Scientist: Merck did not hide Vioxx data

A scientist who helped develop the painkiller Vioxx yesterday rejected assertions by a plaintiff's lawyer that Merck & Co. tried to conceal from regulators unfavorable data about the popular arthritis drug's potential heart-safety problems.
Dr. Briggs Morrison defended the company's handling of a 1995 clinical study that cited positive effects of so-called cox-2 inhibitors such as Vioxx on the body, saying the data were included in Merck's 1998 application to the Food and Drug Administration to sell Vioxx.
But plaintiff's attorney Mark Lanier said Merck's new-drug application filled more than 120 boxes of documents, suggesting that Merck purposely buried data that showed Vioxx made users more susceptible to heart attacks.
''Do you think the FDA really zoned in on that one paper in those 127 boxes?" Lanier asked Morrison.
Morrison, vice president of Merck Research Laboratories, is Merck's first witness in the case, which centers on two New Jersey men who suffered heart attacks while taking the drug.

Merck to pay $475M for pain drugs

Merck & Co., seeking to fill a revenue gap left by the withdrawn painkiller Vioxx, said it will pay as much as $475 million for rights to pain drugs being developed by closely held Neuromed Pharmaceuticals Inc.
euromed will receive an initial fee of $25 million and progress payments that may reach $450 million, Christopher Gallen, chief executive officer of the Conshohocken, Pennsylvania-based company, said Monday in a telephone interview.
The agreement gives Merck Neuromed's most advanced product in development, NMED-160, which is in the second of three stages of human tests needed for U.S. approval. Merck, the fourth- largest U.S. drugmaker, recalled Vioxx in 2004 after its long- term use was tied to a risk of heart attacks and strokes. Vioxx generated $2.5 billion in annual sales before being pulled.
"The market is huge," Gallen said. "It is the single-biggest market for pharma, worth about $28 billion a year."
Whitehouse Station, N.J.-based Merck is responsible for all development costs and activities, the companies said in a statement today. Neuromed, whose research unit is based in Vancouver, British Columbia, will also get research funding for two years as well as royalties from sales of the products.

Drug Sales in Developing Nations Surge

Economic expansion in developing countries helped boost pharmaceutical sales in countries like China and Mexico to double-digit growth last year, outpacing sales in larger markets such as the U.S., Japan and Germany, according to a report released Tuesday.
IMS Health, which provides market information on the pharmaceutical industry, said that drug sales around the world rose 7 percent to $602 billion in 2005, but sales in China increased 20 percent to $9.3 billion and sales in Mexico rose 12 percent to $7.5 billion.
Many countries in the developing world are experiencing significant growth which is allowing them to finance health care improvements, including purchasing more drugs, said Murray Aitken, senior vice president of corporate strategy at IMS.
Sales in Latin America, for example, grew 18.5 percent to $24 billion in 2005 while revenue in the Asia-Pacific region, excluding Japan, and Africa together rose 11 percent to $46.4 billion.
Meanwhile, growth in the ten major markets _ including the United States, Canada, Japan and Germany _ rose 5.7 percent, compared to a 7.2 percent increase in 2004. Drug sales in the United States and Canada, which account for 47 percent of global pharmaceutical sales, grew 5.2 percent to $265.7 billion, a slowdown from the 8.5 percent advance in 2004.
Aitken said growth in the U.S. revenues was tempered by the loss of sales from Cox-2 pain relievers, a class of drugs which includes Merck & Co.'s Vioxx and Celebrex, and Bextra from Pfizer Inc. Merck & Co. removed Vioxx from the market in September 2004 after a study showed it doubled patients risk of heart attack and strokes after 18 months. Pfizer Inc.'s Celebrex, a drug in the same class as Vioxx , was also linked to cardiovascular problems and its sales have swooned.
Aitken also noted that as health care costs become an increasing concern in the United States, insurers are pushing consumers to use generic drugs, which are cheaper.
Last year, 94 products exceeded revenues of $1 billion, with 17 new drugs joining the category known as blockbusters. Among the newcomers were two cholesterol lowering drugs, Crestor from AstraZeneca PLC and Vytorin, which is made by a joint venture between Merck and Schering-Plough Corp.
Five drugs lost blockbuster status including Vioxx and Bextra, which Pfizer removed from the market last year at the request of the U.S. Food and Drug Administration.

