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Dec 6

Two teams ‘full of testosterone’: Ducks ready for grudge rematch with Capitals – The Athletic

IRVINE, Calif. The NHLs top team left quite the impression on the Ducks in their first matchup this season. Some of that impression left a trail of disgust.

The Washington Capitals make their annual visit to Anaheim on Friday night, and Alex Ovechkin is obviously the headliner on their loaded roster. They also have John Carlson, the high-scoring defenseman who is the clear leader in the Norris Trophy race.

Yet, Ovechkin and Carlson might not be the main attractions at Honda Center.

The Ducks and Capitals had a memorable meeting in the nations capital for all the wrong reasons two weeks ago. A wild fracas spurred by a big hit from Capitals forward Brendan Leipsic on Ducks center Derek Grant was capped by Washingtons Garnet Hathaway spitting on Erik Gudbranson in retaliation for a punch the Anaheim defenseman threw as the two were being held by officials.

[ Listen to Point Breakaway for more Ducks coverage ]

The NHL handed...

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Two teams 'full of testosterone': Ducks ready for grudge rematch with Capitals - The Athletic


Dec 6

Testosterone: What It Can And Can’t Do, Signs You’re Low, And How To Increase It – Men’s Health

Feeling tapped out? Foggy? Just not all that into sex? Gotta be your testosterone, some people would have you believe. And were believing it, too, with interest and investment in T-boosters and T-supplements rising steadily in the past decade.

Dont get us wrong: testosterone is one critical hormone. Babies first encounter it in utero, when it triggers the differentiation of boys from girls. In puberty, it contributes to your bone growth and muscle mass, and continues to affect functions including your red-blood-cell production and mood stability.

But the message certain vested interests are sending plays right into the economic and social anxieties men are facing. Its like when anti anxiety meds such as Valium first came onto the scene, says urologist Elizabeth Kavaler. All these middle-aged women were addicted to Valium, because that was the solution to everything. Testosterone has become the new answer for a life of quiet desperation. More and more of us are feeling the exhaustion of uneasiness. We are being asked to do more with less. Were just trying to get through the day alive. Men think, Well, if I just get a little testosterone, Im going to feel great! Kavaler says. And thats not the case.

Theres so much information out there about T much of it speculation and lore that leads us to jump to conclusions about it. Men put all kinds of psychological weight on their testosterone number a low one makes you think youre somehow less manly; a high one means youre basically LeBron James and thats where we get things wrong. Theres little evidence for those stereotypes. Low doesnt automatically imply youre weak or retiring; high doesnt guarantee you muscles or MVP athletic performance.

A low number might not even be a low number for very long. It might just indicate that you havent been treating yourself very well. A high number doesnt mean youre programmed to be aggressive. As long as your T is in the normal range, theres nothing about a high number thats better than a low one, or vice versa. In the name of science and good journalism, I got my testosterone tested twice while writing this story.

It put my assumptions up against a pretty big test, too. What do you really know about this famous hormone? Here, we break down the best and latest information to give you the clearest picture yet of what T means for you.

IT CAN...

BUT TOO MUCH ALSO CAN...

IT CANT...

BUT IT ALSO CANT...

You should have at least two blood tests, since T is constantly in flux. It peaks in the morning, so if youre young and on a typical sleeping schedule, aim to be tested by 10am. If youre over 50, it doesnt matter as much. Also note: vitamins with biotin can lower your score, so skip them for three days before testing.

A T level of 8.64 to 29 nanomoles per litre of blood is considered normal. If you are close to 8.64 and you feel fine, then youre no less healthy than a guy whose level is 35 and also feels fine. Theres an exception to that, though. (See What the Numbers Mean.)

