[indices] Fw: [druginfo] At last, a new antibiotic class - glycylcyclines

["Hamis" <hamis@iafrica.com>]

cross posted with thanks!
Leesette

----- Original Message -----
From: "Andy Gray" <Graya1@ukzn.ac.za>
To: "Drug Information & Policy" <druginfo@healthlink.org.za>
Sent: 17 June 2005 11:28 AM
Subject: [druginfo] At last, a new antibiotic class - glycylcyclines


Hi all

As these two  WP and NYT stories show, launches of new antibiotic classes
are rare events. The challenge now is to find a regulatory framework that
will protect this new agent from misuse and delay the inevitable development of resistance. 

Copied as "fair use".

Zmax is an extended release azithromycin suspension, allowing for one dose
treatment in some indications (see the Yahoo news piece below, provided by
Pfizer). Note the link made to the expiry of the azithromycin patent.

regards
Andy
~~~

http://www.washingtonpost.com/wp-dyn/content/article/2005/06/16/AR2005061601
434.html
FDA Approves New Antibiotic for Resistant Bacteria
Hospital-Acquired Infections Targeted
By Marc Kaufman
Washington Post Staff Writer
Friday, June 17, 2005; Page A14

The Food and Drug Administration approved a new treatment yesterday for
hospital patients with serious bacterial infections, including those
resistant to most other antibiotics.

The new drug, called Tygacil, is from the first new class of antibiotics to
be marketed in several years. The manufacturer, Wyeth Pharmaceuticals, said
the intravenous drug will be used as a first-line treatment for stomach and
skin infections and is effective against enough different bacteria to be
used before doctors know which ones are causing the infection.

"Community and hospital-acquired infections have the real potential to
become a major public health crisis," said Evan Loh, a Wyeth vice president.
"The need for more antibiotics is acute."

The announcement was welcomed by doctors, especially those who are regularly confronted with bacterial infections that are resistant to existing antibiotics.

"It's very difficult to know how to treat and manage badly infected patients today," said Scott R. Schell, a professor of surgery at the Cancer Institute of New Jersey. "For the worst infections and sickest patients there are few options, so any new treatment is very appreciated."

The Centers for Disease Control and Prevention estimates that every year 2
million Americans acquire infections while in hospitals, and 90,000 die.
About 70 percent of the hospital infections are resistant to at least one
class of antibiotics.

The new drug is from a class of medicines called glycylcyclines, which is
related to the tetracycline class. The two are different enough, however,
that Tygacil can be used to treat infections that are resistant to
tetracycline, said Janice Soreth, director of the FDA's division of
anti-infective drugs.

Soreth also said the approval marked an important advance because "it's
another option, another choice out there, and there are a limited number of
options."

Developing new antibiotics is time-consuming and expensive, and drug
companies have been slow to come up with new types in recent years. Wyeth
officials said yesterday that the molecule that became Tygacil was first
synthesized in 1992, and clinical development began in 1997.

"Few broad-spectrum antibiotic agents are currently in development," the
company said in a statement. "Antibiotic development has slowed to the point
that FDA has had few opportunities to approve new agents. In fact,
development and approvals of new antibacterial agents have decreased by 56
percent over the past 20 years."

Although new antibiotics have been few and far between, the use of existing
drugs has grown markedly in both human medicine and to treat and promote the
growth of farm animals. Because bacteria will eventually grow resistant to
any antibiotic they encounter frequently, the pool of resistant bacteria is
expanding fast.

Schell, who spoke on a Wyeth teleconference but said he had no relationship
to the company, said Tygacil is especially welcome because it can defeat a
number of broadly resistant bacteria such as methicillin-resistant
Staphylococcus aureus , and because it is effective against a wide range of
bugs, including E. coli .

"It's important to get the right antibiotic because if you don't choose
right the first time, the patient does poorly," he said. It can take one to
two days of laboratory work to determine exactly what bacteria is causing an
infection.

The company said it is exploring other uses for the drug, including fighting pneumonia and some pediatric infections.

~~~
http://www.nytimes.com/2005/06/17/business/17wyeth.html?
F.D.A. Approves New Antibiotic From Wyeth
By BLOOMBERG NEWS
Published: June 17, 2005

Wyeth said yesterday that it had won federal regulatory approval to sell
Tygacil, the first of a new class of antibiotics able to fight infections
that outwit treatment with existing medications.

The intravenous drug treats a wide variety of potentially fatal infections,
including those caused by E. coli bacteria. Tygacil was approved for stomach
and skin infections, including burns, ulcers and abscesses and may be given
even before doctors determine what bacteria is responsible, Wyeth said.

About 70 percent of the two million infections among hospitalized Americans
each year are resistant to one or more drugs, driving up the cost and
complexity of care, according to the Infectious Diseases Society of America.

Tygacil may change the way doctors treat intensive-care patients and
generate $400 million in worldwide sales by 2010, doctors and analysts said.

"I can readily see this revamping" the way doctors care for patients in
intensive-care units, said Lewis J. Kaplan, an associate professor of
surgery at the Yale University School of Medicine, in an interview last
month. "The easiest place to fail is picking the wrong antibiotic. People
will die."

