PALM BEACH, Florida, May 3, 2018 /PRNewswire/ --
MarketNewsUpdates.com News Commentary
The multi-billion dollar Biotech Industry is witnessing a transformation as it relates to the advancement of transdermal drug delivery patches. On the back of factors like rising number of transdermal drug delivery products, enhanced awareness in developed nations about non-invasive way of drug administering drugs into body. After accounting for more than $30 billion in revenues in 2015, the market segment is projected to continue enjoying considerable growth through 2024, according to a report issued by Grand View Research. The market growth is being driven by the increasing occurrence of chronic diseases that have proven to be difficult to treat with traditional oral medications. Additionally, an increasing demand for drug platforms that can be self-administered is another factor influencing the exponential growth of transdermal drug delivery patches. Active biotech companies in the markets this week include Aequus Pharmaceuticals Inc. (TSX-V: AQS) (OTC: AQSZF), InVivo Therapeutics Holdings Corp. (NASDAQ: NVIV), InspireMD Inc. (NYSE: NSPR), Baxter International Inc. (NYSE: BAX), Medtronic Plc. (NYSE: MDT).
Aequus Pharmaceuticals Inc. (TSX-V: AQS.V) (OTCQB: AQSZF) BREAKING NEWS: Aequus Pharmaceuticals, a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, announced today that the Company has received positive feedback from the US Food and Drug Administration ("FDA") on its pre-Investigational New Drug ("pre-IND") submission for the Company's long-acting anti-nausea transdermal patch, AQS1303. Through the pre-IND feedback, the Company has received clear regulatory guidance for AQS1303. The FDA confirmed that the planned Section 505(b)(2) abbreviated regulatory pathway, which allows for the Company to reference safety and efficacy data of the original oral tablet Diclegis®, is appropriate for submission in a New Drug Application ("NDA") for the program in the United States.
"We are very encouraged with the responses from the FDA on our anti-nausea program," said Doug Janzen, Chairman and CEO of Aequus. "The pre-IND feedback met our expectations, confirming our planned clinical program and providing a clear regulatory path forward. The feedback signals positive support for this program and further confirms our overall strategy of improving patient outcomes through alternative delivery methods. We look forward to using this guidance in conjunction with our current development and clinical progress to optimize AQS1303 for success."
"Camargo's goal is to guide our clients in the most cost- and time-effective manner through the 505(b)(2) regulatory pathway, while driving commercial success for our client-partners," said Ken Phelps, President and Co-Founder of Camargo Pharmaceutical Services. "We look forward to continuing work with Aequus to advance their anti-nausea patch for pregnancy nausea and vomiting, to benefit patients worldwide."
In support of the Company's planned clinical strategy, the FDA indicated that a pharmacokinetic bridging strategy, to allow bridging to the safety and clinical pharmacology information from Diclegis®, and a single clinical efficacy study, would likely be acceptable for an NDA submission. The FDA also outlined additional standard studies required of a transdermal patch to evaluate the local safety and to ensure that consistent and predictable dosing is achieved over the dosing period. Read this and more news for Aequus Pharmaceuticals at http://www.marketnewsupdates.com/news/aqs.html
In other biotech/pharma developments from around the markets:
InVivo Therapeutics Holdings Corp. (NASDAQ: NVIV) closed Wednesday up over 70% at $13.49 with over 3 million shares traded by the market close. InVivo Therapeutics is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children's Hospital and who now is affiliated with Massachusetts General Hospital. In January 2018, the company announced updated clinical evidence, including improvements in patients with acute spinal cord injury (SCI), from its INSPIRE study of the Neuro-Spinal Scaffold™.
InspireMD Inc. (NYSE: NSPR) came to a closed up over 4% at $1.25 on Wednesday with over 3 million shares traded on the day and was also up in afterhours trading of more than 6%. InspireMD recently announced it has received regulatory approval, and has initiated commercialization of its CGuard™ Embolic Prevention System (EPS) and MGuard Prime™ in Vietnam. Both of these devices utilize the company's patented MicroNet™ technology. "Our ability to initiate commercialization for both of the company's devices was due to our capability to coordinate getting three key elements in place concurrently and quickly. Specifically, we secured regulatory approval, a valid import license and product reimbursement, all of which come from Vietnam's Department of Medical Equipment and Health Works (DMEHW), a unit of the Ministry of Health (MOH). Part of this effort was coordinated by DO GIA, our recently appointed distributor in Vietnam.
Baxter International Inc. (NYSE: BAX) recently announced a partnership with the International Society of Nephrology (ISN) to advance chronic kidney disease (CKD) awareness and help improve access to therapy, particularly in low- and middle-income countries (LMIC) - commonly referenced as emerging markets - where the disease prevalence is growing the fastest. The collaboration will support greater disease and therapy research and education, as well as work to help establish better care models that support high standards of care at a lower cost in LMIC. "ISN and Baxter's collaboration aims to address the urgent and growing challenge kidney disease is causing healthcare systems in providing quality care to patients globally," said David Harris, M.D., ISN President, University of Sydney, Australia.
Medtronic Plc. (NYSE: MDT) on Wednesday announced the advanced SynergyTLIFSM workflow - a procedural solution for spine surgery that combines innovative technologies to create a completely navigated minimally invasive procedure that allows fewer intra-operative surgical steps. The announcement was made during the American Association of Neurological Surgeons (AANS) annual meeting in New Orleans, La. The advanced SynergyTLIF Workflow combines the O-arm(TM) System imaging and StealthStation(TM) imaging guidance for navigated: Minimally invasive access; Screw preparation via navigated Stealth-Midas(TM) Drilling System; Interbody disc preparation instruments; Interbody placement of the Elevate(TM) Spinal System expandable interbody device; Screw placement of the CD Horizon(TM) Solera(TM) Voyager(TM) 4.75 and 5.5 ATS(TM) Screws. "The advanced SynergyTLIF workflow allows me to see every step of the patient`s minimally invasive procedure through real-time 3D imaging," said Dr. Jean-Pierre Mobasser, neurosurgeon at Goodman Campbell Brain & Spine/Indiana University, Department of Neurosurgery in Indianapolis, Ind.
DISCLAIMER: MarketNewsUpdates.com (MNU) is a third party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. MNU is NOT affiliated in any manner with any company mentioned herein. MNU and its affiliated companies are a news dissemination solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. MNU's market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities. The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material. All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks. All material included herein is republished content and details which were previously disseminated by the companies mentioned in this release. MNU is not liable for any investment decisions by its readers or subscribers. Investors are cautioned that they may lose all or a portion of their investment when investing in stocks. For current services performed MNU has been compensated forty-nine hundred dollars for news coverage of the current press releases issued by Aequus Pharmaceuticals Inc. by a non-affiliated third party. MNU HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE.
This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may", "future", "plan" or "planned", "will" or "should", "expected," "anticipates", "draft", "eventually" or "projected". You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company's annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and MNU undertakes no obligation to update such statements.