January 2007 Archives

By GARDINER HARRIS, NY Times

The Food and Drug Administration announced changes yesterday that were intended to ensure that marketed drugs are as safe as advertised, including the first effort to do a comprehensive assessment of the safety of drugs 18 months after introduction.

The agency also announced the creation of an advisory panel to improve the way it announces safety worries and a collaboration with the Veterans Health Administration to track how real patients fare after taking drugs.

In an unsourced story, French financial newsletter La Lettre de l'Expansion said a pre-merger deal is thought to have been signed last week.

In Frankfurt trading, shares of Bristol-Myers Squibb jumped 7.5% to close at 21.66 ($27.99). On the New York Stock Exchange, Bristol shares soared $1.22, or 4.7%, to $27.43.

Shares of Sanofi-Aventis slipped 1.4% to finish at 69 euros ($89.16) in Paris. The company's U.S. traded shares lost 77 cents to $44.57 on the NYSE.

NEW YORK (Reuters) - A state jury in Philadelphia on Monday found Wyeth's hormone replacement therapy (HRT) Prempro was responsible for an Arkansas woman's breast cancer and ordered the U.S. drugmaker to pay $1.5 million in compensatory damages, a court official said.

The jury found that Wyeth was negligent in failing to provide adequate warnings about the breast cancer risk associated with Prempro.

The jury is expected to return, possibly as soon as Tuesday, to decide punitive damages after also finding that Wyeth's conduct was "malicious, wanton, willful or oppressive or showed reckless indifference to the interest of others" in its failure to provide proper warnings about its HRT drugs, taken by millions of women to treat symptoms of menopause.

LONDON, Jan. 29, 2007-Documents revealed tonight on BBC One's Panorama programme suggest that Britain's largest drugs company deliberately misled doctors about the safety and effectiveness of its antidepressant and promoted it as a treatment for children.

Panorama (8.30pm, Monday 29 January 2007, BBC One) has had exclusive access to thousands of internal memos which GlaxoSmithKline (GSK) released to lawyers involved in United States legal action against the company.

The documents show that as far back as the late Nineties there was an acknowledgement within GSK that tests had failed to prove that Seroxat was a safe or beneficial treatment for depressed children.

Adherex Technologies is paying GlaxoSmithKline a million dollars up front and a set of milestones in exchange for the outstanding options on the cancer drug eniluracil. GSK shuttered its development program for the therapy after it failed a Phase III trial in combination with 5-FU. Adherex, though, believes that the reason for the failure was an "unexpected dose- and schedule-dependent drug interaction that resulted in the inhibition of 5-FU's activation into an effective anticancer agent."

"While GSK's initial Phase III trials with the product failed, we now have data to support each element of our hypothesis as to why those trials failed," says William P. Peters, M.D., Ph.D., chairman and CEO of Adherex. "We expect to complete our Phase I dose-escalation trial in North America shortly and intend to begin our Phase II trial in breast cancer promptly thereafter. We also have a Phase I/II trial in hepatocellular cancer ongoing in Asia."

read the full press release 

Lilly (LLY) published data showing that Gemzar doubled the median disease-free survival time in patients with pancreatic cancer whose pancreases were surgically removed. In a trial involving 368 patients, the median disease-free survival was 13.4 months in the Gemzar cohort and 6.9 months among those who did not receive chemotherapy. Also, the cancer recurred within 4 years in 92% of those who received no post-surgical drug treatment, but only in 74% of the Gemzar group. Lilly was 3 cents lower at $52.85.

Shire plc (SHPGY) received FDA approval for Lialda, its mesalamine drug with MMX technology. The drug is the only once-daily oral therapy for patients with active, mild to moderate ulcerative colitis. Shire expects to launch Lialda in Q1 of 2007. Shire rose 65 cents to $64.20.

GlaxoSmithKline (GSK) was given a $63 million HHS contract to develop pre-pandemic and pandemic flu vaccines. Glaxo is doing research that combines new adjuvants in combination with antigens to provoke a strong immune response. The goal would be to extend a limited supply of flu vaccines in the face of a pandemic. GSK will also ship 15.5 million treatment courses of flu-drug Relenza for the US stockpile. GSK gained 69 cents to end the day at $55.23.

