Aytu BioScienceが日本でのFiera(R)の国際流通契約を発表

Aytu BioScience, Inc.

2017/10/4 17:28

Aytu BioScienceが日本でのFiera(R)の国際流通契約を発表

AsiaNet 70418 (1556)

【イングルウッド(米コロラド州)2017年10月4日PR Newswire=共同通信JBN】泌尿器分野の新製品の世界的商業化に注力している特殊生命科学会社のAytu BioScience, Inc.(OTOCQX:AYTU)は10月4日、日本におけるFiera(R)の販売、流通についてミツボシ・プロダクト・プラニング株式会社と流通契約を結んだと発表した。ミツボシは不妊と女性の性的ウェルネスに関係する製品の研究、開発、商業化に携わっている特殊生命科学会社である。ミツボシはAytu BioScienceにとり初のFieraの国際流通業者で、同社は将来、Fieraの追加的な国際的流通提携を発表する見込みである。


Aytu BioScienceのジョシュ・ディスブロー最高経営責任者(CEO)は「日本でミツボシと提携し、性的欲求の低さを経験している多くの女性がFieraを利用し、Fieraのような革新的な医薬品でない製品の恩恵を受けられるようにするのは大変うれしい。日本は性的ウェルネスの大規模かつ成長する市場であり、ミツボシはFieraを日本全体の臨床医、消費者の間で重要な女性の性的ウェルネス・ブランドとして確立するのに大変有利な立場にあるとわれわれは信じている」とコメントした。


Aytu BioScienceとミツボシは数カ月以内に日本でFieraを発売開始する見込みである。

▽Aytu BioScience, Inc.について

Aytu BioScienceは商業段階の特殊生命科学会社で、活力、性的ウェルネス、リプロダクティブ・ヘルスへの対応を中心に泌尿器の分野で新製品の世界的商業化に注力している。同社は現在、米国で2つの処方薬、つまり性腺機能低下症(低テストステロン、「低T」)の男性向けにFDA(米食品医薬品局)が初めて承認したこの種で唯一のテストステロンの鼻腔投与剤であるNatesto(R)と、前立腺がんの検出・段階分類用の前立腺特定膜抗原(PSMA)特定のための唯一のFDA承認を受けた造影剤、Prostascint(R)(カプロマブ・ペンデチド)を販売している。さらに、Aytuは酸化ストレスによって起こる男性の不妊の診断と管理のケアの標準になる可能性のある新しい急速精液分析システムのMiOXSYS(R)を開発している。MiOXSYSは米国以外では商業化されており、米国ではCEマークを受け、カナダ保健省の承認を受けた製品であり、Aytuは510k医療機器としてFDAの認可を受けることを目指して米国で臨床試験を行うことを計画している。Aytuの戦略は売り上げを生み出す製品のポートフォリオの増強、集中した商業チームと専門知識を活用した成長市場内の有力ブランドの強化を続けることである。詳しい情報はAytubio.com へ。またAytuはいまでは女性の性的ウェルビーイングと愛情行為に注力した個人の健康、ウェルネス会社のAytuウイメンズ・ヘルス(旧Nuelle,Inc.)を完全子会社化している。Aytuウイメンズ・ヘルスは肉体的覚醒と性的欲求を強化することが科学的に証明されている女性のためのパーソナルケア機器であるFieraを販売している。Fieraは消費者機器であり、いかなる病気、症状に対する治療・軽減・治癒を意図していない。Fieraパーソナルケア機器に関する詳しい情報はfiera.com へ。


Amato and Partners, LLC

Investor Relations Counsel


ソース:Aytu BioScience, Inc.

Aytu BioScience Announces International Distribution Agreement for Fiera(R) in Japan


ENGLEWOOD, Colorado, Oct. 4 2017 /PRNewswire=KYODO JBN/ --

Aytu BioScience, Inc. (OTCQX: AYTU), a specialty life sciences company focused

on global commercialization of novel products in the field of urology, today

announced that the company has entered into a distribution agreement with

Mitsuboshi Product Planning Ltd to market and distribute Fiera in Japan.  

