SUDA Pharmaceuticals Progressing Well in 2019 with Significant Regulatory and Patent Approvals


Australia’s leading oro-mucosal drug delivery company, SUDA Pharmaceuticals Ltd (ASX: SUD) develops low-risk, easy-to-use oral sprays using its OroMist® technology to reformulate existing medications. The company’s oral-delivery technology is not only simple and effective for patients, but also provides less side effects, enhanced tolerability and a faster onset of action. SUDA’s oral sprays have improved the bioavailability of the drug to up to 95 per cent, thereby increasing the effect of the medication.

The company has a broad pipeline of products that are under various stages of development, including ZolpiMist™ for insomnia, ArTiMist® for malaria, Anagrelide for cancer, Ondansetron for nausea, Sumatriptan for migraine headache, Sildenafil for erectile dysfunction, SUD-004 for pulmonary arterial hypertension, SUD-005 for pre-procedural anxiety and epileptic seizures and Cannabinoids.

The company has robust intellectual property with over 50 patents. The management is currently working with the technical team to further strengthen the intellectual property portfolio as it progresses with its R&D efforts.

In 2019, SUDA made substantial progress with its extensive product pipeline, supported by some key regulatory and patent approvals. Let us discuss these key developments below:

ArTiMist® Regulatory Updates

In August this year, SUDA informed that the Australian Therapeutic Goods Administration (TGA) has received the company’s application regarding reconsidering the marketing approval of its ArTiMist® oral spray.  The company notified that the Minister’s delegate decision upon reconsideration is due by (latest) 4th October 2019.

SUDA lodged its appeal with TGA against the preliminary notice of denial received by the company in April 2019. Based on the advisors’ feedback, the company believes that there is a good chance of a successful outcome of the appeal submitted to TGA.

ArTiMist® is the first sublingual spray of the world that has been developed for the treatment of p. falciparum severe paediatric malaria. The spray has been designed considering a child living in a complex environment where the time is of the essence, and healthcare resources are very limited. The spray could be useful as a pre-referral treatment (before being referred to a hospital) when the child first started showing signs of a malaria-like fever.

SUDA is continuing discussions with different pharmaceutical companies (including Sanofi, Novartis, Apexpharma and Protheragen) in relation to the licensing or sale of ArTiMist®.

European Cancer Patent for Anagrelide

Marking a major step in SUDA’s Anagrelide program, the European Patent Office informed about its intention to grant Anagrelide patent titled “Use of Anagrelide for Treating Cancer” in July 2019.  As per the company, the granting of Anagrelide patent is a significant step in SUDA’s commercialisation process.

The patent grant, with an expiry date of December 2035, validates SUDA’s position as the only company across the world holding a patent covering the use of Anagrelide for treating or preventing metastatic disease in the lung or bone in patients with solid cancers and high platelet count. SUDA already owns the intellectual property for the use of Anagrelide in cancer, titled “Prevention and treatment of metastatic disease in thrombocytotic cancer patients”.

Anagrelide is an approved platelet-lowering drug that lowers the risk of thrombotic agents in patients with very high platelet counts as a result of diseases like Polycythemia Rubra and Essential Thrombocythemia. The drug has been marketed in Europe and the US for more than twenty years.

SUDA has recently hired a new Project Director for the Anagrelide program, Dr Richard Franklin, who is focussing on a radically new application, which would see Anagrelide formulated as an oro-mucosal spray.

Marketing Authorisation Application for ZolpiMist™

In April this year, SUDA informed regarding the acceptance of Marketing Authorisation Application (MAA) by TGA for insomnia drug oral spray, ZolpiMist™. After clearing the preliminary assessments, the file was acknowledged by TGA for a full evaluation. The TGA was supposed to take 255 days to finalize its review and deliver a judgment, including possible approval of the Marketing Authorisation for ZolpiMist™.

ZolpiMist™ is an oral spray of zolpidem tartrate that has been developed to treat insomnia in multiple countries. It is a patented, cherry-flavoured oral spray that was approved by the FDA in 2008. In the recently conducted pivotal Phase 3 clinical study, ZolpiMist™ lingual spray demonstrated increased bioavailability and achieved a more rapid onset of sleep relative to zolpidem tablets.

Patent Applications for SUDA’s Sildenafil-Based Products

Reinforcing SUDA’s proprietary position, the European and Chinese Intellectual Property Offices accepted patent applications for the company’s sildenafil-based products in February 2019. The company informed that SUD-004 patent applications for Selective Serotonin Reuptake Inhibitor anti-depressant induced erectile dysfunction (SSRI-ED) and pulmonary arterial hypertension (PAH) were accepted under Chinese Patent Application CN 104822368B and European Patent Application 2787967. The patents were titled as “Oral Spray Formulations and Methods for Administration of Sildenafil (PAH & SSRI-ED)”.

Also, the European Patent Office accepted the company’s patent application for SUD-003 for erectile dysfunction (ED) under European Patent Application 2575765. The patent was titled as “Oral Spray Formulations and Methods for Administration of Sildenafil (ED)”. This patent was validated in France, Germany and the United Kingdom.

The ED, PAH & SSRI-ED patent family provides protection until December 2032.

SUD-003 is an oral spray formulation of Sildenafil that has been developed for the treatment of erectile dysfunction. SUD-004 is based on SUD-003 and has been designed to treat pulmonary arterial hypertension in adults.

As per SUDA, the patents covering the use of SUD-003 and SUD-004 for ED, PAH and SSRI-ED, respectively, enhances the value of its novel oral sprays significantly.

It can be inferred that SUDA has progressed substantially on the regulatory front in 2019. The company is revolutionising the drug delivery industry with its proprietary OroMist® Technology and robust product pipeline.

Stock Performance: SUDA’s stock is currently trading at $0.004 on the ASX with around 3.56 billion outstanding shares.


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