I got my first test at the tail end of a busy week. Id slept less than five hours the night before, then scrambled to the phlebotomist in a daze. My number: 9.9. Thats in the normal range, but just barely. I have no symptoms of low T, but it was hard to shake the feeling that there was something wrong with me, even though I know that normal is normal, no matter where it is in that range. Eleven days later, I was tested again. My number was 14.8. Why such a dramatic change? It might be because Id slept better and cut out my multivitamins. Irrational or not, I felt like more of a man. The whole experience was a microcosm of our relationship with T. We act like its destiny, but its just biology easily misunderstood and more varied than we think.

Common symptoms of below-normal t, which could affect as many as 500,000 men in Australia (generally older men):

1. Lack of energy

Youre lethargic not like you didnt get enough sleep last night but like no matter what you do, you never feel rested.

2. A paunch

Having a dad bod doesnt mean you have low T but it could be one indicator.

3. Lack of libido

Sort of. Its the lack of your base level sex drive that sudden feeling of being turned on by the sexy person you spot on the street that indicates low T, according to Dr Tobias Kohler, of the Mayo Clinic. Its not considered low libido when you dont want to have sex on a Thursday night after youve been crushed by work all week.

4. Erectile problems

Only precipitously low T will keep you limp. But if you have problems getting it up, you may have other issues to solve, which may require a visit to a doctor. Or a little blue pill. Or couples therapy

If your t is truly low youve got three courses of action, says mills, in order of increasing aggressiveness. choose wisely.

1. Lifestyle Adjustment

The single best thing you can do to improve your level is be healthier. Avoid stress, get more sleep and lose weight an enzyme in fat tissue converts testosterone to estrogen. Thats one reason flab can lower your T. Its also why overweight guys can develop man boobs, and why bodybuilders who juice can also develop man boobs they dont have much fat, but theyve jacked their T levels so high that theres a lot of it available to be turned into estrogen. Thinking of T strictly as the male sex hormone oversimplifies the complex hormonal interactions that make our bodies work. Which is also why, if you can avoid it, you dont want to go with the needle-in-the-butt routine to raise your T.

2. A Testicle Stimulant (plus lifestyle adjustment)

If your level is low enough to warrant more aggressive treatment, your doctor can prescribe a drug that causes your pituitary to tell your gonads to make more testosterone. The typical choice is clomiphene citrate (Clomid), a common fertility drug for women. Using it doesnt exempt you from needing to get healthy, though, as it doesnt diminish the risk of losing T to bad sleep and a beer belly.

3. Testosterone Replacement Therapy (and yes, youll still need to adjust your lifestyle)

This should be your last resort. When you give your body T, it stops making its own, and theres no guarantee it can start again. Before you replace it, find a doctor who can help you choose from the following delivery systems (see right), and be glad that weve moved past the early days of replacement therapies, like one in the 1920s that involved transplanting goat testicles into men.

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Testosterone: What It Can And Can't Do, Signs You're Low, And How To Increase It - Men's Health


Dec 6

Testosterone Replacement Therapy Market 2019: Global Key Players, Trends, Share, Industry Size, Segmentation, Opportunities, Forecast To 2025 -…

Industry Analysis of Testosterone Replacement Therapy Market

Testosterone replacement therapy (TRT) is a class of hormone replacement therapy in which androgens, often testosterone, are replaced. Testosterone replacement therapy (TRT) is an FDA-approved medical treatment for men of any age who have low testosterone, a hormone necessary for male sexual development.

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Based on Profile & Business Performance Outstanding Competitors in the market are Endo International, AbbVie, Eli lilly, Pfizer, Actavis (Allergan), Bayer, Novartis, Teva, Mylan, Upsher-Smith, Ferring Pharmaceuticals, Kyowa Kirin, Acerus Pharmaceuticals,.

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About Us:Alexa Reports is a globally celebrated premium market research service provider, with a strong legacy of empowering business with years of experience. We help our clients by implementing decision support system through progressive statistical surveying, in-depth market analysis, and reliable forecast data. Alexa Reports is a globally celebrated premium market research service provider, with a strong legacy of empowering business with years of experience. We help our clients by implementing decision support system through progressive statistical surveying, in-depth market analysis, and reliable forecast data.

