Acrux Limited and Organon to Develop Contraceptive Sprays

MELBOURNE, Australia & OSS, Netherlands--(BUSINESS WIRE)--Drug delivery company Acrux (ASX: ACR), announced today that it has signed an agreement with Organon, the human healthcare business unit of Akzo Nobel (NASDAQ: AKZOY). Organon and Acrux will develop and commercialise contraceptives, delivered through the skin using Acrux’s unique spray technology.

“We are delighted and proud that Organon, with its renowned experience and expertise in contraception, has recognised the benefits that our innovative technology can provide,” said Acrux CEO Richard Treagus. “We are looking forward to working closely with Organon to realise the commercial potential in this large market.”

Organon’s executive vice president, Research and Development, David Nicholson, commented: “Organon recognises the importance of contraceptive choice and offers one of the most comprehensive portfolios of effective, innovative and appealing methods available. This collaboration with Acrux is part of our strategy to vigorously pursue alternative options to extend choices even further.”

Under the agreement, Organon has licensed Acrux’s technology for use with selected contraceptive compounds. Acrux will be responsible for developing formulations of such contraceptive compounds and upon successful completion of this program, Organon will undertake and fund all clinical trials, regulatory submissions, manufacturing and marketing.

For each contraceptive compound that Organon selects to develop, Acrux may receive payments totalling between US$12 million and US$16 million as development and regulatory milestones are achieved. Acrux will also earn royalties on worldwide sales of each product.

Acrux is free to develop and commercialise sprays containing other contraceptive compounds, including Nestorone®, which it is currently advancing through clinical trials.

Worldwide sales of hormonal contraceptive products in 2006 were approximately US$6.7 billion. The availability of a broad range of effective, safe and appealing contraceptive products is viewed as one of the most important issues in contraception. This enables women to choose the method most appropriate to their needs and lifestyle.

About Acrux - www.acrux.com.au

Acrux is an Australian drug delivery company, developing and commercialising a range of patient-preferred, patented pharmaceutical products for global markets, using its innovative technology to administer drugs through the skin. Fast-drying, invisible sprays or liquids provide a delivery platform with low or no skin irritation, superior cosmetic acceptability and simple, accurate and flexible dosing. The technology platform is covered by broad and well-differentiated, issued patents.

Acrux’s products in clinical development include:

  • Estradiol MDTS® (EvaMist™ in the USA) to treat menopause symptoms
  • Testosterone MDTS® to treat decreased libido in women
  • Nestorone® MDTS® contraceptive spray for women
  • Fentanyl UDTS™ to treat chronic pain
  • Testosterone MD-Lotion® to treat testosterone deficiency in men

    Acrux has licensed worldwide rights for certain MDTS® contraceptives to Organon, USA rights for Estradiol MDTS® and Testosterone MDTS® to VIVUS and AUS/NZ distribution rights for Testosterone MDTS® and Fentanyl UDTS™ to CSL Limited. Acrux has also licensed its technology to Eli Lilly and Company for veterinary healthcare products.

    About Organon – www.organon.com

    Organon creates, manufactures and markets innovative prescription medicines that improve the health and quality of human life. Through a combination of innovation and business partnerships, Organon seeks to leverage its position as a leading biopharmaceutical company in each of its core therapeutic fields: fertility, gynecology and selected areas of anesthesia. It has extensive expertise in neuroscience and a rich and focused R&D program. Research areas also include immunology and specific areas of oncology. Organon products are distributed in over 100 countries worldwide, of which more than 50 have an Organon subsidiary. Organon is the human healthcare business unit of Akzo Nobel.

    Safe Harbor Statement

    This press release may contain forward-looking statements. These forward-looking statements, addressing without limitation such key issues as growth strategy, future financial results, market positions, and product development, are based on current expectations of future events and circumstances and can be identified by the fact that they use words such as "will", "anticipate", "estimate", "expect", "project", "intend", "plan", "believe", "target", "forecast", and other words and terms of similar meaning in connection with any discussion of future operating or financial performance or business prospects.

    Such forward-looking statements should be carefully considered, and it should be understood that many factors could cause forecasted and actual results to differ from these forward-looking statements. Organon BioSciences undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or circumstances, or otherwise.

    The forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Organon BioSciences' business, particularly but without limitation including general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment.

    Acrux:

    In Australia: Richard Treagus, +61 3 8379 0100/ +61 417 520 509 Acrux CEO richard.treagus@acrux.com.au

    or

    In the U.S. Pagano& Co. PR Christina Pagano, 212-213-2851/646-382-3871 paganopr@aol.com

    or

    Organon: Monique Mols, +31 (0)412-665440 Director Media Relations monique.mols@organon.com

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