Agepha Pharma

Slovakia - Senec

Pharmaceutical1 H-1B visas (FY2023)

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Focus: Small Molecules

Agepha Pharma is a life sciences company focused on Small Molecules.

NeurologyRespiratoryCardiovascularNephrologyOncology

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Products & Portfolio (8)

42 discontinued products not shown

CLINICAL PHARMACOLOGY Benzonatate acts peripherally by anesthetizing the stretch receptors located in the respiratory passages, lungs, and pleura by dampening their activity and thereby reducing the cough reflex at its source. It begins to act within 15 to 20 minutes and its effect lasts for 3 to 8 hours. Benzonatate has no inhibitory effect on the respiratory center in recommended dosage.

hyperphosphatemia. High serum phosphorus can precipitate serum calcium resulting in ectopic calcification. Hyperphosphatemia also plays a role in the development of secondary hyperparathyroidism in patients with ESRD. 12.1 MECHANISM OF ACTION Calcium acetate, when taken with meals, combines with dietary phosphate to form an insoluble calcium phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration. 12.2 PHARMACODYNAMICS Orally administered calcium acetate from pharmaceutical dosage forms is systemically absorbed up to approximately 40% under fasting conditions and up to approximately 30% under non-fasting conditions. This range represents data from both healthy subjects and renal dialysis patients under various conditions.

serum phosphorus in patients with end stage renal diseaseserum phosphorus in patients with end stage renal disease (ESRD)

acetate, when taken with meals, combines with dietary phosphate to form an insoluble calcium phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration.

serum phosphorus in patients with end stage renal disease (ESRD)

CLINICAL PHARMACOLOGY Ethosuximide suppresses the paroxysmal three cycle per second spike and wave activity associated with lapses of consciousness which is common in absence (petit mal) seizures. The frequency of epileptiform attacks is reduced, apparently by depression of the motor cortex and elevation of the threshold of the central nervous system to convulsive stimuli.

epilepsy

2012

HYDRALAZINE HYDROCHLORIDE

hydralazine hydrochloride

Post-LOE

ORAL · TABLET

CLINICAL PHARMACOLOGY Although the precise mechanism of action of hydrALAZINE is not fully understood, the major effects are on the cardiovascular system. HydrALAZINE apparently lowers blood pressure by exerting a peripheral vasodilating effect through a direct relaxation of vascular smooth muscle. HydrALAZINE, by altering cellular calcium metabolism, interferes with the calcium movements within the vascular smooth muscle that are responsible for initiating or maintaining the contractile state. The peripheral vasodilating effect of hydrALAZINE results in decreased arterial blood pressure (diastolic more than systolic); decreased peripheral vascular resistance; and an increased heart rate, stroke volume, and cardiac output. The preferential dilatation of arterioles, as compared to veins, minimizes postural hypotension and promotes the increase in cardiac output. HydrALAZINE usually increases renin activity in plasma, presumably as a result of increased secretion of renin by the renal juxtaglomerular cells in response to reflex sympathetic discharge. This increase in renin activity leads to the production of angiotensin II, which then causes stimulation of aldosterone and consequent sodium reabsorption. HydrALAZINE also maintains or increases renal and cerebral blood flow. HydrALAZINE is rapidly absorbed after oral administration, and peak plasma levels are reached at 1 to 2 hours. Plasma levels of apparent hydrALAZINE decline with a half-life of 3 to 7 hours. Binding to human plasma protein is 87%. Plasma levels of hydrALAZINE vary widely among individuals. HydrALAZINE is subject to polymorphic acetylation; slow acetylators generally have higher plasma levels of hydrALAZINE and require lower doses to maintain control of blood pressure. HydrALAZINE undergoes extensive hepatic metabolism; it is excreted mainly in the form of metabolites in the urine.

