Compass Point Research to Collaborate With NDA Partners to Develop Migraine Combination Drug
NASHVILLE, TN, Apr 07, 2015 (Marketwired via COMTEX) -- Lori Nesbitt, PharmD, Chief Executive Officer of Compass Point Research, announced today that the company has entered into an agreement with NDA Partners LLC, a highly regarded medical product development and regulatory strategy consultancy, to collaborate in the development of a new combination drug for the treatment of migraine headaches. Compass Point has been retained by the drug sponsor, MultiCorp International, Inc., a publicly traded company located in Sun Valley, CA, to manage the product development program, and NDA Partners will provide the drug development and regulatory expertise needed to prepare a development plan for a 505(b)(2) NDA submission to the US Food & Drug Administration (FDA) and to manage a preIND meeting with the FDA review division.
The product is a combination of two currently FDA approved drugs, diphenhydramine (Benadryl(R)) and trimethobenzamide (Tebamide(R), Tigan(R)), both of which can be delivered in an oral dosage form. Diphenhydramine is used clinically in combination with other dopamine antagonists such as prochloperazine and metoclopramide as first line therapy to treat migraine headaches. Trimethobenzamide is an antiemetic used to prevent nausea and vomiting. In an emergency department-based clinical study conducted in 2005, the drug combination, delivered as a single injection intramuscularly, demonstrated pain relief, tolerability, and efficacy at 24 hours compared to subcutaneous sumatriptan.
NDA Partners has assembled a highly experienced product development team with comprehensive expertise that includes regulatory strategy, nonclinical development, toxicology, CMC, clinical pharmacology, and experience in demonstration of clinical effectiveness of new migraine treatments. The team will be led by Charles Grudzinskas, PhD, a Partner in the firm who has led efforts to develop and register dozens of new medical products, and includes David Feigal, MD, former Director, FDA Center for Devices & Radiological Health (CDRH); Jeanine Kuczik, a Partner in NDA Partners with significant experience in the development of migraine treatments; and Anthony DiSanto, PhD, former Vice President of Worldwide Drug Delivery Research & Development for the Upjohn Company.
"We are very pleased to be able to combine our extensive drug development and operational experience with world class development and regulatory experts from NDA Partners," said Dr. Nesbitt. "Together, we will deliver an outstanding solution for our client."
NDA Partners is a strategy consulting firm specializing in expert product development and regulatory advice to the medical products industry and associated service industries such as law firms, investment funds and government research agencies. The highly experienced Principals and Premier Experts of NDA Partners include two former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; an international team of approximately 60 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and virtual product development teams.
MultiCorp International, Inc. (Sun Valley, CA) is a diversified company that operates in various business sectors including property development, constructions, medical, and hospitality as well as commodities such as oil and gas, and entertainment. The vision of management for the company is to diversify into many fields wherein management's expertise, along with its strategic partner's experience, will enable it to participate in high growth markets and increase profitability.
"This is an important program for us, and we believe we have a potential break-through product under development that can provide longer-lasting relief for those suffering from migraine headaches," said Ben Friedman, Rph and President of MultiCorp International, Inc. "Compass Point has assembled an outstanding team to help us develop this product, and we look forward to working with them to fill this important medical need."
About Compass Point Research
Compass Point Research is a full-service clinical and translational research management and consulting firm. The company's focus is on facilitating all aspects of clinical trials operations for community-based healthcare providers, including drug, device, nutritional supplement and consumer product development from discovery through clinical studies, and post-approval support. In addition, Compass Point develops and coordinates multi-center outcomes and registry trials for industry sponsors, healthcare providers and payers, delivering scientifically rigorous research outcomes in an affordable environment. The company has been able to assist providers with not only eliminating a subsidy for research, but actually realizing a net profit for the department or cost center while adhering to all governing regulations and internal standard operating procedures.
