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Research: Healthcare
Midatech’s lead clinical asset, MTX110, has achieved another regulatory milestone following the decision by the European Medicines Agency (EMA) to grant the drug orphan drug designation for the treatment of gliomas. This includes recurrent glioblastoma (rGBM), diffuse intrinsic pontine glioma (DIPG) and medulloblastoma, currently being targeted by MTX110. ODD should grant Midatech 10 years of market exclusivity on approval, in addition to other incentives such as protocol development assistance and reduced fees. As a reminder, MTX110 already has ODD in DIPG and recently received fast track designation for rGBM by the US FDA.
Midatech Pharma |
MTX110 receives ODD from the EMA for gliomas |
Regulatory update |
Pharma and biotech |
21 June 2022 |
Share price performance Business description
Analysts
Midatech Pharma is a research client of Edison Investment Research Limited |
Midatech’s lead clinical asset, MTX110, has achieved another regulatory milestone following the decision by the European Medicines Agency (EMA) to grant the drug orphan drug designation for the treatment of gliomas. This includes recurrent glioblastoma (rGBM), diffuse intrinsic pontine glioma (DIPG) and medulloblastoma, currently being targeted by MTX110. ODD should grant Midatech 10 years of market exclusivity on approval, in addition to other incentives such as protocol development assistance and reduced fees. As a reminder, MTX110 already has ODD in DIPG and recently received fast track designation for rGBM by the US FDA.
Year end |
Revenue (£m) |
PBT* |
EPS* |
DPS |
DPS |
Yield |
12/18 |
1.94 |
(11.8) |
(339) |
0.0 |
N/A |
N/A |
12/19 |
0.67 |
(10.9) |
(50) |
0.0 |
N/A |
N/A |
12/20 |
0.34 |
(11.1) |
(22.9) |
0.0 |
N/A |
N/A |
12/21 |
0.58 |
(6.1) |
(6.8) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised.
The recent award of ODD by the EMA marks the latest recent regulatory win by the company for its lead clinical asset, MTX110. The EMA grants ODD to therapeutics meeting pre-specified criteria, including treatment of a life-threatening condition and prevalence of a maximum of five in 10,000 in the EU. A key benefit is that, if approved, the drug is likely to receive 10 years of market exclusivity (versus seven years in the US). This essentially means that no other drugs can be approved using the same active ingredient for these indications, significantly enhancing the market opportunity, in our opinion.
As a reminder, MTX110 uses the company’s proprietary MidaSolve technology to solubilise the chemotherapy drug panobinostat, which is delivered through a convection-enhanced delivery (CED) system directly to the site of the tumour. The drug recently received fast track designation from the US FDA for rGBM and Midatech has announced plans to initiate a Phase I study targeting this indication in the next few weeks. The primary objectives will be to assess safety and tolerability in patients with rGBM (dose-escalation study estimated to recruit between 10 and 12 patients), but the study will also track preliminary efficacy signals such as progression-free survival. Midatech expects to release preliminary data from the study by Q422.
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Research: Healthcare
In an encouraging development for Kazia Therapeutics’ efforts towards combating pediatric brain cancers, its lead drug paxalisib has received orphan drug designation (ODD) from the FDA for the treatment of atypical teratoid/rhabdoid tumors (AT/RT). AT/RT is a rare and aggressive childhood brain cancer with a five-year survival rate of c 32%. Approximately 600 people are living with the cancer in the United States, with around 60 new cases reported each year. The ODD accords seven years of market exclusivity in the US on approval, in addition to possible grant funding and tax credits. Kazia is undertaking preclinical studies in AT/RT and has recently presented encouraging data from combination studies in xenograft models. As a reminder, paxalisib already has ODD in malignant gliomas, including glioblastoma (GBM) and diffuse intrinsic pontine glioma (DIPG). Our valuation is unchanged at US$294m or US$22.28/ADR. Please see our Deep dive into childhood brain cancer note, published on 24 May.
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