With the rise in cases of the deadly disease cancer creating havoc across the globe, it is the need of the hour for the pharma participants to gear up and provide cure and treatment solutions to this global concern.
With the huge market opportunity, Australian oro-mucosal drug delivery pharma company, SUDA Pharmaceuticals Ltd (ASX: SUD) announced on 22nd July 2019 that the European Patent Office intends to grant the patent for its Anagrelide drug pertaining to SUDA’s application number 15817516.6, ‘Use of Anagrelide for Treating Cancer’. The patent carries an expiry date of December 2035.
Post receiving this patent, SUDA would be the only company across the globe to possess a patent which covers the use of anagrelide to prevent and treat metastatic diseases in the bones or lungs, in patients who have solid cancers with a high platelet count. The patent covers very broad routes of administration beyond the company’s proprietary oro-mucosal and hydrotrope technologies.
SUDA’s Chairman Paul Hopper reflected on the importance of this grant in the company’s anagrelide program. According to him, European Patent Office’s intent to grant the patent is a significant value creation point for the company as a strong patent position plays a vital role in retrieving the maximum value for a project in the pharma industry.
Role of Platelets in Cancer Progression
Apart from playing a crucial role in controlling the clotting process and wound healing, it has been identified that platelets play an active role in several processes that support cancer. When the platelets get activated by the cancer cells, they release different bio-active materials in the blood stream to help the primary tumour produce its own blood supply and further protect the released cancer cells that move in the body to form new tumours. Realizing the importance of platelets in supporting their growth, the cancer cells send out chemicals to the body to produce more platelets.
It is believed that the overall survival of the patient shortens with more platelets production in the body. Science and medical experts assert that reduction of platelets can be a boon for cancer patients.In this regard, SUDA’s Anagrelide, an FDA approved drug plays a significant role in reducing platelets without affecting any other blood cells.
Further, SUDA plans to step into the Phase 1 cancer clinical trials. It would be interesting to watch the possibilities and events that will unfold for the company post the grant of this significant patent.
Previous Patent Applications
Today’s patent grant from the European Patent Office follows the significant development route of SUDA’s patent portfolio. SUDA began the year with the European and Chinese Intellectual Property Offices accepting its patent applications for the sildenafil-based products in February 2019.
The products given green signal under the patents title of ‘Oral Spray Formulations and Methods for Administration of Sildenafil’ include - SUD-004 for pulmonary arterial hypertension (PAH); and Selective Serotonin Reuptake Inhibitor (SSRI) anti-depressant induced erectile dysfunction (SSRI-ED).
Besides, the European Patent Office also accepted the company’s patent application for SUD-003, a sildenafil-based product for erectile dysfunction; the patent was validated in France, Germany and the UK.
Likewise, SUDA has patent grants in the ANZ region, the US, Russia, Canada, Japan, Singapore and South Africa with several others pending in other jurisdictions.
An overview of SUDA Pharmaceuticals
SUDA Pharmaceuticals Limited (ASX: SUD) is a global leader in reformulating and providing medication via the oral mucosa. The Perth-headquartered company has recently launched its new website- www.sudapharma.com. SUDA uses its proprietary OroMist® technology to develop low-risk oral sprays in an effort to reformulate current pharmaceuticals. Administering drugs through the oral mucosa (palate, cheeks, gum and tongue) has many potential benefits associated with it, including reduced side effects, ease of use, faster response time and lower dosage.
The product pipeline of the company includes ZolpiMist™ which is a first-in-class oral spray prescribed for the short-term treatment of insomnia. ZolpiMist™ is marketed in the United States and the company has the rights to the product outside of the United States and Canada as well.
Stepping ahead in the evolution of drug delivery technology, the company has increased bioavailability of the drug from 25 per cent to as high as 95 per cent through its OroMist® technology.
The company has an extensive knowledge of proven techniques that improve solubility including particle size reduction, novel solvent systems and solid dispersions as well as permeability enhancers and taste masking.
Key events in the recent times
New Agreement in the field of medical grade cannabis: In June 2019, the company signed a binding term sheet for an exclusive licence to develop and deliver an oral spray of pharmaceutical-grade cannabinoid derivatives, with Cann Pharmaceutical Australia Ltd. The agreement was signed to develop an oral spray of pharmaceutical-grade cannabinoids for the treatment of melanoma, epilepsy and motion sickness.
Expansion of Business Development Team: The company informed about the expansion of its business development plan on 4th June 2019. SUDA paced up in the strategic expansion of its business development footprint in the USA, Europe, Russia and China, by entering into agreements with two global specialty consulting groups based in Illinois and Hong Kong, who would work on a success-based remuneration model for SUDA.
Australian TGA Acceptance of ZolpiMist™: The Australian Therapeutic Goods Administration (TGA) accepted SUDA’s Marketing Authorisation Application for its insomnia curing product ZolpiMist™ oral spray in April this year. The company informed that the TGA would deliver its opinion and provide a potential approval of the Authorisation post an extensive evaluation over 255 days.
ArTiMist® Regulatory Update: Most recent on the grant and appeal end, the company provided an ArTiMist® Regulatory Update, stating that it would appeal for the marketing approval of its ArTiMist® oral spray under the Section 60 of the Therapeutic Goods Act of 1989, prior to the deadline of 14th August 2019. SUDA is currently preparing for the submission and intends to submit the appeal prior to the final date of 14th August 2019; hoping for a positive outcome.
Stock Performance: The company's stock soared by 33.33%, settling the days’ trade at AUD 0.004 with a market capitalisation of A$10.67 million and 3.56 billion outstanding shares as on 22 July 2019.
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