A Senate panel voted Wednesday to set a path for generic drugmakers to seek approval of cheaper, copycat versions of expensive biotechnology medicines.
Brand-name manufacturers would receive 12 years of exclusive marketing time before generic competition could start under a bill that cleared the Senate Health, Education, Labor and Pensions Committee by a voice vote.
The House has yet to consider a similar bill. Senate supporters hope both chambers can agree on an approach and include it in a broad Food and Drug Administration bill expected to pass in the coming months.
Biologic medicines are derived from living things. Manufacturers say they are much tougher to produce than traditional, chemical-based medicines and small changes can make the drugs ineffective or potentially harmful.
The costs of biotech medicines often reach tens of thousands of dollars per patient each year. They treat a range of diseases including cancer, multiple sclerosis and rheumatoid arthritis.
Generic competition could save patients and taxpayers billions of dollars, said committee chairman Edward Kennedy.
"The bill reflects a balanced approach that enables patients to have safe, effective and affordable biological drugs, while preserving the incentives that have brought these life-saving advances to the American public," he said.
Kennedy, a Massachusetts Democrat, wrote the bill with Democrat Hillary Clinton of New York and Republicans Mike Enzi of Wyoming and Orrin Hatch of Utah. The senators said both sides compromised, particularly on setting brand-name exclusivity at 12 years.
Sen. Sherrod Brown, an Ohio Democrat, said the period was excessive. He offered but withdrew an amendment to cut it to seven years.
If the measure becomes law, several biotech drugs could be open to generic competition because their patents have expired and they have been sold for at least 12 years, Senate staff said.
They include Amgen (Charts, Fortune 500) anemia drug Epogen and Johnson & Johnson (Charts, Fortune 500) rival Procrit, andBiogen Idec's (Charts) multiple sclerosis treatment, Avonex.
To win FDA approval, a generic company would have to conduct at least one clinical trial to show there were no meaningful differences with the name-brand counterpart. The agency could waive the clinical-trial requirement and rely on animal studies and other data.
The new products "will not be copies of, but rather will be similar to" the original versions, groups representing brand- name makers said in a statement.
The Biotechnology Industry Organization (BIO) and the Massachusetts Biotechnology Council said approval standards were "weakened significantly" by letting clinical-trial requirements be waived.
They also voiced concern the FDA could deem generic versions interchangeable with brand-name products.
"To protect patient safety, Congress should ensure that patients are not given follow-on biologics unless expressly prescribed by a physician," BIO President Jim Greenwood said.
The brand-name companies also said the market exclusivity should extend to 14 years, while generic producers said 12 years was too long.
"Such an arbitrary and excessive period of time is not only unprecedented and unwarranted, but more importantly, would unjustifiably delay access to affordable competition and choice," Kathleen Jaeger, president of the Generic Pharmaceutical Association, said in a statement
Friday, July 13, 2007
Thursday, July 12, 2007
UK Regulator Says Akzo Must Bid For ICI By Aug 9
Akzo Nobel NV (AKZOY) must either make an offer for Imperial Chemical Industries PLC (ICI.LN) or declare that it won't by August 9, the UK Takeover panel said Friday.
The UK Takeover Panel, which is Britain's takeover watchdog, issued the ultimatum after discussions with both parties' advisers. In a statement issued to the London Stock Exchange the regulators said the Dutch company must state its intentions regarding U.K. rival ICI by 5pm on 9 August.
In early June, Akzo Nobel, the world's largest coatings company by market share, made an indicative offer for ICI of 600p per share in cash, valued at GBP7.2 billion (EUR10.65 billion), an offer that ICI rejected on grounds that it "significantly undervalues ICI."
The Takeover Panel said in its statement that each party has accepted the watchdog's ruling. Both Akzo Nobel and ICI declined to comment Friday on the matter.
A trader who asked not to be identified said the regulator's "put up or shut up" ruling places Akzo Nobel on the back foot and indicates that Akzo is still interested, otherwise the meeting with the panel would have resulted in Akzo walking away. The trader said he therefore expects a raised bid from Akzo.
Another trader, who also asked not to be identified, noted media reports Friday that ICI had requested the deadline be set. He said the move seems aimed at getting Akzo to bid higher than its initial indication of 600p per share, and that price talk in the market is now over 650p.
Akzo Nobel is well cashed-up, after having agreed the sale of its OrganonBioSciences unit to Schering-Plough (SHP) for $11 billion cash.
Nonetheless, analysts were mixed as to what Akzo Nobel will do next.
Some, like Tom Muller at Gilissen and James Knight at Collins-Stewart, believe Akzo will raise it's offer. Knight reckons the next bid for ICI will be around 650p, while Muller says it could be as high as 700p.
Muller and Knight both said Akzo needs to make a significant acquisition, and that ICI seems the most logical and complementary target. If Akzo doesn't come back with a new offer, it risks becoming a takeover target itself, they added.
Rabo Securities analyst Mark van der Geest thinks Akzo should use the cash from the sale of its pharmaceuticals unit for smaller, less complicated acquisitions targets as well as return cash to shareholders. Van der Geest doesn't think Akzo Nobel will raise it's offer for ICI.
