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GTx, Inc.

Drug Names(s): Andarine

Description: Andarine is a non-steroidal Selective Androgen Receptor Modulator (SARM) being developed by GTx Inc for cancer cachexia. Andarine selectively modulates testosterone or androgen receptors. It has the ability to reverse osteoporosis, muscle wasting, low testosterone due to cancer in aging men.

Besides, its potential for cancer cachexia, Andarine has implications in treating diseases/conditions caused by low testosterone. Over 50% of men above 60 years (and some women)have low testosterone leading to loss of several physiological function, as listed below. Andarine, maybe an ideal drug for such indications, since it is a non-steroidal, small-molecule oral compound that can selectively activate testosterone receptors.

Some of the potential indications for SARMs:Hypogonadism (Low testosterone),Benign prostatic hyperplasia, Male osteoporosis, Erectile dysfunction, Fertility, Male contraception, Depression, Prevention of hair loss,Chronic muscle wasting conditions, Anemia, Prostate cancer, lossof libido,and Female Health: Sexual dysfunction, endometriosis, Osteoporosis.

Deal Structure: In March 2004, GTx entered into a worldwide collaboration with Johnson & Johnsons Ortho Biotech to develop its Selective Androgen Receptor Modulator (SARM) program. Andarine and other SARMS are likely to be developed.

Under the terms of the agreement, GTx will receive an upfront licensing fee, additional licensing fees, and milestone payments up to $82 million based on Andarine, and up to $45 million for each additional licensed compound achieving specific clinical development decisions or obtaining regulatory approvals. Johnson & Johnson Pharmaceutical Research & Development will be responsible for further clinical development and expenses, and Ortho Biotech will be responsible for commercialization and expenses. Ortho Biotech will have exclusive marketing rights for Andarine in the US and worldwide markets. However, GTx has the option to co-promote Andarine and other licensed SARM compounds to urologists in the U.S. for uses specifically related to men's health. GTx will...See full deal structure in Biomedtracker

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