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Category : Low T

Erectile Dysfunction: A Look at the Most Common Causes – Feed Leader

Erectile dysfunctions are more common than most men believe, and while they can always leave someone in an embarrassing position at an awkward time, the reasons can be benign as well. Unfortunately, not every case of unexpected ED is harmless or temporary. As we look through the common reasons behind erectile dysfunctions, it will uncover both relatively harmless, as well as a few potentially fatal conditions that can be responsible for impotence in men.

The primary action behind impotence can be identified as a lack of blood supply to the penis, which is universal in nature. The causes that can be responsible for the lack of sufficient blood supply are plenty, but the action is always the same, irrespective of the reason. This is directly related to conditions of the heart and the arteries, as it is the heart that pumps blood through arteries and sends them to the extremities via veins and blood vessels.

As a result, any heart condition or vascular condition that can constrict or slow down the flow of blood could at times be responsible for impotence. Common cardiac and arterial health issues that have been proven to cause erectile dysfunction are as follows:

As we age, we lose muscle mass and sexual potency, but the rate of loss is not equal or even similar in all men. Aside from genetics, there are also additional factors that contribute to lowered testosterone in men as young as 30. To know whether or not lowered testosterone levels are responsible for your ED, check the low T symptoms identified by Manual. If you can relate to the symptoms, then rest assured that low T is not just one of the most common causes of impotence, but it is also very treatable with appropriate steps and meds.

Consult with experts to know what sildenafil can do for you and how it should be administered to help you overcome your ED, alongside all the other associated symptoms. Testosterone is the prime male hormone, and in order for a mans body and mind to function in the way that it should, there needs to be a sufficient natural production of it. In case that cannot be achieved, external testosterone therapy might be essential for preventing impotence, hair fall, depression and several other similar symptoms.

Diabetes is a direct and acute cause for erectile dysfunction and that applies to men with both Type I and Type II diabetes. However, men suffering from Type II diabetes experience ED far more often than men with Type I diabetes. Potentially, the damage can be permanent for men with diabetes if they do not act in time to control the disease itself.

Unlike most of the other causes mentioned so far, diabetic men who did not or could not treat their condition from an early stage are likely to experience permanent nerve and blood vessel damage, leading to perpetual impotence. On the other hand, if their blood sugar is kept under control from an early stage with changes in lifestyle and medication, it is possible for men with diabetes to lead a healthy and sexually satisfying life. If you are experiencing frequent episodes of ED, it is probably a good idea to get checked for diabetes. The urgency of the situation will gain more severity in case the patient also has one or more diabetic parent/parents.

Depression is often defined as a purely psychological cause for erectile dysfunction, but it is medically incorrect to use the classification universally. Temporary depression from a genuine cause such as the death of a close family member is mostly psychological in nature. In most cases, men get over temporary and acute depression on their own, or perhaps just by talking about the cause with someone close, or even a professional. However, the same cannot be said about clinical depression, where the brain becomes incapable of producing sufficient levels of dopamine and serotonin.

Unfortunately for those suffering from clinical depression, antidepressants are often found to be directly responsible for causing impotence in men. Since this is a unique scenario where both the disease and the cure can individually and simultaneously cause erectile dysfunctions, its a very tricky situation to deal with. If clinical depression is indeed affecting you and you have been prescribed antidepressants for managing the chemical imbalance, countering the entire scenario would require a combined effort from you, your psychiatrist and your partner. The idea should be to find alternatives to SSRIs and use break periods to help lessen the pharmaceutical and psychophysical causes of impotence as best as possible.

There are two different types of stress, although they often fuel each other, making it difficult to separate one from the other. Physical stress is a result of strenuous physical activities and mental stress is a result of worry, mental trauma, anxiety, depression and the like. As mentioned, one can often be a reason for bringing about the other, but they need not always be mutually inclusive either. Both physical and mental stress is directly linked to erectile dysfunctions though.

If the body is worked to a point of extreme tiredness, it simply may not have enough physical and/or mental energy to power and hold an erection. On the other hand, mental stress creates a distraction for the brain in a negative manner, which keeps it from acting in the way that it should in presence of sexual stimuli. ED caused by physical stress can be easily recovered from with a proper diet and restful sleep, unless it has been going on for a significant while at a stretch.

When the body is being stressed continuously without the sufficient rest and nutrition it needs, that will lead to mental stress accumulation as well. When left unaddressed for a long enough period, the impotence from such cases can take a long time to heal, if at all possible. Mental stress has the same effect and it can disrupt sleep, which is absolutely crucial for the body to recover and be productive during sexual activities. In fact, both physical and mental stress can lead to low testosterone levels, which would then require professional help, as mentioned previously.

Only a doctor with the necessary expertise (endocrinologist or urologist) and experience can help patients uncover the real reason/reasons behind their ED episodes. Even if you believe that you are aware of the cause and it isnt anything to worry about too much, get yourself checked. On the other hand, if it happens only in very rare circumstances, chances are that you have nothing to worry about. Keep an eye on the frequency though, and consult a doctor immediately if the ED episodes seem to be increasing in their occurrence. Not only is that necessary to maintain healthy conjugal relationships, but medical investigations may also reveal one of the more serious causes that we already discussed.

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Erectile Dysfunction: A Look at the Most Common Causes - Feed Leader

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Aytu BioScience Announces Fiscal Q4 2020 Net Revenue of $14.9 Million, an Increase of 82% Sequentially, and 766% Year-Over-Year – BioSpace

ENGLEWOOD, CO / ACCESSWIRE / October 6, 2020 / Aytu BioScience, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company (the "Company") focused on commercializing novel products that address significant patient needs today reported financial results for its fiscal fourth quarter 2020, for the three month period ending June 30, 2020.

Fourth Quarter Fiscal 2020 Financial Highlights

Commenting on the fourth quarter of fiscal 2020, Josh Disbrow, Chief Executive Officer of Aytu BioScience, stated "Revenue increased exponentially in Q4 2020, to $14.9 million, compared to $1.7 million for Q4 2019. It is important to note that this was the first full quarter of revenue from the combined Aytu and Innovus businesses, along with the Cerecor assets. Turning to the bottom line, adjusted EBITDA loss was reduced to just $1.7 million for Q4 2020, compared to a $3.7 million adjusted EBITDA loss for Q4 2019. On the balance sheet, with approximately $48.3 million in cash, cash equivalents and restricted cash after paying $15 million to fully extinguish the Deerfield balloon payment previously due January 2021, we have less than $1 million of debt, and at current spending levels, we believe we have sufficient runway to reach profitability."

