Interview with Thibaud Eckenschwiller, Head of Global Business Operations of Zambon and President and CEO of Zambon USA Ltd.
Why is it important to open a location in the US?
Zambon is committed to growing its presence in the US with innovative treatments to meet the unmet needs of patients with severe respiratory diseases. We have two Phase III clinical programs currently underway in the US and worldwide. Through acquisitions, R&D efforts, collaborative partnerships, and relationships with top scientific leaders, policymakers and patient organizations, we have strengthened our presence in the US, which is a large and significant market for Zambon. Our investment in the US market reinforces our key growth strategy through further globalization and continued investment in Specialty Care, one of our core therapeutic areas.
As a result of our efforts to identify, develop and offer innovative solutions to patients with life-threatening respiratory diseases, Zambon is increasingly becoming recognized as a pioneer in the field.
Will you provide additional information about your PROMIS and BOSTON development programs?
Zambon is actively conducting two Phase III late-stage clinical trials for the treatment of Bronchiolitis Obliterans Syndrome (BOS) and the prevention of exacerbations in Non-cystic Fibrosis Bronchiectasis (NCFB) patients characterized by chronic Pseudomonas aeruginosa colonization. The studies are enrolling patients at over 50 US locations, as well as at other centers worldwide.
- The BOSTON clinical development program is evaluating Liposomal Cyclosporine A for Inhalation (L-CsA-i) administered via the investigational eFlow® Technology nebulizer system for the treatment of BOS, with the goal of minimizing the decline in lung function. If approved, L-CsA-i would be the first treatment indicated for BOS. The program has received FDA Fast Track and Orphan Disease Designations for the treatment of BOS from the EMA and FDA, reflecting the high unmet need of the disease.
- The PROMIS Phase III program is evaluating inhaled colistimethate sodium administered via the I-neb® Adaptive Aerosol Delivery system in patients with NCFB chronically colonized with P. aeruginosa. If approved, it would be the first indicated treatment approved by the FDA for these patients. The program has received a qualified infectious disease product (QIDP) and FDA Fast Track designation for the prevention of pulmonary exacerbations in adult NCFB patients with P. aeruginosa. These designations reinforce Zambon’s commitment to developing a treatment for patients and physicians for this debilitating disease.
Why are the programs of importance to the US market?
Our BOSTON and PROMIS programs are of utmost importance in the US and globally since BOS and NCFB are severe life-altering respiratory diseases. The unmet need is very high and urgent as there are no approved treatments currently available for these patients.
Patients are at the center of everything we do. At Zambon, we work together worldwide focused on our objective of “Innovating cure and care to make patients’ lives better”.
Do you have a US presence in other therapeutic areas?
In addition to the PROMIS and BOSTON development programs, Zambon has two approved products currently being sold in the US through distributor relationships. XADAGO® (safinamide) is a monoamine oxidase type B (MAO-B) inhibitor indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing “off” episodes. MONUROL® (fosfomycin tromethamine) is an antibiotic indicated for the treatment of bladder infections (urinary tract infections or acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis.
What is the focus of the US office?
Our small but growing US team is comprised of clinical development and global commercialization professionals intently focused on bringing new treatment options to patients with life-threatening severe respiratory diseases. Together with our European colleagues, we are managing our PROMIS and BOSTON programs in the US and worldwide. Simultaneously, we are completing the preparatory groundwork to ensure two successful commercial launches in the US and other global markets, upon positive data and receiving the necessary regulatory approvals.
Why did you choose the East coast as the location for your office?
Being on the East coast allows for easier communications with our European colleagues because of the 6-hour time difference, and frequent flight routes make travel to and from Europe convenient.