Investors pocket $761M in deal betting on Biogen’s BG-12

Posted under BG-12, Biogen Idec, Blog, Companies, Diagnostics, Fumaderm, Fumapharm, Funding, Medical Devices, Medical Supply, multiple sclerosis, Pharmaceuticals, Pipeline, Royalty Pharma, Startups, Universities, Videos by rmcbride

Like a lot of biotech investors, Royalty Pharma sees blockbuster potential in Biogen Idec's ($BIIB) experimental BG-12. The New York-based buyer of royalty interests in biopharma products has laid down $761 million for an interest in potential earn-outs to former shareholders of Fumapharm.

Weston MA-based Biogen, the world's largest provider of multiple sclerosis drugs, snapped up Fumapharm in 2006 to acquire BG-12, a potential blockbuster oral MS treatment. The Royalty Pharma deal gives Fumapharm's former shareholders an early reward for their interest in the hottest late-stage drug in Biogen's pipeline and follows two positive Phase III studies of the drug for combatting flare-ups of the autoimmune disease. The success of the program thus far has helped Biogen's shares soar.

Royalty Pharma has made a huge bet on the future of BG-12, which could become the second approved oral drug for treating attacks of the nerve-damaging disease after Novartis' ($NVS) Gilenya. In recent months Biogen Idec has filed for approvals of the drug in the U.S. and Europe, and the biotech giant is gearing up for a major U.S. launch of the MS treatment in 2013. RBC Capital Markets has estimated peak annual sales of BG-12 to hit up to $3 billion. (Royalty is also gaining a stake in the earn-outs tied to a lesser-known drug from Fumapharm called Fumaderm, a treatment used in Germany for plaque psoriasis.) 

"We are pleased to acquire an interest in one of the most promising new therapies addressing the needs of patients with relapsing-remitting multiple sclerosis," Royalty Pharma CEO Pablo Legorreta said. "The combination of efficacy, safety and tolerability of BG-12 shown in the DEFINE and CONFIRM Phase 3 trials, the oral dosing regimen and Biogen Idec's deep commitment to this disease category, leads us to believe that BG-12 has blockbuster potential."

- here's the release

Related Articles:
Biogen Idec builds blockbuster case for new MS drug BG-12
Biogen Idec races to FDA and EMA with a blockbuster app for BG-12

Biogen Idec builds blockbuster case for new MS drug BG-12

Posted under BG-12, Biogen Idec, blockbuster, Blog, Companies, Diagnostics, Doug Williams, Funding, Medical Devices, Medical Supply, multiple sclerosis, Pharmaceuticals, Pipeline, Startups, Universities, Videos by john

Biogen Idec is backing up its blockbuster expectations for the MS drug BG-12 with a slate of efficacy and safety data gathered in a late-stage study. Readied for a scientific review, Biogen ($BIIB) execs touted the safety profile of the drug, which has proven to be Exhibit A in the biotech's case for a successful turnaround.

"The safety profile has continued to hold up nicely from one study to the next," Doug Williams, Biogen's softspoken R&D chief, tells Dow Jones. Add it all up, he adds, and you'll find compelling reasons why the oral treatment--now under review--"should be front-line therapy for patients." 

At two years of therapy patients in the 1400-subject CONFIRM study most frequently had to deal with flushing and some common GI issues like nausea and diarrhea. But incidents of these side effects also quickly dissipated after treatment began. And the control arm also experienced dramatically high rates of adverse events, not at all uncommon in MS. Patients have been willing to subject themselves to significant risks in the past in order to benefit from new treatments.

This is the second batch of late-stage data to be presented to regulators. "Results from CONFIRM complement the profile we have seen for BG-12 throughout its clinical development program, which now includes robust data sets from two global, placebo-controlled Phase III pivotal studies with more than 2,600 multiple sclerosis patients," said Williams.

