ZolpiMist

PERTH, AUSTRALIA – 5 July 2017: SUDA LTD (ASX: SUD), a leader in oro-mucosal drug delivery, today announced that it has entered into an exclusive licence and supply agreement with Teva Pharmaceuticals International GmbH, an affiliate of Teva Pharmaceutical Industries Limited (“Teva”, for SUDA’s novel ZolpiMist™ oral spray of zolpidem tartrate to treat insomnia in multiple countries. Teva is a leading global pharmaceutical company and the world’s largest generic medicines producer. SUDA has granted Teva a licence to ZolpiMist in Brazil, Mexico and Chile, together with an 18-month option to license the product in Argentina, Israel and Australia.

Perth-based SUDA Pharmaceuticals (ASX: SUD) has entered into an exclusive licence agreement with Mitsubishi Tanabe Pharma Singapore Pte Ltd for sales of its ZolpiMist anti-insomnia oral spray in the Asian market.
The supply and distribution agreement, which includes an option period of 12 months, will commence with Singapore, Malaysia and the Philippines and extend into Thailand, Indonesia, Vietnam, Myanmar, Cambodia, Laos and Brunei.

1.Signed 2 licencing deals for ZolpiMist
i. Eddingpharm (Asia) Macao Commercial Offshore Limited (Eddingpharm)
In November 2016, SUDA entered into an exclusive license agreement with Eddingpharm, a leading Chinese pharmaceutical company, for the development and commercialisation of SUDA’s novel ZolpiMist™ oral spray of zolpidem tartrate to treat insomnia in China. Once approved by the Chinese Food and Drug Administration (CFDA), ZolpiMist would be the first imported fast-acting oral spray of zolpidem tartrate available in China.

PERTH, AUSTRALIA – 15 June 2018: SUDA Pharmaceuticals Ltd (ASX: SUD), a leader in oromucosal drug delivery, today announced that Magna Pharmaceuticals, Inc., the global owner of ZolpiMist (zolpidem tartrate oral spray), has exclusively licensed the product in the USA and Canada to Englewood, Colorado-based, Aytu BioScience, Inc. (NASDAQ: AYTU). Aytu is an emerging specialty pharmaceutical company and will add ZolpiMist to its current commercial portfolio which includes a testosterone replacement nasal gel, Natesto. ZolpiMist is an FDA-approved, proprietary, oral spray formulation of zolpidem tartrate and is indicated for the short-term treatment of insomnia characterised by difficulties with sleep initiation. SUDA has an exclusive global licence to ZolpiMist, excluding the USA and Canada. Josh Disbrow, Aytu BioScience's CEO commented: "We are excited to add another approved product to our portfolio. Given the substantial overlap in prescribers of testosterone replacement therapies, and Natesto in particular, and anti-insomnia treatments, the company plans to market both Natesto and ZolpiMist to the primary care physicians we already call on. Our prescribers have embraced the novel nasal delivery of Natesto for the treatment of hypogonadism, and likewise, we believe that ZolpiMist’s uniquely-delivered oral spray will present a unique, complementary clinical story in a similarly large, adjacent therapeutic category." Insomnia is the most common specific sleep disorder, with short-term sleep issues reported by about 30% of US adults. For the twelve months ending February 2018, sales in the US prescription sleep aid category were US$1.8 billion. Over this period, there were over 43 million prescriptions of non-benzodiazepine sleep aids written in the USA, and zolpidem tartrate tablets (brand name Ambien® was the most commonly prescribed. More than 30 million prescriptions of various forms of zolpidem tartrate are prescribed annually in the USA. ZolpiMist's unique oral spray formulation enables high bioavailability via rapid absorption through the oral mucosa and no first-pass metabolism through the liver, resulting in a rapid onset of sleep.