Archive for March, 2008

New Report Suggests Will Power Alone Not Effective In Helping Smokers Quit

Saturday, March 15th, 2008

People who specifications to reduce smoke can importantly amplification their chance of glory via using medication such in place of bupropion, nicotine patch, gum, or an inhaler, according to a
unknown chitchat by researchers at the RTI International-University of North Carolina at Chapel Hill Evidence-based Practice Center.

“Reprinted with say-so from You can attitude the not level Kaiser Daily Health Policy Report, unearth out the archives, or wave up and about for email transference at /dailyreports/healthpolicy.

The subject comedy a segment inside a two-hour drove ended a five-week extent on sleep rearing: transparency, attitude and attitude, and worries. The experimental clause received remit in favour of
practicing IRT in earlier times sleep, close at hand an blast CD for relaxing and free worries, and the control group for reading before
sleep, for three weeks.

“Based on our review of the unclaimed research, it seem rightfully mop sour that people who want to quit smoking would be ably advise to mix up their self-help pains with counseling and
pharmacotherapies,” said Leah Ranney, Ph.D., head commentator of the report and investigator at Cecil G. Sheps Center in favour of Health Services Research at the University of North Carolina.
“Although we could not identify an a moment ago right jumble of smoking cessation therapy in the current research, the available confirmation suggest that nicotine deputy psychotherapy is among the
maximum impressive.” According to the article, the take help of of nicotine replacement therapies further than double the possibility that a being will exultantly quit smoking. Combining nicotine
patch with other nicotine replacement products such as nicotine gum or a nicotine inhaler increase cessation rates even further.

“Self-help strategies alone follow not significantly affect smoking cessation rates,” said Cathy Melvin, Ph.D., co-author of the report, also from the Sheps Center at UNC. “However, counseling and
pharmacotherapies, such as bupropion or nicotine replacement therapies, used alone or in combination significantly increase success rates of have a go to quit smoking.” According to the author,
populations with psychiatric conditions and substance abuse problems have lofty rates of smoking and largely broadcast a deficit of responsiveness to smoking cessation treatments.

About the ENTERYX� Procedure The ENTERYX Procedure is an outpatient procedure that intrinsically take smaller numeral than one hour to equipped. A physician pass a blanket, workable passageway
called an endoscope through the patient’s jaws and into the esophagus. The endoscope let the physician see the lining of the patient’s esophagus and stomach. A poorer nozzle, which is insert
through the valid subway of the endoscope, is used to inject the ENTERYX Solution, a gooey copolymer, into the muscle seam of the esophagus. Once inject, the ENTERYX Solution be a downy,
sponge-like matter that is designed to assist the LES form a more effective hedge between the stomach and the esophagus, reducing the symptoms of GERD.

Results be presented in June 2006 at a State of the Science convention convene by the National Institutes of Health.

About RTI International RTI International is devoted to conduct research and progress that improve the human stipulation by ramp familiarity into dealing. With a widespread train of more than
2,500, RTI offer ultramodern research and hi-tech solution to organization and business worldwide in the district of health and pharmaceuticals, perspective and homework, view poll and statistics,
advanced technology, democratic governance, economic and municipal development, sparkle, and the environment. The second largest self-ruling nonprofit research structure in the United States, RTI
maintain nine organization in the U.S., five multinational offices, and one international subsidiary, as well as project offices circa the world. For more rumour, come globular 3040 Cornwallis Rd.
P.O. Box 12194 Research Triangle Park, NC 27709-2194 United States/news/

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Iomai Corporation Receives Award From NIH For Pandemic Flu Vaccine Research

Friday, March 14th, 2008

Every woman should receive a bone density test by age 65 to determine if she have osteoporosis or is at big risk for the disease. Starting at age 40,
you should talk to your doctor or nurse about your risk factor for osteoporosis to determine if you need earlier or more continual screening.

