Chiesi Farmaceutici

Chiesi Farmaceutici S.p.A. is an Italian family controlled[1][2] global pharmaceutical company based in Parma, Emilia-Romagna. Chiesi has 28 affiliates[3] in the world, nearly 6,000 total employees[4] and provides medicines to patients in more than 80 nations. In 2018 Chiesi currently has revenues of 1.768 billion euros.[4]

Chiesi Farmaceutici
Società per Azioni, (S.p.A.)
(something like a Joint-Stock company)
IndustryPharmaceuticals
Founded1935
Headquarters
Parma
,
Italy
Key people
Alberto Chiesi (President)
Paolo Chiesi (Vice-president & Director of R&D)
Ugo Di Francesco (CEO)
Revenue€1.768 billion (2018)
Number of employees
6000
Websitewww.chiesigroup.com

In June 2019, Chiesi became a certified B Corporation, thus choosing to adopt a new legal status under US and Italian law. This ensures Chiesi a legal protection to pursue a business model placing social and environmental values on equal footing with profits.[5]

Following the acquisition, in 1999, of Huddersfield based Trinity Pharmaceuticals, Chiesi has also had a significant presence in Manchester, United Kingdom.[6]

History

Established in 1935, Chiesi concentrates primarily on developing, producing and marketing respiratory, neonatological and rare disease drugs, along with those for treating muscular and skeletal conditions.

Historical therapeutic solutions are a cortisone preparation indicated for asthma, allergic rhinitis and airway inflammation, launched in 1979,[7] and a surfactant life-saving treatment for premature babies, developed by two researchers at Karolinska Institutet, Tore Curstedt and Bengt Robertson.[8]

In the rare disease area, a treatment for moderate to severe limbal stem cell deficiency (LSCD), developed by the researchers Michele De Luca and Graziella Pellegrini, was the first stem cell therapy to be approved in Europe.[9] As well as developing drugs in-house, Chiesi has a policy of developing drugs in collaboration with pharmaceutical businesses outside Italy.

Chiesi's operations regarding neonatological drugs have come under criticism for patenting drugs that Chiesi has not been instrumental in developing. Because of this behavior, some of Europe's neonatology wards have experienced economic hardships.[10]

The company holds over 3,000 international patents for more than 200 patents families, and employs approximately 800 people dedicated to Research and Development activities, including regulatory in the R&D centres in Parma, Paris, Cary (North Carolina, USA), Chippenham (UK), Oxford (UK), and Sweden. It is especially Chiesi's way of dealing with patents that has caused controversy for the company.

2010 was the year in which turnover broke through the Billion Euro barrier, with Chiesi recording sales growth of 16.4% over the figure for 2009. By 2013 turnover had reach €1,236, with increases coming primarily from outside the Italian home market.[11] Chiesi Farmaceutici closes 2016 on a high with an annual turnover of €1.571 million, an increase of more than +7.0% on the previous year (+9.6% at constant exchange rates), and EBITDA equal to €448 million (a year-on-year increase of over 8.2%). The robust health of the company is reflected by its investment in innovation and development, with R&D expenditure rising by over +12.5% in the 2015–2016 period to reach €340 m in 2016, 21% of total sales. The Group currently has 47 active projects in research and development and 54 active studies in research and development.[4]

Caffeine citrate product

In 2014 Chiesi was granted a 10 years market exclusivity on a caffeine citrate pharmaceutical product, both for oral and intravenous use, for the treatment of apnoea of prematurity, an orphan condition. Many prematurely-born infants have trouble breathing and because of this they need caffeine citrate, which stimulates the nervous system controlling breathing.[12] The market exclusivity expired on July 17, 2019.[10] The marketing authorization holder set the list price at 800 kroner in Denmark (approx. $120, +4000% compared to the cost of galenic formulation). The EU Orphan Medicinal Product regulation prevents the marketing of galenic formulation without the consent of the orphan drug designation holder.[13] Chiesi was accused to exploit legislation that was created to compensate companies that have had substantial expenses with developing new drugs. Chiesi has not clinically developed this form of medication,[10] but has published two real world studies[14][15] on a total of 1606 babies across Europe. Chiesi withheld comment on the list price of the drug.[10]

Therapeutic areas

Chiesi Farmaceutici researches and develops therapeutic solutions for respiratory diseases as Asthma and COPD (Chronic Obstructive Pulmonary Disease), both characterized by a reduction in the respiratory flow but driven by a different pathophysiological pathway.[16] New drugs are based on a technology which allows the creation of spray solutions for inhalation of extrafine particles.[17]

