PHARMACY

Perrigo gets FDA approval for generic KlorCon

BY David Salazar

DUBLIN — Perrigo on Wednesday announced that the Food and Drug Administration had approved the company’s generic KlorCon (potassium chloride) extended-release tablets. 
 
The drug, which is indicated to treat and prevent hypokalemia, or low potassium levels, will be available in 600- and 750-mg dosage strengths. Sales of the drug for the 12 months ending Sept. 15 were $81 million. 
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Diplomat to dispense cancer treatment Cotellic in combination with Zelboraf

BY Michael Johnsen

FLINT, Mich. – Diplomat Pharmacy announced Wednesday that it will dispense Cotellic (cobimetinib) in combination with the BRAF inhibitor Zelboraf (vemurafenib) to treat patients with advanced melanoma that is unresectable (cannot be removed by surgery) or metastatic (cancer that has spread from the primary site).
 
"We are excited to dispense this combination treatment for patients suffering from advanced melanoma," said Gary Kadlec, president of Diplomat. "Patients in search of a new treatment option have an opportunity to explore one, with a therapy that combines the advantages of these two medications for a lasting impact."
 
The combination of Cotellic with Zelboraf helps patients with previously untreated BRAF V600 mutation-positive advanced melanoma live a median of one year (12.3 months) without their disease worsening, compared to 7.2 months with Zelboraf alone.
 
Cotellic is designed to selectively block the activity of MEK, one of a series of enzymes that make up a signaling pathway that helps regulate cell division and survival. Zelboraf binds to and inhibits mutant forms of BRAF, another enzyme in the pathway, to interrupt abnormal signaling that can cause tumor growth.
 
Melanoma is less common, but more aggressive and deadlier than other forms of skin cancer. The BRAF gene is mutated in approximately half of all melanomas. According to the National Cancer Institute, an estimated 73,870 Americans will be diagnosed with melanoma this year and 9,940 will die from the disease.
 
Zelboraf was the first prescription treatment for patients with unresectable or metastatic melanoma with BRAF V600 mutation as detected by a validated test. Zelboraf is not indicated for use in patients with wild-type BRAF melanoma.
 
 
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Drastic price hikes spur policy investigations

BY Richard Monks

Valeant Pharmaceuticals’ decision to raise the prices on a handful of drugs it has acquired over the past few years has led federal lawmakers and the Department of Justice to demand that the company explain its pricing policy.

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In October, Valeant acknowledged receiving subpoenas from federal prosecutors in New York and Massachusetts seeking information on its pricing, distribution and patient assistance policies.

The Department of Justice’s request followed a similar appeal in September by the 18 democrats on the House Committee on Oversight and Government Reform who have asked committee chairman Rep. Jason Chaffetz (R-Utah) to subpoena Valeant to turn over documents explaining the price hikes and have its CEO Michael Pearson testify before the committee.

Earlier in September, the company refused to comply with a request by Rep. Elijah Cummings (D-Md.) and Sen. Bernie Sanders (I-Vt.) to explain why it raised the price of two heart medica tions by several hundred percent immediately after acquiring the rights to them in April.

Valeant has said the requested information is “highly proprietary and confidential.”

Critics contended that Valeant is taking advantage of the fact that most of its drugs do not have generic equivalents and are among the few options available to patients. Since July 2014, the price of Valeant’s blood-clotting drug Mephyton has been increased eight times, and now costs about $58.76 a tablet, up from $9.37. The price of another Valeant drug, the diuretic Edecrin, has gone up nine times since May 2014, rising from about $470 per vial to $4,600 a vial. This summer it increased the price of Cuprimine — a drug used to treat Wilson disease, an inherited disorder that can cause severe liver and nerve damage — to $260 a tablet, more than four times what it cost previously. While no generic equivalent of the drug is available in the United States, generic Cuprimine sells in pharmacies outside the United States for about $1 per pill.

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