Thursday, March 30, 2006

 

Alzheimer's Disease Drug Trials To Start

Humanetics Corporation and Mount Sinai School of Medicine to Begin Clinical Trials of New Alzheimer's Compound; FDA Clears the Way with Approval of Investigational New Drug (IND) Application
 
MINNEAPOLIS--(BUSINESS WIRE)--March 30, 2006--In an announcement today, Humanetics Corporation said that the Food & Drug Administration (FDA) has approved the start of human trials for Humanetics' promising new oral compound, NIC5-15, aimed at combating Alzheimer's disease.
 
Based on the Investigational New Drug Application (IND) submitted to FDA for NIC5-15, Mount Sinai School of Medicine (MSSM) will proceed immediately with Phase I and Phase II studies in a population of early stage Alzheimer's disease patients. The studies will be conducted at Mount Sinai in New York and at the Bronx VA Medical Center. According to Giulio Maria Pasinetti, M.D., Ph.D. of Mount Sinai's Department of Psychiatry and the clinical trials' principal investigator, "the studies will measure safety, dosing, efficacy and biomarkers for Alzheimer's disease."
 
"We are pleased that FDA has approved the start of clinical trials for NIC5-15," stated Ronald Zenk, President and CEO of Humanetics. "NIC5-15 represents the potential for a new class of compounds focused on modifying the disease itself by slowing or preventing its progression," he said.
 
Humanetics and Mount Sinai School of Medicine Working Collaboratively
 
In December 2005, Humanetics entered into two agreements with Mount Sinai School of Medicine connected to the development of NIC5-15. The first is a clinical research agreement related to this announcement, which allows investigators at Mount Sinai to study Alzheimer's patients to assess if NIC5-15 is well tolerated and to compare doses with respect to tolerability and clinical efficacy. The second--an exclusive licensing agreement--provides Humanetics with exclusive rights under pending patents to commercialize products containing NIC5-15.
 
In the earlier pre-clinical studies and animal models, NIC5-15 was found to be effective in preventing the formation or slowing the progression of beta amyloid plaques, which are believed to be a cause of Alzheimer's disease. In animal models specifically, moderate doses of the compound improved cognitive function in mice with Alzheimer's type neuropathology and memory impairment.
 
Discovery and development of NIC5-15 for Alzheimer's disease has been under the direction of Dr. Pasinetti who added that "NIC5-15 was chosen to move into human trials because of its selectivity, safety and potency--making it an ideal agent for long-term prophylactic administration in this population."
 
About Mount Sinai School of Medicine
Located in Manhattan, Mount Sinai School of Medicine is internationally recognized for ground-breaking clinical and basic-science research, and innovative approaches to medical education. Through the Mount Sinai Graduate School of Biological Sciences, Mount Sinai trains biomedical researchers with an emphasis on the rapid translation of discoveries of basic research into new techniques for fighting disease. One indication of Mount Sinai's leadership in scientific investigation is its receipt during fiscal year 2004 of $153.2 million. Mount Sinai now ranks 25th among the nation's medical schools in receipt of research support from NIH. Mount Sinai School of Medicine also is known for unique educational programs such as the Humanities in Medicine program, which creates opportunities for liberal arts students to pursue medical school, and instructional innovations like The Morchand Center, the nation's largest program teaching students and physicians with "standardized patients" to become not only highly skilled, but compassionate caregivers. Long dedicated to improving its community, the School extends its boundaries to work with East Harlem and surrounding communities to provide access to health care and educational programs to at risk populations.
 
About Humanetics Corporation
Humanetics is a privately-held specialty pharmaceutical company headquartered in Minneapolis, Minnesota. The Company is focused on the rapid discovery, development and commercialization of orally-administered bioactive compounds for prevention and treatment of diseases in categories with urgent and unmet needs. The Company has several proprietary compounds in preclinical and/or clinical stages of development in the areas of Alzheimer's disease, bioterrorism and obesity. For further information, visit: http://www.humaneticscorp.com.
 
This Press Release contains discussion of certain expectations regarding Humanetics' future performance. These forward-looking statements are based on the Company's current views and assumptions. Actual results could differ materially from these current expectations and projections, and from historical performance.
 
Contacts
Latitude
Pam Pettinella, 952-404-1853
pam@latitude-c.com

Tuesday, March 28, 2006

 

Waiting Room Patients Targeted In Sick Scheme

VISI Networks Teams with LabCorp(R) to Launch LabCorp Health Network; A Direct-to-Patient Digital Signage Network for LabCorp's Patient Service Centers Nationwide
 
LabCorp Health Network (LHN) - a direct-to-patient digital signage network for LabCorp's Patient Service Centers - is a customized channel of healthcare information specifically designed to provide patients using LabCorp's patient service centers a comfortable waiting environment through the delivery of quality commercial, educational, informational and entertainment segments via an internet driven, nationally networked narrowcast system. (Photo: Business Wire)
 
ORLANDO, Fla.--(BUSINESS WIRE)--March 28, 2006--VISI Networks and Laboratory Corporation of America(R) Holdings (LabCorp(R)) (NYSE:LH), a leading, national provider of diagnostic services and a pioneer in new diagnostic technologies, have teamed to create the LabCorp Health Network - a direct-to-patient digital signage network for LabCorp's Patient Service Centers.
 
