How To Get Rid Of Man Boobs Permanently

How I Overcame My 50-Year Struggle With Gynecomastia

Before we get started, here's a little story from one of my clients, Sammie Fields.

Hey there I’m Sammie.

I’m in my 70s now and I’m finally enjoying my life as a masculine-looking guy. I struggled with gynecomastia ever since puberty. Back in the day it was totally unheard of for a man to have breasts.

Man boobs were quite a rare thing. If you think having man boobs is bad now, try having them in the 60s. I spent my entire life in fear that someone would notice my breasts. I stayed away from women - I was horrified of the bedroom. I also stayed away from the beach and only got out wearing the thickest of clothing to try and conceal myself.

Back then there was no internet, and no information out there to help me. I tried everything I could to try and get rid of my man boobs. I lost weight and tried different diets but all to no avail.

One day however, just a few years ago I came across a newspaper article.

This article complained of how male fish in our waters were becoming feminized. Scientists had studied these male fish and found how they had developed feminine characteristics, even to the point of producing eggs! Apparently this was due to the prevalence of the female hormone estrogen in our water supply.

Apparently, due to most government water filtration systems (including the US), estrogen passes unfiltered right into our taps, and straight into your belly when you drink that glass of water.

The estrogen is being absorbed by us and is resulting in modern man having low sperm counts, fertility problems and gynecomastia. Heck it might even be responsible for the boom in the male cosmetics industry (joke).

So I went out there, did some research and found some other shocking sources of estrogen that exist especially in the modern environment, but were also there in the past albeit in much lower quantities and not as widespread back in the day.

Why am I telling you all this?

Well I lost my man boobs in my mid-sixties. The only way I managed to succeed was after I armed myself with the facts, and all the information I needed to know about the very root cause of my gynecomastia.

If I could get rid of my gynecomastia in my sixties, then I know for a fact that anyone else can do it too. So if you're about to give up or you have given up and are ready to face the world as a pseudo-man, then I'm here to tell you to wake up! Get out of that trance, shake yourself up and inform yourself of real working tactics that have been proven time and time again to help many thousands of guys lose their man boobs permanently using all-natural methods.

And I can't think of a better person to help you than my good friend Robert Hull. I leave you to his very capable hands and I'm sure that you will learn much on his new blog.

Sunday, May 1, 2011

Tall, Obese Males Have Much Higher Risk Of Blood Clot In Deep Veins

Editor's Choice
Academic Journal
Main Category: Obesity / Weight Loss / Fitness
Also Included In: Vascular;��Men's health
Article Date: 28 Apr 2011 - 7:00 PDT

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Tall, obese individuals have a significantly higher risk of developing blood clots in veins deep in the body, this is especially the case for men, Norwegian researchers revealed in the journal Arteriosclerosis, Thrombosis and Vascular Biology.

The authors explain that obese individuals are known to have a higher risk of developing clots in deep veins, especially in the lower limbs, as well as clots in blood vessels of the lungs (pulmonary embolism) - which can strain the heart and cause sudden death. Venous thromboembolism (VTE) refers to both these conditions.

Sigrid K. Braekkan, Ph.D., from the Hematological Research Group at the University of Troms�, Norway, and team compared tall obese men to short-normal weight men (BMI 25, 5ft 7.7 inches tall) and tall, obese women to short normal weight women (up to 5ft 2.6 inches tall). The risk of VTE (age-adjusted) was:

In obese, tall men - 5.28 times higher
In obese, tall women - 2.77 times higher
In normal weight, tall men - 2.57 times higher
In normal weight tall women (over 5ft 6 inches) - no increased risk
In obese, short men - 2.11 times higher
In obese, short women - 1.83 times higher

They found that the risk of developing VTE among tall, obese males was similar to the risk that exists in pregnancy, using oral contraceptives, or having a gene for an inherited predisposition to clotting (Factor V Leiden).

Braekkan said:

"We believe that we observed the increased risk in tall and normal-weight men, but not women, because most women do not get sufficiently tall. The risk may be present in very tall women, but there were too few to investigate this properly."

The authors believe further studies are required to find out what mechanisms are at play in tall, obese individuals regarding VTE risk.

