The Swiss drug company has taken out an option to license the oral formulation of parathyroid hormone, developed by Emisphere Technologies, that was formerly partnered with Lilly. Novartis and Emisphere already have a $34m collaboration for the development of an oral version of human growth hormone.
Eli Lilly pioneered the use of parathyroid hormone in osteoporosis with the launch of its Forsteo (teriparatide: known as Forteo in the US) product in Europe last year.
Parathyroid hormone is the only osteoporosis treatment on the market that rebuilds the bone lost as a result of the disease, but its use is limited by the fact that it must be delivered by subcutaneous injection. As a consequence, many patients prefer to receive treatment using alternative drug classes, such as the bisphosphonates, which can prevent bone breakdown and are orally available.
At present, Forsteo is the only parathyroid hormone-based drug on the market, although intranasal and oral and patch versions are in clinical development. For example, Theratechnologies recently reported initial studies that have shown that its patch can deliver the hormone to the blood at level which rival those achieved with subcutaneous Forsteo.
Emisphere originally licensed its oral formulation of the hormone, based on its eligen technology to Lilly in a collaboration started in 1997 that also looked at oral hGH products. It is currently engaged in litigation concerning the termination of the existing oral PTH collaboration with Lilly.
Novartis' option to license the eligen technology for the development of an oral PTH is dependent upon, amongst other things, Emisphere being in a position to grant such a license to Novartis without infringing a third party's rights.
In addition to the $10 million investment from Novartis, if Novartis exercises its option to the license, Emisphere is eligible for milestone payments totaling up to a maximum of $30 million, plus royalties on sales of the product. The repayment of the note is not contingent on the outcome of the litigation with Lilly.
This agreement marks the third between the two companies. In 2000 Emisphere and Novartis entered into a license agreement for the development of oral salmon calcitonin for the treatment of osteoporosis; in 2004 the two companies entered into an agreement for the development of oral human growth hormone.
The eligen technology is based on the use of synthetic chemical compounds that can carry therapeutic macromolecules across biological membranes such as those of the gastrointestinal tract, making it possible to orally deliver a therapeutic molecule without altering its chemical form or biological integrity.
Emisphere has applied this approach to parathyroid hormone, using a carrier molecule called 4-MOAC (N-8[hydroxy-4-methoxy benzoyl] aminocaprylic acid).