Mr. Disbrow continued, "Taking a closer look at the top line, both of our revenue streams, from the Consumer Health and Rx segments, performed well. On the Consumer Health side, we generated $6.9 million in revenue, an increase compared to Q3. Contributing to those results was organic growth within our core Consumer Health product lines of diabetes care, sexual wellness and bladder health. Additionally, we strengthened our e-commerce business for Consumer Health. Furthermore, our newly launched Consumer Health product, Regoxidine, an over-the-counter foam formulation of minoxidil for hair regrowth, is on track to contribute revenue in excess of seven figures in its first twelve months from launch."

Mr. Disbrow added, "On the Rx side, revenue was $7.9 million, a significant increase compared to Q3. Contributing to Rx revenue was solid contribution from the pediatric franchise. Additional value was created with Natesto gaining preferred status on Express Scripts' national formulary and the Natesto spermatogenesis study results published in the Journal of Urology, both of which we expect to drive prescription growth in the coming quarters. Organic Rx growth was fueled by a relatively balanced contribution across our key products and improved sales execution. Despite the impact COVID has had on physician office access, Q4 represented a record revenue quarter for our Rx business and significant growth over the previous quarters. This is a strong statement about our field execution and clinical value of our products, and I'm pleased to see our call levels now picking back up to near normal in the current quarter to further drive prescription growth."

Mr. Disbrow concluded, "At $14.9 million in record quarterly revenue, with a narrowed Adjusted EBITDA loss, $48.3 million of cash, cash equivalents and restricted cash on the balance sheet, the addition of the Healight opportunity for COVID-19 and future potential non-COVID-19 applications, and our addition to the Russell 2000, we have strong momentum to grow shareholder value in fiscal 2021 and onward."

Conference Call Information

The company will host a live conference call at 4:30 p.m. ET today. The conference call can be accessed by dialing either:

877-407-9124 (toll-free)

201-689-8584 (international)

The webcast will be accessible live at https://www.webcaster4.com/Webcast/Page/2142/37506 and archived on Aytu BioScience's website, within the Investors section under Events & Presentations, at aytubio.com, for 90 days.

A replay of the call will be available for fourteen days. Access the replay by calling 1-877-481-4010 (toll-free) or 919-882-2331 (international) and using the replay access code 37506.

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage 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 recently acquired Pediatric Portfolio includes (i) Cefaclor, a second-generation cephalosporin antibiotic suspension; (ii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iii) 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 also distributes a COVID-19 IgG/IgM rapid test. This antibody test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. Aytu has also licensed the Healight Platform Technology. Healight is a pre-clinical investigational device being studied as a potential treatment for COVID-19 in severely ill, intubated patients and potentially other respiratory illnesses.

Aytu also operates a consumer health subsidiary, Innovus Pharmaceuticals, Inc. ("Innovus"), a specialty pharmaceutical company licensing, developing, and commercializing safe and effective consumer healthcare products designed to improve health and vitality. Innovus commercializes over twenty consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating Rx and consumer health products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

Forward-Looking Statement

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: market and other conditions, our ability to successfully commercialize Healight Platform Technology, our ability to obtain FDA approval for the Healight Platform Technology, the effectiveness of the Healight Platform Technology in treating patients with COVID-19 or other illnesses, our ability to adequately protect the intellectual property associated with the Healight Platform Technology, regulatory delays, the reliability of the Healight Platform Technology in killing viruses and bacteria, market acceptance of UV based medical devices, the regulatory and commercial risks associated with introducing the COVID-19 rapid tests, any delays in shipment that may impact our ability to distribute the COVID-19 rapid tests, any reputational harm we may incur if there are delays in receiving the shipment of the COVID-19 rapid tests, our ability to enforce the exclusivity provisions of the distribution agreements, the reliability of serological testing in detecting COVID-19, shipping delays and their impact on our ability to introduce the COVID-19 rapid tests, the ability of the COVID-19 rapid tests to accurately and reliably test for COVID-19, the manufacturers of the COVID-19 rapid tests' ability to manufacture such testing kits on a high volume scale, manufacturing problems or delays related to the COVID-19 rapid tests, our ability to satisfy any labelling conditions or other FDA or other regulatory conditions to sell the COVID-19 rapid test kits, the demand or lack thereof for the COVID-19 rapid test kits, our ability to obtain additional COVID-19 rapid tests to meet demand, our ability to secure additional tests if the manufacturers of the COVID-19 rapid tests are unable to meet demand, the effects of the business combination of Aytu and the Pediatric Portfolio and the recently completed 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 Pediatric Portfolio, the ultimate timing, outcome and results of integrating the operations the Pediatric Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization.

Contact for Media and Investors:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

Non-GAAP Financial Information

This press release contains a financial measure that does not comply with U.S. generally accepted accounting principles (GAAP), Non-GAAP Adjusted EBITDA. Non-GAAP Adjusted EBITDA excludes (i) amortization, (ii) depreciation, (iii) stock-based compensation, (iv) other expenses comprising net interest expense, (v) non-cash gains and/or losses recognized in the quarter or year due to changes in the fair value of certain of Aytu's financial liabilities, such as contingent consideration, derivative warrant liability, or certain exchanges of debt, (vi) bad debt expense, (vii) impairment of certain long-lived assets; (viii) one-time transaction costs and (ix) costs associated with the Company's Healight technology. Management believes these measures are useful to supplement its GAAP financial statements with this non-GAAP information because management uses such information internally for its operating, budgeting and financial planning purposes. In addition, Aytu believes these non-GAAP financial measures are useful to investors because they allow for greater transparency into the indicators used by management as a basis for its financial and operational decision making. Non-GAAP information is not prepared under a comprehensive set of accounting rules and therefore, should only be read in conjunction with financial information reported under U.S. GAAP when understanding Aytu's operating performance. A reconciliation between GAAP and non-GAAP financial information is provided in the financial statement tables below.

