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Barrier Therapeutics Markets Denavir in Canada

August 25, 2006

Pharmaceutical company Barrier Therapeutics (Nasdaq: BTRX) in Princeton says it plans to commercially market Denavir topical antiviral prescription cream in Canada.

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Denavir is a treatment for herpes labialis, or cold cores, in adults. Cold sores are caused by the herpes simplex type 1 virus. Denvair, which works to block the virus and promote rapid healing of cold sores, is Barrier’s third product released in Canada.

It was approved for use in the U.S. by the FDA in 1996 and sold by Switzerland-based Novartis.

Shares of Barrier Therapeutics were unchanged at $5.43 in morning trading.

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Barrier Therapeutics Announces Launch Of Denavir In Canada - Quick Facts

August 24, 2006

Wednesday, Barrier Therapeutics Inc.Revealed the commercial launch of Denavir 1% in Canada. Denavir is a topical antiviral prescription medication indicated to treat herpes labialis, also known as cold sores, in adults. Denavir is the third product marketed in Canada by Barrier Therapeutics. Other products marketed by the company in Canada include VANIQA Cream 13.9% for slowing the growth of unwanted facial hair in women and Solagé Topical Solution to treat solar lentigines.

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Statistically Significant Phase IIb Clinical Results Of Transport’s Drug/Device Combination Product For Herpes Labialis

August 19, 2006

Published today in the peer-reviewed journal Clinical Infectious Diseases, as a major article, are statistically significant Phase IIb clinical results of Transport Pharmaceuticals’ first-generation drug/device combination product, SoloVir(TM), for herpes labialis, or cold sores. (Topical Iontophoretic Administration of Acyclovir for the Episodic Treatment of Herpes Labialis: A Randomized, Double-Blind, Placebo-Controlled, Clinic-Initiated Trial, V. 43, p. 460)

The results of this proof-of-concept Phase IIb trial demonstrated a one and a half day (or 35 hours) reduction in the intent-to-treat population median time to healing in the active treatment group as compared to the placebo group (113 hours versus 148 hours; p= 0.02). And, for the subgroup patients that were treated at the first visible stage of infection (erythema stage), the difference in healing time between groups was three days (or 71 hours; 49 hours versus 120 hours; p= 0.03). This trial also demonstrated that the drug/device combination was safe and well-tolerated, with total incidences of adverse events reported similar to placebo.

About the Phase IIb Clinical Trial

The Phase IIb trial was designed as a multi-center, randomized, double-blind, placebo-controlled, clinic initiated, proof-of-concept trial to evaluate the safety and efficacy of a single ten minute iontophoretic application of five percent acyclovir cream for the episodic treatment of cold sores at specified stages of infection. The trial studied 200 non-immunocompromised patients with histories of recurrent cold sore outbreaks (3 or more annually) that were aged 18-75 years.

Cold sore lesions were assessed based on physical presentation (swelling, ulcer, crusting, etc.) and scored by an investigator or trained designee prior to dosing and then daily for 10 days at varying stages. The main determining factor for efficacy was time to healing of classic lesions, defined as the time from the beginning of treatment until there was a loss of crust over the sore.

Spotswood Spruance, MD, co-author, Principal Investigator of the study and Professor of Internal Medicine, at the School of Medicine, University of Utah commented, “In the treatment of herpes labialis, there is a real market need for new, innovative patient-friendly products that penetrate the basal epidermis, provide improved efficacy over existing topical treatments, and decrease the healing time. The drug efficacy in this study is particularly noteworthy, given that this was a clinic-initiated study in which patients did not administer treatment until there was visible evidence of a lesion.”
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Eric M. Morrel, Ph.D., Vice President Clinical Research of Transport and co-author added, “Past and recent studies have shown that a brief, early window of therapeutic opportunity may exist to treat herpes labialis, so achieving a high level of antiviral drug in the infected tissue, early in the episode of infection, is believed to be both critical and sufficient in realizing the efficacy of antiviral chemotherapy. Our results with a single, iontophoretic antiviral treatment provide further evidence for this dosing strategy. We will investigate the application of the second-generation drug/device combination in additional Phase II trials.”

