Here is the second article.
Date: February 25, 1997
Senetek PLC Files ANDA for its Auto Injector to Deliver
Epinephrine for Allergic Reaction (Anaphylaxis) Emergencies
ST. LOUIS, Feb. 25 /PRNewswire/ -- Senetek PLC (Nasdaq: SNTKY), announced
today that is has filed an ANDA (Abbreviated New Drug Application) with the
Food and Drug Administration (FDA) for permission to market its patented Auto
Injector(TM) to deliver the drug epinephrine, which is used in the emergency
treatment of severe allergic reactions (anaphylaxis) to insect stings,
medicines, foods or other substances.
Senetek's Auto Injector is a compact, disposable, fully automatic,
pre-filled autoinjector for self-injection by patients. It is designed to
deliver a single dose of epinephrine. The Auto Injector is equipped with an
ultra-fine, 27-gauge subcutaneous injection needle for virtually pain-free
use. Furthermore, the needle is not visible to the user during use, is
convenient to transport and can be used discreetly.
"Everyone is a potential victim of anaphylaxis," said Anthony J. Cataldo,
chairman and CE0 of Senetek PLC. "Senetek's Auto Injector is the 21st
century's answer to injected medication delivery. The Senetek Auto Injector
is user-friendly and is designed to play a significant role in the injectable
market now accountable for $13 billion in worldwide sales. We believe
Senetek's Auto Injector has competitive advantages in this market. This is
the first in a series of generic and proprietary drugs to take advantage of
our platform technology in the home care market."
Anaphylaxis is the potentially fatal response of the body to stimulus to
which it is hypersensitive. Anaphylaxis includes reactions ranging from
itching and hives to shock and death and is precipitated by a number of
agents, including food, drugs, insect stings and exercise. As many as 1 in
3,000 hospital inpatients in the U.S. experience this reaction. It is a
systemic response that can effect almost any organ in the body, and may occur
in response to an antigen to which the person has been previously exposed or
to a substance that has not been previously encountered.
Epinephrine has long been the therapy of choice in an acute anaphylactic
reaction. Because of clear evidence that delayed administration or failure to
use epinephrine has contributed to many fatal reactions to food and insect
bites, the American Academy of Allergy and Immunology (AAAI) has issued
guidelines for use of this epinephrine in anaphylaxis in order to increase
awareness and availability of the drug for immediate use when and where it is
needed. AAAI recommends that epinephrine for injection be included in all
emergency medical treatment kits and be available on airplanes and trains, in
restaurants, and in other public facilities, and should be readily available
in schools.
Senetek's Auto Injector, offering ease of use and painless administration,
also delivers INVICORP(TM), Senetek's drug therapy for treating Erectile
Dysfunction(ED).
Senetek PLC is a medical company providing technologies and solutions for
aging-related health problems. |