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Testosterone Replacement Therapy Market 2019: Global Key Players, Trends, Share, Industry Size, Segmentation, Opportunities, Forecast To 2025 -...


Dec 6

Testosterone Booster Market is Growing Popularity and Players Considering Potential Growth Opportunities in the region 2019-2022 – Montana Ledger

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Testosterone Booster Market is Growing Popularity and Players Considering Potential Growth Opportunities in the region 2019-2022 - Montana Ledger


Dec 5

Are you ready for testosterone replacement therapy? – KTAR.com

Are you ready for testosterone replacement therapy?

It is well known that testosterone plays a role in a mans sex drive, but this vital hormone does more than regulate libido and sperm production. It also has a role in regulating systems throughout the body.

It also affects bone and muscle mass, the way men store fat in the body, and even red blood cell production, according to Healthline. A mans testosterone levels can also affect his mood.

Symptoms of declining testosterone

Testosterone production maxes out in most men around age 17, and then levels stay relatively consistent for the next 10 to 20 years. Sometime between ages 30 and 40, its normal for men to experience a slow decline in testosterone production, averaging about 1% a year, according to Harvard Health.

You lose muscle mass, mental sharpness and libido (sex drive) begins to decline, viTal4men says.

Benefits of testosterone

Research has pinpointed other links between testosterone levels and memory. One study cited by Harvard Health found that World War II veterans who had high testosterone levels in midlife had better preserved tissue in some parts of the brain later in life.

Another study found that men with higher free testosterone levels achieved higher scores on four cognitive function tests, including visual and verbal memory, according to Harvard Health.

Testosterone replacement therapy aims to address the symptoms men experience from low testosterone levels and possibly help protect cognitive function in later life.

You may benefit from testosterone replacement therapy if any of the following apply:

Treatment options

The proper method of testosterone delivery for you is a matter for your physician to determine; however, many find that some gels tend to be messy and less convenient than other treatment modalities, viTal4men says.

These are typical treatment options, according to Harvard Health:

Most men feel improvement in symptoms within four to six weeks of taking testosterone replacement therapy, although changes like increases in muscle mass may take from three to six months, Harvard Health says.

Work with your doctor to find out whether you are experiencing symptoms of low testosterone. Misuse of testosterone can be dangerous, and injections should be administered only by healthcare professionals. Suddenly stopping testosterone treatment can also cause unpleasant withdrawal symptoms, according to drugs.com.

Schedule a free testosterone level test at vital4men.com, and find out if testosterone replacement therapy is right for you.

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Are you ready for testosterone replacement therapy? - KTAR.com


Dec 5

Relugolix Induces Sustained Testosterone Reduction in Advanced PC, Phase 3 Trial Results Show – Prostate Cancer News Today

Treatment with Myovant Sciences relugolix induces a long-lasting reduction in testosterone to castrate levels similar to testosterone levels after medical or chemical castration in nearly all men with advanced prostate cancer who are sensitive to androgen deprivation therapy, updated results from the HERO Phase 3 trial show.In addition to meeting its primary goal sustained castration from weeks 5 to 48 of treatment the trial met six additional secondary goals. These included a faster testosterone suppression than standard treatment with leuprolide acetate, and a rapid drop in prostate specific antigen levels, which are a marker of prostate cancer.The results will support the submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) in the second quarter of 2020, as well as submissions to Japan's and Europe's regulatory agencies.With the exciting results from the HERO study demonstrating the potential of relugolix to provide unique benefits compared to leuprolide, we look forward to submitting an NDA to the FDA, Lynn Seely, MD, president and CEO of Myovant Sciences, said in a press release. We are now closer to our goal of bringing a precision oral medicine to the br

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Relugolix Induces Sustained Testosterone Reduction in Advanced PC, Phase 3 Trial Results Show - Prostate Cancer News Today


Dec 5

Ford v Ferrari Race Re-Creations Better Than The Real Thing – Variety

Over a long career that stretches back 25 years, stuntman and stunt coordinator-turned-second-unit-director and actor Darrin Prescott has choreographed many a spectacular car chase and race in such testosterone-fueled movies as Drive, Deadpool 2, Baby Driver and The Bourne Ultimatum, which won him a Screen Actors Guild award as part of the stunt ensemble.

