Repros Therapeutics, Inc. (RPRX)

[spartex]

Nebido -- yes, IDEV is their trading symbol. Nebido is a testosterone injection I believe (see info below from IDEV site), and imo Androxal drug trumps this drug due to its adverse side-effects over time if I remember the cons correctly from rfj and dewophile.

http://www.indevus.com/site/index.php?option=com_content&task=view&id=26&Itemid=40

NEBIDO is a novel, long-acting injectable testosterone preparation for the treatment of male hypogonadism. NEBIDO is expected to be the first three-month testosterone preparation available in the U.S. in the growing market for testosterone replacement therapies. Indevus acquired U.S. rights to NEBIDO from Schering AG, Germany, in July 2005. Recently approved and launched in Europe, NEBIDO has a substantial data package which the Company will leverage in its U.S. development activities. In March 2006, the Company announced that the U.S. Food and Drug administration (FDA) had accepted its IND for the Phase III pharmacokinetic study of NEBIDO. A New Drug Application is expected to be filed with the FDA in the second quarter of 2007.

On March 26, 2007, the Company provided an update on its' Phase III pharmacokinetic study of NEBIDO. The Phase III pharmacokinetic trial is an ongoing, randomized open-label (unblinded) study scheduled to conclude the key pharmacokinetic evaluations of total serum testosterone concentrations following treatment with NEBIDO. The Company stated that based on the preliminary data, it is highly likely that at least 75% of patients in the 1000 mg arm will achieve a Cavg within the normal range. Further, no patients in the 1000 mg arm exceeded a concentration level of 2500 ng/dL; four of 97 (4.1%) patients had a peak level over 1800 ng/dL; and 10 of 97 (10.3%) patients had a peak level exceeding 1500 ng/dL. The duration of time any patient had a concentration over these thresholds was brief.

Additionally, the Company stated that based on the available data of the 750 mg arm, it is likely that at least 75% of patients will achieve a Cavg within the normal range. No patients in the 750 mg arm exceeded a level of either 2500 ng/dL or 1800 ng/dL, and four of 103 (3.9%) patients had a peak level exceeding 1500 ng/dL.

Preliminary safety data indicates that both doses of the drug are well- tolerated when given every 12 weeks. The Company expects to update this preliminary report when the study is completed by the end of May 2007 and expects to release final results of the trial in June 2007 and file a New Drug Application (NDA) with the FDA during the summer of 2007.

Male hypogonadism is an increasingly recognized medical condition characterized by a reduced or absent secretion of testosterone from the testes. Reduced testosterone levels can lead to health problems and significantly impair quality of life. Common effects of hypogonadism include decreased sexual desire, muscle loss and weakness, as well as an increased risk of osteoporosis. Today, there are an estimated four to five million men in the U.S. who suffer from hypogonadism. Of this group, approximately five percent are currently receiving treatment with testosterone replacement therapy. The market is highly-under treated and is expected to grow by more than 10% annually. The U.S. market has experienced rapid growth to approximately $490 million in 2005.

Hypogonadism is primarily diagnosed and treated by specialty physicians, specifically urologists and endocrinologists. Routine testing of testosterone levels has become a more common part of men's health evaluations by specialists. The three-month dosing schedule would fit in well with the physician-recommended follow-up of every three months making it convenient for patients receiving treatment. Current treatment options include gels, patches, and injections, the latter of which requires 13-26 injections per year. The Company believes that the unique profile of NEBIDO will present an opportunity in the growing market for testosterone replacement, and that physicians and patients currently using other methods of treatment may be willing to switch to NEBIDO because of the many benefits of three-month dosing, including compliance, convenience, and the maintenance of steady serum levels of testosterone for three months.