sexta-feira, 18 de agosto de 2006

NYT (18/08/06): Genéricos em debate, mas nos Estados Unidos.

O New York Times (18/06/2006) divulga a disputa judicial referente aos medicamentos genéricos nos Estados Unidos. Hoje, esse blog foi questionado se havia alguma documentação sobre os genéricos no Brasil. Não soube responder a contento. Agora, temos um relato muito interessando ocorrendo nos Estados Unidos refente ao clopidogrel, um medicamente anti-trombótico que em associação com a aspirina melhora o prognóstico de pacientes com infarto do miocárdio e angina instável. Um comentário interessante: no período que morei nos Estados Unidos era regra as farmácias "esconderem" no setor "over the counter" (receita médica não-obrigatória), os medicamentos genéricos. Sempre ficavam na prateleira próxima ao chão, longe da vista dos clientes. Um comentário importante: como apresentei no meu perfil participei de pesquisa envolvendo o uso de clopidogrel com patrocínio da Bristol-Myers Squibb. Esse é o começo do artigo: A federal court filing provided new details yesterday about accusations that a Bristol-Myers Squibb executive entered a secret side deal with a generic drug maker in hopes of preserving the lucrative monopoly over the anticlotting drug Plavix. O restante do artigo poderá lido pelos inscritos do site do New York Times no endereço http://www.nytimes.com/2006/08/18/business/18drug.html?pagewanted=2&_r=1&adxnnl=0&adxnnlx=1155913522-0Qs5wgHbfD6EUQr5ot2yeQ

5 comentários:

Flavia Saad disse...

Caro Prof. Paulo
trabalho com jornalismo de saúde e acho muito importante a divulgação intensa do assunto, porque a saúde não pode existir sem a informação. Sentia falta mesmo desse tema no mundo dos blogs. Parabéns pela iniciativa.
Se quiser entrar em contato, meu e-mail é flaviasaad@gmail.com
Abraços,
Flávia Saad

Paulo Lotufo disse...

NYT, September 1, 2006.
Generic of Plavix Is Blocked
By STEPHANIE SAUL
Published: September 1, 2006
A federal judge in Manhattan ordered a Canadian company yesterday to stop distributing its generic version of the blockbuster anticlotting drug Plavix, granting a reprieve to Bristol-Myers Squibb and Sanofi-Aventis, which co-market the brand-name drug.

Related
Preliminary Injunction (Sanofi v. Apotex)
Court Opinion (pdf)
The Plavix marketers had seen a drastic erosion of their United States sales since the Canadian company, Apotex, introduced its generic version on Aug. 8 in a challenge to the patent held by the big companies. Analysts say that the large supplies of the generic drug already on the market could continue to impinge on sales of Plavix for several months.
While ordering Apotex to stop shipments, United States District Judge Sidney H. Stein declined a request by Bristol-Myers and Sanofi to recall the generic pills already on the market. The judge ruled that the companies had negotiated away that right in their attempts earlier this year to settle the patent dispute with Apotex.
Judge Stein did say that the patent was likely to be enforceable, based on the evidence and testimony so far. He also observed that Bristol-Myers and Sanofi had suffered “irreparable harm” as a result of the patent infringement.
He nonetheless required Bristol-Myers and Sanofi to post a $400 million bond to compensate Apotex in the event the generic company won in a trial on the validity of the patent, now set to begin in his court next January.
Shares of Bristol-Myers were up more than 9 percent in after-hours trading on the New York Stock Exchange. Shares of Sanofi were little changed.
Bernard C. Sherman, the chief executive of Apotex, a private company based in Toronto, said yesterday that it planned to appeal. “We believe that the ruling is erroneous in many respects,” he said.
Mr. Sherman said that the volume of the Apotex drug already on the market amounted to about three months’ worth of sales, while some analysts have estimated the amount at even more. A spokesman for Bristol-Myers, Tony Plohoros, said the company was trying to assess the amount of generic inventory in wholesale channels. Neither Sanofi nor Bristol-Myers had issued any other statement about the ruling, but in a letter to employees being sent last night, the Bristol-Myers chief executive, Peter R. Dolan, said it was “certainly good news that the preliminary injunction has been granted, but unfortunately the economic and other consequences of the intrusion of the generic product that competes with Plavix in the U.S. market are impossible to fully reverse.”
A Deutsche Bank analyst, Barbara Ryan, said the ruling was relatively good news for Bristol-Myers, which derives 30 percent of its profit from sales of Plavix. The drug, used by 48 million Americans, primarily to prevent the recurrence of stroke and heart attack, had United States sales last year of $3.5 billion

