Could you introduce SIFI Group? SIFI has a mission to improve people’s lives through meaningful eye care innovation. Dating back to 1935, two pharmacists -one of who was my grandfather - founded the company and it remains headquartered on the slopes of the Etna volcano, in Sicily. Since 2015, mid-size private equity firm 21 Invest has backed us. We are a relatively small company, but despite our size, we have invested significantly in innovation and geographical expansion: SIFI has a direct presence in six countries and exports to 20 markets.

Can you tell us more about your company’s international expansion strategy? We established the first subsidiary in Romania in 1998, and, like with Mexico, these were opportunistic moves to capture two markets that, although small, promised a good balance between sustainable prices and relatively low regulatory barriers. Since having the private equity onboard, we accelerated our international growth by setting up greenfield operations in bigger European markets and making acquisitions to complement our legacy portfolio. Our main target is to become a European leader in ophthalmology, so our direct investments will be mostly focused on Europe; meanwhile, we proactively pursue new markets through partners. For instance, we have a partnership with leading pharma Zydus Cadila to commercialize intraocular lenses (IOLs) in India. Most recently, we entered into a JV with biomed company AffaMed Therapeutics to develop our portfolio of IOLs in Greater China.

SIFI offers both pharma products and devices. Can you walk us through your portfolio and portfolio pipeline? Innovation has always stayed at the core of our growth: ever since 1989, SIFI was the first to use hyaluronic acid (HA) in artificial tears for dry eye; later in the 1990s, we became pioneers in ophthalmology prescription-based nutraceuticals. Today, we offer pharma products, OTCs, nutraceuticals and devices, but they all follow the prescription-by-ophthalmologist model. In 2020, ophthalmic consultations were reduced, and eye surgeries halved, which affected demand. However, we pushed forward with our innovations: last year, we launched Well Fusion, an innovative technology for IOLs and Synfo, a novel formulation of artificial tears. I’d like to focus on two innovation programs we’re currently working on: the first is an orphan drug candidate, Polyhexanide, for the treatment of Acanthamoeba Keratitis (AK), currently at the end of a pivotal Phase 3 study; AK is an ultra-rare disease, a devastating infection leading to blindness or corneal transplant. We should see the readout from our Phase 3 study results in Q3 2021 and then file a marketing authorization application to the EMA. The other program I’d like to point out is the PH007 where we test for a novel mechanism in the treatment of dry eye: this is a topical gel applied on the forehead that will stimulate natural tear production. The program is licensed in from a US-start-up and we have finally started enrolling patients in a dose-ranging Phase 2 study, after a year-long delay caused by Covid.

What are your views on Italy’s innovation & investment climate? As an adviser to venture capital firm Panakès Partners, one of the first Italian funds entirely dedicated to life sciences, I have noticed a positive trend to foster innovation in this space. However, funding for early-stage development remains generally limited, and Italy lags behind countries like France, which sees more liquidity. Pricing and market access are challenging in Europe, and more so in Italy, and this aspect hinders the valuations needed for early-stage programs, even though we have seen some legislative developments to award funds to innovative orphan or oncology drugs. Germany is leading the way in digital therapeutics, devoting a specific budget for these technologies, something which is currently inexistent in Italy. Our country has a great tradition in manufacturing in both APIs and CDMO, moreover, we are attracting more clinical trials, which is another means of localizing investments. Nevertheless, we still have a way to go, especially in terms of regulatory efficiency to increase our Country’s competitiveness.