Needle-Free Drug Delivery System Brings Comfort and Peace of Mind to Family
Sunday, June 24th, 12:00 p.m. - 4:00 p.m.
HealthFest, Embarcadero Park North
SAN DIEGO, June 24 /PRNewswire/ -- Nobody likes needles -- especially
children. But for an estimated 10,000-15,000 children in the US who suffer
from pediatric growth hormone deficiency, daily needle injections can be a
normal part of their treatment regimen. However, some of them now have a
different way to take their medication. Cool.click(TM) is the first
needle-free drug delivery system in the US exclusively for use with one brand
of growth hormone, Saizen(R) [somatropin (rDNA origin) for injection].
A family from Anaheim, California, who uses cool.click(TM) will tell their
story at HealthFest, the kick-off event for BIO 2001, the annual International
Meeting & Exhibition of the Biotechnology Industry Organization held at the
San Diego Convention Center this week. On June 24, 2001, from 12:00 p.m. -
4:00 p.m., the McDonalds, parents John and Shary and daughter Meta, age
twelve, will be available to share their experiences with members of the
media. [HealthFest, 2001, Embarcadero Park North, located behind the San Diego
Marriott Hotel & Marina.]
"When we learned Meta was growth hormone deficient and would need daily
injections, she simply refused it," said Shary McDonald. "Once we learned
about cool.click(TM), and the fact that it was needle-free, she changed her
mind and started her growth hormone therapy immediately."
With cool.click(TM), Saizen(R) is dispersed through the skin
subcutaneously in a fine stream in less than a second. Most patients describe
the experience as being similar to the snapping of a rubber band, and most
prefer cool.click(TM) over conventional needles and syringes. The drug is
distributed by the bloodstream exactly the same way as needle injections. As
with needle injection, some injection site reactions may be experienced with
the needle-free delivery system.
Meta McDonald Takes Her Saizen Cool.Click(TM) Therapy in Stride
After being diagnosed with growth hormone deficiency, Meta and her parents
were anxious to find a therapy solution that included no needles. When the
family learned about cool.click(TM), they decided to try it.
"The very first time we used it, we knew it was our answer," said Shary
McDonald.
"With cool.click I don't even know when she's taken her treatment. She
just does it on her own and goes back to her playing," says McDonald. "She
thinks of cool.click(TM) as a fun way to make her grow."
Treatment and Delivery Device Offer Convenience and Peace of Mind
"We are pleased to be able to offer innovative needle-free delivery
systems that meet the changing needs of our growth hormone patients," says Jay
Mohr, Executive Vice President, Metabolic Endocrinology, North America,
Serono, Inc.
"Cool.click(TM) helps to improve the lives of patients by offering them an
alternative," said Mohr.
Recently, Serono (NYSE: SRA) announced an expanded agreement with Bioject
to develop SeroJet(TM), a needle-free system specifically for use with
Serostim(R) [somatropin (rDNA origin) for injection], Serono's recombinant
human growth hormone product to treat AIDS wasting. Serono expects to make
SeroJet(TM) available later in 2001.
"Like cool.click(TM), SeroJet(TM) will provide convenience, less anxiety
and greater needlestick prevention than conventional needles. In many cases it
may even improve patient compliance with treatment," said Mohr.
What is Pediatric Growth Hormone Deficiency?
Pediatric growth hormone deficiency is a result of the body's inability to
produce an adequate amount of growth hormone or to release growth hormone
naturally to stimulate normal growth in a child. Often the child's parents or
family members are the first to notice that their child may not be growing at
the proper rate. Once parents or family members become concerned about a
child's growth pattern, they may discuss the condition with the child's
pediatrician who, if there is a problem, will refer the family to a pediatric
endocrinologist.
A child may be growth hormone deficient if he or she experiences a growth
rate of less than 2 inches per year, between the age of 2 and puberty, or if a
child's height falls below the 5th percentile line for their age. A pediatric
endocrinologist will conduct a series of tests including a complete medical
history, and plotting the child's growth on a growth chart to determine if the
child's growth has leveled off from their established growth curve and the
length of time a child has been growth hormone deficient. Growth hormone
deficiency is treated with growth hormone, and treatment can continue for
several years until the child reaches puberty or maximum growth potential is
reached.
