Morgan Stanley IS HUGE on ELN AGAIN!! UPDATE

[kingofthehill]

here are some of the hilights from todays Morgan Stanley update on Elan

Here are some more excerpts from today's Morgan Stanley report on Elan. It appears that the combination data (Antegren plus Avonex) are not as compelling as the monotherapy data (Antegren alone), which could indicate that Antegren will, to use a technical term, blow away the other MS treatments.

Here is what MS said in today's report:

[M]anagement’s body language, in our view, is that the quality of the monotherapy data is robust and that the Avonex combination data is not significantly better than the monotherapy data, i.e., there appears to be little reason to use combination therapy.

With respect to pricing, management indicated that the decision will be made assuming monotherapy and in the context of the currently marketed products in MS, Crohn’s disease, and rheumatoid arthritis (RA). Management also indicated that the premium quality of the product warrants a premium price. Our models assume $17,500 per patient per year, but given management’s comments and body language, we wouldn’t be surprised if the pricing was in the $18,000-$20,000 range, with the high end of the range not even out of the question.

Management acknowledged that the infusion would be a treatment-regimen change for MS patients and thus it is very focused on planning and facilitating the logistics for physicians and patients.

With respect to manufacturing, Biogen Idec is currently focused on yield improvements at its North Carolina facility. Elan management admitted that the planned product launch is at least 1 year faster than originally expected and thus extra resources have been deployed at the plant to build capacity for the launch

[kingofthehill]

NY TIMES ARTICLE 4/13/04

A Glimmer of Hope for Fading Minds

Published: April 13, 2004


(Page 3 of 3)



The idea was that an immunization might allow immune system cells to chew up the protein and remove it, clearing plaque from the brain. The immunizations worked beautifully in mice, and a few years ago, the manufacturers of the therapy, Elan Pharmaceuticals and Wyeth, began clinical trials in humans.

But when, in 2002, some patients developed severe inflammations of the brain and spinal cord, the trials were abruptly halted. The number of patients affected eventually grew to 18.

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Elan and Wyeth continue to monitor the more than 300 other patients who received the immunizations, but they have stopped the treatment.

One researcher in that study was Dr. David G. Wilkinson, director of the Memory Assessment and Research Center at Moorgreen Hospital in Southampton, England, where 20 patients received immunizations.

When a woman died a year later of unrelated causes, Dr. Wilkinson wanted to examine her brain to find out whether the immunization had affected her Alzheimer's. His research team sliced the brain in thin sections and examined them under a microscope.

"It was really quite astonishing," Dr. Wilkinson said. The woman should have had a brain that was "absolutely peppered with amyloid plaque," but instead, huge areas were devoid of plaque.

"It was one of those, `We remember when we were all sitting around the microscope' days," he said.

Dr. Wilkinson published his finding last year in the journal Nature. Now, he says, four other patients from the trial have died, and their brains have been examined. One was from Portugal and the rest from the United States. In every case, the plaque was mostly gone.

In four of the five cases, the patients had had severe brain inflammations, raising the question of whether it was the immunization or the reaction to it that cleared the plaque. But the fifth patient, who did not develop inflammation, also had little plaque.

"This is the first concrete evidence of a disease-modifying strategy for Alzheimer's disease," Dr. Relkin said.

This particular immunization, he and others cautioned, is obviously not suitable for further study in patients. Wyeth and Elan are back in the clinic with what they hope will be a safer way to immunize. But for now, Dr. Wilkinson said, "we are a long way from a cure."

Nonetheless, he sees himself as an Alzheimer's optimist. "I think we will see a big, big reduction in Alzheimer's," Dr. Wilkinson said. "People shouldn't be so downbeat."

[kingofthehill]

Alzheimer's vaccine shows promise


By BRIAN DALY
Canadian Press


POSTED AT 7:46 PM EDT Thursday, Apr. 15, 2004





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Montreal — Scientists told an Alzheimer's conference on Thursday that they're hopeful a new and improved vaccine can attack brain plaques associated with the debilitating brain disease.

But researchers cautioned the treatment is undergoing preliminary tests to determine whether it produces dangerous side effects that derailed an earlier version of the treatment.

The pharmaceutical firm Elan Corp. is conducting clinical trials of the new vaccine in the United States on a small group of Alzheimer's patients, said Dr. Dale Schenk, Elan's chief scientific officer.

He said it's hoped the vaccine will attack the brain-damaging plaques, called beta amyloid.

“I think the total data is very encouraging, but we still have clinical development to go,” Dr. Schenk told reporters at the conference.

“I feel bullish about it ultimately working and I'm hopeful that it will.”

Alzheimer's researchers suffered a setback in 2002 when trials of the earlier vaccine, produced by Elan, were halted because some patients suffered swelling of the brain.

The brain inflammation, known as meningoencephalitis, was found in four subjects participating in the 360-patient trial. Doctors later discovered 11 more people with the symptoms.

Because the old vaccine induced the immune system to attack the protein that makes up the brain plaques, some scientists had warned that brain inflammation was a potentially serious side effect.

Dr. Schenk said the new treatment works by injecting the antibodies directly into the patient, bypassing the immune system and possibly averting a harmful response.

He wouldn't provide an update on the current Phase 1 trials, which measure potential side effects.

If the first phase is successful, Phase 2 trials would determine whether the vaccine has an effect on Alzheimer's symptoms.

Dr. Roger Nitsch of the University of Zurich said the new vaccine could be promising as long as rates of brain inflammation are reduced or eliminated.

He noted that 6 per cent of patients in the initial trials developed the brain swelling — a rate he said is unacceptable.

“If you are going to vaccinate millions of people, then 6 per cent is too high,” said Dr. Nitsch, whose clinic participated in the earlier trials.

Dr. Nitsch said the old vaccine may still be an option, noting that plaques disappeared from large areas of the brains of vaccinated patients.