Braekkan said:

"In tall people the blood must be pumped a longer distance by the calf-muscle pump, which may cause reduced flow in the legs and thereby raise the risk of clotting.
Understanding and preventing VTE is important because even the first occurrence may be fatal. Obesity, in combination with other VTE risk factors, has been shown to substantially increase the risk, so we wanted to assess the combined effects of tall stature and obesity."

The investigators gathered data from the Troms� study. Troms� is a Norwegian town in which periodic health surveys of adults aged 25 to 97 years are carried out. The height and weight of 26,714 adult males and females were collected, and were followed up for a median of 12.5 years, up to 2007. A total of 461 VTEs occurred.

Obese people have high pressure in the abdomen, this can undermine the calf-muscle pump's ability to return the blood from the lower limbs.

Braekkan said:

"Obesity is also linked to a state of constant low-grade inflammation, and inflammation may render blood more susceptible to clotting."

When assessing their patients' overall risk for dangerous clots, doctors should take into account their height and weight, the authors wrote.

Braekkan said:

"Since body height is not easy to modify, the most important thing is to stay slim, especially if you are tall."

According to the American Heart Association, over 275,000 individuals are hospitalized in the USA annually with deep vein clots or pulmonary embolism.

"Joint Effects of Obesity and Body Height on the Risk of Venous Thromboembolism - The Troms� Study"
Knut H. Borch; Cecilie Nyegaard; John-Bjarne Hansen; Ellisiv B. Mathiesen; Inger Nj�lstad; Tom Wilsgaard; Sigrid K. Br�kkan
Arteriosclerosis, Thrombosis, and Vascular Biology. 2011. doi: 10.1161/ATVBAHA.110.218925

Written by Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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Source: http://www.medicalnewstoday.com/articles/223691.php

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Royal wedding: will you be a blubbering wreck?

Swooning at the altar

Faint heart, fair lady. Should Kate feel light-headed on the steps of the Abbey, a bridesmaid could reach for a bottle of Aromatherapy Associates Support Breathe Essence. The delightful scent of this combination of essential eucalyptus, peppermint and tea-tree oils will clear the head, revive the senses and even decongest the sinuses at a sniff.

Aromatherapy Associates Support Breathe Essence, 10ml for �15.50; aromatherapyassociates.com

Tears of joy

Everyone cries at weddings, but no one wants red eyes in the official portrait. Bausch & Lomb, the contact lens specialists, have developed a new eye drop, Artelac Splash, which might help. It includes compounds found naturally in healthy eyes and tears, such as hyaluronic acid, which binds with water and clings to the surface of the eye, keeping it hydrated and sparkling fresh.

Artelac Splash (30 doses for �10.49); artelac.co.uk and pharmacies

Bridal break-out

Kate will have make-up artists galore to ensure she looks blooming all day. But the rest of us are not so fortunate. Should a distinctly unpatriotic pimple pop up, Pure & Clear Blemish Gel contains extra-strength tea tree oil which has antibacterial properties and will help clear the spot while you cover up with foundation.

Pure & Clear Blemish Gel; �8.17 for 10g; nelsonsnaturalworld.com

Tummy churns

For the thousands who suffer spasms in the stomach brought on by nerves, Buscopan Cramps is a new product that aims to relax the digestive tract rather than act as a pain-killer. Contains an active ingredient called hyoscine butylbromide, and can be used up to four times a day. Available only from pharmacists.

Buscopan Cramps, �4.39; www.stomachcramps.co.uk

Unwanted gifts

Silver toasters and jewelled kettles aside, there are things you really don?t want to pick up at weddings ? germs. But you can?t offend the guests by slapping on the alcohol rub between handshakes. Vicks First Defence Protective Hand Foam has a more pleasant cucumber-mint scent, and kills 99.9 per cent of germs on contact, including swine flu. As it is claimed to last for up to three hours, one sneaky application could last an entire reception line.

Vicks First Defence Protective Hand Foam; 50ml for �3.99; lloydspharmacy.com

Best man?s speech impediment

A tickly cough is the nemesis of the nervous groom, his best man and father of the bride, who pray their speeches won?t start with a squeak. Berry-flavoured Covonia Double Action Cough Lozenges have a dual action: one side warms the mouth and soothes the throat, the other simultaneously targets airways, clears congestion and helps you breathe, making public speaking that little bit easier.

