Merck Has Solid Results in a Cancer Drug Trial

CHICAGO — An experimental drug from Merck that unleashes the body’s immune system significantly shrank tumors in 38 percent of patients with advanced melanoma, putting the company squarely in the race to bring to market one of what many experts view as the most promising class of drugs in years.

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Pfizer signs embryonic stem cell license with UW foundation

By Kathleen Gallagher of the Journal Sentinel
Posted: May. 5, 2009

Pfizer Inc. said Tuesday that it has signed a license with the Wisconsin Alumni Research Foundation to use human embryonic stem cells for the development of new drug therapies. With annual revenue of more than $48 billion,

Pfizer is the biggest of the 35 companies to sign an embryonic stem cell license with the foundation, said Andy DeTienne, WARF's licensing manager for stem cells. Financial terms were not disclosed.

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Court Rules In Pfizer's Favor In Norvasc Patent Case, Finds Synthon Obtained Patent By Inequitable Conduct

NEW YORK, Jan. 31 /PRNewswire-FirstCall/ -- The federal district court in the Eastern District of Virginia (Alexandria) has ruled that Synthon IP obtained, by inequitable conduct, two U.S. patents alleged to cover a process and an intermediate compound used to make the active ingredient in Pfizer's widely-prescribed hypertension medication, Norvasc, Pfizer said today.

Pfizer said the court found that Synthon had knowingly failed to disclose to the U.S. Patent Office Pfizer publications and other information it had in its possession that described the process Synthon sought to patent. "It's very difficult to meet the standards for establishing inequitable conduct," said Allen Waxman, Pfizer's general counsel. "But in this case it is clear that Synthon improperly used Pfizer's own published material to obtain a patent that it then tried to enforce against us."

Pfizer said it intends to seek attorneys' fees from Synthon. The case may be appealed.

Synthon had asserted that Pfizer's process for manufacturing Norvasc --a process Pfizer had not only published but has been using for 15 years --infringed Synthon patents issued in 2003 and 2005. In August of last year, a jury unanimously ruled that one of those patents was not infringed by Pfizer and was invalid on multiple grounds, principally because it was based on Pfizer's prior published work. Synthon had dropped its claim of infringement on the second patent prior to trial.

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Court Affirms $7 Million in Damages for Innogenetics in Patent Infringement Suit

Judge Denies Abbott Laboratories' Requests for New Trial

GENT, Belgium and MADISON, Wis., January 04, 2007 /PRNewswire-FirstCall/ -- Biotechnology Company Innogenetics announced today that a U.S. District Court judge for the Western District of Wisconsin affirmed a previously awarded $7 million damage verdict against Abbott Laboratories for infringing the company's HCV genotyping patent. In the same ruling the judge rejected Abbott's requests for a new trial on infringement and validity.

The January 3, 2007 order also granted Innogenetics' motion for prejudgment interest on the damage award and set a January 11 evidentiary hearing date to consider the company's request for a permanent injunction against Abbott's sale of infringing products. The judge's opinion vacated the jury's determination that Abbott willfully infringed Innogenetics' patent, and declined to award enhanced damages or attorneys fees.

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Ruling Upholds Eli Lilly’s Patent on Drug

By BLOOMBERG NEWS
Eli Lilly & Company won a federal appeals court ruling on Tuesday upholding its patent on Zyprexa, the world’s top-selling schizophrenia drug.

The United States Court of Appeals for the Federal Circuit, in Washington, affirmed a lower court decision that the patent was valid. The Ivax unit of Teva Pharmaceutical Industries and Dr. Reddy’s Laboratories had claimed a federal judge was mistaken in ruling the drug was protected until Lilly’s patent expires in 2011.

In addition, “Lilly did not fail to disclose information” to the patent office, as its rivals suggested, the judges said in their 21-page opinion. The opinion upheld a decision by Judge Richard L. Young of United States District Court in Indianapolis.

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Bone drug still viable: DeLuca

Bone drug still viable: DeLuca
By Jeff Richgels

Despite the ending of its partnership with pharmaceutical giant Pfizer, Madison-based Deltanoid Pharmaceuticals remains confident about prospects for its lead drug.

"It's a very safe compound and it looks like it might work," said UW-Madison Professor Hector DeLuca, who led the team that developed 2MD, a potentially revolutionary osteoporosis drug that is the first to show the ability to stimulate new bone formation, rather than just prevent bone loss.

Osteoporosis is a disease involving the loss of normal bone that results in a susceptibility to fractures. The disease affects some 25 million people in the U.S. and is most frequently seen in postmenopausal women, elderly people and those taking corticosteroids.

Deltanoid is preparing to initiate the second of three phases of clinical trials for 2MD.

Pfizer, which signed a deal with Deltanoid in January 2003, had been conducting its own Phase II trials of 2MD but quit after six months, ending the relationship with Deltanoid last December, DeLuca said.

"It was their design and we did not have any controlling vote in the design of the trial," DeLuca said. "They started out and used very low doses, much lower than we would use. We worked extensively with animals and knew what (dosage) they would tolerate."

"The reasons they didn't go further are not entirely known to us," DeLuca added.

One possibility, he said, is business because Pfizer has several drugs in development "and our's may not have reached their highest priority."

