Ascendis Pharma A/s

Ascendis Pharma Bone Diseases A/s

Ascendis Pharma Endocrinology Division A/s

Sanofi-a Ventis Deutschland Gmbh

Ascendis Pharma Inc.

Ascendis Pharma Growth Disorders A/s

Ascendis Pharma Growth Disorders Division A/s

Complex Biosystems Gmbh

Ascendis Pharma Endocrinology Division

Thomas Wegge

Harald Rau

Ulrich Hersel

Kennett Sprogøe

Joachim Zettler

Felix Cleemann

Guillaume Maitro

Dirk Vetter

Mathias Krusch

Susanne Kindermann

Robert Schnepf

Torben Lessmann

Grethe Nørskov Rasmussen

Grethe Norskov Rasmussen

David Brian Karpf

Oliver Keil

Lars Holten-Andersen

Kennett Sprogoe

Silvia Kaden-Vagt

Nicola Bisek

Steen Jensen

Nina Schubert

Torben Lebmann

Torben Leßmann

Alina Hermann

Evelyn Exner

Thomas Kurpiers

Torben Lessman

Ana Bernhard

Anna Splanemann

Felix Cleenmann

Frank Faltinger

Susanne Kinderman

Silvia Kaden

Kennett Sprogoee

Grethe Noerskov Rasmussen

Kennett SprogØe

Torben LEßMANN

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

A chemically modified human Growth Hormone (rhGH) prepared by attaching a transient linker which comprises a polyethylene glycol. The chemically modified protein may have a much longer lasting rhGH activity than that of the unmodified rhGH, enabling reduced dose and scheduling opportunities and the modified rhGH may not cause lipoatrophy. Also includes methods of use for the treatment and/or prevention of diseases or disorders in which use of growth hormone is beneficial.

PEGylated recombinant human growth hormone compounds

The present invention relates to dry compositions of rhGH polymer prodrug containing a lyoprotectant and, optionally, one or more than one excipient. Such compositions are stable for at least 1 year, when stored at 2-8° C. The invention further relates to methods of manufacturing said compositions, containers comprising such composition as well as a kit of parts.

Dry growth hormone composition transiently linked to a polymer carrier

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

PTH prodrugs

The present invention relates to a polymeric human growth hormone prodrug and dry, liquid and reconstituted pharmaceutical formulation comprising said prodrug. It furthermore relates to their use as medicaments for the treatment of diseases which can be treated with growth hormone and to methods of treatment. It also relates to methods of application of such polymeric human growth hormone prodrug or pharmaceutical formulation.

Polymeric hGH 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 controlled-release CNP agonist having low NPR-C affinity; to pharmaceutical compositions comprising said controlled-release CNP agonist; their use; and to methods of treatment.

Controlled-release CNP agonists with low NPR-C binding

The present invention relates to controlled-release CNP agonists having an at least 5-fold longer degradation half-life in an in vitro NEP degradation assay than the corresponding released CNP agonist, to pharmaceutical compositions comprising said controlled-release CNP agonist, their use and to methods of treatment.

Controlled-release CNP agonists with increased NEP stability

The present invention relates to a polymeric human growth hormone prodrug and dry, liquid and reconstituted pharmaceutical formulations comprising said prodrug. It furthermore relates to their use as medicaments for the treatment of diseases which can be treated with growth hormone and to methods of treatment. It also relates to methods of application of such polymeric human growth hormone prodrug or pharmaceutical formulation.

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Heidelberg, Germany

Thomas Wegge