hypertension

2010

LODOCO

colchicine tablets 0.5 mg

Growth

ORAL · TABLET

12. CLINICAL PHARMACOLOGY 12.1 Mechanism of Action The mechanism of action of colchicine in the prevention of major cardiovascular events is not understood. However, it is known that colchicine disrupts cytoskeletal functions through inhibition of β-tubulin polymerization into microtubules and consequently prevents the activation, degranulation, and migration of neutrophils. Colchicine may also interfere with the intracellular assembly of the inflammasome complex in neutrophils and monocytes that mediates activation of interleukin-1β. These anti-inflammatory effects are consistent with clinical data demonstrating that colchicine reduces high sensitivity C- reactive protein (hs-CRP). 12.2 Pharmacodynamics The pharmacodynamics of colchicine in the intended indication is not completely understood. 12.3 Pharmacokinetics In healthy adults, colchicine exhibits linear pharmacokinetics within a dose range of 0.5 to 1.5 mg. Mean pharmacokinetic parameter values of LODOCO in healthy adults are shown in table 2. Table 2: Summary of LODOCO Pharmacokinetic Parameters in Healthy Adults under Fasting and Fed Conditions BE studies C max ng/ml T max * hours t ½ hours AUC 0-t ng·h/ml Single dose of 0.5 mg (fasting) 2.1± 1.0 1.0 (Range 0.5-2.3) 31.9 18.6± 7.0 Single dose of 0.5 mg (fed) 1.8± 0.4 1.7 (Range 0.7- 3.5) 31.0 16.4 ± 4.4 *Median and range are presented Absorption Oral colchicine intake undergoes an entero-hepatic recirculation. In healthy adults, LODOCO is absorbed when given orally, reaching a mean Cmax 2.1 ng/ml in approximately 1 hour after a single dose administered under fasting conditions. The mean absolute bioavailability of colchicine is reported to be approximately 45%. Effect of food When LODOCO was administered with or following a high-fat, high-calorie meal in a bioavailability study, the results showed a lack of a significant food effect, see Table 2, above. LODOCO may be administered with or without food. The mean peak plasma concentration of LODOCO under fed conditions was found to be 1.8 ng/ml in approximately 1.75 hour. Distribution The mean apparent volume of distribution in healthy volunteers is approximately 1300 L. Colchicine binding to serum protein is 39 ± 5%, primarily to albumin regardless of concentration. After reabsorption, is rapidly removed from the plasma and distributed to various tissues. Colchicine is found in high concentrations in leucocytes, kidneys, the liver, and spleen. Colchicine crosses the placenta. Colchicine also distributes into breast milk. Colchicine can also cross the blood-brain barrier and accumulate within the brain, which contains large amount of tubulin [see Use in Specific Populations (8.1, 8.2)] . Elimination Metabolism Colchicine is demethylated to two primary metabolites, 2-O-demethylcolchicine and 3-O-demethylcolchicine (2- and 3-DMC, respectively) and one minor metabolite, 10-O-demethylcolchicine (also known as colchiceine). In vitro studies using human liver microsomes have shown that CYP3A4 is

myocardial infarction (MI)strokecoronary revascularization+2 more

2023

LURASIDONE HYDROCHLORIDE

lurasidone hydrochloride

Post-LOE

ORAL · TABLET

12.1 Mechanism of Action The mechanism of action of lurasidone in the treatment of schizophrenia and bipolar depression is unclear. However, its efficacy in schizophrenia and bipolar depression could be mediated through a combination of central dopamine D 2 and serotonin Type 2 (5HT 2A ) receptor antagonism. 12.2 Pharmacodynamics Lurasidone is an antagonist with high affinity binding at the dopamine D2 receptors (Ki of 1 nM) and the serotonin 5-HT 2A (Ki of 0.5 nM) and 5-HT 7 (Ki of 0.5 nM) receptors. It also binds with moderate affinity to the human α 2C adrenergic receptors (Ki of 11 nM), is a partial agonist at serotonin 5-HT 1A (Ki of 6.4 nM) receptors, and is an antagonist at the α 2A adrenergic receptors (Ki of 41 nM). Lurasidone exhibits little or no affinity for histamine H 1 and muscarinic M 1 receptors (IC 50 >1,000 nM). ECG Changes The effects of lurasidone on the QTc interval were evaluated in a randomized, double-blind, multiple-dose, parallel-dedicated thorough QT study in 43 patients with schizophrenia or schizoaffective disorder, who were treated with lurasidone hydrochloride tablets doses of 120 mg daily, 600 mg daily and completed the study. The maximum mean (upper 1-sided, 95% CI) increase in baseline- adjusted QTc intervals based on individual correction method (QTcI) was 7.5 (11.7) ms and 4.6 (9.5) ms, for the 120 mg and 600 mg dose groups respectively, observed at 2 to 4 hours after dosing. In this study, there was no apparent dose (exposure)-response relationship. In short-term, placebo-controlled studies in schizophrenia and bipolar depression, no post- baseline QT prolongations exceeding 500 msec were reported in patients treated with lurasidone hydrochloride tablets or placebo. 12.3 Pharmacokinetics Adults The activity of lurasidone is primarily due to the parent drug. The pharmacokinetics of lurasidone is dose-proportional within a total daily dose range of 20 mg to 160 mg. Steady-state concentrations of lurasidone are reached within 7 days of starting lurasidone hydrochloride tablets. Following administration of 40 mg of lurasidone hydrochloride tablets, the mean (%CV) elimination half-life was 18 (7) hours. Absorption and Distribution: Lurasidone is absorbed and reaches peak serum concentrations in approximately 1-3 hours. It is estimated that 9 to 19% of an administered dose is absorbed. Following administration of 40 mg of lurasidone hydrochloride tablets, the mean (%CV) apparent volume of distribution was 6,173 (17.2) L. Lurasidone is highly bound (~99%) to serum proteins. In a food effect study, lurasidone mean C max and AUC were about 3-times and 2-times, respectively, when administered with food compared to the levels observed under fasting conditions. Lurasidone exposure was not affected as meal size was increased from 350 to 1,000 calories and was independent of meal fat content [see ] . In clinical studies, establishing the safety and efficacy of lurasidone hydrochloride tablets, patients were instructed to t

schizophreniadepression

2019

PROPRANOLOL HYDROCHLORIDE

propranolol hydrochloride

Post-LOE

ORAL · TABLET

1986

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Interview Prep Quick Facts

Portfolio: 65 approved products

Top TAs: Respiratory, Neurology, Cardiovascular

H-1B (2023): 1 approval

Portfolio Health

Pre-Launch4 (6%)

Growth1 (2%)

Post-LOE60 (92%)

65 total products

Therapeutic Area Focus

5 marketed

4 marketed

2 marketed

2 marketed

2 marketed

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H-1B Petitions (FY2023)

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Source: USCIS H-1B Employer Data Hub