AYTU BIOSCIENCE, INC. AND SUBSIDIARIESConsolidated Statements of Operations

(Unaudited)

Three Months Ended June 30,

Revenues

Product revenue, net

License revenue, net

Total product revenue

Operating expenses

Cost of sales

Research and development

Selling, general and administrative

Selling, general and administrative - related party

Impairment of intangible assets

Amortization of intangible assets

Total operating expenses

Loss from operations

Other (expense) income

Other (expense), net

(Loss) / gain from change in fair value of contingent consideration

(Loss) on extinguishment of debt

Gain from warrant derivative liability

Total other (expense) income

Net loss

Weighted average number of shares outstanding ofcommon shares outstanding

Basic and diluted net loss per common share

AYTU BIOSCIENCE, INC. AND SUBSIDIARIESConsolidated Balance Sheets

Assets

Current assets

Cash and cash equivalents

Restricted cash

Accounts receivable, net

Inventory, net

Prepaid expenses and other

Other current assets

Total current assets

Fixed assets, net

Right-of-use asset

Licensed assets, net

Patents and tradenames, net

Product technology rights, net

Deposits

Goodwill

Total long-term assets

Total assets

AYTU BIOSCIENCE, INC. AND SUBSIDIARIESConsolidated Balance Sheets, Cont'd

Liabilities

Current liabilities

Accounts payable and other

Accrued liabilities

Accrued compensation

Debt

Contract liability

Current lease liability

Current portion of fixed payment arrangements

Current portion of CVR liabilities

Current portion of contingent consideration

Total current liabilities

Long-term contingent consideration, net of current portion

Long-term lease liability, net of current portion

Long-term fixed payment arrangements, net of current portion

Long-term CVR liabilities, net of current portion

Warrant derivative liability

Total liabilities

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Aytu BioScience Announces Fiscal Q4 2020 Net Revenue of $14.9 Million, an Increase of 82% Sequentially, and 766% Year-Over-Year - BioSpace

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Indianapolis Low T Center & Men’s Clinic | Sleep Apnea …

Indianapolis is the capital city of the state of Indiana and the world-famous Indianapolis 500 car race. This thriving metropolitan area boasts more than 2 million residents and covers 368 square miles of territory. Along with car racing and a booming economy, for men in the area, the Indianapolis Low T Center is an innovative mens health clinic that offers testosterone replacement therapy (TRT) for those with hypogonadism and other hormonal imbalance issues. We work with men to find practical and effective solutions for symptoms related to low T levels and other health symptoms that might be tied to low testosterone levels. This mens clinics offers testing and treatment for allergies, diabetes, cholesterol issues and is a one-stop shop for mens annual physicals.

Men with low testosterone levels often experience a range of symptoms that include fatigue and lethargy, reduced physical desire and a limited ability to achieve an erection, redistribution of body fat and loss of muscle mass. Some men may notice diminished cognitive abilities as a result of low T levels. At the Indianapolis Low T Center, we diagnose and treat issues associated with low testosterone to help you feel your best.

If you frequently awaken during the night choking or gasping for breath, you may be suffering from a condition called sleep apnea. Loud snoring, headaches, fatigue and sleepiness during the day are often attributable to this medical condition, which may affect more than 22 million Americans. Indianapolis Low T Center offers health assessment services and testing for sleep apnea, which may include home sleep monitoring systems to determine the presence and severity of this condition. Our medical staff will work with you to design a treatment plan for your needs and your lifestyle.

Low T Sleep Center Details

If you need help with issues related to your health including having an annual physical, or with the management of certain conditions, including low T levels and sleep apnea, Low T Center of Indianapolis offers comprehensive help and treatment options for you. Schedule your health assessment online today with our team of men's healthcare providers. We are here to serve your needs now and in the future.

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Whats Causing My Low Testosterone?

Low testosterone prevalence

Low testosterone (low T) affects 4 to 5 million men in the US.

Testosterone is an important hormone in the human body. But it starts to decrease each year after age 30. In some men this can be substantial. Between 19 and 39 percent of older men may have low levels of testosterone.

Older men with low T have increasingly sought testosterone replacement therapy (TRT) in recent years. TRT addresses symptoms such as low libido, poor muscle mass, and low energy.

Its not just older men that are affected by low T. Young men, even babies and children, can also have this problem.

Low levels of testosterone that are atypical of normal aging are due to other primary or secondary causes of hypogonadism. Hypogonadism in males happens when the testicles dont produce enough testosterone. Hypogonadism can start during fetal development, during puberty, or during adulthood.

If hypogonadism begins during fetal development, the primary result is impaired growth of external sex organs. Depending on when hypogonadism starts and the level of testosterone present during fetal development, a male child can develop:

Normal growth can be jeopardized if hypogonadism occurs during puberty. Problems occur with:

Later in life, insufficient testosterone can lead to other problems. Symptoms include:

Fatigue and mental fogginess are some commonly reported mental and emotional symptoms in men with low T.

9 Warning signs of low testosterone

The two basic types of hypogonadism are primary and secondary hypogonadism.

Underactive testes cause primary hypogonadism. Thats because they dont manufacture sufficient levels of testosterone for optimal growth and health. This underactivity can be caused by an inherited trait. It can also be acquired by accident or illness.

Inherited conditions include:

Types of testicle damage that can lead to primary hypogonadism include:

Secondary hypogonadism is caused by damage to the pituitary gland or hypothalamus. These parts of the brain control hormone production by the testes.

Inherited or disease conditions in this category include:

Acquired circumstances that can lead to secondary hypogonadism include:

You may be affected by primary, secondary, or a mixed hypogonadism. Mixed hypogonadism is more common with increased age. People undergoing glucocorticoid therapy can develop the condition. It also can affect people with sickle-cell disease, thalassemia, or alcoholism.

Learn more: 5 Natural testosterone boosters

If youre experiencing symptoms of low T, lifestyle changes may help to ease your symptoms.

A good first step is increasing activity levels and maintaining a healthy diet in order to reduce body fat. It can also be helpful to avoid glucocorticoid medications such as prednisone as well as opioid pain medications.

Diet right: 8 Testosterone boosting foods

If lifestyle changes dont work for you, you may need to begin testosterone replacement therapy (TRT) for treatment of low T. TRT can be very important for helping teenage males with hypogonadism experience normal masculine development. Sufficient testosterone levels help maintain health and well-being in adult males.

TRT has side effects, however, including:

A carefully formulated TRT treatment plan should avoid many of these undesirable side effects. Talk with your doctor to evaluate your options.

Options for increasing your testosterone

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Whats Causing My Low Testosterone?

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Safety Concern With Fingolimod to Ocrelizumab Switch in MS – Medscape

A new study suggeststhe need for caution in switching from fingolimod to a B celldepleting anti-CD20 treatment such as ocrelizumab for patients with multiple sclerosis (MS).

Italian researchers report an increased risk for prolonged reductions in T-cell counts, in addition to depletion of B cells, among patients who make this switch. Such depletion could increase the risk for infection, a particular concern in the current COVID era.

