October 20, 2019

Amgen and Watson to Work Together on Generic Drugs

LOS ANGELES — Amgen, the biotechnology company, is planning to develop generic versions of some best-selling drugs.

Amgen said on Monday that it would team up with Watson Pharmaceuticals, a leading generic drug manufacturer, to develop and sell lower-price copycat versions of several biologic cancer drugs.

The companies did not specify which drugs they would develop. But the most likely candidates are the blockbuster products sold by Roche and its Genentech subsidiary — Herceptin for breast cancer, Rituxan for lymphomas and Avastin for various cancers.

Amgen and some other biotechnology companies have long tried to impede the development of generic competition to their drugs, which can cost tens of thousands of dollars a year a patient. They have argued that biologic drugs, which are made in living cells, cannot be precisely copied, unlike drugs made in chemical factories.

But now that pressure to lower health care costs has made such generic competition unavoidable, some of the biotech companies are starting to view it as a natural extension of their business — as long as the cheaper versions they produce are of other companies’ drugs, not their own.

Two weeks ago, Biogen Idec, another leading biotech company, announced a joint venture with Samsung to develop such drugs, which are usually called biosimilars. That partnership will not make copies of any of Biogen’s drugs, and Amgen’s deal with Watson will not copy any Amgen drugs.

While Amgen executives indicated earlier this year that a biosimilar business might make some sense for the company, Monday’s announcement was its formal entry.

“We have purposely been keeping it under wraps as long as we could,” Scott Foraker, who was quietly appointed to head biosimilars at Amgen about a year ago, said in an interview.

Mr. Foraker said Amgen was not being inconsistent, in that it had always said biosimilars have a role, as long as the patent protection on the innovative drug was respected.

Amgen and Watson will split the costs of development roughly in half, with Watson providing up to $400 million in cash or in-kind services. Watson would receive royalties and milestone payments on sales of the drugs.

Mr. Foraker said the deal would allow Amgen to develop biosimilars “in a way that was smart, that didn’t distract the organization from our main innovative business.”

Paul M. Bisaro, chief executive of Watson, said the company had looked at more than 150 potential partners. “We structured the deal with the pre-eminent biologic development company in the world,” he said.

The 2010 law overhauling the health care system orders the Food and Drug Administration to develop rules for the approval of biosimilars. Those rules have not yet emerged, so there is still uncertainty about how extensive clinical trials will have to be.

Amgen and Watson said Amgen would do most of the development, manufacturing and commercialization initially. That is because it is anticipated that biosimilars will need to be marketed, unlike generic drugs.

But over time, the biosimilar market could become more like the market for conventional generic drugs, with competition mainly on price. That would allow Watson to play a greater role.

“Over time, the commercial relationship modifies,” Mr. Bisaro, said. “We both have strengths that make sense for each other no matter how the markets develop.”

Fred Wilkinson, executive vice president of Watson, said his firm would serve as the “conscience” of the partnership, making sure it truly adhered to the idea of making low-cost drugs.

Mr. Bisaro said the drugs might reach the market in the United States around 2018 or 2019, when patents expire. In certain other countries, the drugs could get to the market sooner.

The deal is not exclusive. Watson this year bought a company, Eden Biodesign, that is developing a biosimilar version of a fertility hormone. And Mr. Foraker said Amgen has plans for other biosimilar drugs.

Article source: http://feeds.nytimes.com/click.phdo?i=e76c12a4251e05c1a4c338671ea2e524

Patent Bill Viewed as Bailout for a Law Firm

The provision clarifies how much time pharmaceutical companies have to apply for patent extensions that can provide extra years of protection from generic competition.

But critics, who have labeled the provision “The Dog Ate My Homework Act,” say it is really a special fix for one drug manufacturer, the Medicines Company, and its powerful law firm, WilmerHale. The company and its law firm, with hundreds of millions of dollars in drug sales at stake, lobbied Congress heavily for several years to get the patent laws changed.

The patent office initially said that the company had missed the deadline for applying for a patent extension by a day or two, potentially losing nearly four years of patent protection on its main drug, the anticoagulant Angiomax. The provision would guarantee that the Medicines Company got the extra patent protection, and it would relieve WilmerHale, which was hired to file the application, of a possible malpractice payment to its client.

On Thursday, the Senate is scheduled to vote on an amendment proposed by Senator Jeff Sessions, Republican of Alabama, that would strip the provision from the bill. “The key question is whether we will vote to bail out a law firm that made a mistake and now wants consumers and taxpayers to pay the freight for that error,” Senator Sessions and Senator Tom Coburn, a Republican from Oklahoma, said in a letter sent Wednesday to colleagues. They said the extra patent protection on Angiomax could cost hospitals and consumers $1 billion.

But Mr. Sessions faces an uphill battle because Senate leaders want their colleagues to pass the House version of the bill, which contains that provision, without any amendments, saying any changes could jeopardize the entire legislation.

David E. Redlick, co-chairman of the life sciences practice at WilmerHale, said other companies, including Bayer and AstraZeneca, might also now benefit from patent extensions.

“The repeated assertion that this is a single company bill is just not so,” Mr. Redlick said. He said the existing law had unclear wording. The new provision “will resolve that uncertainty on a permanent basis, which one would hope would be a key purpose of patent reform.”