"The indicative offer of 600p, made in early June, was more than enough for ICI and any higher bid, will destroy value for shareholders," said Van der Geest.
Akzo Nobel has long been seen as interested in ICI, which it has said in the past "represent a highly attractive addition to its focused coatings and chemicals business."
After ICI rejected its indicative offer in June, Akzo said there was no certainty it would present a fresh proposal to ICI.
The UK Takeover Panel, which is Britain's takeover watchdog, issued the ultimatum after discussions with both parties' advisers. In a statement issued to the London Stock Exchange the regulators said the Dutch company must state its intentions regarding U.K. rival ICI by 5pm on 9 August.
In early June, Akzo Nobel, the world's largest coatings company by market share, made an indicative offer for ICI of 600p per share in cash, valued at GBP7.2 billion (EUR10.65 billion), an offer that ICI rejected on grounds that it "significantly undervalues ICI."
The Takeover Panel said in its statement that each party has accepted the watchdog's ruling. Both Akzo Nobel and ICI declined to comment Friday on the matter.
A trader who asked not to be identified said the regulator's "put up or shut up" ruling places Akzo Nobel on the back foot and indicates that Akzo is still interested, otherwise the meeting with the panel would have resulted in Akzo walking away. The trader said he therefore expects a raised bid from Akzo.
Another trader, who also asked not to be identified, noted media reports Friday that ICI had requested the deadline be set. He said the move seems aimed at getting Akzo to bid higher than its initial indication of 600p per share, and that price talk in the market is now over 650p.
Akzo Nobel is well cashed-up, after having agreed the sale of its OrganonBioSciences unit to Schering-Plough (SHP) for $11 billion cash.
Nonetheless, analysts were mixed as to what Akzo Nobel will do next.
Some, like Tom Muller at Gilissen and James Knight at Collins-Stewart, believe Akzo will raise it's offer. Knight reckons the next bid for ICI will be around 650p, while Muller says it could be as high as 700p.
Muller and Knight both said Akzo needs to make a significant acquisition, and that ICI seems the most logical and complementary target. If Akzo doesn't come back with a new offer, it risks becoming a takeover target itself, they added.
Rabo Securities analyst Mark van der Geest thinks Akzo should use the cash from the sale of its pharmaceuticals unit for smaller, less complicated acquisitions targets as well as return cash to shareholders. Van der Geest doesn't think Akzo Nobel will raise it's offer for ICI.
"The indicative offer of 600p, made in early June, was more than enough for ICI and any higher bid, will destroy value for shareholders," said Van der Geest.
Akzo Nobel has long been seen as interested in ICI, which it has said in the past "represent a highly attractive addition to its focused coatings and chemicals business."
After ICI rejected its indicative offer in June, Akzo said there was no certainty it would present a fresh proposal to ICI.
Chinese Regulators Pull Licenses Of 5 Drug Cos -Reports
China's food and drug regulatory agency said it has pulled the production licenses of five drug makers over the last year and penalized 128 others, state media reported Saturday.
The report comes as China faces mounting criticism that the safety of its products is poorly regulated.
The State Food and Drug Administration stripped 128 manufacturers of their Good Manufacturing Practice certificates, a symbol of favorable performance, the China Daily newspaper reported on its Web site Saturday.
The report comes as China faces mounting criticism that the safety of its products is poorly regulated.
The State Food and Drug Administration stripped 128 manufacturers of their Good Manufacturing Practice certificates, a symbol of favorable performance, the China Daily newspaper reported on its Web site Saturday.
High Court In Dublin Rules In Pfizer's Favor In Patent Case
Pfizer Inc. (PFE) said the High Court in Dublin has ruled that the patent covering atorvastatin, the active ingredient in Lipitor, would be infringed by a competitor product from Ranbaxy.
The decision, which is subject to a possible appeal, would prevent Ranbaxy from launching a copycat drug before November 2011.
The decision, which is subject to a possible appeal, would prevent Ranbaxy from launching a copycat drug before November 2011.
Thursday, July 05, 2007
Judge Rules Sanofi's Patent For Plavix Is Valid
A federal judge on Tuesday rejected a bid by Canadian drug maker Apotex Inc. to invalidate the key U.S. patent for Sanofi-Aventis' (SNY) popular blood thinner Plavix.
However, Apotex said Tuesday that it plans to immediately appeal the ruling with the U.S. Court of Appeals for the Federal Circuit in Washington, which typically handles appeals involving patent cases.
In an opinion Tuesday, U.S. District Judge Sidney H. Stein in Manhattan upheld that patent and said Sanofi is entitled to a permanent injunction to prevent Apotex from marketing its own generic version of the drug. Plavix is co-marketed by France's Sanofi and Bristol-Myers Squibb Co. (BMY).
The decision essentially prohibits a generic version of the drug from being introduced into the market for another four years.
"This court now finds that Apotex has failed to prove by clear and convincing evidence that the (key Plavix) patent is invalid or unenforceable, and Sanofi is entitled to a permanent injunction prohibiting Apotex from further infringement," the judge said.
Shares of Bristol-Myers set a 52-week high of $32.07 on Tuesday. They recently were up $1.44, or 4.8%, to $31.75, while Sanofi's shares in the U.S. recently traded up 14 cents, or 0.3%, to $41.49.
