new pharmaceutical products, leaded by the R&D NPP; the life cycle management and the development of non-pharma products, which are characterized by shorter time to market, leaded by the R&D WEP. In agreement with this strategy, the Medical Department is divided into the NPP and the WEP clinical departments, and the Regulatory Affairs is fully integrated since the early development stage.
Since the Angelini Pharma Division has direct presence in 20 Countries, all the RR&D departments are centralized to guarantee the correct management of the differences in terms of therapeutic and market needs, regulatory guidelines and regulations, and pharmacovigilance activities.

Dynamic Pipeline
The RR&D mission is built on the dynamic pipeline concept, where each project can be partially or fully developed in-house or by partners based on the opportunities.
The RR&D makes strategic partnerships with distinguished national and international groups, aimed both to identify innovative solutions and to increase the value and the success probability for in-house research programs, further feeding the technical-scientific network.
The Business Development is fully dedicated to enrich the Company portfolio by the identification of high value external opportunities and the development of partnership. The Scientific Networking & Competitive Intelligence Unit (SN&CI) works in collaboration with the Business Development and the R&D departments to identify research groups able to promote innovation in the RR&D pipeline, either by sharing the research programs or by the acquisition of new early phase products, fitting within the current core areas or opening to new therapeutic scenarios.

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Focus on therapeutic areas

Presently, the main research programs focus on the following therapeutic areas of intervention: pain & inflammation disorders, nervous system diseases & disorders, infection control & infectious diseases.

PAIN & INFLAMMATION DISORDERS
The Angelini R&D has a longstanding tradition in pain and inflammation, acquiring and strengthening the core capabilities in the role of prostaglandins, cytokines and serotoninergic transmission routes in the mechanisms modulating pain and inflammation. Currently, the RR&D research activities focus on either new products or well-known drugs, to be used in monotherapy or in combination, aimed to increase the efficacy and to reduce the side effects. These studies also include formulation approaches to optimize drugs bioavailability and dose regimen.

NERVOUS SYSTEM DISEASES & DISORDERS
The area of CNS-acting drugs, particularly in the mood disorders area, is the field where Angelini has achieved the greatest successes and recognition at world level.
The introduction of trazodone into the clinical practice for the treatment of major depression, which happened in Europe during the ‘60 and in the USA in 1981, changed the therapeutic approach to the treatment of this disease. Trazodone is still used today, thanks to the broad spectrum of neurophysiopharmacological activities and the very good tolerability.
Even now, the RR&D is leading studies on the mechanism of action of trazodone and of new chemical entities showing activity on different molecular targets in neuropsychiatric diseases, allowing the development of considerable expertise in the biochemistry, physiology and pharmacology of the neural mechanisms involved in major depression and in other mood disorders. The studies mainly deal with the problem of the mechanism responsible for the antidepressant activities following their effects on neurotransmission.
Recently, Angelini in-licensed a sustained-release lithium formulation, first ever in Italy, proven to be useful as a mood-stabilizing drug in the treatment of bipolar disorder. The RR&D is presently following the clinical studies in support of the product.
The R&D NPP is further carrying on research activities on new molecular targets responsible for relevant pathologies of the nervous system, such as bipolar disorder, schizophrenia, and multiple sclerosis.

INFECTION CONTROL & INFECTIOUS DISEASES
Starting with the experience of the development of prulifloxacin, the Angelini RR&D strengthened the interest in the anti-infectives area, a field of global concern where pharmacological research has become a priority to solve the serious problem of antibiotic resistance.
At present, the R&D NPP and the R&D WEP activities focus on the evaluation of the antimicrobial efficacy of new products, being used either as monotherapy or in combination, and medical devices made with advanced antibiotic-resistance technologies. Furthermore, the Angelini RR&D is more and more interested in the role of gut, vaginal and dermal microbiota in the maintenance of the wellness state and in the alterations during infection.

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Angelini R&D pipeline

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