Forum Topic Business
  • Conversation: New Project

    • June 13, 2021 3:05 PM BST
    • New Project

      I am doing a new project now, as agent for in-licensing and out-licensing / export development.
      I have three products for in-licensing for international markets, one product is a pharmaceutical and two products are dietary supplements.
      They are already in circulation in multiple markets, including Europe.
      They can be under private trademark in local markets. That could be of interest for your clients. Please take a look - below.
      About products and Company:
      I have a client, a Cyprus company, AVVA, with manufacturing facilities in a number of countries. Owners are private persons and entities, of various nationalities (not only from Cyprus but also Russia, US, and others) residing in Cyprus, they operate in a number of countries.
      Micrazym: Pancreatin Gastro-Resistant Pellets
      They developed a proprietary patented technology to produce digestive enzymes in controlled release pellets protected against gastric acid.
      The original product is Creon (used to be Solvay's now Mylan's).
      That product works better than regular digestive enzymes, and is widely prescribed by pediatricians, general practitioners etc. due to its improved action.
      They are looking to out-license the product for multiple countries (in some countries, they already have partners, in some - no).
      If you wish to offer that product to your clients, is possible under their trademark (TM) or under your own TM.
      Every collaboration scenario is negotiable - finished product, semi-finished, or API for full manufacturing in your country.
      If your company is interested, it can take it for your country and other markets, or just other markets.
      The product has two presentations - 10 000 IU and 25 000 IU. Whereas 25 000 IU is a prescription product, the smaller dose - 10 000 IU is an OTC product, thus, can be registered as an OTC or as a supplement, too, subject to specific countries' regulations. Usually, a supplement is fast to get a marketing authorization, then - OTC, and Rx - the longest, that's why those options are important.
      The product is manufactured at an EU GMP facility (the EU GMP certificate is issued by Cyprus authorities).
      It can benefit your portfolio since it is a proprietary technology product, unique, almost no one has it. Therefore, it will catch attention of medical community and customers, boost professional and public interest to your company and help expand your sales.
      Also, AVVA is looking to out-license two more products, which are dietary supplements by their regulatory status.
      Please find product descriptions for the supplements, below (also can go under your company's trade marks).
      FILTRUM is a non-systemic, universal approach to the diarrhea management.
      Available treatment options fail to be effective unless the specific cause has been identified. The medical community demands for an effective, universal and safe approach without contraindications and safety concerns. It contains Lignin, a polymer of plant origin, a polysaccharide with developed porous structure, obtained by the acid hydrolysis of wood. Lignin possesses a high sorption spectrum activity as well as a high sorption capacity with a pronounced activity towards pathogenic microorganisms and toxicants and not to the symbiotic biota.
      Registration route depends on local requirement. FILTRUM has the following grades:
      - dietary nutritional supplement
      - herbal product / borderline medicine
      Perhaps Filtrum could be registered as a food supplement in Italy.
      Local regulatory guideline is pivotal on the product status.
      Over 30 million FILTRUM packs sold worldwide.
      Reference for the supplement:
      LACTOFILTRUM - management of atopic dermatitis (Eczema).
      Disease burden:
      • 50% of parents stated that adults and other children avoided interacting with their children with AD;
      • 32% of participants believed that AD affected their school or work life;
      • 1.5 hour spent by mothers and fathers, per night attending to AD children.
      LACTOFILTRUM’s development is derived from our understanding of the gut biota and its role on the gastrointestinal integrity and permeability, limiting the interaction of allergens, pathogenic micro-organisms and toxicants, with the endothelium. LACTOFILTRUM is a combination of an enteron sorbent, Lignin hydrolyzed and a prebiotic disaccharide, Lactulose. Due to its composition (indigestible dietary fibers) LACTOFILTRUM tablets are pharmacologically inert, passing though the upper gastrointestinal tract and reach colon unchanged.
      The bifidogenic activity of Lactulose: Lactofiltrum tablets stimulate growth and activity of the intestinal normal flora, providing by that positive environment for immunostimulatory function of normal flora; that leads to suppression of bacterial translocation mechanisms, decrease the number of Enterobacteriaceae, and reduction of intraluminal and systemic endotoxin development.
      Lignin hydrolyzed, having a high sorption capacity, binds and removes allergens, mediators, products of allergic reaction, metabolites, toxins, and active peroxide compounds from intestine.
      Lactulose also stimulates synthesis of short-chain fatty acids by Bifidobacterial and Lactobacilli. Short-chain fatty acids can influence immune modulation, due to their ability to increase the production of IL-10 and TGF-β1 which, being anti-inflammatory cytokines, play a key role in reduction of allergen-induced response.
      Over 40 million LACTOFILTRUM packs sold worldwide
      Reference for the supplement:
      Should that be of interest for you, I will introduce you to AVVA top management, and you will discuss in-licensing that product with them directly.
      Let me know your feedback. Thanks.

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