The company has his focus also on the preterm babies’ care, specifically regarding the treatment of Respiratory Distress Syndrome (RDS) and apnoea conditions, both due to an under-development of the respiratory system. Natural surfactant administered via intra-tracheal route treats RDS, and may also be used for the prophylaxis in neonates at high risk of developing the disease. For the more severe apnoea episodes stimulant drugs are needed, such as caffeine-based treatments.[18]

Chiesi Farmaceutici is developing new therapeutic solutions in the area of rare and ultra-rare diseases. For limbal stem cell deficiency (LSCD), a rare eye condition that may lead to blindness, a stem cell treatment has been developed and is marketed in Europe.[19] In 2018 Chiesi achieved European marketing authorization for velmanase alfa, a first-in-class enzyme replacement therapy for alfa-mannosidosis,[20] an ultra-rare condition. Chiesi is also present in nephropathic cystinosis and is developing a new product in Fabry disease.

Notes and sources
  1. In July 2014 the company website shows a Consiglio di Amministrazione (Board of Directors) comprising eight individuals. Six of these are named "Chiesi"
  2. "Chiesi Farmaceutici S.p.A." chiesigroup.com.
  3. "Chiesi Group is the largest pharmaceutical group in the world to be awarded B Corp certification". Bloomberg L.P. Retrieved 2019-07-08.
  4. "Chiesi Annual report 2018" (PDF). chiesi.com. Retrieved 2019-07-08.
  5. "Chiesi Group | Certified B Corporation". bcorporation.net. Retrieved 2019-07-08.
  6. http://www.chiesi.uk.com/about_chiesi/
  7. https://www.chiesi.com/en/about-us/our-history/. Missing or empty |title= (help)
  8. Curstedt, T.; Halliday, H. L.; Speer, C. P. (2015). "Curstedt T. et al., A unique story in neonatal research: the development of a porcine surfactant, Neonatology 2015". Neonatology. 107 (4): 321–9. doi:10.1159/000381117. PMID 26044099.
  9. "Europe approves Holoclar®, the first stem cell-based medicinal product".
  10. Louise Damløv, "Fra en 20’er til 800 kr: Medicinalfirma hæver prisen på livsvigtig medicin til for tidligt fødte børn" at dr.dk, 11 September 2016
  11. "Chiesi Farmaceutici S.p.A.: Private Company Information – Bloomberg". Bloomberg BusinessWeek.
  12. "European Medicines Agency, "Public summary of opinion on orphan designation caffeine citrate for the treatment of primary apnoea of premature newborns", March 16, 2011" (PDF).
  13. "REGULATION (EC) No 141/2000 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 1999 on orphan medicinal products".
  14. Lista, G.; Fabbri, L.; Polackova, R.; Kiechl-Kohlendorfer, U.; Papagaroufalis, K.; Saenz, P.; Ferrari, F.; Lasagna, G.; Carnielli, V. P.; Peyona PASS Group (2016). "Lista G. et al., "The Real-World Routine Use of Caffeine Citrate in Preterm Infants: A European Postauthorization Safety Study", neonatology 2016, Journal of Caffeine and Adenosine Researc". Neonatology. 109 (3): 221–7. doi:10.1159/000442813. PMID 26820884.
  15. Philip, R. K.; Ismail, A.; Murphy, B.; Mirza, A.; Quinn, C.; Dunworth, M. (2018). "Roy K.P. et al., "Caffeine Treatment for Apnea of Prematurity and the Influence on Dose-Dependent Postnatal Weight Gain Observed Over 15 Years", Journal of Caffeine and Adenosine Research, 2018". Journal of Caffeine and Adenosine Research. 8 (3): 99–106. doi:10.1089/caff.2018.0005. PMC 6150932. PMID 30250944.
  16. "Respiratory". chiesi.com. Retrieved 2019-07-26.
  17. Schofield, Amy (2017-04-04). "Chiesi's triple threat to COPD". Pharmafield. Retrieved 2019-07-26.
  18. "Neonatology". chiesi.com. Retrieved 2019-07-26.
  19. "Chiesi's Holoclar wins UK Prix Galien orphan drug award". PMLive. 2016-09-23. Retrieved 2019-07-26.
  20. McKee, Selina (2018-04-05). "EU green light for Chiesi's Lamzede". PharmaTimes. Retrieved 2019-07-26.
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