Ermutigende Präklinische Studie über Alexions C5 - 500 Beiträge pro Seite

[Reaktionär]

ALEXION`s Anti-Inflammatory C5 Inhibitor Prevents Chronic Autoimmune Platelet Disease

- Preclinical Results Presented at American Society of Hematology -

Cheshire, CT, December 4, 2000 -- Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today
announced that its anti-inflammatory C5 Inhibitor significantly prevented loss of platelets, an
important blood cell responsible for normal clotting, in a model of chronic immune
thrombocytopenia purpura (ITP). The results suggest that Alexion’s C5 Inhibitor may substantially
prevent clotting complications associated with certain autoimmune disorders, such as ITP, lupus,
and thrombocytopenic purpura. If successfully developed, these results would further broaden
Alexion’s portfolio of autoimmune disorders potentially addressable with its C5 Inhibitor therapy
which currently includes five different clinical autoimmune disease programs.

The preclinical results were presented by Dr. Henry M. Rinder, Associate Professor of Laboratory
Medicine at Yale Medical School at a session of the 42nd Annual Meeting of the American Society
of Hematology in San Francisco, California. Dr. Rinder presented results of work performed
collaboratively with Dr. Kenneth Ault, Clinical Professor of Medicine at the University of Vermont, Dr.
Scott Rollins, Vice President of Product Development and Project Management at Alexion, and Dr.
Joseph Craft, Professor of Medicine, Yale Medical School. In these preclinical studies of
spontaneous rodent models of ITP, administration of Alexion’s anti-inflammatory C5 Inhibitor
significantly prevented the severe thrombocytopenia (abnormally low platelet level) and
subsequent elevation of immature reticulated platelets, found in placebo-treated subjects.

“For both children and adults, ITP may be a devastating clinical complication,” stated Dr. Rinder.
“Treatment of patients with ITP, and related autoimmune platelet disorders, still remains a major
clinical problem. These studies confirm the role of terminal complement activation in platelet
clearance in this model of ITP, and could help in the development of new medical options to treat
this condition.”

According to published data, approximately 25,000 adults and children in the U.S. suffer from ITP.
Patients with this condition typically have recurrent and potentially severe bleeding from mucous
membranes and severe post-operative bleeding. Some patients may also have a history of a
pre-existing viral illness or concomitant HIV infection.

“Earlier in our preclinical development, Alexion scientists had focused on the role of complement
activation in platelet dysfunction and we are encouraged by this emerging data supporting the role
of C5 Inhibition in a new clinical indication, ITP,” said Leonard Bell, M.D., President and Chief
Executive Officer of Alexon. “As we continue to evolve and advance our clinical development with
our longer-acting C5 Inhibitor monoclonal antibody 5G1.1, we expect that we will continue to
identify additional patient populations that may benefit from this novel anti-inflammatory
candidate.”

Alexion is engaged in the discovery and development of therapeutic products aimed at treating
patients with a wide array of severe disease states, including cardiovascular and autoimmune
disorders, inflammation and cancer. Alexion’s two lead product candidates are currently in eight
clinical development programs. 5G1.1-SC, in collaboration with Procter & Gamble, is in a Phase
IIb cardiopulmonary bypass efficacy trial and in two Phase II myocardial infarction efficacy trials.
5G1.1 is currently in a Phase II efficacy trial for the chronic treatment of rheumatoid arthritis, a
Phase II efficacy trial for the treatment of membranous nephritis and in Phase Ib pilot studies for
treatment of psoriasis, dermatomyositis, and pemphigoid. Additionally, through the creation of its
wholly owned subsidiary, Alexion Antibody Technologies, Inc., Alexion is engaged in discovering
and developing a portfolio of additional antibody therapeutics targeting severe unmet medical
needs. This press release and further information about Alexion Pharmaceuticals, Inc. can be
found on the World Wide Web at: www.AlexionPharm.com.

This news release contains forward-looking statements. Such statements are subject to certain factors which may
cause Alexion`s plans to differ or results to vary from those expected including unexpected pre-clinical or clinical
results, the need for additional research and testing, delays in manufacturing, access to capital and funding,
delays and adverse changes in development of commercial relationships and a variety of risks set forth from time
to time in Alexion`s filings with the Securities and Exchange Commission, including but not limited to the risks
discussed in Alexion`s Annual Report on Form 10-K for the year ended July 31, 2000. Except in special
circumstances in which a duty to update arises when prior disclosure becomes materially misleading in light of
subsequent events, Alexion does not intend to update any of these forward-looking statements to reflect events or
circumstances after the date hereof or to reflect the occurrence of unanticipated events."

