Oro-mucosal drug delivery giant, SUDA Pharmaceuticals Limited (ASX: SUD) is engaged in the pharmaceutical development of drug delivery technology. To increase bioavailability, the company is reformulating the existing drugs into oral sprays. The company uses its proprietary OroMist® technology to create low-risk oral sprays that can be absorbed directly into the blood stream.
Take a look at the SUDA’s key projects below:
The U.S. FDA had approved the insomnia drug, ZolpiMistTM in 2008. ZolpiMistTM is a cherry-flavoured, patented oro-mucosal spray formulation of zolpidem tartrate, which is marketed under the brand name of Stilnox® or Ambien®.
Deals Transacted for ZolpiMistTM
A key part of the SUDA’s business strategy is to work with partners in developing specific products for them using its technology platform and knowhow. The company has so far transacted with several mid to large pharmaceutical companies, expanding its footprint across the world.
Till date, SUDA has signed license and supply deals with four pharma players for ZolpiMistTM.
Let us look at these license deals below:
Aytu BioScience, Inc
In June 2018, SUDA announced that Magna Pharmaceuticals, the NDA holder for ZolpiMist™ and SUDA’s Licensor, had transferred their rights to ZolpiMist™ to Colorado company, Aytu Biosciences, a specialty pharmaceutical company focused on commercialising novel products that addresses significant patient needs. Aytu, the head licensee, is the marketing authorisation holder of ZolpiMistTM in the U.S., who also has exclusive U.S. and Canadian rights to the insomnia drug.
In August this year, Aytu announced the publication of ZolpiMistTM Phase 3 clinical study results in the Pharmacy and Pharmacology journal. The results demonstrated that the lingual spray formulation of zolpidem, ZolpiMistTM, attains rapid sleep onset in patients seeking short-term treatment for insomnia, relative to the oral tablet form of zolpidem.
Mitsubishi Tanabe Pharma Singapore Pte Ltd
SUDA and Mitsubishi Tanabe Pharma Singapore Pte Ltd or MTPS signed an exclusive license agreement in December 2018, for an exclusive licence for, and supply of ZolpiMistTM for Malaysia, Singapore and Philippines, along with a 12-month option period for Thailand, Indonesia, Vietnam, Myanmar, Cambodia, Laos and Brunei.
The agreement entitled SUDA to receive an upfront fee of USD 100,000 plus milestone and option payments up to USD 880,000. Under the terms of the agreement, SUDA was to receive a double-digit royalty contingent upon net sales of the product in the region.
Teva Pharmaceuticals International GmbH
Teva Pharmaceuticals International GmbH and SUDA entered into an exclusive licence and supply agreement in July 2017, for an exclusive licence for, and supply of ZolpiMistTM for Brazil, Mexico and Chile, along with a 12-month option period for Argentina, Israel and Australia.
Under the terms of the agreement, SUDA was to receive an upfront payment of USD 300,000, and up to USD 1,750,000 in further licence fees, registration milestone payments and commercial milestone payments. SUDA was also entitled to receive a double-digit royalty on net sales less the supply price, once ZolpiMistTM got registered for sale in the territory.
The responsibility for the development, regulatory and commercialisation activities was to be held with Teva, and SUDA was to supply the product to Teva at cost plus an agreed handling fee.
Eddingpharm Macao Commercial Offshore Limited
SUDA and the Chinese pharmaceutical company, Eddingpharm entered into an exclusive license agreement for the development and commercialisation of ZolpiMistTM oral spray in November 2016 to treat insomnia in China.
The agreement entitled SUDA to receive an upfront cash payment of USD 300,000 plus milestone payment of USD 200,000. Under the terms of the agreement, SUDA was to receive escalating tiered royalties on net sales in the territory once the product got registered for sale in China.
The company has terminated this agreement with Eddingpharm and is in advanced discussion with another group to take over the ZolpiMistTM license for China, as well as Hong Kong and Taiwan.
SUDA has by now out-licensed ZolpiMistTM in six countries: Mexico, Philippines, Malaysia, Singapore, Brazil, Chile, with options over Thailand, Indonesia, Vietnam, Myanmar, Cambodia, Laos and Brunei. The company is also negotiating with pharma companies for other countries in South America as well as for China, Korea, Middle East and North Africa, UAE, Kuwait, Spain, Italy, France and Germany.
Besides ZolpiMistTM, the company has also transacted deals for its other products with the following companies:
In line with its business strategy, SUDA has attained significant progress in the development of its products, backed by these major drug delivery partnerships. The company has so far collaborated with some of the leading pharmaceutical companies of the world and is engaged in discussions with some others for the expansion of its drug delivery business.
As on 9th October 2019 at 12:27 PM AEST, SUD is trading at $0.003.
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