In December 2005, MultiCell exclusively licensed LAX-202 from Amarin Neuroscience Limited ("Amarin") for the treatment of fatigue in patients suffering from multiple sclerosis ("MS"). MultiCell renamed LAX-202 to MCT-125, and intends to further evaluate MCT-125 in a pivotal Phase IIb/III clinical trial. In a 138- patient, multi-center, double-blind placebo controlled Phase II clinical trial conducted in the United Kingdom by Amarin, LAX-202 demonstrated efficacy in significantly reducing the levels of fatigue in MS patients enrolled in the study. LAX-202 proved to be effective within four weeks of the first daily oral dosing, and showed efficacy in MS patients who were moderately as well as severely affected. LAX-202 demonstrated efficacy in all MS patient sub-populations including relapsing-remitting, secondary progressive and primary progressive. Patients enrolled in the Phase II trial conducted by Amarin also reported few if any side effects following daily oral dosing of LAX-202. MultiCell intends to proceed with the anticipated Phase IIb/III trial of MCT-125 using the data generated by Amarin for LAX-202 following discussions with the regulatory authorities.
Multicell intends to proceed with the anticipated pivotal Phase IIb/III trial of MCT-125 using the data generated by Amarin for LAX-202 following discussions with the FDA. If MCT-125 is approved for the treatment of fatigue in MS patients by the FDA and other such regulatory agencies, and is successfully commercialized, Multicell estimates MCT-125 could generate up to $3 billion in cumulative worldwide sales during the time MCT-125 is under patent protection. If such revenue forecasts are realized by MCT-125, under the terms of the agreement, Amarin could receive up to $275 million in milestone payments and cumulative royalty payments during the same period.
Dr. Stephen Chang, President of Multicell said, “We are excited about in-licensing MCT-125 from Amarin to complement our emerging MS therapeutics program. MCT-125 targets the fatigue symptom while MCT-175, our internally developed humanized antibody therapeutic, is for treatment of the underlying cause of MS. As we undertake additional clinical studies, we are optimistic MCT-125 will continue to demonstrate efficacy for the treatment of fatigue in MS patients.”
MultiCell has an exclusive license and purchase agreement with Corning of Corning, New York. Under the terms of such agreement, Corning has the right to develop, use, manufacture and sell MultiCell's Fa2N-4 cell lines and related cell culture media for use as a drug discovery assay tool, including biomarker identification for the development of drug development assay tools, and for the performance of absorption, distribution, metabolism, elimination and toxicity assays (ADME/Tox assays). Corning paid MultiCell a non-refundable license fee, purchased certain inventory and equipment related to MultiCell's Fa2N-4 cell line business, hired certain MultiCell scientific personnel, and paid for access to MultiCell's laboratories during the transfer of the Fa2N-4 cell lines to Corning. MultiCell retained and continues to support all of its existing licensees. MultiCell retained the right to use the Fa2N-4 cells for use in applications not related to drug discovery or ADME/Tox assays. MultiCell also retained rights to use the Fa2N-4 cell lines and other cell lines to further develop its Sybiol? liver assist device, to identify drug targets and for other applications related to the Company's internal drug development programs.
The Company has an exclusive license and purchase agreement (the “Agreement”) with Corning of Corning, New York. Under the terms of the Agreement, Corning has the right to develop, use, manufacture, and sell the Company’s Fa2N-4 cell lines and related cell culture media for use as a drug discovery assay tool, including biomarker identification for the development of drug development assay tools, and for the performance of absorption, distribution, metabolism, elimination and toxicity assays (“ADME/Tox assays”). The Company retained and will continue to support all of its existing licensees. The Company retains the right to use the Fa2N-4 cells for use in applications not related to drug discovery or ADME/Tox assays. The Company also retains rights to use the Fa2N-4 cell lines and other cell lines to further develop its Sybiol® liver assist device, to produce therapeutic proteins using the Company’s BioFactories™ technology, to identify drug targets and for other applications related to the Company’s internal drug development programs. In consideration for the license granted, Corning paid the Company $375,000 upon execution of the Agreement, and an additional $375,000 upon the completion of a transition period. In addition, Corning purchased inventory and equipment from the Company and reimbursed the Company for laboratory costs and other expenses during a transition period. The Company is recognizing the income ratably over a 17 year period. The Company recognized $44,118 in income for each of the fiscal years ended November 30, 2013 and 2012. The balance of deferred revenue from this license is $477,942 and $522,059 at November 30, 2013 and 2012, respectively, and will be amortized into revenue through October 2024.