Covonia Double Action Cough Lozenges, �1.62 for 51g pack; covonia.co.uk

Clumsy groom syndrome

With an abundance of champagne and footloose guests on the dancefloor, it wouldn?t be a wedding reception without a few trodden-on toes. You could apply a handful of ice from the wine bucket and elevate your foot for 10 minutes ? or keep handy some arnica cream, the traditional remedy for bruises.

Nelsons Arnicare cream; �6.20 for 50g; boots.com

Source: http://telegraph.feedsportal.com/c/32726/f/568409/s/146796c5/l/0L0Stelegraph0O0Cnews0Cuknews0Croyal0Ewedding0C84687220CRoyal0Ewedding0Ewill0Eyou0Ebe0Ea0Eblubbering0Ewreck0Bhtml/story01.htm

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Chilli peppers 'help to burn fat'

?A sprinkling of red chilli peppers on your dinner keeps hunger pangs at bay,? reports the Daily Mail. It said that spicing up a daily diet with chopped chilli peppers could help curb your appetite.

The effects of capsaicin, the chemical that makes peppers and chillies hot, have been studied again in a small trial investigating what effects hot red (cayenne) pepper has on energy expenditure, body temperature and appetite. It used doses that people would normally eat and found that 1g of pepper reduced cravings for salty, sweet and fatty foods and increased energy expenditure. It noted that this effect was greater among the 12 trial participants who did not normally eat spicy peppers compared�with the 13 who reported being regular users.

The study was reliably carried out but is very small, with only 25 participants. In particular, the differences between regular and non-users�need confirmation in larger studies. Although the news has related this to possible dietary benefits in people trying to lose weight, the participants were all healthy young people of normal weight. This is early preliminary research and further study is needed.

�

Where did the story come from?

The study was carried out by researchers from Purdue University, in the US. Funding was provided by the National Institutes of Health through a National Research Service Award, and the McCormick Science Institute. The study was published in the peer-reviewed medical journal Physiology and Behavior.

In general, the press accurately represent the reporting of this study. However, as the study was conducted in people of normal healthy weight, the suggestion that chillies may be of benefit to people trying to lose weight is an assumption that should not be made on the basis of the current study alone.

�

What kind of research was this?

This was a small, randomised crossover trial, in which the researchers investigated the effect of cayenne red pepper consumption during a meal on skin and body temperature, energy expenditure and appetite levels after the meal. Previous studies have suggested that red peppers (and in particular capsaicin, the chemical that makes peppers and chillies hot) suppress hunger and make the body generate heat. However, these studies have often used more hot pepper or chilli than the average person would choose to eat (for example, 10g/meal, when a person would normally choose to consume about only 1g/meal). This study aimed to test more acceptable cayenne pepper doses consumed during a single meal. In the crossover design, the recruited participants tried, in a random order, three amounts of pepper with their meal: a standard quantity, their chosen quantity or none.

�

What did the research involve?

The researchers recruited 35 participants through public advertisements, who were all young (with an average age of 23 years) and had a healthy body weight (BMI 22.6). To be eligible, participants had to be in good health, non-smokers, have a stable weight and have steady dietary and activity habits. Of these 35, the researchers report results for only 25, as three dropped out before the study began, and seven dropped out for various reasons (for example, intolerance to chilli or unwillingness to abstain from caffeine) during the study. The 25 included 13 who reported regularly eating spicy food and 12 who did not.

Participants attended the study centre for six meal visits, one week apart. For three days before each visit the participants were advised to eat either a high-fat diet (before two visits), a high-carbohydrate diet (before two visits) or their normal diet (before two visits). They also had to avoid alcohol, caffeine or strenuous physical activity on these days. On each test day, the participants were asked to arrive an hour before lunchtime, having fasted for 12 hours beforehand. Physiological tests of their resting energy expenditure, body and skin temperature, and appetite were then taken.

