ASCO15: Exelixis Results for Drug Combo Buoy the Flailing SF Biotech
Published: Jun 01, 2015
June 1, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
South San Francisco, Calif.-based Exelixis, Inc. is clawing its way back up after a brutal 2014, reporting promising data today from a Phase II clinical trial of its lung cancer drug cabozantinib. That news came hot on the heels of another announcement this weekend at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago that it has seen encouraging results for a separate cancer drug it owns.
The flailing biotech saw setback after setback in 2014, barely keeping its head above water after a 160 people, a major reversal from its heyday in 2009, when the firm had over 750. It also had to abandon almost 20,000 square feet of its office space in South San Francisco, vacating a 215,000-square-foot complex on Grand Avenue.
Now, however, Exelixis appears to be gaining some ground back.
“The updated results for the combination of cobimetinib and vemurafenib, including a median progression-free survival of one year in patients with previously untreated BRAF V600 mutation-positive advanced melanoma, are encouraging,” said Michael M. Morrissey, president and chief executive officer of Exelixis, in a statment. “The data underscore the potential for the combination to become a meaningful new treatment option for patients with this type of melanoma. We congratulate Genentech and Roche on two well-run trials, and we look forward to working with them to bring the combination to physicians and patients in the event of potential regulatory approval later this year.”
The ASCO report showed promising data from two trials of cobimetinib in combination with vemurafenib for the treatment of advanced melanoma. Its Phase III pivotal trial was conducted by Genentech (RHHBY) in collaboration with Exelixis. BioSpace recently spoke to Genentech in an exclusive news interview, in which a Genentech exec said the drug also shows promise as a melanoma treatment.
That upbeat news was part of a study, E1512, that examined cabozantinib and erlotinib, alone or in combination, as a potential treatment for EGFR wild-type non-small cell lung cancer (NSCLC) and met its primary endpoint, with a significant increase in progression-free survival (PFS).
Exelixis also said yesterday that it had positive results from a two-stage Phase II investigator-sponsored trial (IST) that evaluated cabozantinib in patients with advanced RET-rearranged lung cancers. Although still in progress, the study already met its primary endpoint and exceeded the predefined targeted number of five objective responses.
“The updated results for the combination of cobimetinib and vemurafenib, including a median progression-free survival of one year in patients with previously untreated BRAF V600 mutation-positive advanced melanoma, are encouraging,” Morrissey said in a statement. “The data underscore the potential for the combination to become a meaningful new treatment option for patients with this type of melanoma.”
On August 11, the U.S. Food and Drug Administration (FDA) will rule on cobimetinib, in combination with a Roche drug, vemurafinib (Zelboraf) for a subset of metastatic melanoma. If the drug combination is approved, Exelixis and Roche will share profits.
Still, money remains an issue for the company. Exelixis currently only has a single product on the market, cabozantinib, which it sells for the treatment of a rare form of thyroid cancer. So far, it’s been a disappointment, bringing in only $40 million in revenue in the last two years—not much incoming cash flow to offset the firm’s $500 million in debt.
Will PfizerKline Become the Next Pharma Player?
The speculation surrounding a possible bid from Pfizer Inc. for struggling GlaxoSmithKline is heating up, after one closely-watched biotech analyst said in a note last week that Pfizer buying the company would “unlock access to its balance sheet and improve its tax situation.”
Gregg Gilbert, a biotech analyst at Deutsche Bank, wrote in a note to investors “Introducing PfizerKline” that he thinks a deal would be “materially accretive” for both companies. Gilbert estimated that a bid priced at $29.86 a share, via half stock and half cash, which would push up Pfizer’s earnings per share by 10 percent to 16 percent beginning in 2016.
“We believe that the company has a sense of urgency to create value by leveraging the power of its balance sheet to do needle-moving deals,” Gilbert wrote. “Since media reports in the past have pointed to the potential for a Pfizer/GSK combination, we are revisiting that theme.”
We want to know, dear readers, if you agree? Should Glaxo continue going it alone, or might Pfizer buy it and create one of the world’s largest pharma players in history?