In his ruling, the judge said he will determine damages in the case at a later date.
"Despite today's decision, we are unwavering in our belief that the (Plavix) patent will ultimately be held invalid, and that the court will find inequitable conduct on the part of Sanofi," Apotex Chief Executive Barry Sherman said in a prepared statement.
Sherman noted that Apotex believes the issues in the Plavix case are similar to those in a patent case involving Pfizer's hypertension drug Norvasc. Apotex began selling a generic version of Norvasc last month after prevailing on appeal.
Sanofi and Bristol-Myers issued a joint statement announcing the Plavix ruling on Tuesday, but didn't make any further comment on the decision.
Dresdner Kleinwort analyst Ben Yeoh said Tuesday that Sanofi's win in the Plavix patent case "is quite a big deal" and he was surprised the shares aren't up more on the news.
"The market may be missing the fact that Sanofi could be due damages worth 50% of net sales, which would add up to hundreds of millions of dollars," Yeoh said.
Last August, Stein halted Apotex from selling its generic version until he could hear the patent case. The Canadian company introduced its generic in early August after state antitrust regulators rejected a proposed settlement in a long-running legal dispute between the companies.
Plavix was the second-biggest-selling drug in the world behind Pfizer Inc.'s (PFE) cholesterol drug Lipitor. The blood thinner generated global sales of $5.9 billion, in 2005, the last full year for which figures are available.
Joseph F. Tooley, an A.G. Edwards Inc. (AGE) analyst, said Tuesday that Bristol-Myers investors seem to be anticipating an increased chance the company could be acquired, given the Plavix ruling and the conclusion of other recent legal issues. Tooley noted the company's stock is trading at a roughly 29% premium to group.
"I think the stock-price reaction to today's ruling reflects the higher likelihood of a takeout now that the Plavix decision is in hand," said Tooley, whose firm had cooled to the idea of Bristol-Myers takeout.
Earlier this month, Bristol-Myers pleaded guilty to two counts of making false statements to the Federal Trade Commission regarding the proposed settlement in the Plavix case and agreed to pay a $1 million fine.
The company also recently completed the terms of a two-year deferred prosecution agreement with federal prosecutors in New Jersey in a separate accounting scandal at the drug maker.
Tooley doesn't own the stock; his firm or an affiliate received compensation from Bristol-Myers in the past 12 months for products or services other than investment banking.
In a research note Tuesday, Chris Schott, a Banc of America Securities analyst, said speculation that Bristol-Myers will be acquired is likely to increase as the Plavix ruling removes "a major overhang for both companies."
"We view the news today as refueling takeout speculation that has been part of the Bristol story since early January when the media - La Lettre de L'Expansion - broached news of talks between Sanofi and Bristol," said Schott, who raised his price target for Bristol-Myers by $2 to $29 a share on Tuesday.
Schott doesn't own Bristol-Myers or Sanofi stock; his firm has performed investment-banking services for Bristol-Myers and Sanofi in the past 12 months.
Tooley and Schott both said they believe the patent will be upheld on appeal. "We estimate that an appellate hearing could occur in late 2008, with a ruling during 2009," Schott said.
In reviewing the patent, Tooley said A.G. Edwards doesn't believe the issues in the Norvasc case and the Plavix case are "exactly the same" and there is "sufficient difference" in the cases for Bristol-Myers and Sanofi to prevail on appeal.
At trial earlier this year, Apotex argued that the key patent for Plavix was invalid because it was anticipated in a prior patent held by Sanofi, and that its development would have been obvious to a person of ordinary skill in the field who examined the prior patent.
Sanofi and Bristol-Myers had claimed Apotex's generic version of the drug infringes on Sanofi's key U.S. patent, which runs through November 2011.
A Sanofi lawyer argued at trial that Plavix was an "extraordinary breakthrough" and wasn't an obvious development. It required a good deal of experimentation by Sanofi's scientists, he said.
However, Apotex said Tuesday that it plans to immediately appeal the ruling with the U.S. Court of Appeals for the Federal Circuit in Washington, which typically handles appeals involving patent cases.
In an opinion Tuesday, U.S. District Judge Sidney H. Stein in Manhattan upheld that patent and said Sanofi is entitled to a permanent injunction to prevent Apotex from marketing its own generic version of the drug. Plavix is co-marketed by France's Sanofi and Bristol-Myers Squibb Co. (BMY).
The decision essentially prohibits a generic version of the drug from being introduced into the market for another four years.
"This court now finds that Apotex has failed to prove by clear and convincing evidence that the (key Plavix) patent is invalid or unenforceable, and Sanofi is entitled to a permanent injunction prohibiting Apotex from further infringement," the judge said.
Shares of Bristol-Myers set a 52-week high of $32.07 on Tuesday. They recently were up $1.44, or 4.8%, to $31.75, while Sanofi's shares in the U.S. recently traded up 14 cents, or 0.3%, to $41.49.
In his ruling, the judge said he will determine damages in the case at a later date.
"Despite today's decision, we are unwavering in our belief that the (Plavix) patent will ultimately be held invalid, and that the court will find inequitable conduct on the part of Sanofi," Apotex Chief Executive Barry Sherman said in a prepared statement.