The participants? chosen quantity of cayenne pepper was added to the meal after the two three-day periods in which they had eaten their normal diet (on average 1.8g/meal was chosen by regular spicy food users and 0.3g for non-users). After the two three-day periods in which they had been eating a high-fat diet, and the two in which they were eating a high-carbohydrate diet, they were randomly assigned to receive either a standard amount of cayenne pepper (1g per meal) or no cayenne pepper.

The study reports that the doses of pepper were given in either capsule form or ?orally? (presumably meaning it was added to the meal in some way). Though it is not clear how the decision to give orally or by capsule was made (for example,�whether it was made randomly on each of the six attendance days or whether participants were assigned to receive the pepper orally on set days and by capsule on others). On the days when no pepper was given, the researchers say that this was by the use of a plain dummy capsule.

The participants ate all meals until comfortably full. During a four-and-a-half-hour period after the meals, their energy expenditure, body and skin temperature, and appetite were again assessed at intervals. Appetite had been assessed at 30-minute intervals using a validated appetite questionnaire with responses such as hunger, fullness or desire to eat rated on a visual analogue scale.

�

What were the basic results?

Compared with eating no pepper, the standard 1g dose of cayenne pepper significantly increased body temperature by an average of 0.02�C (regardless of the preceding three-day diet). Skin temperature decreased by an average of 0.11�C after the high-fat diet and by 0.23�C after the high-carbohydrate diet. Skin temperature was also lower when the pepper was consumed in capsule rather than oral form, but this had no effect on body temperature. The effects on body temperature did not differ between regular and non-users of spicy food.

Pepper had a greater effect on the appetite in those who didn?t usually eat spicy food compared�with people who regularly ate spicy food. Generally, non-users had less desire to eat salty, fatty or sweet foods after eating 1g pepper than those who ate spicy food regularly. There was no difference in effect on appetite when the dose was delivered orally or via a capsule.

There was an increase in energy expenditure (of about 10kcal) following ingestion of 1g of pepper compared with no pepper. While there was no significant difference in energy expenditure between regular and non-users, (i.e. both user groups increased energy expenditure after eating the pepper), the researchers noted that the greatest effect on energy expenditure occurred when non-users took the pepper in oral form (rather than by capsule), and the lowest effect occurred when regular users consumed it in either capsule or oral forms.

�

How did the researchers interpret the results?

The authors conclude that red pepper has weight management potential. However, they also say that individuals who regularly consume hot red peppers may become desensitised to the effects of red pepper on appetite and energy expenditure.

�

Conclusion

This study tested the effects of eating hot red pepper at mealtimes on post-meal energy expenditure, body temperature and appetite. It found that, compared with eating no cayenne pepper with the meal, 1g of pepper reduced salty, sweet and fatty food cravings and also increased energy expenditure. The effect was greater in people who did not normally eat spicy peppers compared with those who reported being regular users.

The study is valuable in that it evaluated amounts of hot pepper that are likely to be consumed as part of a normal diet, whereas previous studies have evaluated unusually high amounts of hot pepper. It also investigated the effects of consumption in different subgroups, namely those who were regular and non-users, different pepper doses, people consuming different pre-test diets (high fat, high carbohydrate or normal), and consumption in capsule or oral form. This multiple subgroup testing can be a statistical weakness, as the more comparisons you carry out the more likely you are to find significant differences by chance, but the researchers have made adjustments for this.

In spite of some strengths, this is a small study and can only really be considered to be preliminary research. Only 35 people were enrolled into the trial and of these only 25 completed it.

The main results pertain to the differences between regular non-users and users of spicy foods, but there were only 12 and 13 of these, respectively. Therefore, observed differences between these small groups of people need confirmation in much larger studies to see whether a true difference exists.

In addition, the participants were healthy young people, with a normal BMI. Although the news has said these findings may lead to possible dietary benefits in people trying to lose weight, this has not been tested in this study.

Further randomised trials investigating the effects of supplementary dietary pepper or chilli in people trying to lose weight could be conducted.