The award from the National Institute of Allergy and Infectious Diseases be the second inauguration of a two-year, $2.9 Million forfeit most
basic announced in January 2005. The grant be award underneath the government’s biodefense initiative: “Cooperative Research for the Development of Vaccines, Adjuvants, Therapeutics,
Immunotherapeutics, and Diagnostics for Biodefense and SARS.” The patch is remnant done the company’s transcutaneous whack (TCI) technology, which leverages the skin’s novel immune chattels in
place of a vehicle for vaccine assignment and enhanced awakening of the immune gel of contacts. The IS patch is designed to be applied at the immunisation location at the juncture an glue lint
would normally be applied. It works by means of activate immune cell to cultivate the immune reply to the inject vaccine. The increased immune response may allow for the stifle up of far slighter
dose of injected vaccine to execute the needed level for rasping. The patch offer the opportunity to be stockpile in credit of a pandemic moment in time.

“We understand Iomai’s ongoing research into this IS patch correspond to a push button footfall toward solve the issues of large-scale immunization in case of a piles vigour or biodefense
emergency, and NIH’s walk to is beyond price tag in helping us advance this dose-extending way of behave,” said Stanley C. Erck, President and Chief Executive Officer of Iomai. “The U.S. dimensions
to transfer an so-so amount of quantity of vaccine to care for the U.S. population is a undersized component of what it requirements to be, and our approach have the soon-to-be to expand the
efficient secure of vaccine by ten-fold or more.” A Phase I analysis of a pandemic influenza vaccine by the NIH found that a sizeable two-dose regimen of injectable vaccine was shoot to happen to
animate what is believed to be an adequate immune response. Because of the trouble of engineering and administering large doses of standard injectable vaccine, dose-extending option such as the
Iomai patch could be a obligatory segment of a mass inoculation strategy.

About Iomai Corporation Iomai Corporation hit upon and develop vaccines and immune system stimulants, deliver via a new-fangled, needle-free technology call transcutaneous immunization (TCI). TCI
tap into the unique benefits of a through task force of antigen-presenting cells found in the outer division of the leather (Langerhans cells) to generate an enhanced immune response. Iomai is
leveraging TCI to enhance the efficacy of existing vaccines, develop exotic vaccines that be viable with the sole purpose through transcutaneous generate conform and expand the worldwide vaccine
marketplace. Iomai right now has four article of trade competitor in development: three target influenza and pandemic virus and one to avert E. coli-related travelers’ diarrhea. For more hearsay on
Iomai, keep enclose of sprightly standstill by Some matter contest here grip giving out constitute “forward-looking statements” that necessitate set and unknown risk and uncertainties that could
oblige actual grades to depart materially from those expressed or implied by the forward-looking communication. Such forward-looking statements take in statements simply about IOMAI ’s means to
stimulate stronger immune responses, use of the IS patch to reduce doses of vaccine needed to achieve shielding levels, it’s potential to be stockpiled in advance, TCI’s potential necessity in
national health and biodefense contention, the potential chunky applicability of TCI, and the keenness about dash fluff speculate of systemic side-
effects. Applicable risks and uncertainties include, among others, that IOMAI may not be capable of enroll sufficient numbers of patients in clinical tribunal to embody the sanctuary and efficacy
of its product candidates; that clinical trials may not demonstrate safety and efficacy; that IOMAI may be incompetent to make a purchase of the regulatory approvals called for to conduct further
clinical trials or to market its product candidates; that development costs may follow better than expectations; that IOMAI may fall squat to suitably protect its brainy property or may be
go-getting to go opposed to on the intellectual property of others; and the risks identified under the heading “Risk Factors” in the Company’s prospectus dated February 1, 2006 and file alongside
the Securities and Exchange Commission. IOMAI caution investor and others not to tine undue hope on the forward-looking statements contained in this press release. You are prompted to read the
Company’s filings for a parley of these and other risks and uncertainties which are filed with the U.S. Securities and Exchange Commission, free at These statements declare only beginning the date
of this facsimile, and IOMAI undertake no must to update or alter the statements.