Another is that Pfizer said it did not see any bone density increases in the six months, but DeLuca said that was not enough time.

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UW scientist finds more ways to fight diseases

UW scientist finds more ways to fight diseases
"Isn't just for bones anymore" says DeLuca
By Samara Kalk Derby

In the beginning, vitamin D research at the University of Wisconsin was all about building better bones, especially for children.

But "vitamin D therapy isn't just for bones anymore," pioneering UW-Madison scientist Hector DeLuca told a crowd of 250 at the Overture Center Tuesday night in a rare public lecture.

Now, he said, the vitamin D frontiers include developing treatments for psoriasis, dialysis patients, diabetes, osteoporosis, prevention of hip fractures, and even cancer.

DeLuca, who holds more than 200 U.S. patents, led his audience through the story of vitamin therapy, beginning in the 1850s, when German biochemists dominated science.

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State hopes to woo Abbott Labs

State hopes to woo Abbott Labs
Governor to discuss economic package
By TOM DAYKIN
tdaykin@journalsentinel.com
Posted: Feb. 28, 2006

Global pharmaceutical maker Abbott Laboratories Inc.'s long-range plans to expand into southeastern Wisconsin are expected to be the subject of a Thursday announcement by Gov. Jim Doyle.

Abbott recently bought almost 500 acres west of I-94 in Kenosha County. Sources said Tuesday that Doyle will discuss a state financing package to help Abbott acquire additional land for its planned development in Pleasant Prairie, a few miles north of the Wisconsin-Illinois border.

Abbott anticipates using the Kenosha County site for future growth, company spokesman Jonathan Hamilton said, but Abbott does not now have any specific development plans in place for the property.


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Supreme Court to hear MedImmune case

Supreme Court to hear MedImmune case
Associated Press

GAITHERSBURG, Md. - The U.S. Supreme Court agreed Tuesday to hear a case on whether drug-maker MedImmune Inc. has the right to sue rival Genentech Inc. over a lucrative drug patent.

MedImmune claims San Francisco-based Genentech and British biotechnology firm Celltech R&D Ltd. improperly schemed to obtain a patent on antibody technology, allegedly in violation of antitrust laws. MedImmune wants the patent invalidated.

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Abbott Labs might have plans in Kenosha County

Abbott Labs might have plans in Kenosha County
Company won't discuss its intentions, but Doyle confirms development talks
By TOM DAYKIN
tdaykin@journalsentinel.com
Posted: Feb. 12, 2006

Pleasant Prairie - Global pharmaceutical maker Abbott Laboratories Inc. has purchased nearly 500 acres just west of I-94 in Kenosha County and is negotiating a state financing package to develop the property.

Abbott, based about 15 miles south of Kenosha County in suburban Chicago, has purchased 467 acres for $34.9 million, according to documents filed with the Kenosha County register of deeds. The parcels are in the northwest quadrant of the I-94/Highway Q interchange, in the village of Pleasant Prairie and the town of Bristol.

A developer not involved with the project estimated that the site is large enough to hold offices and manufacturing facilities that employ thousands of people.


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$1.6 million to help develop Alzheimer's treatments

Drug firm has an angel
$1.6 million to help develop Alzheimer's treatments
By JOHN SCHMID
jschmid@journalsentinel.com
Posted: Feb. 1, 2006

Mithridion Inc., a start-up pharmaceutical firm near Madison, announced Wednesday that it scored a $1.6 million investment to help develop drugs that stop or slow the progression of Alzheimer's disease.

"Very high rewards come with very high risk," said Mithridion chief executive Trevor M. Twose.

Mithridion's funding, announced with fanfare in Madison, is known in the investment trade as early-stage private equity. Such "angel investing" appears to be increasing in Wisconsin, according to a report by NorthStar Economics Inc. think-tank, released in conjunction with the company's announcement.

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Nobelist Discovers Antidepressant Protein in Mouse Brain

A protein that seems to be pivotal in lifting depression has been discovered by a Nobel Laureate researcher funded by the National Institutes of Health’s National Institute of Mental Health (NIMH).

"Mice deficient in this protein, called p11, display depression-like behaviors, while those with sufficient amounts behave as if they have been treated with antidepressants," explained Paul Greengard, Ph.D., a Rockefeller University neuroscientist who received the 2000 Nobel Prize in Physiology or Medicine for discoveries about the workings of such neuronal signaling systems. He and his colleagues found that p11 appears to help regulate signaling of the brain messenger chemical serotonin, a key target of antidepressants, which has been implicated in psychiatric illnesses such as depression and anxiety disorders. They report on their findings in the January 6, 2005 issue of Science.

"This newfound protein may provide a more specific target for new treatments for depression, anxiety disorders and other psychiatric conditions thought to involve malfunctions in the serotonin system," said NIH director Elias Zerhouni, M.D.

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Do ants hold key to drug resistance?

Do ants hold key to drug resistance?
They carry bacteria to fight fungus — and it's worked for millions of years
By SUSANNE RUST
srust@journalsentinel.com
Posted: Jan. 5, 2006

Some ants, it seems, are packing more than your picnic lunch.

According to researchers at the University of Wisconsin-Madison, a particular tribe of ants, known as attine ants, have pockets throughout their thick, outer armor crammed full of antibiotic-producing bacteria. They use these bacteria to kill off a parasitic fungus that could destroy their way of being.

