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Dårlig nyt for Biogen.

13448 tumult 13/6 2009 01:56

Dårlig nyt for patienterne.
Godt nyt for Genmab.?

NEW YORK -(Dow Jones)- Biogen Idec Inc. (BIIB) reported that an eighth
patient on its multiple sclerosis drug Tysabri, sold with Elan PLC (ELN), has
developed a rare brain infection.

A suspected link to progressive multifocal leukoencephalopathy, or PML, led
to Tysabri being pulled from the market for 18 months beginning in 2005. Prior
to Friday, the company has reported that seven people had confirmed cases of
PML, with one dying, since the relaunch. The most recent case was reported on
May 22.

Shares of Biogen closed Friday down 8 cents at $51.38, while Elan rose 16
cents, or 2, to $8.16.

The drug was allowed back on the market in 2006 because of its effectiveness
in fighting the degenerative disease, and the PML incidence remains well below
the long-projected risk of one in 1,000 patients developing the infection.

The patient with the latest confirmed PML case took 35 doses of the monthly
medication, the most of any of the post-launch cases, and was located overseas.
Only two of the eight cases since last July were located in the U.S.

Earlier this year, Biogen retreated from its long-held goal to reach 100,000
patients on Tysabri by the end of 2010. As of the end of March, about 40,000
patients were using Tysabri, up from 37,600 patients at the end of December.

Some believe that duration of therapy plays a role in Tysabris risk. About
6,800 patients have used the drug for more than two years as of the end of

Biogen is posting a case update on the Internet every Friday at 4:30 p.m. EDT
until July 24 - the third anniversary of the drugs relaunch - by which time it
expects the risk/benefit profile of Tysabri to be clearer.

Tysabri had 2008 sales of $813 million, but its longer-term sales trajectory,
which is key to Biogens future growth, will depend on the true incidence of
PML, which is still coming into focus.

13/6 2009 12:56 Solsen 013464

Nu skal vi så lige have beviset for at arzerra har lav frekvens af PLM - så kører pengemaskien !

Men det endelige bevis har vi ikke fået endnu.

13/6 2009 13:04 Solsen 013465

Best in Class: Biogen Idec Clinging to Its Crown
Adam Feuerstein
05/19/09 - 08:57 AM EDT
Biogen Idec(BIIB Quote) has leveraged a market-leading multiple sclerosis drug franchise to become one of the world's largest biotech companies. But in the next few years, new medicines to treat the degenerative nerve disease are expected to arrive, potentially threatening the steady growth enjoyed by Biogen Idec over the past dozen years.

Two of these new multiple sclerosis drugs are pills, which if approved would be the first oral therapies for the disease and offer patients a more convenient treatment than current drugs, all of which are given by injections or infusions.

Biogen Idec, however, is not rolling over for the competition. The company has an oral multiple sclerosis drug of its own in late-stage clinical trials. And the long track record of safety and efficacy for its market-leading product Avonex is a competitive advantage that newer drugs will not have once they come to market.

Avonex remains the foundation of Biogen Idec's multiple sclerosis franchise. The drug has been the most prescribed treatment for multiple sclerosis for the past 12 years. Avonex sales in 2008 rose 18% to $2.2 billion, which accounted for more than half of Biogen Idec's total revenue for the year.

And Avonex has remained No. 1 despite strong competition from the other drugs in the so-called "ABCR" class of multiple sclerosis medicines. These include Betaseron from Bayer, Copaxone from Teva Laboratories(TEVA Quote) and German drugmaker Merck KGaA's Rebif.

As a more mature drug, Avonex is no longer the main growth driver for Biogen Idec. In fact, most analysts expect Avonex sales growth to fall into the single digits this year and next, driven largely by price increases.

The onus for Biogen Idec's growth is now on Tysabri. Tysabri is the newest and most effective multiple sclerosis drug on the market, but it's also been tarnished somewhat because of its association with progressive multifocal leukoencephalopathy (PML), a severe and potentially fatal brain infection.

Increased reports of Tysabri patients diagnosed with PML, while still rare and below the expectations set out in the drug's label, have nonetheless made doctors wary of prescribing the drug. The number of new patients taking Tysabri have slowed in recent quarters, despite efforts by Biogen Idec and its partner, Elan(ELN Quote), to re-invigorate sales.

