PharmaEngine gets full Taiwan FDA nod to sell Onivyde

Taipei-based PharmaEngine has secured Taiwan FDA full approval for a product license of pancreatic cancer drug Onivyde, clearing a two-step process that paves the way for sales to start in Taiwan in the second quarter after selling back global rights to Merrimack Pharmaceuticals 5 years ago.

Approval in the U.S. for Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin to treat metastatic pancreatic cancer, was received for Cambridge, MA-based Merrimack Pharmaceuticals ($MACK) in October last year.

The Taiwan FDA also took a cue from the U.S. FDA approval in October in an initial step that assessed factors such as chemistry, manufacturing and clinical data. But it also required a second step related to labeling and package inserts before full approval that was cleared this week.

"The approval of the commercial packaging materials and the GMP approval letters for two U.S. manufacturing sites have been issued to allow the Taiwan FDA to grant the product license of Onivyde," PharmaEngine said in a release.

"Currently, we are focus on the Onivyde launch (in) collaboration with our license partner, Merrimack Pharmaceuticals," the PharmaEngine release said. "Moreover, we will continue developing other potential Onivyde indications."

PharmaEngine, which according to its website is dedicated to drug development of new drugs for cancer and Asian prevalent diseases, has 2 other programs outside of PEP02 (MM-398), or Onivyde, according to the site. Under a separate deal, Merrimack got most of the international rights to the drug back in 2011--after it had been licensed out to PharmaEngine earlier by previous holder Hermes Biosciences--by paying $10 million upfront and promising up to $210 million more in milestones.

It now holds marketing rights in Europe and all of Asia, with the exception of Taiwan.

The second candidate is PEP503 (NBTXR3) licensed from Paris-based Nanobiotix in 2012. It's in a global pivotal trial of soft tissue sarcoma aimed at enhancing the tumor killing capability of radiation therapy, according to the website.

The third candidate is PEP06 in collaboration with China-based Guangzhou BeBetter Medicine with an indication listed for solid tumors, but it's still in the research phase with no other information published on the candidate.

In December, the National Health Research Institutes in Taiwan said clinical trials at eight hospitals showed Onivyde could extend lives by six months and raise survival rates by 50%.

- here's the release