And according to Cameron Currie, a UW bacteriologist, the ants, the bacteria they cultivate and the fungus they fear have been in a stalemate for millions of years. This prompts the question: How come the fungus has not evolved to resist this particular strain of bacteria? This question could trigger insights into the battle against antibiotic-resistant strains of disease.

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Toxicology-on-a-Chip Tool Readies for Market

Toxicology-on-a-Chip Tool Readies for Market
University and biotech company collaboration prepares MetaChip for technology transfer

TROY, N.Y. — Recalls of popular prescription drugs are raising public concern about the general safety of new pharmaceuticals. A collaborative group of researchers says that identifying which drug candidates are toxic early in the discovery process can help prevent harmful pharmaceuticals from being placed on the market in the first place, and they have developed a tool to do it.

Researchers at Rensselaer Polytechnic Institute, University of California-Berkeley, and Solidus Biosciences Inc. have developed a biochip, called the MetaChip, which can analyze drug candidates for toxicity and eliminate harmful ones before they advance to pre-clinical stages. Now beginning the second phase of funding for the National Institutes of Health (NIH)-supported project, researchers are working to optimize the technology for the end user: pharmaceutical and biotechnology companies. The researchers are working to bring the MetaChip to market within a year.

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Statins may simulate stem cells for heart repair

BUFFALO, N.Y. -- The drug pravastatin, which is used widely to decrease high cholesterol, may provide a previously unknown cardiovascular benefit in addition to lowering lipids.
Researchers at the University at Buffalo have found that pravastatin, the generic name of one of the statins currently prescribed to lower cholesterol, increased the concentration of endogenous stem cells that may participate in cardiac repair independent of any cholesterol-lowering action.

They also found that high doses of pravastatin improved cardiac function and coronary blood flow in an animal model in which flow had been artificially restricted, creating a condition known as hibernating myocardium. In this condition, heart cells reduce their function and oxygen needs and become dormant in response to insufficient blood flow.

Results of the study were presented today (Nov. 16, 2005) at the American Heart Association's 2005 Scientific Sessions in Dallas, Texas. "It is well known that stem cells have the potential to regenerate organs," said Gen Suzuki, M.D., Ph.D., research assistant professor in the UB School of Medicine and Biomedical Sciences and first author on the study.

"In the field of cardiology, adult stem cells isolated from bone marrow currently are being used to repair damaged heart tissue," Suzuki said. "Many animal and early clinical studies using this source of stem cells are ongoing right now."

Earlier reports have shown that HMG-CoA reductase inhibitors, known as statins, increased the number of circulating bone-marrow-derived or hematopoietic stem cells in blood, Suzuki said, but most work has focused on their effects in improving blood flow. Their localization in the heart or ability to increase cardiac-muscle-cell numbers has never been studied, he said.

The UB study employs a unique swine model of hibernating myocardium created by scientists in UB's Center for Research in Cardiovascular Medicine. Researchers treated normal pigs and pigs with hibernating myocardium with pravastatin for four weeks, and compared the results with normal pigs and pigs with hibernating myocardium that did not receive the statin.

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Patent Reform Criticism

In patent reform debate, high-tech firms lose ground to drug industry
Friday, September 16, 2005

By Erica Werner, The Associated Press

WASHINGTON -- Opposition from drug and biotech companies has forced lawmakers to water down a bill cracking down on the so-called patent trolls who are bedeviling the high-tech industry.

Those are people who get patents for products they never plan to make, just so they can sue for infringement if a company does turn out something similar.

But the resulting draft legislation drew criticism from a top Democrat at a hearing Thursday, and a warning from a high-tech group that said lawmakers could be risking the industry's support.

"We have a bill which to my way of thinking has stripped out very significant reforms," Rep. Howard Berman, D-Calif., said at a hearing of the House Judiciary Committee's subcommittee on intellectual property.

"The support of our industry for this legislation should not be taken for granted," Emery Simon, an attorney for the Business Software Alliance, told Rep. Lamar Smith, R-Texas, the chairman of the subcommittee.

Drug companies don't have the high-tech industry's problem with patent trolls. Instead, they depend heavily on patents -- and the ability to sue to enforce them -- to safeguard their intellectual property and raise money while they develop new products.

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Building starts on space for Promega

Building starts on space for Promega
00:00 am 8/25/05
MARV BALOUSEK mbalousek@madison.com

Construction began Wednesday on a three-building office and retail project in the Fitchburg Center that will provide additional space for Promega Corp.

The $22 million, 84,000-square-foot project near Cheryl Parkway and Fish Hatchery Road will contain 62,000 square feet occupied by Promega and 22,000 square feet of retail space.

Promega aims to add more than 100 employees over the next five years and the company plans to expand its manufacturing and research space.

"This expansion by Promega promises to be a signature project within Fitchburg Center," said Mayor Tom Clauder in a statement. "This development accomplishes our economic development objectives by assisting one of our major employers to expand."

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Enhancing the anti-cancer properties of a digitalis

UW-MADISON SCIENTISTS ZERO IN ON DRUGS' SWEET SPOTS

MADISON - Employing a simple new technique to manipulate the sugars that power many front-line drugs, a team of Wisconsin scientists has , a drug commonly used to treat heart disease.