Dennis I. Goldberg, Ph.D., President and Chief Executive Officer of Transport and co-author added, “The strong results of this Phase IIb proof-of- concept study and an earlier clinical study are the basis for advancing Transport’s lead product, SoloVir(TM), forward into the clinic.”

Dr. Goldberg continued, “Our low voltage, wireless, handheld, reusable portable computer-controlled iontophoretic applicator device has been optimized to allow rapid self-administration of a novel formulation of acyclovir designed for electrokinetic delivery. Our latest proprietary, highly concentrated and soluble acyclovir formulation presents the opportunity to substantially improve efficacy, safety and convenience compared with topical acyclovir. We look forward to conducting additional Phase II trials in the next twelve months.”

About Transport’s Iontophoresis Delivery Platform

Transport’s drug/delivery platform is based on the combination of iontophoresis, a technology employing a low-voltage electrical charge to locally deliver larger amounts of medications through the skin, and proprietary drug formulations optimized for electrokinetic delivery. The Company has developed a small, wireless microprocessor-controlled drug delivery device and pre-filled drug reservoir cartridges that will allow patients to self-administer topical drugs for a variety of indications. The system consists of a reusable control unit and disposable, single-use medicated cartridges. The pre-filled cartridges contain a single unit dose of drug optimized for electrokinetic delivery.

To date, Transport has clinically validated its technology in several US clinical trials in more than 750 patients using the company’s first-generation iontophoretic device and an approved topical acyclovir formulation.

About Herpes Labialis

Approximately 20-40 percent of the adult population experience recurrent outbreaks of herpes labialis, or cold sores. Currently approved treatments for herpes labialis are acyclovir cream, penciclovir cream, n-docosonal 10 percent cream, and the oral prodrug of acyclovir, valacyclovir. Multiple studies of acyclovir have suggested that the nominal efficacy of the topical formulation as it is currently marketed is the result of inadequate penetration of the drug into the target site of infection, the basal epidermis layer of the skin.

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Doctor Feelgood

August 15, 2006

I’M A healthy 30-year-old male and I get a new cold sore practically every fortnight at the moment, despite using tea-tree oil, Blistex and a number of other remedies. Although they only last a couple of days, they are very unsightly and painful. I have heard that strong sunlight and eating certain nuts can encourage a cold sore to appear. Is this true?

Answer

You’re right to avoid nuts. It’s also thought that dairy produce makes cold sores worse. Soothing treatments such as an ice cube held against the sore for a few minutes, or making a paste of baking soda and water and smearing that on can help.

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But since the cause is a herpes virus, the best cure is an antiviral treatment. I suggest aciclovir cold-sore cream, applied five times daily at the first sign of a cold sore - and if they’re recurrent your doctor might give you some aciclovir tablets to take. The key is early treatment, so start it at the first buzz of discomfort. And yes, keep out of the sun, as sunlight can provoke an attack and makes it really uncomfortable.

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Doctor’s busy, ER’s full - where do you go? Urgent care

August 11, 2006

One day last month, Judy Bradley was walking up some wooden stairs. She tripped on a “weird overhang” and cut her leg on one of the steps.

“It was gushing blood,” says Bradley, 68, of Wildwood, Mo.

She knew the cut needed stitches, but it was a Saturday evening. Her primary care physician’s office was closed, and she didn’t want the long wait of an emergency room.

She put pressure on the wound and told her husband to take her to the St. Luke’s Urgent Care center in Ellisville, Mo., that she had visited a few years ago.

“I knew it closed at 8, and we got there 10 minutes before 8,” she says. “They saw me hobbling out of the car, greeted me at the door … and within 45 minutes I was done.”

Her cut required nine stitches.

“They took care of it immediately, did a professional job and were friendly and nice,” she says.

Elizabeth Sparks, mother of four, likes urgent care for a similar reason: convenience.

“It’s just easier to go there,” she says. “And I know (my kids) are going to get good care.”

Sparks, 39, says she’s taken her kids there for everything from strep throat to a broken toe. “I take them to their regular doctor for checkups, but I take them to urgent care for just about everything else. It’s right down the street, and we usually get in and get out really quickly.”

Urgent care centers are facilities dedicated to treating conditions that require prompt medical attention but do not pose an immediate health threat. You need no appointment, and the centers are open nearly year-round for extended hours.

