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

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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

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Samsung plans ambitious rollout of biosims at deep discounts

Posted under antibodies, Biogen Idec, Biologics, biosimilars, Blog, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Samsung, Startups, Universities, Videos by john

Samsung BioLogics is moving fast with some ambitious plans to start marketing biosmilars at a deep discount while striking more development deals like the one it has with Biogen Idec ($BIIB) and ramping up its own work on novel biologics. And it's betting that its global rep in the electronics market and construction industry will help make the conglomerate a leading contender in the biopharma business.

Samsung, better known for flat screen TV sets than therapeutics, tells the Financial Times that it will put the finishing touches to its manufacturing site outside of Seoul by June, with plans to have global regulatory sanctions in place by the end of this year. That would set the stage for Samsung and its partner Biogen Idec to have a slate of biosimilars ready to market in 2015, and it plans to offer generic antibodies at half the current price they're available.

"Biopharmaceutical companies are good for sales, and biotech companies for innovation, but neither is good for manufacturing," Tae-Han Kim, the president of Samsung BioLogics, tells the Financial Times. "It is in Samsung's DNA to produce products at low prices while meeting legal and industry requirements. The price of monoclonal antibodies is very expensive and not affordable to all patients. That is a heavy burden on governments and [healthcare] payers."

The article doesn't make clear exactly where Samsung will offer deep discounts. But for the U.S. market, analysts have been projecting far more modest discounts of about 10% to 20%. A 50% discount would represent a much greater challenge to drugmakers.

The FT also just drops word of Samsung's plans to develop new therapies at the end of the story, with no explanation of what it plans to focus on.

- here's the article from the Financial Times

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RNAi developer Arrowhead snags startup Alvos in stock deal

Posted under Arrowhead Research, Biogen Idec, Blog, Companies, Diagnostics, Funding, M&A, Medical Devices, Medical Supply, Pharmaceuticals, Rib-X Pharmaceuticals, RNAi, Startups, Universities, Videos by rmcbride

Arrowhead Research has bought Alvos Therapeutics and the small company's peptides that home in on tumor targets. Alvos is getting 315,467 restricted shares in Arrowhead ($ARWR) common stock upfront, with $23.5 million in additional stock awards tied to development and regulatory milestones.

Alvos, previously called Mercator Therapeutics, boasts founders from MD Anderson Cancer Center and veteran biotech insiders Roy Lobb, a former Biogen Idec ($BIIB) scientist and co-founder of Avila Therapeutics (sold to Celgene ($CELG) for $350 million in January) as well as Mark Leuchtenberger, who is chief executive of antibiotics developer Rib-X Pharma, a 2011 Fierce 15 company. Alvos raised $2 million in a seed round in summer 2010 to license homing peptides from MD Anderson that have shown an ability to carry drugs to tumors while limiting side effects on healthy tissues.

Arrowhead, which bought Swiss drug giant Roche's ($RHHBY) RNA-interference (RNAi) assets last year, says Alvos' homing peptides could help the company deliver RNAi treatments into cancer cells and carry a variety of other anti-cancer drugs. One of the major challenges in RNAi drug development has been delivering the gene-silencing therapies to tissues deep in the body, and earlier efforts to achieve this have fallen short. The programs under development at Alvos (which had been operating in the Boston area at the time of its 2010 seed funding) will move to Arrowhead's R&D outpost in Madison, WI, according to the buyer.

Alvos, clearly, never matured as much as Lobb and Leuchtenberger's previous companies, and a vast majority of the payout from Arrowhead will depend on the future success of the biotech's programs. Leuchtenberger hasn't returned a message left on his cell phone this morning to discuss the deal. Arrowhead is planning a conference call to review the transaction at 4:30 pm ET.

In Arrowhead's release, Lobb, the chief scientist at Alvos, said: "We were attracted to Arrowhead as an acquirer because of its ability to accelerate development of the platform through its excellent scientific staff and state-of-the-art facilities."

In 2010, Leuchtenberger told me for an article in Xconomy that a special aspect of the technology the company licensed from MD Anderson was the ability to do organ-specific screening of peptides in humans with cancer, enabling researchers to find peptide-receptor pairs that could help them develop treatments that bring targeted fights to tumors.

- here's Arrowhead's release

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