The study showed that among patients who had been taking ocrelizumab, those who were switched from fingolimod had a greater risk for lymphocytopenia throughout the 12 months of follow-up compared with patients who were switched from other therapies or who had not taken other therapies.

The results were presented by Doriana Landi, MD, at the recent 8th Joint European Committee for Treatment and Research in Multiple SclerosisAmericas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS) 2020, this year known as MSVirtual2020.

Landi is a postdoctoral researcher and clinical neurologist at the Multiple Sclerosis Clinical and Research Unit, Fondazione Policlinico Tor Vergatal, Rome, Italy.

"It has been thought that ocrelizumab and similar drugs just deplete CD20 B cells. But there is now evidence that the CD20 is also expressed on certain T-cell subtypes, and levels of these cells are also reduced by anti-CD20 drugs," she explained.

"It may be just a small effect, but we wanted to look at this with regard to starting ocrelizumab after other treatments, particularly fingolimod, which itself is associated with pronounced lymphocytopenia," she said.

This was an observational study of patients starting therapy with ocrelizumab. The patients were divided into three groups: those who had switched from fingolimod; those who had switched from other treatments (dimethyl fumarate, interferon-beta, glatiramer acetate, natalizumab, teriflunomide); and patients who were treatment naive.

Lymphocyte subtype counts (CD3+, CD4+, CD8+ and CD20+) were taken at baseline and every 6 months after treatment with ocrelizumab was initiated.

A sample of 135 patients was analyzed (37 had switched from fingolimod, 64 had switched from other drugs, and 34 were treatment naive). Median time between washout was 73 days for fingolimod and 68 days for other treatments.

Results showed that at baseline, in comparison with treatment-naive patients, those who had switched from fingolimod experienced a significant decrease in CD3+ (1204 vs 1735 cells/mm3; P = .0003), CD4+ (551 vs 997 cells/mm3; P < .0001), CD8+ (430 vs 537 cells/mm3; P = .027), and CD20+ (88 vs 191 cells/mm3; P = .021) lymphocytes.

After 6 months, the proportion of patients with CD3, CD4, and CD8 lymphocytopenia (below laboratory reference values) was significantly higher among patients who had switched from fingolimod compared to patients who had switched from other treatments or who had not taken other treatments.

At 12 months, there was a trend toward greater CD4 and CD8 lymphocytopenia compared to the other two groups. Data at 18 and 24 months have not been confirmed, owing to the limited number of available values.

There was no difference in B-cell counts among the three groups.

"We found that ocrelizumab had a small effect on reducing T cells which was similar in the three groups of patients, but patients who had previously received fingolimod were more likely to have low T-cell counts at baseline and to be lymphocytopenic at 6 months and at 12 months after ocrelizumab," Landi told Medscape Medical News.

"So the T cells don't recover on ocrelizumab, and some patients have a risk of double immunosuppression (low levels of both T and B cells)," she added. "This is relevant, as it may increase the risk of opportunistic infections."

After correcting for baseline values, the effect of ocrelizumab appeared similar in all three groups. There was a small percentage reduction in certain T cells.

"If the patients had a reasonable cell count at baseline, that probably isn't too much of an issue; they will likely stay in normal levels. But if they start with a low lymphocyte count, then even a small reduction with ocrelizumab may put them into double immunosuppression," Landi noted.

"We don't know how long this double lymphocytopenia will last. We need to follow patients longer. So far in our study, the mean follow-up is 12 months," she said.

The researchers are also monitoring infection risk but have not as yet analyzed the data.

Landi explained that fingolimod is a popular drug, but if MS is still active while a patient is taking the drug or if safety concerns arise, then treatment would normally be switched to a different therapy, and ocrelizumab is becoming one of the more commonly used options.

"In the clinical trials with ocrelizumab, few patients had been pretreated with fingolimod, so we don't have good data on that," she said.

She recommends that clinicians evaluate T-cell substrates when making this switch. "It would be a good idea to wait a bit after fingolimod discontinuation to let lymphocytes recover, but this has to be balanced by concerns over efficacy. If we wait too long, then the relapse rate may start to increase. Several studies are ongoing to evaluate this at present."

Landi points out that the risk for double immunosuppression could be more of a problem in the current COVID crisis, insofar as both T cells and B cells are involved with antiviral responses.

"We know that COVID causes a reduction in T cells even in healthy people. If patients already have a low peripheral T-cell count and they then contract COVID, this could be a problem. We need to evaluate B- and T-cell counts in patients with worse COVID outcomes to understand this better," Landi commented.

"We believe clinicians should be aware of this issue when switching from fingolimod to ocrelizumab and that this could represent an additional risk regarding COVID, so we need to be cautious."

She suggested that during the COVID-19 pandemic, it may be better for patients for whom fingolimod is being discontinued and who have very low lymphocyte counts to be switched to drugs that do not induce lymphocytopenia.

Commenting for Medscape Medical News, Robert J. Fox, MD, said: "This study is important because we have little evidence to guide how we change patients from one therapy to another."

Although in this study there was a prolonged reduction of lymphocytes in patients who were switched to ocrelizumab from fingolimod compared to other MS therapies, "it doesn't address what clinicians really want to know: are there safety concerns?" Fox, who is a staff neurologist at the Mellen Center for Multiple Sclersois, Cleveland Clinic, Cleveland, Ohio, added.

"We know that lymphocyte reduction isn't related to risk of infection with either fingolimod or dimethyl fumarate, so we still don't know if patients transitioning from other MS therapies to ocrelizumab are at higher risk of infections," Fox said.

"This study suggests a mechanism if there is an increased risk, but it's putting the cart before the horse. Is there an increased risk in the first place? At this point, I haven't seen data to suggest that there is."

Landi reports consultancies for Sanofi-Genzyme, Merck-Serono, Teva, Biogen, and Roche. Fox has disclosed no relevant financial relationships.

8th Joint European Committee for Treatment and Research in Multiple Sclerosis-Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS) 2020: Session FC02.03, presented September 13, 2020.

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Safety Concern With Fingolimod to Ocrelizumab Switch in MS - Medscape

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Could This Device Help Save Covid-19 Patients Before the ICU? – Houstonia Magazine

ONE OF THE MOST DIFFICULT ASPECTS OF LIFE IN A COVID-19 world is the uncertainty. Not only are we facing an unseen opponent that we barely understand, but none of us know, should we contract the virus, whether well be part of the group that barely registers any symptoms or if well rapidly end up in a drug-induced haze on a ventilator in the ICU. More troubling still, neither do the doctors treating us.

