SAN FRANCISCO, Jan. 11 /PRNewswire-FirstCall/ -- MedImmune, Inc.
(Nasdaq: MEDI) today provided an update to investors at the JPMorgan 23rd
Annual Healthcare Conference, including sharing preliminary results from the
company's clinical oncology trials with Vitaxin(R). MedImmune also reviewed
the status of its development and commercial activities for its influenza
vaccine franchise, including refining its sales expectations for FluMist(R)
(Influenza Virus Vaccine Live, Intranasal) for the 2004-2005 influenza season.
Vitaxin Oncology Program
MedImmune's clinical oncology program for Vitaxin includes three Phase 1
and two Phase 2 trials involving patients with refractory solid tumors.
Preliminary results from these trials thus far indicate that the drug is
generally well tolerated and suggest evidence of potential clinical activity.
In MedImmune's Phase 2 melanoma study, 112 patients received either
Vitaxin (n=57) or Vitaxin-plus-DTIC (dacarbazine) (n=55), the drug used as
standard of care for advanced melanoma. The first planned analysis of data
from this study, completed in December, looked at objective response rates and
progression-free survival. Patients treated with Vitaxin alone in this Phase
2 study appeared to have comparable outcomes to patients treated with DTIC
alone (n=385) when compared with the results of a recently completed Phase 3
trial of Genasense(R) (oblimersen sodium), as presented on May 3, 2004 at the
FDA Oncology Drug Advisory Committee Meeting. However, those patients
receiving Vitaxin-plus-DTIC appear to have improved outcomes over patients
receiving DTIC alone. Median overall survival has not yet been reached in
either Vitaxin arm through the 9-month assessment point. The company
announced today that the preliminary data from this study was submitted as an
abstract to the 2005 Annual Meeting of the America Society of Clinical
Oncology (ASCO) to be held May 13-17 in Orlando, Florida.
MedImmune's Phase 2 prostate cancer trial has enrolled a total of 95
patients to date. The last 65 of these patients have been enrolled under an
amended protocol that includes the most current standard of care for prostate
cancer patients (i.e., docetaxel with prednisone every three weeks).
MedImmune's prostate cancer trial is designed to compare treating patients
with this standard of care with and without Vitaxin. Approximately 110
patients will be enrolled under the new protocol in this randomized, open-
label study. MedImmune plans to conduct an interim analysis in March 2005 of
the first 60 patients enrolled under the new protocol.
David M. Mott, chief executive officer and president, stated: "Our
oncology program for Vitaxin continues to make encouraging progress. We are
collecting additional survival data from our melanoma trial, as well as
enrolling and treating prostate cancer patients in a separate Phase 2 study
with Vitaxin. By the time of the 2005 ASCO meeting, we expect to have
completed the next planned analysis of the melanoma study, looking at overall
survival at 12 months, which we plan to use along with preliminary results
from our Phase 2 prostate trial in determining our next step in developing
Vitaxin is a monoclonal antibody that targets the alpha-v beta-3 integrin,
a protein expressed on the surface of newly forming blood vessels, certain
tumor types and on a number of other cell types, including mature osteoclasts.
Based on preclinical models, the alpha-v beta-3 integrin has been implicated
in a number of disease processes, including angiogenesis, growth and
metastasis of tumors, and osteoclast migration and bone resorption.
MedImmune's Influenza Vaccine Franchise
MedImmune also provided an update on its influenza vaccine program that is
focused primarily on developing a superior influenza vaccine for children,
which it hopes to launch in the U.S. in 2007. Toward that end, the company
plans to unblind its pivotal Phase 3 study for its second-generation,
intranasal influenza vaccine, called CAIV-T, in the second half of 2005. This
study compares CAIV-T against the injectable vaccine in children between the
ages of 6 and 59 months. It was initiated in October 2004 and completed
enrollment of 8,492 children in approximately one week.
MedImmune currently markets FluMist, the first-generation intranasal
influenza vaccine, in the United States. In October 2004, due in large part
to the national shortage of the injectable influenza vaccine this season,
MedImmune increased its sales expectations for FluMist from approximately
450,000 doses to a range of one million to two million doses. At today's
investor conference, the company refined its expectation for the current
influenza season to the range of 1.7 million to 2 million doses, noting that
some sales for the 2004-2005 season may be recorded in early 2005.
Commenting on FluMist, Mott said: "The turmoil in the flu vaccine
marketplace this season has allowed us to make more rapid progress with
FluMist than we had previously anticipated. However, as we have previously
indicated we don't anticipate FluMist becoming a meaningful contributor to
revenue growth or to profitability until we introduce the refrigerator-stable
formulation, CAIV-T, with an expanded indicated population. Our development
plans don't anticipate that next generation product being available in the
marketplace prior to 2007. In the interim, we will continue to focus our
efforts on product development and on educating healthcare providers about the
benefits of a live, attenuated, intranasal vaccine."
FluMist is the first live, attenuated influenza vaccine indicated for
active immunization for the prevention of disease caused by influenza A and B
viruses in healthy children and adolescents, 5 to 17 years of age, and healthy
adults, 18 to 49 years of age.
There are risks associated with all vaccines, including FluMist. FluMist
does not protect 100-percent of individuals vaccinated, or may not protect
against viral strains not represented in the vaccine. FluMist is
contraindicated in persons with hypersensitivity to any component of the
vaccine, including eggs; in children and adolescents receiving aspirin therapy
or aspirin-containing therapy; in individuals with a history of Guillain-Barre
syndrome; and in individuals with known or suspected immune deficiency. The
safety and efficacy of FluMist have not been established in pregnant women or
for patients with chronic underlying medical conditions, including asthma or
reactive airways disease; the vaccine should not be administered to these
patients. See Prescribing Information for indications and usage, dosage and
administration and safety information.
About MedImmune, Inc.
MedImmune strives to provide better medicines to patients, new medical
options for physicians, rewarding careers to employees, and increased value to
shareholders. Dedicated to advancing science and medicine to help people live
better lives, the company is focused on the areas of infectious disease,
cancer and inflammatory diseases. With approximately 1,900 employees
worldwide, MedImmune is headquartered in Maryland. For more information, visit
the company's website.
This announcement contains, in addition to historical information, certain
forward-looking statements that involve risks and uncertainties, in
particular, related to the development and commercial prospects of Vitaxin,
FluMist and CAIV-T. Such statements reflect management's current views and
are based on certain assumptions. Actual results could differ materially from
those currently anticipated as a result of a number of factors, including
risks and uncertainties discussed in MedImmune's filings with the U.S.
Securities and Exchange Commission. There can be no assurance that such
development efforts will succeed, that such products will receive required
regulatory clearance or that, even if such regulatory clearance is received,
such products will ultimately achieve commercial success.
Genasense(R) is a registered trademark of Genta, Inc.
SOURCE MedImmune, Inc.
CONTACT:Media: Jamie Lacey +1-301-398-4035or Investors: John Filler
+1-301-398-4086 both of MedImmune, Inc.
Web site: http://www.medimmune.com