By Evelyn Pringle

Over the past year, the Bush administration's FDA has been the focus of non-stop investigations and with the Democrats in control of Congress, a long overdue overhaul of the agency is in the cards.

The Government Accountability Office has identified serious problems within the FDA. In an April 21, 2006, report, the GAO found the FDA's performance "disorganized," "bureaucratic," and undermined by infighting between drug evaluation administrators whose allegiance is with the pharmaceutical industry, and the Office of Drug Safety.

According to the GAO, the drug safety office is under-funded, lacks independence and lacks decision-making responsibility. It also criticized the way FDA scientists were prevented from speaking at advisory committee meetings on drugs they were studying.

Drug companies increasingly are reaching legal settlements that delay the introduction of cheaper generic medicines and cheat Americans of billions of dollars in savings, regulators on Wednesday told lawmakers seeking to ban the agreements.

The Federal Trade Commission and others allege the settlements allow brand-name pharmaceutical companies to pay off would-be generic competitors, which then agree to delay introduction of their less costly but otherwise identical versions of the original medicines.

The FTC issued a report Wednesday, to coincide with a Senate Judiciary Committee hearing on the topic, that shows the settlements have become more common since two 2005 appeals court decisions upheld their legality.

TRENTON, N.J. (AP) - A New Jersey appellate court panel on Tuesday opened the door to a potential class action lawsuit against Merck & Co. on behalf of people who took its now-withdrawn painkiller Vioxx and want the company to pay for tests to detect possible heart ailments.

The ruling by the Appellate Division of the Superior Court of New Jersey came as jury selection began in Atlantic City for the next product liability trial over Merck's one-time blockbuster arthritis pill.

That trial, before Superior Court Judge Carol Higbee, is slated to begin with opening arguments Monday. It includes two plaintiffs: the son of a man who died of a heart attack after taking Vioxx and a retrial for a man who survived a heart attack, lost his first trial against Merck and was granted a new trial because of new evidence.

WASHINGTON, Jan. 11 /PRNewswire-USNewswire/ -- A proposed user-fee deal negotiated in private between the pharmaceutical industry and the FDA earmarks some funds for drug safety, but Consumers Union says the Administration must significantly fund comprehensive safety efforts, and Congress must pass new laws, to adequately protect the public from dangerous drugs.

"At a time when countless drugs have safety problems, it isn't enough to just rely on money paid by the pharmaceutical industry to fund needed drug safety reforms," said Bill Vaughan, senior policy analyst for Consumers Union, publisher of Consumer Reports.

"To address the wholly inadequate drug safety system, consumers need a commitment from the Administration to completely fund drug safety, and new laws that will ensure we don't have any more Vioxx-type disasters," Vaughan said.

Jan. 11 (Bloomberg) -- Barr Pharmaceuticals Inc., the second-largest U.S. maker of generic drugs, is lobbying for a U.S. law that for the first time would routinely allow the sale of copies of medicines made from biotechnology.

"It's what we're eating and breathing," said Jake Hansen, Barr's chief lobbyist in Washington. The company is dispatching about a dozen representatives to press Congress for the law, along with lobbyists from other generic-drug makers. "It's definitely our main focus."

The biotech industry, which includes companies such as Amgen Inc. and Genentech Inc., is countering with its own lobbying campaign. The biotech drugmakers say making copies of gene-based medications, which are more complex than traditional treatments, could pose health risks.

WASHINGTON--(BUSINESS WIRE)--The recommended improvements to the Prescription Drug User Fee Act (PDUFA) announced today by the Food and Drug Administration (FDA) will allow continued enhancement of FDA’s post-market safety capacity and help ensure careful, timely and transparent review of new drugs and biologics, said the Biotechnology Industry Organization (BIO). The FDA’s recommendations come as a result of extensive discussion and input from industry, as well as patient organizations, consumer groups and other stakeholders. Since its inception in 1992, PDUFA has helped to enable FDA to approve more than 1,100 new medicines and reduced review times for innovative drugs and biologics, providing patients and doctors with earlier access to breakthrough treatments. The current PDUFA agreement is set to expire on September 30, 2007.

