Novartis study reveals achievement of suitable PK profile of new formulation

Pharmaceutical Company Product News

Novartis' study has revealed the achievement of a suitable PK profile of a new oral formulation of Parathyroid Hormone (PTH).

Using Eligen technology from Emisphere Technologies, the initial research involving 20 healthy postmenopausal female patients aged 40 to 70 years old resulted in peak concentrations in the range of those treated with the subcutaneous formulation Forteo (teriparatide).

It is hoped the programme will be further developed, as the trial reported no significant adverse affects, drug-exposure related discontinuation or hypocalcaemia.

Recombinant PTH is currently approved for the treatment of osteoporosis and is available by injection.

Michael Novinski, president and chief executive officer of Emisphere Technologies, said: "Oral PTH is a significant early-stage product to the Emisphere pipeline, albeit earlier stage."

"These study results were very critical. They may confirm the formulation and the technology and set the stage for an important development plan."

Osteoporosis is a disease associated with a gradual weakening and thinning of the bones, meaning they are more susceptible to fractures.

The condition occurs more frequently in women after menopauses and, can lead to disabling fractures, lost mobility or chronic back pain if left untreated.

In other news, Novartis has announced its Rasilez provides greater reduction in high blood pressure by an additional 2.3 mmHg in patients aged 65 and over, following a study.

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