The LabCorp Health Network (LHN) is a customized channel of healthcare information specifically designed to provide patients using LabCorp's patient service centers a comfortable waiting environment through the delivery of quality commercial, educational, informational and entertainment segments via an internet driven, nationally networked narrowcast system. Presented on large, flat-panel screens installed in LabCorp's Patient Service Centers, LHN provides an opportunity for advertisers and content partners to reach a health conscious audience with known demographic and statistical data.
 
"Through the LabCorp Health Network, we are providing a dynamic channel to educate patients and visitors as to the latest testing procedures and preventive measures they can take to lead happier and healthier lives," said Joseph Erhart, CEO of VISI Networks.
 
"We are extremely excited about this network. This private channel represents an opportunity for LabCorp and their content partners to reach a sizeable health conscious audience with relevant messaging that connects directly with their customer base in a way that was previously impossible," said Michael Erhart, VP of Business Development for VISI Networks. "By being able to deliver messages directly to real patients - ensuring they receive the most up-to-date information in a timely manner - this narrowcast network establishes itself as a superior alternative to traditional media."
 
Currently, the LabCorp Health Network can be found in over 300 of LabCorp's more than 1,300 Patient Service Centers in the U.S.
 
About VISI Networks
 
Founded by nationally recognized wayfinding and signage information display system expert Joseph Erhart, VISI Networks develops proprietary network information display systems capable of delivering high-impact digital multimedia messages to targeted consumers. VISI Networks has tested their infrastructure with networks in Florida Hospital Critical Care Centers, SunTrust Bank and Orlando-Sanford International Airport. To learn more about VISI Networks, visit www.VISInetworks.com.
 
About LabCorp(R)
 
Laboratory Corporation of America(R) Holdings, a S&P 500 company with an investment-grade credit rating, is a pioneer in commercializing new diagnostic technologies and the first in its industry to embrace genomic testing. With annual revenues of $3.3 billion in 2005, approximately 24,000 employees nationwide, and more than 220,000 clients, LabCorp offers clinical assays ranging from routine blood analyses to HIV and genomic testing. LabCorp combines its expertise in innovative clinical testing technology with its Centers of Excellence: The Center for Molecular Biology and Pathology, in Research Triangle Park, NC; National Genetics Institute, Inc. in Los Angeles, CA; ViroMed Laboratories, Inc. based in Minneapolis, MN; The Center for Esoteric Testing in Burlington, NC; DIANON Systems, Inc. based in Stratford, CT, US LABS based in Irvine, CA, and Esoterix and its Colorado Coagulation, Endocrine Sciences, and Cytometry Associates laboratories. LabCorp clients include physicians, government agencies, managed care organizations, hospitals, clinical labs, and pharmaceutical companies. To learn more about LabCorp, visit www.LabCorp.com.
 
Contacts
Media Contacts
Tier 1 Public Relations
Dan Dyer, 513-478-7818
ddyer@tier1pr.com
or
LabCorp
Pam Sherry, 336-436-4855
sherryp@labcorp.com
OR
Advertising Contact
VISI Networks Inc.
Jenny Sue Rhoades, 407-566-1437
jennysue@visinetworks.comAt A Glance
VISI Networks
Source: via Business Wire
Updated  03/24/2006  by company 

[Editor's comments: Great. Now when I have to see a doctor I can look forward to having my desperate-for-a-distraction mind feed commercial messages not unlike waiting for a plane at the airport. I predict the day is near when you use a public restroom and close the door you will sit (or stand) to have a yammering screen that wants to take your moment of privacy and join you for a little marketing one-on-one.
 
It's information.  It's advertising.  It's intrusive.  And It's obnoxious.
 
(hris ]

Wednesday, March 15, 2006

 

Vioxx Rushed, Execs Knew

 

Merck executive acknowledges pressure to bring Vioxx to market
Winston-Salem Journal - Winston-Salem,NC,USA
calculated in the 1990s that it would lose $611 million in sales if it failed to develop its Vioxx painkiller before a rival introduced a similar product, the ...

Merck accused of rushing Vioxx
New Zealand Herald - New Zealand
Drug company Merck & Co accelerated development of its Vioxx pain reliever because it calculated it could lose more than US$600 million ($925.49 million) a ...

Vioxx plaintiff admits files don't reflect his claim
OregonLive.com - Portland,OR,USA
SAN FRANCISCO -- The city of Santa Clara, Calif., agreed to pay Enron Corp. creditors $36.5 million to settle a lawsuit over terminated ...

