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Feb
02

Biogen Idec: The Patriots of Biotechs

Posted under BG-12, Biogen Idec, Blog, Companies, CONFIRM study, Diagnostics, Funding, George A. Scangos, Guest Blog, Medical Devices, Medical Supply, MS, Patriots, Pharmaceuticals, Startups, Tysabri, Universities, Videos by Guest Blogger
The Patriots of Biotechs
The Patriots of biotechs is how researcher and analyst and researcher Jessica King Holden thinks of Boston’s Biotech Idec (the oldest and largest biotech in the world).
“It may have taken some hits, but it always seems to manage to come back in the end, though it might not be pretty,” says Holden. “Somehow the group takes setbacks and turns them into positives.”
The company’s new coach, I mean CEO and director, George A. Scangos, who took over almost a year ago lost no time in restructuring the pipeline, putting in his own team of top managers, and injecting his own personal brand of enthusiasm to play in an organization that was, in his words, moving too slowly and too cautiously. He is also seems blessed with of good timing.
The news last Friday was that Bioen Idec with is partner
Elan Corp. won FDA approval for a label change on its controversial multiple-sclerosis drug Tysabri.
Sales of the drug, which annually produces between $1-2 billion worldwide, may double in light of the label change.  Tysabi was issued a safety recall in 2005 due to three cases of the deadly brain infection Progressive Multifocal Leukooenchepalopathy (PML) in patients taking the drug.
But wait: Can Biogen Idec now be reaping the benefits from even a side effect (how’s that for a spectacular field play?)?
Tysabri, an immunosuppressant, may well lead to PML in patients who have dormant JC Virus in the brain. By testing for JC antibodies, patients can now be screened for risk of PML allowing for a wider use of Tysabri. A new test marketed by Quest Diagnostics (DGX) and developed by Biogen Idec and Elan, called Statify JCV, can test for the antibody associated with exposure to the JC Virus. If patients test positive for JC Virus antibodies, risk for PML is increased.
For the many patients then who will test negative for the antibodies, an avenue for Tysabri treatment will be open. To date, 201 cases of PML in nearly 100,000 patients taking the drug had been reported worldwide. Before Statify JCV, determining risk of developing PML in patients was not possible.
Sales of the drug, which annually produces between $1-2 billion worldwide, may double in light of the label change, according to Holden. (See Holden’s analysis here http://seekingalpha.com/article/321144-biogen-idec-turns-a-mess-into-a-double-win)
Biogen Idec’s good news was compounded on the same day that Novartis’ announced its competing oral MS drug, Gilenya, is being investigated for potentially causing heart problems after 11 deaths had been reported in Europe. Shares of Novartis fell nearly 4% on the news.
“Novartis’ stumble also could be Biogen Idec’s benefit, as it has seemingly navigated past its own roadblock with even more in potential profits,” says Holden.
Belichick, I mean CEO Scangos’s, blessed timing was further display last October when Biogen Idec’s own oral drug MS, BG-12,  (in Phase III study of oral BG-12 in relapsing-remitting multiple sclerosis) sparked excitement at a MS conference in Amsterdam  and quickly boosted the drug to stardom.
(The big point in with these competing MS drugs is that both Novartis’s Gilenya and Biogen Idec’s BG-12 are drugs administered orally. The three older and proven existing drugs (along with Tysabi) have to be injected by the patients themselves.
Recently Citeline, an Information business unit, and the world’s leading research authority on pharmaceutical clinical trials reviewed the results presented at the 5th Joint Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS/ACTRIMS), a major multiple sclerosis conference held in Amsterdam.
The results from the CONFIRM study showed that BG-12 beat Teva’s Copaxone, which reduced the ARR by only 29 percent (p< 0.02) compared with placebo at two years.
Copaxon (the leading one of three older existing  MS drugs that have  dominated the therapeutic space for year has to be injected daily)
“With two robust and positive pivotal clinical trials that exposed BG-12 to over 2,600 patients, the drug is well positioned as a top MS therapy of choice and a formidable competitor to Gilenya from Novartis, which gained FDA approval in September 2010,” said  Dr. Heidi Chen from Citeline
And now With Gilenya’s troubles there’s an even clearer path to a touch down and market hold.
CEO Scangos might well be sporting one of Belichick’s famous hoodies this weekend as he basks in his own first year triumph in bringing his company to victory.

