Denmark's Forward Pharma has a plan to contend with Biogen Idec ($BIIB) and its multibillion-selling multiple sclerosis drug Tecfidera, eyeing $200 million in a U.S. IPO to bankroll its offensive.
Forward's case revolves around FP187, a Phase III MS treatment using a proprietary formulation of dimethyl fumarate (DMF), the same active ingredient in Biogen's drug. On the clinical side, the company plans to begin a late-stage trial testing FP187 against relapsing-remitting MS this year, earmarking $80 million of its potential IPO haul for that purpose. From there, Forward expects to launch a Phase III psoriasis study on the drug in 2015 and spend another $12 million or so on its preclinical assets.
But the biotech's attack on Tecfidera is two-pronged, and Forward is setting aside another $25 million of IPO cash to fund an intellectual property fight. Forward was founded in 2005 to develop some assets acquired from Sweden's Aditech Pharma, among them some slow-release formulations of DMF to treat MS. Looking at Tecfidera, Forward believes its patents predate Biogen's, and an official from the U.S. Patent and Trademark Office agrees, according to the company.
In its filing with the SEC, Forward said a USPTO official told the company it will be designated as "senior party" when it appears before a three-judge panel to argue who got to DMF first, meaning Forward is presumed to be the first inventor and Biogen will have to make its case to the contrary. The USPTO panel is yet to be scheduled, according to Forward.
If things go Forward's way, Biogen could be significantly hampered in its ability to market Tecfidera, a drug that brought in more than $700 million last quarter and has skyrocketed since winning FDA approval last year.
"We do not believe Forward Pharma's patent filings will affect our ability to market Tecfidera," Biogen said in a statement. "We have a strong IP portfolio protecting Tecfidera, which grew out of our pioneering efforts in bringing this important medicine to patients."
Aside from its patent challenge, Forward next expects to enroll about 2,000 patients in its Phase III trial, comparing FP187 with active beta interferon over 48 weeks with a primary efficacy endpoint of annualized relapse rate. The company estimates the MS market at around $15 billion currently and expects it to grow 10% per year.
If its Wall Street debut works out, Forward will have pulled off the biggest biotech IPO of 2014, standing out in a year already poised to set records for deals and valuations in the industry.
- read the filing