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 5 th 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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