“That’s the main focus of this practice model,” says Dr. Larry Murrow, medical director of urgent care at St. Anthony’s Medical Center. “Our goal is to provide convenience for the consumer. I think in the future we are going to see more and more of this type of medicine. It’s a matter of the patient’s time needs being so great. Everyone is so intensely scheduled, it’s difficult to get in to see a primary care physician.”

St. Anthony’s operates three urgent care centers. This year, estimates call for 60,000 visits among the three centers.

St. Luke’s Hospital operates four urgent care centers. For the fiscal year that ended in June, they reported 88,000 visits, says Linda Hayden, nursing director for urgent care at St. Luke’s. That’s about a 10 percent increase over last year.

These days you can find urgent care centers, both private and hospital-run, in most communities in the area. Hayden says the popularity has grown exponentially in the past five years.

“I think the public is more aware of what we do here,” she says. “But I also think the wait times in ERs have contributed to it. And so have busy lifestyles. If someone is ill at work, they want to be seen on their way home. If someone wakes up with a sore throat on Saturday morning, they want to get in and get treated so they can be better by Monday.”

The urge for convenience is not only spawning more urgent care centers, but also health clinics planned to open at some Walgreens, Medicine Shoppe and Schnucks stores, which will be staffed by nurse practitioners and overseen by off-site doctors. The clinics will serve patients with common ailments such as a cold, flu and sore throat, and some will offer flu shots. None has opened yet.

What to go there for:

Urgent care centers, which are staffed by board-certified physicians and nurses, are equipped to deal with minor emergencies, such as a cut to the eye or a sprained ankle, and especially minor illnesses, such as a sinus infection.

“People would prefer to be seen immediately,” says Murrow. “That’s why we offer the hours we do.”

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At many centers, patients need no appointment; they just walk in the door and tell the receptionist why they’d like to see a doctor. The receptionist takes down all relevant information, and usually within minutes the patient is in to see the doctor.

The centers are equipped with X-ray facilities and some limited lab capabilities. If a doctor needs more work done, he or she will send the patient to the hospital. At some centers, the goal is to get the patient out the door within 60 minutes. At others, the goal is to get the patient seen within 15 to 30 minutes.

The centers are not intended for someone experiencing any kind of life-threatening situation, including chest pain, loss of consciousness or a head injury, says Murrow.

ERs and primary care doctors:

In recent years there has been a drop in the number of doctors entering primary care practice.

Because of that, there are fewer appointments to be had with those doctors.

“Sometimes you can’t get in for several days, and when you can, it’s often at an inconvenient time for those who work,” says Murrow.

In addition, the increasing number of uninsured patients is sending more people to the emergency room. In a report last year by the U.S. Centers for Disease Control and Prevention, emergency department visits increased from 90.3 million to 113.9 million annually from 1993 to 2003. Of people actually treated at the emergency room, 40 percent of the cases were deemed nonurgent or semi-urgent, the report said. Most of those would have been more appropriately treated in an urgent care center. In addition, the report stated that the average emergency room visit in the U.S. took 3.2 hours.

In many hospitals across the region, there is an emphasis on taking some of the load off of emergency rooms. That’s where urgent care centers come in.

At St. Luke’s, emergency room staffers will refer a patient who calls to an urgent care center if the symptoms warrant it.

“That’s a large part of the reason there’s an emphasis on growing urgent care,” says Murrow. “As the volume (in emergency rooms) decreases, it’s good for everyone. Wait time decreases. We have increased efficiency, and that’s good for the doctors and the patients.”

Drawbacks:

One of the drawbacks to urgent care is cost. Most insurance companies categorize it as an emergency room visit, so your co-pay could be five to 10 times higher than it is for a regular doctor appointment.

But Hayden says convenience outweighs the cost for many of their patients. “Sometimes it’s worth it to pay that,” she says.

In addition, even the people who run the centers say urgent care is not meant to replace primary care physicians.

At the St. Luke’s centers, they work closely with the primary care physicians, even sending your file to them once you have been in.

“We value primary care physicians,” says Hayden. “We strive to work hand in hand with them. They are important to our business, and we are important to theirs. Many times, when an office is closed, they will leave our address and phone number on the recorder.”

