Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Japan Slashed the Price of Opdivo by 50% Last Year – Can Trump Do the Same Here in the U.S.?

Japan Slashed the Price of Opdivo by 50% Last Year – Can Trump Do the Same Here in the U.S.? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

President Donald Trump has pledged to reverse what he describes as "astronomical" drug prices in the U.S. Thousands of miles away, Japan, long a profit sanctuary for multinational pharmaceutical companies, is taking a similar tack.

 

About $93 billion is spent annually on medications in Japan, and the government plays a key role on prices because it covers about 40 percent of the country’s health spending via its national insurance scheme. In December, officials announced plans to review drug prices more frequently: annually for all therapies and quarterly for the newest and most expensive ones that are used widely.

 

In November, the government unexpectedly decided to slash the price of Opdivo by half to 75,100 yen ($660) for 20 mg bottles after an oncologist estimated that it could cost the national health system $15 billion annually. That forced Ono, the company that co-developed the drug with Bristol-Myers and sells it in Japan, to lower its profit outlook for the current fiscal year by 25 percent.

 

Despite the protests, the Japanese pressures are nowhere near done for pharma. The government is already preparing to assess the price levels of seven drugs for the next round next year. Gilead’s Sovaldi and Ono and Bristol-Myers Opdivo are among the drugs selected for another round of reviews and could potentially face even more reductions. Gilead declined to comment.

 

The government will push for tighter cost control going forward, said Atsushi Seki, a Tokyo-based pharma analyst at UBS Group AG. “It will also put more pressure on drug prices as drugmakers seek combination therapies of expensive medicines.’’

Pharma Guy's insight:

Not if Gottlieb - who is on BMS's board - is approved as FDA Commish!

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What's BMS Doing on Facebook?

What's BMS Doing on Facebook? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The BMS corporate Facebook page features its collaborations to develop new cancer therapies, but it's low man on the totem pole in terms of "likes."

 

Read more about this here.

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Keytruda v. Opdivo Advertising Channels: Which Reigns Supreme? Direct to Physicians or Direct to Patients?

Keytruda v. Opdivo Advertising Channels: Which Reigns Supreme? Direct to Physicians or Direct to Patients? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Merck's Keytruda and Bristol-Myers Squibb's Opdivo, for all their similarities, have taken markedly different commercial strategies to selling their immuno-oncology drugs.

 

Merck has spent more than double what Bristol-Myers Squibb has spent on Opdivo to promote Keytruda in professional journals targeting doctors. BMS has chosen a different route, electing to make huge splashes in direct-to-consumer advertising.

 

In the first half of 2016, Keytruda was the thirteenth most advertised brand in professional journals, with Merck doling out more than $2 million to target doctors, according to Kantar Media. During the same time period, Opdivo didn't even break into the top 20 of advertised pharmaceutical brands — Bristol-Myers Squibb spent $863,000 on professional ads for the drug, significantly less than what Merck spent.

 

But that's not to say BMS hasn't promoted Opdivo. The company spent $37 million on DTC ads in the first quarter of 2016 and a total of $125 million advertising the therapy in 2015, while Merck spent only $7.3 million in DTC spending over the same time period. In fact, Bristol-Myers Squibb promoted the drug directly to consumers to such an extent that it came under fire from investors last year.

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Deutsche Bank Analyst Questions Value of DTC to Promote Cancer Drug

Deutsche Bank Analyst Questions Value of DTC to Promote Cancer Drug | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Bristol-Myers Squibb CEO Giovanni Caforio defended the company's first branded cancer TV spot Thursday during a call with investors. 


Caforio said the drugmaker chose DTC for its second-line lung cancer drug Opdivo to dispel pessimism created from a history of cancer drugs that lack “significant value.”


Deutsche Bank analyst Gregg Gilbert questioned the channel's usefulness for the indication during the company's full-year earnings call, saying that he expected adoption of immunoncology drugs like Opdivo to grow whether or not the company promoted the drug to patients. 


Carforio responded that the TV campaign was necessary due to the “long history of treatments that have not delivered significant value to patients with lung cancer," adding “there is pessimism for many patients, and the number of patients—particularly in the second-line setting—are not being treated as aggressively as they should.

Pharma Guy's insight:

So, basically, this DTC campaign's goal is to enlist  patients to put pressure on physicians to treat them more "aggressively." Does that mean that direct-to-physician promotion - i.e., sales reps - is not working and/or clinical trial results/outcomes are NOT convincing docs? That should have been the real question.

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Merck’s New Keytruda DTC Ad is a “TRU Story” Told by a Fake Patient (Actor)

Merck’s New Keytruda DTC Ad is a “TRU Story” Told by a Fake Patient (Actor) | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Merck on Monday launched a direct-to-consumer campaign for Keytruda, just months after the drug became the first anti-PD-1 immunotherapy to receive a first-line indication to treat advanced lung cancer.

 

The black- and- white ad tells the story of a woman — an actor portraying a patient — diagnosed with advanced non-small cell lung cancer. She thought her diagnosis meant the start of chemotherapy and would leave her with only months left to live. After finding out that her tumors expressed high levels of the PD-L1 protein, which is a biomarker for Keytruda, she learned she now had a new treatment available to her. She said her scans after treatment with Keytruda showed “good news.”

 

The company has spent an estimated $1.2 million on Keytruda ads Monday and Tuesday for 77 broadcasts, according to iSpot.tv.

 

The ninety-second spot, “Sharon's Tru Story,” likely signals a shift in the drugmaker's marketing strategy, which until now focused on targeting doctors through professional journal ads. Bristol-Myers Squibb in October 2015 launched a DTC campaign for Opdivo, a competing immunotherapy (read “Opdivo TV Ads Educate Patients About the Positive, Not the Negative Trial Data;” http://sco.lt/5OtIdl).