Sherman noted that Apotex believes the issues in the Plavix case are similar to those in a patent case involving Pfizer's hypertension drug Norvasc. Apotex began selling a generic version of Norvasc last month after prevailing on appeal.
Sanofi and Bristol-Myers issued a joint statement announcing the Plavix ruling on Tuesday, but didn't make any further comment on the decision.
Dresdner Kleinwort analyst Ben Yeoh said Tuesday that Sanofi's win in the Plavix patent case "is quite a big deal" and he was surprised the shares aren't up more on the news.
"The market may be missing the fact that Sanofi could be due damages worth 50% of net sales, which would add up to hundreds of millions of dollars," Yeoh said.
Last August, Stein halted Apotex from selling its generic version until he could hear the patent case. The Canadian company introduced its generic in early August after state antitrust regulators rejected a proposed settlement in a long-running legal dispute between the companies.
Plavix was the second-biggest-selling drug in the world behind Pfizer Inc.'s (PFE) cholesterol drug Lipitor. The blood thinner generated global sales of $5.9 billion, in 2005, the last full year for which figures are available.
Joseph F. Tooley, an A.G. Edwards Inc. (AGE) analyst, said Tuesday that Bristol-Myers investors seem to be anticipating an increased chance the company could be acquired, given the Plavix ruling and the conclusion of other recent legal issues. Tooley noted the company's stock is trading at a roughly 29% premium to group.
"I think the stock-price reaction to today's ruling reflects the higher likelihood of a takeout now that the Plavix decision is in hand," said Tooley, whose firm had cooled to the idea of Bristol-Myers takeout.
Earlier this month, Bristol-Myers pleaded guilty to two counts of making false statements to the Federal Trade Commission regarding the proposed settlement in the Plavix case and agreed to pay a $1 million fine.
The company also recently completed the terms of a two-year deferred prosecution agreement with federal prosecutors in New Jersey in a separate accounting scandal at the drug maker.
Tooley doesn't own the stock; his firm or an affiliate received compensation from Bristol-Myers in the past 12 months for products or services other than investment banking.
In a research note Tuesday, Chris Schott, a Banc of America Securities analyst, said speculation that Bristol-Myers will be acquired is likely to increase as the Plavix ruling removes "a major overhang for both companies."
"We view the news today as refueling takeout speculation that has been part of the Bristol story since early January when the media - La Lettre de L'Expansion - broached news of talks between Sanofi and Bristol," said Schott, who raised his price target for Bristol-Myers by $2 to $29 a share on Tuesday.
Schott doesn't own Bristol-Myers or Sanofi stock; his firm has performed investment-banking services for Bristol-Myers and Sanofi in the past 12 months.
Tooley and Schott both said they believe the patent will be upheld on appeal. "We estimate that an appellate hearing could occur in late 2008, with a ruling during 2009," Schott said.
In reviewing the patent, Tooley said A.G. Edwards doesn't believe the issues in the Norvasc case and the Plavix case are "exactly the same" and there is "sufficient difference" in the cases for Bristol-Myers and Sanofi to prevail on appeal.
At trial earlier this year, Apotex argued that the key patent for Plavix was invalid because it was anticipated in a prior patent held by Sanofi, and that its development would have been obvious to a person of ordinary skill in the field who examined the prior patent.
Sanofi and Bristol-Myers had claimed Apotex's generic version of the drug infringes on Sanofi's key U.S. patent, which runs through November 2011.
A Sanofi lawyer argued at trial that Plavix was an "extraordinary breakthrough" and wasn't an obvious development. It required a good deal of experimentation by Sanofi's scientists, he said.
Ruling On Drug Pricing Faults Three Companies
A federal judge ruled that pharmaceutical companies AstraZeneca Plc, Schering-Plough Corp. and Bristol-Myers Squibb Co. engaged in unfair and deceptive trade practices regarding some of their drug prices.
The decision could make the companies more vulnerable in future cases. The judge ruled that Johnson & Johnson didn't violate the law.
The four companies were defendants in a suit that alleged they inflated the average wholesale prices, or AWP, they reported for certain drugs. The AWP has been used as a benchmark by insurers to calculate drug reimbursements. But it has come under heavy scrutiny in recent years amid allegations that manufacturers inflated that measure artificially to boost profits. In 2003, Medicare ceased using the AWP as a basis for drug reimbursements, but some third-party payers continued to reference it.
In the case, U.S. District Court Judge Patti B. Saris in Boston applied Massachusetts state law. Given her decision in this first stage, it is likely the judge will certify a national class to deal with the claims from other states. She ordered AstraZeneca to pay damages of $4.45 million to non-Medicare third-party payers and Bristol-Myers Squibb to pay damages of $183,000. The ruling affects third-party payers who paid for certain prescription drugs from December 1997 to 2003.
In her opinion, Judge Saris wrote that "Unscrupulously taking advantage of the flawed AWP system . . . by establishing secret mega-spreads far beyond the standard industry markup was unethical and oppressive." She also wrote that such practices, "caused real injuries to the insurers and patients" who paid inflated prices for life-sustaining drugs.