Murrow agrees.

“There are a lot of things we can do and a lot of things we can’t do,” says Murrow. “Your primary care doctor knows you, knows your history, and you should still try to see that doctor.”

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Like a Head Cold

August 10, 2006

You know what I hate about meetings? They give you the appearance that they are finished, but they really aren’t. Sort of like a head cold. You get it and think it is over three days later…but then you notice you still have the lingering sore throat…and your back hurts from coughing…and you are tired because you didn’t sleep well…and…and…and…

Finally you realize it didn’t really leave, it just morphed into something else…just like a meeting that morphs into a follow-up conversation…and an email string…and all I want to do is follow the market!

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Pardon the rant, but I thought it was worth doing as a reminder that everyone has outside distractions and limitations put on them. In an idea world we would all have a trading cave that allowed in only what we thought would help us. But in the real world, we have jobs, families, and emergencies that fight for our attention.

The key is to be cognizant that this is happening and realize that you may not be in your best fighting shape. The other key is have routines that you can fall into to help get you back “in shape”.

In situations like this I limit my focus to the basics. I start with looking at the broad market indices, checking the charts and reviewing my prior comments. Perhaps I am just overly doltish, but I found it is helpful to have my thoughts down in writing as a way of keeping an even keel…

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Lions Tracks: Kitna cold in public practice

August 6, 2006

Inside the Lions training camp in Allen Park and Detroit

Saturday’s news: The team held its only public practice of training camp at Ford Field in front of 22,992 fans. It was a regular padded practice and the team went through their normal routine of drills, including 7-on-7 and 9-on-7, although a few were shortened. The only difference is that, for the first time, the Lions worked on some actual game situations, such as making offensive and defensive substitutions and getting special teams units on the field.

Long gone: During the first week of training camp, the starting offense did a good job of connecting on a lot of downfield passes, but quarterback Jon Kitna couldn’t hit anything he attempted deep Saturday night.

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One-sided: Because it was just another practice, there wasn’t a lot to get excited about, but most of the cheers from the crowd were for good offensive plays, like running back Kevin Jones’ touchdown catch, a big reception by wide receiver Roy Williams and a scoring catch by tight end Marcus Pollard. It’s more difficult for fans to get excited about the defense because defenders didn’t hit anybody during the workout. Still, second-round draft pick Daniel Bullocks had a nice interception off a post pattern.

Coach’s slant: For the second time in 10 days, Marinelli has canceled a practice. After five consecutive two-a-days, Marinelli eliminated an afternoon workout last Wednesday. He’s been so happy with the team’s performance so far that he also canceled the only practice scheduled for today. “I kind of go day by day, feeling it,” Marinelli said. “When you plan things out in advance, sometimes that’s not always the best. They’re humming right now. They’ve earned it. And I think it’s good when you don’t know something is coming.”

Sideline view: Rookie running back Brian Calhoun needs to impress the coaching staff during preseason games, but not with his running and receiving ability. The coaches will be surprised if he doesn’t excel in those areas. Instead, Calhoun must show that he has the intelligence to pick up blitz schemes and the technique and strength to block blitzing linebackers or defensive backs. If Calhoun can’t prove his reliability in those areas, he won’t be playing much during the regular season.

Bumps and bruises: A final decision hasn’t been made yet, but it appears guard Damien Woody will miss the next two weeks following surgery on his right hand. Woody re-fractured the bone he broke during the off-season. If the bone surgically repaired, he’ll return to action in a couple of weeks. Wide receiver Eddie Drummond was sidelined because of a sore groin while tackle Barry Stokes has a hamstring pull. Running back Kevin Jones (thigh) and cornerback Fernando Bryant (hamstring) saw limited action.

What’s next: The Lions will return to two-a-day workouts Monday and Tuesday. The first preseason game is 7:30 p.m. Friday against the Denver Broncos at Ford Field.

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FDA Approves Supplemental New Drug Application for Antiviral Treatment Famvir(R) (Famciclovir)

August 2, 2006

Famvir approved to treat recurrent genital herpes outbreaks with single day of therapy

Famvir approved to treat cold sores with single dose of therapy

EAST HANOVER, NJ — July 31, 2006 — Novartis Pharmaceuticals Corporation announced today the U.S. Food and Drug Administration (FDA) approved prescription Famvir® (famciclovir) tablets as a single-day treatment for immunocompetent patients with recurrent genital herpes (RGH), based on a supplemental new drug application (sNDA).

