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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