While bringing Dyloject onto a major Western market is validation, selling the drug while developing two others is draining
Javelin's resources. "Moving from a development company to a commercial business is a big deal," says Driscoll. "Javelin may
have bit off more than they can chew."
So now Javelin is out shopping for a Big Pharma commercialization partner interested in its pain portfolio, which the company
values at $700 million. Patricia Bank, an analyst with Pacific Growth Equities, writes that a partnership or acquisition can
happen even by year end. But interest may come from outside the US. With the UK's regulatory OK under its belt, Javelin plans
to file Dyloject simultaneously in the rest of the big European markets, which would make it a more attractive asset to European
But the big prize in terms of sales still remains the United States—where there's a reflex reaction to cringe at the word
"NSAID." So even though FDA has approved two diclofenac molecules in the last year, says Driscoll, US marketing approval is
by no means "a slam dunk." "The Australians, FDA, and most other regulators in the world have acknowledged the benefit of
NSAIDs when they're used at a minimal dose for the shortest period of time," says Juan Sanchez, an analyst for Landenburg.
"But you still have the stigma."
TRENDWATCH "There's activity coming from outside the US in terms of potential acquirers," says Maik Klasen, Frost & Sullivan. "The one hurdle Big Pharma has [whether from the US or abroad] is they are looking for very solid numbers
in terms of clinical data
Orphan drugs make their mark
There's something to be said for the spirit of independence. Just take Martine Rothblatt, now CEO of United Therapeutics.
She has succeeded by pioneering her own path. Rothblatt was the one to invent global satellite radio, which she created along
with the company Sirius. In the years that followed, she helped draft the United Nations' declaration on the human genome
and human rights, wrote a book that proposes bringing peace to the Middle East by making Israel and Palestine the 51st and
52nd States, and established a nonprofit to foster personal cyberconsciousness. Oh, and her movie about a half-human, half-machine
murderer should be out soon, too.
In that context, starting a pharma firm from scratch is one of the more mundane activities Rothblatt has undertaken. But to
develop a drug for pulmonary arterial hypertension (PAH), a disease her daughter was diagnosed with in 1992, she knew she
had to do it herself. PAH involves a tightening of blood vessels connected to the lungs, which can cause heart failure.
Rothblatt tried to drum up a cure through grants, but eventually paid $25,000 for the rights to a PAH compound shelved by
GSK, which came to the market in 2002 as Remodulin (treprostinil), with an orphan drug designation. Since then, sales have
exploded. UT is on track to deliver its sixth straight year of 30 percent growth.
UT has filed an NDA for Viveta, an inhaled version of Remodulin, which is currently dosed through continuous infusion. This
is thought to grow the drug's sales further still by offering a more convenient dosing and additional efficacy indications.
The PDUFA date is April 2009.
Certainly, the company's success puts it under the M&A microscope. Will it continue to fly solo? "UT believes it can deliver
the best value to its shareholders by remaining independent and continuing the successful performance it has shown year in
and year out," says Rothblatt. Of course, Genentech and Ventana didn't want to be bought either. "If the price is right,"
says Landenburg analyst Juan Sanchez, "Every company is for sale these days."