FOSTER CITY, Calif. – The departure of a top oncology scientist at Gilead Sciences (GILD) may have been a precursor to the company’s troubles its cancer drug Zydelig has seen in recent clinical trials.
Former Genentech (RHHBY) scientist Philippe Bishop, who was tapped to lead clinical development of Gilead's cancer drug pipeline, left the company in February, The Street’s Adam Feuerstein reported. Shortly after his departure from the company, Gilead halted six trials studying Zydelig in combination with other drugs for cancer treatments following reported concerns of adverse effects and deaths. Gilead told Feuerstein the departure of Bishop, who joined the company in 2014, was not related to the trials, but the two events coming so close together might be enough of a flag for investors concerned about the company’s oncology pipeline. Gilead did not release details of Bishop’s departure, but Norbert Bischofberger, Gilead’s chief science officer told Feuerstein that the two mutually “came to the conclusion it was best he depart.”
Zydelig gained regulatory approval in the United States in 2014 for three blood cancers—for relapsed chronic lymphocytic leukemia in combination with Roche (RHHBY)'s Rituxan (rituximab); to treat patients with relapsed follicular B-cell non-Hodgkin lymphoma; and relapsed small lymphocytic lymphoma. In Europe, Zydelig for the treatment of chronic lymphocytic leukemia in combination with Rituxan. It is approved on its own for treating follicular lymphoma, a type of non-Hodgkin lymphoma. Zydelig generated $132 million in revenue during its first full year on the market, the San Francisco Business Times said.
Gilead received a warning from the European Medicines Agency last week following reports of harmful side effects and infections in three clinical trials where Gilead’s drug was being used in combination with other cancer therapies. The clinical trials involved patients with chronic lymphocytic leukemia and indolent non-Hodgkin lymphoma. However, the study in chronic lymphocytic leukemia investigated combinations of medicines are currently not approved, the European Medicines Agency said on Friday.
In the United States, Zydelig carries a Boxed Warning regarding serious and fatal toxicities including liver toxicity, diarrhea and colon inflammation (colitis), lung inflammation (pneumonitis) and intestinal perforation, the FDA said when it approved the drug.
Zydelig’s approval came on the heels of other CLL treatments, including Roche’s Gazyva, a follow-up drug to Rituxan, and Imbruvica, the blockbuster treatment from AbbVie (ABBV) and Johnson & Johnson (JNJ). Imbruvica, which has estimated sales of $11 billion, was recently granted FDA approval for front-line use against CLL, which makes it the first “chemotherapy-free option for patients suffering from the disease,” Bidnessetc noted earlier this week.
With the halting of the Zydelig trials, the question now is how will Gilead, known for its blockbuster hepatitis treatments, proceed with its oncology programs? Bischofberger told The Street’s Feuerstein he has confidence in the company’s developmental oncology pipeline, but has not ruled out striking a deal to acquire a cancer treatment. Bischofberger did say the company was likely to avoid exploring the development of immuno-oncology targets like the PD-1 checkpoint inhibitors.
"Strategically, what we want to do, instead, is to ask the question: What is it about the 70 percent to 80 percent of people that don't have a response to anti-PD1 therapy," Bischofberger told The Street. "We're absolutely very interested in immuno-oncology but only if it is a truly differentiated compound from what is on the market or in late-stage clinical studies."
With Bishop’s departure, Gilead will also have to determine who will lead the oncology development. Right now John McHutchison, executive vice president of clinical research, is in charge of the cancer pipeline while the company searches for a replacement, a Gilead spokesperson told Feuerstein.
Gilead’s stock is down this morning, trading at $89.74 per share as of this writing. Following this morning’s opening, the stock jumped to $90.19 per share, before slipping. Since a December high of $103.78 per share, Gilead’s stock has been on a steady decline.
Former Genentech (RHHBY) scientist Philippe Bishop, who was tapped to lead clinical development of Gilead's cancer drug pipeline, left the company in February, The Street’s Adam Feuerstein reported. Shortly after his departure from the company, Gilead halted six trials studying Zydelig in combination with other drugs for cancer treatments following reported concerns of adverse effects and deaths. Gilead told Feuerstein the departure of Bishop, who joined the company in 2014, was not related to the trials, but the two events coming so close together might be enough of a flag for investors concerned about the company’s oncology pipeline. Gilead did not release details of Bishop’s departure, but Norbert Bischofberger, Gilead’s chief science officer told Feuerstein that the two mutually “came to the conclusion it was best he depart.”
Zydelig gained regulatory approval in the United States in 2014 for three blood cancers—for relapsed chronic lymphocytic leukemia in combination with Roche (RHHBY)'s Rituxan (rituximab); to treat patients with relapsed follicular B-cell non-Hodgkin lymphoma; and relapsed small lymphocytic lymphoma. In Europe, Zydelig for the treatment of chronic lymphocytic leukemia in combination with Rituxan. It is approved on its own for treating follicular lymphoma, a type of non-Hodgkin lymphoma. Zydelig generated $132 million in revenue during its first full year on the market, the San Francisco Business Times said.
Gilead received a warning from the European Medicines Agency last week following reports of harmful side effects and infections in three clinical trials where Gilead’s drug was being used in combination with other cancer therapies. The clinical trials involved patients with chronic lymphocytic leukemia and indolent non-Hodgkin lymphoma. However, the study in chronic lymphocytic leukemia investigated combinations of medicines are currently not approved, the European Medicines Agency said on Friday.
In the United States, Zydelig carries a Boxed Warning regarding serious and fatal toxicities including liver toxicity, diarrhea and colon inflammation (colitis), lung inflammation (pneumonitis) and intestinal perforation, the FDA said when it approved the drug.
Zydelig’s approval came on the heels of other CLL treatments, including Roche’s Gazyva, a follow-up drug to Rituxan, and Imbruvica, the blockbuster treatment from AbbVie (ABBV) and Johnson & Johnson (JNJ). Imbruvica, which has estimated sales of $11 billion, was recently granted FDA approval for front-line use against CLL, which makes it the first “chemotherapy-free option for patients suffering from the disease,” Bidnessetc noted earlier this week.
With the halting of the Zydelig trials, the question now is how will Gilead, known for its blockbuster hepatitis treatments, proceed with its oncology programs? Bischofberger told The Street’s Feuerstein he has confidence in the company’s developmental oncology pipeline, but has not ruled out striking a deal to acquire a cancer treatment. Bischofberger did say the company was likely to avoid exploring the development of immuno-oncology targets like the PD-1 checkpoint inhibitors.
"Strategically, what we want to do, instead, is to ask the question: What is it about the 70 percent to 80 percent of people that don't have a response to anti-PD1 therapy," Bischofberger told The Street. "We're absolutely very interested in immuno-oncology but only if it is a truly differentiated compound from what is on the market or in late-stage clinical studies."
With Bishop’s departure, Gilead will also have to determine who will lead the oncology development. Right now John McHutchison, executive vice president of clinical research, is in charge of the cancer pipeline while the company searches for a replacement, a Gilead spokesperson told Feuerstein.
Gilead’s stock is down this morning, trading at $89.74 per share as of this writing. Following this morning’s opening, the stock jumped to $90.19 per share, before slipping. Since a December high of $103.78 per share, Gilead’s stock has been on a steady decline.
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