But when director James Mangold called him up to play famous racer Bob Bondurant and supervise the second-unit action crew for Ford v Ferrari, he knew itd be a special job.

He loved what wed done on Baby Driver, and when I asked him how we were going to handle all the classic race cars on this, he just said, Were going to build em, Prescott says.

This was music to Prescotts ears, as Ford v Ferrari chronicles the story of race car legends Carroll Shelby (Matt Damon) and Ken Miles (Christian Bale) and culminates in the historic showdown between the Ford Motor Co. and legendary Ferrari at the grueling 1966 24-hour Le Mans race in France. Those cars are now priceless museum pieces, so high-performance replicas had to be built.

We rarely get the opportunity to build cars like these, Prescott says. Usually, when I get a call like this, they always have big eyes. They always tell you theres going to be McLarens and Lamborghinis, and ultimately you end up with Corvettes and some sort of product placement. But they actually pulled it off and delivered this time.

Coupled with Mangolds determination to use real cars was his plan to re-create and shoot the famous Le Mans race all in camera, rather than using CGI, says Prescott. That presented quite a few big challenges. The first and biggest was that the original Le Mans course doesnt exist anymore or at least, nothing like it used to be.

The filmmakers used several locations in Georgia to double for Le Mans in the films climactic sequence, which lasts some 40 minutes. So we had to tie all those locations together to make it all as seamless as possible, he says. And then Jim wanted to make sure we maintained an authentic camera style. He didnt want any big swooping camera moves and any hint of the beauty shot approach you see in all the car commercials. And because the cars were exact period replicas, there was very little room to mount cameras and roll cages in them.

With all the restrictions, Prescott and his core team, which included stunt coordinators Robert Nagle and Jeremy Fry (also a driver), focused on sheer speed and storytelling. Every shot had a purpose, and sometimes on second unit and with action its easy to forget all that, he says. But Jim was adamant about that, more so than anyone else Ive ever worked with.

Prescott shot wide-angle anamorphic for eight weeks using a team of a dozen professional drivers, some of whom had actually won Le Mans, he says. With the anamorphic lenses, we had to cram the cars right up into the lens maybe just six inches from camera, which you can only achieve with drivers of that caliber. On top of that, the cars are so close to each other and theyd be doing 140 mph with the camera car inches off their nose. But the truth is, they actually had to dumb it down. It was nothing to these guys as theyre used to going 200 mph.But few crew members were used to racing in the sweltering heat and humidity of a Georgia summer. They had to wear these special, iced cool suits, as the track pavement temperature was 140 degrees, Prescott says. That was almost the hardest part of the whole shoot.

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Ford v Ferrari Race Re-Creations Better Than The Real Thing - Variety


Dec 5

The Wolf of Wall Street Immersive Experience, review: an overlong scenario with the barely contained testosterone of a stag party – inews

CultureArtsOf all the groups you probably wouldnt want to be part of, the hyper-adrenalised, hardscrabble populace of Jordan Belfort's memoir is one

Friday, 29th November 2019, 4:42 pm

The Wolf of Wall Street Immersive Experience, Sun Street, London,

Of all the groups you probably wouldnt want to be part of, surely the hyper-adrenalised, hardscrabble populace of The Wolf of Wall Street, the Jordan Belfort memoir made into an amphetamine rush of a film by Martin Scorsese in 2013, must rank near the very top. And yet here, against expectation, is an immersive theatre adaptation. Whats more, it is being staged just a coke-fuelled trot from Londons City equivalent of the do-or-die New York milieu from which Belfort has since emerged, post-imprisonment, as some sort of anti-heroic guru.

