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C h a i n D r u g s t o r e D a i l y S u n d a y, A u g u s t 7 , 2 0 1 6 7 0 VALUE BRANDS FOR PATIENTS, PHYSICIANS, PHARMACIES, PAYORS An interview with Carlos Alfaras, Chief Executive Officer, Gensco Pharma. CDD: Tell our readers about Gensco Pharma. CA: Gensco is a specialty pharmaceuti- cal manufacturer focused on developing and commercializing prescription trans- dermal products since 2012. Our capa- bilities allow us to quickly launch prod- ucts into significant niche markets. We have a strong Medical Advisory Board, including key medical advisors such as Dr. James Andrews and Dr. Gary Meyerson. Our products are distributed through all major and secondary whole- salers and dispensed by major pharma- cy partners including Walgreens and CVS Health. CDD: What's the current market for transdermal prescription products? CA: The current United States market for transdermal products is $8.4 billion and growing to over $10 billion in 2017. Oral drug delivery has well docu- mented problems, and transdermal tech- nology provides significant benefit for physicians, patients and payors in effica- cy, safety and value by avoiding costly adverse effects and improving patient adherence. Transdermal technologies provide benefits for systemic drug delivery and local delivery of currently approved products, the latter not being subject to FDA's stringent requirements regarding therapeutic effects. CDD: What are Gensco's currently mar- keted value brands? CA: Gensco's two established legacy brands in the pain market are SpeedGel Rx and LiDORx. In 2015, we launched ColciGel, the first transdermal medica- tion for gout which is a $2.5 billion mar- ket. All of our products are available with our proprietary MDose™, metered dose technology. CDD: What can you tell our readers about your pipeline? CA: Our research and develop- ment pipeline for transdermal products is well positioned to extend the life cycle of products originally introduced in another form, such as tablets or capsules. Our pipeline in 2016 is extremely strong. Midyear, Gensco will launch an FDA approved Prescription Hydrogel for the treatment of painful wounds, including diabetic skin ulcers, pressure wounds and burns. Our team of scientists are devel- oping a Transdermal Corticosteroid with an expected launch by the end of 2016. Eventually, we will include a few orally administered medications that will be a good adjunct therapeutic fit with our products. CDD: What does Gensco provide in the way of patient assistance programs? CA: Copay assistance and cash pay pro- grams are available to all patients through participating pharmacies. As a pharmaceutical manufacturer, we have a responsibility to provide access to safe and effective medications. We recognize the need to assist with the financial burden as our duty. Our corporate focus is to utilize our resources on innovative research and the devel- opment of unique delivery systems, and it aligns with our pharmacy partner's efforts to improve access and the quality of life for patients who suffer from pain and debilitating diseases. CDD: What additional insights do you have about Gensco's value brands? CA: We at Gensco are passionate about continuing to develop partnerships with what we call the 4Ps: Patients, Physicians, Pharmacists and Payors. We are constantly in communication with PBMs and our pharmacy clients to mes- sage healthcare providers and their respective patients on the efficacious benefits as well as the financial value of Gensco products. We expect to continue offering Gensco Brands to the industry which consistently provide efficacy, safe- ty and value. For more information, go to www .genscolabs.com or call 855.743.6726 (7GENSCO). BIOSIG TECHNOLOGIES ANNOUNCES ADVANCED RESEARCH PROGRAM WITH MAYO CLINIC BioSig Technologies, Inc. has announced the establishment of an advanced research program with Dr. Samuel Asirvatham at Mayo Clinic in Rochester, Minnesota. This program has been designed to build upon the initial studies conducted at Mayo Clinic in March, June and November 2015 through a tripling of investment to fully characterize and develop novel features discovered during this prior preclinical work. These fea- tures have the potential to make a signif- icant impact in the treatment of complex arrhythmias. "We are extremely pleased to contin- ue our sponsored research activities with Dr. Asirvatham and his colleagues at Mayo Clinic," said Greg Cash, President and Chief Executive Officer of BioSig Technologies. "The previous studies con- firmed the potential of PURE EP to improve the clarity of cardiac signals while minimizing electrical noise in the cardiac electrophysiology laboratory." About BioSig Technologies BioSig Technologies is a medical device company that is developing a proprietary technology platform designed to improve the $4 billion EP marketplace. Led by a proven management team and a veteran, independent Board of