Eli Lilly & Co., the maker of the impotence pill Cialis, bought exclusive rights from Acrux Ltd. to an underarm testosterone lotion called Axiron for men with limited sex drive due to low levels of the hormone.
Indianapolis-based Lilly will pay Acrux of West Melbourne, Australia, a $50 million license fee plus $3 million when manufacturing assets are transferred, the companies said today in a statement. Acrux may earn $87 million more if U.S. regulators approve the drug for marketing, $195 million in commercial milestone payments as well as royalty payments on future sales, the companies said.
Acrux filed a marketing application with the U.S. Food and Drug Administration in January in an effort to enter a global market for testosterone therapies valued at more than $1 billion a year. More than a third of American men older than 45 years have low testosterone, doctors found in a 2006 study. It can sap sex drive and cause impotence, osteoporosis and memory loss, according to the Mayo Clinic in Rochester, Minnesota.
“The addition of Axiron reinforces Lilly’s commitment to men’s health and, if approved, could provide a new treatment option for men suffering from low testosterone,” said Bryce Carmine, president of Lilly’s Bio-Medicines.
Results of a clinical trial released in September showed Acrux’s lotion, called Axiron, normalized testosterone levels in 84 percent of men after four months.
Acrux, which has never made a profit, was spun off from Monash University a decade ago and now has the chance to make a profit and provide dividends to shareholders, Ross Dobinson, the company’s chairman, said in a statement released today.
The company’s agreement with Lilly is “believed to be the largest licensing deal ever stuck by an Australian biotech company,” Dobinson said.
Acrux rose 3 cents, or 1.3 percent, to A$2.41 in trading on the Australian stock exchange as of 11:20 a.m. in Sydney. The shares have surged more than fivefold in the past year.
Axiron is a fast-drying, pleasant smelling testosterone 2% solution to be applied to the armpits once daily
Axiron, testosterone underarm to boost sex drive in men developed by Acrux Ltd will reach markets soon.
Axiron spray, when applied underarm in men with low sex drive because of decreased amounts of testosterone, restored the normal level of the hormone in most of the men, studies found.
Axiron spray restored levels of testosterone to normal in 84 percent of testosterone-deficient men after four months, Acrux said in a statement. Axiron has been studied 155 men in six countries and 26 sites.
Men were permitted to use an underarm deodorant or antiperspirant during the trial. More than half of the men continued to apply an underarm deodorant or antiperspirant as part of their daily routine and an analysis of these subgroups showed that this had no impact on the efficacy of Axiron treatment.
Mood, sexual desire, sexual activity and sexual performance before and after 4 months of treatment showed significant improvement from baseline across all measures.
Men, who applied Axiron reported having twice as much sex and 80 percent more libido on average. Men under study also had a 35 percent increase in sexual performance and a 13 percent increase in positive mood.
Acrux is targeting to file a New Drug Application (NDA) in the United States for the end of 2009 and Axiron is expected to enter market in early 2011.
Acrux has already received strong interest from a number of potential marketing partners for Axiron.
Global sales in testosterone market for the year to March 2009 exceeded US$1 billion for the first time, and sales in the US market grew by more than 20%, according to IMS data. Sales of testosterone gels in the US grew to US$0.7 billion.
Last year Acrux published results from market research conducted in both patients and physicians in the USA, in which two thirds of patients confirmed that they would prefer Axiron to their existing gel treatment and 87% of physicians said that they would offer Axiron to their patients that currently use gels.
4% of patients who tried Axiron rated it better than the testosterone gels in its ability to reduce the risk of transference of testosterone to others.
In addition, 92% of physicians surveyed who prescribe gels as first line therapy rated Axiron as very good or excellent in its ability to reduce the risk of transference to others when compared to the gels. Axiron has been designed to overcome the drawbacks associated with the current gel treatments.
Large volumes of gel are applied by hand and rubbed on to the abdomen, shoulders or arms. They are considered messy,sticky, slow-drying and may have an unpleasant odour to some patients.
One of the biggest drawbacks of testosterone gels is the risk of transference to other people through contact with the application site or from residue left on the hands following application.
Axiron is a faster-drying and pleasant smelling solution that is applied to the armpits once daily, using a convenient and ergonomic “no-touch” applicator designed in Australia.
The armpit is a unique application site for transdermal drug delivery and it offers significant advantages to the patient in terms of convenience and may have a lower risk of transference from patient to others.
Androgel, a product made by Brussels-based Solvay SA, had sales of 337 million euros ($493 million) in 2008, according to data compiled by Bloomberg. A testosterone gel made by Malvern, Pennsylvania-based Auxilium Pharmaceuticals Inc. had 2008 sales of $125 million.
Testosterone deficiency in men (hypogonadism) is associated with a number of symptoms including lethargy, depression, reduced libido and decrease in muscle mass and bone density. Estimates of men over 50 years of age having testosterone levels below the normal healthy range vary from 10% to 39%. However, in the majority of men this remains undiagnosed, with only around 5% to 10% of those with the condition receiving treatment.
Acrux is an Australian drug deliveryfirm developing and commercialising a range of pharmaceutical products for global markets, using innovative, patented technology to administer drugs through the skin.
Sources:
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