China's TaiMed Biologics has won the FDA's breakthrough therapy designation (BTD) for its HIV therapy, ibalizumab (TMB-355), making it apparently the first Chinese med to get onto the list.
TaiMed's manufacturing partner, Shanghai-based WuXi PharmaTech ($WX), put out word of the BTD win late last week, highlighting an antibody that belongs to a class of viral-entry drugs now in development. WuXi plans to partner on filing a rolling BLA in search of an approval for what the CRO says would be the first therapeutic with a made-in-China stamp that's launched in the U.S. market.
A little under a year ago WuXi heralded the FDA's approval of a batch of ibalizumab manufactured in Shanghai for patients being treated under an IND. About four years ago TaiMed partnered with Canada's Ambrilia on HIV compounds, paying a modest $250,000 upfront with $7.6 million in milestones. But according to TaiMed's website, this drug has been in the works for years.
Ibalizumab works by barring the virus' entry into cells by hitting the CD4 receptor, a primary mechanism in the spread of infection.
The FDA's breakthrough drug status is designed to accelerate the approval of cutting-edge therapies by providing open-door access to regulators. But this particular program has been winding its way through clinical studies for more than a decade. The Taiwan-based company says that the FDA granted "fast track" status close to 12 years ago and successfully completed a Phase IIb in 2011 after seeing a big drop in the viral load in patients recruited for a Phase IIa that ended in 2006.
There's been considerable discussion about the impact the BTD program has had on the drugs that have been picked for special status at the agency. A number of transatlantic Big Pharmas have been able to nab some accelerated approvals on cancer drugs designated as BTDs. But few Asian companies have benefited, with the possible exception of Japan's Takeda, which recently won BTD status for ixazomib (MLN9708), a multiple myeloma product it obtained in the buyout of Boston's Millennium.
"This is the fourth WuXi-manufactured product to be so designated, reflecting the high quality of the molecules that we choose to work on," says WuXi CEO Ge Li in a statement. "We will give TaiMed our full support as they advance this promising product candidate through regulatory review."
- here's the release