Suda Pharmaceuticals Is All Set To Commercialize SUD-001H

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Suda Pharmaceuticals

Suda Pharmaceuticals Limited (ASX:SUD) announced regarding its entry into an exclusive product development, licence and supply agreement with the fully owned subsidiary of Strides Pharma Science Ltd, Strides Pharma Global Pte Ltd on November 8, 2018.

The agreement is done for the development and commercialisation of SUDA’s novel SUD-001H fast acting oral spray of sumatriptan in the United States. The spray based on Suda’s proprietary OroMist hydrotrope technology is used to treat migraine. SUD-001H would be the first novel fast-acting oral spray of sumatriptan in the US market after it gets approval by the US Food and Drug Administration (FDA). 

Suda’s Chairman and Chief executive officer Stephen Carter expressed his views regarding the need for SUD-001H. Normal migraine type headache can last for approximately 72 hours. Some patients experienced needle type pain, while some have very bad health problems reported under migraine. Severe nausea and vomiting was also experienced by some of the patients having migraine attack. Sensitivity to noise and light was also encountered by few patients. As per the survey estimates by the National Headache Foundation, more than 36 million people in the US experience migraine headaches. As per the research report, the US migraine treatment market was valued at US$1.2 billion in 2017.

SUD-001H offers an attractive treatment option with rapid absorption of the drug. It uses an oral spray formulation of GlaxoSmithKline’s sumatriptan drug, currently been used to treat acute migraine in adults. Drug provided through the oral mucosa with the help of novel Oro Mist platform comes with various advantages over traditional administration forms. The ease of use, faster response time, lower dosage and reduced side effects are some of the benefits of the OroMist platform. Strides will give Suda an up-front payment of US$400,000 (A$560,000) and a further payment of US$600,000 under this development and commercialisation agreement. The payment will made upon reaching various milestones as well as after the first clinical study, and submission of the product and its approval. Product development services for SUD-001H will be funded by Strides. Suda will receive royalties and a handling fee once commercialization is done. Strides will hold the first right of refusal when looking to sell into other regions including the New Zealand, EU, Australian, Japan, South Africa and Canada. Suda will be working through the FDA approval procedures under this agreement.

In order to assess the potential for SUD-001H for the treatment of adult migraine, a primary marketing assessment of the US market was commissioned by Suda. The results from the market assessment confirmed the immediate need for a product that could provide a quick relief with low dose. During the evaluation process, varied practitioners responded highly positive towards SUD-001H.

Highly supportive response from the medical practitioners towards the use of SUD-001H and ease of use, quick response time with low dosage will support the development of the oral spray. Suda’s share price have moved 20% up from the previous closing levels to current levels of $0.006 on November 8, 2018.


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