Mystic Healthcare & Rehabilitation Center LLC

August 1, 2017 By Alex Keown , BioSpace.com Breaking News Staff LONDON –With AstraZeneca reeling from the failure of its critical Phase III Mystic lung cancer trial and recently-quelled rumors of company chief Pascal Soriot , some companies may think it’s time to snap up the company. But, that might be harder to accomplish, analysts suggest. It was only three years ago that AstraZeneca and Soriot fended off pharma giant Pfizer and its $119 billion offer. Even though AstraZeneca is seen by many to be in a weak position now, it’s unlikely that Pfizer will look to open its wallet for the U.K.-based company. Nor are companies such as Novartis , Sanofi and GlaxoSmithKline looking to make such a big acquisition, Reuters noted this morning. Citing an unnamed banking source, the industry is unlikely to see any “mega-mergers” this year, at least until there is greater certainty on how the U.S. Congress will amend the federal tax code. The banking source, Reuters reported, said the pharma industry is in a “wait and see” mode right now when it comes to large-scale M&A. Some companies may want to make a bid for AstraZeneca to gain access to its pipeline of oncology drugs such as Imfinzi, Tagrisso or acalabrutinib, but, Reuters pointed out that Pfizer is the key to whether or not any company will actually make a move on AstraZeneca. One unnamed banker the news agency spoke with said companies that may be eying AstraZeneca will wait to see what Pfizer does next as far as M&A goes. “Pfizer has taken a break on M&A for now and no-one expects them to make another move for AstraZeneca. But M&A is like a game of chess and nobody will go after AstraZeneca until Pfizer picks its next target,” the unnamed banker told Reuters . Pfizer may make a move soon though. The company missed its revenue predictions for the quarter. Sales were negatively impacted by falling demand for its older drugs. The company also said its pneumonia vaccine Prevnar saw sales drop by 8 percent during the quarter. In early May, analysts were suggesting that Pfizer needed to make another big acquisition in order to spur growth . It’s also unlikely that GSK will actually make a play for AstraZeneca. Last week, Emma Walmsley , GSK’s chief executive officer, streamlined the company’s developmental programs by killing more than 30 preclinical and clinical programs. Additionally, Walmsley announced the company was going to allocate 80 percent of its research-and-development budget to respiratory and HIV/infectious diseases. There are also some additional political concerns in the United Kingdom. Lawmakers in that country are concerned about what an acquisition of a large company like AstraZeneca could do to British employment. They are concerned about large-scale job losses, Reuters said. Soriot told Reuters that it’s common for takeover talk to occur after a company sees a notable trial failure. But, he also said that if Mystic had hit its endpoints, then analysts would also speculate whether or not the company was in play due to the potential revenue streams. “Any company that has a very good pipeline, like we do, is of course attractive. But if Mystic was positive, I’m sure you’d be asking me the same question,” Soriot told Reuters . While AstraZeneca hit a big snag with Mystic, the company has seen some positive news snagging two Breakthrough Therapy Designations from the U.S. Food and Drug Administration this week, an announcement that its EGFR tyrosine kinase inhibitor Tagrisso met Phase III endpoints in a lung cancer trial. Additionally the company struck a deal worth up to $8.5 billion with Merck to collaborate on combining AstraZeneca’s PARP inhibitor Lynparza with Merck’s PD-1 inhibitor Keytruda to test against multiple cancer types.

July 31, 2017 By Alex Keown , BioSpace.com Breaking News Staff WASHINGTON – After a tough week, London-based AstraZeneca received some good news. This morning, the company announced the U.S. Food and Drug Administration awarded Imfinzi (duravulumab) the Breakthrough Therapy Designation for treatment of some lung cancer patients. Imfinzi, a PD-L1 inhibitor, received the designation for patients with locally-advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy. The FDA’s Breakthrough Therapy Designation is designed to expedite the development and regulatory review of new medicines that are intended to treat a serious condition and that have shown encouraging early clinical results. The FDA granted the designation following the announcement of interim results from its Phase III Pacific Trial in May. Interim results from the trial showed that Imfinzi had already met its primary endpoint, which was statistically significant and clinically meaningful progression-free survival (PFS). It also showed a favorable benefit/risk profile. AstraZeneca and MedImmune , its biologics research and development arm, are still awaiting results on overall survival. Sean Bohen , AstraZeneca’s chief medical officer, touted the FDA’s decision. In a statement this morning, he said Imfinzi, if approved for this lung cancer designation, will provide a needed treatment option. The current standard of care is chemotherapy and radiation followed by active surveillance to monitor for progression. The prognosis remains poor and long-term survival rates are low. “For patients who have not progressed following chemoradiation therapy the only current option is active monitoring. Unfortunately, for the majority of patients, their cancer will progress to metastatic disease, typically within 12 months. Imfinzi is the first immuno-oncology medicine to show a clinically-significant benefit in this earlier, non-metastatic setting, so following the Breakthrough Designation we hope to bring it to patients as soon as possible,” Bohen said in a statement. Imfinzi has previously received accelerated approval from the FDA for the treatment of advanced bladder cancer. The FDA’s decision somewhat softens the blow that AstraZeneca took last week after the company announced that Imfinzi in combination with tremelimumab, a CTLA-4 inhibitor, failed to meet endpoints in the highly critical Phase III Mystic trial. AstraZeneca said the Mystic trial did not meet its primary endpoint in progression free survival in patients whose tumors express PD-L1 on 25 percent or more of their cancer cells. Adding insult to injury, AstraZeneca said that although it was not formally tested, Imfinzi as a monotherapy would also have failed to meet a pre-specified threshold of progression free survival over standard of care in the same disease setting. Not only did AstraZeneca deal with the fallout from the Mystic trial, the company was also plagued by rumors its CEO Pascal Soriot was abandoning ship for Israel-based Teva Pharmaceuticals . The company ultimately denied the rumors, but only after taking several days to do so, costing it about $4 billion in market value as investors dumped shares of company stock. Investors are reacting positively to the FDA’s designation for Imfinzi. This morning, shares are up slightly, trading at $30.68 as of 10:12 a.m. Last week shares fell to a six-month low of $28.53 following the announcement of the Mystic failure.