What if there were a way to find out? OncologistDr. Cassian Yee of MD Anderson thinks the key to unlocking this mystery may very well be pumping inside our veins.

For more than 25 years Yee has been studying the use of T-cells, a type of white blood cell called lymphocytes, in his cancer research. They are like soldiers that are trained by the bodys immune system, he says. They go to sites of disease, the battlefield, and coordinate an attack on the enemy, the virus or cancer cell. When their job is completed, they return to the barracks and keep vigilant for any further attacks.

After reading reports that noted lower levels of T-cells in patientswith severe cases ofCovid-19, specificallythose who experiencedrespiratory failure, theoncologist realized thatdeveloping a test to quicklydetermine a patients T-cellcount could go a long waytoward helping medical personnel predict which patients are more prone to experiencing the viruss most deadly symptoms, long before doctors have to get machines to start breathing for them.

Technically this kind of lab test already exists, says Yee; its just not fast or easily available (were talking expensive and bulky equipment and results that take about half a day to process), especially when time is of the essence and equipment is in short supply. So Yee teamed up withKevin McHugh andPeter Lillehoj of Rice University to create a point-of-care device that would allow medical personnel to conduct these tests quickly and cheaply, key factors that could make this item crucial for both Texas Medical Center hospitals and underserved clinics on the front lines of the outbreak.

Using a small amount of blood, the teams point-of-care device will separate the different kinds of blood cells in the sample, count the lymphocytes, and spit out a quantifiable numberideally in about 15 minutes or less. Doctors will then use this number to determine whether a Covid-19 patient is more likely to suffer poor oxygenation. If doctors know beforehand that certain patients have low T-cell numbers and are thus more prone to experiencing the symptoms, including lung deterioration, that have been shown to be fatal in some, they could start more aggressively treating those patients long before they have to be put on ventilators. Its a bit like, Can this patient go home and safely recuperate, or should they stay in the hospital because they might need the ICU? explains McHugh, who specializes in bioengineering.

There are other potential uses for this device as well. While Yee and his team dont expect their point-of-care prototype device to be ready until January 2021 at the earliest, that hasnt stopped them from considering the technologys uses beyond the current coronavirus pandemic.

Wed love to be able to eventually move this into other viral diseases, such as HIV, Yee says. Perhaps even when patients are undergoing some type of treatment for their cancer.

Continue reading here:
Could This Device Help Save Covid-19 Patients Before the ICU? - Houstonia Magazine

Recommendation and review posted by Alexandra Lee Anderson

Equipping the Immune System to Fight Against COVID-19 – BioSpace

The coronavirus that causes COVID-19 has one major advantage over us it is a new human virus. Most people have not encountered the virus before, meaning their immune system is not primed and ready to fight it. When someone gets sick with COVID-19, there is a lag in an efficient immune response, giving the virus time to do significant damage before the immune system can reign in the infection.

It essentially becomes a race between how fast your immune system can clear the virus and how quickly the virus can replicate and induce damage, Agustin Melian, MD, Chief Medical Officer and Head of Global Medical Sciences at AlloVir, told BioSpace.

To develop an effective treatment or vaccine for COVID-19, scientists must understand how the immune system is impacted during the disease. One type of immune cell that is particularly important in the bodys response to COVID-19 is T-cells. T-cells perform many functions, including recognizing invading viruses such as the coronavirus that causes COVID-19.

Multiple studies from Wuhan, China reported that COVID-19 patients had very low T-cell counts; the sicker the patient, the lower their T-cell count. Lower T-cell counts were correlated with poorer outcomes (including higher risk of death) and T-cells isolated from COVID-19 patients also showed signs of exhaustion.

The elderly, patients with low T-cell numbers, and patients who express exhaustion markers on their T-cells are high risk groups in which nave cell responses (responses against a virus they have never seen before) may be deficient or delayed, thus allowing the virus to induce a large amount of damage, Dr. Melian explained. These patients may, therefore, benefit from AlloVirs approach which is designed to restore natural T-cell immunity in high risk patients.

Could giving high-risk COVID-19 patients functional T-cells against the coronavirus boost their immune system and help them recover? This is the question AlloVir aims to answer.

AlloVir creates allogeneic (off-the-shelf) virus-specific T-cells designed to treat common and devastating viral-associated diseases in vulnerable patients, such as those who are immunocompromised or patients who received an organ or stem cell transplant. Now, they are expanding their anti-viral T-cell arsenal and taking aim at COVID-19.

We believe AlloVirs technology is well positioned to treat patients with COVID-19 because our technology is designed to provide SARS-CoV-2 specific T-cell immunity while leaving non-infected cells intact, Dr. Melian commented. Our virus-specific T-cell candidates have been used to treat more than 275 immunocompromised patients with life-threatening viral infections and diseases and we believe it our approach may also have promise in treating COVID-19.

Fighting viruses with T-cells in immunocompromised patients

When you get infected with a virus, your immune system responds to the foreign threat by making specific T-cells that can recognize the virus. These specific T-cells prompt your immune system to destroy any cells infected by the virus.

However, if you have a T-cell deficiency, your immune system cannot robustly protect you. This is a major problem because an otherwise innocuous virus can become a serious infection, causing complications, and possibly even be life-threatening.

That is where AlloVir comes in. They address the underlying problem the weakened immune system. A weakened immune system can be beefed up by giving patients with T-cell deficiencies off-the-shelf virus-specific T-cells (VSTs) originally taken from healthy people. This restores their natural T-cell immunity and helps their immune system fight off the viruses.

At AlloVir, we are a leading innovator in discovering and developing allogeneic, virus-specific T-cell immunotherapies, Dr. Melian said. We are now excited to be applying our capabilities in discovering and developing SARS-CoV-2 specific T-cells to join the fight in developing a COVID-19 program for patients at high risk of severe and devastating disease.

AlloVirs virus-specific T-cell platform

To create AlloVirs T-cell therapies, the target virus is first studied carefully to identify its specific antigens (unique molecules on the outside of each virus that are specific to the virus and alert the immune system). The best antigens those that induce a strong T-cell response are used to create the therapy.

Next, blood is taken from healthy donors who have been exposed to the virus of interest and T-cells are isolated from the blood. The T-cells are activated in the lab they are trained to recognize the identified viral antigens, enabling the T-cells to selectively recognize only the desired virus.

