PHARMACY

FDA denies BioAlliance Pharma’s NDA for Loramyc

BY Allison Cerra

PARIS BioAlliance Pharma SA, the specialty pharmaceutical company focused on the treatment of opportunistic infections in cancer and AIDS, announced that the FDA did not accept the NDA for Loramyc (miconazole) mucoadhesive buccal tablet to be filed, based on the lack of a tablet imprint code.

Loramyc was approved in Europe in 2007 and is currently marketed in several EU territories including France, Germany, the UK, Sweden, Finland and Denmark.

While the EU does not require a unique tablet identifier, the U.S. FDA does require a tablet imprint code for drug identification purposes. Prior to the initial filing, BioAlliance initiated the development of a debossed tablet to fulfill this requirement. BioAlliance will work closely with the FDA on the introduction of the debossed tablet and will soon after resubmit the Loramyc application.

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Genetic abnormality found in males may lead to development of male contraceptive, study finds

BY Michael Johnsen

IOWA CITY, Iowa A newly discovered genetic abnormality that appears to prevent some men from conceiving children could be the key for developing a male contraceptive, according to University of Iowa researchers reporting their findings in the April 2 online edition of the American Journal of Human Genetics.

Although female oral contraceptives were developed more than 40 years ago and have proven very effective for family planning, no similar pharmacological contraceptive has been developed for males. Surveys conducted by the Medical Research Council Reproductive Biology Unit in the United Kingdom, suggest that men would be willing to use a pharmacological contraceptive if one was available. Presently, the only contraceptives available for men are condoms or a vasectomy.

“We have identified CATSPER1 as a gene that is involved in non-syndromic male infertility in humans, a finding which could lead to future infertility therapies that replace the gene or the protein,” stated Michael Hildebrand, co-lead author of the study and a UI postdoctoral researcher in otolaryngology at the UI Roy J. and Lucille A. Carver College of Medicine. “But, perhaps even more importantly, this finding could have implications for male contraception.”

The research team, which included scientists from the University of Social Welfare and Rehabilitation Sciences in Tehran, Iran, discovered the male infertility gene while studying the genetics of families from Iran — a population that has relatively high rates of disease-causing gene mutations.

Although the team’s research with these Iranian families focuses on identifying genetic causes of deafness, collecting genetic information from this population allowed the researchers to identify two families where male infertility that was not part of a syndrome appeared to be inherited. The affected men’s infertility was diagnosed with a routine semen analysis.

Harvard University studies on mouse models that lack the CATSPER1 gene reveal how sperm is affected when the protein is missing or abnormal. These studies show that CATSPER1 mutations affect sperm motility, specifically the very vigorous hyperactive motion the sperm uses when it is entering the egg during fertilization.

“Our research suggests that the defect in sperm hyperactivity that is seen in mice without CATSPER1 will also occur in humans with the genetic mutation,” Hildebrand said. “Identification of targets such as the CATSPER1 gene that are involved in the fertility process and are specific for sperm — potentially minimizing side effects of a drug targeting the protein’s function — provide new targets for a pharmacological male contraceptive.”

Several approaches to male contraception are currently under investigation at other institutions. One approach that could potentially target CATSPER1 is immunocontraception where antibodies are developed that bind to a targeted protein and block its function. Immunocontraception is still in early stages of development and in order to be useful it will need to be proven effective, safe and reversible.

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Mylan, Schering-Plough settle patent suit for allergy medication

BY Alaric DeArment

PITTSBURGH Mylan has settled patent litigation related to a generic version of Schering-Plough’s Clarinex allergy medication, the Pittsburgh-based generic drug maker announced Wednesday.

Under the settlement of the case, in the U.S. District Court of New Jersey, Mylan will have the right to market desloratadine tablets in the 5 mg strength in the United States starting July 1, 2012 or earlier, depending on certain circumstances, provided the Food and Drug Administration approves Mylan’s regulatory application. Depending on the status of Clarinex at that time, Mylan’s version may be a prescription or OTC drug.

Clarinex had sales of about $284 million in 2008, according to IMS Health data.

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