*** San Diego-based Imprimis Pharmaceuticals Inc. is a compound drug maker
- They have manufactured a drug with the same active ingredients in Daraprim, pyrimethamine and leucovorin
- The price of Daraprim was risen 5000 percent by Turing Pharmaceuticals
- Imprimis will sell a 100-capsule bottle for $99
- Daraprim treats a rare parasitic infection called toxoplasmosis that mainly strikes pregnant women, cancer patients and AIDS patients
- The New York Attorney General is investigating Turing Pharmaceuticals because the company might be ‘unlawfully’ restraining competition
- Turing is reportedly distributing Daraprim only through a limited number of specialty pharmacies to stop manufactures making generic versions **
Stepping into the furor over eye-popping price spikes for old generic medicines, a maker of compounded drugs will begin selling $1 doses of Daraprim, whose price recently was jacked up to $750 per pill by Turing Pharmaceuticals.
San Diego-based Imprimis Pharmaceuticals Inc., which mixes approved drug ingredients to fill individual patient prescriptions, said Thursday it will supply capsules containing Daraprim’s active ingredients, pyrimethamine and leucovorin, for $99 for a 100-capsule bottle - or $1 per capsule.
The move to provide cheap alternatives to Daraprim is an attack on Turing CEO Martin Shkreli, who immediately rose the price of the drug by 5,000 per cent after his company acquired it last month.
The 3 1/2-year-old drug compounding firm also plans to start making inexpensive versions of other generic drugs whose prices have skyrocketed, Chief Executive Mark Baum told The Associated Press.
‘We are looking at all of these cases where the sole-source generic companies are jacking the price way up,’ Baum said in an interview.
'There’ll be many more of these compounded drugs coming in the near future.
The high price of prescription medicines in the U.S. — from drugs for cancer and rare diseases that cost hundreds of thousands of dollars a year down to once-cheap generic drugs now costing many times their old price — has become a hot issue in the 2016 presidential race.
News that Turing, Valeant Pharmaceuticals International Inc. and other drugmakers have bought rights to old, cheap medicines that are the only treatment for serious diseases and then hiked prices severalfold has angered patients.
It’s triggered government investigations, politicians’ proposals to fight ‘price gouging,’ heavy media scrutiny and a big slump in biotech stock prices.
At the eye of the storm is former hedge fund manager Shkreli, head of Turing Pharmaceuticals, scorned last month for buying rights to and then increasing by more than 5,000 percent the price of Daraprim, a 62-year old drug with no competition.
The startup drugmaker paid Impax Laboratories $55 million in August for rights to Daraprim, which treats a rare parasitic infection called toxoplasmosis that mainly strikes pregnant women, cancer patients and AIDS patients.
Imprimis, which primarily makes compounded drugs to treat cataracts and urological conditions, will work with health insurers and prescription benefit managers in each state to make its new capsules and other compounded generic medicines widely available, Baum said.
‘We’re geared up. We’re ready to go as soon as the orders come in,’ he said.
Compounded drugs are typically made to fill a doctor’s prescription for an individual patient, sometimes because the mass-produced version is in short supply or completely unavailable and sometimes to allow for customized formulations or dosages.
Compounders don’t need Food and Drug Administration approval to do that, unlike drugmakers making huge batches of drugs on complex production lines.
Baum said Imprimis will produce its pyrimethamine/leucovorin capsules, using bulk ingredients from manufacturing plants approved by the FDA, at its own facilities in Allen, Texas; Folcroft, Pennsylvania; Irvine, California, and Randolph, New Jersey.
Turing’s Shkreli, under fire from all sides, said late last month that he would lower the price of Daraprim, but hasn’t so far.
A Turing spokesman didn’t respond to a request for comment Thursday but recently noted the company is capping patient copayments at $10.
Earlier this month, New York Attorney General Eric Schneiderman’s antitrust bureau said it was investigating Turing Pharamaceuticals over concerns that the company might be ‘unlawfully’ restraining competition.
Turing is reportedly doing this by distributing the drug Daraprim only through a limited number of specialty pharmacies in order to prevent generic manufacturers from obtaining access to samples to make their own version.
The company promised to lower the price after facing outrage over its price hike, but has yet to do so, according to CNN Money.
Schneiderman’s letter informs Shkreli that he is required to retain all documents that could be relevant to the investigation.
While competition might ordinarily be expected to deter such a massive price increase, it appears that Turing may have taken steps to prevent that competition from arising,’ said the letter, which was first obtained by The New York Times.
Messages left with Turing were not immediately returned.
The announcement from the New York Attorney General comes just a day after Shkreli called out Democratic presidential candidates Hillary Clinton and Bernie Sanders on Twitter, claiming they didn’t understand why he was raising the price.
‘Dear @BernieSanders & @HillaryClinton, I have an important question for you. Get back to me whenever,’ he wrote on Twitter.
He attached a photo in which he discusses the evolution of toxoplasmosis over the 62 years Daraprim has been used to treat the infection, which can cause serious and life-threatening problems, primarily in babies and people with compromised immune systems, including AIDS and cancer patients.
‘Would you prefer (1) a lower price of our medicine, which is overwhelmingly paid for by ‘Corporate America’ and their insurers (who are reporting record profits) or (2) that we use our resources to research a new drug for resistant trains of this neglected disease,’ the text read.