After the T-cells have learned to recognize the specific virus, they are expanded to generate multitudes of cells. Once the activated, specific T-cells are created, they can be cryopreserved and kept for a long time, making them readily available as soon as a patient needs them. The entire process, from antigen selection to donor to ready-to-go T-cell treatment, can be completed in a matter of weeks. This process can be seen in the visual below.

Source: AlloVir

Patients are matched using the companys proprietary human leukocyte antigen (HLA)-matching formula. HLAs are proteins on the surface of cells that regulate the immune system.

Our proprietary donor selection algorithm, known as Cytokin enables us to cover >95 percent of patients in our target population from cells derived from a small number of donors, Dr. Melian said. This proprietary process of prospectively manufacturing cells for off-the-shelf use enables us to study our allogeneic cell therapies in large numbers of patients that suffer from global health crises, like seasonal influenza and, as we are discussing, the COVID-19 pandemic.

These T-cells are advantageous because they are active against a single virus or multiple viruses, are not patient-specific (so they are readily available) and are a single treatment that provides lasting protection. The biggest bonus is the immediate off-the-shelf use for time-sensitive infections in vulnerable populations, added Dr. Melian.

In addition to developing their COVID-19 therapy (called ALVR109), AlloVir has two other multi-virus specific T-cell therapies in development: Viralym-M (ALVR105) and ALVR106. Both therapies focus on treating viral diseases common to stem cell and solid organ transplant patients and other vulnerable populations.

Viralym-M targets six common viruses: BK virus (BKV), cytomegalovirus (CMV), adenovirus (AdV), Epstein-Barr virus (EBV, also called human herpesvirus 4), human herpesvirus 6, and JC virus (also called human polyomavirus 2). Although these viruses are widespread and infect most people, they only cause severe problems in people with weakened immune systems due to age, organ or stem cell transplant, or disease (such as diabetes or AIDS). In a Phase 2 study, 93 percent of 38 allogeneic stem cell transplant patients had a clinical response to Viralym-M treatment and functional Viralym-M cells lasted up to 12 weeks in the patients.

ALVR106 targets four common respiratory viruses: influenza, parainfluenza virus, respiratory syncytial virus (RSV), and human meta-pneumovirus (HMPV). While these viruses tend to cause mild to moderate respiratory illnesses, they can cause severe, life-threatening illness, especially in people with weakened immune systems. ALVR106 is still in preclinical development but clinical trials are expected to begin this year. Overall, AlloVir expects to have three new proof-of-concept (POC) Phase 1b/2 and three pivotal Phase 3 studies started over the next 6-18 months.

Off-the-shelf T-cells against COVID-19

While AlloVir originally designed their T-cell therapies for transplant patients, their platform can potentially be applied to any virus to create virus-specific T-cells. This versatility allowed AlloVir to pivot and create T-cells against SARS-CoV-2, the virus that causes COVID-19. This new investigational therapy, called ALVR109, is being developed as a stand-alone treatment, though it may also be incorporated into their ALVR106 respiratory virus therapy at some point in the future.

Normally, the body would make virus-specific T-cells on their own and these would clear the virus, commented Dr. Melian. We enable that process in patients who otherwise would be T-cell deficient to restore T-cell immunity by giving ex vivo expanded cells that come from patients who already have demonstrated a potent immune response and have cleared the infection.

The process of creating coronavirus-specific T-cells is the same as creating their other virus-specific T-cell therapies. First, blood is taken from people who have recovered from COVID-19 and the T-cells are isolated. Then, the cells are stimulated with viral antigens in the lab, expanded, and cryopreserved.

We purposely choose a broad range of viral antigens to stimulate the T-cells to ensure the virus cant circumvent the virus-specific T-cell therapy by mutating or developing resistance, Dr. Melian said. Working with a wide spectrum of viral activity is different than other approaches that just focus on one viral antigen.

An open-label Phase 1 trial (called BAT IT) is anticipated to start within the next few months. Initial clinical studies of ALVR109 aim to treat high-risk COVID-19 patients, such as the elderly, to prevent organ damage. Prophylaxis studies, where the T-cells could be given to high-risk or immunocompromised patients who are not currently sick with COVID-19, may be considered later.

Coronavirus-specific T-cells vs. COVID-19 convalescent plasma

You may be wondering if another treatment that uses blood from COVID-19 survivors, called convalescent plasma therapy, is similar to AlloVirs T-cell therapy. In convalescent plasma treatment, antibodies from COVID-19 survivors are isolated from their blood by separating out their plasma (the liquid part of the blood). The plasma is given to COVID-19 patients to help their immune system fight off the infection.

Although convalescent plasma and AlloVirs coronavirus-specific T-cell treatments are both derived from COVID-19 survivors blood, the two treatments are fundamentally different.

Antibodies and T-cells work in different areas of the immune system, explained Dr. Melian. Antibodies can go after viruses in circulating blood but cant necessarily see viruses in infected cells. On the other hand, T-cells are pleotropic and directly attack virally infected cells, turning off the viral factories. T-cells are interesting because it is a live therapy they can home to virally-infected cells and direct the immune system.

Dr. Melian went on to explain that T-cell approach may be more comprehensive because they can support other immune cells that work against viruses, such as B-cells that make viral-specific antibodies. T-cells can also stimulate cytokines including interferon (a group of signaling proteins the immune system uses to respond to viruses), which further activates the bodys antiviral response.

Providing virus-specific antibodies may be beneficial and protective for some viral infections, Dr. Melian added. We dont know how these antibodies affect COVID-19 patients yet, but COVID-19 has a high mortality rate despite standard of care treatment. In this respect, it is important that all viable approaches to treatment be evaluated and I am very pleased to see these therapies have entered clinical testing.

Convalescent plasma and AlloVirs coronavirus-specific T-cell therapies are not mutually exclusive, so they could even be used together.

More:
Equipping the Immune System to Fight Against COVID-19 - BioSpace

Recommendation and review posted by Alexandra Lee Anderson

Aytu BioScience Announces Manufacture and Delivery of Healight(TM) Devices for Use in COVID-19 Clinical Study – Yahoo Finance

Delivery of Investigational Endotracheal Ultraviolet-A Light Catheter Devices Enables Near-Term Initiation of Planned Clinical Studies in Severely Ill COVID-19 Patients

ENGLEWOOD, CO / ACCESSWIRE / August 17, 2020 / Aytu BioScience, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company (the "Company") focused on commercializing novel products that address significant patient needs, today announced the delivery of Healight investigational devices. The delivery of these pilot scale Healight devices, designed and developed by Sterling Medical Devices ("Sterling"), enables the initiation of COVID-19 investigational clinical studies, which are expected to begin in the near-term.

