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3-3-06
“One way to tell whether the hype about a new drug is warranted is to look at the reaction of its competitors. From the competition's perspective, the year that Tysabri has been off the market has been a gift. Now that Tysabri appears poised to return to the market, Elan's competitors are acting as though they are preparing for the worse."
“The stakes are high. Tysabri has the potential to completely change the competitive landscape in a $4B market. Every day it seems like there are articles or reports both positive and negative on Tysabri and Elan is in a quiet period.
“Teva Pharmaceutical's (TEVA) Copaxone generated almost $1.2 billion of revenue in 2005 -- about 25%% of their total revenue and more of their profits. In January, Teva acquired IVAX pharmaceuticals, a generic drug manufacturer. To finance this transaction Lehman Brothers and Citigroup underwrote a $1.25 billion debt offering. The folks at Teva and the clients of Lehman and Citigroup who bought the debt cannot be excited at the prospect of Copaxone¹s sales being impacted by Tysabri's return.
“On Tuesday, Bloomberg reported that Teva Pharmaceuticals paid a marketing agent to publicize an abstract of an as yet unpublished article comparing Tysabri's effect on the human immune system to AIDS. The way the media reported the story made it sound like Tysabri gave patients AIDS-like symptoms. I think the authors of this paper would be aghast to see their research used in this way. It's true that both Tysabri and AIDS suppress the immune system. Tysabri suppresses your immune system when its beneficial to do so such as when you have an autoimmune disease like MS. AIDS suppresses your immune system to your detriment.”
Source: Ken Kam, at Marketocracy.com, March 3, 2006 |
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2-28-06
Excerpts from the Bloomberg article referred to by Mr. Kam:
Tysabri Mutes Immune Cells as Much as HIV in Study Tysabri, the multiple-sclerosis drug withdrawn because of a link to a fatal brain infection, can deplete immune-system cells as much as HIV, researchers found. Biogen shares fell the most in 11 months.
The amount of immune-system cells in spinal fluid of patients given Tysabri fell as low as levels seen in people infected with the virus that causes AIDS, according to a study led by neurologists from the University of Texas.
“This is an immunosuppressant drug and it suppresses the immune system,” said David Blaustein, a former assistant professor of medicine at Yale University who now manages health-care investments at Suttonbrook Investments in New York, in an interview today. He said he owns Elan shares. ``It means the drug is working. It doesn't mean Tysabri equals AIDS.”
The study's lead researchers, Michael Racke, a professor of neurology at the University of Texas Southwestern Medical Center in Dallas, and Olaf Stuve, assistant professor of neurology at the same institution, declined to comment before they make the presentation.
“We don't want to make any comment,” Stuve said today in a telephone interview. “We have submitted a manuscript to a scientific journal which has not been accepted yet.”
Teva Pharmaceutical Industries Ltd., the Petah Tikva, Israel-based maker of the multiple-sclerosis drug Copaxone, circulated copies of the abstract yesterday to the media through an outside spokesman, Peter Steinerman in New York.
“Other competitors will try to do everything they can to bring about criticism,” said Lars Ekman, head of research and development for Elan. “These are speculative exercises done by the competition, positioned and designed to undermine a new drug.” Ekman said he heard about the study but hasn't seen it.
Source: Excerpts from February 28, 2006 Bloomberg article, by Angela Zimm
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2-10-06
UK Pharmaceutical Body Reprimands GlaxoSmithKline, Merck, Serono
Friday February 10, 2006 11:51AM
LONDON -(Dow Jones)- The Association of the British Pharmaceutical Industry has ruled that three of its members ……….. have all broken its code of conduct.
The ABPI also found that Swiss biotech company Serono SA (SRA) used aggressive marketing in material sent to doctors to highlight the benefits of its multiple sclerosis treatment Rebif.
The information material recommended Rebif as "a way forward" for patients who had been taking Biogen Idec's (BIIB) and Elan Corp. PLC's (ELN) multiple sclerosis treatment Tysabri before trials were suspended on safety grounds.
The ABPI ruled that Serono's guidelines to doctors were in breach of its code of practice. As a result, Serono has had to issue a corrective statement.
A spokeswoman for Serono confirmed the company has issued a correction as requested by the industry body. "There was no intention to breach the code. Steps have been taken that such breaches are not repeated again," she said.
Source: Dow Jones Newswires, Elena Berton |
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2-6-06
MS patients interested in learning about Tysabri should be cautious about what they may hear, as those responsible for marketing the competing older less effective products (currently selling about $4 billion annually) will do what they can to cause uncertainty and even fear among MS patients to avoid losing "market share." There are hundreds of sales representatives with the major drug companies that have been selling these older treatments who have a vested interest in blocking Tysabri or at least slowing its introduction, as there is great concern that they will lose many of their current customers to this more effective drug once it is reinstated by the FDA. To many in the drug industry, profits, not patients, come first.
For example, in a Reuter's interview on February 6, 2006, the Chief Financial Officer of Serono (which markets Rebif ® with Pfizer), Stuart Grant, said that, "there was nothing concerning about Rebif sales, despite softer demand in non-U.S. markets, and that the goal remained for the drug to be the biggest selling MS treatment worldwide this year despite the relaunch of a rival product. 'We do see a possibility of Tysabri coming back and we have our own internal battle plan to combat reentry,' Grant said, referring to Biogen Idec and Elan Corp's drug."
Source: "Serono sales, profits miss forecasts, mum on M&A," Reuters, February 6, 2006, by Tom Armitage. |
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