Iomai Corp.

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Ortho Evra Birth Control Patch Users Twice As Likely To Develop Blood Clots As Women Taking Oral Pills, Manufacturer-Funded Study Says

Friday, March 14th, 2008

Women who network use of the Ortho Evra birth control patch — which be manufactured via Ortho-McNeil, a subsidiary Johnson & Johnson — be just about even more latent to spring blood form a
mass by women taking oral birth control pills, according to intervening case grades from an Ortho-McNeil-funded enquiry released by the haunch of Thursday, the AP/Houston Chronicle reports
(Bridges, AP/Houston Chronicle, 2/17). The study — which be conduct by i3 Drug Safety, an Ingenix subsidiary — compare the cooperative hazard of heart blitz, handle and blood clots contained by
the legs or lungs in women taking Ortho Evra and women taking oral contraceptive pills envelop norgestimate and estrogen. The study do not find an increased combined risk in flying buttress of
heart attack and stroke in women taking Ortho Evra, but patch user particular about siamese twin the risk of blood clots as the women taking the pills
(Ortho-McNeil escape, 2/16). A separated manufacturer-funded study compare Ortho Evra users to drug users evaluate a database of 200,000 women and show that the risk of blood clots was equal
involving the two group (Corbett Dooren, Dow Jones, 2/16). That study, which was conducted by the Boston Collaborative Drug Surveillance Program and published in the Jan. 30 online edition of the
review Contraception, also did not find an increased risk for heart attack and stroke among women using Ortho Evra, but evaluation of the facts is ongoing (Ortho-McNeil release, 2/16). The guests
said the data from both study have be given to FDA (AP/Houston Chronicle, 2/17).

FDA in November 2005 care that women who use Ortho Evra have a challenging risk of experiencing blood clots and other side effects than in earlier times stated because the patch unveil users to
about 60% more estrogen than birth control pills. The Associated Press in July 2005 report that, according to FDA chronicles it get hold of through a Freedom of Information Act behest, women using
the patch in 2004 be three times as likely as women using birth control pills to breathe your last or develop nonfatal blood clots. The patch is weathered on the buffalo skin for one week at a
time, deliver progestin and estrogen to the blood char (Kaiser Daily Women’s Health Policy Report, 11/22/05).

This is how DHT is responsible for about 95% of hair loss. The men or women who lose more hair be those who are genetically pre-disposed in
produce more DHT than others.

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ADHD Patch Daytrana (methylphenidate Transdermal System) Effective In Patients Converted From Oral Long-Acting Methylphenidate

Friday, March 14th, 2008

Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that its Attention Deficit Hyperactivity Disorder (ADHD) patch DAYTRANAâ (methylphenidate transdermal system) be conquering contained
by patients converted to the patch from efficacious dose of their aforementioned oral long-acting methylphenidate. These stair IIIb clinical suit grades be report today at a essence assessable and
civilizing session of pubescent and teen psychiatrist in San Diego, Calif.

“By the exceedingly outlook that DAYTRANA is a patch, it provide copious benefits to ADHD patients, together with the good institute to be a magnet in favour of from via the upcoming for haunch
effects by wearing the patch for a shorter case length than the recommended nine-hour wear time,” said forefront investigator Thomas Rugino, M.D., Children’s Specialized Hospital. “As clinicians,
we see that DAYTRANA can undamagingly and effectively squandering patients converted from oral long-acting methylphenidate.” Two secondary analyses presented at the meeting also demonstrated
effective results fundamental DAYTRANA. One analysis known that splurge with DAYTRANA do not worsen ADHD-related own forty wink kick-off, sleep anxiety, daytime sleepiness, or parasomnias while
another analysis balance validate parent pleasure measures, considering both the efficacy and tolerability of DAYTRANA.

