Monica A. Kolinsky, Ph.D.

Experience

  • Represented Medivir AB in its acquisition of two clinical stage oncology programs from Tetralogic Pharmaceuticals Corporation, including remetinostat, a skin-directed HDAC inhibitor, and birinapant, a bivalent SMAC mimetic, and all intellectual property and data associated with Tetralogic’s HDAC inhibitor and SMAC mimetics projects. Medivir will also assume agreements or certain obligations with other third parties, including an agreement with Merck & Co., Inc. (MSD outside of the US and Canada) for a phase I study of birinapant in combination with Keytruda™, subject to confirmation from Merck.  Tetralogic and other third party licensees are eligible to receive various development milestone payments and royalties.
  • Represented Cormorant Pharmaceuticals AB in its stock purchase agreement in connection with the sale to Bristol-Myers Squibb Company (BMS) of all of Cormorant’s outstanding capital stock and in which BMS obtained full rights to Cormorant's lead antibody candidate, HuMax-IL8. HuMax-IL8 is a Phase 1/2 monoclonal antibody targeted against interleukin-8 (IL-8) that represents a complementary immuno-oncology mechanism of action to T-cell directed antibodies and co-stimulatory molecules. Payments by BMS to the Cormorant equity holders could reach a total of $520 million if all clinical and regulatory milestones are achieved.
  • Represented Probi AB (publ) (NASDAQ OMX), in the acquisition of the operations of TNTGamble, Inc. d/b/a Nutraceutix®, a leading U.S. manufacturer and supplier of probiotics, headquartered in Redmond, WA, with operations in Lafayette, CO.
  • BioInvent International AB’s collaboration with Transgene S.A. to co-develop next generation oncolytic virus candidates encoding a CTLA-4 antibody sequence—potentially with additional transgenes— capable to treating multiple types of solid tumors. Under the terms of the agreement, Transgene will contribute its virus design and engineering expertise and BioInvent will provide its cancer biology and antibody expertise as well as anti-CTLA-4 monoclonal antibody coding sequences.  The collaboration’s research and development costs, and revenues and royalties from candidates generated by the collaboration, will be shared 50:50.
  • Immunova LLC’s joint venture with SalvaRx Limited focused on the use of nanolipogel technology invented at Yale University. The joint venture agreement creates a new company called Saugatuck Therapeutics Ltd which has acquired an exclusive license from Yale University through Immunova for the use of the nanolipogel platform for delivering DNA aptamers and certain aptamer-based combination products. Under the terms of the agreement, SalvaRx will initially invest $1 million to be release in tranches on the completion of milestones.  The first tranche will provide Saugatuck $300,000 to be used to establish proof of concept for the joint venture.
  • Aptar Pharma’s (part of AptarGroup, Inc.) partnership with Kali Care to develop connected ophthalmic drug delivery devices by combining Aptar’s ophthalmic device expertise and Kali Care’s proprietary digital monitoring system for ophthalmic medications in order to address the challenge of monitoring adherence in ophthalmic clinical trials.
  • BioInvent International AB’s collaboration and license agreement with Pfizer Inc. to undertake a research collaboration to discover and develop novel immuno-regulatory antibodies to treat cancer. BioInvent will apply its unbiased translational drug discovery platform (“F.I.R.S.T.”) to identify novel oncology targets and therapeutic antibodies targeting tumor-associated myeloid cells. BioInvent will receive approximately $10 million in early payments, including an upfront payment, early research funding and an equity investment.  Assuming five antibodies are developed through to commercialization, BioInvent would be eligible for potential future development milestone payments of more than $0.5 billion through the term of the deal, as well as double digit royalties on sales of products that result from the collaboration.
