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[dolly999]

Hey friends!

Hab mal ne Frage: Kennt jemand die Gründe für den starken Kursverlust der Medicines Company? (MDCO)!
Wäre euch sehr dankbar über infos

[superguergen]

Mehr Angebot als Nachfrage

[meislo]

StreetInsider Alert for MDCO


Jun 4, 2004 (streetinsider.com via COMTEX) -- The Medicines Company (Nasdaq:
MDCO) is lower in pre-open action after the company received a review letter
from the FDA relating to the Company`s application to amend the existing
Angiomax label. In its letter, the FDA stated that the application is not
approvable due to deficiencies in the study methods used.

[meislo]

WR Hambrecht & Co.


Jun 4, 2004 (JAGfn.com via COMTEX) -- MDCO: Reit Buy - MDCO announced it
received a Non-Approvable letter on its supplemental NDA to expand the label of
Angiomax. The company had submitted the sNDA in August 2003 for use in the PCI
setting and to include patients undergoing coronary angioplasty with
heparin-induced thrombocytopenia (HIT) and thrombosis syndrome (HITTS). We note
management had previously anticipated an expanded label in H2:04. Management
maintained FY04 guidance and we are not changing our estimates. We believe the
company can still continue to garner solid Angiomax growth in its current and
off-label settings. MDCO has gained significant market share with its current
label and peer reviewed publications of positive clinical data in these settings
from more than 7,000 patients in the REPLACE-1, REPLACE-2, and other trials. In
our view, the added benefit of the label change would have been marginal, and we
do not expect this latest FDA action to have a significant impact on how current
customers use the product. However, its competitors will likely try to
aggressively capitalize on this regulatory stumble, adding additional risk to
our already aggressive sales forecast of $143M. Maintain BUY rating. We remain
confident that Angiomax will ultimately emerge as a standard of care in the cath
lab and maintain our price target of $38, or 34x times our FY:06 EPS estimate of
$1.37 discounted at 22.5%.

[BarnyXXL]

#2:

äähhh, ja ist auch ein Grund!


#1:

Guckst Du hier:


FDA nixes Medicines` label change
Drug maker to discuss Angiomax issue with agency
By CBS MarketWatch
Last Update: 7:38 PM ET June 3, 2004

SAN FRANCISCO (CBS.MW) -- The Medicines Company said Thursday that the U.S. Food and Drug Administration has rejected its application to amend the label on its Angiomax drug, citing alleged deficiencies in study methods and analysis of clinical data.

The Parsippany, N.J.-based manufacturer (MDCO: news, chart, profile) of drugs used in acute hospital care said it plans to meet with regulators to discuss the allegations. Angiomax, the company`s first product, is an anticoagulant used in coronary angioplasty.

Ahead of the after-hours announcement, shares of Medicines Company closed Thursday at $31.48, down 67 cents or 2.08 percent.

The company said the FDA`s action won`t change its 2004 earnings forecast of $10 million to $17 million on revenue of $130 million to $135 million.

[meislo]

The Medicines Company Scheduled to Present at Pacific Growth Equities Conference


PARSIPPANY, N.J., Jun 4, 2004 (BUSINESS WIRE) -- The Medicines Company
(Nasdaq: MDCO) is scheduled to present at the Pacific Growth Equities Life
Sciences Growth conference on Thursday, June 10 at 9:00 am Pacific Time (Noon
Eastern time).

Dave Stack, President and CEO, is expected to provide an update on company
operations; Angiomax(R) (bivalirudin) marketing; current clinical trials of
Angiomax, Clevelox(TM) (clevidipine) and cangrelor; regulatory updates for
Angiomax registration in Europe and application to amend the existing U.S.
label; and financial status.

The presentation will be webcast with links available at The Medicines Company`s
website: http://www.themedicinescompany.com.

About The Medicines Company: The Medicines Company meets the demands of the
world`s most advanced medical practitioners by developing products that improve
acute hospital care. The Company markets Angiomax(R) (bivalirudin), an
anticoagulant approved in the U.S. and other countries for use in patients
undergoing percutaneous transluminal coronary angioplasty (PTCA) procedures. The
Medicines Company creates value using its range of clinical and commercial
skills to develop products acquired from leading life science innovators.

SOURCE: The Medicines Company