MultiCell Technologies is Granted U.S. Patent for Immortalized Human Liver Cell Lines MultiCell Strengthens Its Liver Cancer Drug Target Identification and Cancer Stem Cell Research Program
WOONSOCKET, R.I., Aug. 20 /PRNewswire-FirstCall/
WOONSOCKET, R.I., Aug. 20 /PRNewswire-FirstCall/ -- MultiCell Technologies, Inc. (OTC Bulletin Board: MCET) announced today it has been granted U.S. patent 7,566,567 by the United States of America Patent and Trademark Office covering its Fa2N-4 and Ea1C-35 immortalized human hepatocyte cell lines. The Fa2N-4 and Ea1C-35 immortalized human hepatocyte cell lines were derived from normal human liver cells, and are nontumorigenic, stable in culture, and produce therapeutic plasma proteins in cell culture. The Fa2N-4 cell line has also been engineered to function as a proxy for normal human liver cells for use in performing drug toxicity assays. MultiCell has licensed several pharmaceutical companies rights to use the Fa2N-4 cell line for drug toxicity applications including Pfizer, Bristol-Myers Squibb, and Eisai Pharmaceuticals. MultiCell licensed Corning, Inc. to sell the Fa2N-4 cell line and media within the drug discovery and life science research markets for drug toxicity (Tox) applications as well as for drug adsorption, distribution, metabolism and excretion (ADME) studies. MultiCell retained worldwide exclusive ownership of the Fa2N-4 and Ea1C-35 cell lines for all applications other than ADME/Tox, including drug target identification and using the cell lines for the production of therapeutic plasma proteins.
MultiCell Technologies Files U.S. and International Patent Applications for the Treatment of Liver Cancer
MultiCell Technologies, Inc. March 20, 2014 8:39 AM
WOONSOCKET, R.I., March 20, 2014 /PRNewswire/ -- MultiCell Technologies, Inc. (OTC Bulletin Board: MCET) has filed additional U.S. and international patent applications covering MCT-485 and its composition of matter, biological targets, mechanism of action, and methods and formulations for therapeutic use.
Any proprietary protection that we can obtain and maintain will be important to our business.
On September 7, 2005, MCTI, entered into an Asset Contribution Agreement (the “Asset Contribution Agreement”) with MultiCell, Alliance Pharmaceutical Corp. (“Alliance”), and Astral, Inc. (“Astral,” and together with Alliance, (“Transferors”). Pursuant to the Asset Contribution Agreement, MCTI issued 490,000 shares of common stock to Alliance in consideration for the acquisition of certain assets and the assumption of certain liabilities relating to Transferors’ business. The intellectual property acquired by MCTI includes ten United States and 20 foreign issued and pending patents and patent applications related to chimeric antibody technology, treatment of Type 1 diabetes, T-cell tolerance, TLR technology, dendritic cells, dsRNA technology and immunosuppression.
In December 2003, we acquired the exclusive worldwide rights to US Patent # 6,129,911, for Liver Stem Cells from Rhode Island Hospital. We agreed to pay an annual license fee of $20,000 for the first three years of the applicable license agreement and $10,000 per annum thereafter until a product is developed. Once a product is developed, if ever, the annual license fee will end and we will pay Rhode Island Hospital a five percent royalty on net sales of any product we sell covered by the patent until we pay an aggregate of $550,000 in royalties and a two percent royalty thereafter until the expiration of the patent. The expiration date of this patent is October 10, 2017.
In April 2005, we were granted US Patent # 6,872,389 for the liver stem cell invention of Dr. Ron Faris, MultiCell’s former Senior Vice President and Chief Scientific Officer. This patent contains 24 claims to a method of obtaining a population of liver cell clusters from adult stem cells and is an important enhancement to our adult stem cell portfolio. The expiration date of this patent is July 8, 2019.