  • Affibody AB’s collaboration and license agreement with Alexion Pharmaceuticals, Inc. to co-develop ABY-039 for rare Immunoglobulin G (IgG)-mediated autoimmune diseases. Currently in Phase 1 development, ABY-039 is a bivalent antibody-mimetic that targets the neonatal Fc receptor (FcRn). ABY-039 has been specifically designed to combine Affibody’s proprietary protein therapeutics platforms to achieve a long half-life, which, along with its small size provides the potential for less frequent, convenient, at-home subcutaneous administration.  Under the terms of the agreement, Affibody is eligible to receive up to $650 million in upfront payments, and development and sales milestones, and tiered low double-digit royalties. Affibody retained the rights to lead clinical development of ABY-039 in an undisclosed indication and has the option to co-promote ABY-039 in the United States.
  • Klaria AB’s exclusive development agreements with Purdue Pharma (Canada) for each of KL-00514, a naloxone buccal film intended for acute treatment of intentional or accidental opioid overdose, and KL-01401, an epinephrine oromucosal film for emergency treatment of severe anaphylactic reactions.  The co-development programs for each product will include formulation selection and optimization, pre-clinical studies and clinical trials.  The development agreements both include global license options for Purdue’s independently associated network of companies upon achievement of defined milestones. Purdue Pharma (Canada) will pay Klaria a combination of upfront, milestone, success-based payments plus a royalty on sales and possible income from Klaria’s exclusive supply of the product. Staged, success-based payments during the development phase and regulatory approval process will total around $2.3 million for KL-00514 and $55.2 million for KL-01401.
  • BioInvent International AB's manufacturing agreement with CardioVax for the production of orticumab, previously known as BI-204, following on from a global license agreement signed between BioInvent and CardioVax for the development of antibody therapeutics for treatment of inflammatory diseases.  BioInvent is expected to generate short-term manufacturing revenue of around US$3 million.
  • Photocure ASA’s exclusive distribution agreement with Combat Medical for the Nordic region for Combat’s patented medical device designed for the delivery of Hyperthermic Intra-Vesical Chemotherapy (HIVEC®) for non-muscle invasive bladder cancer.
  • PledPharma AB’s license agreement with Solasia Pharma K.K. for exclusive development and commercialization in several major Asian markets of PledPharma’s product PledOx®, for prevention of chemotherapy-induced peripheral neuropathy in colorectal cancer patients. Solasia will pay up front, development, regulatory and sales milestones of up to around US$ 83 million, and industry standard royalty rates on sales for a deal pertaining to an in-licensed asset in Phase III development. Solasia will also fully finance an expansion of the Phase III program to include Asian patients.
  • Immunova LLC’s exclusive license of its IMM-01 nanolipogel drug delivery technology to Modulate Therapeutics Inc. for delivering a TGF beta inhibitor combined with IL-2 to tumors.  Modulate Therapeutics Inc., a special purpose company based in Montréal, Québec, plans to develop, to clinical proof-of-concept, IMM-01 which is designed to re-engage the immune system in order to recognize and eradicate neoplastic disease.
  • Targovax ASA’s clinical trial cooperation agreement with Sotio a.s. to conduct a collaboration study combining ONCOS-102 and Sotio's dendritic cell therapy to evaluate the safety and tolerability in the treatment of advanced prostate cancer.
  • Alligator Bioscience AB’s collaboration and license with Janssen Biotech under which Janssen is granted an exclusive, worldwide license to Alligator’s clinical candidate ADC-1013, an agonistic fully human monoclonal antibody targeting CD40, an immuno-stimulatory receptor. Alligator receives an up-front payment plus additional contingent payments upon reaching certain pre-determined development, regulatory and commercial milestones up to a potential total of US$700 million. Alligator is also eligible to receive tiered royalties on worldwide net sales. In a simultaneous transaction a Janssen affiliate subscribed for new shares of Alligator common stock.
  • Photocure ASA’s exclusive worldwide license agreement with Asieris Meditech Co., Ltd to develop and commercialize Cevira® for the treatment of HPV-induced cervical precancerous lesions.  Under the agreement, Photocure will receive a total signing fee of $5 million within six months of signing.  Photocure would also be eligible to receive up to $54 million upon Asieris’ achievement of certain clinical and regulatory milestones in China, the US and EU, and up to an additional $14 million for approval of a second indication in China, the US and the EU.  Additionally, sales milestone payments and royalties of 10 to 20% will apply in all markets.