Reporting the work in the Aug. 8 edition of the Proceedings of the National Academy of Sciences, a team led by University of Wisconsin-Madison professor of pharmaceutical sciences Jon S. Thorson, describes a series of experiments that boosted the cell-killing potency and tumor specificity of the drug, derived from the foxglove plant and used to stimulate the heart. The drug is suspected to have anti-cancer properties, but its use to treat cancer has been little explored.

The new work is important because it provides scientists and drug companies with a quick and easy way to manipulate the sugars found in chemicals produced in nature. Such chemicals - often found in microbes, plants and marine organisms - are the bedrock agents upon which many leading drugs are built. The ways sugar groups are organized on a molecule often dictate the agent's biological effects.

Continue reading "Enhancing the anti-cancer properties of a digitalis" »

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Merck ordered to license antibiotic production to rival in Italy

Merck ordered to license antibiotic production to rival in Italy UPDATE
06.21.2005, 10:59 AM

MILAN (AFX) - The Italian antitrust authority said it ordered Merck & Co Inc to license production of an antibiotic to another producer in Italy for export sales.

In February, the authority launched an inquiry into Merck's refusal to grant a licence for Italian production of imipenem cilastatina, the active ingredient in its Tienam product, to a rival for sales in European countries where Merck's patent has already expired, it said.

'Merck is holder in Italy of a monopoly right that gives it the exclusive right to sell Tienam, an antibiotic aimed at treating particularly serious infections, above all in hospitals,' it said.

'The authority has decided that Merck should allow, via award of a licence, the production and stocking in Italy of the main ingredient imipenem cilastatina,' it said.

This would allow other chemical companies with Italian plants to be ready, when the inquiry is closed, to export the antibiotic to European countries where Merck's patent has expired.

These exports would come before the arrival on these markets of generic products in competition with Merck's Tienam, it said, saying that this decision is an application of EU antitrust rules.

In details from the full decision, the authority said its investigation follows the denial of a request for a licence from Italian firm ACS Dobfar SpA, which has 270 mln eur annual sales.

Under Italian law, Dobfar filed a request with the industry ministry in November 2002 to obtain a licence to produce the Merck-patented product.

In 2004, during talks between the companies, Merck told Dobfar it did not want to licence the ingredient because of the need for know-how to produce it, and worries on low quality production.

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A labyrinth from lab to marketplace

A labyrinth from lab to marketplace
Rats engineered for drug testing
By KATHLEEN GALLAGHER
kgallagher@journalsentinel.com
Posted: June 1, 2005
A good idea usually isn't enough.

When it comes to transferring technology - moving ideas out of the laboratory and making them commercially viable - protecting intellectual property, finding financing and targeting the right markets are all important.

PhysioGenix Inc. in Wauwatosa, one of five finalists for the Governor's Small Business Technology Transfer Award, says it has all those pieces in place and is on the path toward turning what observers agree is a really good idea into a viable, job-creating, Wisconsin-based company.

"Our focus is on generating profitable revenue today, and I'm confident we have the products and services that will be in high demand with the pharmaceutical industry," said John J. Seman, who took over as PhysioGenix president and chief executive officer late last year.

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J&J sees 10-13 new drugs approved by 2007

J&J sees 10-13 new drugs approved by 2007
Thursday May 26, 2:44 pm ET
By Toni Clarke and Julie Steenhuysen


NEW YORK/CHICAGO (Reuters) - Johnson & Johnson (NYSE:JNJ - News) , which like other major drugmakers faces a growing number of patent expirations, on Thursday said it plans to file and receive marketing approval for 10 to 13 new drug compounds by 2007.

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Abbott drug OK seen as Bone Care boost

Abbott drug OK seen as Bone Care boost

The Capital Times
May 27, 2005

As expected, the U.S. Food and Drug Administration has given Abbott Laboratories Inc. approval to sell a capsule form of its injectable drug Zemplar for treating a complication of chronic kidney disease.

Zemplar is a synthetic version of vitamin D that counteracts secondary hyperparathyroidism, or SHPT, a condition that damages bones and vital organs.

Abbott has been selling an injectable form of Zemplar for the 300,000 to 400,000 patients with chronic kidney disease who require dialysis. The oral form is for the much larger market of about 8 million kidney disease patients who do not yet require dialysis.

Middleton-based Bone Care International's Hectorol drug is approved for both markets, and the company sees giant Abbott's marketing muscle as an aid in opening up the pre-dialysis market.


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Astellas Pharma, Boehringer Ingelheim Pharmaceuticals Jointly Sue Flomax Generic for Patent Infringement in US

Astellas Pharma, Boehringer Ingelheim Pharmaceuticals Jointly Sue Flomax Generic for Patent Infringement in US

Tokyo (JCNN) - On May 16, Astellas Pharma and Boehringer Ingelheim Pharmaceuticals (BIPI), a US subsidiary of Boehringer Ingelheim of Germany, jointly announced that they have filed a patent infringement lawsuit in the US against Ranbaxy, which has recently submitted an abbreviated new drug application (ANDA) for a generic product of Flomax, Astellas' proprietary drug designed for the treatment of benign prostatic hyperplasia.