The judge asked for more information before deciding on further restitution to third-party payers for co-payments for some drugs. Plaintiffs' attorney Steve Berman said the decision "positions the litigation very well for us. In our view, the companies are now on the hook." Mr. Berman said the damages could be significant in the next round of the litigation. Plaintiffs will be seeking damages of $500 million from AstraZeneca, which could be doubled or trebled, per individual states' laws.
A spokeswoman for AstraZeneca said the company competed responsibly with respect to pricing its drugs and said the suit was "without merit." The company is considering its appellate options. A Bristol-Myers Squibb spokeswoman said the company intends to appeal the damages and maintained that the company isn't responsible for the wholesale price reimbursement benchmark used by insurance companies, insisting its internal practices are fair and reasonable. A Schering-Plough spokesman said the company was pleased the court had narrowed the scope of the case from the plaintiff's original suit. It is also considering an appeal.
The decision could make the companies more vulnerable in future cases. The judge ruled that Johnson & Johnson didn't violate the law.
The four companies were defendants in a suit that alleged they inflated the average wholesale prices, or AWP, they reported for certain drugs. The AWP has been used as a benchmark by insurers to calculate drug reimbursements. But it has come under heavy scrutiny in recent years amid allegations that manufacturers inflated that measure artificially to boost profits. In 2003, Medicare ceased using the AWP as a basis for drug reimbursements, but some third-party payers continued to reference it.
In the case, U.S. District Court Judge Patti B. Saris in Boston applied Massachusetts state law. Given her decision in this first stage, it is likely the judge will certify a national class to deal with the claims from other states. She ordered AstraZeneca to pay damages of $4.45 million to non-Medicare third-party payers and Bristol-Myers Squibb to pay damages of $183,000. The ruling affects third-party payers who paid for certain prescription drugs from December 1997 to 2003.
In her opinion, Judge Saris wrote that "Unscrupulously taking advantage of the flawed AWP system . . . by establishing secret mega-spreads far beyond the standard industry markup was unethical and oppressive." She also wrote that such practices, "caused real injuries to the insurers and patients" who paid inflated prices for life-sustaining drugs.
The judge asked for more information before deciding on further restitution to third-party payers for co-payments for some drugs. Plaintiffs' attorney Steve Berman said the decision "positions the litigation very well for us. In our view, the companies are now on the hook." Mr. Berman said the damages could be significant in the next round of the litigation. Plaintiffs will be seeking damages of $500 million from AstraZeneca, which could be doubled or trebled, per individual states' laws.
A spokeswoman for AstraZeneca said the company competed responsibly with respect to pricing its drugs and said the suit was "without merit." The company is considering its appellate options. A Bristol-Myers Squibb spokeswoman said the company intends to appeal the damages and maintained that the company isn't responsible for the wholesale price reimbursement benchmark used by insurance companies, insisting its internal practices are fair and reasonable. A Schering-Plough spokesman said the company was pleased the court had narrowed the scope of the case from the plaintiff's original suit. It is also considering an appeal.
New Vioxx Study May Cast Doubt On Merck Claims
In a new blow to Merck & Co.'s defense in the Vioxx litigation, results from a yet-to-be-published study suggest that increased heart risks associated with the painkiller began immediately after patients started taking the drug.
Since Merck withdrew Vioxx from the market in September 2004, it has argued that patients weren't at any heightened risk of a serious cardiovascular event unless they had taken the medicine for at least 18 months.
The new study, known as Victor, was conducted by researchers at Oxford University in England. A Merck defense attorney sent a copy of the study to New Jersey Superior Court Judge Carol E. Higbee along with a letter saying that it was "our understanding that this manuscript has been accepted" for publication by the New England Journal of Medicine.
The study, which was designed to see whether the drug would curb progression of colon cancer, compared Vioxx, known generically as rofecoxib, with placebo in a total of 2,434 patients who were followed for two years. The study was halted when Merck pulled Vioxx from the market after another study, known as Approve, linked the drug to an increased risk of heart attacks and strokes. The new report includes only information about cardiovascular findings.
According to the manuscript, 16 of the 23 cardiovascular events occurred in the Vioxx patents, and half of those occurred in patients within 12 months of taking the drug. "It would appear . . . that patients do not need to take rofecoxib for 18 months to be at increased risk of a cardiovascular thrombotic event," the authors wrote. The study also suggests that by 14 days after patients stopped taking the drug, the risk of heart and stroke went away.
In the wake of the withdrawal, Merck faces about 28,000 lawsuits. Of those that have gone to trial, the company has won 10 and lost five.
A spokeswoman for the New England Journal of Medicine, citing publication policy, declined to discuss the status of the manuscript. In a statement, Merck's outside counsel Ted Mayer said, "The reported findings with respect to confirmed thrombotic events in short-term use are not supported by the data found in the other available large placebo studies with Vioxx, including Alzheimer's studies, ViP and Approve."
Since Merck withdrew Vioxx from the market in September 2004, it has argued that patients weren't at any heightened risk of a serious cardiovascular event unless they had taken the medicine for at least 18 months.
