SUDA Pharmaceuticals Ltd (ASX: SUD) is transforming the drug delivery technology to improve the lifestyle and health of the global community by offering innovative and high-quality oro-mucosal spray pharmaceutical products to aid in the treatment of various diseases. To increase bioavailability, SUDA reformulates the available pharmaceuticals into an oral spray using its OroMist® technology.
SUDA has a broad pipeline of products that includes a US FDA approved insomnia drug and several other products that are in varied development stages. The below figure shows the key projects under SUDA’s product pipeline and their respective development stages:
Let us discuss each of the company’s key projects in some detail below:
Insomnia Drug: ZolpiMist™
ZolpiMist™ is a cherry-flavoured, patented, US FDA approved oro-mucosal spray formulation of zolpidem tartrate, a non-benzodiazepine prescribed for the short-term treatment of insomnia. Zolpidem tablets are marketed under the brand name of Stilnox® or Ambien®. As per the company, Zolpidem tartrate is the most commonly prescribed sleep aid available in the market which holds a market share of more than 70 per cent.
The recently published ZolpiMist™ clinical study results demonstrated the effectiveness of the oral spray in delivering faster sleep onset relative to zolpidem tablets. The remarkable clinical study results were published in the Pharmacy and Pharmacology journal.
Aytu BioScience is SUDA’s marketing authorisation holder in the USA for ZolpiMist™ that has exclusive U.S. and Canadian rights to the lingual spray. SUDA had also entered into licence and supply agreements for ZolpiMist™ with some major pharmaceutical companies including Eddingpharm, Teva Pharmaceuticals and Mitsubishi Tanabe Pharma. SUDA has made speedy progress on the global roll out of the ZolpiMist™ with most major markets being addressed including Brazil, Mainland China, Australia, Singapore, Indonesia, etc.
SUDA has been in talks with several pharma companies for the license of ZolpiMist™ in other countries of South America, along with Italy, the Middle East, UAE, Spain, Germany, North Africa, Kuwait, Korea and France.
SUDA is also targeting for registration of ZolpiMist™ by the Australian TGA (Therapeutic Goods Administration). In April 2019, SUDA informed that the TGA has considered and acknowledged its Marketing Authorisation file for ZolpiMist™ for evaluation. For the evaluation process, the TGA was to take 255 days to finalise its review and deliver an opinion on the ZolpiMist™ Marketing Authorisation.
Malaria Drug: ArTiMist®
ArTiMist® is the first sublingual spray across the world, which has been designed to treat p. falciparum severe paediatric malaria. The active pharmaceutical ingredient or API in the sublingual spray ArTiMist® is anti-malarial artemether, which is currently administered either orally in a tablet form or intramuscular injection. The ArTiMist® spray is managed and owned by the company’s subsidiary, Malaria Research Company Pty Ltd.
ArTiMist® is particularly effective in the treatment of young infants and children who are suffering from malaria-linked gastro-intestinal problems and are unable to bear oral treatments. It can be useful as a pre-referral treatment when a child first demonstrates signs of a malaria-type fever, prior to being referred to hospital.
Whilst all TGA reviewers of the ArTimist application recommended the drug for approval the Advisory Committee on Medicine have initially informed SUDA of denial for the Marketing Authorisation Application of its ArTiMist® oral spray following the submission of application with the TGA. However, SUDA has recently lodged and received acknowledgement of receipt of their appeal to the denial from the TGA for review of the marketing approval of the sublingual spray ArTiMist®.
Cancer Drug: Anagrelide (SUD-018)
Anagrelide is an approved generic drug used as an anti-thrombotic agent for treating a rare blood disorder, where the platelet count of the patient is too high. There is substantial scientific evidence available which confirms that cancer patients with high platelet counts have a poor prognosis, so a drug which reduces the platelet count could play a significant role in cancer treatment.
Anagrelide can potentially be developed as a powerful anti-cancer agent, but it is generally restricted in its existing formulation by cardio-stimulatory implications. If Anagrelide can be delivered via SUDA’s oro-mucosal spray, this toxicity will be potentially avoided. The reformulation work of Anagrelide oral spray is currently in progress at the company.
