Menarini’s challenge, new antibiotics on the model of orphan drugs

Try lining up 16 billion tablets. An almost impossible goal to imagine. But which in 2023 represented the operational reality of the 18 Menarini production plantsan Italian pharmaceutical company that is increasingly opening up to the world.

The growth of the pharmaceutical company

The growth was supported by volume growth with 833 million units of which 609 million were produced internally, representing an increase of 9.3%. These are some of the figures presented by Lucia Aleotti, shareholder and member of the Menarini Board, in a meeting held in Florence, the city that has hosted the company since 1915. Present in 140 countries around the world with subsidiaries, distributors and licensees, the group is developing a future that moves along some main directions through targeted acquisitions.

New drugs available

After the acquisition of Stemline, the availability of Elacestranta drug intended for the monotherapy treatment of advanced or metastatic breast cancer (positive for hormone receptors but not for HER-2). The medicine has already been approved by the EMA in Europe and the FDA in the USA. And it is developing Tagraxofuspfor the treatment of specific blood tumorstarget for other medicines such as Selinexor (for the treatment of multiple myeloma) and other active ingredients in a previous research phase. Not only. The availability of is approaching new drugs aimed at reducing cholesterol and therefore to limit the risk of heart attacks, strokes and cardiovascular diseases which recognize LDL cholesterol as a causal factor. It is the case of Howitzertrapibassociated or not with other medicines with a mechanism of action that integrates to facilitate the achievement of the objective.

New antibiotics on the model of orphan drugs

Finally, there is the chapter new antibiotics. Medicines for a few patients, who however have an extreme need. “What do we do when, despite everything, we have a patient with a resistant infection? – explains Aleotti. You need a powerful antibiotic. The company carries out the drug with incredible difficulties, it is very difficult because they are drugs for a few patients which must be treated quickly otherwise they are gone within ten hours. If instead of giving a premium to make the area attractive, we continue to look at the prices of antibiotics from decades ago, the message I receive as an entrepreneur is not to invest in new antibiotics. The only model that can really work is that of orphan drugs with a prize for those who develop these innovative drugs.”

In short: for a pharmaceutical company it is basic accept and make global challenges our own, such as that of antibiotic resistance, for which solutions must be found not only on the research front, but also on the regulatory situation. Because if it is fatal that antibiotics progressively become less effective against bacteria that “learn” to develop mechanisms of resistance to the action of the drug, it is essential that there are drugs that can make the difference between life and death of patients facing resistant infections. But it is equally important that these antibiotics are used only when they are really needed, with the necessary appropriateness, and that they are therefore considered in the same way as drugs for rare diseases. That is, fundamental, basic. But also able to be recognized for their innovation.

With the collaboration of Federico Mereta