Solution for "Problem Child" Drugs
by Rober A. Morrison, PhD
Bioinvension
The mother of a problem child was prescribed an antidepressant by a psychiatrist since she was upset and worried about her child. On her next visit the psychiatrist asked if the medicine had calmed her down. The woman said yes and when the doctor then asked about her child she replied, “Who cares?”
A drug with alleged adverse side effects is very much like a problem child and one company seems to care by developing a remedy for the problem. In a previous research note we described certain aspects of the Perlegen Sciences intellectual property portfolio involving whole genome scanning to identify genetic markers associated with drug efficacy and/or safety. Perlegen intends to use the genetic technology as a solution for the problems associated with a key class of drugs designated as TZDs. The company recently announced completion of the collection of DNA samples from diabetic patients treated with TZD drugs Actos® and Avandia® for the purpose of identifying genetic variability associated with adverse events. A key side effect of TZDs is fluid retention which leads to edema, weight gain, and possibly heart failure. In fact, in the aftermath of the controversy concerning Avandia® and alleged risk of heart disease, the FDA requested a black box warning be included on labels for both drugs due to the risk of cardiovascular events. Early results from Perlegen demonstrated a significant genetic component to the adverse side effect profile of the TZDs. While the company stated that they hope to provide patients and physicians with critical decision-making information, it did not disclose how this would be accomplished.
The Perlegen announcement of the new TZD program comes not long after the company decided to postpone plans for an IPO due to disappointing results from a pharmacogenomics study that concerned identification of genetic variation associated with therapeutic response to its own TZD drug, neoglitazone.
Our research indicates that the TZD adverse event program is not the first such effort by Perlegen. Presumably via support from Eli Lilly (LLY), Perelgen developed a method of identifying phenotypes among patients taking a drug that causes side effects including weight gain, insulin resistance and/or obesity. The presumption of Eli Lilly involvement is due to the specific drug which appears to cause the side effects-olanzapine (a.k.a. Zyprexa®) and the fact that Perlegen established a collaboration with the drug giant back in 2002. Was this prophecy on the part of Lilly or realization that they had a problem child in the making?
Earlier this year, Lilly agreed to pay approximately $500 million to settle 18,000 lawsuits from people who claimed they developed diabetes or other diseases after taking Zyprexa®. Including earlier settlements, Lilly has now agreed to pay at least $1.2 billion to 28,500 people who claim they were injured by the drug and at least 1,200 suits are still pending. Lilly nor Perlegen has announced how or if the results of the work will be commercialized. Left to speculation, and considering that Lilly has thus far defended Zyprexa® from notable generic competition, the application of the genetic screening may be utilized to resurrect the Zyprexa® brand representing one of the first examples of pharmacogenomics in drug life cycle management. Given the fact that prescriptions for Zyprexa® have dropped due to the side effects as well as competition from several brand-name atypical antipsychotic drug competitors, application of the Perlegen technology to eliminate patients that experience the adverse side effects could transform a problem child into an angel.
Bioinvension is a regular contributor to BioHealth Investor
_________________
Bioinvension
The mother of a problem child was prescribed an antidepressant by a psychiatrist since she was upset and worried about her child. On her next visit the psychiatrist asked if the medicine had calmed her down. The woman said yes and when the doctor then asked about her child she replied, “Who cares?”
A drug with alleged adverse side effects is very much like a problem child and one company seems to care by developing a remedy for the problem. In a previous research note we described certain aspects of the Perlegen Sciences intellectual property portfolio involving whole genome scanning to identify genetic markers associated with drug efficacy and/or safety. Perlegen intends to use the genetic technology as a solution for the problems associated with a key class of drugs designated as TZDs. The company recently announced completion of the collection of DNA samples from diabetic patients treated with TZD drugs Actos® and Avandia® for the purpose of identifying genetic variability associated with adverse events. A key side effect of TZDs is fluid retention which leads to edema, weight gain, and possibly heart failure. In fact, in the aftermath of the controversy concerning Avandia® and alleged risk of heart disease, the FDA requested a black box warning be included on labels for both drugs due to the risk of cardiovascular events. Early results from Perlegen demonstrated a significant genetic component to the adverse side effect profile of the TZDs. While the company stated that they hope to provide patients and physicians with critical decision-making information, it did not disclose how this would be accomplished.
The Perlegen announcement of the new TZD program comes not long after the company decided to postpone plans for an IPO due to disappointing results from a pharmacogenomics study that concerned identification of genetic variation associated with therapeutic response to its own TZD drug, neoglitazone.
Our research indicates that the TZD adverse event program is not the first such effort by Perlegen. Presumably via support from Eli Lilly (LLY), Perelgen developed a method of identifying phenotypes among patients taking a drug that causes side effects including weight gain, insulin resistance and/or obesity. The presumption of Eli Lilly involvement is due to the specific drug which appears to cause the side effects-olanzapine (a.k.a. Zyprexa®) and the fact that Perlegen established a collaboration with the drug giant back in 2002. Was this prophecy on the part of Lilly or realization that they had a problem child in the making?
Earlier this year, Lilly agreed to pay approximately $500 million to settle 18,000 lawsuits from people who claimed they developed diabetes or other diseases after taking Zyprexa®. Including earlier settlements, Lilly has now agreed to pay at least $1.2 billion to 28,500 people who claim they were injured by the drug and at least 1,200 suits are still pending. Lilly nor Perlegen has announced how or if the results of the work will be commercialized. Left to speculation, and considering that Lilly has thus far defended Zyprexa® from notable generic competition, the application of the genetic screening may be utilized to resurrect the Zyprexa® brand representing one of the first examples of pharmacogenomics in drug life cycle management. Given the fact that prescriptions for Zyprexa® have dropped due to the side effects as well as competition from several brand-name atypical antipsychotic drug competitors, application of the Perlegen technology to eliminate patients that experience the adverse side effects could transform a problem child into an angel.
Bioinvension is a regular contributor to BioHealth Investor
_________________
posted by Nico at
2:22 PM
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