Links To The Headlines

A sprinkling of red chilli peppers on your dinner 'keeps hunger pangs at bay'.�Daily Mail, April 27 2011

Red-hot tip to burn fat.�Daily Express, April 27 2011

Links To Science

Ludy MJ, Mattes RD.�The effects of hedonically acceptable red pepper doses on thermogenesis and appetite. Physiology & Behavior 2011 102; 251-258

Source: http://www.nhs.uk/news/2010/04April/Pages/chilli-peppers-fat-burning-and-appetite.aspx

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New Hair Loss Prevention Robot Approved By FDA

Editor's Choice
Main Category: Medical Devices / Diagnostics
Also Included In: Men's health
Article Date: 27 Apr 2011 - 12:00 PDT

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In an attempt to fight balding, The Food and Drug Administration has approved a machine called the Artas System for commercial use that intends to bring one's follicles back to life.

The System combines several features including an interactive, image-guided robotic arm, special imaging technologies, small dermal punches and a computer interface.

After the System is positioned over the patient's scalp, Artas is capable of identifying and harvesting follicular units. The follicular units are stored until they are implanted into the patient's recipient area using manual techniques.

The production company says the system can improve extraction rates to 750 to 1,000 units per hour. This is much quicker and less invasive than traditional harvesting techniques.

However there is a catch; only males with brown or black hair are candidates.

There are many causes for hair loss in men. However, in the overwhelming majority of males with hair loss, the cause is hereditary androgenetic alopecia, more commonly known as "male pattern baldness." The tendency for male pattern hair loss is genetically inherited from either side of the family.

According to the manufacter's website:

"The presence of the hormone, dihydrotestosterone (DHT), in a genetically susceptible man, is necessary for this problem to occur and begins to develop after puberty. Hair on the scalp that is genetically susceptible (the hairline, crown and top of the scalp), starts to shrink in its shaft diameter and potential length, until it eventually disappears in a process known as hair miniaturization. The hair on the back and sides of the scalp is usually genetically 'permanent' hair, which is destined to remain for that man's lifetime."

What can be done for a man losing his hair that wants to keep it around? First, hair restoration surgery offers a permanent solution to lost scalp hair. Modern techniques of surgical hair transplantation can restore lost hair and replace the hairline with your own natural growing hair, which needs no more care than the ordinary washing, styling, and trimming you have always done.

Hair transplantation involves removing permanent hair-bearing skin from the back and/or sides of the scalp. There are two main techniques by which hair follicles can be harvested from the donor area: follicular unit extraction (FUE) and strip harvesting. FUE involves using a small dermal punch (e.g. 1mm in diameter or smaller) to individually dissect out follicular units directly from the scalp. Strip harvesting is carried out by excising a strip of scalp from the donor area and dissecting out the follicular units under a microscope.

These small follicular unit grafts are then meticulously implanted into the bald or thinning area of the scalp (recipient area) so as not to injure any follicles already existing in the area and at the same angle as the other hairs present. The creation of small follicular unit grafts has enabled hair restoration surgeons to create natural appearing hairlines and results.

Second, medical treatments are now offered in the form of a pill (finasteride) and a topical liquid (minoxidil). They require a life-long treatment however to maintain their effect.

Then there is the good old fashioned wig. Hairpieces are a non-surgical means to restore hair by covering bald areas of the scalp. There is a large variety of means for attaching these such as glues, "weaves," and clips.

Source: Restoration Robotics

Written by Sy Kraft

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Um androgenetic alopecia has nothing to do with aging.

posted by G. Floyd on 27 Apr 2011 at 1:52 pm

The opening sentence: "What ever happened to aging gracefully?" was offensive to me as a sufferer of male pattern baldness and completely irrelevant since MPB has nothing to do with aging. I began losing my hair in my early 20's and the disease has greatly reduced my quality of life. I have no wrinkles, gray hair, or any other symptoms of advanced age and the vast majority of other males my age do not exhibit any hair loss caused by male pattern baldness. Combating this disease through actual science and products like the one mentioned in this article offer quite a bit of hope to those currently struggling with MPB. I would like to see the author stick to the facts and refrain from editorializin her opinions on the "lack of grace" she perceives in treating androgenetic alopecia.

The mechanism of hair miniaturization is completely independent of the mechanism of cell aging. The author even quotes the (correct) current scientific thought on the causes of male pattern baldness. So I'm not sure why she saw fit to take a jab at those who are investigating the possibility of increasing their quality of life through new androgenetic alopecia treatments.