“The PDUFA recommendations announced today are a win-win,” said BIO president and CEO Jim Greenwood. “If enacted, they will help enhance and improve drug safety while providing resources to continue to enable efficient and comprehensive review of new drugs. These proposals underscore our industry’s commitment to ensuring the government has the needed resources to complete safety reviews for new drugs and biologics in a timely manner.”

After investigating the deaths of three infants between 1 and 6 months of age linked to cough and cold medication use, officials with the U.S. Centers for Disease Control and Prevention are emphasizing that these drugs should be used only after talking with a physician.

Between 2004 and 2005, approximately 1,500 children younger than 2 years old were treated in U.S. emergency departments for adverse events associated with cough and cold medications, Dr. A. Srinivasan and colleagues at the CDC note in the January 12th issue of the Morbidity and Mortality Weekly Report

For each of the three dead infants, a medical examiner or coroner determined that the cough and cold medications were the underlying causes of death.

Boasting its 20th consecutive profitable quarter, biotechnology powerhouse Genentech on Wednesday reported a 75 percent increase in net income for the fourth quarter of 2006, compared with the same period a year ago.

The South San Francisco company's net income for the three-month period that ended Dec. 31 totaled $594 million, or 55 cents a share. That was up from $339 million, or 31 cents a share, for the fourth quarter of 2005.

Aside from stock options or other special expenses unrelated to its ongoing operations, Genentech said it would have earned 61 cents a share, 5 cents more than what most analysts surveyed by Thomson Financial had predicted.

WASHINGTON--(BUSINESS WIRE)--The recommended improvements to the Prescription Drug User Fee Act (PDUFA) announced today by the Food and Drug Administration (FDA) will allow continued enhancement of FDA’s post-market safety capacity and help ensure careful, timely and transparent review of new drugs and biologics, said the Biotechnology Industry Organization (BIO). The FDA’s recommendations come as a result of extensive discussion and input from industry, as well as patient organizations, consumer groups and other stakeholders. Since its inception in 1992, PDUFA has helped to enable FDA to approve more than 1,100 new medicines and reduced review times for innovative drugs and biologics, providing patients and doctors with earlier access to breakthrough treatments. The current PDUFA agreement is set to expire on September 30, 2007.

“The PDUFA recommendations announced today are a win-win,” said BIO president and CEO Jim Greenwood. “If enacted, they will help enhance and improve drug safety while providing resources to continue to enable efficient and comprehensive review of new drugs. These proposals underscore our industry’s commitment to ensuring the government has the needed resources to complete safety reviews for new drugs and biologics in a timely manner.”

Eli Lilly has paid out 700 million dollars to over 8,000 litigants who accused the company of injuring them with the antipsychotic drug Zyprexa.

Author: Evelyn Pringle

On January 3, 2007, a hearing was held before Judge Jack Weinstein in a US District Court in New York, on a motion by Eli Lilly to extend an injunction to conceal company documents that show Lilly hid the lethal side effects of Zyprexa for a decade and engaged in an illegal off-label marketing scheme to promote the drug for unapproved uses.

Zyprexa is only FDA approved to treat adults with conditions related to schizophrenia and bipolar disorder, and yet its Eli Lilly's number one best selling drug with sales of over $4 billion last year.

U.S. spending on health care hit nearly $2 trillion in 2005, fueled by the cost of hospital care, doctor fees and prescription drugs, government experts said in an annual report released on Tuesday.

Health-care spending grew 6.9 percent to about $1.99 trillion from about $1.86 trillion in 2004, a slower pace than the 7.9 percent increase a year earlier, the report by the National Health Statistics Group found. The increase outpaced a 3.4 percent rise in inflation in 2005.

The statistics group is part of the Centers for Medicare and Medicaid Services (CMS), the single largest payer for U.S. health care.

State government on Jan. 1 stopped covering emergency 30-day supplies of prescription drugs for seniors having difficulty obtaining medications under the new federal Medicare benefit. Before expiring, the program had covered 150 prescriptions per day, according to its supporters.

