The “Prempro jury levies damages against Wyeth - FiercePharma” plus 4 more

Prempro jury levies damages against Wyeth - FiercePharma
Pa. jury weighs punitives in Prempro-cancer case - Product Design & Development
Phase 2 Data From Oral NKTR-118 Presented at American College of ... - Yahoo Finance
Hunting for the Prozac gene - Genetic Engineering News
Military wives unite to cope with cancer, deployment - MSNBC

Prempro jury levies damages against Wyeth - FiercePharma

Posted: 27 Oct 2009 07:08 AM PDT

For the third time in a row, the jury in a drug liability case has sided against pharma. Having already concluded that Wyeth's Prempro hormone replacement therapy was linked to plaintiff Cindy Barton's breast cancer, the 8-member panel awarded $3.75 million in compensatory damages.

The jury had also found that Wyeth hid evidence of the potential cancer risk, and for that it levied punitive damages. That amount is under court seal, however, pending the verdict in another Prempro case in Philadelphia. Wyeth had argued that news of punitive damages in this case could sway the jurors in the other case. That means the award will be sealed for at least a month, the Philadelphia Inquirer notes.

Now part of Pfizer, Wyeth faces some 9,000 plaintiffs claiming hormone-replacement injuries. Some 1,500 cases are pending in Philadelphia alone, the Associated Press reports. In a similar case tried in Nevada two years ago, a jury also found Wyeth at fault and awarded the three plaintiffs $135 million; the judge reduced that award to $35 million.

- get the news from the Inquirer
- see the AP story

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Pa. jury weighs punitives in Prempro-cancer case - Product Design & Development

Posted: 26 Oct 2009 02:19 PM PDT

Pa. jury weighs punitives in Prempro-cancer case

PHILADELPHIA (AP) — A Philadelphia jury is weighing punitive damages against drugmaker Wyeth after finding a link between an Illinois woman's breast cancer and the hormone-replacement drug she took.

Connie Barton's case is one of a handful of Prempro lawsuits to go to trial out of several thousand filed across the country. About 1,500 are pending in Philadelphia.

The Philadelphia jury awarded $3.75 million in compensatory damages Friday. They say the company's actions were willful and warrant punitive damages.

The 64-year-old Barton is a retired hospital records clerk from Peoria, Ill. She took Prempro for five years before her 2002 cancer diagnosis.

Her lawyers say Wyeth hid evidence of a cancer link.

Wyeth says women are now fully informed of the risks.

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Phase 2 Data From Oral NKTR-118 Presented at American College of ... - Yahoo Finance

Posted: 27 Oct 2009 09:53 AM PDT

SAN DIEGO, Oct. 27 /PRNewswire-FirstCall/ -- Data from a phase II study demonstrated that oral NKTR-118 improved lower gastrointestinal dysfunction by increasing the frequency of bowel movements in patients with opioid-induced constipation, while simultaneously preserving opioid-mediated analgesia. NKTR-118, an oral peripherally-acting opioid antagonist, is an investigational product candidate in clinical development for the treatment of opioid-induced constipation.

(Logo: http://www.newscom.com/cgi-bin/prnh/20091027/PH99766LOGO )

In the phase II double blind, randomized, placebo-controlled study of 208 patients with opioid-induced constipation, NKTR-118 achieved the primary endpoint of change from baseline in spontaneous bowel movements (SBMs). Patients receiving either 25 mg or 50 mg of oral NKTR-118 once daily had a significantly greater change from baseline in SBMs during the first week of treatment than patients receiving placebo. The mean change from baseline in SBMs per week for patients receiving 25 mg NKTR-118 was 3.6 versus 1.9 in the placebo group (p= 0.002). Patients receiving 50 mg NKTR-118 had a mean change from baseline in SBMs per week of 4.4 versus 1.9 in the placebo group (p=0.0001). The increase from baseline in SBMs versus placebo averaged over the four-week treatment period was significant for both the 25 mg (p=0.002) and 50 mg (p<0.0001) dose groups. Results for the 5 mg dose of NKTR-118 were not significant.

The study also showed that there was a statistically significant difference in median time to first SBM for patients in the 25 mg and 50 mg dose cohorts as compared to placebo. Median time to first SBM for patients in the 25 mg dose cohort was 6.6 hours as compared to placebo which was 48.6 hours (p=0.001), and for patients in the 50 mg dose cohort, median time to first SBM was 2.9 hours as compared to placebo, which was 44.9 hours (p<0.002). Results for the 5 mg dose of NKTR-118 were not significant.

