Pharma firm hikes life-saving drug price by 5,500%

[waltky]

Valeant in the spotlight over drug pricing...

Valeant hires attorney, crisis management firm as U.S. scrutiny mounts
13 Dec.`15 - U.S. pharmaceuticals firm Valeant, under mounting pressure from Congress and prosecutors over its drug pricing, has hired an attorney in Washington, DC and crisis public relations experts with political connections, according to sources familiar with the matter.

The move, confirmed by sources and through documents viewed by Reuters, signals a shift for Valeant Pharmaceuticals, which does not maintain a large presence on Capitol Hill. In recent months the company has attracted scrutiny over steep price hikes on some of its drugs, potentially anti-competitive behavior in its contact lens business and close ties to a specialty pharmacy with aggressive billing practices. Valeant shares have lost nearly 75 percent of their value following the disclosures. Billionaire Bill Ackman, one of Valeant’s largest shareholders, has said the company made a "meaningful mistake" of underinvesting in public relations as it dealt with questions about its business practices.

Valeant recently retained attorney Robert Kelner, a partner at the law firm Covington & Burling, to help respond to congressional inquiries, including an investigation led by an oversight committee in the U.S. House of Representatives, according to a November 20 letter seen by Reuters that was sent to Democratic Congressman Elijah Cummings of Maryland. Covington’s attorney roster includes former Attorney General Eric Holder, and it has represented major drugmakers such as Johnson & Johnson and Pfizer.

Valeant has separately tapped Vianovo, a boutique crisis public affairs firm run by former political campaign and government aides that specializes in "high-stakes brand, policy and crisis issues" and counts Wal-Mart and IBM among its clientele, according to a person familiar with the matter. Vianovo has also lobbied on behalf of companies including Apache Corp, as well as health care networks such as Adventist Healthcare, according to government records. Valeant’s lobbying efforts are far more modest than that of industry peers, and the company has spent less than $250,000 for the first half of 2015, according to reports filed by its lobbyists. Pharmaceutical giant Pfizer, by contrast, spent $4.9 million during the first half of 2015.

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[waltky]

Valeant stocks take a plunge...

Valeant CEO subpoenaed to testify before U.S. Senate panel
28 Mar.`16 WASHINGTON (Reuters) - The chief executive of Valeant Pharmaceuticals International Inc, which is under scrutiny for dramatically hiking the price of older drugs, has been summoned to testify at a U.S. congressional hearing on April 27, the panel said on Monday.

The Senate Special Committee on Aging hearing comes as the Canadian-based company is coping with a variety of federal investigations into its accounting practices that led to a restatement and delays in the filing of its annual report. Valeant said last week CEO Michael Pearson would step down, after a board committee probing the company's ties to specialty pharmacy Philidor Rx Services had found accounting problems dating back to December 2014. Billionaire William Ackman, whose Pershing Square Capital Management owns a 9 percent stake in Valeant, has joined the company's board. A spokesperson for Valeant did not immediately respond to an email seeking comment.

U.S. prosecutors in Massachusetts and Manhattan are probing Valeant's pricing and distribution channels, while the Securities and Exchange Commission is investigating its accounting and disclosure issues. The Senate committee is one of two congressional bodies that are looking into aggressive prescription drug pricing. Both committees are particularly focused on Valeant and Turing Pharmaceuticals, a private company founded by Martin Shkreli, a 32-year-old entrepreneur who has come under fire for raising the price of the drug Daraprim by more than 5,000 percent to $750 a pill.

In February, the U.S. House Committee on Oversight and Government Reform held a long and contentious hearing on drug pricing. At that hearing, Shkreli, who is facing unrelated securities fraud charges, asserted his Fifth Amendment right against self-incrimination. Pearson did not testify at the hearing in the U.S. House of Representatives because he was on medical leave. Howard Schiller, Valeant's then-interim CEO and former chief financial officer, testified in Pearson's place. Since then, however, Valeant has publicly accused Schiller and the company's corporate controller with "improper conduct" which helped contribute to a misstatement of its financial results. Schiller, through his attorneys, has denied any wrongdoing.

Valeant CEO subpoenaed to testify before U.S. Senate panel

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Valeant share plunge after CEO subpoenaed by Congress
Mar. 28, 2016 — Shares of beleaguered Canadian drugmaker Valeant Pharmaceuticals plunged again Monday after its CEO was subpoenaed by a congressional committee.

The Senate Aging Committee said in a statement that J. Michael Pearson, Valeant's CEO since September 2010, is among the witnesses expected to testify on April 27. The committee is holding its third hearing since December on soaring prices for prescription medicines, which are becoming unaffordable for many patients. The high prices for many drugs — some costing $100,000 or more for a course of treatment — also are straining the budgets of insurers and government health programs. The most expensive drugs are generally ones for cancer and rare diseases, but the trend includes many brand-name drugs that have had hefty price hikes year after year, as well as old drugs with limited competition.