Paulo Lotufo disse...

na versão brasileira do Wall Street Journal (04/09/06) há menção que apesar da justiça ter sustado as vendas de Apotex, a quantidade desse medicamento nas farmácias permite vendas até 2007. O Apotex em 3 semanas assumiu 75% das vendas de clopidogrel. Como o clopidogrel é medicamento da Sanofi-Aventis, licenciado para a Bristo Myers Squibb, há divergência sobre o prazo de licença da patente. Esse é o motivo da disputa jurídica.

Paulo Lotufo disse...

Bristol-Myers Ousts CEO Dolan,
Names Cornelius Interim Successor
By JOHN CARREYROU and BARBARA MARTINEZ
September 12, 2006 12:05 p.m.
Directors at Bristol-Myers Squibb Co. on Tuesday ousted Chief Executive Peter Dolan amid pressure from a federal monitor. Board member James Cornelius was appointed interim chief executive of the drug maker.
Mr. Dolan's departure came as no surprise -- shareholders have been increasingly disappointed in his performance during the five years he held the position. He pursued a deal to delay generic competition to the company's best-selling drug, blood-thinner Plavix, a violation of an agreement with prosecutors. That seemed to be the last straw after an accounting scandal and a dismal stock performance. Bristol-Myers shares have fallen nearly 60% since Mr. Dolan became CEO in May 2001.
BRISTOL-MYERS STATEMENT
Read the full text of Bristol-Myers Squibb's statement on the ouster of CEO Peter Dolan and the drug maker's general counsel.
In late-morning trading, shares of Bristol-Myers were up 51 cents, or 2.2%, to $23.90 on the New York Stock Exchange.
Mr. Cornelius has been a director on Bristol's board since January 2005 and has served as chairman emeritus of medical-device maker Guidant Corp. since 2000.
Bristol-Myers's general counsel Richard Willard will also leave the company. Sandra Leung, vice president and corporate secretary, was appointed as acting general counsel. Both executive changes are effective immediately.
The board had little choice but to accept a federal monitor's recommendation when directors met today to determine the fate of Messrs. Dolan and Willard. The company is operating under the terms of a deferred-prosecution agreement reached with the U.S. Attorney in New Jersey last year following a three-year investigation into a $2.5 billion scandal at the company involving "channel stuffing," or overloading wholesalers with inventory to meet quarterly sales targets.
The Bristol-Myers monitor, former federal Judge Frederick B. Lacey, recommended to a special session of the company's board late yesterday that it terminate Mr. Dolan and Bristol-Myers General Counsel Richard Willard, the company said. The meeting was attended by the U.S. Attorney for New Jersey, Christopher Christie, who appointed Mr. Lacey last year in the settlement agreement.
Mr. Lacey made his recommendation after finding Bristol-Myers's handling of Plavix violated the terms of the deferred-prosecution agreement. It wasn't clear what specific actions Mr. Lacey was concerned about, but companies under such agreements are broadly expected to be on their best behavior. The Plavix deal unraveled after the Justice Department's antitrust unit opened a criminal probe into it and the Federal Bureau of Investigation raided Mr. Dolan's office in July.
Mr. Dolan's removal marks the third ouster of a chief executive of a big U.S. drug company in the past 16 months, underscoring the difficulties facing an industry reeling from an unprecedented number of patent expirations, increasing litigation costs and heightened competition from nimble generic-drug makers. Though still highly profitable, branded-drug makers also face financial pressure from pharmacy-benefit managers, who use their negotiating power and quick access to new generic pills to leverage lower drug prices.
