September 16, 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.

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Novelties: Beyond the Breathalyzer: Seeking Telltale Signs of Disease

But in the future, personal breath monitoring may include far more than breath fresheners.

Scientists are building sophisticated electronic and chemical sniffers that examine the puffs of exhaled air for telltale signs of cancer, tuberculosis, asthma and other maladies, as well as for radiation exposure.

“There are clear signatures in the breath for liver disease, kidney disease, heart disease” and diseases of the lungs, said Dr. Raed Dweik, director of the pulmonary vascular program at the Cleveland Clinic, who studies breath analysis. “My sense is that breath analysis is the future of medical testing, complementing many of the blood and imaging steps we do today.”

“Breath is a rich matrix that can reflect our state of health or disease,” Dr. Dweik said. In fact, he observed, breath is so rich in chemical compounds that fully understanding it has proved challenging. Each exhalation contains gases like carbon dioxide, of course, but also the volatile remains of recent snacks, medicines and even compounds inhaled from things like carpeting, upholstery or various kinds of air pollution.

But monitors can sort out these exhaled substances with increasing sensitivity, bringing breath analysis closer to widespread use as a noninvasive tool in medical diagnosis and treatment.

Menssana Research, a biotechnology company in Fort Lee, N.J., is testing a desktop system called BreathLink for use in rapid identification of active pulmonary tuberculosis and other diseases, said Dr. Michael Phillips, the company’s chief executive and a professor of clinical medicine at New York Medical College in Valhalla, N.Y. The system is designed to work wherever there is an Internet connection.

Its analyzers can detect compounds in the breath in concentrations of parts per trillion — a billion times more sensitive than breath analyzers used by the police to detect blood-alcohol concentrations, Dr. Phillips said. To use Breathlink, a person breathes into a long tube, and a breath sample is collected and analyzed within the apparatus. The device can then detail chemical concentrations of the breath in graphics.

“Then we can send that information to our lab in New Jersey from anywhere in the world” for further analysis, he said.

BreathLink grows out of the company’s earlier work on Heartsbreath, a procedure that monitors exhalations of patients with heart transplants for signs of rejection. Heartsbreath, approved by the Food and Drug Administration as a humanitarian device, has not yet been widely adopted, Dr. Phillips said, in part because Medicare has declined to cover the test until further clinical studies demonstrate its efficacy. Those studies are continuing, Dr. Phillips said.

The detection of one compound in the breath, nitric oxide, is already used widely in treatment of asthma, said Dr. Marielle W. H. Pijnenburg, who specializes in pediatric respiratory medicine at Erasmus University Medical Center in Rotterdam, the Netherlands.

“It’s a very small molecule,” she said, “but if you look at patients of asthma, they have higher levels of it in their exhaled air. It reflects their allergic inflammation in the lungs.”

Dr. Pijnenburg said that the breath analyzers used to detect nitric oxide are expensive, however — and that the results, while useful, are not applicable to all asthma patients. “Nitric oxide alone is too simple to reflect the complex processes going on in the lungs for asthma,” she said. Future devices will measure many other molecules that may be related to the disease.

One of these devices may be a portable breath analyzer for pediatric asthma that will look for five common inflammatory markers of the disease, said Frederick A. Dombrose, president of the Hartwell Foundation in Memphis. The foundation, which supports research in children’s health, has awarded a grant to Cristina E. Davis, an associate professor of mechanical and aerospace engineering at the University of California, Davis, to develop the analyzer.

“We want a hand-held device that is convenient for children to hold and use, so that they can monitor their condition,” Mr. Dombrose said.

AT the Cleveland Clinic, Dr. Peter Mazzone is analyzing the breath of patients to determine whether they have lung cancer. In his test, breath is drawn across sensors that change color and are then captured on digital cameras. The patterns are then compared with those of people without the disease. His tests have reached 85 percent accuracy so far in spotting people with the illness, he said.

But some trained dogs, he pointed out, can sniff out cancer with 99 percent accuracy — although without, for example, the ability to identify particular compounds the way some analyzers can.

“We are getting better and better,” he said. “But whether we will ever approach the accuracy of the dog — we don’t know.”

E-mail: novelties@nytimes.com.

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