- In January 2017, BioCorRx® retained Innovation Science Solutions, LLC, ("ISS"), a leading scientific consulting firm, to help guide the Company's regulatory strategy to the U.S. Food and Drug Administration (FDA).
- In April 2017, BioCorRx® entered into an agreement with DynamiCare Health™, Inc. to develop a co-branded mobile application to support patients engaged in counseling for the treatment of alcoholism or opioid addiction and receiving long-term naltrexone treatment.
- In June 2017, BioCorRx® announced its partnership with Virtual Reality Medical Center (VRMC) to conduct a study on the BioCorRx Recovery Program and the Company's long-lasting naltrexone implant.
- In October 2017, BioCorRx® launched its new weight management pilot program.
- In November, BioCorRx® entered into a confidentiality agreement with the National Institute on Drug Abuse (NIDA), a U.S. federal-government research institution, to share confidential information and potentially collaborate on future research, development and commercialization of the Company's therapies and programs for opioid use disorder.
- In December 2017, BioCorRx® announced a distribution deal with CereCare, LLC for the BioCorRx Recovery Program.
- In December 2017, BioCorRx® submitted its pre-Investigational New Drug (pre-IND) package to the U.S. Food & Drug Administration (FDA) for the Company's naltrexone implant, BICX102.
- Rolled out BioCorRx® Recovery Program in 14 additional locations in 5 different states throughout the year.
- In January 2018, BioCorRx® retained regulatory drug experts Priya Jambhekar and Bruce Firestone, PhD, to assist with the drug development and regulatory processes.
- On January 24, 2018, BioCorRx® held a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA).
- On February 12, 2018, the FDA deemed the 505(b)(2) pathway as an acceptable route for approval for BICX102, a sustained release naltrexone implant for the treatment of opioid and alcohol use disorders; the Company plans to apply for dual indications, both opioid use disorder and alcohol use disorder, within the same application.
- In the first quarter of 2018, BioCorRx®, in collaboration with One Day at a Time Program (ODAAT), announced a pilot for the BioCorRx® Recovery Program in Philadelphia, Pennsylvania.
- In March 2018, BioCorRx® reported it has successfully enrolled twelve individuals to date in the new weight management pilot program, and the initial results have been positive as reported by patients.
"Regarding BICX102, we held a pre-IND meeting with the FDA in the beginning of 2018 with NIDA in attendance. The FDA deemed the 505(b)(2) pathway as an acceptable pathway for BICX102. As a result of the meeting, we are seeking dual indications which could equate to millions of dollars in savings on studies and application fees to the FDA that are typically required for new drug applications. Another important meeting outcome is that we are not required to do efficacy studies given the existing data on the effectiveness of naltrexone, which has been approved multiple times by the FDA in various forms. Now that we have had time to process the responses from the FDA and formalize the development plan more precisely with our team of experts, we are much closer to finalizing the NIDA grant application. We hope to submit the application this month for this new grant opportunity specific to the opioid epidemic. In the meantime, we are evaluating several funding opportunities recently presented to the company now that the FDA meeting has been completed and responses received. We are thankful for the continual support we receive from our long term strategic investors. With their help we have created a real opportunity to make a difference in these epidemics, while also creating value for our partners and shareholders."Lourdes Felix, CFO, COO and Director, commented, "We report that we continue to maintain a low cash burn despite the fact we are moving forward aggressively with the regulatory process for our naltrexone implant, BICX102 and delivering substantial results with our progress. The Company's current focus is on finalizing our budget for getting our product to market. We are going to be applying for the NIDA grant and, if approved, the grant will help subsidize the cost of our clinical trials. We are also in discussion with several companies for partnerships, which can potentially reduce the cost of bringing these therapies to market. We anticipate FDA approval can be achieved in 2020. Our goal is to rapidly capture market share, and just 1% of the overall market would equate to over $200 million in revenue. In the ensuing years, we expect to grow our market share, and believe we can surpass $700 million in sales, with just 3% market penetration. These conservative assumptions are based on the market potential of approximately 4.2 million Americans that proactively seek treatment for substance use disorder every year. There is also the potential for higher reimbursement due to the long-lasting effects of the naltrexone implant. Overall, we believe we are making significant headway in advancing our naltrexone implant, BICX102, as we continue to roll out our BioCorRx Recovery Program to clinics and medical professionals nationwide."
About BioCorRxBioCorRx Inc. (OTCQB: BICX) is an addiction treatment company offering a unique approach to the treatment of substance abuse addiction. The BioCorRx® Recovery Program, a non-addictive, medication-assisted treatment (MAT) program, consists of two main components. The first component of the program consists of an outpatient implant procedure performed by a licensed physician. The implant delivers the non-addictive medicine, naltrexone, an opioid antagonist that can significantly reduce physical cravings for alcohol and opioids. The second component of the program developed by BioCorRx Inc. is a one-on-one counseling program specifically tailored for the treatment of alcoholism and other substance abuse addictions for those receiving long-term naltrexone treatment. The Company also has an R&D subsidiary, BioCorRx Pharmaceuticals, which is currently developing injectable and implantable naltrexone products for potential future regulatory approval. For more information on BICX, visit www.BioCorRx.com. Safe Harbor Statement The information in this release includes forward-looking statements. These forward-looking statements generally are identified by the words "believe," "project," "estimate," "become," "plan," "will," and similar expressions. These forward-looking statements involve known and unknown risks as well as uncertainties. Although the Company believes that its expectations are based on reasonable assumptions, the actual results that the Company may achieve may differ materially from any forward-looking statements, which reflect the opinions of the management of the Company only as of the date hereof.
BioCorRx Inc.investors@BioCorRx.com714-462-4880Investor Relations:Crescendo Communications, LLC(212) 671-1020 firstname.lastname@example.org