- here's the press release
- get the Dow Jones report

Special Report: BG-12 - 15 top blockbuster contenders

Related Articles:
Biogen Idec races to FDA and EMA with a blockbuster app for BG-12
Biogen readies its app after BG-12 beats Copaxone in PhIII MS study
 

Ono’s oral MS drug eliminates brain lesions in promising PhII study

Posted under BG-12, Blog, cladribine, Clinical Trials, Companies, Diagnostics, Funding, Gilenya, Medical Devices, Medical Supply, Merck KgAA, multiple sclerosis, Ono Pharmaceutical, ONO-4641, Pharmaceuticals, Pipeline, Startups, Universities, Videos by john

An oral MS drug was credited with eliminating a large percentage of the brain lesions characteristic of the disease, encouraging the developers at Japan's Ono Pharmaceutical as they lay the foundation for a late-stage program.

The star of the Phase II show was ONO-4641, a tablet on which Ono partnered with Merck KGaA after the German pharma company scuttled its troubled cladribine program. Once a leader in the race to develop the first oral MS drug, Merck KGaA was forced to regroup after the cladribine failure. But with Novartis' ($NVS) Gilenya now under a cloud as regulators in Europe and the U.S. review patient deaths and reevaluate the risk/benefit profile of the drug, rivals in the MS market see improved opportunities for new therapies.

Investigators recruited 407 patients for the study, providing three different doses of ONO-4641 on a daily basis for 26 weeks. Brain scans were performed once every four weeks. And at the end of the study, the investigators found that a mid-range dose eliminated 92% of the brain lesions compared with a placebo. The trial supervisors concluded that there were cardiovascular issues raised among the patients--including changes in blood pressure--as well as liver enzyme elevation.

"In light of recent issues in the oral MS drug market, this is welcome news," said study author Dr. Timothy Vollmer of the University of Colorado in Denver. The results will be presented at the American Academy of Neurology meeting later this month.

Ono faces some stiff competition among MS drug developers. Biogen Idec ($BIIB) has been garnering promising results for its BG-12--now up for review--while Teva Pharmaceutical's ($TEVA) laquinimod pill is in late-stage studies.

- here's the press release

Related Articles:
Merck KGaA bolsters MS pipeline in $20M pact with Ono
FDA's safety concerns force Merck KGaA to kill cladribine MS program
Watchdog says FDA should consider restricting Gilenya

Biogen Idec races to FDA and EMA with a blockbuster app for BG-12

Posted under BG-12, Biogen Idec, Blog, Companies, Diagnostics, Funding, George Scangos, Gilenya, Lemtrada, Medical Devices, Medical Supply, multiple sclerosis, Novartis, Pharmaceuticals, Startups, Universities, Videos by John Carroll

Biogen Idec has filed an NDA on BG-12, taking another step forward in its blockbuster quest to gain an approval on its best near-term hope for a game-changing new treatment. Biogen ($BIIB) racked up promising late-stage data on the program, giving the company good odds for achieving an ultimate OK from the FDA. And the Cambridge, MA-based biotech is putting the final touches on an EMA submission aimed at redefining the market for MS drugs in Europe.

BG-12 is a "real potential blockbuster in the space," Biogen R&D chief Doug Williams tells FierceBiotech. "The safety profile is really quite good, and the benefit/risk profile is really positive."

Biogen is hoping to land a priority review for the treatment, says Williams, which would shave four months off the standard 10-month regulatory cycle. But even if it doesn't, the developer can be upbeat about its prospects for an approval in late 2012 or early 2013. For Biogen Idec, which plans to spend about a quarter of its revenue on R&D this year, the ability to look forward to major league approvals gives the big biotech company some critical leeway with analysts.

"We think BG-12 is going to be a very successful drug in the marketplace," says Williams. "In this business, you have to make consistent investments in R&D over a period of time. That has paid off."

Speed is of the utmost importance right now. Novartis ($NVS) made it to the MS market first with Gilenya. Now the analysts expect that BG-12 will move in to snag significant market share. And if Biogen does nail down key approvals early, they'll continue to cast a shadow over Sanofi's ($SNY) big plans for Lemtrada, the experimental MS drug obtained in the Genzyme buyout.

Williams notes that while there's no head-to-head data with Gilenya, BG-12 can compete on data demonstrating "extremely strong disease control activity across a broad range of parameters."

- here's the press release

Special Report: BG-12 - 15 top blockbuster contenders

Related Articles:
Biogen readies its app after BG-12 beats Copaxone in PhIII MS study
Biogen boosts R&D budget after research cutbacks
Sanofi chief can't spark much enthusiasm for new MS drugs