The two companies request an order that the date of approval of Ranbaxy's ANDA not be earlier than the expiration on October 27, 2009 of Astellas' US patent on tamsulosin HCI.

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Bone Care advances latest drug

Bone Care advances latest drug

By Jeff Richgels
May 17, 2005

As Bone Care released more details on its pending acquisition by biotech giant Genzyme Corp., the Middleton-based pharmaceutical maker also announced a step forward for the latest generation of its drug line.

Early data have shown that the new vitamin D compound, "LR-103," has fewer side effects while being just as effective as Hectorol, Bone Care's lead drug that has been on the market for several years. Hectorol treats secondary hyperparathyroidism, a condition that can harm bones and vital organs, including the heart, in patients with chronic kidney disease.

"This is what we affectionately refer to as 'Son of Hectorol,' " Charles Bishop, Bone Care chief scientific officer, said of LR-103, which he said could become the company's new flagship drug.

The early data comes from an ongoing Phase I clinical study with LR-103 in cancer patients, Bishop said.

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Vote on Bone Care sale is June 30

Vote on Bone Care sale is June 30
00:00 am 5/17/05
Judy Newman Wisconsin State Journal

June 30 is the date that Bone Care International's shareholders will vote on a plan to let Genzyme Corp. buy the company for $33 a share, or a total of $600 million.

Meanwhile, Bone Care has the right to consider other offers - but not to solicit them. And if the Middleton specialty pharmaceutical company jilts Genzyme for a better offer, Bone Care will have to pay Genzyme nearly $20 million.

Those are among the terms of the agreement between the two companies, according to papers filed Friday with the Securities and Exchange Commission.

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Court approves delay in Plavix patent infringement suit

1 May 2005, 16:52 GMT - The patent infringement suit surrounding Sanofi-Aventis's Plavix, the world's third largest selling medication, was previously scheduled for May 13, 2005. Canadian company Apotex and India's Dr Reddy's Laboratories, have been challenging the patent since 2002 in the hope of selling cheaper versions of Plavix in the US.

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Blue Cross and Blue Shield Sue GlaxoSmithKline over Paxil Patent Abuse

Insurers sue maker of Paxil over generics
David Phelps, Star Tribune
May 12, 2005 PAXIL0512

Blue Cross and Blue Shield of Minnesota, in a broad lawsuit filed Wednesday, alleges that drug maker GlaxoSmithKline manipulated the federal patent system to keep cheaper generic alternatives to the popular antidepressant Paxil from reaching the marketplace.

Blue Cross and 18 other insurers from across the state allege that GlaxoSmithKline violated federal and state antitrust laws and fraud laws and engaged in deceptive trade practices. The lawsuit was filed in U.S. District Court in Minneapolis.

Nancy Pekarek, a spokeswoman for GlaxoSmithKline, said the company had not yet seen the lawsuit and would have no comment on its allegations.

The lawsuit seeks unspecified financial damages. Blue Cross senior counsel Tom Gilde said each insurer would review its claims data to determine the amount they would seek from GlaxoSmithKline.

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The Story of Valium

`Chill pill' eased nerves across nation; Leo Sternbach's invention, Valium, was hit, but addiction soon followed

BY PAULA SCHLEIS

Knight Ridder Newspapers

AKRON, Ohio - (KRT) - There once was a cure for the desperate housewife. It was called Valium.

Today, there are those who would argue that the ``chill pill'' was more curse than cure because of its addictive qualities. But there is no doubt that Valium - still widely used, though more carefully prescribed - is a cultural icon.

It all started with the Great Tranquilizer War of 1954.

Leo Sternbach, a Croatian chemist working in the New Jersey lab of Hoffman-LaRoche Inc., was under the gun to create something to compete against Miltown, an anti-anxiety drug from a rival pharmaceutical company. His superiors suggested he try tinkering with the chemicals used in Miltown, just enough to avoid a patent lawsuit.

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IBM and Rockwell to target life sciences manufacturers

IBM and Rockwell to target life sciences manufacturers

Published: 27 Apr 2005

IBM and Rockwell to target life sciences manufacturers

Software giant IBM is working with Milwaukee, Wisconsin-based Rockwell Automation to deliver manufacturing technology to life sciences companies as part of its Value-Driven Compliance Solutions framework.

The aim of the collaboration effort, known as Proof-of-Concept, is to help pharmaceutical companies use information integration to identify and capitalize on opportunities to reduce risk and increase operational efficiencies.

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WARF suit says firm violated contract

WARF suit says firm violated contract

The Capital Times
April 21, 2005

The Wisconsin Alumni Research Foundation, the technology transfer and licensing arm of the UW-Madison, has filed a lawsuit against Xenon Pharmaceuticals Inc., charging it with breach of contract and other violations of its agreement with WARF.

Attorneys for WARF said the suit, filed Wednesday in U.S. District Court in Madison, seeks to ensure that the interests of UW-Madison and its inventors are protected and that WARF receives its contractual share of a $157-million agreement entered into by Xenon, which is in British Columbia, Canada.

WARF licensed certain rights to Xenon in 2001 for an invention by university researchers related to cholesterol, obesity and diabetes.

