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Licencing Opportunities List

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Elan Drug Technologies
Elan Drug Technologies

Elan Drug Technologies has a number of products available for licensing to pharmaceutical companies in the U.S. and worldwide. These products have incorporated one or more of our drug delivery technologies and are at late stage development or approved for marketing. Other products at earlier stage development are also available for licensing.

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Product Availability List 2011 Non-Confidential Information Pack DATE: Q1 2011
Product Availability List Non-Confidential Information Pack | DATE: 2011 Elan Drug Technologies’ Product Availability List Elan Drug Technologies has a number of products available for licensing to pharmaceutical companies in the U.S. and worldwide. These products have incorporated one or more of our drug delivery technologies and are at late stage development or approved for marketing. Other products at earlier stage development are also available for licensing. If you are interested in discussing any of these product opportunities in more detail or wish to obtain more information under confidentiality or wish to discuss in-licensing opportunities in general, please contact us: USA Scott Jenkins – Shawn.Bridy@elan.com ROW Sarah Carty – Sarah.Carty@elan.com Page 2 of 13 More detailed non-confidential packages are available on request on all products profiled here
Product Availability List Non-Confidential Information Pack | DATE: 2011 Docetaxel Solvent Free Formulation Taxanes/Solid Tumour cancers. Class/Indication Lyphophilised, nanoparticulate IV formulation of Dosage Form Docetaxel. Preclinical dose ranging studies performed. Dosage Strength Unlike Taxotere®, Elan Drug Technologies' NanoCrystal® formulation does not require solvents such as polysorbate 80 and ethanol to solubilise the drug. The NanoCrystal® formulation contains sterilised water and GRAS stabilisers and is devoid of solvents. Comment Elan Drug Technologies is seeking a licensing partner that has development and marketing expertise in oncology to develop and market this unique formulation of docetaxel. Clinical development. Licensing Status Available for licensing all territories. Page 3 of 13 More detailed non-confidential packages are available on request on all products profiled here
Product Availability List Non-Confidential Information Pack | DATE: 2011 Twice Daily, novel controlled release hydrocodone for Severe Pain Opioid for severe pain relief. Class/indication Twice daily. Dosage Frequency Oral dosage form using the SODAS® technology. Dosage Form A novel, oral, single-entity, controlled-release formulation of hydrocodone, developed using Elan Drug Technologies’ SODAS® technology, is being studied for the treatment of moderate to severe chronic pain in individuals who require around-the-clock opioid therapy for the control of pain in the US. Comment At present there are no products available as single- entity, controlled-release formulations of hydrocodone in the United States. Using Elan Drug Technologies’ SODAS® technology, this product, offers a unique, controlled-release profile which utilises both immediate release and extended release properties designed to enable twice daily dosing. Phase II trials complete, undergoing Phase III studies in the US. Licensing Status Available for licensing in all territories ex-US. Page 4 of 13 More detailed non-confidential packages are available on request on all products profiled here
Product Availability List Non-Confidential Information Pack | DATE: 2011 Intravenous, Once Daily, Rapid Onset, Non-Opioid for Acute Pain Management Non-steroidal anti-inflammatory, pain relief. Class/indication Once daily. Dosage Frequency Intravenous Formulation using NanoCrystal® technology Dosage Form Elan Drug Technologies is seeking a licensing and development partner for its’ novel NanoCrystal® formulation of an IV NSAID for use targeting acute pain relief. Comment An aqueous IV formulation whose target profile includes a rapid onset of action and a 24-hour duration of action. It is stable at ambient temperature and available in a ready to use vial. No refrigeration or reconstitution is required prior to administration. Phase II trials complete. Licensing Status Available for licensing in all territories. Page 5 of 13 More detailed non-confidential packages are available on request on all products profiled here