Tysabri sales totaled $813 million in 2008, a year-over-year increase of 137%. Sales are expected to top $1 billion this year and grow again in 2010, but new competition post-2010, including from new oral drugs, has analysts and investors worried that Tysabri's promise could be short-lived.

This is one reason why Biogen Idec trades at a lower forward price-to-earnings multiple (12 times 2010) than many of its big-cap biotech peers.

Biogen Idec shares, at Monday's close of $50.70, are up 6.45% since the end of 2008 and are actually out-performing every other large-cap biotech stock in 2009. The stock's success this year is more likely due to the ongoing proxy fight with financier Carl Icahn and persistent rumors that Biogen Idec will be acquired than anything to do with Avonex and Tysabri.

The latest competitive threats in multiple sclerosis showed themselves late last month at the American Academy of Neurology (AAN) annual meeting. The most attention was paid to two oral drugs, cladribine from German drug maker Merck KGaA and FTY-720, developed by Novartis(NVS Quote).

Both cladribine and FTY-720 delivered efficacy better than the ABCR drugs, including Avonex, and more in-line with Tysabri. However, that greater potency came at the cost of added side effects and toxicity that put the drugs' approvability and long-term safety under some doubt.

If approved, however, both oral drugs will be more convenient than Tysabri, which requires monthly infusions. And with Tysabri dealing with its own safety issues, the drug is more vulnerable to market share erosion than the ABCRs, which are expected to remain the cornerstone of first-line multiple sclerosis therapy.

In a survey of neurologists conducted after the AAN meeting, between 40% and 50% said they would probably use cladribine and FTY-720 as second-line therapy for their multiple sclerosis patients, according to a J.P. Morgan report.

"This implies that doctors expect Tysabri share to decline once the oral agents are available. This is below expectations, where many bulls expect Tysabri to maintain its share once the oral competition arrives, especially given the negative safety data that has emerged for FTY-720 and cladribine. While survey data are not always precise, we think that directionally this could point to a headwind for Tysabri, " wrote J.P. Morgan's biotech analyst Geoff Meacham.

If one or more of these oral drugs are delayed or rejected by health regulators, Biogen Idec's growth outlook improves significantly. German Merck is guiding toward a mid-year 2009 submission of cladribine to health regulators in the U.S. and Europe. The approval strategy is risky, however, because the company is relying on a single phase III clinical trial instead of the customary two trials typically filed to support approval of a multiple sclerosis drug.

Cladribine may also run into trouble because its use could be curtailed in women of child-bearing age, which happens to be the majority of multiple sclerosis patients.

The safety issues that have cropped up for Novartis with FTY-720 -- patient deaths while on study, a potential link to cancer, swelling of the eye and increased infections -- may give regulators much pause and prevent the drug from ever getting approved. And even if FTY-720 does make it to market, doctors could be very wary of prescribing it to their patients for years until longer-term safety data is collected.

Meantime, Biogen Idec is moving ahead with its own oral multiple sclerosis drug, BG-12, as well as a longer-acting form of Avonex. And the company continues to insist that doctors will grow more comfortable with Tysabri's risk-benefit profile over time.

13/6 2009 18:47 kosmokrator 013471

Det er vel svært at påvise før markedet. Hvis risiskoen er under 1 ud af 1000 patienter udvikler det gennem hele deres (livs)lange behandling så kan ingen patienter med PML i fase 3 rapporteret fra Genmab ikke være et sikkert bevis.

13/6 2009 19:15 Solsen 013474

Nu er der faktisk konstateret et tilfælde i CLL fase 3.

Men der må helst ikke komme nogen i RA/MS studierne - det vil øge risikoen for at arzerra ikke vil kunne få ret megen gennemslagskraft i disse to meget værdifulde indikationer !

14/6 2009 22:18 thro 013500

1. At en patient med CLL får PML er ligegyldigt, da de pga. deres sygdom i sig selv er så imunsuppremeret at de kan udvikle PML. Og kemoterapi kan også give det.
Der er langt vigtigere om man får det ved behandling af fx RA.

2. 8 tilfælde af PML i snart 40.000 behandlede patienter er så lavt at det ikke får betydning for Tysabri. Der er langt færre tilfælde efter markedsføringen end der var under studierne. På American Academy of Neurologys årsmøde i maj måned så jeg den nyeste opdatering af sikkerheden ved Tysabri, vor de største experter i MS var til stede. Det virkede ikke skræmmende, selvom man selvfølgelig er bange for langtidseffekten.

