http://www.saworldview.com/
tlc le pdf en haut et à droite ,pour nicox c'est page 5 et 6
Fighting in the Face of Distress
Undervalued and cash-strapped, a global industry wrestles with its future
by
Mike May
Along
the Mediterranean coast of France, people are concerned with more than
films. Just 20 minutes to the north of Cannes lies Sophia Antipolis—a
technology park with clients ranging from Agilent Technologies to W3C,
the World Wide Web Consortium. This is also home to NicOx, a company
focused on producing drugs from compounds that release the well-known
signaling molecule nitric oxide. NicOx is alive today only because of
its failures in the past. In short, NicOx once focused on ideas
more than products. “That was almost killing us,” says Michele Garufi,
chairman and chief executive officer of NicOx. Like many small
companies in biotech, NicOx once operated as if it existed in an
academic environment rather than a commercial one. “In 2003, we said:
‘It’s time to be concrete, because we have no money, and we must invest
every penny in a product that becomes a reality, rather than merely a
hope.’” That transition turned NicOx toward pushing ahead naproxcinod,
its anti-inflammatory compound under development for treating the signs
and symptoms of osteoarthritis. By concentrating on producing a
product it took just five years for NicOx to get naproxcinod through
Phase III trials, which showed that this drug is effective and safe.
Consequently NicOx expects to file a new drug application in 2009. As
Garufi points out: “It’s very important for a biotech company to get
something on the market even if it is a niche indication in a small
market.” If naproxcinod does get to market, though, it will be far
beyond a niche. It will be gigantic. Garufi estimates the market as a
“possible billion dollars a year in the U.S.” So it is possible
to face failure and then fight back toward success. While today’s
economic environment makes many biotechnology companies around the
world struggle, a range of experts envision success even during a down
economy. Assessing the Environment
"Our companies take
10 to 15 years to take a product from bench to bedside,” notes Alan
Eisenberg, executive vice president for the Biotechnology Industry
Organization’s emerging company section. “During that time there is
preclinical testing and testing that goes on in humans—first for
safety, then efficacy and finally larger-scale population testing. That
length of time and complexity represents high levels of risk from a
financial standpoint." That risk, though, is not entirely new. In fact,
biotechnology in the United States started feeling the crunch in 2007.
“We entered a credit crisis beginning in August 2007,” Eisenberg says,
“and that became a capital crisis.” As a result, investors started
looking for lower-risk opportunities in 2008. That creates problems for
companies developing new therapeutics, a high-cost enterprise. As
Eisenberg explains: “Projects get delayed, and some get shelved,
because companies can’t raise capital.” A similar divide exists
in Europe. “Most companies in Europe with products on the market are
selling medical products that are not immediately affected by the
economic downturn,” says Willy De Greef, secretary general for
EuropaBio, “but start-ups or companies working on their pipeline that
don’t have a current cash flow are in for some very difficult times.”
(See sidebar “Europe’s No Silicon Valley.”) For a brand new
start-up in Europe, De Greef declares, “I wouldn’t want to be the
manager looking for money this year.” On the other hand, if a company
finished a round of raising capital in 2008, De Greef thinks that it
should survive, as long as the company has enough money for a couple of
years. “CFOs who have turned down all of the unneccessaries and use
their money sparingly will probably do okay-ish,” De Greef says. Beyond
the challenges faced by start-ups, some experts see today’s financial
trouble crippling mid-stage companies. “A company that is just getting
back Phase II data or starting a Phase III trial often need tens of
millions of dollars,” according to Spencer Feldman, an attorney with
Greenberg Traurig in New York city and an expert on providing counsel
to emerging biotechnology companies. “That is difficult to get right
now.” Feldman adds that large pharmaceutical companies often use this
situation to their advantage. He continues: “These mid-size companies
are left abandoned, giving big pharma the opportunity to come in and
buy the valuable IP in bankruptcy or in a distressed selling situation.”
un autre lien
http://formularyjournal.modernmedicine.com/drug+watch
avec naproxcinod
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Mar 11 Aoû - 22:23