Product Availability List Non-Confidential Information Pack | DATE: 2011 Megestrol acetate Progestins/Cachexia. Class/Indication 5ml. Dosage Frequency Oral suspension using the NanoCrystal® technology. Dosage Form 625mg/5ml. Dosage Strength Through applying the NanoCrystal® technology, a superior more palatable product with a significantly lower dosage than original product was developed. Therapeutic Viscosity reduced 16-fold, volume swallowed reduced by Advantage 75% and has a free of food effect. Indicated for treatment of anorexia, cachexia or unexplained significant weight loss in patients with AIDS. Approved and launched in the US in 2005 as Megace® ES. Licensing Status Available for licensing in all territories ex-US. Phase III studies complete in Europe. Page 6 of 13 More detailed non-confidential packages are available on request on all products profiled here
Product Availability List Non-Confidential Information Pack | DATE: 2011 Morphine Once Daily (Avinza®, Morphelan®) Narcotic analgesic/Severe chronic pain. Class/indication Once daily. Dosage Frequency Multiparticulate SODAS® beads in hard gelatin capsules. Dosage Form 30mg, 60mg, 90mg and 120mg. Dosage Strength Elan Drug Technologies has received approval with the FDA and is marketing through a licensing partner in the U.S. their once daily oral morphine product which gives round the clock pain relief without breakthrough pain. Comment Other once daily formulations, which have been launched, do not provide adequate cover for full 24-hour relief and often have to be supplemented with other analgesics to relieve breakthrough pain - this Elan Drug Technologies formulation overcomes this problem. Approved and launched in the US in 2002. Licensing Status Filed in Europe, available for licensing in all territories ex-North America. Page 7 of 13 More detailed non-confidential packages are available on request on all products profiled here
Product Availability List Non-Confidential Information Pack | DATE: 2011 Naproxen Sodium (Naprelan®) Non-steroidal anti-inflammatory/anti-rheumatic, pain Class/Indication relief. Once daily. Dosage Frequency High-density multiparticulate IPDAS® cores in a Dosage Form specialised table matrix 500 mg Dosage Strength Elan Drug Technologies has developed a once daily form of Naproxen for use as anti-rheumatic/arthritic and analgesic. The specialised tablet matrix allows for rapid disintegration and a micro-dispersion of the IPDAS® Comment cores in the gastrointestinal tract. The nature of the controlled diffusion and absorption of Naprelan® reduces gastrointestinal side effects normally seen with naproxen. Launched in the US and Canada. Licensing Status Available for licensing in all territories ex-North America. Page 8 of 13 More detailed non-confidential packages are available on request on all products profiled here
Product Availability List Non-Confidential Information Pack | DATE: 2011 Novel Diagnostic Imaging Agents Diagnostic imaging agents. Class/Indication Nanoparticulate size diagnostic agents using Dosage Form NanoCrystal® formulation Elan Drug Technologies’ portfolio of novel, NanoCrystal® diagnostic imaging agents have clear advantages over current iodinated contrast agents. A portfolio of patent protected diagnostic agents is available for licensing which have excellent contrast for an extended period of time. EDT’s portfolio of NanoCrystal® imaging agents are Comment poorly-water soluble, non-osmotic, iodine-rich compounds. Adjustable hydrolysable linkages allow for a controlled elimination and slow diffusion of the Nano- DI agents which provide significantly longer residence time than current iodinated agents. EDT has a portfolio of imaging compounds in pre-clinical development. Lead compounds have been identified, which have been found to be stable. Licensing Status To date, in vivo studies have been completed in rabbits. Available for licensing in all territories worldwide. Page 9 of 13 More detailed non-confidential packages are available on request on all products profiled here
Product Availability List Non-Confidential Information Pack | DATE: 2011 Verapamil (Verelan®) Calcium antagonist/Antihypertensive/antianginal. Class/Indication Once daily. Dosage Frequency Multiparticulate SODAS® beads in hard gelatin capsules. Dosage Form 80 mg, 120 mg, 180 mg, 240 mg and 360mg. Dosage Strength Verelan® is a unique once daily formulation of Verapamil. It is approved for once daily administration up to the maximum total daily dose, whereas other SR products Comment are required to be administered in divided doses. Also, Verelan® does not exhibit any food effects and a wide range of dosage options are available, allowing for easy titration for all patients. Launched in US, Japan and some European and Asian markets. Licensing Status Available for licensing in number of European territories. Page 10 of 13 More detailed non-confidential packages are available on request on all products profiled here
