By Toni Clarke
July 4 (Reuters) – The U.S. Food and Drug Administration has
approved Swedish drugmaker Orexo AB’s drug to treat
opioid addiction, the company said on Thursday, sending its
shares up as much as 14.3 percent in Stockholm.
The drug, Zubsolv, is a tablet that dissolves under the
tongue. It combines the drugs buprenorphine and naloxone and
will compete with similar products, Subutex and Suboxone, made
by British’s Reckitt-Benckiser Group Plc.
Orexo says its drug offers a benefit to patients over
Suboxone because it uses less drug to achieve the same effect.
It also has a menthol flavor it says patients in a study
preferred.
In March, the FDA rejected a similar drug from Titan
Pharmaceuticals Inc and asked for additional data
proving it worked. Titan’s drug, Probuphine, is a long-acting
version of Suboxone that is implanted under the skin.
To date, the market for buprenorphine has been dominated by
Reckitt, a consumer goods company whose products range from
cleaning supplies to condoms. Suboxone and Subutex generated
sales of roughly $1.3 billion in 2012.
Orexo said opioid dependence affects nearly 5 million people
in the United States and that only 20 percent receive treatment.
The company said it expects peak sales of the drug to be at
least $500 million.
Suboxone and Subutex lost market exclusivity in 2009, and
while generic competitors introduced cheap copies of Subutex,
they were slow to develop alternatives to Suboxone. In the
meantime, Reckitt persuaded many physicians to switch from
Suboxone tablets to Suboxone Film, a newer, patent-protected
wafer-like strip that patients dissolve under the tongue.
At the end of 2012, according to Reckitt, Suboxone Film had
captured 64 percent of the market.
Earlier this year, the FDA approved generic versions of
Suboxone tablets from Amneal Pharmaceuticals LLC and Actavis Inc
.
Orexo said it expects to launch the drug in the U.S. around
September. It said on Monday it had signed a deal with contract
sales organization Publicis Touchpoint Solutions under which
both companies would share in the investment and profit.
Once Publicis has recovered its investment and an agreed
upon return, the amount of which was undisclosed, Publicis would
receive a single digit share of the profit until the contract
ends in December 2016.
Orexo’s shares were up 7.75 kronor, or 11.74 percent, to
73.75 in midmorning trading on the Stockholm Stock Exchange.
Earlier they rose as high as 75.50.
