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Tuesday, June 4, 2019

#Biotech/ #Pharma Stock Snapshot-The Pain Gain: More OTC Pain Alternatives see Continued Growth (OTCQB: $INNV) (NYSE: $PFNX) (NASDAQ: $HRTX) (OTC: $NPHC)

#Biotech/ #Pharma Stock Snapshot-The Pain Gain: More OTC Pain Alternatives see Continued Growth (OTCQB: $INNV) (NYSE: $PFNX) (NASDAQ: $HRTX) (OTC: $NPHC)

Point Roberts WA, Delta BC – June 4, 2019 -, a leading investor news resource covering biotechnology and pharmaceutical stocks releases a sector snapshot reporting on the continued growth in OTC analgesics as consumers look for more affordable and effective options for pain.

In a recent report from Digital Journal “The global  OTC analgesics market is projected to register an above-average CAGR during 2017 to 2022. Global sales of OTC analgesics is estimated to account for nearly US$ 25,000 Million in revenues by 2022-end.”

“The trend of using off-label drugs that are affordable and unapproved, but effective in treating diseases, has been witnessing an upsurge over the past few years. Various off-label drugs including tricyclic antidepressants, antihistamines, anticonvulsants, selective serotonin reuptake inhibitors, anti-anxiety drugs, and steroids are being increasingly utilized for managing symptoms of pain. Symptom management associated with pain has now become convenient and easy, owing to widely available OTC analgesics, which are prescribed with approved drugs, implied as maintenance therapies. High potential has been observed for the market growth of OTC analgesics around the world, wherein demand as well as sales of pain medication including pain relievers, and pain killers, are gaining higher popularity among consumers.”

“In addition, demand for the non-narcotic pain medications has been rising significantly, owing to ill effects of consuming narcotic drugs. These factors are expected to influence growth of the global market for OTC analgesics in the upcoming years. Topical analgesic distributors as well as manufacturers are concentrating on enhancing their product portfolio, with an aim to benefit from potential growth opportunities in developing as well as developed markets. The aforementioned factors will augment the growth of global OTC analgesics market. Usually, OTC analgesic drugs are bought in large quantities, as these drugs are used for relieving different types of pain. Emergence of healthcare reforms, coupled with favorable regulatory norms across the globe, have been encouraging the uptake and initiations of various pain management programs, with an aim to lower the entire healthcare costs. These instances are estimated to pave the way for the development of effective OTC analgesics,” the report continued.

Innovus Pharmaceuticals, Inc. (OTCQB: INNV), an emerging commercial-stage pharmaceutical company that delivers safe, innovative and effective over-the-counter medicine and consumer care products to improve men’s and women's health and respiratory diseases, just announced that it has entered into a supply relationship with a third party to supply Innovus Pharma with Omeprazole 20mg tablets and Omeprazole 20mg 24 hours delayed release capsules indicated for the treatment of frequent heartburn under the approved abbreviated new drug application (“ANDA”) No. 207891 from the US Food and Drug Administration.  Innovus Pharma will launch the drug under its own trademark OmepraCare™ 20mg tablets and OmepraCare™ DR 20mg 24 hours delayed release capsules.

“We continue to execute on our plan to launch new OTC drugs in niche therapeutic areas where there is a need for national brands to leverage our success with FlutiCare® and other drugs and devices we have in the United States.  OmepraCare DR™ is the third ANDA OTC drug that we intent to commercialize in the US this year,” said Dr. Bassam Damaj, Innovus Pharma’s President and Chief Executive Officer.  “We believe that the market opportunity for us with this product is fairly large given the success of the product Prilosec® OTC and the relatively large size of the market. Our goal is to launch OmepraCare™ in the US in the second half of this year,” added Dr. Damaj.

“In addition, it is our current intention to add up to 10 additional ANDA OTC products to our US drug pipeline,” he continued.