Product Availability List Non-Confidential Information Pack | DATE: 2011 Verapamil PM (Verelan® PM) Calcium antagonist/ Antihypertensive/antianginal. Class/Indication Dosage Frequency Once daily. Multiparticulate CODAS® beads in hard gelatin capsules. Dosage Form 100mg, 200mg and 300mg. Dosage Strength Verelan® PM is a unique once daily formulation of Verapamil which offers the patient maximum protection against the morning surge in blood pressure when patients are most at risk. The CODAS® technology provides peak dose levels in Comment the early morning. Also, Verelan® PM does not exhibit any food effects and a wide range of dosage options are available, allowing for easy titration for all patients. Launched in the US. Licensing Status Available for licensing all territories ex-US. Page 11 of 13 More detailed non-confidential packages are available on request on all products profiled here
Product Availability List Non-Confidential Information Pack | DATE: 2011 Company Profile Elan Drug Technologies is seeking a marketing partner on an exclusive or territory basis. Elan Drug Technologies will retain commercial manufacturing rights of these products. Elan believes this directly benefits the potential partner due its expertise and successful track record in formulation, scale-up and manufacturing. About Elan Drug Technologies Elan Drug Technologies is the world’s leading drug delivery company and is a business unit of Elan (NYSE:ELN). As a fully integrated drug delivery business, we deliver clinically meaningful benefits to patients, by using our extensive experience and proprietary delivery technologies in partnership with pharmaceutical companies to develop new and innovative products. For 40 years, we have been applying our skills and knowledge from concept development, right through to full scale manufacturing. We have been, and continue to be, the drug delivery provider of choice for a broad range of pharmaceutical companies, including many of the world’s largest pharmaceutical companies. For more information about Elan’s technology offerings, please visit http://www.elandrugtechnologies.com. Page 12 of 13 More detailed non-confidential packages are available on request on all products profiled here
Contact us USA ROW Shawn Bridy Dr Sarah Carty Director, Business Development Director, Business Development Elan Drug Technologies Elan Drug Technologies 3500 Horizon Drive Treasury Buildings, Lwr Grand Canal St, King of Prussia, PA 19406 Dublin 2, Ireland T 610 270 8442 T +353 1 709 4046 E shawn.bridy@elan.com E sarah.carty@elan.com

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Licencing Opportunities List

  • 1. Product Availability List 2011 Non-Confidential Information Pack DATE: Q1 2011
  • 2. Product Availability List Non-Confidential Information Pack | DATE: 2011 Elan Drug Technologies’ Product Availability List Elan Drug Technologies has a number of products available for licensing to pharmaceutical companies in the U.S. and worldwide. These products have incorporated one or more of our drug delivery technologies and are at late stage development or approved for marketing. Other products at earlier stage development are also available for licensing. If you are interested in discussing any of these product opportunities in more detail or wish to obtain more information under confidentiality or wish to discuss in-licensing opportunities in general, please contact us: USA Scott Jenkins – Shawn.Bridy@elan.com ROW Sarah Carty – Sarah.Carty@elan.com Page 2 of 13 More detailed non-confidential packages are available on request on all products profiled here
  • 3. Product Availability List Non-Confidential Information Pack | DATE: 2011 Docetaxel Solvent Free Formulation Taxanes/Solid Tumour cancers. Class/Indication Lyphophilised, nanoparticulate IV formulation of Dosage Form Docetaxel. Preclinical dose ranging studies performed. Dosage Strength Unlike Taxotere®, Elan Drug Technologies' NanoCrystal® formulation does not require solvents such as polysorbate 80 and ethanol to solubilise the drug. The NanoCrystal® formulation contains sterilised water and GRAS stabilisers and is devoid of solvents. Comment Elan Drug Technologies is seeking a licensing partner that has development and marketing expertise in oncology to develop and market this unique formulation of docetaxel. Clinical development. Licensing Status Available for licensing all territories. Page 3 of 13 More detailed non-confidential packages are available on request on all products profiled here
