ASLAN Pharmaceuticals Receives Favorable Opinion From the European Patent Office on Composition of Matter Patent Application for Farudodstat
- ASLAN Pharmaceuticals receives a favorable patentability opinion from the European Patent Office for a polymorph patent application for farudodstat.
- The new patent, if granted in national stages, will extend effective patent protection for farudodstat until at least 2043.
- Farudodstat is a potent DHODH inhibitor with the potential to be a first-in-class treatment for alopecia areata.
- ASLAN is currently conducting a Phase 2a proof-of-concept trial for alopecia areata with an interim readout expected in mid-2024.
- The new patent will significantly enhance the commercial exclusivity of farudodstat and strengthen the company's plans for patent protection in key commercial territories.
- Dr. Carl Firth, CEO of ASLAN Pharmaceuticals, emphasizes the importance of bringing safe and effective treatment options to alopecia areata patients.
- None.
Insights
The receipt of a favorable patentability opinion from the European Patent Office (EPO) for a new polymorph patent application of farudodstat is a significant step for ASLAN Pharmaceuticals. This development is crucial as it has the potential to extend the commercial exclusivity of the drug until at least 2043. Patent protection is a key driver in the pharmaceutical industry as it allows a company to recoup its investment in drug development and generate profits without competition from generic versions. Extended patent life not only provides a longer market exclusivity period but also enhances the attractiveness of the drug to potential partners and investors.
From a commercial perspective, securing patent protection in all key markets is essential for maximizing the return on investment. The recognition of novelty and inventiveness by the EPO suggests that ASLAN has a strong case for obtaining patents in national stages. If the patents are granted, the company could see increased market valuation and investor interest, as the extended protection period offers a more favorable timeline for commercialization and revenue generation.
ASLAN Pharmaceuticals' position in the stock market may be positively influenced by the news of the favorable patentability opinion for farudodstat. Investors often react to such news with optimism, as extended patent protection can lead to a more secure revenue stream. From a financial analysis standpoint, the potential extension of farudodstat's patent life until 2043 could lead to upward revisions in revenue forecasts and net present value calculations of the drug. This is particularly important for a clinical-stage company that relies on future income from its pipeline to justify its valuation.
Given that farudodstat is a potential first-in-class treatment for alopecia areata, a disease with limited treatment options, the commercial potential is significant. The financial implications of the patent extension will depend on the outcome of the ongoing Phase 2a proof-of-concept trial and subsequent clinical trials. Positive trial results could further enhance the drug's value proposition and lead to a stronger market position upon eventual approval.
The clinical significance of farudodstat as a potent, oral dihydroorotate dehydrogenase (DHODH) inhibitor for the treatment of alopecia areata is noteworthy. DHODH inhibitors work by interfering with the metabolic processes of rapidly proliferating cells, such as those involved in the immune response that contributes to alopecia areata. Farudodstat's potential as a first-in-class treatment underscores its innovative mechanism of action, which could offer a novel therapeutic option for patients with few existing treatments.
The ongoing Phase 2a proof-of-concept trial, the FAST-AA Study, is critical in determining the drug's efficacy and safety. The medical community and potential patients will be closely watching the interim readout expected in mid-2024. The success of this trial is pivotal not only for the future of farudodstat but also for the patients suffering from alopecia areata. If the trial outcomes are positive, the extended patent protection will ensure that ASLAN can capitalize on its investment in the development of this potentially groundbreaking treatment.
- New Composition of Matter Patent for farudodstat would strengthen intellectual property protection and provide commercial exclusivity for farudodstat until at least 2043
SAN MATEO, Calif. and SINGAPORE, Feb. 29, 2024 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals Ltd. (Nasdaq: ASLN), a clinical-stage, immunology focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced it has received a favorable patentability opinion from the European Patent Office (EPO) acting as the International Examiner on a polymorph patent application for farudodstat which, if granted in the national stages, will extend effective patent protection for farudodstat until at least 2043.
Farudodstat is a potent, oral dihydroorotate dehydrogenase (DHODH) inhibitor with the potential to be a first-in-class treatment option for alopecia areata (AA). ASLAN is currently conducting a Phase 2a proof-of-concept trial in AA (the “FAST-AA Study”) and an interim readout from the study is expected mid-2024.
