Replies to post #71455 on Biotech Values

[DewDiligence]

It’s a joke that BIIB and ELN have not officially rescinded the 100K-in-2010 forecast. No one on Wall Street (or anywhere else) still believes it.

[DewDiligence]

Blood-Cleansing Treatment Could Make Tysabri Safer

[The ‘plasma exchange’ technique described here is old hat, but an article about it was published today in Neurology.]

http://www.bloomberg.com/apps/news?pid=20601103&sid=afWzOTYu40VQ

›February 2, 2009 18:02 EST
By Rob Waters

Feb. 2 (Bloomberg) -- A blood-washing treatment may whisk Biogen Idec Inc.’s Tysabri from the bloodstreams of patients with multiple sclerosis, potentially neutralizing a rare side effect before it turns deadly.

Tysabri was pulled from the market in February 2005 by Biogen and its marketing partner, Elan Corp., after three patients developed a viral brain disease called progressive multifocal leukoencephalopathy, or PML, and two of them died.

Since U.S. regulators allowed the companies to resume selling the drug in July 2006, four new cases of the brain disease have been reported among Tysabri users. All four patients were treated with the blood-washing method and only one of them died, said Robert Fox, medical director of the Mellen Center for Multiple Sclerosis at the Cleveland Clinic. A study led by Fox, funded by Biogen, and published today in the journal Neurology showed that blood-washing reduced Tysabri to acceptable levels within two weeks.

“If you decide that a patient needs to get rid of the drug, you want to do it as fast as you can,” Fox said in a telephone interview today. “We were able to reduce Tysabri levels by 92 percent” with the treatment.

Tysabri, Biogen’s second-best-selling medicine, is approved to treat multiple sclerosis patients who aren’t helped by other drugs. Tysabri generated $597 million in sales in the first nine months of 2008, and sales growth slowed in the fourth quarter, Chief Executive Officer James Mullen told investors on Jan. 13 at the JPMorgan Healthcare Conference in San Francisco.

Purifying Plasma

The blood-washing method, known to doctors as plasmapheresis or plasma exchange, draws blood from a patient’s arm. Purified plasma, the liquid component of blood, is then returned to the other arm during a two- to three-hour process. In Fox’s study, 12 Tysabri users who didn’t have the brain disease had three blood- washing sessions to see if the approach could work. In all 12, Tysabri levels were lowered by an amount that Fox said may stop the progression of the brain illness if they had it.

Because Fox and his colleagues had presented early results from the study at medical meetings in 2007 and 2008, doctors used the technique on the four patients who developed the brain disease last year.

The technique could improve clinical outcomes for Tysabri patients who develop PML, said Shannon Altimari, a Biogen spokeswoman.

Medical consultants advising Leerink Swann & Co. said they believe the report “could make physicians more comfortable with prescribing Tysabri,” said William Tanner, a Leerink analyst, in a note to investors today. The decline in the number of new patients starting Tysabri may have stabilized, “perhaps providing an opportunity for regrowth in the next few quarters,” he said.‹

[DewDiligence]

BIIB finally admits its Tysabri guidance has been unrealistic. (Most
analysts and investors already knew this, of course: #msg-31249570.)
4Q08 Tysabri sales of $218M were down 8% from 3Q08, which is
not exactly the trajectory one expects from a purported growth driver.

http://finance.yahoo.com/news/Biogen-cuts-Tysabri-rb-14278162.html

›Biogen Cuts Tysabri Outlook

Friday February 6, 2009, 10:02 am EST
By Toni Clarke

BOSTON (Reuters) - Biogen Idec Inc (NasdaqGS: BIIB ) scaled back growth projections for its multiple sclerosis drug Tysabri on Friday and said another patient has developed the potentially deadly brain infection known as PML.

Biogen reported higher fourth-quarter earnings but sales of Tysabri fell short of expectations and the company's shares fell more than 3.5 percent in early trading.

Jim Mullen, Biogen's chief executive officer, told analysts on the company's fourth-quarter earnings call that it will be "difficult" to achieve the company's previous forecast that 100,000 patients will be taking Tysabri by the end of 2010.

In addition, the company reported a new case of progressive multifocal leukoecephalopathy, or PML, a potentially deadly brain infection that has curbed the drug's sales.

Tysabri, which the company markets with Elan Corp Plc (NYSE: ELN), was temporarily withdrawn from the market in 2005 after it was linked with PML but reintroduced in July 2006 with stricter safety warnings. The newest case is the fifth since it was reintroduced and was contracted by a patient in Europe.

Cambridge, Massachusetts-based Biogen said its fourth-quarter net earnings rose 3 percent to $207 million, or 70 cents a share, from $201.2 million, or 67 cents a share, a year earlier.

Earnings excluding one-time items were 93 cents a share. Analysts had expected 92 cents, according to Reuters Estimates. Revenue rose to $1.07 billion from $893.3 million. Analysts were expecting revenue of $1.09 billion.

Total sales of Tysabri, which Biogen sells with Elan Corp Plc of Ireland, were $218 million, of which $115 million was in the United States and $103 million in the rest of the world. That fell short of the consensus estimate of total worldwide sales of Tysabri of $250 million.

"Tysabri sales numbers are going from bad to worse," said Corey Davis, an analyst at Natixis Bleichroeder in a research note. "We anticipate that the sales forecasts will now have to dip below $1 billion for 2009.

Biogen said it expected 2009 earnings excluding one-time items to be above $4 a share. Analysts had forecast $3.63 a share.

The company said it expected revenue growth at a high single-digit percentage rate for the year.‹