  • 4. Product Availability List Non-Confidential Information Pack | DATE: 2011 Twice Daily, novel controlled release hydrocodone for Severe Pain Opioid for severe pain relief. Class/indication Twice daily. Dosage Frequency Oral dosage form using the SODAS® technology. Dosage Form A novel, oral, single-entity, controlled-release formulation of hydrocodone, developed using Elan Drug Technologies’ SODAS® technology, is being studied for the treatment of moderate to severe chronic pain in individuals who require around-the-clock opioid therapy for the control of pain in the US. Comment At present there are no products available as single- entity, controlled-release formulations of hydrocodone in the United States. Using Elan Drug Technologies’ SODAS® technology, this product, offers a unique, controlled-release profile which utilises both immediate release and extended release properties designed to enable twice daily dosing. Phase II trials complete, undergoing Phase III studies in the US. Licensing Status Available for licensing in all territories ex-US. Page 4 of 13 More detailed non-confidential packages are available on request on all products profiled here
  • 5. Product Availability List Non-Confidential Information Pack | DATE: 2011 Intravenous, Once Daily, Rapid Onset, Non-Opioid for Acute Pain Management Non-steroidal anti-inflammatory, pain relief. Class/indication Once daily. Dosage Frequency Intravenous Formulation using NanoCrystal® technology Dosage Form Elan Drug Technologies is seeking a licensing and development partner for its’ novel NanoCrystal® formulation of an IV NSAID for use targeting acute pain relief. Comment An aqueous IV formulation whose target profile includes a rapid onset of action and a 24-hour duration of action. It is stable at ambient temperature and available in a ready to use vial. No refrigeration or reconstitution is required prior to administration. Phase II trials complete. Licensing Status Available for licensing in all territories. Page 5 of 13 More detailed non-confidential packages are available on request on all products profiled here
  • 6. Product Availability List Non-Confidential Information Pack | DATE: 2011 Megestrol acetate Progestins/Cachexia. Class/Indication 5ml. Dosage Frequency Oral suspension using the NanoCrystal® technology. Dosage Form 625mg/5ml. Dosage Strength Through applying the NanoCrystal® technology, a superior more palatable product with a significantly lower dosage than original product was developed. Therapeutic Viscosity reduced 16-fold, volume swallowed reduced by Advantage 75% and has a free of food effect. Indicated for treatment of anorexia, cachexia or unexplained significant weight loss in patients with AIDS. Approved and launched in the US in 2005 as Megace® ES. Licensing Status Available for licensing in all territories ex-US. Phase III studies complete in Europe. Page 6 of 13 More detailed non-confidential packages are available on request on all products profiled here
  • 7. Product Availability List Non-Confidential Information Pack | DATE: 2011 Morphine Once Daily (Avinza®, Morphelan®) Narcotic analgesic/Severe chronic pain. Class/indication Once daily. Dosage Frequency Multiparticulate SODAS® beads in hard gelatin capsules. Dosage Form 30mg, 60mg, 90mg and 120mg. Dosage Strength Elan Drug Technologies has received approval with the FDA and is marketing through a licensing partner in the U.S. their once daily oral morphine product which gives round the clock pain relief without breakthrough pain. Comment Other once daily formulations, which have been launched, do not provide adequate cover for full 24-hour relief and often have to be supplemented with other analgesics to relieve breakthrough pain - this Elan Drug Technologies formulation overcomes this problem. Approved and launched in the US in 2002. Licensing Status Filed in Europe, available for licensing in all territories ex-North America. Page 7 of 13 More detailed non-confidential packages are available on request on all products profiled here
  • 8. Product Availability List Non-Confidential Information Pack | DATE: 2011 Naproxen Sodium (Naprelan®) Non-steroidal anti-inflammatory/anti-rheumatic, pain Class/Indication relief. Once daily. Dosage Frequency High-density multiparticulate IPDAS® cores in a Dosage Form specialised table matrix 500 mg Dosage Strength Elan Drug Technologies has developed a once daily form of Naproxen for use as anti-rheumatic/arthritic and analgesic. The specialised tablet matrix allows for rapid disintegration and a micro-dispersion of the IPDAS® Comment cores in the gastrointestinal tract. The nature of the controlled diffusion and absorption of Naprelan® reduces gastrointestinal side effects normally seen with naproxen. Launched in the US and Canada. Licensing Status Available for licensing in all territories ex-North America. Page 8 of 13 More detailed non-confidential packages are available on request on all products profiled here