The new study, known as Victor, was conducted by researchers at Oxford University in England. A Merck defense attorney sent a copy of the study to New Jersey Superior Court Judge Carol E. Higbee along with a letter saying that it was "our understanding that this manuscript has been accepted" for publication by the New England Journal of Medicine.
The study, which was designed to see whether the drug would curb progression of colon cancer, compared Vioxx, known generically as rofecoxib, with placebo in a total of 2,434 patients who were followed for two years. The study was halted when Merck pulled Vioxx from the market after another study, known as Approve, linked the drug to an increased risk of heart attacks and strokes. The new report includes only information about cardiovascular findings.
According to the manuscript, 16 of the 23 cardiovascular events occurred in the Vioxx patents, and half of those occurred in patients within 12 months of taking the drug. "It would appear . . . that patients do not need to take rofecoxib for 18 months to be at increased risk of a cardiovascular thrombotic event," the authors wrote. The study also suggests that by 14 days after patients stopped taking the drug, the risk of heart and stroke went away.
In the wake of the withdrawal, Merck faces about 28,000 lawsuits. Of those that have gone to trial, the company has won 10 and lost five.
A spokeswoman for the New England Journal of Medicine, citing publication policy, declined to discuss the status of the manuscript. In a statement, Merck's outside counsel Ted Mayer said, "The reported findings with respect to confirmed thrombotic events in short-term use are not supported by the data found in the other available large placebo studies with Vioxx, including Alzheimer's studies, ViP and Approve."
NICE OKs Elan, Biogen MS Treatment Tysabri
Ireland-based Elan Corp. (ELN) and U.S.-based Biogen Idec (BIIB) said Tuesday they welcome the U.K. National Institute for Health and Clinical Excellence recommendation for the use of their drug Tysabri, the first NICE approval for any multiple sclerosis drug.
The companies said Tysabri represents a significant advance in MS treatment, offering hope of delaying the progression of disability and reducing the frequency of relapses.
According to the companies, treatment with Tysabri over two years leads to a 68% relative reduction in clinical relapses and a 54% relative reduction in the risk of sustained disability progression compared with placebo.
As of late May, the treatment was being used in about 12,000 patients in both commercial use and clinical trials in the U.S., Germany, France, Ireland and other countries.
However, said one analyst who follows the sector, a key approval for the drug is still awaited from the U.S. Food and Drug Administration.
"This has to be seen in that context," he said, though he added that approval in the U.K. clearly bodes well for the drug.
The companies said Tysabri represents a significant advance in MS treatment, offering hope of delaying the progression of disability and reducing the frequency of relapses.
According to the companies, treatment with Tysabri over two years leads to a 68% relative reduction in clinical relapses and a 54% relative reduction in the risk of sustained disability progression compared with placebo.
As of late May, the treatment was being used in about 12,000 patients in both commercial use and clinical trials in the U.S., Germany, France, Ireland and other countries.
However, said one analyst who follows the sector, a key approval for the drug is still awaited from the U.S. Food and Drug Administration.
"This has to be seen in that context," he said, though he added that approval in the U.K. clearly bodes well for the drug.
Friday, June 22, 2007
Pfizer, Conn. Attorney General Probing Co Security Breach
Pfizer Inc. (PFE) has been investigating a security breach exposing personal information, including social-security numbers, of about 17,000 current and former employees.
The Connecticut Attorney General's office said Monday it is investigating the matter and, in a letter to Pfizer, requested additional information on the issue. Blumenthal said 305 Connecticut residents were affected.
"I remain concerned about the possibility that credit-card fraud and identity theft will arise from the breach of this personally identifying information," Attorney General Richard Blumenthal said in a letter to a Pfizer legal representative.
Blumenthal asked the company to reimburse the affected employees for credit freezes. He also requested Pfizer answer about a dozen questions about the incident.
The breach apparently resulted from an employee installing unauthorized file-sharing software onto a Pfizer laptop computer, according to a letter from a Pfizer legal representative sent to attorneys general on May 30. The letter said that 15,700 employees have definitely had their information accessed, and 1,250 may have had it accessed.
"Keep in mind that Pfizer has no indication that any unauthorized individual has used or is using your personal information," said Lisa Goldman, Pfizer privacy officer, in a letter to employees dated June 1.
Pfizer is investigating the matter and has already taken steps to aid employees. The company has agreed to fund $25,000 of identity-theft insurance for affected employees with no deductible, the letter said. Pfizer has also paid for a credit-monitoring service with Experian at no cost to employees.
Pfizer also said it contacted the three major U.S. credit agencies to inform them of the incident.
Recently, Pfizer shares were up 20 cents at $26.30 on volume of 37.7 million compared with average daily volume of 35.5 million.
Wednesday, January 17, 2007
House Passes Drug-Price Bill
House passage Friday of legislation taking a swipe at drug companies is just the first front in the new Democratic Congress's battle with the health-care industry. The next target: insurers, who will face demands for cuts in their Medicare subsidies.
On a 255-to-170 vote, the House passed legislation that would require the government to negotiate prescription prices with the pharmaceutical industry. Currently, private insurers handle the negotiations for Medicare and the government is barred from getting involved, an arrangement that critics say leads to higher prices than if the government used its clout. Twenty-four Republicans joined the Democratic majority in backing the measure, but its prospects are less certain in the closely divided Senate, and President Bush has threatened a veto.