Merck & Co., Whitehouse Station, N.J., last year pushed then-CEO Raymond Gilmartin into early retirement after withdrawing the painkiller Vioxx from the market in 2004. Pfizer Inc., the world's biggest drug maker, ousted Henry McKinnell in late July, replacing him with a former lawyer. As at Bristol-Myers, the stocks of both companies have been battered in the past two years.
Under the terms of its deferred-prosecution agreement, by which it avoided charges of conspiracy to commit securities fraud, Bristol-Myers was supposed to stay out of trouble for two years to avoid an indictment. The agreement, which gave Mr. Lacey unusually broad oversight powers, also forced Mr. Dolan to surrender his chairman title to a senior member of the Bristol-Myers board, James B. Robinson III.
Mr. Lacey, who was appointed to monitor the drug maker for two years through next April, has been attending all the company's board meetings and filing regular reports to Mr. Christie. As part of the agreement, he was given free reign to recommend changes at the company to keep it within bounds.
Mr. Dolan's handling of Plavix already had put him on shaky ground with the board. After learning that the company's Plavix cash-cow was under threat from generic competition, he negotiated a deal that would have paid Canada's Apotex Inc. tens of millions of dollars to delay its introduction of a copycat drug. That pact, aimed at settling Apotex's legal challenge of the Plavix patent, unraveled in late July when the Department of Justice's antitrust division opened an investigation into it and state attorneys general rejected it.
In filings to the federal court in New York overseeing the patent litigation, Apotex has alleged that Bristol-Myers struck a verbal side agreement with it during the settlement negotiations that it then hid from regulators. A lawyer for Bristol-Myers has denied this to the court and has suggested that Apotex fabricated the allegation to torpedo the settlement.
In the meantime, Apotex used binding concessions it obtained during the negotiations to launch a knockoff version on Aug. 8, after the deal was rejected by regulators. The generic version quickly conquered 75% of the market, costing Bristol-Myers as much as $600 million in lost sales. The court overseeing the patent case ordered Apotex to stop selling the generic version on Aug. 31, but didn't force it to recall the product already in the distribution channel.
Bristol-Myers pursued the deal with Apotex even though U.S. regulators have been hostile to such agreements on the grounds that they hurt consumers by keeping lower cost versions of life-saving drugs off the market. The Federal Trade Commission has criticized similar deals and has fought one of them all the way to the U.S. Supreme Court.
Nine board members attended last night's special session, according to a person familiar with the matter. No one from management was there, though two lawyers, Mary Jo White and Kenneth Conboy, were on hand to advise the board. After Mr. Lacey briefed board members and issued his recommendation, Mr. Christie spoke to the board and signaled he supported Mr. Lacey's recommendation. The recommendation to fire the two executives "was made from a corporate-governance perspective in the handling of the patent issue over Plavix," the person familiar with the matter said, declining to provide further details.