Since Aytu signed a master services agreement with Sterling in April for Healight, the Company, Sterling, and its collaborators have sourced Healight device components and finalized design of the investigational devices for use in upcoming clinical studies.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "A significant amount of work has gone into the development of the Healight investigational device, and we thank all of our collaborators for their efforts. We are looking forward to taking the next steps and advancing Healight as quickly as possible. As the COVID-19 pandemic continues, the investigation and development of novel potential therapies remains a high priority for numerous companies, and Aytu is proud to be part of this important effort. If Healight demonstrates safety and effectiveness in upcoming, planned studies, we are hopeful it can become an important tool in the COVID-19 fight."

The Healight technology platform employs proprietary methods of administering intermittent ultraviolet (UV) A light via a novel respiratory tract device. Pre-clinical findings indicate the technology's significant impact on reducing a wide range of viral and bacterial loads, including the coronavirus HCoV-229E. Recently published pre-clinical data have been the basis of discussions with the FDA for a path to enable human use for the potential treatment of SARS-CoV-2 in intubated patients in the intensive care unit (ICU). Beyond the initial pursuit of a potential SARS-CoV-2 ICU indication, additional experimental studies of mixed infection suggest broader potential clinical applications for the technology across a range of viral and bacterial pathogens. This may include nosocomial bacteria implicated in ventilator-associated pneumonia (VAP).

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage 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 also distributes a COVID-19 IgG/IgM rapid test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma.

Aytu also operates a subsidiary focused on consumer health, Innovus Pharmaceuticals, Inc. ("Innovus"), a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Story continues

Aytu's strategy is to continue building its portfolio of revenue-generating Rx and consumer health products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about

About Sterling Medical Devices

Founded in 1998, Sterling Medical Devices (SMD), specializes in the product design and engineering of medical devices for the healthcare industry. Dedicated to resolving their clients' medical device design and engineering challenges, SMD addresses the whole development process, including, product design and human factors, systems, software, electronics, mechanical, quality, compliance, and global regulatory submissions. The company utilizes the latest tools and technology to streamline the engineering process to speed regulatory registrations, clearances, and/or approvals of Class I, II, and III devices. To date, the company has spearheaded the production of over 1,100 projects for more than 300 clients. SMD is internationally recognized and is FDA QSR 21 CFR Part 820 and Part 11 compliant, ISO 13485 registered, and IEC 62304, ISO 14971, IEC 60601, and IEC 62366 compliant. For more information, please visit http://www.sterlingmedicaldevices.com or call 201.227.7569 x2.

Forward-Looking Statement

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: market and other conditions, the regulatory and commercial risks associated with introducing the COVID-19 rapid test, the effectiveness of the COVID-19 rapid rest, market acceptance of the National Cancer Institute or other independently conducted studies' testing results, the regulatory, clinical, manufacturing, and commercial risks associated with the investigational Healight device, effects of the business combination of Aytu and the Commercial Portfolio and the 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, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, 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.

Contact for Investors:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/601817/Aytu-BioScience-Announces-Manufacture-and-Delivery-of-HealightTM-Devices-for-Use-in-COVID-19-Clinical-Study

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Aytu BioScience Announces Manufacture and Delivery of Healight(TM) Devices for Use in COVID-19 Clinical Study - Yahoo Finance

Recommendation and review posted by Alexandra Lee Anderson

Aytu BioScience Announces Regulatory Approval of ZolpiMist(R) by Australian Therapeutic Goods Administration – Yahoo Finance

Aytu BioScience's Sublicensee SUDA Pharmaceuticals Secures TGA Approval, Enabling Near-Term Commercialization of ZolpiMist

ENGLEWOOD, CO / ACCESSWIRE / July 30, 2020 / Aytu BioScience, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company (the "Company") focused on commercializing novel products that address significant patient needs, today announced the approval of ZolpiMist (zolpidem tartrate oral spray) by the Therapeutic Goods Administration (TGA) in Australia. This approval, which was secured by the Company's ZolpiMist sublicensee SUDA Pharmaceuticals Ltd ("SUDA"), enables near-term commercialization of ZolpiMist in Australia. SUDA (ASX:SUD) is a publicly-listed drug delivery company focused on oro-mucosal administration and is headquartered in Perth, Western Australia.

With this approval by Australia's TGA, ZolpiMist will be included on the Australian Register of Therapeutic Goods and can now be commercialized and supplied within Australia. Further, this approval will assist SUDA's current ZolpiMist sublicensees, Teva Pharmaceuticals, Mitsubishi Tanabe Pharma Singapore and MTP Korea, in their submissions in their respective territories.

On March 9, 2010 Aytu BioScience announced a global distribution agreement for ZolpiMist with SUDA whereby the Company assumed a milestone and royalty-based licensing agreement with SUDA. As specified in the companies' global licensing agreement, SUDA will pay Aytu a portion of each upfront and milestone payment received from sublicensees, and Aytu will receive ongoing royalty payments on sales generated by SUDA's sublicensees as ZolpiMist is launched in each territory.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, stated, "We congratulate the SUDA team for obtaining TGA approval for ZolpiMist and look forward to SUDA and their partners moving ZolpiMist closer to commercialization in Australia and elsewhere. This is an exciting time for SUDA and represents an important milestone for Aytu as we move closer to realizing ex-US licensing revenue for ZolpiMist."

Story continues

Dr. Michael Baker, Chief Executive Officer and Managing Director of SUDA, commented, "The TGA submission was a combined effort by SUDA's technical team as well as our regulatory consultant, Pharma To Market. Obtaining the approval indicates the calibre of our staff and is also a key benefit to our partners for ZolpiMist. We are delighted by the outcome and look forward to seeing the commencement of commercial sales in the foreseeable future."

The global sleep aid market is currently estimated at almost $50 billion in annual revenue, and annual revenue is estimated to reach nearly $80 billion in 2022.

About Aytu BioScience, Inc.Aytu BioScience is a commercial-stage 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 also distributes a COVID-19 IgG/IgM rapid test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma.