And if your response to the very fact of this show is, Why?, well, join the club. Whereas writer-director Alexander Wright hit paydirt with an ongoing, comparably immersive Great Gatsby, a story that allows for lots of fancy-dress shenanigans, whats the appeal of losing the celluloid filter between us and Jordan and his money-mad acolytes? Not long into the (overlong) scenario, I had a puzzling sense of dj vu until I realised that I hadnt experienced such barely contained testosterone since I found myself some years back on a flight to Prague with a stag party. (The same group was virtually comatose on the flight back.)

Theres little chance of nodding off here once events indoctrinate us into the code of omert (mispronounced, by the way) at the stock-trading firm of Stratton Oakmont, where Belfort made his fortune before his fall from grace. Asked to drop to our knees (at which point, cue any number of unprintable follow-ons), we then pursue one of several different storylines, or tracks, across 27 rooms watched over by various minders in case things get a bit too, um, frisky. New York-style hot dogs are on sale to ramp up an authenticity not always evident in the wearisomely Goodfellas-esque accents.

I ended up pursuing the domestic narrative, which meant making the acquaintance of the amiable Rhiannon Harper-Raffertys Nadine, wife to Oliver Tilneys hardworking but strangely absent Jordan and mother to their seven-year-old daughter Chandler, played at the performance by the adorable, apparently unfazed Suri De Jesus: one assumes she isnt within earshot when her onstage mum is described as having a delectable vagina.

Lest proceedings be seen to be too in love with a monstrous world from which most of us would run a mile, my fellow playgoers were given a moralistic, virtue-signalling finish that may or may not find an equivalent in the other stories going on elsewhere in the building. At the end, you can grab a drink and mingle with the very lovely cast: the actors I met seemed lightyears removed from the venal environs they must inhabit seven times a week, and praise be for that. THEARTSDESK.COM

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The Wolf of Wall Street Immersive Experience, review: an overlong scenario with the barely contained testosterone of a stag party - inews


Dec 5

MiOXSYS Male Infertility Test Will be Featured in Product Symposium at the 8th Annual Congress of the German Federation of Reproductive Biology and…

ENGLEWOOD, CO / ACCESSWIRE / December 5, 2019 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, announced that MiOXSYS will be featured in a Product Symposium at the 8th Annual Congress of the German Federation of Reproductive Biology and Medicine held December 5-7, 2019 in Leipzig, Germany.

During the symposium, multiple clinical presentations featuring the MiOXSYS System will be made Friday, December 6, 2019 by leading andrologists and reproductive medicine experts from around the world. Professor Christian Schuppe, Professor and Chair of Urology at the University of Giessen, will chair the symposium.

The Product Symposium will be conducted at 10:30 AM CET at the Kongreshalle am Zoo Leipzig, Schiller Room.

Symposium Presenters & Presentations:

Moderator: Professor Dr. med. Hans-Christian SchuppeClinic and Policlinic for Urology, Pediatric Urology and AndrologyUniversity Hospital Giessen und Marburg (UKGM) - GiessenGiessen, Germany

Presentation I: Oxidative Stress in Semen: Causes, Diagnosis and Significance for Assisted Reproduction

Presenter: Professor Dr. Ralf Henkel, PhD.Department of Medical BioscienceUniversity of the Western CapeBellville, South Africa

Presentation II: Sperm in Danger: Oxidative Stress and Inflammation

Presenter: Professor Dr. med. Jean-Pierre AllamClinic and Policlinic for of Dermatology and AllergyUniversity Hospital Bonn (UKB)Bonn, Germany

The MiOXSYS System is currently in use in over thirty countries around the world and is CE Marked and cleared by Health Canada, the Australian Therapeutic Goods Administration (TGA), and Mexico's COFEPRAS.

