Britannia Pharmaceuticals Ltd: Phase 3 TOLEDO Study Shows Apomorphine Infusion Provides Effective Relief of Persistent Motor Fluctuations in Parkinson's Disease (PD) Patients Whose Symptoms are Uncontrolled With Oral Medication

LONDON,Aug. 3,2018 -- Britannia Pharmaceuticals Ltd has announced publication of the results of the double-blind phase of the TOLEDO study inLancet Neurology[1].

Treatment with APO-go®/MOVAPO®(apomorphine) subcutaneous infusion for 12 weeks gave significantly greater reductions in OFF time (periods when PD medications don't work) from baseline compared with placebo: -2.47 h/day versus -0.58 h/day,respectively - a treatment difference of almost 2 hours (p=0.0025) and double the change in OFF time recognised as meaningful to PD patients. These reductions were seen in the first week of treatment with APO-go®/MOVAPO®infusion.

Compared with placebo,significantly greater increases in ON time (periods with good motor control) without troublesome dyskinesia - 'good' ON time - from baseline were observed with APO-go®/MOVAPO®infusion: 2·77 h/day versus 0·80 h/day,respectively (p=0·0008),and patients could also reduce the dosage and number of administrations of concomitant oral PD medications significantly (p=0.0014).

APO-go®/MOVAPO[®/]infusion is an established therapy for PD,a disease characterised by progressive degeneration of dopamine-containing neurons in the brain,resulting in loss of motor control. TOLEDO is the first multicentre,randomised,double-blind trial to investigate its efficacy and safety in PD and was undertaken in 107 patients from 23 hospitals in 7 countries whose symptoms were uncontrolled despite taking multiple medications.

Clinical improvements were reflected in patients' assessment of treatment: significantly more APO-go®/ MOVAPO®infusion patients rated themselves as 'improved' (71%) versus placebo (18%; p<0.0001).

Professor Regina Katzenschlager,lead investigator of TOLEDO,commented:

"TOLEDOisan important addition toourknowledge,providingLevel 1evidencefor the first timeand confirmingprevious observational studies. Apomorphine infusion is effectiveandwell tolerated bypatients experiencing debilitating treatment response fluctuations despite optimised treatment."

Professor Andrew Lees,an investigator in the pivotal clinical trial that led to apomorphine being licensed for PD treatment in the UK,added:

"We hopethepositive results of theTOLEDO study willhelp ensure apomorphine infusion,whichis delivered using a small,ambulatory mini-pump,isincorporated into nationalPD treatmentguidelines."

The TOLEDO study is sponsored by Britannia Pharmaceuticals Ltd.,part of the STADA Arzneimittel AG group of companies and manufacturer of apomorphine products.

Founded in 1982,Britannia Pharmaceuticals Limited is a pharmaceutical company based in Reading,UK,specialising in the neurology market.

Britannia is owned by Frankfurt-based STADA Arzneimittel AG.

APO-go®products are marketed in the UK by Britannia Pharmaceuticals Ltd and transferred with the acquisition of Britannia into the STADA portfolio in 2007. APO-go®products are marketed outside the UK through own affiliates and licensing partners.

For informationabout:

Britannia PharmaceuticalsLtd:

http://www.britannia-pharm.com

TOLEDO study:

https://www.clinicaltrials.gov/ct2/show/NCT02006121?term=NCT02006121&rank=1

For the APO-go®infusionSmPC:

https://www.medicines.org.uk/emc/product/3908/smpc

[1]Katzenschlager R,et al.Lancet Neurology,2018. Published online July 25,2018http://dx.doi.org/10.1016/S1474-4422(18)30239-4