He included a passage of text which claims that the use of Daraprim has ‘eventually led to the inevitable selection of resistant strains’.
‘Does it make sense that we’re using a 70-year-old drug to treat an ever-evolving parasie? Why hasn’t ‘big pharma’ cared about innovation in toxoplasmosis?’ he asked.
‘If Turing didn’t show up and show interest in the illness, how long would it take for a new toxoplasmosis medicine to develop?’
Turing obtained rights to sell the drug, the only U.S.-approved treatment for toxoplasmosis, in August.
The company had said it would use profits to improve the drug’s formulation and develop new, better drugs for the infection. It also stressed that some patients can get financial aid from the company to obtain the drug.
But the price hike sparked outrage from medical groups representing doctors who care for patients with HIV and other infectious diseases, because Daraprim treats patients with compromised immune systems.
Hillary Rodham Clinton called Turing’s price hike ‘outrageous’ in a tweet last month. While campaigning for the Democratic nomination for president, she outlined a broad plan aimed at holding down the cost of prescription drugs.
In an interview with Bloomberg in September, Shkreli made it clear that the drug would be available to all those who need it, and that even if there was a dispute with an insurer the patient would be sent their pills while things were being sorted.
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He was then asked at one point to address whether or not his price hike might lead to competitors making generic versions of the drug to which he responded: 'Sure, and I think that’s a great thing. At the end of the day if you look at diseases like myeloma or multiple sclerosis they’ve been transformed immensely by profit incentive.
'This drug is from the 1940s. We can make a better drug for this disease.'
He went on to say; 'We’re spending tens of millions of dollars to make a better version of Daraprim that is more effective, less toxic.
'Daraprim is a very toxic drug, and these patients deserve a drug company that is turning a profit - a fair profit - and is also developing a drug that is better for them. They don’t deserve a drug that is 70- years old. They deserve modern medicine that can cure toxoplasmosis quickly.'
Shkreli was raised in the Sheepshead Bay section of Brooklyn by immigrant, working class parents from Albania and Croatia, according to Bloomberg Business.
He went to Hunter College High school in Manhattan, a secondary school for gifted students, and recently presented his alma mater with a $1million donation. He graduated from Baruch Collge in 2005.
He was a college intern for Jim Cramer, the hedge fund manager and now host of CNBC’s Mad Money. But Cramer, tweeted 'I just kept hearing all day about some kid who was an intern at my old shop 15 years ago; I don’t even know him. Enough!'
When he faced outrage in September over the Darprim price hike, Shkreli responded to the backlash by Tweeting a link the lyrics to the Eminem song The Way I Am.
‘And it seems like the media immediately points a finger at me,’ he Tweeted. ‘So I point one back at em, but not the index or pinkie.’
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Douchebag
When Shkreli made headlines for the massive price change of Daraprim, media sites scoured the internet for information about the CEO’s past.
His OK Cupid account, which has since been deleted, reveals that he ‘started a drug company to find treatments for rare and severe diseases’.
He says on the profile that he couldn’t live without cats, music, family, time, hope and good food, adding that he spends a lot of time thinking about ‘human suffering’.
He claims on the page to have plenty of spare time and that he’s ‘excited to build a relationship and share my life with someone’.
Earlier this month, a woman claimed to have matched with Shkreli on Tinder and sparked a debate with the CEO over the dating app.
The woman, Eve Peyser, claimed she messaged Shkreli to find out ‘why he did what he did’ and ‘understand the stories that greedy people tell themselves so they can function in the world’.
Before founding Turing, Shkreli worked as a hedge funder who at one time was accused of trying to manipulate FDA regulations on drug companies whose stocks he was shorting, according to Gawker.
He worked with companies including Cramer, Berkowitz, & Co and Intrepid Capital Management before founding his own hedge fund when he was in his 20s.
He was once publicly scolded by Citizens for Responsibility and Ethics in Washington, after writing writing scathing blog posts about companies he was shorting, accusing them of having problems.
Without success, the group urged the Department of Justice to investigate Shkreli after accusing him of ‘spreading unfounded and inaccurate rumors about drugs owned by companies he was shorting’.
He was forced out of the last drug company he founded, Retrophin, which specialized in buying the rights to little-known drugs and increasing their prices.
They increased the price of a drug that treats a rare kidney disease by 2,000 per cent, according to Fusion.
Retrophin forced Shkreli out of the company and is now suing the former hedge funder for $65million, after accusations of looting the company.
According to the lawsuit, Shkreli’s former hedge fund, MSMB - another company he founded - was left ‘virtually bankrupt’ after Shkreli made a single trade with Merril Lynch in February 2011.
Shkreli allegedly used Retrophin’s funds to pay MSMB investors who had lost money in the trade, Retrophin’s board of directors claims.
‘Shkreli was the paradigm faithless servant,’ the complaint states. 'Shkreli used his control over Retrophin to enrich himself, and to pay off claims of MSMB investors (who he had defrauded).'
On the day the lawsuit was filed, Shkreli gave a shout out to Wu-Tang Clan in a Tweet, writing, ‘I am not the one to f*** with #wutang’.
Shkreli also engaged previously in a bizarre 'campaign of ‘harassment’ of a former employee of Retrophin and his immediate family, according to court documents.
Shkreli allegedly gained access to social media accounts belonging to that ex-employee, and contacted him and his relatives directly, including his teenage son and wife, as he accused the worker of defrauding the company.