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Lilly Wins Ruling Blocking Generic Forms of Top-Selling Zyprexa

Lilly Wins Ruling Blocking Generic Forms of Top-Selling Zyprexa

April 14 (Bloomberg) -- Eli Lilly & Co. won a court ruling that will prevent generic-drug makers from selling low-cost versions of its $4.4 billion-a-year Zyprexa schizophrenia drug before 2011.

U.S. District Judge Richard L. Young's decision to uphold the patent on the key ingredient in Zyprexa is a defeat for Ivax Corp., Dr. Reddy's Laboratories Ltd. and Teva Pharmaceutical Industries Ltd., which wanted to sell copies of the drug. The ruling was posted on the Indianapolis court's Web site today.

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Supreme Court to hear patent law case

Supreme Court to hear patent law case
by Caitlin Kiley
Tuesday, April 12, 2005

The Supreme Court will hear a patent case regarding the protection of research tools April 20 which numerous organizations and universities, including the Wisconsin Alumni Research Association, have taken active roles in the case’s discussion.

WARF filed an amicus brief along with several other universities encouraging the court to protect intellectual property.

The case pits Merck, a German pharmaceutical company, against Integra Life Sciences, a medical technology company. Merck and its supporters are arguing for a broader interpretation of a 1984 “safe harbor” law allowing companies to use patented materials and information without being accused of infringing on patents. The exemption currently extends only to those planning to apply for research approval from the Food and Drug Administration.

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Branded drug companies give generics a taste of their own medicine

Branded drug companies give generics a taste of their own medicine
Pharmaceutical News
Published: Wednesday, 6-Apr-2005

To defend market share, more branded drug companies today release generic versions of their branded drugs before other generic companies enter the market, according to a study by pharmaceutical intelligence firm, Cutting Edge Information.
Marketing generic versions of a company's own brand, an increasingly popular generic strategy, prevents revenue loss upon patent expiry. Branded drug companies who create their own generic drugs take advantage of their existing resources to control the market. The strategy limits overall competition by making entry into the market less desirable for other generic companies, thus channeling a portion of generic revenues back to itself.

Most branded drug companies wait to promote their own generics until another generic company announces its intentions to enter the market. Reaching the market first not only allows the branded drug company to leverage the price of the generic market, it also maintains a portion of generic drug prescriptions that constitute 50% of all U.S. drug prescriptions.

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Small drug companies generate interest

Small drug companies generate interest
By KATHLEEN GALLAGHER
kgallagher@journalsentinel.com
Posted: April 3, 2005
Proposals and disposals in the medical industry have caught the eye of one local investment manager.

Consolidation - driven by the need to boost growth - and the increasing popularity of disposable products got Richard P. Imperiale looking for a way to play these two separate but powerful trends.

"We're in the third inning of what looks like it's going to be a long ball games here in terms of both of these trends," said Imperiale, president of Forward Uniplan Advisors Inc., a Union Grove money management firm.

Big pharmaceutical companies are searching for new ways to grow because of fewer drugs in their pipelines and a large number of drug patents expiring.

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Pfizer says judge halts sales of generic Accupril

Pfizer says judge halts sales of generic Accupril

Wed March 30, 2005 6:21 AM GMT+05:30
LOS ANGELES (Reuters) - Pfizer Inc. said on Tuesday a judge has halted sales of generic versions of its blood pressure medicine Accupril sold by Teva Pharmaceuticals Inc. and Ranbaxy Laboratories Ltd.

U.S. District Court of New Jersey Judge Dickinson Debevoise granted the preliminary injunction after finding that Pfizer was likely to prevail in its patent infringement lawsuit filed against Teva and Ranbaxy on Jan. 28.

The judge ordered Israel-based Teva and India's Ranbaxy to immediately stop marketing the product, known generically as quinapril, that Teva launched in December 2004 under its own label as part of an agreement with Ranbaxy, Pfizer said.

Pfizer said it will seek damages resulting from lost sales caused by competition from the cheaper generic versions of its drug. Accupril had U.S. sales of $387 million in 2004.

Pfizer said the judge also denied Ranbaxy's and Teva's request to stay the injunction, while the world's largest drugmaker seeks a permanent injunction of generic sales of the blood pressure medicine.

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Pfizer Contests Lipitor Rule

Pfizer Contests Lipitor Rule

By Robert Steyer
TheStreet.com Staff Reporter
3/29/2005 2:18 PM EST

Pfizer (PFE:NYSE - news - research) said Tuesday that it would appeal a decision by the Austrian Patent Office that invalidated a patent on the main ingredient in its cholesterol-fighting drug Lipitor.

Pfizer says the patent challenge, filed by the Indian generic drug company Ranbaxy Laboratories, doesn't affect litigation in other countries, including the U.S. Ranbaxy also is challenging the U.S. patent which expires in 2011.

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Indian parliament's upper house approves drug patents bill

Indian parliament's upper house approves drug patents bill

Wed Mar 23, 9:11 AM ET Health - AFP

NEW DELHI (AFP) - Indian parliament's upper house approved a controversial drug patents bill which critics warn could deprive millions of poor people of low-cost life savings drugs.

The approval paves the way for the bill, which prohibits domestic firms from copying low-cost generic versions of patented drugs, to become law.

