Axiron Generic Launched In The United States
Released
Released
Announcement PDF
ACRUX (ACR) - ASX ANNOUNCEMENT
6 JULY 2017
AXIRON® GENERIC LAUNCHED IN THE UNITED STATES
On 6 July 2017, Acrux confirmed that a generic version of Axiron® (testosterone topical
solution) has been launched in the United States by Perrigo.
Acrux also confirmed the availability of an Authorised Generic version of Axiron in the United
States, through a marketing and distribution agreement between Eli Lilly and Company (Lilly)
and a leading authorised generics company. The Authorised Generic provides patients with the
similar experience of the Axiron branded product at a price that competes with generics. Acrux
will receive a royalty from the sales of Axiron and the Authorised Generic.
Lilly and Acrux continue to believe that the Axiron axilla application patent is valid and
enforceable. Lilly and Acrux are committed to asserting their intellectual property rights for
Axiron and the Appeal, and proceedings remain underway. The Appeal is expected to be heard
in the third quarter 2017.
For further information, contact
Michael Kotsanis, CEO and Managing Director: 03 8379 0100
About the appeal litigation
On 23rd August 2016, Acrux, and its partner Eli Lilly and Company, appealed the decision by the
United States District Court for the Southern District of Indiana, in which the Axiron®
formulation and axilla application patents granted by the US Patent and Trademark Office were
held invalid, and in which the applicator patent was held valid but not infringed by the majority
of parties. During the pendency of the appeal, the formulation patent expired and is no longer
subject to the appeal proceedings. Lilly and Acrux are represented by Finnegan, Henderson,
Farabow, Garrett & Dunner, LLP which is a firm with significant expertise in patent litigation in
the United States.
About Acrux
Acrux (ASX: ACR) is a pharmaceutical company dedicated to developing and commercialising
specialty and generic topical pharmaceuticals. Incorporated in 1998 and using in house facilities
and capabilities, Acrux has successfully developed and commercialised through licensees a
number of pharmaceutical products in the US and Europe using the Patchless Patch™, a fastdrying and invisible topical application technology. Marketed products include Axiron®,
Evamist® and Lenzetto®. More recently, in addition to specialty products, Acrux has identified
and initiated development of a range of generic products. Acrux is leveraging its on-site
laboratories, GMP manufacturing suite, clinical and commercial experience to bring more
products to market. Acrux encourages collaboration and is well positioned to discuss partnering
and product development.
For further information on Acrux, visit www.acrux.com.au
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