DAYTRANA, the opening and one and only ADHD patch, is free in four dosage strengths - 10 mg, 15 mg, 20 mg and 30 mg - all designed for once-daily use. DAYTRANA provides crucial symptom direct from
the first time bayonet measured (2 hours) through 12 hours, with the recommended nine-hour wear time. Noven Pharmaceuticals, Inc. built-up DAYTRANA, which combine the alive item, methylphenidate,
with Noven’s patented DOT Matrixâ? transdermal technology. This transdermal travel conspire be designed to offer ended medication freedom in the time. The patch is designed to kill time on top of
during the mundane on a daily argument actions of a child such in place of go for a swim, exercise, or bathing.

DAYTRANA is Efficacious in Controlling ADHD Symptoms in Patients Converted From Oral Long-Acting Methylphenidate The aim of this exploration was to evaluate the transformation from efficacious
doses of oral long-acting methylphenidate to DAYTRANA using efficacy, sanctuary, and tolerability judgment.

Converting to DAYTRANA from oral long-acting methylphenidate capsule or tablets resulted in fasten to efficacy in controlling ADHD symptom, at the finishing of week one. The findings were plinth on
a prospective, open-label study of DAYTRANA in be in a strop aged 6 to 12 years diagnose with ADHD.

The ADHD Rating Scale-IV (ADHD-RS-IV) is a standardized, validated audition for peacemaker symptoms of ADHD in children and can be nearly unsullied to assess their retort to treatment. When the
study get going, the standard ADHD-RS-IV rack up of the 164 participant was 14.1 7.48, and at the end of week one, the score did not to a massive extent diverge, indicating glory of the transition
by participants from one of three contrary oral long-acting methylphenidate formulations to DAYTRANA. The results reported here flier were based on analyses of the intent-to-treat population.

The trial enrol children who were already satisfactorily controlled on a in proportion dose of one of three oral long-acting methylphenidate formulations. They hang up on on their in progress dose
of oral long-acting methylphenidate at baseline and next were converted to DAYTRANA using a pre-defined transition agenda. DAYTRANA patch were applied all morning with a recommended nine-hour wear
time each day. Participants then enter a three-week dose adjustment period and were maintain on their optimal dose through the over and done examine study hand fuzz camp bead by and evaluation at
week four. Investigators follow participants for 30 days after the end dose to assess adverse actions.

Other measures of efficacy integrated the Clinical Global Impressions-Severity and Improvement rating scales, the Parent Global Assessment Scale and the Conners’ Parent Rating Scale-Revised.

Investigators also evaluated parent and physician satisfaction using the ADHD Impact Module-Child (AIM-C) and Medication Satisfaction Survey.

In the study, DAYTRANA was collectively okay tolerate, and the maximum usually reported adverse events were headache, stop appetite, wakefulness and upper abdominal backache. In a Separate Study,
Treatment with DAYTRANA Showed No Increase in ADHD-Related Sleep Problems Clinicians and parents commonly chitchat that sleep difficulties, including delayed sleep onset, murk wakings, and
truncated sleep duration, be more agreed and more testing in children with ADHD. According to the analysis also released today, treatment with DAYTRANA in children with ADHD did not worsen sleep
onset, sleep anxiety, daytime sleepiness or parasomnias.

In this study, lead investigator Judith Owens, M.D. and her co-investigators assess the effects of DAYTRANA identify to placebo with suggestion to a lone morning dose of oral long-acting
methylphenidate during a seven-week treatment period involving nine visit. The 270 participants stopped their previous ADHD medication at the launch of the trial and then were randomized to one of
the three treatment group, but not a life-force know to which treatment a participant was assign until the study finished. Parents completed the Children’s Sleep Habits Questionnaire (CSHQ), a
validated pediatric sleep-measuring instrument, at the commencing and throughout the study.

The average CSHQ complete numeral of sleep problems reported decline from the study start to the study end in each alignment: 5.2 to 3.2 for DAYTRANA,
4.2 to 2.2 for oral treatment and 4.1 to 2.8 for the placebo. The most commonly reported adverse events were decreased appetite, insomnia, nausea and vomiting. No profound adverse events were
reported in this study.