Hosting of this Product Showcase does not imply endorsement of the MiOXSYS System by German Federation of Reproductive Biology and Medicine Congress.

About Aytu BioScience, Inc.

Aytu BioScience is a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: the effects of the business combination of Aytu and the Commercial Portfolio and the previously announced, but not yet consummated, merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, the failure to obtain the required votes of Innovus' shareholders or Aytu's shareholders to approve the Merger and related matters, the risk that a condition to closing of the Merger may not be satisfied, that either party may terminate the merger agreement or that the closing of the Merger might be delayed or not occur at all, the price per share utilized in the formula for the initial $8 million merger consideration in the Merger may not be reflective of the current market price of Aytu's common stock on the closing date, potential adverse reactions or changes to business or employee relationships, including those resulting from the announcement or completion of the Merger, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

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MiOXSYS Male Infertility Test Will be Featured in Product Symposium at the 8th Annual Congress of the German Federation of Reproductive Biology and...


Dec 5

Expanded U.S. NATETSO Partnership Between Acerus Pharmaceuticals and Aytu BioScience Is Now Fully Operational – Financial Post

TORONTO Acerus Pharmaceuticals Corporation (TSX:ASP, OTCQB:ASPCF) today announced that the revised commercial partnership agreement with Aytu Bioscience (Aytu) to accelerate the growth of NATESTO in the United States is now closed and fully effective as of December 1, 2019. Both parties have mutually waived the closing conditions of the revised partnership agreement, including the requirement that Acerus complete a raise of a minimum of USD 10 million on or before the end of January 2020, enabling Acerus to launch a U.S.-based specialty sales force, which will promote NATESTO to urologists and endocrinologists. Aytu will continue to book all NATESTO revenue in the United States and they will promote NATESTO to all other specialties including internal medicine and family practice.

To accelerate the launch of Acerus U.S. commercial team, Aytu has agreed to transfer 5 current sales personnel to Acerus as of December 2, 2019. These staff will operate as Acerus employees but they will remain on Aytus payroll until the earlier of the date on which Acerus is ready to fully assume the personnel or June 30, 2020. Aytu will deduct the costs of these sales personnel from quarterly payments otherwise owed to Acerus under the revised agreement, with a final accounting to be done once per year. Throughout 2020, Acerus will be building out a complete US-based specialty care sales force and other commercial functions, significantly increasing the number of employees working directly on NATESTO in the United States.

This co-promotion is expected to significantly increase sales force coverage of targeted U.S. prescribers, putting a higher promotional focus on urologists and endocrinologists, while enabling Aytu to focus its promotional efforts in primary care and other specialties.

Acerus is extremely pleased to see our revised partnership with Aytu moving to execution mode as we strongly believe that the performance of NATESTO in the U.S. will benefit from an enhanced commercial focus on urology and endocrinology, said Ed Gudaitis, President and Chief Executive Officer of Acerus. We are happy to welcome the former Aytu staff to the Acerus team. With this revised partnership, Acerus is effectively pivoting its focus of effort to the U.S. NATESTO opportunity. As such, we have implemented a resource reallocation program within our Canadian office that has led to a greater than 50% reduction in headcount so that we can align our SG&A spend appropriately.

On July 29, 2019 the companies agreed to expand their commercial partnership and amend and restate the original 2016 NATESTO exclusive U.S. license agreement. Under the terms of the new agreement, Aytu returns the NDA for NATESTO in the U.S. back to Acerus. Going forward Acerus will assume all regulatory and clinical responsibilities and costs for the product in the U.S. Acerus will take on a more expansive role in matters such as U.S. marketing, reimbursement and medical strategy as part of the companies joint commercialization committee, and will launch a specialist sales force focused on urologists and endocrinologists (Acerus Sales Channel). Aytu will retain its primary care sales force (Aytu Sales Channel) and will continue to book all product net revenue while serving as the exclusive U.S. supplier of NATESTO to wholesalers, pharmacies and other customers that receive a direct shipment. Financial payments will be based upon a tiered level of net revenue, post cost of goods sold (COGS), based on annual sales performance in the respective Acerus and Aytu Sales Channels.

