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2 High-Risk Biotechs Ready to Rock—Maybe
8/30/2016 6:42:32 AM
2 High-Risk Biotechs Ready to Rock—Maybe August 30, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Biotech companies are generally known for cutting-edge technology, incredibly high burn rates, long timelines, and volatile stocks. They are very high-risk-high-reward stock investments. Todd Campbell, writing for The Motley Fool, takes a look at two biotech companies with late-stage clinical programs that if they pan out, would be well worth the risky investment.
Headquartered in Mechelen, Belgium, Galapagos NV (GLPG) is making headway in two specific areas: cystic fibrosis and rheumatoid arthritis. At the company’s recent second-quarter filing, Onno van de Stolpe, the company’s chief executive officer said in a statement, “The main focus of the investors has been on our cystic fibrosis and filgotinib programs. We are pleased with the successful outcome of the RA discussions between Gilead (GILD) and the regulatory authorities. We expect to have filgotinib in two Phase III studies and one Phase II/III study before year end, which is a hallmark for Galapago. In cystic fibrosis we are on track to nominate the triple combo therapy with the aim to start treating class II patients in clinical trials in 2017.”
As part of Galapagos’ deal with AbbVie (ABBV) for CF, it’s eligible for up to $600 million in milestone payments. The two companies would split profits down the middle in co-promotion territories. Galapagos will also get royalties in other territories that range from the mid-teens to 20 percent. Data on the Phase II trial of GLPG 1837 is due later this year.
On the filgotinib deal with Gilead Sciences (GILD), Galapagos received $725 million upfront. $425 million of that gave Gilead a 15 percent stake in the company. If the drug is approved, they will split profits 50/50 in co-promotion territories. Galapagos is eligible to get 20 percent or more royalties in other territories.
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Kite Pharma (KITE), headquartered in Santa Monica, California, is focused on immuno-oncology, specifically on engineering T cells to target cancer cells. The company currently has a mid-stage clinical trial of KTE-C19 in blood cancer, and is expected data by the end of the year.
Campbell writes, “Although cancer trials are notorious for disappointing investors, evidence suggests KTE-C19 may be the exception. In June, Kite Pharma updated investors on Phase I results of KTE-C19 in DLBCL. After receiving one single treatment of KTE-C19, there were three complete remissions at the nine-month mark in patients who were refractory to chemotherapy. Overall, the objective respond rate was 71 percent in the seven-person study.”
Kite, which is worth around $3.1 billion, has been cited as a potential acquisition target for Gilead Sciences (GILD).
At the company’s August 8 second-quarter financial filing, it indicated it had finished enrollment for it Phase II trial of ZUMA-1, a study of engineered T-cells in chemorefractory CLBCL patients. In addition, KTE-C19 was allowed access to the Priority Medicines (PRIME) regulatory initiative from the European Medicines Agency (EMA), and provided data at the June 2016 annual meeting of the American Society of Clinical Oncology (ASCO) on KTE-C19 that showed promise.
“During the second quarter we continued to expand our pipeline, broaden our engineered cell therapy capabilities through access to key enabling technologies, and advance the development of KTE-C19 as a potential first-to-market breakthrough immunotherapy for patients with advanced non-Hodgkin lymphoma (NHL),” said Arie Belldegrun, Kite’s chairman, president and chief executive officer, in a statement. “We have enrolled all 72 chemorefractory diffuse large B-cell lymphoma (CLBCL) patients in the pivotal portion of our ZUMA-1 study, and Kite remains on track to announce interim data from approximately 50 of these patients at three-month follow-up later this quarter. Subject to these interim results and discussions with the FDA, we expect to submit a Biologics License Application (BLA) for KTE-C19 by the end of 2016.”
Read at BioSpace.com