While Italy’s biotech landscape is generally held to be somewhat immature in comparison to more established markets such as Germany, France or the UK, that does not imply a deficit of innovation. On the contrary, the Italian life science scene is increasingly strong when it comes to behind-the-scenes, incremental innovation.
The Catania-based ophthalmic speciality player, SIFI group, serves as a good illustration. “Ophthalmology is a market that has historically been characterized by incremental more than disruptive or radical innovation but represents a fascinating niche because the anatomical condition of the eye makes it a perfect testbed for new technologies like artificial intelligence, cell and gene therapies, and new surgical techniques,” notes Fabrizio Chines, the company’s president and CEO.
He explains that SIFI can be credited as being one of the pioneers of intraocular lenses, a category lately joined by all the majors including J&J, Alcon, and Bausch & Lomb. More recently the company has pushed the envelope again with ‘Well Fusion,’ a unique binocular implants system that corrects presbyopia, providing a high quality of vision across all distances and thus bestowing a far superior quality of life upon patients.
Meanwhile, the company has been making waves for its ‘generic-plus’ projects – value-added therapies that are not originators – for the treatment of glaucoma. “We are offering material improvements to patients and payers on the originator products by, for example, working for longer durations, or not containing cornea-damaging preservatives,” explains Chines. “It should be noted that we don’t see ourselves as a generic company, but rather as a partner to ophthalmologists, striving to bring innovation, albeit gradually, to make a real difference for patients and payers alike,” he insists.
We don’t see ourselves as a generic company, but rather as a partner to ophthalmologists, striving to bring innovation, albeit gradually, to make a real difference for patients and payers alike
Others have busied themselves with slight innovations to a molecule or delivery system, but often with profound positive consequences for the patient. Ticino-headquartered IBSA Group’s Italian market subsidiary has, for instance, revolutionized how pregnant women take progesterone so as reduce the risk of miscarriage. “Previously, these women had to undergo very painful intramuscular injections administered by a doctor during pregnancy because progesterone is not soluble in water, only in oil. We within IBSA Farmaceutici took chemical vessels that are called beta cyclodextrin that wrap up the progesterone molecule and make it soluble in one milliliter of water. This single milliliter can now be easily self-administered and is painless because it involves only a subcutaneous injection,” explains Luca Crippa, the company’s CEO and managing director. “This exemplifies the kind of thing we do. What we really excel at is taking an existing molecule and propelling it to the next level,” he emphasizes.
Then there is Bormioli Pharma which has won great acclaim for its work in re-designing medicines packaging to make for much more optimal patient experiences. “We noticed that there was a pressing need to improve access to medicines for people with disabilities and consider the needs of the patient from a packaging perspective. This is particularly important with medicines as those suffering from illness often experience difficulties associated with managing and self-administering the drug,” recalls the company’s CEO Andrea Lodetti.
“Our business has evolved over time from a pure commodity producer into a partner and solution provider for the pharmaceutical industry. Previously, customers’ inquiries needed to match the capabilities of the business. Today, Bormioli Pharma works on both core development cooperation and joint innovation activity with the customers to collaboratively design solutions. Bormioli Pharma concentrates on delivery solutions such as the container and dosing of a drug, something that is generally overlooked by pharmaceutical companies. Moreover, Bormioli Pharma researches the experience specific to certain individuals such as nurses, mothers, or people with disabilities and harnesses those insights to design packaging that can provide an optimal and bespoke solution,” elaborates Lodetti.
One of the challenges in this market, compared to other countries, is that the reimbursement system does not properly reward incremental innovation
Where there is still much room for improvement, however, is in the Italian state’s recognition and appreciation of this kind of innovation on the fringes. “One of the challenges in this market, compared to other countries, is that the reimbursement system does not properly reward incremental innovation. We sometimes experience great difficulty in convincing the authorities to reward the value-added component in something that some might erroneously think of as just another me-too generic drug,” bemoans Crippa.
“Let’s not forget that even in the generic space, there is a great deal of scope for innovation around complementary devices and administration pathways, all of which ultimately benefit in terms of compliance, accessibility, bioavailability, administration, or even improved shelf life and sustainability. The time is ripe to properly acknowledge the great work our incremental innovators are delivering,” agrees Michele Uda, director general of Egualia, Italy’s generics association.