Saizen(R) [somatropin (rDNA origin) for injection] is approved by the FDA
for the treatment of pediatric growth deficiency. Saizen(R) was first
introduced by Serono in 1989, and is currently registered for the following
growth disorders: pediatric growth hormone deficiency (81 countries), Turner
Syndrome (68 countries) and chronic renal failure (29 countries). Saizen(R)
has been on the market in the US since 1996 for pediatric growth hormone
deficiency using conventional needle-syringe delivery.
Cool.click(TM) was developed for Saizen(R) and introduced to the market in
2000 in partnership with Bioject Medical Technologies, Inc., a leading
developer and manufacturer of jet injection systems for needle-free drug
delivery, through an exclusive license agreement. For information about
Saizen(R) and cool.click(TM) including appropriate use, precautions and
contraindications visit http://www.howkidsgrow.com or call 1-888-275-7376.
Some of the statements in this press release are forward looking. Such
statements are inherently subject to known and unknown risks, uncertainties
and other factors that may cause actual results, performance or achievements
of Serono S.A. and affiliates to be materially different from those expected
or anticipated in the forward-looking statements. Forward-looking statements
are based on Serono's current expectations and assumptions, which may be
affected by a number of factors, including those discussed in this press
release and more fully described in Serono's Annual Report on Form 20-F filed
with the U.S. Securities and Exchange Commission on April 23, 2001. These
factors include any failure or delay in Serono's ability to develop new
products, any failure to receive anticipated regulatory approvals, any
problems in commercializing current products as a result of competition or
other factors, our ability to obtain reimbursement coverage for our products,
and government regulations limiting our ability to sell our products. Serono
has no responsibility to update the forward-looking statements contained in
this press release to reflect events or circumstances occurring after the date
of this press release.
About Serono
Serono, Inc. located in Norwell, MA, is the US affiliate of Serono, S.A.,
a global biotechnology leader, headquartered in Geneva, Switzerland. The
Company has six recombinant products on the market, Gonal-F(R), Luveris(R),
Ovidrel(R), Rebif(R), Serostim(R) and Saizen(R).(1) In addition to being the
world leader in reproductive health, Serono has strong market positions in
neurology, metabolism and growth. The Company's research programs are focused
on growing these businesses and on establishing new therapeutic areas.
Currently, there are eleven molecules in development.
In 2000, Serono achieved worldwide revenues of US$1.240 billion, and a net
income of US$301 million, making it the third largest biotech company in the
world based on revenues. The Company operates in 45 countries, and its
products are sold in over 100 countries. Bearer shares of Serono S.A., the
holding company, are traded on the SWX Swiss Exchange (SEO) and its American
Depositary Shares are traded on the New York Stock Exchange (SRA).
About Bioject
Bioject Medical Technologies, Inc., based in Portland, Oregon, is an
innovative developer and manufacturer of needle-free drug delivery systems.
Needle-free injection works by forcing medication at high speed through a tiny
orifice held against the skin. This creates a fine stream of high-pressure
fluid that penetrates the skin, depositing medication in the tissue beneath.
Bioject's partners include Amgen, AngioSense, and Serono. Bioject's
needle-free injection technology improves patient comfort, virtually
eliminates the risk of contaminated needlestick injuries, and can improve the
immune response of some vaccines.
(1) Package inserts for the company's US products are available at
http://www.seronousa.com or by calling 1-888-275-7376. Luveris(R) and
Rebif(R) are currently not approved in the U.S.
CONTACT: Jennifer Bianco
Serono, Inc.
781 681 2124 (office)
781 983 4176 (mobile-on-site at BIO 2001)
SOURCE Serono, Inc.
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Related links:
http://www.seronousa.com
http://www.howkidsgrow.com
CONTACT:
Jennifer Bianco of Serono, 781-681-2124, or
mobile-on-site at BIO 2001, 781-983-4176
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