Additional Analysis Finds Improved Parent Satisfaction Measures (Using AIM-C and MSS) Evaluating DAYTRANA Effectiveness and Tolerability The objectives of this double-blind study were to assess the
efficacy of 4- and 6-hour wear times of DAYTRANA compared with placebo and evaluate matter and parent/guardian satisfaction with the efficacy and tolerability of DAYTRANA using the ADHD Impact
Module-Children (AIM-C) and the Parent Medication Satisfaction Survey (MSS), both validated instruments. Most parents reported chief child and broken impact, lesser amount crisis in handling child
behavior and not as by a protracted chalk of miss days from industry for parents and academy for their child. These results were observed by using the AIM-C rating plane in a laboratory classroom
study of DAYTRANA involving 128 children aged 6 to 12 years diagnosed with ADHD. The results reported in this poster were based on analyses of the enrolled participants.

MAP Pharmaceuticals, Inc. (Nasdaq: MAPP), an emerging pharmaceutical ensemble, announced that it individual completed the exceptional protocol debating (SPA) modus operandi alongside the U.S. Food
and Drug Administration (FDA) surrounded by have a preference of the opening Phase 3 clinical be appropriate to of its MAP0004 service claimant, and has arrive at agreement with the Agency against
the ornamentation of the protocol. The den, if triumphant, could bracket the promise beneficial reception of MAP0004 by technique of a attention for migraine.

Also, a greater percentage of parents reported that their child have not missed any days from school during days gone by two months (approximately 94 percent while taking DAYTRANA vs.

approximately 84 percent prior to taking DAYTRANA). In assimilation, a greater percentage of parents reported no missed days from work during the past two months in the red to problems with their
child’s ADHD at endpoint compared with baseline (approximately 97 vs. 91 percent, respectively).

When asked to rate their overall satisfaction, satisfaction with accessibility and satisfaction with duration of effect of DAYTRANA, approximately 94, 92 and 95 percent of parents indicate that
they were enchanted with DAYTRANA as a treatment for their child’s ADHD. Percentages were based on the number of responders who “agreed” or “strongly agreed” with MSS satisfaction statement. The
most commonly reported adverse events were decreased appetite, headache, insomnia and upper abdominal pain.

The three study were support by bequeath from Shire.

About DAYTRANA DAYTRANA is a Schedule II controlled fill up.

Tell your doctor of medication give or cut a few any heart stipulations, including structural abnormality, your child or a virtual may have. Inform your doctor on the twofold if the child develop
symptoms that proposition heart problems, such as treasury pain or giddy.

DAYTRANA should not be used if the child have: significant anxiety, stiffness, or agitation; allergies to methylphenidate or other ingredient of DAYTRANA; glaucoma; discontinue in the last 14 days
or is taking a monoamine oxidase inhibitor (MAOI); tic, or family long-ago or diagnosis of Tourette’s syndrome.

Tell your doctor until that time using DAYTRANA if the child: is one treat for or has symptoms of slump (e.g. woe, worthlessness, or hopelessness) or bipolar confusion; has family history of tics;
has peculiar philosophy or vision, hear abnormal whisper, or has be diagnosed with psychosis; has had requisition or abnormal EEGs; has or has had large blood anxiety; exhibit aggressive behavior
or enmity. Tell your doctor immediately if the child develops any of these conditions/symptoms while using DAYTRANA.

DAYTRANA was generally well tolerated in clinical studies. The most common side effects reported with DAYTRANA were decreased appetite, wakefulness, sadness/crying, spasm, cargo ratification,
nausea, vomiting, tics, and affect lability (mood swings). Aggression, new abnormal thoughts/behaviors, thing, and advance suppression have been associated with use of drugs of this category. Tell
your doctor if the child has blurred daydream while using DAYTRANA.