This follows Innovus announcement of receiving the CPNP notification number required to commercialize Diabasens® in all 28 member countries of the European Union. This represents the fourth Innovus Pharma product to receive CPNP notification in the European Union in the last few years, the others being for Zestra®, Zestra Glide® and Sensum+®. The product will be available as an over-the-counter (“OTC”) or behind the counter product and does not require a prescription.

“We are pleased to announce the receipt of the CPNP in the European Union for Diabasens®, our current best-selling product. The clearance to market the product in Europe follows the recently announced approval from Health Canada for the relief of neuropathy pain,” said Dr. Bassam Damaj. “This is one of several products we have filed in Europe for which we expect to receive the notification to commercialize in the near future.”

Pfenex Inc. (NYSE: PFNX) and Alvogen also expressed their interest in the EU, as they announced that the European Medicines Agency (EMA) accepted the Marketing Authorization Application (MAA) submitted by their partner Alvogen for PF708 (teriparatide).  The product is proposed as a therapeutic equivalent in the treatment of osteoporosis to Forteo®and is filed with the EMA as a biosimilar in the treatment of osteoporosis to Forsteo®, which achieved $289 million sales in the EU and $1.6 billion in global product sales in 2018. This acceptance means the EMA considers the MAA to be complete and initiates the EMA's formal review process.

“The acceptance of the PF708 MAA filing is an important milestone for Pfenex and Alvogen and demonstrates that through our collaborative partnership, we continue making progress towards potential approvals beyond the United States,” said Eef Schimmelpennink, Chief Executive Officer of Pfenex. “Subject to applicable regulatory approvals for Europe, PF708 will be commercialized by Theramex, a leading global specialty pharmaceutical company dedicated to Women’s Health.”

“We are very pleased with the EMA’s acceptance of the MAA for review. This is an important milestone and underlines the successful and valuable partnership between Pfenex and Alvogen to bring biosimilar Teriparatide to market and deliver on our mission to provide high quality, affordable healthcare for patients. The EMA will review the application under the centralized marketing authorization procedure. If approved by the EMA, biosimilar Teriparatide would receive marketing authorization in all 28 member states of the European Union (EU), as well as in Iceland, Liechtenstein and Norway,” stated Faysal Kalmoua, Executive Vice President of Alvogen’s Global Portfolio.

Heron Therapeutics, Inc. (NASDAQ: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, recently announced that the results from the pivotal Phase 3 EPOCH 1 bunionectomy study of the investigational agent HTX-011 have been published online by the Regional Anesthesia & Pain Medicine (RAPM) journal. The article, entitled "HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in bunionectomy: phase III results from the randomized EPOCH 1 study," will also be published in the July 2019 print issue of RAPM. HTX-011 achieved all primary and key secondary endpoints in the EPOCH 1 study, demonstrating statistically significant reductions in both pain intensity and the use of opioid rescue medications following surgery and an increase in the proportion of patients who were opioid-free.

HTX-011 is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug Meloxicam in a 33:1 ratio. It is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control.

In the EPOCH 1 study, all primary and key secondary endpoints were achieved. HTX-011 provided superior and sustained pain reduction compared to placebo and bupivacaine solution through the critical 72-hour postoperative window, when pain is often most severe. Significant reductions in pain occurred both early (in the first 8 through 24 hours) and were sustained from 24 through 72 hours. In addition to reductions in average pain intensity scores, HTX-011 significantly reduced the proportion of patients experiencing severe pain through 72 hours compared to placebo and bupivacaine solution. Significant reductions in pain were consistent with the significant decrease in total opioid consumption and the significant increase in opioid-free patients receiving HTX-011, both through 72 hours and as compared to placebo and bupivacaine solution. Most patients that required no opioids in the first 72 hours after surgery (82%) continued to be opioid-free through 28 days. HTX-011 was well tolerated, with a safety profile comparable to placebo and bupivacaine solution.

