|
Dumpster diving
The Deal
By Alex Lash
Thursday, September 7, 2006
Who says you can't teach an old drug new tricks?
As many life-science funds tire of bankrolling the long march
of biotech R&D, they look to invest in companies with drugs
either on the market or close to it. One way to bypass the
early stages of development is the pharmaceutical equivalent
of dumpster diving.
The preferred name is "repurposing" ò find an existing drug
and aim it at a new target. If done right, a company will
have the low costs of a startup but an advanced product that
could reach the market in a few years instead of the typical
decade or more.
Sofinnova Ventures general partner Jim Healy characterizes
the investment opportunity as "late-stage products at early-stage
prices." That's because repurposed drugs ò or "retooled,"
Healy calls them ò can be cheap to acquire and, if blessed
with a good safety record in previous lives, have fewer hurdles
to gain Food and Drug Administration approval.
A few VCs like Healy are catching on, but not many. Repurposing
is part of a larger industry niche known as "specialty pharma,"
a catch-all term for companies that shun early R&D or focus
on a specific disease area. But even specialty pharma investments
are rare, with five totaling $167 million in 2005 and so far
five more this year totaling $108 million, according to Dow
Jones VentureOne. (Older data were not available.)
Of the 16 pure-play drug IPOs in 2005, three were specialty
pharmas. This year, two of nine so far are specialty: Vanda
Pharmaceuticals Inc. and Novacea Inc., a Sofinnova investment.
(Healy is a board member.) Healy says two-thirds of Sofinnova's
portfolio is specialty pharma, with "the top of the list"
devoted to repurposing.
Dumpster divers are an even smaller niche, looking for drugs
whose original owners went deep into human testing but for
various reasons ò other than safety ò dropped them.
One company that sees new gold in old threads is Somaxon
Pharmaceuticals Inc. of San Diego, one of the most successful
biotech issues in the past twelve months. It debuted Dec.
15 at $11, has topped $20 twice, and now trades near $15.
The company's lead drug, a sleep aid called Silenor, is a
lower dose of the antidepressant doxepin, in use since the
1960s. It is in Phase 3 testing, a fast track for a company
that formed in 2003.
"It's all about capital efficiency," says Lou Bock,
managing director of BA Venture Partners in Foster
City, Calif., and, until April, a Somaxon board member. Bock
says getting Silenor to an NDA ò shorthand for asking the
Food and Drug Administration for the OK to sell a drug ò will
cost $150 million, five times less than rival sleep drug Indiplon,
which ran into approval snags this summer.
BAVP joined Somaxon's $23 million B round in June 2004 and
re-upped for the $60 million C round a year later. It did
not lead in either round but kept enough leverage to own 15%
at the initial public offering. Its post-IPO share was 11%.
Entrepreneurs or VCs looking to build startups around repurposed
drugs have a big pool from which to choose. There are about
5,000 discontinued drugs in the public domain, with about
150 added each year, says Andrew Reaume, chief executive of
Melior Discovery Inc. of Exton, Pa. Melior is working
farther down the pipeline than Somaxon and has a more unusual
approach to repurposing.
Reaume and his team have built a special testing system to
cull the pool into candidates worthy of carrying forward again
into clinical trials. (His count only includes small-molecule
drugs made through chemical synthesis; the boom in biologics
such as proteins and antibodies is too recent.)
With a well-regarded industry chemist on its advisory board,
Melior is taking a different tack than other repurposers.
Instead of trying to pop a drug back into clinical trials
in Phase 2, as Somaxon did with Silenor, Melior aims to streamline
preclinical work, get FDA permission to enter the clinic,
and speed through early trials. He wouldn't cite numbers,
but he says it's "so much cheaper and faster" that the company
hopes to have two compounds in Phase 1 trials by the beginning
of 2008. Melior received its seed funding in January 2005
that included $500,000 from BioAdvance, a greenhouse fund
for the Philadelphia region.
"It's a flexible business plan they can tune up or down,"
says BioAdvance managing director Barbara Schilberg. "They
can develop for their own pipeline, they can do service deals,
they can outlicense. And it's risk-adjusted because they select
compounds that have shown safety at least through Phase 2."
Safety is the sweet spot for most investors looking to fund
repurposers. If a drug has made it to Phase 2 or 3, there's
a much better chance it won't cause adverse effects even when
targeted at a new disease. And the further the drug has progressed,
the more data it has accumulated, which leads VCs to "the
idea of using drugs with years of safety databases and thousands
of patient exposures," Bock says.
If a drug has made it that far without safety problems, it's
probably been dropped for other reasons: It isn't proving
much better than similar drugs on the market, or the parent
company is changing its own therapeutic focus. Like movie
scripts that never quite get it right, discontinued drugs
can sit on a shelf for years.
Once it's off the shelf, however, a repurposed drug can move
fast. Investors hope the companies producing them do the same.
"Our target is to get [our companies] public in three years
or less," Healy says. Seventy million dollars is the pre-IPO
investment target, he says, "but we prefer it closer to $50
million."

|