Directors, Minneapolis-based BioSig Technologies is preparing to commercialize its PURE EP™ System. The PURE EP System is a surface electrocardiogram and intracardiac multichannel signal acquisition and analysis system designed to assist elec- trophysiologists in making clinical decisions in real-time by acquiring and displaying high-fidelity cardiac signal recordings and providing clarity of data which may be used to guide the electro- physiologists in identifying ablation targets – areas of tissue to treat that oth- erwise create a heart rhythm distur- bance (arrhythmia). Analysts forecast the global market for EP devices will grow at a 12.1 percent compound annual growth rate, from $2.5 billion in 2012 to $5.5 billion by 2019, making it one of the fastest growing med- ical device segments. Just in the U.S., the number of Atrial Fibrillation (AF) and Ventricular Tachycardia (VT) arrhythmia ablations is forecast to grow at 10.5 per- cent from 2012 to 2017. BioSig intends to seek FDA 510(k) clearance for the PURE EP System. The company has achieved proof of concept validation through UCLA labs, and has performed pre-clinical studies at the Mayo Clinic in Minnesota. The company is collaborating with several of the nation's most prestigious cardiac arrhythmia centers, including Texas Cardiac Arrhythmia Institute, UCLA Cardiac Arrhythmia Center and Mayo Clinic. For more information, visit www.biosigtech.com. BIOLINE LAUNCHES NEW EPIK MIRNA SELECT KITS Bioline, The PCR Company, a wholly- owned subsidiary of Meridian Bioscience, Inc., is proud to announce the worldwide release of the EPIK™ miRNA Select Assays, developed for study of individual microRNA (miRNA) molecules. The EPIK miRNA Select Kits compliment the EPIK miRNA Panel Assays released at the end of 2015, and demonstrates the continued collaboration between MiRXES in Singapore and Bioline. Recent studies continue to show the clinical value of individual miRNA mol- ecules that are released from tissues and cells. The expression of certain individ- ual miRNA molecules correlates with specific disease conditions, making them promising biomarker candidates for the early detection of disease, prognosis and monitoring of treatment. These individual assays use the same novel approach developed by MiRXES for the panel assays, which employs miRNA specific reverse transcriptase primers and hemi-nested real-time PCR primers along with Bioline reverse tran- scriptase, SensiSMART™ with SYBR ® Green and highly optimized buffers. The resulting assays enable detection of extremely low levels of miRNA with very high specificity, allowing the dis- crimination between closely related miRNA sequences. Marco Calzavara, President of Bioline, commented, "I am very pleased to announce the release of the EPIK miRNA Select Kits, following the suc- cessful release of the EPIK miRNA Panels, this increases our portfolio of high quality miRNA kits, helping researchers with miRNA expression pro- filing, quantification and in biomarker discovery." Richard L. Eberly, President of Meridian Life Science, Inc., stated, "We remained committed to expanding the rapidly growing portfolio of highly spe- cialized molecular biology products from Bioline. The release of the EPIK miRNA Select Assays and the enhanced perform- ance are an important addition, as they provide another set of valuable research tools for our life science customers in creating more accurate and non-invasive molecular diagnostic assays." About Meridian Bioscience, Inc. Meridian is a fully integrated life sci- ence company that develops, manufac- tures, markets and distributes a broad range of innovative diagnostic test kits, purified reagents and related products and offers biopharmaceutical enabling technologies. Utilizing a variety of methods, these products and diagnostic tests provide accuracy, simplicity and speed in the early diagnosis and treat- ment of common medical conditions, such as gastrointestinal, viral and respi- ratory infections. Meridian's diagnostic products are used outside of the human body and require little or no special equipment. The company's products are designed to enhance patient well- being while reducing the total outcome costs of healthcare. Meridian has strong market positions in the areas of gastrointestinal and upper respiratory infections, serology, parasitology and fungal disease diagnosis. In addition, Meridian is a supplier of rare reagents, specialty biologicals and related tech- nologies used by biopharmaceutical companies engaged in research for new drugs and vaccines. The company mar- kets its products and technologies to hospitals, reference laboratories, research centers, diagnostics manufac- turers and biotech companies in more than 70 countries around the world. Meridian's website address is www.meridianbioscience.com. For more information, visit www.bioline .com, www.meridianlifescience.com, or www.meridianbioscience.com. SBYR is a registered trademark of Life Technologies.