We have an exclusive, long-term license agreement with Rhode Island Hospital for use of the following patents owned by the hospital related to liver cell lines and Liver Assist Devices (LADs):
US Patent #6,017,760, Isolation and Culture of Porcine Hepatocytes, expires October 9, 2015; US Patent #6,107,043, Immortalized Hepatocytes, expires February 8, 2019; US Patent #6,129,911, Liver Stem Cell, expires October 10, 2017; and US Patent #6,872,389 Liver Stem Cell expires on July 8, 2019.
If we generate revenues and pay royalties, the annual license fee structure does not apply. Our agreement with Rhode Island Hospital provides that we would pay a five percent royalty until we pay Rhode Island Hospital an aggregate of $550,000. After that, the royalty percentage decreases to two percent for the life of the patents.
On November 3, 2003, Xenogenics was notified by the United States Patent and Trademark Office that its patent application for an “Artificial Liver Apparatus And Method”, the Sybiol® Synthetic Bio-Liver Device, would be allowed. United States patent 6,858,146 was issued in 2005. The expiration date of this patent is February 22, 2026. The Sybiol® trademark is registered in the United States Patent and Trademark Office, number 2,048,080.
Xenogenic’s Ideal BioStent™ is covered by patents owned by Rutgers and exclusively licensed to Xenogenics. The license between Xenogenics and Rutgers includes exclusive license rights and option to 23 issued patents and 61 patent applications with claims encompassing the basic design and synthesis of certain bioabsorbable polymers and their use in combination with drugs in medical devices.
The patent estate acquired by Xenogenics as part of its acquisition of the Ideal BioStent™ includes one issued U.S. patent and four patent applications. This patent estate covers the composition and synthesis of the Ideal BioStent™ proprietary bioabsorbable polymers, admixing of drugs and bioabsorbable polymers for therapeutic applications, and the use of these bioabsorbable polymers in stents and other medical devices.
US Patent #6,017,760, Isolation and Culture of Porcine Hepatocytes, expires October 9, 2015
Isolation and culture of porcine hepatocytes US 6017760 A
ABSTRACT
A perfusion device such as a liver assist device containing a housing defining a perfusion inlet and a perfusion outlet, a porous membrane structure mounted within said housing to define a perfusion compartment and an adjacent hepatocyte compartment, and porcine hepatocytes isolated from a porcine liver by retrograde perfusion.
US Patent #6,107,043, Immortalized Hepatocytes, expires February 8, 2019
Immortalized hepatocytes US 6107043 A
ABSTRACT
The invention features a virally-immortalized mammalian hepatocyte, which is derived from a normal liver cell, has differentiated hepatocyte-specific metabolic activity, has the ability to proliferate, and is nontumorigenic after prolonged culture.
US Patent #6,129,911, Liver Stem Cell, expires October 10, 2017
Liver stem cell US 6129911 A
ABSTRACT
The invention provides a primary liver stem cell and a cell doublet consisting of a hepatocyte and the stem cell, both of which are derived from normal liver tissue. Methods of isolating the cells, genetically altering the cells, and using the cells for transplantation are also within the invention.
US Patent #6,872,389 Liver Stem Cell expires on July 8, 2019
Liver stem cell US 6872389 B1
ABSTRACT
The invention provides methods of isolating a primary liver stem cell by identifying a cell doublet containing a hepatocytes and the stem cell and isolating the doublet from liver tissue.
US Patent #6,858,146 Artificial Liver Apparatus And Method
Artificial liver apparatus and method US 6858146 B1
ABSTRACT
Artificial liver devices and methods for using the devices to purify a biological fluid are disclosed. The methods include the use of living hepatocytes (23) which are either unattached or attached to inert carriers and suspended in a cell culture medium which circulates in the devices with the hepatocytes (23). Blood or plasma passes on one side (7?) of semi-permeable membranes, on the other side (7) of which is the cell culture medium and across which is a concentration and/or pressure gradient. Solutes diffusing across the membrane into the cell culture medium are metabolized by the hepatocytes (23) and/or captured by additional removal means (4). Those undesirable substances which do not diffuse out of the blood or plasma into the hepatocyte containing culture medium are captured by additional removal means (50).
Patent Portfolio of MultiCell Technologies, Inc., MultiCell Immunotherapeutics and majority-owned subsidiary, Xenogenics. Patents already published which can be found in the public domain.
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