He also said that a federal judge ruled last year that the Medicines Company had filed its application on time. So the patent extension is expected to be granted, and WilmerHale would never have to make the malpractice payment, even without the legislation, he said. The legislation provides insurance in case the court ruling is reversed, he said.

Applications for patent extensions must be made within 60 days of a drug’s approval by the Food and Drug Administration.

The United States Patent and Trademark Office ruled that the Medicines Company, which filed its application in 2001, had missed the deadline by a day or two.

As a result, Angiomax could have been vulnerable to generic competition as early as September 2010, instead of June 2015. Sales of Angiomax accounted for virtually all of the Medicines Company’s $437.6 million in revenue last year.

The company, based in Parsippany, N.J., sued the Patent Office, arguing that since it had received F.D.A. approval for Angiomax after the customary close of business on a Friday, the 60-day clock should not have started ticking until the next Monday.

In August 2010, a federal judge agreed and the government did not appeal. The Patent Office, which granted interim patent extensions during the lawsuit, is working on the final extension.

But APP Pharmaceuticals, a drug company that wants to sell a generic version of Angiomax, is trying to have the judge’s decision overturned.

The amendment would change the patent law to agree with the judge’s interpretation of the deadline calculations.

The Medicines Company has been pressing for years for a legislative solution, spending more than $17 million since 2005 on prominent lobbyists, including former House majority leaders Richard Gephardt, a Democrat, and Dick Armey, a Republican.

The company has been assisted in its effort by WilmerHale, known formally as Wilmer Cutler Pickering Hale and Dorr.

Article source: http://feeds.nytimes.com/click.phdo?i=c80012459a8f3ea9e70d323885bf5f25

Patent Bill Could Save Law Firm $214 Million

The provision clarifies how much time pharmaceutical companies have to apply for patent extensions that can provide extra years of protection from generic competition.

But critics, who have labeled the provision “The Dog Ate My Homework Act,” say it is really a special fix for one drug manufacturer, the Medicines Company, and its powerful law firm, WilmerHale. The company and its law firm, with hundreds of millions of dollars in drug sales at stake, lobbied Congress heavily for several years to get the patent laws changed.

Back in 2001, the company missed the deadline for applying for a patent extension by a day or two, potentially losing nearly four years of patent protection on its main drug, the anticoagulant Angiomax. The provision would guarantee that the Medicines Company would get the extra patent protection, and it would relieve WilmerHale, which was hired to file the application, of a possible malpractice payment to its client.

On Thursday, the Senate is scheduled to vote on an amendment proposed by Senator Jeff Sessions, Republican of Alabama, that would strip the provision from the bill. “The key question is whether we will vote to bail out a law firm that made a mistake and now wants consumers and taxpayers to pay the freight for that error,” Senator Sessions and Senator Tom Coburn, a Republican from Oklahoma, said in a letter sent Wednesday to colleagues. They said the extra patent protection on Angiomax could cost hospitals and consumers $1 billion.

But Mr. Sessions faces an uphill battle because Senate leaders want their colleagues to pass the House version of the bill, which contains that provision, without any amendments, saying any changes could jeopardize the entire legislation.

David E. Redlick, co-chairman of the life sciences practice at WilmerHale, said other companies, including Bayer and AstraZeneca, also missed filing deadlines and might now benefit from patent extensions.

“The repeated assertion that this is a single company bill is just not so,” Mr. Redlick said. He said the existing law had unclear wording. The new provision “will resolve that uncertainty on a permanent basis, which one would hope would be a key purpose of patent reform.”

He also said that a federal judge ruled last year that the Medicines Company had filed its application on time. So the patent extension is expected to be granted, and WilmerHale would never have to make the malpractice payment, even without the legislation, he said. The legislation provides insurance in case the court ruling is reversed, he said.

Applications for patent extensions must be made within 60 days of a drug’s approval by the Food and Drug Administration.

The United States Patent and Trademark Office ruled that the Medicines Company, which filed its application in 2001, had missed the deadline by a day or two.

As a result, Angiomax could have been vulnerable to generic competition as early as September 2010, instead of June 2015. Sales of Angiomax accounted for virtually all of the Medicines Company’s $437.6 million in revenue last year.

The company, based in Parsippany, N.J., sued the Patent Office, arguing that since it had received F.D.A. approval for Angiomax after the customary close of business on a Friday, the 60-day clock should not have started ticking until the next Monday.

In August 2010, a federal judge agreed and the government did not appeal. The Patent Office, which granted interim patent extensions during the lawsuit, is working on the final extension.

But APP Pharmaceuticals, a drug company that wants to sell a generic version of Angiomax, is trying to have the judge’s decision overturned.

The amendment would change the patent law to agree with the judge’s interpretation of the deadline calculations.

The Medicines Company has been pressing for years for a legislative solution, spending more than $17 million since 2005 on prominent lobbyists, including former House majority leaders Richard Gephardt, a Democrat, and Dick Armey, a Republican.

The company has been assisted in its effort by WilmerHale, known formally as Wilmer Cutler Pickering Hale and Dorr.

Article source: http://feeds.nytimes.com/click.phdo?i=c80012459a8f3ea9e70d323885bf5f25