Proactiveinvestors Australia Aytu BioScience Inc https://www.proactiveinvestors.com.au Proactiveinvestors Australia Aytu BioScience Inc RSS feed en Tue, 18 Jun 2019 11:50:05 +1000 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[News - Aytu BioScience gains on licensing deal to distribute sleep aid outside the US and Canada ]]> https://www.proactiveinvestors.com.au/companies/news/215946/aytu-bioscience-gains-on-licensing-deal-to-distribute-sleep-aid-outside-the-us-and-canada-215946.html Aytu BioScience Inc (NASDAQ:AYTU) strengthened Wednesday after announcing a licensing agreement to distribute its ZolpiMist oral spray sleep aid outside the US and Canada.

The arrangement calls for SUDA Pharmaceuticals Ltd of Perth, Australia, to lead commercial development and sublicensing efforts for ZolpiMist in Europe, Asia and Latin America. Aytu, based in Englewood, Colorado, has assumed a perpetual, exclusive global licensing agreement with SUDA from Magna Pharmaceuticals, the former new drug application (NDA) holder of ZolpiMist.

Shares of the company surged 32% to $1.45 in Wednesday’s Nasdaq trading.

READ: Aytu's first steps into $2B testosterone market

ZolpiMist is the only Food and Drug Administration-approved oral spray formulation of zolpidem tartrate, according to Aytu. In the US, zolpidem tartrate tablets are marketed under the brand name Ambien from Sanofi SA (NASDAQ:SNY).

''We are pleased to be partnering with SUDA as they develop ZolpiMist commercial opportunities around the world,” Aytu CEO Josh Disbrow said in a statement.

SUDA, a drug delivery company focused on oro-mucosal administration, has already signed sublicensing agreements in key markets with large, multinational drug companies and has agreements in place in China, Chile, Brazil and throughout Southeast Asia.

Under their deal, SUDA will pay Aytu a portion of each upfront and milestone payment received from sublicensees, and Aytu will receive ongoing royalty payments on sales generated by SUDA's sublicensees as ZolpiMist is launched in various territories.

SUDA CEO Stephen Carter said the company “has a number of discussions in place to further the global footprint of the ZolpiMist brand.”

Contact Dennis Fitzgerald at dennis@proactiveinvestors.com

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Wed, 06 Mar 2019 15:38:00 +1100 https://www.proactiveinvestors.com.au/companies/news/215946/aytu-bioscience-gains-on-licensing-deal-to-distribute-sleep-aid-outside-the-us-and-canada-215946.html
<![CDATA[News - Aytu's first steps into $2bln testosterone market ]]> https://www.proactiveinvestors.com.au/companies/news/125184/aytu-s-first-steps-into-2bln-testosterone-market-125184.html Aytu Bioscience, Inc. (OTCQX: AYTU) has entered into the testosterone replacement market with the acquisition of the rights to Natesto.

The speciality pharmaceuticals company secured a long-term, exclusive US commercial rights license from Acerus Pharmaceuticals.

Natesto is the first nasal formulation of testosterone approved by the US Food and Drug Administration as a replacement therapy for men diagnosed with hypogonadism, or low testosterone.

“Natesto has significant potential to satisfy the needs of many men not satisfied with current Low T treatment options,” said Aytu’s chief executive Josh Disbrow.

There are an estimated 13mln men in the US suffering with the condition and the nasal application prevents testosterone transference associated with other topical products.

It was approved by the FDA in 2014 and is protected by several Orange Book-listed patents.

The group anticipates further expanding its current urology focused sales force and initiating its promotion of Natesto into the $2bn US testosterone replacement market in July 2016.

Securing the rights to commercialize Natesto in the US represented the group’s most significant transaction to date, said Disbrow.

Aytu will pay a $2mln upfront with an additional purchase of $2mln of Acerus stocks.

Additional payments totalling $6mln will also be made in 2017. Acerus will also receive a supply price to manufacture the product calculated as a percentage of the US net sales until February 2024, capped at $12mln in annual net sales.

“This partnership further expands on our strategy to build a complementary portfolio of unique urology assets, and we expect Natesto to be a key value driver for Aytu going forward,” added Disbrow.

Shares were down 2.7% to $0.55.

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Mon, 25 Apr 2016 13:55:00 +1000 https://www.proactiveinvestors.com.au/companies/news/125184/aytu-s-first-steps-into-2bln-testosterone-market-125184.html
<![CDATA[News - Aytu BioScience Inc gets approval for male infertility diagnostics ]]> https://www.proactiveinvestors.com.au/companies/news/124280/aytu-bioscience-inc-gets-approval-for-male-infertility-diagnostics-124280.html Aytu Bioscience Inc (OTCMKT:AYTU) told investor it has received approval from Health Canada for its MiOXSYS System which is designed to aid diagnostics for male fertility.

MiOXSYS is an in vitro diagnostic platform that assesses the level of oxidative stress in semen, and the new Health Canada approval will allow Aytu to market the product in Canada.

The product is already cleared for sale in the European Union, following the granting of a CE mark in January, and the company recently made its first commercial sales in the Middle East.

Aytu said it would now also seek strategic opportunities to build partnerships with prominent hospitals, academic centers, and early MiOXSYS users in Canada.

American approval, via the US Food & Drugs Administration, is also being sought.

John Disbrow, Aytu chief executive, said: "Achievement of this milestone reflects our focus on commercializing best-in-class urology products and marketing those products strategically.

“As we pursue FDA clearance of MiOXSYS in the United States, we expect to benefit greatly from these early commercialization efforts in key markets.

“In Europe and the Middle East, our urology customers are already beginning to see the value of MiOXSYS, and this interest is being driven by the widespread need for improved diagnosis in the field of male infertility."

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Thu, 31 Mar 2016 09:26:00 +1100 https://www.proactiveinvestors.com.au/companies/news/124280/aytu-bioscience-inc-gets-approval-for-male-infertility-diagnostics-124280.html