To establish a high performing commercial footprint in the U.S., Acerus has engaged Syneos Health (NASDAQ: SYNH), a leading integrated biopharmaceutical solutions organization including the industrys largest Contract Commercial Organization (CCO), to be its commercialization partner. Syneos Health has extensive experience in Mens Health and with NATESTO, and offers an end-to-end model that will enable Acerus to rapidly stand up a U.S. commercial team; to scale across all aspects of commercialization, including medical and regulatory affairs, managed markets, marketing and sales; and will provide greater flexibility and effectiveness in resource deployment.

Low testosterone is estimated to affect approximately 39% of men over 45 years old in the U.S.; however, because the condition is underdiagnosed the overall prevalence is uncertain1. While patients have access to other treatment options, NATESTO is unique in that it is administered in seconds via a convenient and simple nasal gel applicator, addressing the risk of testosterone transference associated with other topical products, which carry black box warnings on their product labels.

About NATESTO (Testosterone) Nasal Gel

NATESTO is a nasal gel formulation of testosterone developed by Acerus Pharmaceutical Corporation and indicated as a replacement therapy for men diagnosed with conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism). It is the first and only nasally-administered testosterone product approved by the U.S. Food and Drug Administration, Health Canada and South Korea Ministry of Food and Drug Safety (MFDS), available in a no-touch dispenser with a metered dose pump. A copy of the NATESTO Canadian product monograph can be found at: http://www.aceruspharma.com/English/products-and-pipeline/NATESTO /default.aspx. For further information, specific to the U.S. product dosing and administration, please visit: http://www.NATESTO .com.

About Acerus

Acerus Pharmaceuticals Corporation is a Canadian-based specialty pharmaceutical company focused on the commercialization and development of innovative prescription products that improve patient experience, with a primary focus in the field of mens health. The Company commercializes its products via its own salesforce in Canada, and through a global network of licensed distributors in the U.S. and other territories.

Acerus shares trade on TSX under the symbol ASP and on OTCQB under the symbol ASPCF. For more information, visit http://www.aceruspharma.com and follow us on Twitter and LinkedIn.

Notice Regarding Forward-Looking Statements

Information in this press release that is not current or historical factual information may constitute forward looking information within the meaning of securities laws. Implicit in this information are assumptions regarding our future operational results. These assumptions, although considered reasonable by the company at the time of preparation, may prove to be incorrect. Readers are cautioned that actual performance of the company is subject to a number of risks and uncertainties, including with respect to the commercial performance of NATESTO in the United States, and could differ materially from what is currently expected as set out above. For more exhaustive information on these risks and uncertainties you should refer to our annual information form dated March 4, 2019 which is available at http://www.sedar.com. Forward-looking information contained in this press release is based on our current estimates, expectations and projections, which we believe are reasonable as of the current date. You should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While we may elect to, we are under no obligation and do not undertake to update this information at any particular time, whether as a result of new information, future events or otherwise, except as required by applicable securities law.

1 Mulligan T, Frick MF, et al. Prevalence of hypogonadism in males aged at least 45 years: the HIM study. Int J Clin Pract. 2006 Jul 1; 60(7): 762769

View source version on businesswire.com: https://www.businesswire.com/news/home/20191202005215/en/

Contacts

Media: Edward Gudaitis President and Chief Executive Officer egudaitis@aceruspharma.com (905) 817-8194

Read the original:
Expanded U.S. NATETSO Partnership Between Acerus Pharmaceuticals and Aytu BioScience Is Now Fully Operational - Financial Post



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