Neuromed strikes major Merck deal

Neuromed Pharmaceuticals Ltd., a closely held, eight-year-old biotech spinoff from the University of British Columbia, has struck a drug research deal valued at up to $500-million (U.S.) with giant Merck & Co. Inc., the richest collaboration ever in Canada that could set the stage for going public.
Still reeling from the recall of its $2.5-billion-a-year Vioxx painkiller, Merck has obtained exclusive rights to Neuromed's experimental drugs for chronic pain and anxiety, including NMED-160, which is in mid-stage trials to treat arthritis pain.
"This is a good example of what's possible in Canada, where you have a university that's very supportive of research and willing to transition that research into products," said Neuromed president and chief executive officer Christopher Gallen.
UBC professor Terrance Snutch set up Neuromed in 1998 with $3.2-million in venture capital. The initiative was based on his research to selectively block the influx of calcium into nerve cells that cause pain signals. Drugs known as calcium channel blockers have been used for several decades to treat high blood pressure and relieve heart-related chest pain.
Mr. Snutch, who is now chief scientific officer of the Vancouver-based company, took the process one step further by targeting the point where pain signals are transmitted from one nerve cell to another. That gave rise to NMED-160 as a treatment for pain that originates in nerves and inflammatory conditions, such as arthritis, instead of pain from an external injury.
By selectively regulating the concentration of calcium in cells, he said the company also has a family of compounds in addition to NMED-160 that have the potential to become new treatments for epilepsy and cardiovascular disease, and are outside of the scope of the Merck accord.
"This is a new category of therapeutics that we think has the potential to be huge," Dr. Gallen said, pointing to the last big technology platform to treat central nervous system disorders -- selective serotonin reuptake inhibitors (SSRIs), including anti-depressants such as Prozac.
He said NMED-160 has the potential to be as powerful as morphine and other opiates but without the side effects of addiction and motor function impairment.
Merck, based in Whitehouse Station, N.J., has agreed to make an initial $25-million payment to Neuromed and finance its research for two years, with an option to renew for an additional two years. Should NMED-160 win regulatory approvals globally, Merck would pay Neuromed an additional $202-million. The payments would grow to $450-million if the drug is later approved for a second use. Neuromed would also receive royalties on any sales by Merck.
Janet Skidmore, a spokeswoman for Merck, the fourth-largest U.S. drug maker, said the deal is not an attempt to replace Vioxx, which was yanked from the market in 2004 after its long-term use was tied to an increased risk of heart attacks and strokes.
She said Merck has identified pain as one of nine medical treatment areas that it is focusing on.
Dr. Gallen said Neuromed had been in partnering talks for several years with a group of pharmaceutical companies before selecting Merck because of its research, clinical development and ability to market pain drugs.
Earlier this month, the company raised $25-million in its fourth round of venture capital financing, for a total of $76-million since 1998. "Up until now, we've been focused on development, financing and partnering, but now we will strongly consider an IPO [initial public offering]," Dr. Gallen said.
The deal
- Merck gains exclusive rights to Neuromed's experimental drugs for chronic pain and anxiety, including NMED-160
- Merck pays $25-million up front and finances Neuromed's research for two years, with an option to renew for two more years.
- Should NMED-160 win regulatory approvals globally, Merck would pay Neuromed an additional $202-million.
- Payments would grow to $450-million if it is approved for a second use.
- Neuromed receives royalties on any Merck sales.

Courthouse bomb scare delays Vioxx trial

A high-profile drug liability trial was delayed briefly Wednesday when a device believed to be used in bomb detection training was discovered in the courthouse, authorities said.
Authorities evacuated the Atlantic County Civil Courthouse, where two men's case against Merck & Co. over its withdrawn painkiller Vioxx is in its third week, at about 8:06 a.m. after a sheriff's deputy discovered it in the drawer of a first-floor office, said Atlantic County Undersheriff John Tuohy.
About 100 people poured into the street as bomb technicians, police and firefighters responded, said Lt. Michael Tullio, a spokesman for the city police.
The device looked like a pipe bomb, with nails, wires, a battery and electrical tape wrapped around it, according to a courthouse employee who saw it but declined to give his name.
"It looked real, put it to you that way," said Tuohy. "Could it have been live? I don't know."
Tullio said the device was apparently left behind after a training exercise, although neither Tuohy nor Tullio knew how long ago that may have been.
Tuohy said it has been at least four years since such an exercise was held in the building because of more sophisticated screening equipment at the entrances.
"They believe it was a training aid that was secured and forgotten about and then found, and because nobody knew when and there's this national trial going on, they decided to err on the side of caution," said Tullio.
The three-story building, located two blocks from the famed Atlantic City Boardwalk, was declared safe about 9:40 a.m. and workers were allowed back in then.
The Vioxx trial, which had been scheduled to begin about 9:30 a.m., resumed about 10:20 a.m.