The state-sponsored Medicare Party D Safety Net program was enacted by the Legislature and signed by former governor Mitt Romney in December 2005 and lapsed on Dec. 31, 2006, after the House and Senate could not agree on an extension -- the Senate favored one, but it was dropped by the House in deliberations on an unrelated bill.

According to Health Care For All, an advocacy group that is pushing for the benefit's restoration, individuals are walking away from pharmacy counters without prescribed medications because they can't afford to pay for them.

Biotech drug developer Peregrine Pharmaceuticals Inc. said Tuesday that a recently published animal study showed a technology it licenses could be effective in determining what cancer treatment works in a given patient sooner.

An animal study appearing in the Jan. 1 edition of Clinical Cancer Research showed that microbubbles used in mice being treated for pancreatic cancer allowed ultrasound imaging to determine whether cancer therapies designed to choke off the blood supply to tumors were working or not.

The study used the Vascular Targeting Agent technology that Peregrine licenses exclusively from the University of Texas from Southwestern Medical Center, which conducted the study appearing the journal.

By Jim Edwards

NEW YORK -- Sometimes marketers can do almost everything right to launch a product, but it still doesn't catch on.

That apparently is the case with Rozerem, an insomnia drug from Takeda. In the sleep-drug category, which is known for advertising clichés like white-coated doctors and happily sleeping couples, Takeda took a chance on an eye-catching campaign featuring Abe Lincoln and a beaver.

The company also took a creative approach to its media buy, tapping alternatives like coffee sleeves and airplane seat trays. Moreover, it waited a year after the drug's approval to start consumer advertising so doctors would be familiar with the drug.

Before you buy a car, would you want to know how many complaints people had made to the manufacturer about defects, or how many warranty claims had been paid, or how many dealers had reported problems with the vehicle?

Federal law says you have a right to such info. But the Bush administration and the auto industry are quietly trying to change that.

In 2000, Congress passed the Transportation, Recall Enhancement, Accountability and Documentation Act to address regulators' failure to spot defects in Firestone tires that were linked to numerous deaths.

BRISBANE, Calif., Jan. 5 -- VaxGen Inc. announced today that it has restructured the company to significantly reduce operating costs and is actively pursuing avenues to enhance shareholder value through a strategic transaction.

Additionally, the company announced that Lance K. Gordon, Ph.D., has resigned as VaxGen's President, CEO and Executive Director. He will remain as an adviser to the company. VaxGen's Board of Directors unanimously appointed James P. Panek, VaxGen's Executive Vice President, as the company's new President and CEO and appointed him to fill the board vacancy left by Dr. Gordon.

"Lance Gordon was the architect of VaxGen's strategy to become a leader in biodefense and to develop its now significant capabilities in process development and GMP biopharmaceutical manufacturing," said Randall L-W. Caudill, Chairman of VaxGen's Board of Directors. "In addition, under his leadership, VaxGen played a pivotal role in the establishment of Celltrion, an undertaking which recently culminated in the realization of substantial financial benefit through the sale of VaxGen's holdings in Celltrion. The entire board thanks him for his contributions and wishes him the best in his future endeavors."

by Dani Veracity

Last year, Public Citizen, a national non-profit public interest organization, exposed that while conflicts of interest at the FDA's drug advisory committees are common and often have serious dollars at stake, advisory committee members and voting consultants rarely step down because of them. If a new conflict-of-interest amendment by Congressman Maurice Hinchey, D-NY, goes through, this will soon change for the better.

The foundation of the American drug approval process is theoretically objective science; however, the very nature of the process often allows subjectivity to come into play. In order for a new pharmaceutical to be approved by the FDA, the Center for Drug Evaluation and Research (CDER) looks at the pre-approval clinical trials paid for by the drug's maker and determines whether the drug is safe and effective. This is done at a rate of 25 to 30 new pharmaceutical drugs per year, according to Public Citizen.

DARMSTADT, Germany (AFX) - Merck KGaA is considering selling its generics drugs business to focus on new medication, according to a report in Handelsblatt newspaper, citing sources.