The price-negotiation bill is just the new Congress's first maneuver on health care, after many Democrats promised on the campaign trail to lower drug costs in Medicare, the federal health program for the elderly and disabled. Beyond that, key Democrats are attacking another big change Republicans brought to Medicare while they controlled Congress. As part of 2003 Medicare drug-benefit legislation, lawmakers seeking to inject more private-sector involvement in the program dramatically increased federal payments to private insurance plans operating in the Medicare Advantage arm of the program.
In Medicare Advantage, private insurers provide seniors a full range of medical benefits as an alternative to the government-run program. Seniors automatically become eligible for Medicare when they turn 65, but then have the choice to sign up instead for coverage through a private Medicare Advantage plan.
Democrats say the payment increases in the legislation -- projected to be worth as much as $46 billion over the decade beginning in 2004 -- are a waste of taxpayer money, and they view Medicare Advantage as an attempt by Republicans to privatize the traditional program. Now, some Democrats want to reduce payments to the private plans, and budgetary concerns are heightening the pressure on the payments to insurers.
The State Children's Health Insurance Program, a federal block grant, will soon need to be reauthorized, and many Democrats would like to expand it. Congress is also likely to boost Medicare payments to doctors. At a time when Democrats are aiming to be fiscally responsible, such spending would likely have to be offset.
"There are precious few areas where we can save money. Medicare Advantage is a prime target to pick up a few dollars," says Rep. Pete Stark, the California Democrat who heads the House Ways and Means panel's health subcommittee. In the Senate, a Democratic aide predicts Medicare Advantage money will become "the standard pay-for" in lawmakers' legislative proposals.
Following a lobbying and advertising blitz by drug companies to block the Democratic attacks, health insurers are preparing their own counterattack. America's Health Insurance Plans, the industry's Washington-based trade group, is telling lawmakers that cuts in insurer subsidies would be tantamount to cuts in benefits for constituents, and it has readied maps to show the growth of Medicare Advantage plans throughout the country, compared to relatively sparse numbers before government payments increased.
It will tap the Coalition for Medicare Choices, a group for Medicare Advantage beneficiaries that AHIP started and funds, to bring satisfied customers to Congress. And AHIP will highlight research showing that a large portion of Medicare Advantage beneficiaries are minorities or have low incomes -- populations shown to suffer disproportionately from chronic health problems that plans say they can manage better than the government.
Of about 44 million Medicare beneficiaries, 7.6 million, or 17%, were in Medicare Advantage plans as of December 2006. That compares with about 6.1 million, or 14%, who were enrolled in the plans in December 2005.
"This is the ultimate in constituency politics," says Karen Ignagni, AHIP'S president and chief executive.
Beyond their philosophical complaints, many Democrats say Medicare Advantage wastes government money. Former House Democratic aide Brian Biles has done a study concluding that, on average, the government is spending $922 more each year for every beneficiary in Medicare Advantage, compared to what would have been spent if the person had remained in regular Medicare.
In 2005, the "overpayment," as Democrats call it, totaled $5.2 billion, according to a November 2006 report by Mr. Biles and others for the Commonwealth Fund, a private, nonprofit foundation that supports health research. An independent panel that advises Congress on Medicare also documented the payment differential. "It's a problem because it causes us to waste a lot of taxpayer money," Mr. Stark says. "I see no reason to do it."
AHIP disagrees with the methodology used in the study, and it points to Medicare data showing that Medicare Advantage beneficiaries save an average of $82 a month, in reduced out-of-pocket costs and extra benefits, compared to people in the traditional program. Insurers say the program has also succeeded in extending and expanding Medicare Advantage to rural areas, where it was lacking. And that means they can count on rural-state legislators to battle the Democratic attacks.
"We wanted equity in those plans. . . . We've got it now," says Iowa Republican Sen. Charles Grassley. "People in Iowa ought to have the same choices as those in New York, Miami and Los Angeles."
High Court Eases Way For Patent Challenges
The Supreme Court continued to reassert its oversight of patent law yesterday with a ruling that weakens intellectual-property protections by making it easier for legal challenges to patents.
The 8-1 decision put the justices on the side of those who have complained that existing rules stifle innovation, and it is their latest rebuke to the specialized panel that hears patent appeals, the U.S. Court of Appeals for the Federal Circuit, for rulings skewing property rights in favor of patent holders. The high court this term has also heard a separate case appealing obstacles imposed by the Federal Circuit against challenges to a patent on grounds that the invention is "obvious." A decision on that is pending.
Yesterday's opinion, by Justice Antonin Scalia, reversed the Federal Circuit's rule that if a company pays royalties for a patent, it forfeits the right to challenge the patent's validity. That has deterred companies from filing challenges because they would be at risk for treble damages for infringement if the patent were found to be valid.
The decision is a victory for MedImmune Inc., a Gaithersburg, Md., pharmaceuticals company that derives about 80% of its revenue from the respiratory-tract drug at issue, Synagis. Under protest, MedImmune paid a royalty to Genentech Inc., of South San Francisco, Calif., to avoid a patent-infringement suit over a component antibody.