Paulo Lotufo disse...

Bristol-Myers Ousts CEO Dolan,
Names Cornelius Interim Successor
By JOHN CARREYROU and BARBARA MARTINEZ
September 12, 2006 12:05 p.m.
Directors at Bristol-Myers Squibb Co. on Tuesday ousted Chief Executive Peter Dolan amid pressure from a federal monitor. Board member James Cornelius was appointed interim chief executive of the drug maker.
Mr. Dolan's departure came as no surprise -- shareholders have been increasingly disappointed in his performance during the five years he held the position. He pursued a deal to delay generic competition to the company's best-selling drug, blood-thinner Plavix, a violation of an agreement with prosecutors. That seemed to be the last straw after an accounting scandal and a dismal stock performance. Bristol-Myers shares have fallen nearly 60% since Mr. Dolan became CEO in May 2001.
BRISTOL-MYERS STATEMENT
Read the full text of Bristol-Myers Squibb's statement on the ouster of CEO Peter Dolan and the drug maker's general counsel.
In late-morning trading, shares of Bristol-Myers were up 51 cents, or 2.2%, to $23.90 on the New York Stock Exchange.
Mr. Cornelius has been a director on Bristol's board since January 2005 and has served as chairman emeritus of medical-device maker Guidant Corp. since 2000.
Bristol-Myers's general counsel Richard Willard will also leave the company. Sandra Leung, vice president and corporate secretary, was appointed as acting general counsel. Both executive changes are effective immediately.
The board had little choice but to accept a federal monitor's recommendation when directors met today to determine the fate of Messrs. Dolan and Willard. The company is operating under the terms of a deferred-prosecution agreement reached with the U.S. Attorney in New Jersey last year following a three-year investigation into a $2.5 billion scandal at the company involving "channel stuffing," or overloading wholesalers with inventory to meet quarterly sales targets.
The Bristol-Myers monitor, former federal Judge Frederick B. Lacey, recommended to a special session of the company's board late yesterday that it terminate Mr. Dolan and Bristol-Myers General Counsel Richard Willard, the company said. The meeting was attended by the U.S. Attorney for New Jersey, Christopher Christie, who appointed Mr. Lacey last year in the settlement agreement.
Mr. Lacey made his recommendation after finding Bristol-Myers's handling of Plavix violated the terms of the deferred-prosecution agreement. It wasn't clear what specific actions Mr. Lacey was concerned about, but companies under such agreements are broadly expected to be on their best behavior. The Plavix deal unraveled after the Justice Department's antitrust unit opened a criminal probe into it and the Federal Bureau of Investigation raided Mr. Dolan's office in July.
Mr. Dolan's removal marks the third ouster of a chief executive of a big U.S. drug company in the past 16 months, underscoring the difficulties facing an industry reeling from an unprecedented number of patent expirations, increasing litigation costs and heightened competition from nimble generic-drug makers. Though still highly profitable, branded-drug makers also face financial pressure from pharmacy-benefit managers, who use their negotiating power and quick access to new generic pills to leverage lower drug prices.
Merck & Co., Whitehouse Station, N.J., last year pushed then-CEO Raymond Gilmartin into early retirement after withdrawing the painkiller Vioxx from the market in 2004. Pfizer Inc., the world's biggest drug maker, ousted Henry McKinnell in late July, replacing him with a former lawyer. As at Bristol-Myers, the stocks of both companies have been battered in the past two years.
Under the terms of its deferred-prosecution agreement, by which it avoided charges of conspiracy to commit securities fraud, Bristol-Myers was supposed to stay out of trouble for two years to avoid an indictment. The agreement, which gave Mr. Lacey unusually broad oversight powers, also forced Mr. Dolan to surrender his chairman title to a senior member of the Bristol-Myers board, James B. Robinson III.
Mr. Lacey, who was appointed to monitor the drug maker for two years through next April, has been attending all the company's board meetings and filing regular reports to Mr. Christie. As part of the agreement, he was given free reign to recommend changes at the company to keep it within bounds.
Mr. Dolan's handling of Plavix already had put him on shaky ground with the board. After learning that the company's Plavix cash-cow was under threat from generic competition, he negotiated a deal that would have paid Canada's Apotex Inc. tens of millions of dollars to delay its introduction of a copycat drug. That pact, aimed at settling Apotex's legal challenge of the Plavix patent, unraveled in late July when the Department of Justice's antitrust division opened an investigation into it and state attorneys general rejected it.
In filings to the federal court in New York overseeing the patent litigation, Apotex has alleged that Bristol-Myers struck a verbal side agreement with it during the settlement negotiations that it then hid from regulators. A lawyer for Bristol-Myers has denied this to the court and has suggested that Apotex fabricated the allegation to torpedo the settlement.
In the meantime, Apotex used binding concessions it obtained during the negotiations to launch a knockoff version on Aug. 8, after the deal was rejected by regulators. The generic version quickly conquered 75% of the market, costing Bristol-Myers as much as $600 million in lost sales. The court overseeing the patent case ordered Apotex to stop selling the generic version on Aug. 31, but didn't force it to recall the product already in the distribution channel.
Bristol-Myers pursued the deal with Apotex even though U.S. regulators have been hostile to such agreements on the grounds that they hurt consumers by keeping lower cost versions of life-saving drugs off the market. The Federal Trade Commission has criticized similar deals and has fought one of them all the way to the U.S. Supreme Court.
Nine board members attended last night's special session, according to a person familiar with the matter. No one from management was there, though two lawyers, Mary Jo White and Kenneth Conboy, were on hand to advise the board. After Mr. Lacey briefed board members and issued his recommendation, Mr. Christie spoke to the board and signaled he supported Mr. Lacey's recommendation. The recommendation to fire the two executives "was made from a corporate-governance perspective in the handling of the patent issue over Plavix," the person familiar with the matter said, declining to provide further details.