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Another option

posted by not hanging on on 27 Apr 2011 at 2:10 pm

Bic razors. You'll never see me with a comb-over or a horrid scar on the back of my scalp trying to hang on to what little hair I have left. I'll have my shiny and clean-shaven head for the rest of my life now. And the ladies dig it :)

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Skin Grafting

posted by g on 27 Apr 2011 at 10:59 pm

skin grafting is painful. i know a guy who had a partial op done to move hair. couldnt finish. now looks ridiculous

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Thanks for Modifying The Article

posted by G. Floyd on 29 Apr 2011 at 11:51 am

Thank you for editing the opening sentence of your article. I appreciate it.

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The Hidden Health Benefits of Sex

"Having sex regularly can do more than make you feel closer to your partner?it can actually make you physically healthier," says Hilda Hutcherson, M.D., a clinical professor of obstetrics and gynecology at Columbia University and author of Pleasure: A Woman's Guide to Getting the Sex You Want, Need, and Deserve. Check out a few of the surprising perks you can reap from great sex.

Use Of Costly Breast Cancer Therapy Strongly Influenced By Reimbursement Policy

Academic Journal
Main Category: Breast Cancer
Also Included In: Women's Health / Gynecology;��Cancer / Oncology
Article Date: 29 Apr 2011 - 13:00 PDT

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What Medicare would pay for and where a radiation oncologist practiced were two factors that strongly influenced the choice of intensity-modulated radiation therapy (IMRT) for treating breast cancer, according to an article published April 29 online in the Journal of the National Cancer Institute. The use of IMRT and the cost of radiation therapy increased sharply over the period of the study.

IMRT is a radiation delivery technique that modulates the radiation beams to conform to the shape of the tumor or tumor bed in an attempt to maximize the dose of radiation to the tumor while minimizing the dose to adjacent normal tissues. Compared to conventional, two- or three-dimensional radiation therapy, IMRT may reduce acute skin toxicity and improve cosmetic outcomes for women undergoing breast conservation therapy.

But there are simpler approaches to three-dimensional treatment that may provide the same benefits at lower cost. It is thus controversial whether such treatments justify billing Medicare for IMRT.

To look at clinical, demographic, and other factors associated with billing for IMRT in Medicare beneficiaries with breast cancer, Benjamin D. Smith, M.D., of the M. D. Anderson Cancer Center in Houston, Texas, and colleagues used Medicare data for 26,163 women with localized breast cancer who had undergone surgery and radiation therapy from 2001 through 2005.

They found that Medicare billing for IMRT increased more than 10-fold (increasing from 0.9% to 11.2% of the diagnosed patients) in that period. The average cost of radiation within the first year of diagnosis was $7,179 without IMRT and $15,230 with IMRT.

In regions of the country where local Medicare carriers covered IMRT, billing for this treatment was more than five times higher than in regions where it was not covered. Furthermore, IMRT billing was more frequent for patients treated by radiation oncologists in freestanding radiation centers (7.6% had IMRT) compared to those treated in hospital-based outpatient clinics (5.4% had IMRT).

In their discussion, the authors note that there are two ways to achieve intensity modulation of the radiation beam, one called field-in-field forward planning and one called inverse planning. The second is more expensive, requiring more physician and treatment planning time. Most Medicare carriers require inverse planning to reimburse for IMRT, although the two approaches likely have similar outcomes for treatment of the breast only, according to the authors.

They write that their data "suggest that with respect to breast radiation therapy, much of the variation in cost can be directly attributed to inconsistent treatment definitions and reimbursement rates authorized by Medicare and its intermediaries."

In an accompanying editorial, Lisa A. Kachnic, M.D., of Boston University School of Medicine, and Simon N. Powell, M.D., Ph.D., of Memorial Sloan-Kettering Cancer Center, New York, note that the evidence supporting the routine use of inverse-planned IMRT for patients requiring breast only treatment is weak. They suggest that the true value of inverse- planned IMRT will most likely be for patients with complex anatomy or those with more advanced breast cancer who require comprehensive lymph node treatment such as radiation to the internal mammary nodal chain. IMRT may also help to protect the underlying lung and heart, they say. However large randomized trials are needed to determine whether it actually has these benefits.