“We are very pleased to have received a positive preliminary opinion from the EPO on the Composition of Matter patent application for farudodstat, and recognition that all of our claims were novel and inventive. If granted in the national stages, the new patent will extend the patent protection on farudodstat until at least 2043. This will significantly enhance the commercial exclusivity of farudodstat and is an important achievement in our plans to strengthen the patent protection for farudodstat in all key commercial territories. With so few treatment options available to alopecia areata patients, our ambition is to bring a safe and effective treatment option to patients,” said Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals.
About farudodstat
Farudodstat is a potent, oral DHODH inhibitor that suppresses immune cell proliferation and IFN-γ secretion by blocking de novo production of pyrimidines required for DNA replication. Compared to first-generation DHODH inhibitors, farudodstat has been shown to be approximately 30 times more potent in its inhibition of DHODH and T cell activity and has demonstrated a well-tolerated safety profile. ASLAN has generated data showing that farudodstat can potentially protect against the loss of immune privilege in hair follicles, supporting its potential as a first-in-class treatment option for AA. A Phase 2a proof-of-concept trial in AA, the FAST-AA study, is currently underway with an interim readout expected mid-2024.
About ASLAN Pharmaceuticals
ASLAN Pharmaceuticals (Nasdaq: ASLN) is a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients. ASLAN is developing eblasakimab, a potential first-in-class antibody targeting the IL-13 receptor in moderate-to-severe atopic dermatitis (AD) with the potential to improve upon current biologics used to treat allergic disease, and has reported positive topline data from a Phase 2b dose-ranging study in moderate-to-severe AD patients. ASLAN is also developing farudodstat, a potent oral inhibitor of the enzyme DHODH as a potential first-in-class treatment for AA in a Phase 2a, proof-of-concept trial with an interim readout expected mid-2024. ASLAN has teams in San Mateo, California, and in Singapore. For additional information please visit the ASLAN website or follow ASLAN on LinkedIn.
Forward-looking statements
This release contains forward-looking statements. These statements are based on the current beliefs and expectations of the management of ASLAN Pharmaceuticals Limited and/or its affiliates (the "Company"). These forward-looking statements may include, but are not limited to statements regarding the Company’s business strategy and clinical development plans; the term of the Company’s patent protection; the Company’s plans to develop and commercialize eblasakimab and farudodstat; the safety and efficacy of eblasakimab and farudodstat; the Company’s plans and expected timing with respect to manufacturing activities, clinical trials, clinical trial enrolment and clinical trial results for eblasakimab and farudodstat; the potential of eblasakimab as a first-in-class treatment for atopic dermatitis and of farudodstat as a first-in-class treatment for alopecia areata; the potential benefits, capabilities and results of the Company’s collaboration efforts. The Company’s estimates, projections and other forward-looking statements are based on management's current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations, or financial performance, and inherently involve significant known and unknown risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of many risks and uncertainties, which include, unexpected safety or efficacy data observed during preclinical or clinical studies; the fact that results of earlier studies and trials may not be predictive of future trial results; clinical site activation rates or clinical trial enrolment rates that are lower than expected; the impact of the COVID-19 pandemic, the ongoing conflict between Ukraine and Russia, as well as ongoing conflicts in the Middle East on the Company’s business and the global economy; general market conditions; changes in the competitive landscape; and the Company’s ability to obtain sufficient financing to fund its strategic and clinical development plans. Other factors that may cause actual results to differ from those expressed or implied in such forward-looking statements are described in the Company’s US Securities and Exchange Commission filings and reports (Commission File No. 001- 38475), including the Company’s Annual Report on Form 20-F filed with the US Securities and Exchange Commission on March 24, 2023. All statements other than statements of historical fact are forward-looking statements. The words “may,” “could,” “will,” “estimate,” “anticipate,” “intend,” “expect,” “plan,” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes are intended to identify estimates, projections, and other forward-looking statements. Estimates, projections, and other forward-looking statements speak only as of the date they were made, and, except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement.
Media and IR contacts
| Emma Thompson Spurwing Communications Tel: +65 6206 7350 Email: ASLAN@spurwingcomms.com | Ashley R. Robinson LifeSci Advisors, LLC Tel: +1 (617) 430-7577 Email: arr@lifesciadvisors.com |
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