Under a 2004 Federal Circuit ruling, the act of paying a royalty precluded challenging the patent's validity. The Federal Circuit reasoned that since the license payment obviated an infringement suit, there was no controversy between the companies. In general, federal courts may only decide cases and controversies, not rule on theoretical disputes or issue advisory opinions.
Justice Scalia wrote that a party shouldn't have to "bet the farm" to challenge a patent. He cited several prior cases where the court allowed parties to challenge laws as unconstitutional without breaking them -- and thus exposing themselves to criminal punishment. Moreover, he wrote, the Supreme Court in 1943 had decided a similar patent case by ruling that "the fact that royalties were being paid did not" make the dispute "hypothetical or abstract."
The Bush administration supported MedImmune, contending that allowing challenges would help weed out invalid patents that stifle innovation. "Public policy strongly favors ridding the economy of invalid patents, which impede efficient licensing, hinder competition, and undermine incentives for innovation," the government said in a friend-of-the-court brief.
The implications could be greatest for the biotechnology industry, where huge profits can turn on a relatively small number of patents, according to Pamela Samuelson, co-director of the Center for Law and Technology at the University of California, Berkeley. Prof. Samuelson said the Supreme Court is telling the Federal Circuit to be "more balanced and less patent-owner friendly."
"Everybody knows there are a lot of weak patents out there," she said. "A lot of inventors take very substantial risks going out into a field of technology, and sometimes they get their foot blown off when some patent is out there like a land mine."
However, some predicted a chilling effect. "This decision allows companies that have taken out licenses to challenge the validity of a patent while also enjoying the benefits of that very same patent," said Charles Barquist, a patent litigator in Morrison & Foerster LLP's Los Angeles office. "MedImmune turns all fundamental assumptions about the stability and finality of a patent license completely on their head," he added in a statement late yesterday. "The Court has upset the risk/benefit calculation that underlies virtually every patent license."
Genentech issued as statement downplaying the significance of the ruling, saying the Supreme Court "only addressed the threshold jurisdictional issue of whether there need to be further proceedings to finally decide this case. It does not express an opinion concerning the merits of MedImmune's claims against Genentech . . ."
Indeed, MedImmune General Counsel William Bertrand said the victory won't have an immediate impact on his company's bottom line, as it has been paying royalties all along and the ruling doesn't nullify the patent at issue, but it does enable resumption of the challenge.
Eric Schmidt, a biotech analyst at Cowen and Co., sees modest potential impact on Genentech's future earnings from the decision. An adverse decision, should MedImmune prevail at trial, could have an impact of four cents a share on earnings, he said. Genentech receives royalties from licensees as well as paying some royalties to the City of Hope Hospital, in Duarte, Calif., under the patent, Mr. Schmidt said. The company's annual income from all royalties is approaching $1 billion a year.
MedImmune's Synagis, which racked up $1.24 billion in 2005 sales, is an injectable product containing protective antibodies that help guard infants and young children against respiratory syncytial virus, or RSV, a common childhood infection responsible for about 125,000 hospitalizations a year in the U.S. alone, a spokeswoman said.
US Bipartisan Bill To Allow Drug Imports Unveiled
Republican and Democratic lawmakers of both houses of Congress teamed up Wednesday to announce a bill to allow the importation of federally approved drugs into the U.S. from foreign countries.
The bill is the eighth attempt in as many years to reverse a law passed in 1987 which banned the import of drugs approved by the Food and Drug Administration into the U.S. from other countries.
The Pharmaceutical Market Access and Drug Safety Act has been sponsored by Sens. Byron Dorgan, D-ND, and Olympia Snow, R-ME, and Reps. Jo Ann Emerson, R-MO, and Rahn Emanuel, D-IL, in the House of Representatives.
All four expressed confidence that the proposed law would be successful in votes in both chambers. The Democratic leadership in both the Senate and the House have committed themselves to allowing the bill to be voted on the floor, although not to a particular timetable.
At a press conference in the Senate media gallery, Dorgan pointed to the fact that drugs in Canada and in European countries are commonly much cheaper than the same drugs are in the U.S.
Dorgan held up two jars of the popular cholesterol fighting medicine Lipitor, manufactured by drug major Pfizer Inc. (PFE). The medication in both was made in Ireland and then exported to the U.S. and Canada, where it was priced 65% cheaper than in the U.S.
"We want to put downward pressure on the price of prescription drugs," said Dorgan. "Currently, the big drug manufacturers can monopoly price their medicines here, and as a result, American consumers pay the highest prices in the world for prescription drugs."
The legislation would allow individuals to directly order medication from outside the U.S. when using a Canadian pharmacy that is registered with the FDA. It would also allow U.S. licensed pharmacists and wholesalers to import FDA-approved medications from a number of major industrialized nations.
President George W. Bush has spoken out against similar attempts by Congress in the past. Were the bill to pass both chambers successfully, the White House would be left facing the politically unpopular decision to invoke a veto.
The move has the backing of the powerful lobby group, the AARP.
"It's an embarrassment that the very same medications Americans pay top dollar for in the U.S. cost so much less in Canada and Europe. Americans are getting a raw deal," said Bill Novelli, AARP chief executive, in a statement.
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