Contact Lori A. Nesbitt, PharmD, MBA Chief Executive Officer Office: 615-522-5424 Mobile: 615-418-8987 Fax: 615-522-5401 Email: email@example.com
SOURCE: Compass Point Research
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The medical industry has seen many changes in the past few years, and MultiCorp will continue to operate in this sector. When identifying potential acquisitions in this sector, MultiCorp has a significant advantage over other companies looking for qualified businesses.
Our past work with major healthcare companies such as United Healthcare, Kaiser, and Tenet, to name a few, bodes well for MultiCorp's future. As with any new technology in the medical field, working with the actual companies that can pay for the products/services is the key to generating revenue in this sector.
MultiCorp will look to grow its business now and in the future by identifying breakthroughs in the tele-medicine and tele-health sectors, hospital and clinic construction and operations, healthcare insurance and managed professional groups.
The company has submitted bids throughout the world to build and operate several hospitals, clinics, and other similar medical businesses that offer cutting-edge solutions for countries that have been lagging behind in delivering proper medical care.
The company is also looking to penetrate all facets of the Obamacare solutions for patients and companies that are having a hard time navigating this system. Through alliances with healthcare insurers, medical professionals, and software solution companies, MultiCorp expects to grow in the medical sector for many years to come.
MULTICORP INTERNATIONAL, INC ENGAGES BIOREGENERATIVE SCIENCES, INC and NORTH COUNTY CLINICAL RESEARCH TO DEVELOP CLINICAL TRIAL PROCEDURES ON PATENTED MIGRAINE MEDICINE
Apr 16, 2014
OTC Disclosure & News Service
Sun Valley, CA -
Procedure Report will Set Stage to begin Clinical Trials on Migraine Medication
April 16, 2014 6:00 AM PT
SUN VALLEY, CA - MultiCorp International, Inc, (OTC Pink: MCIC - News) has engaged Dr. Greg Maguire of BioRegenerative Sciences, Inc along with Dr. Valentin Isacescu of North County Clinical Research to work with the company to develop a clear path to begin clinical trials on their patented migraine medicine for eventual approval by the FDA.
The company released the following statement, "We're extremely excited to have such a qualified and experienced group to assist the company in mapping out a clear strategy for the migraine medication to gain approval from the FDA. While we understand this could be a long process, having a group that is so well versed on the proper procedures clinical trials require to gain approval, we feel we've chosen the perfect group to accomplish this portion of the process in the most expeditious manner possible. Once the report is completed in the next four to six weeks, the company will have a clear understanding as to the requirements from the FDA on beginning clinical trials", stated Mr. Paul D. Lisenby, CEO of MultiCorp International, Inc. Mr. Lisenby added, "We feel this medication could become a major player in the $3.2 billion dollar segment of the migraine pharmaceutical vertical."
Dr. Greg Maguire, CEO of BioRegenerative Sciences, Inc, stated, "Our group is very excited to help bring this important new drug candidate for migraines through the FDA 505(b)(2) NDA approval process. Dr Valentin Isacescu added, "Migraine is such a debilitating disorder for so many patients and a tremendous need exists for a medication to prevent and control this malady."
About MultiCorp International, Inc.
MultiCorp International, Inc is a diverse company that operates in various business sectors that show true growth potential. The company builds on its executives experience in property development, constructions, medical, hospitality, agribusiness, commodities such as oil and gas, and entertainment. The company looks to expand through acquisitions of solid business models and management that have the potential to grow exponentially. The company will have additional subsidiaries that will eventually grow into being their own public entity, be sold, or continue to operate within MultiCorp. For further information please contact them at firstname.lastname@example.org
About BioRegenerative Sciences, Inc.
BioRegenerative Sciences, Inc. is a privately held corporation headquartered in San Diego, CA and currently has fifteen patent pending products on the market and is further developing a portfolio of therapeutic and cosmeceutical products and services based on BRS's core stem cell-based S2RM(R) Technology. For more information, please email: email@example.com, or call BRS at 858. 521.9203.
