September 23, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Thousand Oaks, Calif.-based Amgen and Dublin, Ireland-based Allergan plc announced positive results today for a Phase III study on non-squamous cell lung cancer (NSCLC).
The two companies studied the efficacy and safety of ABP 215 compared to Avastin (bevacizumab) in adults with NSCLC. The primary endpoint, an assessment of objective response rates (ORR), was within guidelines, and safety and immunogenicity were comparable to bevacizumab.
ABP 215 is a biosimilar to bevacizumab. The drugs work by binding to vascular endothelial growth factor (VEGF) and inhibiting the interaction of VEGF with two receptors, VEGF receptor-1 and -2, which slows down or prevents the growth of new blood vessels to solid tumors.
“Amgen is committed to bringing high-quality, reliably supplied medicine to patients and we’re excited to leverage our development and manufacturing capabilities in oncology for our biosimilars. The positive Phase III results from ABP 215 study showed clinical equivalence in efficacy, and comparable safety and immunogenicity, to bevacizumab,” said Sean Harper, executive vice president of research and development at Amgen in a statement. “Non-small cell lung cancer is the leading cause of cancer death in both men and women in the U.S. and the EU. ABP 215 holds the potential to advance access to treatment options for oncology patients.”
The two companies formed a collaboration in December 2011 to develop and commercialize four cancer antibody biosimilar drugs. Biosimilars were made possible by the passing of The Patient Protection and Affordable Care Act (ACA), which amended the Public Health Serviced Act (PHS Act), creating an abbreviated licensure pathway for biosimilars. Biosimilars are defined as being biosimilar or interchangeable with FDA-licensed biological products.
There is perhaps some irony in Amgen developing biosimilars, in that the company is facing stiff competition from generic and biosimilar drugs to their own blockbuster products, many of which are facing patent expiration. Novartis AG ADR’s Sandoz has launched a biosimilar to Amgen’s Neupogen called Zarxio.
After a bitter lawsuit between Novartis and Amgen, a federal appeals court ruled in July that Novartis’s Sandoz could start selling Zarxio on Sept. 2. Biosimilars, reported the Wall Street Journal, are estimated to save approximately $44 billion in U.S. health care costs over the next decade. A big part of the lawsuit revolved around whether Sandoz had to give Amgen a complete copy of its biosimilar application. Sandoz filed with the FDA, but by law it is supposed to supply the application to the company its biosimilar is copying. This application begins what is dubbed a “patent dance,” which is an opportunity for the originating company to review the drug application and evaluate which of its patents might be violated and where litigation might focus.
Neupogen is one of three of Amgen’s biggest drugs, including Neulasta and Epotin Alfa. In 2014, those three drugs accounted for almost 40 percent of company revenue, making up a total of $7.8 billion in sales.
Amgen is currently pushing to expand its oncology drug pipeline, while simultaneously working to enter the cholesterol and cardiovascular drug market. On Sept. 16, Amgen announced it planned to acquire Naarden, Netherlands-based Dezima Pharma B.V., a privately-held company focused on treatments for dyslipidemia. As part of the Dezima deal, Amgen 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 2016. 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.
In this new study, Amgen and Allergen show that their biosimilar drug is as effective as Roche AG’s Avastin in lung cancer. Avastin brought in $6.5 billion in sales last year. It is reported to have another eight biosimilars in development.
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?