Vioxx plaintiff weakened by heart attack: daughter

The daughter of a man who blames Merck & Co.'s Vioxx arthritis medicine for his heart attack cried on the witness stand on Monday as she told a New Jersey court that her father had lost much of his strength since the June 2003 attack.
In emotional testimony lasting about 30 minutes, Jackie Cona, 23, said her father Thomas Cona had been athletic and had played an active role in her childhood and that of her sister Jamie, 28. But his heart attack had left him weak and unable to participate in normal family activities.
"He's like my grandfather, that's not my dad," she said, tearfully, in response to questioning from one of Cona's attorneys, Benedict Morelli.
Jackie Cona, a graduate student of speech therapy, told the jury of seven women and two men that her father now can't walk more than about 25 feet without resting, and sometimes takes morning naps, which he would never have done before his heart attack.
Thomas Cona, 59, and John McDarby, 77, are suing Merck in the latest product-liability suit over Vioxx, which the company voluntarily withdrew in September 2004 after a study showed the risk of heart attack and stroke doubled in patients who took the drug for at least 18 months.
Both Cona and McDarby took the pain drug for more than 18 months.
Cona, an avid golfer, told the court last week that he had returned to the golf course 10 days after his heart attack, and acknowledged that he had played golf 57 times during the remainder of 2003, and more than 60 times in both 2004 and 2005.
On the day of Cona's heart attack, his daughter said she visited him in the hospital. "He was white as a ghost, tubes everywhere, IVs, bags hanging," she told jurors in Atlantic County Superior Court.
"Every time that monitor went off, my heart kind of jumped because I had never been in a hospital before," she told the court. "I could see in his eyes he was scared. I just remember him saying, 'I'm just too young for this.'"
At the end of testimony in which she often struggled to keep her composure, Jackie Cona said she faces the possibility that her father may not live to see her married. "My dad might not be able to walk me down the aisle," she cried.
Almost 10,000 people have filed lawsuits against Merck, claiming the company was long aware of heart risks associated with Vioxx but failed to adequately warn users of its dangers because it put profits before safety.
Merck has said it will fight each case.
This trial -- the second state trial in New Jersey, where about half the cases have been filed -- is the first to hear cases of long-term Vioxx users.
In the first New Jersey trial, an Atlantic City jury last year denied a claim by Idaho postal worker Frederick Humeston that Vioxx had caused his heart attack.
Jurors said after the trial they thought Humeston's attack had been caused by his preexisting health problems rather than by Vioxx.
Only one plaintiff has so far won a Vioxx suit. A Texas jury awarded $253 million last August to the widow of a Wal-Mart worker who had taken Vioxx and died from a heart attack. Merck is appealing that verdict.

Merck buys drug to plug Vioxx sales gap

In a move to fill a huge sales gap left when it pulled Vioxx from the market nearly two years ago, Merck & Co. agreed to pay up to $475 million for the rights to experimental pain treatments being developed a privately-held biotech firm. Whitehouse Station, N.J.-based Merck will pay Neuromed Pharmaceuticals Ltd. an initial $25 million in cash for the right to research, develop and sell Neuromed’s experimental pain treatments, including the firm’s lead product -- NMED-160 -- currently in mid-stage clinical trials.
If NMED-160 is successfully developed and launched, Merck would pay $202 million in milestone payments, which could grow to $450 million if the drug is later approved for a second use. Neuromed would also receive research funding for two years and Merck would make additional payments if other compounds were developed under the terms of the agreement. Merck, which lost $2.5 billion when it withdrew its Vioxx pain killer from the market in September 2004 because of heart attack and stroke risks, has been battling numerous product liability lawsuits related to the drug. The drug maker won two cases -- one Federal and one in New Jersey -- but there are still more than 9,600 lawsuits outstanding. Neuromed was founded in 1998 as a spin-off from the University of British Columbia.