AstraZeneca Plunges After Setback in Crucial Lung-Cancer Drug Tria MYSTIC TRIAL By James Paton and Naomi Kresge July 27, 2017, 2:22 AM EDT July 27, 2017, 6:19 AM EDT Drug combination fails to meet key target in Mystic study Trial to continue testing for improving life expectancy AstraZeneca Plc plunged by a record after suffering a setback to its next-generation cancer medicine, hurting Chief Executive Officer Pascal Soriot’s ambition to join the league of the world’s five largest drugmakers.
A combination of two immuno-therapies -- part of a new class of drugs that activate the body’s defense system to attack tumors -- failed to do better than chemotherapy in checking the growth of lung tumors in some patients in the study dubbed Mystic, the U.K. drugmaker said in a statement on Thursday. The drugs were poised to generate more than $7 billion in sales by 2022, according to analysts’ estimates compiled by Bloomberg, and would have made the Imfinzi treatment into Astra’s best-selling medicine.
The failure calls into question Soriot’s ability to deliver on his growth strategy, put in place to keep the company independent when he rebuffed Pfizer Inc.’s $117 billion takeover bid three years ago, and may make the firm vulnerable again. Imfinzi is the cornerstone of Astra’s cancer-drugs portfolio and its success is vital for the drugmaker to meet Soriot’s goal of boosting revenue to $45 billion by 2023.
“Not everything has gone the way we’d like it to go,” Soriot told reporters on a call. He pointed to results due in the first half of next year from the study that will show whether Imfinzi alone or in combination with a drug known as tremelimumab can help improve life expectancy. “The most important result is still to come.”
Stock Plummets
Shares of Astra plummeted almost 17 percent, wiping out 10.8 billion pounds ($14.2 billion) in market value. The stock traded down to 42.79 pounds as of 10:42 a.m. in London trading. The stock had soared to a record last month in anticipation of the trial results, briefly climbing past the 55 pounds a share that Pfizer offered three years ago.
“This is obviously very bad news,” with the only hope now pegged to the overall survival results that are pending, said Rudi Van den Eynde, an Astra shareholder who manages the pharmaceutical and biotech strategies at Candriam Investors Group in Belgium. “They are now more vulnerable, but the bride is a bit less desirable also.’’
The Mystic study is a crucial test for Astra’s immuno-therapies in its race with rivals including Merck & Co., Roche Holding AG and Bristol-Myers Squibb Co. to dominate the market for cancer treatments. Deadly lung tumors have become a key battleground for drugmakers in the closely contested race to develop life-saving cancer therapies.
Last year, after Bristol-Myers unexpectedly lost its lead following the failure of a key study, Astra amended the design of its three-year study to improve Imfinzi’s odds. For Bristol-Myers, the failure of its Opdivo immuno-therapy in a clinical trial for lung cancer was in large part responsible for a quarter of its market value being wiped out from a year ago, and led to speculation about a potential sale of the company.
‘A Reversal’
The Mystic result “shows how volatile” the market for these treatments are, Roche’s Chief Executive Officer Severin Schwan told reporters in Basel on Thursday.
“One can see how quickly things develop,” Schwan said. “If you remember, it wasn’t too long ago that people were saying BMS would rule the immune therapy market with its drug. There’s been a reversal here.”
The disappointing results extend a tumultuous few weeks for Astra as speculation about Soriot’s future mounted following a media report that he’d accepted the top position at Teva Pharmaceutical Industries Ltd.
In a July 16 staff memo, the CEO urged employees to remain focused on the U.K. drugmaker’s goals and ignore rumors, though he refrained from directly addressing the Israeli publication’s article on his plans. Both companies have also officially declined to comment on the veracity of the report; an Astra spokeswoman would only say that Soriot would be speaking to investors and analysts as he normally does when Astra reports quarterly results.
“I’m not a quitter,” Soriot told reporters on Thursday, while again declining to answer specific questions on any discussions with Teva. “I’m proud to be the CEO of this company and I look forward to continuing on our journey ahead and continuing to lead the incredible team.”
Tough Goal
Meanwhile, Astra has already suffered one setback on its way to meeting its long-term revenue target, with heart pill Brilinta -- forecast by the company to generate $3.5 billion in sales by 2023 -- failing in two key studies last year.
The drugmaker separately posted an unexpected increase in second-quarter profit. Core earnings per share, a measure that excludes some costs, rose to 87 cents, the Cambridge, England-based drugmaker said Thursday in a statement. That beat the 80 cent-average estimate of analysts surveyed by Bloomberg. Sales fell 10 percent to $5.05 billion, and compared with the $5 billion estimate of analysts.
Astra and Merck also reached an agreement to develop and commercialize Lynparza for different types of cancer. Merck will pay the U.K. company as much as $8.5 billion. That includes $1.6 billion in an upfront payment, plus $750 million for license options and up to $6.15 billion if the drug achieves regulatory and sales milestones.
At the same time, Astra said its lung-cancer drug Tagrisso met the main goal of checking the growth of tumors in a late-stage study dubbed Flaura, giving it the potential to become the first line of treatment. The company said it will start talks with global health authorities on the data ahead of seeking regulatory approval.
In the Mystic study, the drug combination failed to demonstrate a significant improve in a measure called progression free survival in people whose tumors expressed the PD-L1 biomarker on 25 percent or more of their cancer cells.
maverick_1 Wednesday, 07/12/17 04:14:10 PM Re: None Post # 212350 of 212685 Go AZN/TEVA: CEO of AZN after arduous housecleaning not willing to wait for highly awaited Mystic trial results due shortly bolting for TEVA raises ominous signs for AZN IMHO:
DIFFERENT STROKES FOR DIFFERENT FOLKS ========================================================== My initial portents of this based on 40 yrs of analytical experience as a top tier stock analyst and a money manager with exposure to top performing hedge fund managers wasn't that off!: AND I don't specialize in AZN although I did own Big Rx's in the late '80s. "Why would he seriously consider and agree to what was reported in Tel Aviv's Calcalist!
However, in his soul searching and avoiding negative feedback of bolting to TEVA BEFORE Mystic Trial results, Pascal had to see this through for AZN. Pascal could still revive his agreement with TEVA depending on how he come to terms with his assessment of the Pro's/Con's.
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