Recently, SUDA has appointed a new Project Director, Dr Richard Franklin for Anagrelide project. Mr Franklin will supervise the project till the completion of Phase 1 clinical studies. The European Patent Office has also recently issued a notice to SUDA about its intention to grant Anagrelide patent, marking a remarkable step in the commercialisation process of Anagrelide.
Nausea Drug: Ondansetron (SUD-002)
SUDA’s ondansetron project is a mint-flavoured, first-in-class oral spray formulation of ondansetron, a most commonly prescribed antiemetic to treat vomiting and nausea induced by radiation therapy or chemotherapy regimen. Ondansetron is marketed by GlaxoSmithKline in tablet form under the brand name Zofran®.
SUD-002 has the potential to attain therapeutic drug levels by supplying a micro-mist of concentrated ondansetron orally, offering the required alternative to patients who face trouble in swallowing.
Migraine Headache Drug: Sumatriptan (SUD-001)
SUDA’s SUD-001 is a mint-flavoured, first-in-class oral spray formulation of Sumatriptan, a most commonly prescribed drug for adults used for the treatment of acute migraine. Sumatriptan is marketed by GlaxoSmithKline in a tablet form and in a nasal spray under the brand name Imitrex®.
SUDA is optimising a 2nd generation formulation of Sumatriptan using its novel permeation-enhancing technology for Strides Pharma Science Ltd. The new formulation is expected to offer better bioavailability and faster onset of action than the original SUD-001.
SUDA has an attractive licensing deal with Strides Pharma Global Pte Ltd for the development and commercialisation of SUD-001 for the United States. It is a fully funded development program with clinical trials of more than $4m to be funded by Strides. The company will supply the finished product to Strides.
Erectile Dysfunction Drug: Sildenafil (SUD-003)
DuroMist™ or SUD-003 is a oral spray formulation of Sildenafil, sprayed over the tongue to treat erectile dysfunction. The DuroMist™ spray has the potential for reduced food effect, increased patient convenience and lower dose. Sildenafil is marketed by Pfizer in tablet form under the brand name Viagra®.
SUDA has been granted a patent for SUD-003 in New Zealand, Australia, Canada, South Africa, Russia, Japan, Singapore and the USA. Further patent applications are pending in other jurisdictions.
Pulmonary Arterial Hypertension Drug: SUD-004
Based on SUD-003, SUD-004 has been designed to treat pulmonary arterial hypertension in adults. SUD-004 is also an oral spray formulation of Sildenafil, which is marketed in tablet form by Pfizer as Revatio®.
Pre-Procedural Anxiety and Epileptic Seizures Drug: SUD-005
SUDA’s Midazolam oral spray is a strawberry/mint-flavoured, first-in-class oral spray formulation of Midazolam, used for treating pre-procedural anxiety and epileptic seizures in imaging and dental procedures. SUDA has developed a Midazolam oro-mucosal spray at two dose levels (2.5mg and 5.0mg) utilising its permeation-enhancing technology.
SUDA has framed a development plan for Midazolam with the initial target indication being for the emergency treatment and management of epileptic seizures in children.
The company is fully licensed to produce and purchase cannabinoid products. It has recently engaged in a binding term sheet with CPA (Cann Pharmaceutical Australia) to supply and develop a pharma-grade cannabinoid derivatives oral spray for treating melanoma, drug-resistant epilepsy and motion sickness.
Previously, the company entered into a feasibility study with Zelda Therapeutics to formulate an oral spray of pharma-grade cannabinoid derivatives.
SUDA is using its novel permeation-enhancing OroMist® technology to transform the existing billion-dollar oral delivery drugs industry. The reformulation of the medications into an oral spray offers fast approval & significantly lower cost under the FDA’s accelerated 505 (b)(2) pathway to approval. The company is progressing well with its extensive pipeline of products targeted at treatment of the diverse health conditions.
Stock Performance: SUDA’s stock is currently the trading at AUD 0.004 (12:35 PM AEST, 21st August 2019), up 33.33%.
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