Aytu also operates a subsidiary focused on consumer health, Innovus Pharmaceuticals, Inc. ("Innovus"), a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating Rx and consumer health products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

About SUDA Pharmaceuticals Ltd SUDA Pharmaceuticals Ltd (ASX:SUD) is a drug delivery company focused on oro-mucosal administration, headquartered in Perth, Western Australia. The Company is developing low-risk oral sprays using its OroMist technology to reformulate existing pharmaceuticals. The many potential benefits of administering drugs through the oral mucosa (i.e.: cheeks, tongue, gums and palate) include ease of use, lower dosage, reduced side effects and faster response time. SUDA's product pipeline includes ZolpiMist, a first-in-class oral spray of zolpidem for insomnia. ZolpiMist is marketed in the USA and SUDA has rights to the product outside of the US and Canada. Other products in development include oral sprays for the treatment of: migraine headache; chemotherapy-induced nausea and vomiting; erectile dysfunction; pulmonary hypertension; epileptic seizures and pre-procedural anxiety and cancer. For more information, visit http://www.sudapharma.com

Forward-Looking StatementThis 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: market and other conditions, the regulatory and commercial risks associated with introducing the COVID-19 rapid test, the effectiveness of the COVID-19 rapid rest, market acceptance of the National Cancer Institute or other independently conducted studies' testing results, the regulatory, clinical, and commercial risks associated with the investigational Healight device, effects of the business combination of Aytu and the Commercial Portfolio and the 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, risks relating to gaining market acceptance of our products, including the risks associated with ZolpiMist's commercial success in Australia and elsewhere, obtaining or maintaining reimbursement by third-party payors for our prescription products, 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.

Contact for Investors:James CarbonaraHayden IR(646) 755-7412james@haydenir.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/599574/Aytu-BioScience-Announces-Regulatory-Approval-of-ZolpiMistR-by-Australian-Therapeutic-Goods-Administration

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Aytu BioScience Announces Regulatory Approval of ZolpiMist(R) by Australian Therapeutic Goods Administration - Yahoo Finance

Recommendation and review posted by Alexandra Lee Anderson

Aytu BioScience Announces Regulatory Approval of ZolpiMist(R) by Australian Therapeutic Goods Administration – BioSpace

Aytu BioScience's Sublicensee SUDA Pharmaceuticals Secures TGA Approval, Enabling Near-Term Commercialization of ZolpiMist

ENGLEWOOD, CO / ACCESSWIRE / July 30, 2020 / Aytu BioScience , Inc. (NASDAQ:AYTU), a specialty pharmaceutical company (the "Company") focused on commercializing novel products that address significant patient needs, today announced the approval of ZolpiMist (zolpidem tartrate oral spray) by the Therapeutic Goods Administration (TGA) in Australia. This approval, which was secured by the Company's ZolpiMist sublicensee SUDA Pharmaceuticals Ltd ("SUDA"), enables near-term commercialization of ZolpiMist in Australia. SUDA (ASX:SUD) is a publicly-listed drug delivery company focused on oro-mucosal administration and is headquartered in Perth, Western Australia.

With this approval by Australia's TGA, ZolpiMist will be included on the Australian Register of Therapeutic Goods and can now be commercialized and supplied within Australia. Further, this approval will assist SUDA's current ZolpiMist sublicensees, Teva Pharmaceuticals, Mitsubishi Tanabe Pharma Singapore and MTP Korea, in their submissions in their respective territories.

On March 9, 2010 Aytu BioScience announced a global distribution agreement for ZolpiMist with SUDA whereby the Company assumed a milestone and royalty-based licensing agreement with SUDA. As specified in the companies' global licensing agreement, SUDA will pay Aytu a portion of each upfront and milestone payment received from sublicensees, and Aytu will receive ongoing royalty payments on sales generated by SUDA's sublicensees as ZolpiMist is launched in each territory.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, stated, "We congratulate the SUDA team for obtaining TGA approval for ZolpiMist and look forward to SUDA and their partners moving ZolpiMist closer to commercialization in Australia and elsewhere. This is an exciting time for SUDA and represents an important milestone for Aytu as we move closer to realizing ex-US licensing revenue for ZolpiMist."

Dr. Michael Baker, Chief Executive Officer and Managing Director of SUDA, commented, "The TGA submission was a combined effort by SUDA's technical team as well as our regulatory consultant, Pharma To Market. Obtaining the approval indicates the calibre of our staff and is also a key benefit to our partners for ZolpiMist. We are delighted by the outcome and look forward to seeing the commencement of commercial sales in the foreseeable future."

The global sleep aid market is currently estimated at almost $50 billion in annual revenue, and annual revenue is estimated to reach nearly $80 billion in 2022.

About Aytu BioScience, Inc.Aytu BioScience is a commercial-stage 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 also distributes a COVID-19 IgG/IgM rapid test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma.

Aytu also operates a subsidiary focused on consumer health, Innovus Pharmaceuticals, Inc. ("Innovus"), a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating Rx and consumer health products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

About SUDA Pharmaceuticals Ltd SUDA Pharmaceuticals Ltd (ASX:SUD) is a drug delivery company focused on oro-mucosal administration, headquartered in Perth, Western Australia. The Company is developing low-risk oral sprays using its OroMist technology to reformulate existing pharmaceuticals. The many potential benefits of administering drugs through the oral mucosa (i.e.: cheeks, tongue, gums and palate) include ease of use, lower dosage, reduced side effects and faster response time. SUDA's product pipeline includes ZolpiMist, a first-in-class oral spray of zolpidem for insomnia. ZolpiMist is marketed in the USA and SUDA has rights to the product outside of the US and Canada. Other products in development include oral sprays for the treatment of: migraine headache; chemotherapy-induced nausea and vomiting; erectile dysfunction; pulmonary hypertension; epileptic seizures and pre-procedural anxiety and cancer. For more information, visit http://www.sudapharma.com

Forward-Looking StatementThis 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: market and other conditions, the regulatory and commercial risks associated with introducing the COVID-19 rapid test, the effectiveness of the COVID-19 rapid rest, market acceptance of the National Cancer Institute or other independently conducted studies' testing results, the regulatory, clinical, and commercial risks associated with the investigational Healight device, effects of the business combination of Aytu and the Commercial Portfolio and the 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, risks relating to gaining market acceptance of our products, including the risks associated with ZolpiMist's commercial success in Australia and elsewhere, obtaining or maintaining reimbursement by third-party payors for our prescription products, 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.

Contact for Investors:James CarbonaraHayden IR(646) 755-7412james@haydenir.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com:https://www.accesswire.com/599574/Aytu-BioScience-Announces-Regulatory-Approval-of-ZolpiMistR-by-Australian-Therapeutic-Goods-Administration

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Aytu BioScience Announces Regulatory Approval of ZolpiMist(R) by Australian Therapeutic Goods Administration - BioSpace

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