The Food and Drug Administration approval is the first for Tygacil, part of
a new class of medicines called glycylcyclines. The drug is under review
elsewhere in the world, including Europe, Canada, Mexico and Taiwan.

Shares of Wyeth, which is based in Madison, N.J., rose 31 cents, to close at
$43.50.

Wyeth's biggest product is Effexor, an antidepressant that generated $868
million in first-quarter sales. It also makes the Prevnar meningitis vaccine
and the Zosyn antibiotic.

Tygacil may have competition from Johnson & Johnson, which is developing the
antibiotics ceftobiprole and doripenem to fight drug-resistant bacteria and
hospital infections.

Earlier this week, Pfizer won approval for its Zmax antibiotic to treat
mild-to-moderate sinus infections and pneumonia. The company plans to switch
patients to Zmax from Zithromax, which generates $1.85 billion in annual
sales and will face generic competition later this year.

~~~
http://biz.yahoo.com/prnews/050613/nym227.html?.v=9
Pfizer's Single-Dose Antibiotic Zmax(TM) Receives FDA Approval
Monday June 13, 2:59 pm ET
Zmax Is First Single-Dose Oral Antibiotic for Adults With Certain Types of
Sinusitis and Pneumonia

NEW YORK, June 13 /PRNewswire-FirstCall/ -- Pfizer Inc said today that the
U.S. Food and Drug Administration has approved Zmax(TM) (azithromycin
extended release) for oral suspension, a one-dose-only treatment for
mild-to-moderate acute bacterial sinusitis (ABS) and community-acquired
pneumonia (CAP) in adults.

Using microsphere technology, ZMax delivers a complete course of therapy in
a single two-gram dose. In the first 24 hours after a dose of Zmax, the
amount of drug that gets into the tissue is three times higher than a
standard dose of immediate-release azithromycin. Immediate-release
azithromycin has been available in the United States since 1992 under the
trade name Zithromax.. This "front loading" of Zmax provides high drug
levels earlier in the course of infection when the bacterial burden is
likely to be highest.

"A single, high-dose antibiotic is an important advance in treating certain
types of sinusitis and pneumonia in adults," said Dr. Joseph Feczko, chief
medical officer at Pfizer. "Results showed that one dose of Zmax was as
effective as currently available treatments that must be taken for seven to
ten days."

Zmax's innovative microsphere technology allows for release of the medicine
in the small intestine rather than in the stomach, which results in a
favorable side-effect profile. In addition, the high tissue penetration and
long half-life of azithromycin make it possible to deliver the entire course
of therapy as a single dose.

"The benefit of this type of short-course, high-dose therapy is that it
allows patients to be treated with a single dose of antibiotic," said Dr.
Michael Niederman, Chairman, Department of Medicine, Winthrop University
Hospital, and Professor of Medicine, State University of New York at Stony
Brook. "An antibiotic taken just once can address compliance issues and may
minimize the emergence of antibiotic resistance."

Zmax is indicated for acute bacterial sinusitis due to Haemophilus
influenzae, Moraxella catarrhalis or Streptococcus pneumoniae and community-
acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae,
Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients appropriate
for oral therapy.

The Zmax adult clinical research program included outpatients with mild-
to-moderate acute bacterial sinusitis and community-acquired pneumonia, and
acute bacterial exacerbations of chronic bronchitis (AECB).

Pfizer withdrew its application for the treatment of AECB while the FDA
re-evaluates how it reviews investigational antibiotics for this indication.

Zmax offers a safety profile comparable to other antibiotic treatments for
certain types of sinusitis and pneumonia and is generally well tolerated.
Side effects were generally mild to moderate. Overall, in the pivotal
studies the most common treatment-related adverse reactions in adult
subjects receiving a single (2 g) dose of Zmax were diarrhea/loose stools
(11.6%), nausea (3.9%), abdominal pain (2.7%), headache (1.3%), and vomiting (1.1%). In the majority of Zmax-treated patients, diarrhea resolved within two days.

Zmax is contraindicated in patients with known hypersensitivity to
azithromycin, erythromycin, or any other macrolide or ketolide antibiotic.
If an allergic reaction occurs, discontinue drug and institute appropriate
therapy. Physicians should be aware that reappearance of the allergic
symptoms may occur when symptomatic therapy for the allergic reaction is
discontinued. Pseudomembranous colitis has been reported with nearly all
antibacterial agents. It is important to consider this diagnosis in patients who present with diarrhea.




~~~~~~~~~~~~~~~~~~~
Andy Gray MSc(Pharm) FPS
* Senior Lecturer
Dept of Therapeutics and Medicines Management
* Study Pharmacist
Centre for the AIDS Programme of Research
in South Africa (CAPRISA)
Nelson R Mandela School of Medicine
University of KwaZulu-Natal
PBag 7 Congella 4013
South Africa
Tel: +27-31-2604334/4298 Fax: +27-31-2604338
email: graya1@ukzn.ac.za or andy@gray.za.net
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