Famvir significantly reduced the time to healing of non-aborted lesions, as well as time to resolution of studied symptoms in RGH patients with lesions by almost two days. The FDA also approved Famvir as a single-dose treatment for recurrent herpes labialis (cold sores) in immunocompetent patients.
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“Famvir is the first and only antiviral approved to treat recurrent genital herpes in a single day,” said Gregory Geba, MD MPH, Vice President and Therapeutic Area Head of Respiratory, Dermatology and Infectious Diseases, Novartis Pharmaceuticals Corporation. “The new data demonstrates that Famvir can minimize a recurrent genital herpes outbreak, and stop symptoms such as pain and burning, in a median of less than a day. More importantly, Famvir can also stop an outbreak from occurring altogether in many patients.”

When an outbreak is triggered in the body, there is a narrow window of opportunity for treatment since the virus is replicating most actively in the first hours of an outbreak. Data shows that when patients were treated with the oral antiviral Famvir during this critical period of time, it shortened the duration of outbreaks and improved the time to resolution of symptoms. Millions of Americans live with the pain and discomfort associated with the outbreaks brought on by these conditions.

The new approved dosage of Famvir for RGH is 1,000 mg twice daily for one day. Therapy should be initiated within six hours of the first sign of prodromal symptoms, such as tingling, itching, burning or lesion appearance. Ninety-one percent of patients can identify their prodrome allowing them to initiate therapy in this narrow window of opportunity.

Similarly, the cold sore virus is most active during the first hours of an outbreak. Data shows that when a single 1,500 mg dose of Famvir therapy is initiated within one hour of the first sign of symptoms (tingling, itching or burning) of a cold sore, Famvir significantly reduced the time to healing by a median of almost two days, as well as the time to resolution of pain and tenderness by a median of one day.

“This is exciting news for the millions of people who live with these conditions,” said Dr. Geba. “Treating at the first sign of symptoms, when the virus is generally most active, significantly influences the management of outbreaks.”

About the Data
Recurrent Genital Herpes (RGH): Results from the multicenter, multinational, randomized, double-blind, placebo-controlled study comparing single-day Famvir (1,000 mg orally twice; n=163) with placebo (n=166) showed that when immunocompetent adult patients with RGH initiated therapy with Famvir at the first symptom/sign of an outbreak (within six hours), Famvir significantly reduced (PDiscount Pharmacy - Buy Pharmacy at discount prices including free shipping.Discount Pharmacy provides confortable and easy way to order discount pharmacy online.

Famvir also significantly reduced (PAbout Genital Herpes
Genital herpes is one of the most common sexually transmitted diseases in the United States. Approximately one in five or about 50 million Americans are infected with genital herpes. Nearly 90 percent of people affected with genital herpes may not know they are infected. Anyone who is sexually active with an infected partner can get genital herpes; however, typically more women are diagnosed with genital herpes than men.

There is no cure for genital herpes. Oral antiviral medications such as Famvir are indicated to treat or suppress RGH. People with recurrent genital herpes can treat it suppressively, by taking medication every day, or episodically, by taking medication when each outbreak occurs. The majority of people who use prescription treatment for genital herpes manage their symptoms through episodic treatment.

About Cold Sores
Cold sores, medically known as herpes labialis, are an infection of the mouth area with the herpes simplex virus. It is estimated that cold sores affect 66 percent of American adults — with most Americans being infected by the age of 20 years. Annually, approximately 100 million episodes of recurrent cold sores occur in the U.S. Oral antiviral medications can shorten the course of an outbreak and improve the time to resolution of symptoms (pain and tenderness) associated with cold sores. However, there is no cure for cold sores.

About Famvir
Famvir (famciclovir) tablets are indicated for the treatment or suppression of recurrent genital herpes in immunocompetent patients; the treatment of recurrent herpes labialis (cold sores) in immunocompetent patients; the treatment of recurrent mucocutaneous herpes simplex infections in HIV-infected patients; and the treatment of acute herpes zoster (shingles).

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