UPDATE: Mondobiotech Drug Gets New Hope, But Questions Remain
February 12 2010 - 3:32PM
Dow Jones News
Switzerland's Mondobiotech Holding AG (RARE.EB) received a key
lifeline for one of its lead pipeline products from United
Therapeutics Corp. (UTHR), which is attempting to expand its reach
in treating a form of high blood pressure.
The move gives the drug, aviptadil, another chance after Biogen
Idec Inc. (BIIB) dropped the product following its evaluation of
the data and the potential market. Mondobiotech estimates the drug
has a sales potential of 1 billion Swiss Francs, or about $928
million. However, others aren't as optimistic.
"A new partner for aviptadil doesn't increase the product's
chances to reach the market," said Andrew Weiss, biotech analyst
with Zurich-based bank Vontobel. "Actually, the fact that Biogen
seems to have had a negative read-out indicates a higher risk for
the drug candidate."
"The drug failed to convince Biogen Idec's scientists that this
is a $1 billion drug. Otherwise, they would have not returned it,"
he said.
Officials from Mondobiotech weren't available for comment.
Aviptadil is being studied as a treatment for pulmonary arterial
hypertension, a competitive area with major players continuing to
fight for a slice of the growing market. Cowen & Co. projects
the worldwide annual market at about $4 billion, with current
therapies only penetrating to about $1.5 billion to $2 billion.
Pulmonary arterial hypertension, or PAH, is continuous high
blood pressure in the pulmonary arteries that makes patients
susceptible to heart failure. The market is dominated by Swiss drug
maker Actelion Ltd.'s (ATLN.VX) Tracleer pill, which generated 2008
sales of CHF1.3 billion, or about $1.2 billion. Other drug makers
include Gilead Sciences Inc. (GILD) and Pfizer Inc. (PFE), while a
number of companies are also developing new treatments.
United Therapeutics sells three treatments for the condition,
and the deal with Mondobiotech, revealed earlier this month, shows
its efforts to continue its presence.
"We are always looking to expand our reach within pulmonary
arterial hypertension," said Andrew Fisher, United Therapeutics
spokesman.
The latest data on the drug haven't been detailed, and both
United Therapeutics and Biogen declined to comment. A Biogen
spokeswoman said the company walked away from aviptadil in December
after evaluating its data and the potential market.
Fisher said the drug remains in Phase 2 testing as the company
plans to see how patients respond to higher doses before it decides
on the next step in the program.
Its development is already well behind Mondobiotech's original
projections for a 2007 launch, and Chief Executive Fabio Cavalli
recently said he expects the drug to reach the market in 2012.
Mondobiotech went public in Switzerland last August by way of a
placement of existing shares that have lost 68% since their first
day of trading to close at CHF122 Friday--mainly due to raising
capital despite having no products on the market yet.
Still, the stock price gives the company a market valuation
close to CHF700 million, which some consider hugely overvalued,
because aviptadil is one of the company's most advanced development
products.
"Applying a usual early-stage biotech company model, we reach a
fair value of around CHF20 per share or a market capitalization of
between CHF100 million and CHF120 million," analyst Weiss said.
Fisher declined to provide financial details of the licensing
deal, but said United Therapeutics has complete control of the
program and that any subsequent payments to Mondobiotech are
"back-end weighted," meaning they will come at later stages of
development.
Meanwhile, Mondobiotech--whose headquarters in a 16th century
Capuchin monastery in central Switzerland is currently undergoing
renovation with the help of star architect Norman Foster--has
decided to raise capital, but the uptake has been slow so far.
"Mondo resorting to a capital hike shows that the company needs
funding. They have a large infrastructure--including Mr. Cavalli's
corporate jet--and no products on the market yet," Weiss said.
-By Thomas Gryta, Dow Jones Newswires; 212-416-2169;
thomas.gryta@dowjones.com
-By Julia Mengewein, Dow Jones Newswires; +41-43-443-80-45;
julia.mengewein@dowjones.com
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