Biotech and Pain Management Therapeutics Segments Projected to Grow

Actualizado el 12 de enero, 2018 - 15.00hs.

Biotech and Pain Management Therapeutics Segments Projected to Grow News Commentary

PR Newswire

NEW YORK, January 12, 2018 /PRNewswire/ --

According to EP Vantage, the editorial arm of Evaluate Ltd., in 2017 the FDA has given green light to 43 novel drugs, which are forecast to be generating a combined $32bn in US sales in five-years' time. The report indicates that the upward momentum seen in the pharma and biotech sectors during 2017 is expected to continue into 2018, with more novel medicines set to hit the market and investor support for the industry remaining strong. Amy Brown, report author, explained, "Venture capital funds are very well stocked going into 2018, and both public and private investors look set to remain supportive of innovative, early-stage drug developers… However, there is evidence that expectations have got ahead of themselves in certain areas - particularly in immuno-oncology. To keep investors on side next year the industry needs to deliver some big pipeline wins, and important new drug launches need to perform." BioCorRx Inc. (OTC: BICX), Palatin Technologies, Inc. (NYSE: PTN), Stellar Biotechnologies, Inc. (NASDAQ: SBOT), Protalix BioTherapeutics, Inc. (NYSE: PLX), Regulus Therapeutics Inc. (NASDAQ: RGLS)

Opioids are the most widely prescribed medications or the treatment of chronic pain conditions, which is a major sector of the pharma and biotech industries. According to business intelligence provider GBI Research, the U.S. market for opioids will grow to $17.7 billion by 2021, at a compound annual growth rate of 7 percent. The report indicates that the U.S. consumes 80 percent of the world's legal and illegal opioids, which are highly addictive and are the country's most abused prescription drug. Deekshita Allavarapu, Analyst for GBI Research, explains: "The FDA has raised concerns over the high use, and the potential for misuse, of opioids. This could lead to the enforcement of regulatory checks that affect the opioid treatment market and its potential growth."

BioCorRx Inc. (OTCQB: BICX) on January 5th the company announced breaking news that, "it has retained regulatory drug experts Priya Jambhekar and Bruce Firestone, PhD, to assist with the drug development and regulatory process for BioCorRx's product pipeline. Ms. Jambhekar and Dr. Firestone are additions to the Company's current team, which is preparing for its pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) scheduled on January 24, 2018. As previously announced, the Company is seeking FDA approval for BICX102, a naltrexone implant for the treatment of opioid and alcohol use disorders. 

Ms. Jambhekar is a drug development entrepreneur with over 25 years of executive experience in worldwide regulatory, quality, clinical and pharmacovigilance operations, as well as early and late stage development product registration and commercial support. She has held positions including Global Senior Vice President of Regulatory & Quality Operations at Paramount BioSciences, Global Vice President at Ethicon, a Johnson & Johnson company, and Worldwide Vice President of Regulatory and Government Relations at Alkermes. Other senior positions include Baxter ACC, as Regulatory Head of Compliance, and Bristol-Myers Squibb, as Manager of Regulatory, Safety, Compliance. She is also certified by the Regulatory Affairs Professional Society and the New Jersey Pharmaceutical Quality Control and Assurance Society.

Dr. Firestone has over three decades of pharmaceutical research & development experience with on-time delivery of over 15 product approvals as new chemical entities and line extensions. Dr. Firestone is an accomplished author with over 40 publications, abstracts and patents. He also has extensive chemistry, manufacturing and controls (CMC) expertise with: small molecules, drug and drug-device combinations, sustained-release products, semisolids, topical and intravitreal routes of administration. He has held senior positions at Allergan and is an expert in pharmaceutical product development, manufacturing process development and scale-up, technology transfer, process validation, risk management, technology assessment, due diligence, CMC documentation, and CMC strategy." 

Brady Granier, President, CEO and Director, stated, "Priya and Bruce are valuable additions to the BioCorRx team and we are honored to have them on board. They both bring extensive regulatory and manufacturing experience in drug development and have proven track records bringing drugs to market. We look forward to their contributions as we accelerate our efforts to obtain FDA approval for our naltrexone product that we feel will help many families suffering from the current opioid epidemic and massive alcohol dependence problem."

Palatin Technologies, Inc. (NYSE: PTN) is a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential. Recently, the company announced that the U.S. Food and Drug Administration (FDA) has notified Palatin that it may proceed with its clinical investigation of subcutaneous injection PL-8177 as a potential treatment for patients with ulcerative colitis. The notice to proceed was received following Palatin's submission of an investigational new drug (IND) application for this program. Palatin expects to commence a Phase 1 single and multiple ascending dose study in the current quarter. PL-8177, a selective melanocortin receptor 1 (MC1r) agonist peptide, is Palatin's lead clinical development candidate for ulcerative colitis and other inflammatory bowel diseases. Agents that modulate the MC1r system may have therapeutic potential in a variety of inflammatory disease indications.

Stellar Biotechnologies, Inc. (NASDAQ: SBOT) is the leader in sustainable manufacture of Keyhole Limpet Hemocyanin (KLH), an immune-stimulating protein utilized as a carrier molecule in therapeutic vaccines (targeting cancers, immune disorders, Alzheimer's and inflammatory diseases) and for assessing immune system function. On December 1, 2017, the company reported financial results for the fiscal year ended September 30, 2017 and provided an update on its business. During fiscal year 2017, the company advanced a number of strategic initiatives to optimize its manufacturing operations and to secure additional locations for the biologic source of KLH. Stellar currently has multiple customers with KLH-based drug candidates in Phase 2 studies. While the outcomes of these clinical studies cannot be predicted, the company is preparing for the possible impact that favorable clinical results could have on the KLH market and the company's supply capabilities.

Protalix BioTherapeutics, Inc. (NYSE: PLX) is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx®. Protalix's unique expression system presents a proprietary method for developing recombinant proteins in a cost-effective, industrial-scale manner. On January 2, 2018, the company announced interim data from the first 14 patients that completed, to date, the Company's phase II clinical trial of OPRX-106 (oral anti-TNF) in patients with ulcerative colitis. The phase II clinical trial is a randomized, open label, 2-arm study of OPRX-106 in patients with active mild to moderate ulcerative colitis. A total of 24 patients were enrolled and randomized to receive 2 mg or 8 mg of OPRX-106, administered orally, once daily, for 8 weeks. The first 14 patients have completed the study, and four patients are currently in treatment and follow-up. The trial evaluated key efficacy endpoints including clinical response and remission utilizing the Mayo score, as well as safety and pharmacokinetics.

Regulus Therapeutics Inc. (NASDAQ: RGLS) is a clinical stage biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs. On December 19, 2017, the company announced that it has initiated the first-in-human Phase I study of RGLS4326 and completed dosing of the first cohort of healthy volunteers. RGLS4326 is in development for the treatment of autosomal dominant polycystic kidney disease, or ADPKD. RGLS4326 is being studied in a Phase I randomized, double-blind, placebo-controlled, single ascending dose study designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of RGLS4326 administered subcutaneously in healthy volunteers.

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