Biotech Values

[urche]

Lasoxifene


Laso is one of the reasons I decided to invest in PFE. As I recall, the deal with Ligand was restructured last year in a way that PFE has more to gain (or lose) with laso, while PFE gave up some of its interest in an oncology drug (for lung ca). Although primarily in the pipeline as a drug for osteoporosis (improved SERM), it has interesting "side effects" that cause improved lipid profile and benefit for atrophic vaginits. It is also touted to improve sex drive. Will we hear next about Laso's benefit on memory?

Anyway, here is an update on Laso's progress:
http://biz.yahoo.com/bw/050203/35213_1.html

Pfizer Submits SNDA to Expand Potential Market for Lasofoxifene
Thursday February 3, 9:00 am ET
Triggers Ligand Royalty Buy-Out Option from Salk and Expands Potential Ligand Royalty Revenue


SAN DIEGO--(BUSINESS WIRE)--Feb. 3, 2005--Ligand Pharmaceuticals Incorporated (Nasdaq:LGND - News) announced today that Pfizer has confirmed a December 2004 FDA filing of a supplemental NDA for the use of lasofoxifene for the treatment of vaginal atrophy. This follows an August 2004 NDA filing by Pfizer for use of lasofoxifene in the prevention of osteoporosis. Lasofoxifene is a selective estrogen receptor modulator (SERM) and the first of Ligand's royalty-bearing products to get to the NDA submission stage. Lasofoxifene is also being developed by Pfizer for the treatment of osteoporosis.

According to an estimate published in the May 15, 2000 issue of American Family Physician, from ten to 40 per cent of postmenopausal women have symptoms of vaginal atrophy including dryness, burning, itching and soreness. This often leads to an increased susceptibility to urinary and vaginal infections and to a decrease in sexual activity and associated emotional distress. Census figures show that more than 42 million American women are age 50 or older, the approximate age when menopause begins.

According to the National Osteoporosis Foundation, eight million American women have osteoporosis and almost 27 million women are estimated to have osteopenia (low bone mass), placing them at increased risk for osteoporosis.

"If approved for this additional indication, lasofoxifene could provide an important new therapeutic option to improve the urogenital health and quality of life for postmenopausal women in this often overlooked and under-diagnosed condition," said Andres Negro-Vilar, M.D. PhD, Ligand's executive vice president of research and development and chief scientific officer. "A clinical trial presented at the October 2004 meeting of the North American Menopause Society by D. Portman et al. shows that lasofoxifene but not raloxifene (Evista®) significantly improves the clinical symptoms of vaginal atrophy compared to placebo and is the first SERM to demonstrate these positive effects. A second study by G. Bachmann et al. confirmed the improvements in vaginal atrophy by lasofoxifene compared to placebo."

Under the terms of the agreement between Ligand and Pfizer, Ligand is entitled to receive an additional milestone upon the first FDA approval of lasofoxifene and, if marketed, royalty payments equal to 6% of net sales of lasofoxifene worldwide for any indication.

As a result of the supplemental lasofoxifene NDA filing, Ligand has exercised an option to pay the Salk Institute $1.12 million to buy out royalty payments due on future sales of the product in this additional indication. In March of 2004 Ligand exercised a previous option and paid Salk $1.12 million to buy out royalty payments due on total sales of lasofoxifene for the prevention of osteoporosis.

Ligand has sold to Royalty Pharma the rights to a total of 3.0125% of net sales of lasofoxifene and each of the other two SERM products for a period of ten years following first commercial sale of each product. Ligand retains an approximately equal portion of lasofoxifene and other SERM's net sales going forward and for periods that may exceed ten years. The royalty rates owed to Royalty Pharma may be reduced by one third if SERM product sales exceed certain thresholds across all indications.

"We are very pleased with the supplemental NDA filing for lasofoxifene in this exciting, new, large-market indication as the first of three SERM products which, if successful, could significantly expand our royalty revenue," said Paul V. Maier, Ligand's senior vice president and chief financial officer. "It also underscores the maturation of our portfolio of milestone and royalty-bearing drugs in human development. We believe Wyeth will proceed to NDA filing for bazedoxifene, our second SERM, for prevention of osteoporosis in the first half of 2006 and for combination bazedoxifene CE, our third SERM, in 2007. These drugs and several others in the diabetes, cardiovascular disease and contraception fields provide an exciting major opportunity for milestone and royalty revenues to complement our growing specialty pain and oncology business revenues and increase shareholder value."