"Patients who take opioids are at risk of experiencing the painful and potentially serious side effect of opioid-induced constipation (OIC) -- which can require patients to seek remedies only available in a hospital or in-office setting," said Dr. Lynn Webster, Medical Director of Lifetree Clinical Research and lead clinical investigator of the phase II trial. "The results of the NKTR-118 phase II trial presented today indicate that, if approved, this product may have the potential to offer patients suffering from OIC a simple and non-invasive oral treatment that may improve their gastrointestinal function."

The study also showed there was no apparent reversal of opioid-mediated analgesia with any of the NKTR-118 dose groups, as measured by no change in Numeric Rating Scale (NRS) pain scores and no increase in mean daily opiate use.

The most commonly reported side effects from this Phase II study of NKTR-118 were dose dependent gastrointestinal-related effects. The majority of side effects for both the 5 and 25 mg dose cohorts were graded as mild by the investigators. Side effects included diarrhea (13% at 25 mg and 31% at 50 mg, versus 4% and 5% for the placebo arms), nausea (13% for 25 mg and 20% for 50 mg, versus 19% and 8% for the placebo arms) and abdominal pain (30% for 25 mg and 17% for 50 mg, versus 7% and 0% for the placebo arm). No treatment-related serious adverse events (SAE) for the 5 or 25 mg cohorts were observed. Only one patient experienced an SAE of hospitalization due to abdominal cramping in the 50 mg cohort.

These data from the Phase II clinical trial of NKTR-118 were presented today during the oral plenary session of the American College of Gastroenterology (ACG) 2009 Annual Clinical Meeting.

About NKTR-118

On September 21, 2009, AstraZeneca and Nektar Therapeutics announced that they entered into an exclusive worldwide license agreement for NKTR-118 and NKTR-119.

NKTR-118 is an investigational drug candidate that combines Nektar's advanced small molecule polymer conjugate technology platform with naloxol, a derivative of the opioid-antagonist drug, naloxone.

Top line results of the phase II study were presented at the American Academy of Pain Management in early October, 2009.

About Opioid-Induced Constipation

It is estimated that for those patients who take opiates chronically for pain management, anywhere from 40-90% of such patients will develop constipation. Less than half of those patients find effective relief from current treatment options that include prescription and over-the-counter laxatives and stool softeners. These symptoms of bowel dysfunction are a result of the drug binding to the mu-opioid receptor in the gut (1). Opioid-induced bowel dysfunction encompasses symptoms such as constipation, bloating, abdominal cramping, and gastroesophageal reflux. Constipation is the hallmark of this syndrome and is generally its most prominent component.

According to IMS Health, about 230 million prescriptions were written for opioids in 2007 in the United States alone. This is estimated to represent about 65-75% of the worldwide opioid market. Currently, there are no oral drugs approved that are indicated to treat opioid-induced constipation. Opioid bowel dysfunction and opioid-induced constipation can significantly impact quality of life and increase healthcare utilization.

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit: www.astrazeneca.com.

About Nektar

Nektar Therapeutics (Nasdaq: NKTR - News) is a biopharmaceutical company developing novel therapeutics based on its PEGylation and advanced polymer conjugation technology platforms. Nektar's technology and drug development expertise have enabled nine approved products in the U.S. or Europe for partners, which include leading biopharmaceutical companies, including UCB's Cimzia®, Roche's PEGASYS® for hepatitis C and Amgen's Neulasta® for neutropenia. Nektar has created a robust pipeline of potentially high-value therapeutics to address unmet medical needs by leveraging and expanding its technology platforms to improve and enable molecules. Nektar is currently conducting clinical and preclinical programs in oncology, pain and other therapeutic areas. NKTR-102, PEGylated irinotecan, is currently in Phase 2 clinical studies in ovarian, breast and colorectal cancer. NKTR-105, PEGylated docetaxel, is currently in a Phase 1 clinical study in patients with refractory solid tumors.

Nektar is headquartered in San Carlos, California, with additional R&D operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.

1. Panchal SJ, Muller-Schwefe P, Wurzelmann JI. Opioid-induced bowel dysfunction: prevalence, pathophysiology and burden. Int J Clin Pract. 2007;61(7):1181-1187.

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Hunting for the Prozac gene - Genetic Engineering News

Posted: 27 Oct 2009 08:48 AM PDT

Oct 27 2009, 11:20 AM EST

Hunting for the Prozac gene

EUREKALERT

Contact: George Hunka
ghunka@aftau.org
212-742-9070
American Friends of Tel Aviv University

Tel Aviv University seeks genetic 'Prozac markers' to find a simple test for treating depression

Prozac works wonders for some depressed people, but not for others. In some cases, patients derive little benefit and at worst, it can lead to bizarre hallucinations and fits of rage. Researchers and doctors remain puzzled as to what causes the wide range of reaction to Prozac and similar antidepressants.

The answer, Tel Aviv University researchers believe, can be found in a patient's genes. And if their research is successful, these scientists may be able to provide psychiatrists with a simple genetic test to revolutionize the treatment of depression.

