BPAX CEO Wants to Sell Co…
And the sun sets in the west….
Here’s today’s Bloomberg story on BioSante, which says nothing new.
BioSante’s Female Sex Drug Spurs Deal-Making Talks, CEO Says
2011-07-11 17:08:42.437 GMT
By Catherine Larkin
July 11 (Bloomberg) — BioSante Pharmaceuticals Inc. is in
talks to partner on its sex gel to raise female libido or sell
the company, according to Chief Executive Officer Stephen Simes.
Scientists have tried to chemically treat female sexual
dysfunction since Pfizer Inc.’s Viagra, with $1.9 billion in
2010 sales, was introduced 13 years ago for erectile dysfunction
in men. After failed attempts by Pfizer, Boehringer Ingelheim
GmbH and Procter & Gamble Co., BioSante, based in Lincolnshire,
Illinois, is next in line seeking to capitalize on the idea.
The market for a female sex drug may mirror sales for male
products at about $4 billion a year, said Jason Butler, an
analyst at JMP Securities in New York. Simes, in an interview,
said he aims to seek U.S. regulatory next year for his LibiGel
testosterone gel, in anticipation of U.S. sales in 2013. In the
meantime, there have been talks about possible deals with
“many, many companies,” he said.
“BioSante was an underdog,” said Elemer Piros, an analyst
at Rodman & Renshaw in New York, in a July 8 phone interview.
“Nobody really wanted to touch BioSante when they had a three-,
four-, five-year window ahead of them. The company is just being
recognized, just starting to appear on people’s radar screens.”
The company’s shares have more than doubled this year to
$3.60 at the end of trading on July 8. Four analysts surveyed by
Bloomberg estimate they’ll reach $5.50 within a year.
BioSante may fetch an acquisition price as high as $1
billion as early as the first quarter of next year if two
studies of 500 women each find the drug increases desire and
sexual experiences, Piros said. The data is due to be reported
by the end of the year, the company said.
$540 Million in Sales
Chris Holterhoff, an analyst at Oppenheimer & Co. in New
York, estimates 2015 sales of $540 million for LibiGel, with use
by 6 percent of potential patients. Possible use of the drug
beyond its officially approved designation for postmenopausal
women may double that revenue, Piros said.
A “very conservative” estimate may be a licensing deal
for $100 million plus future royalties, or an acquisition in the
range of $300 million to $500 million, Simes said. He
acknowledged a higher price may be possible with “a significant
premium” over the company’s market cap of about $337 million.
“What we think is the gating factor to partner interest
and to approval is very strong safety data,” Holterhoff said in
a July 8 telephone interview.
LibiGel also is being tested for cardiovascular safety and
a potential risk of breast cancer in a study of more than 3,600
women. Researchers monitoring that study have not found an
imbalance in risks that would require the study to be stopped
early, which Piros said is “good enough proximal information”
to suggest the drug is safe.
“We believe the value of LibiGel will increase as new
efficacy and safety data become available and these data will be
available beginning in the coming months,” Simes said today.
The safety data will be available in the third quarter of
next year, according to the company.
“There’s a broad range of potential partners and acquirers
for this product,” JMP’s Butler said in a July 8 telephone
interview. “You can look at any of the mid-to-large specialty
pharmaceutical companies as well as any of the global pharmas.”
Pfizer, based in New York, and Eli Lilly & Co., of
Indianapolis, would make good partners because they have
successfully marketed sex medicines for men, Butler said.
Oppenheimer’s Holterhoff also identified Endo Pharmaceuticals or
Warner Chilcott Plc.
Raul Damas, a Pfizer spokesman, said in an e-mailed
response that the world’s largest drugmaker has “no current
plans to develop medicines for female sexual dysfunction.”
Kevin Wiggins, a spokesman for Chadds Ford, Pennsylvania-
based Endo, said the company doesn’t comment on market
speculation. Lilly spokesman Mark Taylor said the company
doesn’t comment on possible business development activity.
Voice-mail and e-mail messages weren’t immediately returned by
Emily Hill, a spokeswoman for Dublin-based Warner Chilcott.
Testosterone, while often characterized as a male hormone,
also plays a role in women’s libido. The amount of testosterone
produced naturally by a woman’s body decreases with age,
especially after menopause. The goal of therapy is to increase
hormone levels to the normal range of a premenopausal woman.
There were 4 million prescriptions for male testosterone gels
written to women in 2009, representing about 30 percent of the
females who report sexual problems to their doctors, Simes said.
LibiGel is applied to the upper arm once daily in pea-sized
amounts, unlike male testosterone gels that are often slathered
across the upper body.
BioSante licensed the drug in 2000 and had planned for the
drug to reach the market years ago before the FDA asked for more
safety data in the wake of the 2004 withdrawal of Merck & Co.’s
Vioxx painkiller over heart risks.
So far the delays haven’t spooked investors, Simes said.
“People are impressed with the market opportunity and at
least today there is no competition,” he said. “We didn’t
expect it to take this long to get this product for women. It’s
taken a lot more time and a lot more money.”
Pfizer stopped developing Viagra for women in 2004 because
studies didn’t show a benefit. Later that year, Cincinnati-based
P&G withdrew its application to sell a female testosterone patch
after the FDA asked for more safety information. Closely held
Boehringer, of Ingelheim, Germany, abandoned its flibanserin
pill last year after failing to convince the FDA that it was
safe and effective in women.
For Related News and Information:
Today’s most popular health-care stories: MNI HEA <GO>
Russell 3000 Health-Care Index: RGUSH <INDEX> MRR 10 <GO>
Bloomberg Industries pharmaceuticals analysis: BI PRHM <GO>
BioSante’s relative value: BPAX US <EQUITY> RV <GO>
FDA review of new medicines: TNI FDA NP BN <GO>
Bloomberg Drug Database: BDRG <GO>
—With assistance from Naomi Kresge in Berlin. Editors: Bruce
Rule, Andrew Pollack