Mitsuboshi is a specialty life sciences company engaged in the research,

development and commercialization of products related to infertility and female

sexual wellness.  Mitsuboshi is the company's first international distributor

of Fiera, and the company expects to announce additional international

distribution partnerships for Fiera in the future.

Logo – (http://mma.prnewswire.com/media/566335/aytu_logo_800x300.jpg )

"We are very pleased to have partnered with Mitsuboshi in Japan to make Fiera

available for the many women that experience low sexual desire and may benefit

from an innovative, non-drug product like Fiera," commented Josh Disbrow, Chief

Executive Officer of Aytu BioScience.  He continued, "Japan is a large and

growing sexual wellness market, and we believe that Mitsuboshi is very well

positioned to establish Fiera as an important female sexual wellness brand

among both clinicians and consumers throughout Japan."

Up to 9 million Japanese women express one or more sexual concerns.  The

Japanese sexual wellness market has been estimated at over $270 million


Aytu BioScience and Mitsuboshi expect to launch Fiera in Japan in the next

several months.

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty life sciences company focused

on global commercialization of novel products in the field of urology, with a

focus on products addressing vitality, sexual wellness, and reproductive

health. The company currently markets two prescription products in the U.S.:

Natesto(R), the first and only FDA-approved nasal formulation of testosterone

for men with hypogonadism (low testosterone, or "Low T") and ProstaScint(R)

(capromab pendetide), the only FDA-approved imaging agent specific to prostate

specific membrane antigen (PSMA) for prostate cancer detection and staging.

Additionally, Aytu is developing MiOXSYS(R), a novel, rapid semen analysis

system with the potential to become a standard of care for the diagnosis and

management of male infertility caused by oxidative stress. MiOXSYS(R) is

commercialized outside the U.S. where it is a CE Marked, Health Canada cleared

product, and Aytu is planning U.S.-based clinical trials in pursuit of 510k

medical device clearance by the FDA. Aytu's strategy is to continue building

its portfolio of revenue-generating products, leveraging its focused commercial

team and expertise to build leading brands within growing markets. For more

information visit aytubio.com. Aytu also now owns wholly-owned subsidiary Aytu

Women's Health (formerly Nuelle, Inc.), a personal health and wellness company

focused on women's sexual wellbeing and intimacy. Aytu Women's Health markets

Fiera, a personal care device for women that is scientifically proven to

enhance physical arousal and sexual desire. Fiera is a consumer device and is

not intended to treat, mitigate, or cure any disease or medical condition. For

more information about the Fiera personal care device visit fiera.com.

Forward Looking Statement

This press release includes forward-looking statements within the meaning of

Section 27A of the Securities Act of 1933, as amended, and Section 21E of the

Securities Exchange Act of 1934, or the Exchange Act. All statements other than

statements of historical facts contained in this presentation, including

statements regarding our anticipated future clinical and regulatory events,

future financial position, business strategy and plans and objectives of

management for future operations, are forward-looking statements. Forward

looking statements are generally written in the future tense and/or are

preceded by words such as "may," "will," "should," "forecast," "could,"

"expect," "suggest," "believe," "estimate," "continue," "anticipate," "intend,"

"plan," or similar words, or the negatives of such terms or other variations on

such terms or comparable terminology. These statements are just predictions and

are subject to risks and uncertainties that could cause the actual events or

results to differ materially. These risks and uncertainties include, among

others: the launch of Fiera in Japan, risks relating to gaining market

acceptance of our products, obtaining reimbursement by third-party payors, the

potential future commercialization of our product candidates, the anticipated

start dates, durations and completion dates, as well as the potential future

results, of our ongoing and future clinical trials, the anticipated designs of

our future clinical trials, anticipated future regulatory submissions and

events, our anticipated future cash position and future events under our

current and potential future collaborations. We also refer you to the risks

described in "Risk Factors" in Part I, Item 1A of Aytu BioScience, Inc.'s

Annual Report on Form 10-K and in the other reports and documents we file with

the Securities and Exchange Commission from time to time.

Investor contact:

Amato and Partners, LLC

Investor Relations Counsel


SOURCE: Aytu BioScience, Inc.