UPDATED: Startup Epirus lays claim to a PhIII success for Remicade biosimilar

A low-profile startup in Boston backed by some marquee venture groups has posted positive data from a Phase III study of its biosimilar of Remicade, a blockbuster rheumatoid arthritis drug.

Epirus Biopharmaceuticals CEO Amit Munshi--a co-founder at Kythera ($KYTH)--says that BOW-015 achieved an ACR20 response rate of 89.8% at week 16, compared to 86.4% for Remicade. Investigators assigned 127 RA patients to the BOW-15 arm and 62 to the Remicade group. "This outcome met its prespecified statistical endpoint and was within a 15% equivalence margin at a 95% confidence interval," says a company statement. And the company--which touted early-stage results just at the beginning of the year--says the data pave the way to regulatory filings in emerging markets.

Munshi has come up with a new strategy for biosimilar development work. Rather than focus primarily on the U.S. and Europe, two huge markets attracting the attention of multinational players, he's zeroed in on emerging markets like South Africa and Brazil. By partnering with manufacturers already on the ground, he tells FierceBiotech, the company can improve its chances of pushing ahead with local regulators while gaining government support to build facilities and winning government contracts for lower-priced therapies.

"In the long term it's hard for a small biotech to compete with the Koreans," Munshi adds. "The Koreans are formidable competitors in whatever sector they get involved in."

Munshi says he took over as CEO of Epirus about a year ago when it was a virtual company in Menlo Park, CA, and moved it to Boston, where it is easier to hire industry professionals. The company now has about 20 staffers, he says, including a small team in Europe. And the biotech has just raised a venture round from its backers, though the CEO isn't saying right now how much money that involves. 

Epirus has attracted some high-profile venture backers. TPG Biotech, an arm of the multibillion-dollar group at TPG Capital, and 5AM Ventures joined forces with Montreux Equity Partners to back the biosimilars company.

Remicade is a big target in the nascent biosimilar market. Johnson & Johnson ($JNJ) and Merck ($MRK) market the drug, which earns about $6 billion a year. Just a few weeks ago Hospira ($HSP) and South Korea's Celltrion won EMA support for their copycat versions of Remicade. 

Last year Munshi was associated with Percivia, a failed biosimilar joint venture involving Crucell and Royal DSM ($DSM). Jim Mullen, the former CEO at Biogen Idec ($BIIB), was listed as the chairman with Munshi as CEO. But Munshi says the JV foundered following J&J's takeover of Crucell. A biosimilar venture, he says, didn't fit with J&J's corporate strategy. So he moved on to Epirus.

A number of early biosimilar efforts have foundered over the past year as development efforts ran into serious patent issues or faced higher-than-expected costs. Just a few weeks ago Teva Pharmaceutical Industries ($TEVA) and Lonza formally scrapped their struggling partnership aimed at developing a knockoff of Rituxan. But big partnerships involving players like Samsung and Biogen Idec continue to forge ahead. And Novartis' ($NVS) Sandoz unit has 5 projects in late-stage development.

Europe remains far ahead of the U.S. in biosimilar development. The FDA has yet to finalize development rules, and payers have been clamoring for some resolution to help accelerate the arrival of less expensive biologics.

"The data supporting BOW-015's clinical comparability to Remicade, combined with the focus of Epirus on emerging markets, will help expand patient access to this important medicine," noted Jonathan Kay, a professor at the University of Massachusetts Medical School, in the statement. Dr. Kay is a clinical adviser to the biotech.

- here's the press release