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Refunds for Some Antidepressant Users Who Were Prevented from Using Generic

Refunds available for antidepressant

By WILLIAM McCALL
Associated Press

March 17, 2005

PORTLAND — As part of a $36 million national settlement over the cost of the antidepressant drug Remeron, Oregon Attorney General Hardy Myers today joined other states to launch a campaign to notify consumers of possible refunds.

A 10-month investigation by the attorneys general of Oregon, Texas and Florida into allegations that Organan USA Inc. tried to prevent consumer access to lower-cost generic versions of the drug led to the settlement, filed in federal court last October in New Jersey, where Organan is based.
The pharmaceutical company is a subsidiary of Akzo Nobel NV, the world’s largest paint manufacturer, based in Arnhem, The Netherlands.

Myers said thousands of consumers in Oregon and nationally may be entitled to refunds after purchasing Remeron between June 15, 2001 and January 25, 2005.

The drug also is sold under the generic name Mirtzapine.

The states alleged in their lawsuit that Organon illegally extended its monopoly on the drug by improperly listing a new “combination therapy” patent with the U.S. Food and Drug Administration.

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Eminent Domain for Intellectual Property?

Eminent Domain Urged As Tool to Cut Drug Costs

By Susan Levine
Washington Post Staff Writer
Thursday, March 17, 2005; Page DZ03

As prescription drug costs spiral ever higher for the city and its residents, council member David Catania wants the District to be able to claim by eminent domain the formulas of certain widely used medicines so that they could be manufactured for significant savings.

Catania's radical proposal, which will get its first hearing Tuesday before the health committee that he chairs, would take one of government's traditional powers into very different territory. Instead of invoking eminent domain to seize real property, as is often done when land is needed for a project in the public interest, the city, through the mayor's declaration of a public health emergency, would appropriate the patents for these prescriptions as "intellectual property."

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FDA approval for Temodar (temozolomide) capsules for newly diagnosed glioblastoma multiforme

Approval for Temodar (temozolomide) capsules for newly diagnosed glioblastoma multiforme
Pharmaceutical News
Published: Wednesday, 16-Mar-2005

Schering-Plough today reported that the U.S. Food and Drug Administration (FDA) has granted approval for Temodar (temozolomide) Capsules for use in combination with radiotherapy for the treatment of adult patients with newly diagnosed glioblastoma multiforme (GBM), a form of malignant brain cancer.
The approval was based on data that demonstrated a significant overall survival benefit in patients who were treated with Temodar in combination with radiotherapy. Concurrent with the approval for newly diagnosed GBM, Temodar also received full approval for the treatment of adult patients with refractory anaplastic astrocytoma (AA), another form of brain tumor. Temodar received accelerated approval for AA in 1999 and is currently marketed for this indication in the United States.

"Temodar represents an important component for patients and physicians in the fight against GBM and validates the real benefits of chemotherapy in treating this disease," said Dr. Henry Friedman, co-director, Clinical Neuro-Oncology Program, The Brain Tumor Center at Duke. "After 26 years of practicing neuro-oncology, I view Temodar as a significant advancement in battling GBM."

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Biovail Sues Impax Over Wellbutrin XL Patent

Biovail Sues Impax Over Wellbutrin XL Patent

Wed March 9, 2005 5:37 PM GMT-05:00
TORONTO (Reuters) - A Biovail Corp. subsidiary is suing Impax Laboratories Inc. over Impax's attempts to bring a generic version of Biovail's antidepressant drug Wellbutrin XL to market, Impax said on Wednesday.

The lawsuit by Biovail Laboratories, filed in the United States District Court, eastern district of Pennsylvania, alleges patent infringement related to Impax's filing for approval to sell a generic version of Wellbutrin XL, Impax said.

Hayward, California-based Impax said it believes its generic versions of Wellbutrin XL 150 mg and 300 mg tablets do not infringe on Biovail's listed patents. It also said the listed patents are invalid or unenforceable.

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WHO members urged to sign Kyoto-style medical treaty

WHO members urged to sign Kyoto-style medical treaty
By Andrew Jack in London
Published: February 25 2005 02:00 | Last updated: February 25 2005 02:00

Countries around the world should sign up to a Kyoto-style treaty designed to boost medical innovation and affordable treatment, according to a petition submitted yesterday to the World Health Organisation by non-governmental organisations, academics and politicians.

Member states should pledge to invest a percentage of their gross domestic product in medical innovation, and would be allowed to trade "credits" with others through a mechanism similar to that in the Kyoto protocol designed to reduce environmental emissions.

They should also consider redirecting funding away from a traditional model based on intellectual property protection, and encourage the use of open sourcing to stimulate the sharing of information among medical researchers.

The letter, which draws on a draft medical research and development treaty drawn up over the past two years, is part of a broader debate on how to boost innovative research and development at a time when the "pipelines" of new medicines of the large pharmaceutical groups have been drying up.

It is also designed to address concerns that the current system does not have the incentives to encourage research into finding treatments for many "neglected diseases" in the developing world, which affect millions of people with only modest means to pay for medicines.

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Pfizer to buy Idun Pharmaceuticals

Pfizer to Buy Idun Pharmaceuticals
02.24.2005, 10:42 AM

Pfizer Inc. reported Thursday that it agreed to buy privately held biopharmaceutical company Idun Pharmaceuticals Inc. for its caspase inhibitor technology, which is designed to help control cell death, and its patent portfolio.