Merck (nyse: MRK )'s generics unit could be worth around 4 bln eur, added the report.

The company's supervisory board has already given 'the green light' to look for a buyer, the report stated, citing sources.

Pfizer Inc., Amgen Inc. and the rest of the U.S. pharmaceutical industry awoke to a new reality this week: a Congress controlled by Democrats determined to impose costly restrictions on their business.

Five committees are planning investigations into how to lower prices paid by Medicare, improve drug-safety enforcement and make generic medications available faster. Further probes and policy salvos may follow.

The pharmaceutical firms depend on a friendly federal government: A sixth of 2006 growth in the $252 billion U.S. drug market came from Medicare, according to estimates from IMS Health Inc., a Fairfield, Conn.-based research firm. Moreover, both Democrats and the companies are well aware that the industry gave at least two-thirds of its political donations to Republicans in recent elections.

Jan. 5 (Bloomberg) -- Weight-loss treatments need more study to prove they also help people live longer before doctors can be sure the benefits are greater than the risks and that the high cost is justified, researchers said in today's Lancet.

While drugs such as Roche Holding AG's Xenical and Abbott Laboratories' Meridia have proven to help patients lose weight, tests that show treatments save lives or cut deadly risks such as heart disease should be required, Raj Padwal and Sumit Majumdar of the University of Alberta Hospital in Edmonton said in the journal.

Roche, Abbott and France's Sanofi-Aventis SA already sell weight-loss products and the rising level of obesity around the world is attracting Pfizer Inc. and Merck & Co. Sedentary lifestyles and high-fat diets have caused the number of obese Americans to double over the past 30 years to around 31 percent of the population, according to the U.S. government. About 65 percent of the population is classed as overweight.

INDIANAPOLIS -- Eli Lilly and Co. said Thursday that it will settle about 18,000 additional lawsuits alleging that the drug maker did not adequately warn patients that its anti-psychotic medication Zyprexa carries a heightened risk of diabetes.

Lilly did not disclose the amount of the settlement but said in a statement that it would take a fourth-quarter settlement charge that is not expected to exceed $500 million.

The announcement follows a settlement in June 2005 under which the Indianapolis-based company agreed to pay about $700 million to resolve more than 8,000 similar lawsuits involving Zyprexa, its top-selling drug.

Two UK-based academics have devised a way to invent new medicines and get them to market at a fraction of the cost charged by big drug companies, enabling millions in poor countries to be cured of infectious diseases and potentially slashing the NHS drugs bill.

Sunil Shaunak, professor of infectious diseases at Imperial College, based at Hammersmith hospital, calls their revolutionary new model "ethical pharmaceuticals".

Improvements they devise to the molecular structure of an existing, expensive drug turn it technically into a new medicine which is no longer under a 20-year patent to a multinational drug company and can be made and sold cheaply.

This week marks the 100th Anniversary of the implementation of the Pure Food and Drug Act, a landmark piece of legislation calling for federal inspection of food products and paving the way for the creation of the Food and Drug Administration. However, as a January 2 New York Times editorial points out, advances in food safety are far from adequate considering how much time has elapsed.

Though nearly a century had passed, 2006 may have been the nadir of the federal food safety era. A spinach contamination outbreak in the fall killed three, and mysterious Taco Bell food poisonings only aggravated national concern. The Times editorial points out that anti-government conservatism has been a contributing factor in the declining safety:

People taking two drugs to treat symptoms of Parkinson's disease may be at risk of heart valve damage, a potentially life-threatening side-effect, two studies on European patients suggest.

The drugs are pergolide, sold as Permax, and cabergoline, sold as Dostinex. The medications are not the main treatment for the disease, which affects about six million people worldwide.

In Thursday's New England Journal of Medicine, Italian researchers said about one-quarter of 155 patients taking pergolide or cabergoline had moderate to severe heart valve problems compared with a control group.

Jan. 4 (Bloomberg) -- U.S. regulators approved 18 new drugs in 2006, close to an eight-year low, as drugmakers struggled to develop products for hard-to-treat disorders.

