Chiesi - Jobs & Pipeline

Products & Portfolio (16)

7 discontinued products not shown

BETHKIS

tobramycin inhalation

Peak

INHALATION · SOLUTION

[see Clinical Pharmacology ( )] .

cystic fibrosis patients with Pseudomonas aeruginosa

2012

30

CARDENE

nicardipine hydrochloride

LOE Approaching

INJECTION · INJECTABLE

concentrations. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. The effects of nicardipine are more selective to vascular smooth muscle than cardiac muscle. In animal models, nicardipine produced relaxation of coronary vascular smooth muscle at drug levels which cause little or no negative inotropic effect.

hypertension

1992

15

CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER

nicardipine hydrochloride

LOE Approaching

INTRAVENOUS · INJECTABLE

concentrations. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. The effects of nicardipine are more selective to vascular smooth muscle than cardiac muscle. In animal models, nicardipine produced relaxation of coronary vascular smooth muscle at drug levels which cause little or no negative inotropic effect.

hypertension

1992

15

CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER

nicardipine hydrochloride

LOE Approaching

INTRAVENOUS · INJECTABLE

concentrations. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. The effects of nicardipine are more selective to vascular smooth muscle than cardiac muscle. In animal models, nicardipine produced relaxation of coronary vascular smooth muscle at drug levels which cause little or no negative inotropic effect.

hypertension

1992

15

CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER

nicardipine hydrochloride

LOE Approaching

INTRAVENOUS · INJECTABLE

concentrations. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. The effects of nicardipine are more selective to vascular smooth muscle than cardiac muscle. In animal models, nicardipine produced relaxation of coronary vascular smooth muscle at drug levels which cause little or no negative inotropic effect.

SMINTRAVENOUS · EMULSION

Calcium Channel Antagonists

blood pressurenot desirable

INTRATRACHEAL · SUSPENSION

alpha-galactosidase A. ELFABRIO provides an exogenous source of alpha-galactosidase A. ELFABRIO is internalized and transported into lysosomes where it is thought to exert enzymatic activity and reduce accumulated globotriaosylceramide (Gb3).

Iron Chelating Activity

Iron Chelating Activity

12.1 Mechanism of Action The mechanism of action of FILSUVEZ in the treatment of wounds associated with epidermolysis bullosa is unknown. 12.2 Pharmacodynamics Pharmacodynamics of FILSUVEZ are unknown. 12.3 Pharmacokinetics Absorption Systemic exposure to betulin was assessed in the 66 evaluable subjects aged ≥13 months to ≤52 years with dystrophic and junctional EB in the clinical trial EASE using venous blood sampling and validated liquid chromatography with tandem mass spectrometry assay. Following treatment with FILSUVEZ once daily (n=27), every 2 (n=33) or 3 days (n=4) or once weekly (n=2) for 90 days with a mean treatment area of 12% body surface area or affected wound surface area of 0.11 m at baseline, betulin blood concentrations in 68% subjects (n=45) were below the lower limit of quantification of 10 ng/mL on Day 90. The highest concentrations of betulin in adult and pediatric subjects with a median age of 10 years (range: ≥13 months to <18 years) were 33 ng/mL and 207 ng/mL, respectively, which were observed on Day 90. Distribution Plasma protein binding of betulin in vitro is >99.9 %. Metabolism The in vitro study indicated that incubation of 1 µmol/L betulin with human hepatocytes generated several unidentified phase I and/or phase II metabolites. In vitro, betulin was mainly metabolized by cytochrome P450 (CYP)3A. The relative contribution of CYP3A and phase II metabolizing enzymes in the overall metabolism of betulin has not been fully characterized. Drug Interaction Studies Clinical Studies No clinical studies evaluating the drug interaction potential of FILSUVEZ have been conducted. In Vitro Studies CYP Enzymes: Betulin inhibited CYP3A and CYP2C8 with an IC 50 value of >0.17 µmol/L (75 ng/mL). Betulin up to 10 µmol/L (4427 ng/mL) did not induce CYP 1A2, 2B6, or 3A4. These findings suggest that FILSUVEZ has no clinically meaningful effect on the PK of drugs metabolized by CYP 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, or 3A.

wounds associated with dystrophicjunctional epidermolysis bullosa in adultolder

P2Y12 Receptor Antagonists

2015

0

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Interview Prep Quick Facts

Portfolio: 23 approved products

Top TAs: Cardiovascular, Hematology, Rare Diseases

Portfolio Health

Growth2 (9%)

Peak10 (43%)

LOE Approaching11 (48%)

23 total products

Therapeutic Area Focus

9 marketed

3 marketed

2 marketed

2 marketed

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1 marketed

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