By Marylyn Donahue, Special Projects Editor, Pharmaceutical Executive

The Patriots of biotechs is how researcher and analyst and researcher Jessica King Holden thinks of Boston’s Biogen Idec (the oldest and largest biotech in the world).

“It may have taken some hits, but it always seems to manage to come back in the end, though it might not be pretty,” says Holden. “Somehow the group takes setbacks and turns them into positives.”

The company’s new coach, I mean CEO and director, George A. Scangos, who took over almost a year ago lost no time in restructuring the pipeline, putting in his own team of top managers, and injecting his own personal brand of enthusiasm to play in an organization that was, in his words, moving too slowly and too cautiously. He is also seems blessed with of good timing.

The news last Friday was that Biogen Idec with its partner Elan Corp. won FDA approval for a label change on its controversial multiple-sclerosis drug Tysabri. Sales of the drug, which annually produces between $1-2 billion worldwide, may double in light of the label change.  Tysabi was issued a safety recall in 2005 due to three cases of the deadly brain infection Progressive Multifocal Leukooenchepalopathy (PML) in patients taking the drug.

But wait: Can Biogen Idec now be reaping the benefits from even a side effect (how’s that for a spectacular field play?)? Tysabri, an immunosuppressant, may well lead to PML in patients who have dormant JC Virus in the brain. By testing for JC antibodies, patients can now be screened for risk of PML allowing for a wider use of Tysabri. A new test marketed by Quest Diagnostics (DGX) and developed by Biogen Idec and Elan, called Statify JCV, can test for the antibody associated with exposure to the JC Virus. If patients test positive for JC Virus antibodies, risk for PML is increased.

For the many patients then who will test negative for the antibodies, an avenue for Tysabri treatment will be open. To date, 201 cases of PML in nearly 100,000 patients taking the drug had been reported worldwide. Before Statify JCV, determining risk of developing PML in patients was not possible.

Sales of the drug, which annually produces between $1-2 billion worldwide, may double in light of the label change, according to Holden. (See Holden’s analysis here). Biogen Idec’s good news was compounded on the same day that Novartis’ announced its competing oral MS drug, Gilenya, is being investigated for potentially causing heart problems after 11 deaths had been reported in Europe. Shares of Novartis fell nearly 4% on the news.

“Novartis’ stumble also could be Biogen Idec’s benefit, as it has seemingly navigated past its own roadblock with even more in potential profits,” says Holden.

Belichick, I mean CEO Scangos’s, blessed timing was further display last October when Biogen Idec’s own oral drug MS, BG-12,  (in Phase III study of oral BG-12 in relapsing-remitting multiple sclerosis) sparked excitement at a MS conference in Amsterdam  and quickly boosted the drug to stardom. (The big point in with these competing MS drugs is that both Novartis’s Gilenya and Biogen Idec’s BG-12 are drugs administered orally. The three older and proven existing drugs (along with Tysabi) have to be injected by the patients themselves.

Recently Citeline, an Information business unit, and the world’s leading research authority on pharmaceutical clinical trials reviewed the results presented at the 5th Joint Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS/ACTRIMS), a major multiple sclerosis conference held in Amsterdam.

The results from the CONFIRM study showed that BG-12 beat Teva’s Copaxone, which reduced the ARR by only 29 percent (p< 0.02) compared with placebo at two years.

Copaxon (the leading one of three older existing  MS drugs that have  dominated the therapeutic space for year has to be injected daily).

“With two robust and positive pivotal clinical trials that exposed BG-12 to over 2,600 patients, the drug is well positioned as a top MS therapy of choice and a formidable competitor to Gilenya from Novartis, which gained FDA approval in September 2010,” said  Dr. Heidi Chen from Citeline

And now With Gilenya’s troubles there’s an even clearer path to a touch down and market hold.

CEO Scangos might well be sporting one of Belichick’s famous hoodies this weekend as he basks in his own first year triumph in bringing his company to victory.

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