TORONTO (Reuters) - Two Canadian drugmakers, Theratechnologies and Aeterna Zentaris, are looking for partners to market their treatments outside of North America even as they await U.S. regulatory approvals.
Quebec City-based Aeterna has already locked up a North American marketing and partnership agreement with Keryx Biopharmaceuticals for its colon cancer drug, which U.S. regulators put on a fast track for possible approval. That would signal a U.S. launch in 2012.
The company is now looking to strike similar deals in other countries, and it aims to market the drug as a treatment for other forms of cancers, such as multiple myeloma, a type of blood cancer, as well.
Europe, Australia and emerging countries such as China, Brazil and Indonesia are among its target areas, its Chief Medical Officer Paul Blake said.
“We would like agreements wherever possible,” Blake said on the sidelines of an industry conference in Toronto on Wednesday. “I don’t think multiple myeloma has a particular geographic niche unlike some diseases. There are fairly standard incidences around the world.”
Small biotechs tend to partner with global companies with deep pockets that can help fund the development and marketing of the drug. In return companies such as Aeterna receive royalties or milestones payments.
Theratechnologies, which awaits U.S. approval of its experimental drug to treat excess abdominal fat associated with HIV, is also looking to strike partnership deals.
The Montreal-based company already has a U.S. licensing agreement with Merck KGaA’s EMD Serono division and stands to collect about $215 million in milestone payments from Serono if it is approved. It aims to begin marketing the treatment in the United States later this year.
Theratech Chief Executive Yves Rosconi said the company is talking with a number of companies in Europe, the Middle East and Brazil.
“To have one drug, with one territory covered, is really not efficient. You have to really get as much as possible,” he said. “For us it flows straight down to the bottom line having other territories covered.”
AETERNA SEES “NO PRESSURE”
Earlier this week, the U.S. Food and Drug Administration granted fast-track status to Aeterna’s colon cancer drug. The FDA could decide on whether to approve a drug within six months, rather than the usual 10 to 12-month review period.
The designation usually is reserved for drugs designed to treat serious diseases when no other treatments are currently available.
Aeterna and Keryx expect to begin a phase 3 trial for the treatment, called perifosine, sometime this quarter. The trial is expected to end in 2011, followed by a U.S. launch for perifosine in 2012.
Typically approvals in other countries follow in quick order after the U.S. approval, but Dennis Turpin, Aeterna’s chief financial officer, said they were in no hurry to firm up agreements.
“We are in discussions, but there is no pressure for us to make a deal tomorrow morning,” he said. “We just want to deliver additional data and be in the best possible position to make the best deal possible.”
Theratech’s Rosconi said the company expects to announce at least two deals by the end of the year with possible launches sometime in 2011 if the treatment receives the U.S. nod.
“I would rather have a better deal than a quick deal just to impress the gallery,” Rosconi said.
However, Rosconi said he wants future agreements to be based on a higher royalty payment of total sales as opposed to riskier milestone payments, which are contingent on meeting certain goals.
Reporting by Scott Anderson; Editing by Frank McGurty