[Reaktionär]

sorry, und hier ist noch die Quelle....

http://www.alexionpharmaceuticals.com/news/index.cfm
mfg
rxn

[augur]

Hi Reaktionär,

könntest du dich (für Ausländer) auch mal etwas präziser ausdrücken, um was es hier geht?

Danke, augur

[Dauphin]

@ all

Gibt es außer Gewinnmitnahmen noch irgendwelche Gründe, die zu
den Kurlverlusten der letzten Tage geführt haben?

USB Piper Jaffray gibt ALXN gestern ein "strong buy" mit KZ 160 US $.

Momentan wird unter hohen Umsätzen die 50 US $ Marke hart umkämpft.

MfG Dauphin

[dismas]

So, hier die DUMMERWEISE zuerst im Abgenix-Thread gepostete (mögliche?) Erklärung für den Kursverfall: Quelle http://biz.yahoo.com/rf/010131/n31509270.html

Alexion tumbles on confusion over heart-trial drug data
By Ransdell Pierson

NEW YORK, Jan 31 (Reuters) - Shares of Alexion Pharmaceuticals Inc. (NasdaqNM:ALXN - news) fell sharply on Wednesday as analysts cited confusion with trial data on the company`s experimental anti-inflammatory drug used to treat patients undergoing heart surgery.

Shares of the Cheshire, Conn.-based biotech firm closed down $7-11/16 to $52-5/16, or almost 13 percent, on the Nasdaq. That follows declines of $9 on Tuesday and $5-3/4 on Monday -- for a total drop of 30 percent since Jan. 26.

Alexion on Jan. 23 issued a statement that indicated clinical trial data showed strong efficacy of its drug, pexelizumab, in reducing death and heart attacks among patients who underwent coronary artery bypass graft surgery (CABG).

In the statement, the company described positive preliminary results from the Phase II trial as ``unanticipated`` and Alexion Chief Executive Leonard Bell said the data ``substantially surpassed ... pre-trial expectations.``

Shares of the firm, which is developing pexelizumab in collaboration with the pharmaceuticals unit of consumer products giant Procter & Gamble (NYSE:PG - news), shot up and closed almost 25 percent higher that day.

But data highlighted in the Jan. 23 release, as it turns out, referred to secondary trial data involving a subgroup of patients tested, not to data about the primary goal of the trial among all 914 patients tested. At the time, many assumed the statement referred to the primary goals of the trial, analysts said.

Alexion issued another statement on the evening of Friday, Jan. 26, saying the drug actually failed in its combined primary goal, or endpoint, of reducing small heart attacks, neurological deficits and damage to the left ventricle, the heart`s pumping chamber.

``In the original press release, there was no mention at all of a primary endpoint, not even a passing reference. It made (the trial) sound like an overwhelming success, when it actually missed its primary endpoint,`` said drug analyst Robert Leboyer of Leerink Swann & Co.

Another analyst, who asked not to be mentioned by name, said data from the trial were impressive enough that the company now plans a larger Phase III trial of the drug in heart-surgery patients.

``But people don`t feel comfortable with the company anymore. There`s a lot of disbelief in the data. People would feel more comfortable if Alexion had done an upfront analysis`` in the first statement, the analyst said.

Bell, a former Yale professor of medicine, told Reuters in an interview on Wednesday that he and his company had been straightforward with investors and analysts.

``We feel we disclosed everything in a detailed fashion,`` Bell said. Although the primary goal did not appear in the first statement, Bell said Alexion officials gave a detailed explanation of the primary goals of the trial in a conference call with analysts the day the release went out.

``We fully disclosed (the data on the primary goal) in the conference call. I think we made a full disclosure with about an hour-long discussion when we exquisitely went over our data,`` Bell said.

Based on favorable results among a subgroup of patients in the heart-surgery trial, Bell said the firm plans to conduct its follow-up Phase III study ``in mid-2001.``

Procter & Gamble spokeswoman Marlene Feder said Alexion`s results were ``promising`` and that P&G would continue to assist Alexion develop and test the drug.

``Our scientists will work with them to design their clinical trials going forward,`` Feder said. She declined to comment on Alexion`s Jan. 23 statement.

(Additional reporting by Jed Seltzer)