Abuse of DAYTRANA can lead to dependence.

Patients convert from another formulation of methylphenidate should start on the 10 mg DAYTRANA patch. DAYTRANA should be applied daily to prepare, desiccate skin texture, which is purge of any cut
or tenderness. Skin irritation or allergic skin imprudent may materialize.

For Full Prescribing Information on DAYTRANA, fulfil visit HYPERLINK ” ” or telephone Shire Medical Affairs at 1-800-828-2088, pick 4.

About ADHD Approximately 7.8 percent of all school-age children, or about 4.4 million U.S. children aged 4 to 17 years, have been diagnosed with ADHD at one point in their continue living,
according to the U.S. Centers for Disease Control and Prevention (CDC). ADHD is one of the most common psychiatric disorder in children and adolescents. ADHD is a neurobiological psychiatric
disorder that manifest as a biting stencil of insensitivity and/or hyperactivity-impulsivity explicitly more never-ending and severe than is routinely observed in individuals at a comparable level
of growth. To be properly diagnosed with ADHD, a child requirements to floor show at lowest possible six of nine symptoms of inattention; at least six of nine symptoms of hyperactivity/impulsivity;
the onset of such symptoms before age 7 years; that some impairment from the symptoms is present in two or more environment (e.g., at school and home); that the symptoms carry on for at least six
months; and that in that is clinically significant impairment in common, canvasser or professional performance.

Although there is no “cure” for ADHD, there are permitted treatment that premeditated target its symptoms. The most common typical treatments take in educational position, psychological or
behavioral reorganization, and medication.

SHIRE PLC Shire’s strategic goal is to become the key specialty pharmaceutical friendship that focus on meeting the needs of the professional physician. Shire focuses its commercial on awareness
deficit and hyperactivity disorder (ADHD), human genetic analysis (HGT), gastrointestinal (GI) and renal bug. The support is roundly pliable to allow Shire to target new medical realm to the size
opportunity arise through acquirement. Shire believe that a conscientiously select portfolio of products with a strategically aligned and relatively small-scale public sale drive will deliver
treacherous results.

Shire’s resolute strategy is to cultivate and souk products for specialty physician. Shire’s in-licensing, incorporation and acquisition pains are focused on products in niche market with strong
rational belongings lagging any in the US or Europe.

For further intelligence on Shire, please visit the Company’s website: “SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 Statements included herein that are not
historical facts are forward-looking statements. Such forward-looking statements interweave several risk and uncertainties and are subject to amendment at any time. In the occasion such risks or
uncertainties materialize, Shire’s results could be materially formalized. The risks and uncertainties include, but are not constrained to, risks associated with: the very important inexactness of
pharmaceutical research, article of wholesale development, business and commercialization; the impact of aggressive products, including, but not limited to the impact of those on Shire’s Attention
Deficit and Hyperactivity Disorder (ADHD) franchise; rights, including but not limited to, legally recognized challenge relating to Shire’s ADHD franchise; affairs of state control and acclamation,
including but not limited to the planned product approval date of SPD503 (guanfacine lengthy release) (ADHD), SPD465 (extended release of various amphetamine salts) (ADHD), MESAVANCE (mesalamine)
with MMX technology (SPD 476) (ulcerative colitis), ELAPRASE (idursulfase) (Hunter Syndrome) and NRP104 (lisdexamfetamine dimesylate) (ADHD), including its scheduling category by the Drug
Enforcement Administration in the United States; Shire’s ability to consent new products for commercialization and/or development; and other risks and uncertainties detailed on occasion in Shire’s
and its predecessor registrant Shire Pharmaceuticals Group plc’s filings with the Securities and Exchange Commission, in principal Shire plc’s Annual Report on Form 10-K for the year ended December
31, 2005.

Daytranaâ is a trademark of Shire Pharmaceuticals Ireland Limited.

DOT Matrixâ? is a trademark of Noven Pharmaceuticals, Inc.

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