In the meantime, the editorialists write, this study "appears to confirm the suspicion of many, both within and outside of the healthcare industry, that medical decision making is too heavily influenced by reimbursement rather than medical necessity."

Source
The Journal of the National Cancer Institute

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Unigene Completes Patient Enrollment Of Oral PTH Phase 2 Study For The Treatment Of Osteoporosis In Postmenopausal Women

Main Category: Bones / Orthopedics
Also Included In: Menopause;��Clinical Trials / Drug Trials;��Women's Health / Gynecology
Article Date: 28 Apr 2011 - 6:00 PDT

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Unigene Laboratories, Inc. (OTCBB: UGNE) a leader in the design, delivery, manufacture and development of peptide-based therapeutics announced today that the Company has completed patient enrollment of its Phase 2 study with an experimental oral parathyroid hormone (PTH) analog for the treatment of osteoporosis in postmenopausal women. Unigene is developing its oral PTH in collaboration with GlaxoSmithKline (GSK) as part of an exclusive worldwide licensing agreement. According to the agreement with GSK, Unigene will receive a $4M milestone payment for completion of Phase 2 patient enrollment.

Ashleigh Palmer, President and Chief Executive Officer of Unigene Laboratories, Inc., said, "The completion of enrollment in this Phase 2 study with our proprietary oral formulation of the recombinantly produced PTH analog is a significant development milestone for Unigene. We are thrilled to have achieved this goal and remain focused on advancing this program that we believe has the potential to address an important medical need." Palmer continued, "I am extremely impressed with the Unigene team's execution of this study in just four months since the signing of our collaboration with GSK, and believe this not only showcases our clinical trial expertise, but represents an important competitive advantage."

Phase 2 Study Design

This multicenter, double blind with respect to placebo, randomized, repeat dose placebo controlled study will include an open label comparator arm of the Forsteo� injectable formulation. The primary endpoint will be an increase in bone mineral density (BMD) at the lumbar spine in subjects at 24 weeks in 93 postmenopausal osteoporotic women following once daily treatment with the orally delivered PTH analog compared to baseline. Secondary endpoints will evaluate biochemical markers of bone formation and resorption, as well as the safety, tolerability and pharmacokinetics of the oral formulation.

The Company expects to report top-line results before year end.

About Osteoporosis

Osteoporosis is a disease in which bones become brittle and so are more likely to break. In osteoporotic women and men, the density and quality of bone are reduced, leading to deterioration of the skeleton and increased risk of fracture. It's often diagnosed only after an osteoporosis-related fracture happens because prior to such an event, the patient has no outward signs or symptoms. The disease has a significant impact on patients' quality of life and it is estimated that one in three women and one in five men over the age of 50 will develop osteoporosis during their lifetimes.

The prevalence of osteoporosis is growing as the number of post-menopausal women rises, along with the general increase in life expectancy. Osteoporosis affects an estimated 75 million people in Europe, the US and Japan. In women over 45, osteoporosis accounts for more days spent in hospital than many other diseases, including diabetes, heart attack and breast cancer. There is currently no cure for osteoporosis, but available treatments can strengthen bones and help reduce the risk of fractures.

About Unigene-GSK Agreement

On December 10, 2010, Unigene entered into an amended and restated exclusive worldwide license agreement with GSK to develop and commercialize an oral formulation of a recombinantly produced PTH analog for the treatment of osteoporosis in postmenopausal women. Under the terms of the amended and restated agreement, Unigene is responsible for the manufacture of the PTH and the conduct of the Phase 2 study. The Company received an upfront payment of $4M to cover costs associated with the Phase 2 study, and will also receive an additional $4M payment upon completion of Phase 2 patient enrollment, as well as further payments of up to $142M based on the achievement of regulatory and commercialization milestones. In addition, Unigene is eligible to receive tiered double-digit royalties in the low-to-mid teens on global sales. Once the Phase 2 study has been completed and based on a review of the data, GSK may elect to assume responsibility for all future development and commercialization of the product.

Source:
Unigene Laboratories, Inc.

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