Though youd find this interesting:
Gensia Sicor Receives Approvable Letter From FDA For Genesa(R) System In Radionuclide Imaging
SAN DIEGO, May 13 /PRNewswire/ -- Gensia Sicor Inc. today announced that it
has received a letter from the U.S. Food and Drug Administration (FDA)
indicating that its New Drug Application (NDA) for the GenESA(R) System is
approvable. The GenESA System will be indicated for use in the diagnosis of
coronary artery disease in conjunction with radionuclide myocardial perfusion
imaging (radionuclide imaging) for patients who cannot exercise adequately.
Approval of the product is contingent on acceptance by the FDA of final
labeling. The Company anticipates being able to respond promptly to the request
for final labeling and hopes to launch the product in the U.S. through its
Gensia Automedics subsidiary in the third quarter of 1997.
"This approvable letter is a major milestone for Gensia Sicor," said David F.
Hale, President and Chief Executive Officer. "This will be our first approval
in the U.S. of a proprietary product discovered and developed by the Company.
In addition, we believe it will be the first product approved by the FDA for
pharmacological stress testing that was designed and has been shown to simulate
the cardiac effects of exercise. We also believe this will be the first new
drug-new medical device combination product approved by the FDA."
Hale added, "We believe the product has demonstrated utility in stress
echocardiography, although echocardiography was not included in the GenESA
System labeling at this time. We plan to consult with the FDA as soon as
possible to discuss what further steps are needed to expand the labeling to
include the use of the GenESA System with echocardiography."
The GenESA System combines a novel drug, arbutamine, and a computer-
controlled, closed-loop drug delivery system designed to pharmacologically
stress the heart to aid in the diagnosis of coronary artery disease (CAD) when
used in conjunction with commonly used stress testing techniques. The GenESA
Device delivers arbutamine to the patient intravenously and automatically
adjusts the rate of infusion in order to obtain the desired heart rate profile
necessary for the physician to make a diagnosis.
There are an estimated 4.5 million cardiac imaging tests performed in the U.S.
each year. The Company believes that 25-35% of these tests are performed on
patients unable to exercise adequately to complete a cardiac stress test. The
majority of these patients are tested using radionuclide perfusion imaging,
which involves the injection of a radioisotope and the use of a gamma camera to
detect perfusion defects indicative of CAD.
According to Daniel S. Berman, MD, Director of Nuclear Cardiology at
Cedars-Sinai Medical Center, Los Angeles, "Because of arbutamine's mechanism of
action simulating the cardiac effects of exercise and the convenient control
features provided by the GenESA infusion device, I expect this drug to have
significant use in the diagnosis of coronary artery disease using radionuclide
perfusion imaging."
Gensia Sicor has conducted clinical trials with the GenESA System in over
2,000 patients in North America and Europe. The pivotal Phase 3 clinical trials
consisted of several multicenter, international protocols designed to establish
the safety and efficacy of the GenESA System. The results of these studies were
published in the November 1995 issue of the Journal of the American College of
Cardiology. The data from these trials were supplemented by an NDA Amendment,
submitted to the FDA in November 1996, containing data from a further
multicenter trial in over 1,000 patients. Overall, more than 100 experienced
clinical sites for cardiac stress testing have participated in the GenESA System
clinical program.
Gensia Sicor's research scientists discovered and developed the drug
arbutamine, a new catecholamine which increases heart rate, cardiac
contractility (force of contraction) and systolic blood pressure. The GenESA
Device was developed jointly by Gensia Sicor and Protocol Systems, Inc.
(Nasdaq:PCOL) of Beaverton, Oregon, which will supply the product to Gensia
Sicor under a long-term supply agreement. The GenESA Device utilizes a unique
closed-loop system that customizes the infusion rate and dose given to each
patient because drug delivery is adjusted automatically based on the patient's
individual heart rate response. The Company believes that the automatic dosing
and monitoring capabilities offered by the GenESA System will be attractive
features for physicians performing pharmacologic stress testing procedures.
Gensia Sicor intends to market the GenESA System through its newly formed
subsidiary, Gensia Automedics, Inc., based in San Diego. Gensia Sicor is
transferring its medical products sales organization of 25 people into Gensia
Automedics. This hospital based sales organization will launch the GenESA
System in the U.S. The Company expects to have devices and drug produced and
ready to ship when the final approval is received from the FDA. Gensia Sicor is
also in the process of transferring all of its licensed and proprietary medical
products, including the Laryngeal Mask Airway, the GenESA System, Brevibloc(R)
and the Feedback Controlled Heparin System to this subsidiary. Gensia Sicor is
exploring private and public financing for this subsidiary, subject to certain
third party consents.
Gensia Clinical Partners, L.P. owns certain rights to the GenESA System
technology which are subject to a purchase option by Gensia Sicor.
Gensia Sicor Inc. is a specialty pharmaceutical company focused on the
development, manufacture and marketing of pharmaceutical products for the
worldwide oncology and injectable pharmaceutical markets. Gensia Sicor's
commercial pharmaceutical businesses include Gensia Laboratories, Ltd., a
California based manufacturer and marketer of multisource injectable drugs,
SICOR-Societa Italiana Corticosteroidi S.p.A. in Milan Italy, and Sintesis Lerma
S.A. de C.V. in Toluca, Mexico which produce specialty bulk drug substances, and
Lemery S.A. de C.V. in Mexico City which manufactures injectable and oral
finished multisource drug products, as well as Gensia Automedics. Gensia Sicor
has also formed a subsidiary, Metabasis Therapeutics, Inc., which conducts basic
research in four primary areas: pain, diabetes, inflammation and cardiovascular
disease.
This press release contains forward looking statements that are subject to
risks and uncertainties that could cause actual results to differ materially
from those set forth in the forward looking statements, including whether the
GenESA System will be approved by the FDA and launched in the third quarter of
1997, whether the Company will be successful in obtaining expanded labeling in
echocardiography for the GenESA System, and the risk factors set forth in Gensia
Sicor's recent filing on Form 10-K with the Securities and Exchange Commission.
These forward looking statements represent the Company's judgment as of the date
of this press release. The Company disclaims any intent or obligation to update
these forward looking statements.
Roader |