The number of medicines recommended for sale in 2006 and 2005 dropped from the annual average of 26 drugs recorded in the previous six years, according to U.S. data. Last year's approvals include Pfizer Inc.'s cancer treatment Sutent and Merck & Co.'s diabetes drug Januvia.

Drugmakers are spending more on research and developing fewer drugs, the U.S. reported last month. The failure rate of compounds in testing has increased as companies target intractable diseases, a government study said. London-based AstraZeneca Plc, for example, scuttled three experimental drugs last year, including treatments for diabetes and stroke.

Jan. 2 (Bloomberg) -- A consumer group said U.S. food regulators have backed away from plans to limit a cancer-causing byproduct that forms during the baking or frying of foods, including products from PepsiCo Inc., the largest U.S. maker of salty snacks.

The group, the Center for Science in the Public Interest, based in Washington, sent a letter to U.S. Food and Drug Administration Commissioner Andrew C. von Eschenbach on Dec. 1, urging him to follow through on agency promises to limit acrylamide. Swedish scientists discovered in 2002 that the substance develops in carbohydrate-rich foods, such as potatoes and breakfast cereals.

After initially reporting variations in acrylamide levels in branded products within the same food categories, the FDA has stopped publishing the information, and food makers refuse to provide it to the public, said Michael F. Jacobson, executive director of the Center. He said the FDA isn't reporting test results or setting limits.

by Paul Howard, The Examiner

WASHINGTON - William Osler, one of the founding faculty members at Johns Hopkins Medical School, once remarked: “If it were not for the great variability among individuals, medicine might as well be a science and not an art.” A century later, medicine is, despite its technical prowess, in many ways still an art — albeit an expensive one.

Pfizer learned that lesson the hard way in early December, when they halted development of their much anticipated “good cholesterol” boosting drug, torcetrapib. A late-stage clinical trial revealed excess deaths and cardiovascular problems in patients taking the drug together with Lipitor, compared to Lipitor alone.

In the 15,000-patient trial, there were 82 deaths for the torcetrapib combo vs. 51 for Lipitor. The failure cost Pfizer $800 million in research costs, $20 billion in market capitalization and 15 years of research.

Pfizer (PFE) is an enormous company with approximately $52B in sales per year, $12B in profit per year, and $180B market cap. The company has a large stable of prescription medications such as Lipitor, Norvasc, Zoloft, Viagra, Celebrex and others.

Lipitor is the number one selling prescription drug worldwide with over $12B in sales. Pfizer also has a gigantic research effort, spending several billion dollars per year to bring out more prescription medicines. Also, as seen by the purchases of Warner-Lambert and Pharmacia, Pfizer is willing to buy other companies to expand its product portfolio. Additionally, PFE often buys the rights to compounds being tested by much smaller companies.

It's a sure bet drug developer Liponex Inc. will be feeling one of those things at the end of February when it reports do-or-die clinical results for a new treatment to raise levels of "good" cholesterol and reduce heart disease.

"This is the Holy Grail of cardiovascular R&D," claims Duncan Emerton, an analyst with British market research firm Datamonitor PLC, referring to the link between raising good cholesterol, or HDL, and melting plaque buildup in arteries that can cause heart attacks and stroke.

On the other hand, statin drugs, of which Lipitor is the best known, have created a $32-billion-a-year (U.S.) market by lowering "bad" cholesterol, or LDL. But they only halt the buildup of additional plaque. Studies have shown that a 1-per-cent drop in LDL can reduce the risk of developing heart disease by 1 per cent, but a 1-per-cent increase in HDL can reduce the risk by 3 per cent.

By Robert Steyer, The Street.com

For the big drugmakers, next year could be the stock-market equivalent of Pushme-Pullyu, the two-headed creature of Doctor Doolittle fame that tried to go in different directions at the same time and ultimately got nowhere.

Maybe a little standing in place doesn't sound too bad to long-time investors in the sector, considering the management ousters, failed clinical trials and patent losses that have become commonplace.

Even better would be to find the 2007 edition of Merck, which despite mixed results on the Vioxx-litigation front turned in a gain of more than 30% this year, making it one of the best performers on the Dow Jones Industrial Average.