Financial terms of the agreement were not disclosed. Pfizer said it expects the transaction to close during the second quarter.

Caspases are a group of cellular proteases, or enzymes that cause the decomposition of protein, that are involved with inflammation and apoptosis, or cell death. The San Diego-based company's lead caspase inhibitor, IDN-6556, is in mid-stage clinical trials for use in liver transplant patients and patients infected with hepatitis C. Pfizer said the treatment is well tolerated and significantly improves markers of liver damage.

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Research kindles hope for strokes

Drug helps cases with few treatment options
By JOHN FAUBER
jfauber@journalsentinel.com
Posted: Feb. 23, 2005

In what could become the first major breakthrough in the treatment of the most deadly and disabling form of stroke, doctors reported today that a hemophilia drug substantially reduced death, disability and bleeding in the brains of patients.

"I never dreamed we would see results this powerful," said lead author Stephan Mayer. "This literally looks like it might be a magic bullet if you get it in soon enough."

The findings, reported today in the New England Journal of Medicine, have created excitement among stroke specialists and raised the hope of a significant new therapy for intracerebral stroke, a condition that has few treatment options.

Stroke doctors at the University of Wisconsin-Madison and the Medical College of Wisconsin say they hope to get into an upcoming phase 3 trial, which will be needed for Food and Drug Administration approval of the drug for so-called bleeding strokes. And, based on the findings, they now may begin using the drug on a limited basis.

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Merck KGaA v. Integra

Briefs are starting to roll in for the U.S. Supreme Court case of Merk KGaA v. Inegra. It is hoped that the Justices will resolve confusion regarding the research safe harbor or experimental use exception in patent law. The oral arguments are expected toward the end of the session.

Link to Patently Obvious

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Novartis Buys Drugmakers Hexal and Eon

Update 2: Novartis Buys Drugmakers Hexal and Eon
02.21.2005, 08:18 AM

Novartis AG announced Monday that it will buy generic drugmakers Eon Labs of the United States and Hexal AG of Germany for $8.3 billion, creating the world's largest generic drug company.

The Swiss pharmaceutical giant said it will buy all of Hexal and the two-thirds of Eon Labs that the German company owns for 5.65 billion euros (about $7.3 billion). In addition, Novartis expects to spend close to $1 billion to buy the remaining Eon Labs shares, which trade on the Nasdaq Stock Market.

The acquisitions, to be integrated into the Novartis generics subsidiary Sandoz, will create the world's largest company specializing in generic versions of drugs that have lost patent protection.

Sandoz's 2004 annual sales including the other companies would be $5.1 billion, ahead of Israel's Teva Pharmaceuticals Inc., which will hold the top spot until the deal closes in the second half of this year.

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Pfizer and Microsoft Join Forces Against Viagra SPAM

Pfizer, Microsoft sue over illegal Viagra
Sites, spammers selling cheap versions of drug
Updated: 12:05 p.m. ET Feb. 10, 2005

NEW YORK - Pfizer Inc. and Microsoft Corp. said Thursday they filed parallel lawsuits against Web site operators and spam advertisers that they say sell illegal cheap versions of Pfizer’s erectile dysfunction drug Viagra.

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Biotech Drugs' Generic Future Debated

Biotech Drugs' Generic Future Debated
Medications Are Hard to Afford -- but May Also Be Hard to Copy

By Marc Kaufman
Washington Post Staff Writer
Thursday, February 10, 2005; Page A01

MALVERN, Pa. -- To more than half a million patients suffering from rheumatoid arthritis or Crohn's disease, Remicade has brought life-changing treatment and relief.

But the drug, a genetically engineered protein produced not by chemistry but by living cells in a manufacturing process that requires 310 discrete steps, also brings a heavy financial burden. The manufacturer estimates that each patient will pay $14,000 to $16,000 a year for Remicade, and that people generally will take it indefinitely.

For those helped by Remicade, made by Centocor Inc., a biotech subsidiary of Johnson & Johnson, the drug represents a realization of the promise of biotechnology -- to treat disease with laboratory-created versions of proteins and other essential building blocks of the body's cells. But for employers, health insurers and the already stressed Medicaid and Medicare programs that pay the bills, the drug represents something else -- a serious threat to their financial well-being.

With complicated and costly "biologics" such as Remicade increasingly seen as the wave of the pharmaceutical future, health care experts warn that they will drive the nation's fast-growing bill for drugs far higher. And that prospect has set off a fierce battle in Washington over the multibillion-dollar question of whether to open the door to lower-cost generic or "follow-on" versions of the pricey biologics.

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Synthon, Pfizer in legal wrangle

Synthon, Pfizer in legal wrangle
Kim Nilsen

RESEARCH TRIANGLE PARK - In a bid to shield more than $3 billion in sales of a high blood pressure drug, Pfizer Inc. is suing generic drug company Synthon Pharmaceuticals.

Synthon Laboratories, a subsidiary of the drug company, is seeking U.S. Food and Drug Administration approval for a lower-cost medication that would rival the drug Norvasc, Pfizer's top-selling high blood pressure drug.

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