[Corrected 8/14/14, 8:11pm. See below.] When Amgen (NASDAQ: [[ticker:AMGN]]) bought South San Francisco-based Onyx Pharmaceuticals last year for $10.4 billion, it expected great things from Onyx’s multiple myeloma treatment carfilzomib (Kyprolis), which won its first approval in 2012 in a limited patient population.
Those expectations went a bit sideways this week, as Amgen said late Wednesday that carfilzomib did not meaningfully extend the lives of patients whose multiple myeloma was in advanced stages and not responsive to other treatments. It was a Phase 3 trial with 315 patients that Amgen hoped would pave the way for the use of carfilzomib as a single agent outside the U.S. It has not been approved outside the U.S., but has the green light in the U.S. as a single agent for patients who have failed at least two other kinds of myeloma treatments. [An earlier version of this story incorrectly described carfilzomib’s approved method of use. We regret the error.]
However, Amgen says it’s still confident asking regulators to approve carfilzomib in Europe and other places where it hasn’t gotten the nod yet, because a different Phase 3 trial using the drug in a combination therapy yielded positive results last week. That trial, dubbed ASPIRE, treated nearly 800 patients with a combination of carfilzomib and two other drugs and kept patients’ myeloma at bay longer than a two-drug combo without carfilzomib. “[W]e believe the results from ASPIRE will be sufficient to support regulatory submissions around the world,” Onyx president Pablo Cagnoni said in a statement. Cagnoni, who took over from Onyx CEO Tony Coles after the Amgen deal, runs Onyx as an Amgen subsidiary with its own business model, according to this report.
Other news from the coast this week included a big IPO, more bad news for Dendreon (and its investors), a few more drips of information about Google’s Calico startup, and practically next door to Onyx, another clinical setback from fellow South San Franciscans Rigel. Let’s get to the roundup.
—Beleaguered Seattle biotech Dendreon (NASDAQ: [[ticker:DNDN]]) said Monday it isn’t likely to repay $620 million in debt due in 2016, which it warned could strip current shareholders of their ownership. The warning was tucked into the company’s quarterly report. Shares closed Wednesday at $1.42 a piece, down about 33 percent from their position before the debt situation was revealed. Sales of its prostate cancer treatment sipuleucel-T (Provenge) were up 12 percent year over year to $82 million for the quarter.
—-San Diego-based biotech Otonomy (NASDAQ: [[ticker:OTIC]]), developing treatments for the inner and middle ear, raised $100 million in an upsized initial public offering Tuesday. The company priced 6.25 million shares at $16 each, which was the high end of Otonomy’s estimate, and sold 1 million more shares than expected. The company plans to use the proceeds to seek regulatory approval for its lead drug candidate, a sustained-release form of the antibiotic ciprofloxacin intended to reduce infections in children undergoing ear tube placement surgery.
—Rigel Pharmaceuticals (NASDAQ: [[ticker:RIGL]]) said Wednesday its dry eye treatment R348 failed in a Phase 2 study, sending its share price down more than 13 percent. The South San Francisco, CA-based biotech’s stock ended the day at $2.67 a share and continued to fall Thursday morning. The treatment did not cause any serious side effects, and Rigel will continue to test it against dry eye in patients with graft-versus-host disease. Rigel also said it would stop a Phase 1 test of another drug, R118, in patients with a type of muscle pain caused by peripheral arterial disease, because of side effects.
—The press caught wind this week of the new website for Calico (short for California Life Company), an anti-aging startup bankrolled by the venture arm of tech giant Google (NASDAQ: [[ticker:GOOG]]). The website shows the top executives at Calico, some of whom were announced when it launched in September, and it gives a few general descriptions of Calico’s mission, but not much else. Since its unveiling last year, the company has brought on Bob Cohen, a former oncology fellow at Genentech, and Jonathan Lewis, who will run business development after doing the same at Belgian biopharma UCB and, before that, holding top BD jobs at Roche and Genentech.
—The Scripps Research Institute of San Diego named biochemist James Paulson as acting president and CEO while trustees conduct a nationwide search for a new president. Paulson, chairman of the institute’s department of cell and molecular biology, is taking the helm from Michael Marletta, who left the institute following an uproar after revelations that he proposed
