STADA Strengthens Specialty Partnership Role Via US Filing
Having over decades established itself as a leader and go-to-partner in generics and consumer health products, German-headquartered STADA is increasingly adding to its portfolio and pipeline of differentiated speciality pharmaceuticals. And here, partnerships play an essential role.
As testament to this speciality partnership strategy, STADA’s US commercial partner Supernus has just filed a New Drug Application (NDA) with US Food and Drug Administration for an apomorphine infusion pump (SPN-830) for the continuous treatment of ON-OFF episodes in adults with Parkinson’s disease (PD) whose motor control is unsatisfactory with oral levodopa and at least one other non-invasive PD therapy.
The NDA filing for apomorphine infusion pump for continuous treatment of ON-OFF episodes in adults with Parkinson’s disease is based on data from an extensive development program completed by STADA’s Britannia Pharmaceuticals and its US partners.
Supernus earlier this year acquired US licenses from STADA’s Britannia Pharmaceuticals neurology and central nervous system center of excellence for the marketed APOKYN® (apomorphine) pen as well as for the apomorphine pump candidate.
STADA CEO Peter Goldschmidt sees the NDA submission as part of STADA’s broader strategy of adding speciality medicines such as biosimilars and other injectables to its existing portfolio. “Our partner Supernus’ filing is further evidence of how STADA is working around the world to develop value-added medicines and to expand its offering of speciality pharmaceuticals in addition to standard generics and consumer healthcare products,“ he asserts.
Among the most prominent of STADA’s recent initiatives in the speciality pharma sector was the first-to-market generic introduction last year in 14 European countries of the multiple myeloma treatment bortezomib. Through creative analysis and circumvention of formulation patents covering Janssen’s Velcade lyophilized original, STADA was able to bring a ready-to-use solution to the market ahead of the competition.
Biosimilars are also a major area of focus for STADA, with the company having built on its decade-long success with Silapo (epoetin zeta) by striking a deal with leading developer Alvotech for seven pipeline candidates, such as a biosimilar of AbbVie’s Humira (adalimumab) 100mg/ml blockbuster.
STADA has also bolstered its biosimilars pipeline through a partnership with Sweden’s Xbrane. https://www.stada.com/blog/posts/2019/may/strategic-biosimilar-development-partnership-stada-and-xbrane-strengthen-collaboration
This partnership with Xbrane includes global rights to a biosimilar of the ophthalmology blockbuster Lucentis (ranibizumab). In line with its vision of being the go-to-partner for speciality pharmaceuticals, as well as for generics and consumer health products, STADA licensed North American rights to this biosimilar to eyecare specialist Bausch & Lomb.
STADA’s alliance in the US with Supernus for speciality apomorphine products not only fits perfectly with this partnership vision; it also helps to deliver on STADA’s purpose of caring for people’s health as a caring partner.
Robert Wood, managing director of STADA’s Britannia Pharmaceuticals center of excellence for speciality CNS therapies, explains: “Submission of this NDA for an apomorphine infusion pump is an important step in the partnership between Supernus and STADA’s Britannia with the goal of offering US patients, caregivers and health professionals a broader range of treatments for Parkinson’s disease.”
Supernus’ NDA for SPN-830 is based on data from an extensive development program completed by Britannia and US WorldMeds (USWM, LLC). The program includes the TOLEDO study, a pivotal Phase III study (conducted in Europe, ref. Katzenschlager et al, Lancet Neurology 2018; 17: 749–59) and a supportive safety and efficacy study conducted in the US. The infusion pump is intended for the continuous treatment of ON-OFF episodes in adults with PD whose motor control is unsatisfactory with oral levodopa and at least one other non-invasive PD therapy.
TOLEDO was a Phase III, multi-center, double-blind, placebo-controlled study that investigated the efficacy and safety of apomorphine subcutaneous infusion in PD subjects whose motor fluctuations were not adequately controlled on optimized treatment. The US study is an open-label study that investigated the safety and effectiveness of SPN-830. The study eligibility criteria, apomorphine administration and dosing, study schedule, and efficacy and safety measures in both studies were similar.
Both studies included PD subjects with average daily OFF time ≥3 hours. The primary efficacy endpoint in both studies was the change from baseline to Week-12 in mean daily OFF time over 24 hours recorded by the subject in a motor symptom diary. In TOLEDO, the reduction in mean daily OFF time with SPN-830 in comparison with placebo was statistically significant (SPN-830: 2.47 hours, n=53; placebo: 0.58 hours, n= 53; p=0.0025). In the US study, mean daily OFF time decreased from baseline to Week-12 by 3.0 hours (n=94, p<0.0001). Treatment-related adverse events (AEs) were predominantly mild or moderate in severity. Infusion site AEs, nausea and dyskinesia were the most frequently reported AEs related to study treatment.