  • 9. Product Availability List Non-Confidential Information Pack | DATE: 2011 Novel Diagnostic Imaging Agents Diagnostic imaging agents. Class/Indication Nanoparticulate size diagnostic agents using Dosage Form NanoCrystal® formulation Elan Drug Technologies’ portfolio of novel, NanoCrystal® diagnostic imaging agents have clear advantages over current iodinated contrast agents. A portfolio of patent protected diagnostic agents is available for licensing which have excellent contrast for an extended period of time. EDT’s portfolio of NanoCrystal® imaging agents are Comment poorly-water soluble, non-osmotic, iodine-rich compounds. Adjustable hydrolysable linkages allow for a controlled elimination and slow diffusion of the Nano- DI agents which provide significantly longer residence time than current iodinated agents. EDT has a portfolio of imaging compounds in pre-clinical development. Lead compounds have been identified, which have been found to be stable. Licensing Status To date, in vivo studies have been completed in rabbits. Available for licensing in all territories worldwide. Page 9 of 13 More detailed non-confidential packages are available on request on all products profiled here
  • 10. Product Availability List Non-Confidential Information Pack | DATE: 2011 Verapamil (Verelan®) Calcium antagonist/Antihypertensive/antianginal. Class/Indication Once daily. Dosage Frequency Multiparticulate SODAS® beads in hard gelatin capsules. Dosage Form 80 mg, 120 mg, 180 mg, 240 mg and 360mg. Dosage Strength Verelan® is a unique once daily formulation of Verapamil. It is approved for once daily administration up to the maximum total daily dose, whereas other SR products Comment are required to be administered in divided doses. Also, Verelan® does not exhibit any food effects and a wide range of dosage options are available, allowing for easy titration for all patients. Launched in US, Japan and some European and Asian markets. Licensing Status Available for licensing in number of European territories. Page 10 of 13 More detailed non-confidential packages are available on request on all products profiled here
  • 11. Product Availability List Non-Confidential Information Pack | DATE: 2011 Verapamil PM (Verelan® PM) Calcium antagonist/ Antihypertensive/antianginal. Class/Indication Dosage Frequency Once daily. Multiparticulate CODAS® beads in hard gelatin capsules. Dosage Form 100mg, 200mg and 300mg. Dosage Strength Verelan® PM is a unique once daily formulation of Verapamil which offers the patient maximum protection against the morning surge in blood pressure when patients are most at risk. The CODAS® technology provides peak dose levels in Comment the early morning. Also, Verelan® PM does not exhibit any food effects and a wide range of dosage options are available, allowing for easy titration for all patients. Launched in the US. Licensing Status Available for licensing all territories ex-US. Page 11 of 13 More detailed non-confidential packages are available on request on all products profiled here
  • 12. Product Availability List Non-Confidential Information Pack | DATE: 2011 Company Profile Elan Drug Technologies is seeking a marketing partner on an exclusive or territory basis. Elan Drug Technologies will retain commercial manufacturing rights of these products. Elan believes this directly benefits the potential partner due its expertise and successful track record in formulation, scale-up and manufacturing. About Elan Drug Technologies Elan Drug Technologies is the world’s leading drug delivery company and is a business unit of Elan (NYSE:ELN). As a fully integrated drug delivery business, we deliver clinically meaningful benefits to patients, by using our extensive experience and proprietary delivery technologies in partnership with pharmaceutical companies to develop new and innovative products. For 40 years, we have been applying our skills and knowledge from concept development, right through to full scale manufacturing. We have been, and continue to be, the drug delivery provider of choice for a broad range of pharmaceutical companies, including many of the world’s largest pharmaceutical companies. For more information about Elan’s technology offerings, please visit http://www.elandrugtechnologies.com. Page 12 of 13 More detailed non-confidential packages are available on request on all products profiled here
  • 13. Contact us USA ROW Shawn Bridy Dr Sarah Carty Director, Business Development Director, Business Development Elan Drug Technologies Elan Drug Technologies 3500 Horizon Drive Treasury Buildings, Lwr Grand Canal St, King of Prussia, PA 19406 Dublin 2, Ireland T 610 270 8442 T +353 1 709 4046 E shawn.bridy@elan.com E sarah.carty@elan.com