PHARMACY

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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Investors, limited window put merger pressure on generic drug makers

BY Richard Monks

A merger frenzy has hit the generics sector this year with a spate of acquisitions and hostile-takeover bids making headlines and reshaping the industry.

Analysts and those who closely follow the pharmaceutical business said the rush to make deals is coming from a combination of investor pressure and a narrowing window of opportunity for generic drug makers to expand their operations.

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An increasing number of drug makers, they said, view acquisitions as the only way to keep their revenues growing as fast as investors expect. In addition, they noted that the changing nature of the industry — where medications are becoming more complex and research and development costs continue to rise — makes it less expensive for a company to acquire another supplier’s portfolio than to develop new drugs in-house.

In addition, they said current low interest rates make capital cheap and allow companies to fund their acquisitions with debt. With rates likely to go up soon, generics companies are facing a limited window of opportunity to make a deal.

Consolidation has reduced competition among generics suppliers, and many said it has become a main factor behind the rising prices that have plagued the industry over the past year. By reducing the field of competitors, generics companies are in better position to negotiate prices for drugs with pharmacy benefit managers, public and private insurers, and patients.

One of the year’s first mergers came in May when Endo Inter national agreed to acquire Par Pharmaceutical for slightly more than $8 billion. The deal, which is expected to close shortly, will add Par’s high-barrier-to-entry generics, niche brands and branded and generic aseptic injectables to Endo’s portfolio. In late September, Endo agreed to sell two generic drugs to Rising Pharmaceuticals to satisfy antitrust concerns.

However, no generics manufacturer has garnered so much attention this year from regulators and investors as Teva Pharmaceutical Industries. In March, the Jerusalem-based company agreed to pay $3.2 billion to acquire Auspex Pharmaceuticals, a La Jolla, Calif.-based company that, while it has not yet brought any products to market, is developing several drugs that focus on the central nervous system to treat such disorders as Huntington’s disease, tardive dyskinesia and Tourette syndrome.

Then in July, after its hostile takeover attempt was rebuffed by My-lan, Teva reached a deal to acquire Allergan‘s generics business for $40.5 billion.

More recently, Teva acquired the Mexican drug maker Representaciones e Investigaciones Médicas, S.A. de C.V. and Gecko Health Innovations, a company that is focused on developing software and product solutions to simplify chronic respiratory disease management.

Meanwhile, by refusing to accept Teva’s $40 billion offer, Mylan was able to continue with an unsolicited bid it made in April to acquire Perrigo. After its original $29 billion offer, Mylan has extended three consecutively higher bids, with each offer being deemed undervalued by the Perrigo management. In September, the companies brought legal action against each other.

While Wall Street’s reaction has been mixed to the proposed deal, at least one analyst recently expressed deep reservations about a Mylan-Perrigo merger.

“The more we look at the Mylan-Perrigo transaction, the less we like it,” Sanford C. Bernstein & Co.’s Ronny Gal wrote in a letter to investors in October, noting that he is “increasingly seeing challenges on the horizon for some of the Perrigo businesses, which lead us to question the [merger’s] rationale.”

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