Ascendis Pharma Bone Diseases A/s

Ascendis Pharma A/s

Guillaume Maitro

Thomas Wegge

Kennett Sprogøe

Joachim Zettler

Mathias Krusch

Felix Cleemann

Harald Rau

Ulrich Hersel

David Brian Karpf

Oliver Keil

Lars Holten-Andersen

Nicola Bisek

Torben Lessmann

Kennett Sprogoe

Dirk Vetter

Tobias Voigt

Nora Kaluza

Kennett SprogØe

The present invention relates to pharmaceutical compositions comprising a controlled-release PTH compound or a pharmaceutically acceptable salt, hydrate, or solvate thereof, for use in a method of treating, controlling, delaying or preventing a condition which can be treated, controlled, delayed or prevented with PTH, wherein the pharmaceutical composition comprising the controlled-release PTH compound is administered in accordance with a dosage regimen in which dose adjustment in response to hypocalcemia or hypercalcemia is performed in increments of no more than 25%.

Incremental dose finding in controlled-release PTH compounds

The invention provides a method of treating or controlling hypoparathyroidism in a human patient by administering to the human patient a pharmaceutical composition comprising a controlled-release PTH compound or a pharmaceutically acceptable salt thereof. The controlled-release PTH compound comprises a PTH moiety reversibly conjugated to a branched polyethylene glycol carrier. The composition is administered by subcutaneous injection no more frequently than once every 24 hours with a dosage of the controlled-release PTH compound that corresponds to no more than 70% of the molar equivalent dose of PTH 1-84 administered by subcutaneous injection at the same dosing frequency required to maintain a serum albumin-adjusted calcium level in serum of above 8.5 mg/dL over a 24 hour period.

Controlled-release PTH compound

The present invention relates to PTH prodrugs, pharmaceutical compositions comprising such PTH prodrugs and their uses.

PTH prodrugs

The present invention relates to a controlled-release parathyroid hormone (PTH) compound in which PTH(1-34) is reversibly conjugated to a branched polyethylene glycol. The invention further relates to a pharmaceutical composition of the compound. The compound or pharmaceutical composition is useful for treatment, control, delay or prevention of a condition that can be treated, controlled, delayed or prevented with PTH.

The present invention relates to a pharmaceutical composition comprising a PTH compound, wherein after subcutaneous administration the pharmacokinetic profile of the PTH compound exhibits a peak to trough ratio of less than 4 within one injection interval.

PTH compounds with low peak-to-trough ratios

The present invention relates to a polymeric prodrug for use in the treatment, prevention and/or diagnosis a disease of the joint and pharmaceutical compositions and medical devices comprising said polymeric prodrugs.

Diagnosis, prevention and treatment of diseases of the joint

Prodrugs or a pharmaceutically acceptable salt thereof which comprise a covalent treprostinil carrier conjugate, as well as their pharmaceutical composition, may be used as medicaments, especially for diseases or disorders which can be treated by treprostinil, such as pulmonary arterial hypertension (PAH).

Carrier-linked treprostinil prodrugs

The present invention relates to carrier-linked prostanoid prodrugs of formula (I) Z&#x2014;(X-L-PG)(I), wherein Z, X, L, PGand y have the meaning as indicated in the description and claims; pharmaceutically acceptable salts thereof and pharmaceutical compositions comprising the same. It further relates to their use as medicaments, especially for treating, controlling, delaying or preventing pulmonary arterial hypertension.

Carrier-linked prostanoid prodrugs

The present invention relates to prodrugs or a pharmaceutically acceptable salt thereof comprising a covalent treprostinil carrier conjugate as well as pharmaceutical composition comprising said compounds. The compounds may be used as medicaments, especially for diseases or disorders which can be treated by treprostinil, such as pulmonary arterial hypertension (PAH).

The present invention relates to pharmaceutical composition for subcutaneous injection comprising a paliperidone compound wherein the composition releases the paliperidone with an immediate onset of action and continuously for at least 3 weeks, and wherein the composition has a pharmacokinetic profile in vivo with substantially no burst release of the paliperidone. The compositions are useful as medicaments for the treatment of psychotic disorders and diseases.

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Mannheim, Germany

Guillaume Maitro