Merck Defends Vioxx as 'One of Most-Studied' Drugs as Latest Trial ...
Insurance Journal - USA
insisted at the start of another Vioxx trial that the company adequately investigated the drug's safety and asserted it was heart disease and other ailments ...

Merck rushed Vioxx development, court told
Reuters - USA
By Jon Hurdle. ATLANTIC CITY, NJ, March 7 (Reuters) - Merck & Co. Inc. (MRK.N: Quote, Profile, Research) accelerated development of its Vioxx pain drug because ...

Merck accused of withholding Vioxx facts
NewKerala.com - Ernakulam,Kerala,India
ATLANTIC CITY, NJ: A trial is under way in Atlantic City, NJ, in which pharmaceutical maker Merck & Co. is accused of withholding Vioxx safety information. ...

Plaintiff takes stand, describes heart attack he blames on Vioxx
East Valley Tribune - Mesa,AZ,USA
ATLANTIC CITY, NJ -A man who blames Vioxx for his heart attack took the stand in his lawsuit against Merck & Co. on Friday, acknowledging ...

Merck rushed Vioxx development, court told
Reuters - USA
... accelerated development of its Vioxx pain drug because it calculated it could lose more than $600 million a year if it did not beat competitors to market, a ...

Jury Sees Merck Documents in Vioxx Case
CBS News - USA
(AP) A jury hearing a Vioxx product liability case got its first look Tuesday at e-mail messages, internal documents and other materials showing manufacturer ...

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Monday, March 06, 2006

 

Vioxx Length Of Use Seen As Key In Murky Merck Trial

Length of time using Vioxx seen key in Merck trial

By Anna Driver

NEW YORK (Reuters) - Opening arguments in the next Vioxx liability trial start on Monday as Merck & Co. (MRK.N: Quote, Profile, Research) faces the lone lawyer who has beaten the company in one of these cases -- this time representing two long-term users of the painkiller who say it caused their heart attacks.

So far, two juries have found Merck not liable, while Mark Lanier, a flamboyant Texas lawyer, helped secure a $253 million judgment for the widow of a Vioxx user last August. The trial, set to begin next week in New Jersey Superior Court in Atlantic City, marks the first involving plaintiffs who took the painkiller for more than 18 months.

Merck withdrew the arthritis drug from the market in September 2004 after a study showed the risk of heart attack and stroke doubled in patients who took Vioxx for at least 18 months. The company, based in Whitehouse, New Jersey, faces nearly 10,000 lawsuits from people accusing it of hiding health risks of a medicine that once generated annual sales of $2.5 billion.

In earlier trials, Merck maintained there was no evidence of heightened risk for short-term Vioxx users. "The length of exposure is a critical issue in these cases," Howard Erichson, a law professor at Seton Hall University, said. "The scientific evidence on causation is stronger for long-term use than short-term use, but that doesn't mean the defendant just lays down."

Lanier is representing Thomas Cona, a 59-year-old New Jersey businessman who says he took Vioxx for 22 months prior to suffering a heart attack in June 2003. The other plaintiff, John McDarby, 77, says he took Vioxx for four years and had a heart attack in April 2004 after a fall in which he also broke his hip.

"I think what you are going to see is that the plaintiffs are going to have a difficult task showing that Vioxx caused their heart attacks," Chuck Harrell, one of Merck's attorneys in Atlantic City, said. "Each of them had multiple pre-existing risk factors that are well known to cause heart attacks." Both men had a history of high blood pressure and high cholesterol and were smokers, Harrell said.

In court documents, Merck, citing prescription records, has also argued that Cona was not even a long-term user of Vioxx.

LANIER FACTOR?

Some even say the outcome of the trial could hinge on the performance of Lanier, a gifted attorney and preacher who has won hundreds of millions of dollars in damages for his clients in product liability cases. "Only one out of four juries was able to reach a conclusion that Merck had withheld important information about Vioxx even though they all received similar factual records," Benjamin Zipursky, a professor at Fordham University School of Law, said.

"One obvious conjecture is that Mr. Lanier has the ability to present these facts in a way that is highly persuasive to the ordinary people sitting on juries," he said. Still, there is some doubt about whether Lanier's folksy Southern style will play in Atlantic City, where an eight-woman and two-man jury was selected to hear the case.

"With trial lawyers, rapport with the jury is very important," Howard Erichson, a law professor at Seton Hall University, said. "An out-of-state lawyer may find it more difficult to connect with a jury, but it's all about preparation."

Merck is based in New Jersey, but its lead attorney in the case is Christy Jones, from the Jackson, Mississippi, firm of Butler, Snow, O'Mara, Stevens & Cannada. The trial is expected to last three to four weeks, an attorney for Merck said.

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