About North County Clinical Research
North County Clinical Research (NCCR) is a dedicated clinical research site located in the North County of San Diego. We specialize in central nervous system (CNS) indications, some medical indications, drug dependence, alcohol dependence, nicotine dependence, sleep disorders, and chronic pain clinical trials. We are comprised of physicians and research staff with over 20 years of combined experience conducting phase II through phase IV clinical trials. Our site is affiliated with Aurora Behavioral Health Care which provides excellent opportunities for recruitment and inpatient clinical trials.
For more information, please visit their website at http://www.nccresearch.com/
Multicorp International, Inc Acquires 70% Ownership in Patented Migraine Headache Medication
|Multicorp International, Inc Acquires 70% Ownership in Patented Migraine Headache Medication |
Company Seeking Clinical Trial Partner to Begin Testing in First Quarter of 2014
SUN VALLEY, CA--(Marketwired - Dec 17, 2013) - MultiCorp International, Inc, (OTC Pink: MCIC) has acquired a 70% stake in a patented migraine medication. The company released the following statement:
"MultiCorp International, Inc has acquired a 70% ownership in a patented migraine medicine that has shown to aid in the symptoms of migraine headaches. According to www.migraine.com in the U.S. alone more than 37 million people suffer from migraines and globally over 330 million people have migraines on a constant basis. The medication was developed by a physician that MultiCorp will work closely with in order to gain FDA approval for the medication. The company plans to begin clinical trials in the first quarter of 2014 and hope to have the medication to market as soon as possible. The information on the patent can be found at http://www.faqs.org/patents/app/20090018205. Under the terms of the agreement, MultiCorp will have full authority to oversee the clinical trials of the product, marketing and selling of the medication, as well the overall business of getting the product to market as quickly as possible and retaining a 70% interest in the product. With the average cost of $145 per month in medication for migraine sufferers, the market for this product is exponential here in the U.S. and globally."
For companies wishing to assist MultiCorp in clinical trials, please email us at firstname.lastname@example.org
About MultiCorp International
MultiCorp International, Inc is a diverse company that operates in various business sectors that show true growth potential. The company builds on its executives experience in property development, constructions, medical, and hospitality as well as commodities such as oil and gas, and entertainment.
MultiCorp seeks out and acquires companies in several targeted business fields that have strong potential, seasoned management experience, and show true potential for exponential growth.
While our process may seem simple to some - look for and acquire companies in growth sectors - our standards are set high. A complete due diligence package must be met before any consideration is made to move forward. If, at any time, any component of our criteria is not met, that potential business will not be considered to become part of MultiCorp International, Inc.
MultiCorp will continue to build and grow in the future. Our expansion will be global in nature and the company continues to look at projects/companies throughout the world. The vision of management for MultiCorp is to diversify into many fields wherein management's expertise along with our strategic partners experience will raise the company's bottom line profitability
Paul D. Lisenby - Chairman and CEO
Mr. Lisenby has been in the capital markets since 1996. Paul managed a $100 million fund that invested in small cap companies, large indexes as well as private equity funding. In addition, Paul was responsible for negotiating several acquisitions to include a software company valued at $186 million dollars as well as several other companies that brought in over $200 million in revenue throughout his executive career. Mr. Lisenby has been at the helm of MultiCorp since its inception in 2007 as XTend Medical. Mr. Lisenby holds a BA and MBA.
Ben Friedman - President
Mr. Friedman has worked in the medical and pharmacology business for over 35 years. A licensed pharmacist, Mr. Friedman has overseen developing several proprietary prescription compounds and several OTC medications throughout his career. In addition, Ben owned hotels and other properties he's developed. Ben also has been working in the capital markets since 2005 wherein his financial acumen has helped companies raise in excess of $15 million in private funding. Mr. Friedman currently holds a BA in business and is currently licensed to practice pharmacy in California and hold his board certification in pharmacology
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MultiCorp International, Inc
10771 Sherman Way
Sun Valley, CA 91352
Phone: (818) 255-2476
Fax: (818) 255-2122
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As of Sept 30, 2012 the company has 1,392,887,031
shares of common stock issued and outstanding.