 

[Read “Keytruda v. Opdivo Advertising Channels: Which Reigns Supreme? Direct to Physicians or Direct to Patients?”; http://sco.lt/95gSRt]

 

Merck's new campaign comes at a time when the drugmaker is within reach of pole position over Opdivo, a competing immuno-oncology drug. BMS' bid for using Opdivo in first-line lung cancer was delayed in August after a clinical-trial failure. Merck secured FDA approval for Keytruda in advanced first-line lung-cancer in October.

Pharma Guy's insight:

I thought actors playing patients in drug ads was a thing of the past.

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Immunotherapy Drugs: A Chance to Live Longer or Die from Myriad Side Effects

Immunotherapy Drugs: A Chance to Live Longer or Die from Myriad Side Effects | Pharmaguy's Insights Into Drug Industry News | Scoop.it

So-called immunotherapy drugs [e.g., Opdivo, Yervoy, Ketruda] have been hailed as a breakthrough in cancer treatment, attracting billions of research dollars and offering new hope to patients out of options. But as their use grows, doctors are finding that they pose serious risks that stem from the very thing that makes them effective. An unleashed immune system can attack healthy, vital organs: notably the bowel, the liver and the lungs, but also the kidneys, the adrenal and pituitary glands, the pancreas and, in rare cases, the heart.

 

Doctors at Yale believe immunotherapy is causing a new type of acute-onset diabetes, with at least 17 cases there so far, Mr. Peal’s among them. In cancer clinics around the world, and in drug trials, myriad other side effects are showing up. Studies are finding that severe reactions occur nearly 20 percent of the time with certain drugs, and in more than half of patients when some drugs are used in combination.

 

Another recent paper found that 30 percent of patients experienced “interesting, rare or unexpected side effects,” with a quarter of the reactions described as severe, life-threatening or requiring hospitalization. Some patients have died, including five in recent months in clinical trials of a new immunotherapy drug being tested by Juno Therapeutics Inc.

 

“We are playing with fire,” said Dr. John Timmerman, an oncologist and immunotherapy researcher at the University of California, Los Angeles, who recently lost a patient to side effects. The woman’s immunotherapy drugs had successfully “melted away” her cancer, he said, but some weeks later, she got cold and flulike symptoms and died in the emergency room from an inflammatory response that Dr. Timmerman described as “a mass riot, an uprising” of her immune system.

 

“We’ve heard about immunotherapy as God’s gift, the chosen elixir, the cure for cancer,” he said. “We haven’t heard much about the collateral damage.”

 

Despite the warnings, physicians like Dr. Timmerman remain hugely supportive of drugs that are saving the lives of people who would otherwise die. Far better to cope with diabetes, hepatitis or arthritis, the thinking goes, than to die. Most reactions are not nearly so bad and are treatable.

 

The rub, doctors and researchers say, is that the medical system — from front-line nurses to oncologists to emergency rooms — is too often caught off guard. This is happening for a number of reasons: The drugs are new, so many side effects just have not been seen. Symptoms appear at random, sometimes months after treatment, and can initially seem innocuous. Finally, oncologists are now trying to treat patients with a combination of two or more immunotherapy drugs, hoping for more effective treatment but sometimes getting amplified risks.

 

In the meantime, these drugs are moving from academic centers into cancer clinics across the country, where oncologists in smaller cities most likely have less experience with the side effects.

 

And with lives to be saved and billions of dollars to be made — $250,000 or more is the list price for a year of some regimens — not enough research has been done into the risks of the new therapies, said William Murphy, a professor of dermatology at the University of California, Davis, who reviews immunotherapy-related grants for the government.

 

It is “a massively understudied area,” Dr. Murphy said, adding: “The No. 1 priority is anti-tumor effects. Everything else, however severe, is considered the price worth paying.”

Pharma Guy's insight:

Additional Reading:

  • “Opdivo TV Ads Educate Patients About the Positive, Not the Negative Trial Data;” http://sco.lt/5OtIdl
  • “Oncologists Say Cancer Drug Advertising Fosters Misinterpretation of Efficacy by Patients”; http://sco.lt/8Imgdd
  • “Opdivo Puts BMS Way Ahead in Revenue Generated by New Drug Sales”; http://sco.lt/5MWTVh
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Opdivo Puts BMS Way Ahead in Revenue Generated by New Drug Sales

Opdivo Puts BMS Way Ahead in Revenue Generated by New Drug Sales | Pharmaguy's Insights Into Drug Industry News | Scoop.it

When it comes to measuring success in the world of pharma, one closely watched gauge is the amount of revenue a drugmaker generates from new medicines. The figure can serve as a proxy for growth potential and give investors an indication of how productive a company's research pipeline is, or how fruitful an acquisition turned out to be.

 

Case in point: A Bloomberg Intelligence analysis of drugs approved since 2010 would appear at first glance to show Bristol-Myers Squibb as the clear winner. No other large pharmaceutical company had a higher proportion of sales from new drugs in the second quarter, and it wasn't even close. Newer drugs accounted for 42 percent of Bristol-Myers' revenue in the period, while runner-up Novo Nordisk managed just 24 percent. By 2020, analysts expect these new Bristol-Myers drugs to account for an industry leading 64 percent of its revenue.

 

But numbers alone don't tell the whole story. Bristol-Myers gets substantially more sales from recently approved medicines than any other company, but the majority of the revenue comes from just two drugs (one of those is Opdivo).

Pharma Guy's insight:

But does Opdivo work? Read “BMS: Thank Opdivo Trial Participants by Pulling Ads from TV - It Doesn't Work!”; http://sco.lt/5OSoXR

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