15/6 2009 00:34 tumult 013502

Jeg ved ikke om Tysabri er "brygget" på musegener ligesom Rituxan, men måske er det netop på langtidsbehandlingen Genmab også kan vinde her.

Some believe that duration of therapy plays a role in Tysabris risk. About 6,800 patients have used the drug for more than two years as of the end of March.

15/6 2009 00:54 thro 013504

Natalizumab er rekombinant humaniseret anti-α4-integrin antistof produceret i en murin cellelinje ved rekombinant DNA-teknologi. Tilhører gruppen selektive adhæsionsmolekylehæmmere.

Ja Natalizumab/Tysabri er produceret på mus men humaniseret.

Det har nok ikke noget med sagen at gøre. Forskelen på de murine og humane antistoffer er risikoen for at danne antistoffer mod dem. Hvis der dannes antistoffer mod midlerne, så virker de jo ikke længere og dermed får du heller ikke PML. PML er måske et uundgåeligt onde ved langvarig effektiv immun supression, derfor er det vigtigt at udvælge de patienter som virkelig får glæde af stofferne og så monitorere dem under behandlingen.
Hvis man har agressiv MS sidder man måske i kørestol efter fem års sygdom, derfor er det vel også rimeligt at løbe en risiko på < 1 procent for at udvikle PML som man ved korrekt monitorering kan undgå de mest alvorlige følger af.

15/6 2009 00:56 thro 013505

Risiko < 1 promille skulle der have stået

15/6 2009 01:51 Stinker 013508

Hej thro, Tak for belæringen. Jeg tror vi er flere der lytter med stor interesse når du går til tavlen!

Vedr. det generelle spørgsmål om et givent antistof er humant eller murint tillader jeg mig at supplere med et link til nomenklaturen for navngivningen af monoclonale antistoffer.

Med den i hånden kan uindviede (som jeg selv) enkelt se stoffets herkomst, idet næstsidste stavelse i det generiske navn angiver dette.
Stavelserne -u-, -zu- og -xi- angiver således at stoffet er hhv. humant, humaniseret eller kimærisk.

15/6 2009 10:47 Solsen 013516

Jeg konstaterede blot, at et tilfælde PML er registreret - men rigtigt uden betydning og en helt anden patientgruppe.

Men det er stadig en afgørende faktor, at PML ikke registreres i forsøgene i MS/RA da det meget vel kan forsinke godkendelsestiden eller helt holde Arzerra væk fra disse indikationer.

Men tak for opdateringen.

29/6 2009 19:01 tumult 014464

Drug stocks slid into the red early Monday as shares of Biogen Idec fell on
news that another case of brain disease PML had been discovered in a user of
its multiple-sclerosis drug Tysabri.

The NYSE Arca Pharmaceutical Index (DRG) slipped 0.5 to 260.05, and the NYSE
Arca Biotechnology Index (BTK) dipped 1 to 694.02.

Shares of Biogen (BIIB) were off 6 to $46.99.

On Friday, Biogen reported its tenth case of PML since Tysabri was put back
on the market in 2006. It is also the fourth such case reported since mid-May.
One person has died of the disorder since the relaunch.

In 2005, the drug was taken off the market for several months after it was
linked to PML, a potentially fatal brain disease, in a handful of Tysabri

Tysabri is co-marketed with Elan Corp. (ELN). Shares of Elan were down 4 to

Shares of Sanofi-Aventis (SNY) rose 3 to $28.76 after falling about 6

On Monday, Sanofi once again defended the safety of its long-acting insulin
product Lantus, asserting that clinical trials have not associated the product
with cancer. The European medical journal Diabetologia over the weekend
reportedly questioned whether there might be a link, and called for more
medical research into the matter.

Shares of Novo Nordisk A/S (NVO) added 1 to $53.33. Novo Nordisk, which
markets a similar product, said Sunday that none of its long-acting insulin
products has ever been linked to cancer.

29/6 2009 19:12 014465

Er det ikke Tysabri vi skal rocker tæve med EGFR?

29/6 2009 19:25 tumult 014466

Tysabri er vel konkurent til Arzerra i MS, så hvis Arzerra viser sig at have færre bivirkninger så....

29/6 2009 19:39 alpehue 014470

Også for Novartis, der er ved at købe sig ind i Elan.

betyder elan ikke elendig på svensk