Metabolites Sample Clauses

Metabolites. Notwithstanding the rights granted to Jazz in Section 2.2(a), Concert retains the right under Concert’s interest in the Development Inventions and Development Patents to make, have made, use, sell, have sold, offer for sale and import any product (other than a product containing a Jazz Compound) in the Field in the Territory wherein such product, when administered to a human, produces a metabolite that is also a metabolite of gamma-hydroxybutyrate, provided that such produced metabolite (i) is not therapeutically effective for any Indication for which deuterated gamma-hydroxybutyrate or gamma-hydroxybutyrate has been shown to be effective or (ii) is produced in insufficient quantities to be therapeutically effective for any such Indication.
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Metabolites. The relationship between the accumulation of metabolites and the tissue and organ damage that underlies the acute and long-term complications of classic galactosemia is unclear. Classic galactosemic patients accumulate high levels of galactose, gal-1P, and galactitol in their blood and tissues. Galactonate is also produced in high quantities, but is excreted in urine and does not build up in tissues (Xxxxxx et al. 2000; Tyfield and Xxxxxx 2002). In utero studies have shown that at 10 weeks of gestation, a classic galactosemic fetus displayed elevated levels of galactitol in the amniotic fluid. At 20 weeks, two fetuses studied showed elevated levels of gal-1P in the blood and high levels of galactose, gal-1P, and galactitol in their livers. These levels were similar to those seen in newborn infants succumbing to the disease (Ng et al. 1977; Xxxxx et al. 1980; Xxxxxx et al. 2000). Additionally, high gal-1P levels have been found in the umbilical cord blood of classic galactosemic babies of mothers who adhered to a galactose restricted diet during pregnancy. The restriction of dietary galactose during pregnancy does not correlate with an improvement in prognosis or outcome in patients (Xxxxxxxx et al. 1990; Gitzelmann 1995; Xxxxxx 1996). These data suggest that metabolite toxicity and subsequent damage to tissues and organs may begin in utero. Additionally, the removal of galactose from the diet is not sufficient to avoid this damage. Classic galactosemic patients who adhere to a galactose restricted diet, which prevents or reverses the acute and potentially lethal symptoms of the disease early in life, show marked improvement in metabolic abnormalities. Galactitol and gal-1P levels, however, sometimes remain higher than normal and several studies have correlated high gal-1P levels with the severity of the acute complications in classic galactosemia (Xxxxxxx et al. 1988; Xxxxxxxx et al. 1990; Ng et al. 1991; Xxxxxxx et al. 1994; Gitzelmann and Xxxxxxxx 1995; Xu et al. 1995; Tyfield and Xxxxxx 2002; de Jongh et al. 2008; Xxxxxxxxx-Xxxx and Xxxxxx 2008). It is not apparent whether the residual elevation of gal-1P in treated patients is due to the fact that it is impossible to completely remove galactose from the human diet or due to the endogenous production of galactose via the Leloir pathway (Xxxxx et al. 1995; Xxxxx et al. 2004). Gal-1P One longstanding hypothesis in this field is that the cellular accumulation of gal- 1P contributes to the acute and long-te...

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