Elan Drug Technologies

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Products Available for Licensing

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. The following is a list of some of our late stage/approved products. For more information on these and other product licensing opportunities contact us.

Docetaxel Solvent Free Formulation

Class/Indication	Taxanes/Solid Tumour cancers
Dosage Form	Lyphophilised, nanoparticulate IV formulation of Docetaxel
Dosage Strength	Preclinical dose ranging studies performed.
Comment	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. 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.
Licensing Status	Clinical development Available for licensing all territories

Intravenous, Once Daily, Rapid Onset, Non-Opioid for Acute Pain Management

Class/Indication	Non-steroidal anti-inflammatory, pain relief.
Dosage Frequency	Once daily.
Dosage Form	Intravenous Formulation using NanoCrystal® technology
Comment	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. 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.
Licensing Status	Phase I development is complete, Phase II trials ongoing with scheduled timeline for completion of Phase II trials in Q4 2010. Available for licensing in all territories.

Megesterol acetate

Class/Indication	Progestins/Cachexia
Dosage Frequency	5ml
Dosage Form	Oral suspension using the NanoCrystal® technology
Dosage Strength	625mg/5ml
Therapeutic Advantage	Through applying the NanoCrystal® technology, a superior more palatable product with a significantly lower dosage than original product was developed. Viscosity reduced 16-fold, volume swallowed reduced by 75% and has a free of food effect. Indicated for treatment of anorexia, cachexia or unexplained significant weight loss in patients with AIDS.
Licensing Status	Approved and launched in the US in 2005. Available for licensing in all territories ex-US, Phase III studies complete in Europe.

Morphine Once Daily (Avinza^®, Morphelan^™)

Class/Indication	Narcotic analgesic/Severe chronic pain
Dosage Frequency	Once daily
Dosage Form	Multiparticulate SODAS® beads in hard gelatin capsules
Dosage Strength	30mg, 60mg, 90mg and 120mg
Comment	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. 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.
Licensing Status	Approved and launched in the US in 2002. Available for licensing in all territories ex-North America, filed in Europe.

Naproxen Sodium (Naprelan^®)

Class/Indication	Non-steroidal anti-inflammatory/anti-rheumatic, pain relief.
Dosage Frequency	Once daily.
Dosage Form	High-density multiparticulate IPDAS® cores in a specialised table matrix
Dosage Strength	500 mg, 375 mg and 750mg
Comment	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® cores in the gastrointestinal tract. The nature of the controlled diffusion and absorption of Naprelan® reduces gastro-intestinal side effects normally seen with naproxen.
Licensing Status	Launched in the US and Canada. Available for licensing in all territories ex-North America.

Novel Diagnostic Imaging Agents

Class/Indication	Diagnostic imaging agents.
Dosage Frequency	Nanoparticulate size diagnostic agents using NanoCrystal® formulation
Comment	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 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.
Licensing Status	EDT has a portfolio of imaging compounds in pre-clinical development. Lead compounds have been identified, which have been found to be stable. To date, in vivo studies have been completed in rabbits. Available for licensing in all territories worldwide.

Verapamil (Verelan^®)

Class/Indication	Antihypertensive/antianginal(calcium antagonist).
Dosage Frequency	Once daily.
Dosage Form	Multiparticulate SODAS beads in hard gelatin capsules.
Dosage Strength	80 mg, 120 mg, 180 mg, 240 mg and 360mg.
Comment	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 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.
Licensing Status	Launched in US, Japan and some European and Asian markets. Available for licensing in number of European territories.

Verapamil PM (Verelan^® PM)

Class/Indication	Calcium antagonist/Antihypertensive/antianginal.
Dosage Frequency	Once daily.
Dosage Form	Multiparticulate CODAS® beads in hard gelatin capsules
Dosage Strength	100mg, 200mg and 300mg.
Comment	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 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.
Licensing Status	Launched in the US. Available for licensing all territories ex-US.