Hunting for "the Prozac gene" ― its response biomarker, in science-speak ― is the foundation of a new Tel Aviv University project established by a unique biobank in TAU's Sackler School of Medicine. Initiated by the biobank's director Dr. David Gurwitz, and his student Ayelet Morag, the researchers are attempting to discover reliable pharmacogenic markers for antidepressants such as Prozac.

"Many drugs for treating depression are on the market," says Dr. Gurwitz. "The most popular ones ― including Prozac ― are the selective serotonin reuptake inhibitors (SSRIs). But they only work for about 60% of people with depression. A drug from other families of antidepressants could be effective for the other 40%," he says. "We are working to move the treatment of depression from a trial-and-error approach to a best-fit, personalized regimen."

A genetic basis for psychiatric treatment

Dr. Gurwitz says the key is in our genes, and the first step to unlocking the puzzle lies in discovering relevant biomarkers, the biological elements in blood or DNA that provide clues for disease or conditions such as blood glucose in diabetes, blood pressure in heart disease, and hormones released in pregnancy. Clinicians already base treatments for cancer patients on genetic tests. This has proven especially useful for breast-cancer, where drugs such as Tamoxifen or Herceptin are prescribed only after genetic tests show that they would benefit the patient.

"Why not embrace the same approach for treating depression?" he asks. "We've designed an experiment to search for elements that can determine who will ― and who won't ― benefit from drugs such as Prozac," says Dr. Gurwitz.

An effective response to "extreme responders"

The researchers will explore "whole-genome gene expression profiles" in cell lines from healthy people. Since Prozac and similar antidepressants are known to inhibit the growth of blood cells, they are now screening a large collection of cell lines to determine which have the strongest and weakest growth-inhibition responses to SSRIs like Prozac. Those cells that exhibit extreme responses will then be screened across the entire human genome, to find out which genetic make-up works best with SSRIs.

Dr. Gurwitz believes that among our 25,000 human genes, only a few hundred will show a difference between the two types of "extreme responder" cells. In the next phase of their study, they will explore which of those "hits" can be valuable clinical biomarkers for the response to Prozac, a study that can subsequently be done by psychiatrists.

"Ours is a unique model because it does not make presumptions," says Dr. Gurwitz. "Research on Prozac response biomarkers over the past 20 years has focused on genes related to the brain metabolism of serotonin, long suspected as the cause of depression," he adds. "However, after many years of research with this focus, it is now obvious that the approach has failed. We realize that we must look at the entire repertoire of human genes."

"Psychiatric pharmacology remains a black box," says Dr. Gurwitz. "Nobody knows why some people respond to Prozac-type SSRI anti-depressants, while others are helped by other kinds of antidepressants. The World Health Organization predicts by the year 2020, costs and lost productivity from depression will exceed those of cardiovascular disease as the leading cause of health expenditure in developed countries. We hope to produce a clear test for antidepressant drug responses to improve the odds for successful treatment."

American Friends of Tel Aviv University (www.aftau.org) supports Israel's leading and most comprehensive center of higher learning. In independent rankings, TAU's innovations and discoveries are cited more often by the global scientific community than all but 20 other universities worldwide.

Internationally recognized for the scope and groundbreaking nature of its research programs, Tel Aviv University consistently produces work with profound implications for the future.

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Military wives unite to cope with cancer, deployment - MSNBC

Posted: 27 Oct 2009 09:24 AM PDT

It looked like a lot of breast cancer awareness marches: a sea of pink hats, boas, t-shirts and hair dye. But in this particular crowd was a bond that ran even deeper than cancer.

Laura Reichert and Susan Allen are best friends who have become more like sisters over the past few months. Allen suffers from stage 3 colon cancer. Reichert watched her beloved grandmother die from breast cancer. They both know the pain in their own way.

What unites the two Tacoma Community College students even more closely, however, is the fact that both women have husband who are fighting in America's wars.

"It's a bond that you can't really describe," says Reichert, whose husband deploys for his first tour of duty in Iraq nenxt year.

"She been through things that I'll need help with, and hopefully I can be there for her, as well," said Reichert.

One way Reichert is already helping her friend is by organizing a cancer awareness walk on their college campus today. The march wound across TCC and ended with a fashion show.

"Having cancer is hard enough, but dealing with it while your husband is away is even worse," says Allen, whose husband recently retunrned for a one year tour in Iraq.

"Just knowing Laura was and is always there for me help so much," she says. "We're both heading into scary places between deployment and cancer. I know it will be a lot easier for each of us with a friend to lean on," says Allen.

TCC is also hosting a fundraiser for the Susan G. Komen Foundation at tonight's volleyball game on campus.

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Breast Cancer

Tuesday, October 27, 2009