Executives at Valeant Pharmaceuticals International Inc., Turing Pharmaceuticals and several other drugmakers have been buying up rights to those old drugs and then jacking up prices many times over what they had cost. Executives of the companies have been invited or subpoenaed to testify at hearings on the issue held by multiple Congressional committees. Valeant is in crisis, with three ongoing federal probes into its accounting and business practices, insurers demanding bigger discounts from its inflated list prices for many of its drugs and executives leaving. Activist investor Bill Ackman's Pershing Square Capital Management, one of Valeant's largest shareholders, just took over two positions on its board of directors to try to salvage the fund's investment in Valeant.

The company, based in Laval, Quebec, has repeatedly delayed filing its fourth-quarter and full-year 2015 results while a committee it appointed investigates accounting practices that resulted in the company prematurely reporting sales in late 2014 made to Valeant's former partner, the now-defunct mail-order pharmacy Philidor. Those delays put Valeant in danger of defaulting on agreements with its creditors and bondholders that require the company to file its annual financial report with the U.S. Securities and Exchange commission this month. Shares of Valeant Pharmaceuticals International Inc. fell 6.4 percent Monday afternoon, to $29.09.

Valeant shares have fallen steadily from a high of $263.81 last August, as its prices and accounting practices came under scrutiny. The company grew rapidly in the last several years with a spree of acquisitions, which pushed its debt to about $30 billion. Now Valeant says it will stick to modest or no price increases, which upends its business strategy, and it's in talks to sell noncore assets to pay down some of its debt. The company announced last week that Pearson, who recently returned from a two-month medical leave, would depart the company as soon as a replacement was found. Neither Pearson nor Valeant has said whether he's resigned or been fired.

Valeant share plunge after CEO subpoenaed by Congress

 

[HenryBHough]

So why has Our Kenyan Emperor not nationalized all drug production?

Lost his pen?

Lost his phone?

 

[Sun Devil 92]

So why has Our Kenyan Emperor not nationalized all drug production?

Lost his pen?

Lost his phone?

Valerie Jarrett hasn't told him to do it.

 

[waltky]

Aussie high school students recreate Daraprim generic...

Aussie students recreate Shkreli’s price-hike drug
Fri, Dec 02, 2016 - A group of Australian high-school students have managed to recreate a life-saving drug that rose from US$13.50 to US$750 a tablet overnight after an unscrupulous price increase by former US hedge fund manager Martin Shkreli.

The Sydney Grammar students reproduced the drug, Daraprim, used to treat a rare, but deadly parasitic infection, in their high-school laboratory with support from the University of Sydney and global members of the Open Source Malaria consortium. Alice Williamson, a post-doctoral teaching fellow with the University of Sydney’s school of chemistry, said she could not stop dwelling on the story of Shkreli, who acquired Daraprim last year through his company, Turing Pharmaceuticals, and almost immediately and exorbitantly raised the price. The drug is used to treat malaria and to prevent toxoplasmosis infection in people with HIV.

The move made him a public villain, a label he embraced as he also became known as “Pharma Bro.” “I couldn’t get this story out of my head, it just seemed so unfair, especially since the drug is so cheap to make and had been sold so cheaply for so long,” Williamson said. “I said: ‘Why don’t we get students to make Daraprim in the lab,’ because to me the route looked pretty simple. I thought if we could show that students could make it in the lab with no real training, we could really show how ridiculous this price hike was and that there was no way it could be justified.” Sydney Grammar could afford to pay for the equipment and chemicals, and had the facilities. The group of year 11 students were talented and confident, Williamson said, and decided to give it a go.

The students made their work open to the Internet, and scientists anywhere in the world were able to view all the data generated and mentor the students to accelerate their progress. Williamson and university associate professor Matthew Todd also mentored the students. Todd told the Guardian Australia that what the students had achieved was “a little Breaking Bad,” a television show about a struggling high-school chemistry teacher who works with one of his former students to produce and sell crystal meth. “With the right guidance, they could do everything safely,” Todd said. “There were clues in literature already from patents around these molecules, but they had to change things as some reagents were nasty and dangerous, so some invention was needed on their part. The open source platform meant as they posted data in real time, Alice, myself and others could guide them.”

He said the open nature of the project demystified science and revealed the number of roadblocks the students had faced in coming up with the final product, which involved three complicated chemical steps. “With science results you can be presented with a polished finished product that hides the false steps along the way,” he said. “The students’ real-time diary highlights their whole process and is a very transparent way of doing things,” he added. The students realized they had succeeded two weeks ago when their teacher, Malcolm Binns, took Todd and Williamson a sample. “Alice did the analysis and looked at the screen, and said: ‘Oh my god, they’ve done it, and not only have they done it, it’s super pure. It’s A-grade.’ I couldn’t believe my eyes,” Todd said. “That was the moment. I realized they had nailed it. The students were over the moon,” he said.

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[Bleipriester]

All that shit is free in my country. FREE!

F
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