"This publication demonstrates that HTX-011 can significantly reduce postoperative pain, including severe pain, for 72 hours post-surgery and reduce the need for opioids compared to bupivacaine solution," said Eugene Viscusi, MD, Professor of Anesthesiology and Chief of Pain Medicine in the Department of Anesthesiology at the Sidney Kimmel Medical College of Thomas Jefferson University in Philadelphia, Pennsylvania. "Surgery can contribute to the opioid problem, as it is often a patient's initial introduction to opioids, and it also can be the trigger for misuse and abuse due to unused pills from discharge prescriptions. Each year, an estimated 2.6 million Americans may become persistent opioid users following initial opioid exposure after surgery. The results from EPOCH 1 suggest that HTX-011 can be used to control pain effectively after surgery, thereby reducing the reliance on opioids and preventing the flow of unused opioid pills into our homes and communities."

Nutra Pharma Corporation (OTC: NPHC), a biotechnology company marketing Nyloxin® and Pet Pain-Away™ in the over-the-counter (OTC) pain management market, recently announced that the iRemedy Healthcare Companies has added the entire Nyloxin product line to their marketplace.

“We are pleased to be working with iRemedy to expand the marketing of Nyloxin,” explained Rik J. Deitsch, Chairman and CEO of Nutra Pharma Corporation. “We have only recently brought the Nyloxin product line back under our control and updated both the Nyloxin website and the Nutra Pharma corporate website. These efforts to increase internet awareness will continue as we join other marketing groups to greatly expand our reach to educate consumers about Nyloxin and get the product into the hands of those who need it most,” he continued. “We will also be working with iRemedy to increase the visibility of Nyloxin in the medical space in an effort to educate healthcare professionals about the power of Nyloxin as an analgesic of choice,” he concluded.

By adding Nyloxin to the iRemedy vendor network, Nutra Pharma will have the ability to process orders, access sales channels, gain promotion online with paid ads and social media, and work with thousands of independent medical representatives targeting medical practices, hospitals and other healthcare providers. The iRemedy vendor program includes infrastructure services like online promotions, order capture, order fulfillment, and can be extended to include marketing and sales team development.

“This marketplace e-commerce approach, one that is built on quality control and compliance, is revolutionizing healthcare by providing market access to emerging device, drug and supply companies. Just as Amazon, Netflix and iTunes revolutionized their markets by creating efficient and accessible distribution communities, iRemedy is bringing marketplace efficiency to the US healthcare market,” stated Tony Paquin, CEO of iRemedy. “We’re excited to be working with Nutra Pharma and we know that providing people alternatives to narcotics-based pain relief medication is necessary for good communal health. That’s why we love this product and we’re glad to have it as part of the iRemedy family,” he concluded.  

Nyloxin® is a safe, non-narcotic, and non-addictive homeopathic pain reliever for the relief of pain without impairing cognitive function. Nyloxin® offers several benefits as pain relievers and anti-inflammatory agents. Nyloxin® has a well-defined safety profile. Since the early 1930s, the active pharmaceutical ingredient (API), Asian cobra venom, has been studied in more than 46 human clinical studies.

Another report from Future Market Insights also focused on the increased use of OTC pain medications saying, “The OTC (over-the-counter) pain medication market surpassed US$ 18 billion in 2018, with growth influenced by changing perceptions on generic pharmaceutical drugs, according to a recent study published by Future Market Insights (FMI). The study opines that market revenue will rev up at an improved rate of 3.7% to exceed US$ 19.3 billion in 2019.”

“As more consumers make the shift to generic drugs to reduce total spending on non-prescription or OTC pain medication, various governing bodies, such as the United States Food and Drug Administration (FDA), have implemented stringent regulations and labeling rules to ensure the safety and effectiveness of OTC pain medications. This is allowing for leading companies in the OTC pain medication market to collaborate with generic drug-makers to capitalize on the trend of consumer inclination towards generic versions of branded OTC pain medications”, finds FMI.

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