Acerus Pharma Hosting Key Opinion Leader Meeting on Unique Clinical Evidence of NATESTO® for Treatment of Hypogonadism
TORONTO--(BUSINESS WIRE)--Oct 23, 2019--
Acerus Pharmaceuticals Corporation (TSX:ASP, OTCQB:ASPCF) today announced it will host a Key Opinion Leader (KOL) meeting on new, unique clinical evidence supporting the expanded use of NATESTO ® for the treatment of hypogonadism on Wednesday, October 30 th in New York City.
The event will feature a presentation by KOL Dr. Ranjith Ramasamy, MD, University of Miami, who will discuss the current treatment landscape, unmet medical need, and new clinical evidence for men with hypogonadism. Dr. Ramasamy will be available to answer questions at the conclusion of the presentation.
Acerus Pharma’s management team will provide an update on the global commercialization of NATESTO ®, the company’s core asset. As well, management will discuss the company’s revised strategy for the U.S. market and their pending restated partnership with Aytu BioScience.
Ranjith Ramasamy is the Director of Reproductive Urology as well as an Associate Professor in Department of Urology at the University of Miami in Florida. Dr. Ramasamy completed his Urology residency training at Weil Cornell Medical College and New York-Presbyterian Hospital. He then completed a National Institutes of Health sponsored fellowship in Male Reproductive medicine and Surgery at Baylor College of Medicine. To date, he has published over 200 manuscripts in peer-reviewed journals and several book chapters; he currently serves on the editorial board of several journals. Outside of clinical medicine and academic research, Dr. Ramasamy has made a significant effort to share his wealth of knowledge and serve as a mentor for future urologists. He created ‘Urology’ an app used by trainees across the world to help prepare for urology board examinations. As a physician, Dr. Ramasamy maintains a dedication to patient care, academia and the training of future urologists by directing a fellowship program in Andrology. Dr. Ramasamy is currently leading important clinical trials at the University of Miami for erectile dysfunction, Peyronie’s disease and hypogonadism.
This event is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals only. Please RSVP in advance if you plan to attend, as space is limited. Members of the media and the public are invited to participate via the live broadcast and replay via the following link: webcast or by visiting http://lifesci.rampard.com/20191030/reg.jsp. The webcast replay will remain available for 6 months following the live presentation.
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://s2.q4cdn.com/417379002/files/doc_downloads/NATESTO-PM-APR-2019-EN.pdf. For further information, specific to the U.S. product dosing and administration, please visit: www.NATESTO.com.
IMPORTANT SAFETY INFORMATION
NATESTO ® is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism).
Contraindications: Men with known or suspected carcinoma of the prostate or breast; women; pregnant and nursing women should avoid skin contact with NATESTO ®; men with known hypersensitivity to any of its ingredients.
Other relevant warnings and precautions: Nasal adverse reactions, including nasopharyngitis, rhinorrhea, epistaxis, nasal discomfort and nasal scabbing; use with caution in patients with pre-existing cardiovascular (e.g., congestive heart failure, ischemic heart disease), renal, or hepatic disease; nasal disorders; nasal or sinus surgery; nasal fracture within previous 6 months or deviated anterior nasal septum; mucosal inflammatory disorders; and sinus disease; should not be used to improve body composition, bone and muscle mass, increase lean body mass, decrease total fat mass, enhancement of athletic performance, nor for the treatment of male infertility or sexual dysfunction if testosterone deficiency has not been established; schedule G controlled substance; must monitor the occurrence of prostatic hyperplasia, prostate cancer and breast cancer. verify the existence of a pre-existing prostate cancer before starting treatment with testosterone replacement; in patients with skeletal metastases, regular monitoring of serum calcium concentrations is recommended; use with caution in patients with hypertension; in patients suffering from severe cardiac, hepatic, or renal insufficiency or ischaemic heart disease, treatment with testosterone may cause serious complications characterized by edema, with or without congestive cardiac failure, and in such cases, treatment must be stopped immediately; myocardial infarction, stroke, and venous thromboembolic events (deep vein thrombosis, pulmonary embolism): if these events are suspected, treatment with NATESTO ® should be discontinued and appropriate assessment and management should be initiated; assess cardiovascular risk before starting treatment with testosterone replacement; diabetics should be followed carefully and the insulin or oral hypoglycemic dosage adjusted accordingly; hypercalciuria/hypercalcemia may be exacerbated by androgen treatment; may be necessary to reduce the dose of oral anticoagulants in patients who take them; treatment may potentiate sleep apnea; the patient may develop gynecomastia (1 to 3%), priapism or oligospermia; laboratory tests, performed routinely, are recommended: testosterone, hemoglobin and hematocrit, liver function tests, PSA, digital rectal examination, lipid profile, breast exam, international normalized ratio (INR) and prothrombin time in patients taking anticoagulants.” Consult the Product Monograph at: http://s2.q4cdn.com/417379002/files/doc_downloads/NATESTO-PM-EN.pdf for more information about conditions of clinical use, contraindications, warnings, precautions, adverse reactions, interactions and dosing.
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 men’s health. The Company commercializes its products via its own salesforce in Canada, through a pending joint third-party and co-promotion partnership in the U.S. and through a global network of licensed distributors in other territories. Acerus’ shares trade on TSX under the symbol ASP and on OTCQB under the symbol ASPCF. For more information, visit 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 ® and the impact of the Spermatogenesis study on such performance, 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 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.
View source version on businesswire.com:https://www.businesswire.com/news/home/20191023005199/en/
President and Chief Executive Officer
(905) 817-8194Tim McCarthy
LifeSci Advisors, LLC
KEYWORD: NORTH AMERICA CANADA
INDUSTRY KEYWORD: BIOTECHNOLOGY PHARMACEUTICAL HEALTH
SOURCE: Acerus Pharmaceuticals Corporation
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PUB: 10/23/2019 07:00 AM/DISC: 10/23/2019 07:01 AM