September 23, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Analysts are noting that Amgen , in addition working to revitalize its oncology medicine pipeline, is pushing hard into the cardiac medicine arena.
Amgen, headquartered in Thousand Oaks, Calif., announced Friday that the U.S. Food and Drug Administration (FDA) had accepted the company’s supplemental New Drug Application (sDNA) for Kyprolis (carfilzomib) for Injection for patients with relapsed myeloma. It had also recently received approval for Kyprolis in combination with Revlimid (lenalidomide) and dexamethasone in relapsed multiple myeloma.
That’s a good thing, because the company’s older blockbuster drugs, Neulasta, Neupogen and Epotin Alfa are facing patent expirations. Those drugs made up $7.8 billion of the company’s revenue in 2014, approximately 40 percent. It’s also facing significant competition now and in the future from biosimilars and generics. A prime example is Novartis AG ADR’s Sandoz launching a biosimilar to Neupogen called Zarxio.
But it is also making forays into cardiac care. On Sept. 16, Amgen announced it planned to acquire Naaarden, Netherlands-based Dezima Pharma B.V., a privately-held company focused on treatments for dyslipidemia.
“With the recent launches of Repatha (evolocumab) and Corlanor (ivabradine), and today’s acquisition of Dezima, Amgen is proud to be on the leading edge of an exciting new wave of treatments for cardiovascular disease, an illness impacting millions of people worldwide,” said Robert Bradway, chairman and chief executive officer of Amgen in a statement.
The Dezima deal was for $300 million in cash up front and up to $1.5 billion or more in royalties. Perhaps more importantly, it acquired TA-8995, a drug to treat high cholesterol.
The recently approved Repatha is to be used for a rare form of high cholesterol related to specific genetic mutations, or in patients who have already had a stroke or other cardiovascular event. Although yet to be approved for broader usage, many analysts think it might be in the future. The drug is currently priced at $14,100.
The company is now conducting a cardiovascular outcomes trial of Repatha with data expected in 2017. If the data is positive, then Repatha could be prescribed for a much bigger patient population. It’s unclear if patients would want to come in for an injection over taking a daily pill or if payers would view the high price as being worth whatever improvements patients would likely receive from current lower-priced statins and lifestyle improvements like diet and exercise.
Repatha is an injectable medication, taken every two weeks or monthly. TA-8995 is an oral medication taken once a day that is designed to improve good cholesterol and decrease so-called bad cholesterol. The experimental drug cut low-density lipoprotein cholesterol (LDL-C) by 45 to 48 percent compared to baseline in a Phase IIB clinical trial.
“TA-8995 has demonstrated dramatic LDL-C lowering,” said Sean Harper, Amgen executive vice president of research and development, in a statement. “With a portfolio of TA-8995 and Repatha, our recently launched LDL-C lowering PCSK9 inhibitor, we will be able to offer more treatment options with different mechanisms of action and modes of administration across varying LDL-C levels and risk profiles.”
Will the Presidential Election Change the Face of the Way Prescription Drugs are Sold in the United States?
Although Turing Pharmaceuticals announced it will revise its 5,000 percent increase of a newly acquired drug to treat toxoplasmosis, the move sparked a public outcry that resulted in one presidential candidate calling for price caps on prescription medication.
In August, Turing Pharmaceuticals acquired toxoplasmosis drug Daraprim from Impax Laboratories and increased the price of the medication from $13.50 per tablet to $750 per tablet, a 5,000 percent increase. Turing Chief Executive Officer Martin Shkreli defended the increase, saying the revenues would be used to subsidize new research into treatments for toxoplasmosis. Has since said the company will reduce the price, but did not specify what the price would be.
Democratic presidential candidate Hillary Clinton said if elected she would cap monthly out-of-pocket costs for prescription drugs at $250 to avoid “price gouging.” Her comment sent the stock market into a state of flux, with several large companies seeing a drop in their stock of up to 10 percent. The Nasdaq Biotechnology Index dropped 4.4 percent and the SPDR S&P Biotech ETF dropped by 6 percent.
BioSpace wants to know what you think: Will the presidential election change the face of the way prescription drugs are sold in the United States?
