The Zacks Analyst Blog Highlights: Bristol Myers, Merck, Roche, Lilly And AstraZeneca

For Immediate Release

Chicago, IL –June 10, 2019 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Bristol Myers (NYSE:BMY) , Merck (NYSE:MRK) , Roche (OTC:RHHBY) , Lilly (NYSE:LLY) and AstraZeneca (NYSE:AZN) .

Here are highlights from Friday’s Analyst Blog:

Pharma Stock Roundup: BMY, MRK, RHHBY and More

This week was ruled by cancer data presentations at the annual meeting of the American Society of Clinical Oncology (“ASCO”) in Chicago by pharma bigwigs like Bristol Myers, Merck and Roche among others. In other news, Lilly’s new migraine drug, Emgality and Merck’s antibacterial medicine Zerbaxa were approved by the FDA for new indications.

Recap of the Week’s Most Important Stories

Update from ASCO: Merck presented data from several cancer studies of its PD-L1 inhibitor, Keytruda and PARP inhibitor, Lynparza.

It presented follow-up data from lung cancer studies on Keytruda. Data from the phase Ib KEYNOTE-001 study (n=550) showed that five-year overall survival (OS) rates for Keytruda were 23.2% in treatment-naïve lung cancer patients and 15.5% in previously treated lung cancer patients. Historically, the five-year survival rate in advanced lung cancer patients in the United States has been around 5%. Keytruda’s five-year survival rates thus represent a huge improvement over these historical rates. Follow up lung cancer data from the KEYNOTE-189 study showed that Keytruda in combination with Lilly’s Alimta (pemetrexed) and platinum chemotherapy reduced the risk of death by 44% compared with chemotherapy alone as a first-line treatment option for metastatic non-squamous non-small cell lung cancer (NSCLC) in patients with no EGFR or ALK genomic tumor aberrations.

Merck and partner AstraZeneca announced detailed data from the phase III POLO study evaluating Lynparza for germline BRCA-mutated metastatic pancreatic cancer patients who did not progress on chemotherapy. The data showed that at six months, more than twice as many patients being treated with Lynparza were progression free compared to those on placebo. Lynparza reduced the risk of disease progression or death by 47%. Full data presented from phase III SOLO 3 study on Lynparza in advanced ovarian cancer demonstrated a 72% objective response rate compared to 51% in patients receiving chemotherapy

Bristol-Myers presented data from multiple studies on its PD-L1 inhibitor, Opdivo, at ASCO including the longest follow-up data for the Opdivo plus Yervoy combination in advanced melanoma patients. A five-year analysis of the phase I CA209-004 study showed that overall survival (OS) rates were stable at 57% in the Opdivo plus Yervoy arm, with a median follow-up of 43.1 months in all patients, at four years or longer. Moreover, data presented from multiple analyses of CheckMate - 067 study demonstrated that the quality of life was maintained throughout the course of Opdivo plus Yervoy treatment and follow-up. These data clearly reinforce the long-term efficacy of the combination treatment in advanced melanoma.

FDA Grants Approval to Lilly’s Emgality for Cluster Headache:The FDA granted approval to Lilly’s CGRP antibody, Emgality injection (300 mg) for the preventive treatment of episodic cluster headache in adult patients. Emgality is now the only CGRP antibody approved for two headache disorders— migraine and episodic cluster headache. Emgality was launched for preventive treatment of migraine last year along with two other CGRP antibodies, Amgen (NASDAQ:AMGN) and Novartis’ Aimovig and Teva’s Ajovy. The approval for this expanded patient population gives Lilly’s Emgality an edge over the other two CGRP pain medications.

FDA Ok’s Expanded Use of Merck’s Zerbaxa: The FDA granted approval to Merck’s antibacterial medicine, Zerbaxa for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). Zerbaxa, a combination of ceftolozane and tazobactam, is presently marketed for some complicated urinary tract infections.

AstraZeneca’s Calquence Improves Survival in 2^nd CLL Study: AstraZeneca’s phase III study evaluating Calquence combination compared to standard-of-care medicines for previously-untreated chronic lymphocytic leukaemia (CLL) met the primary endpoint. Interim data from the ELEVATE-TN study showed that treatment with Calquence in combination with obinutuzumab led to statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) — the primary endpoint — compared with chemotherapy-based combination of chlorambucil and obinutuzumab.

This is the second CLL study on Calquence to have met the primary endpoint. In May, AstraZeneca announced positive results from the ASCEND study evaluating Calquence in relapsed/recurrent disease setting. Calquence is presently marketed for the treatment of relapsed or refractory mantle cell lymphoma (MCL). It is being developed in phase III studies for the larger CLLindication and AstraZeneca expects to file regulatory applications based on data from the ASCEND and ELEVATE-TN studies later this year and get approval for CLL

FDA and CHMP Nod to At-home Administration Options for Glaxo’s Nucala: The FDA granted approval to two new self-administered options for Glaxo’s asthma drug Nucala, an autoinjector and a pre-filled safety syringe, to be taken once every four weeks.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) also issued a positive opinion recommending approval for the two new self-administered options, a pre-filled pen and a pre-filled safety syringe, to be taken once every four weeks

The NYSE ARCA Pharmaceutical Index rose 2.45% in the last five trading sessions.

Large Cap Pharmaceuticals Industry 5YR % Return

Last week, all the stocks were in the green with J&J (NYSE:JNJ) gaining the most (4.2%).

In the past six months, Merck has been the biggest gainer (5.2%) while Bristol-Myers declined the most (12.2%).

(See the last pharma stock roundup here: MRK's Cancer Biotech Buyout, ABBV, LLY's Pipeline Updates)

What's Next in the Pharma World?

Watch out for regular pipeline and regulatory updates next week.

More Stock News: This Is Bigger than the iPhone!

It could become the mother of all technological revolutions. Apple (NASDAQ:AAPL) sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.

Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.

Click here for the 6 trades >>

Media Contact

Zacks Investment Research

800-767-3771 ext. 9339

support@zacks.com

http://www.zacks.com

Past performance is no guarantee of future results. Inherent in any investment is the potential for loss. This material is being provided for informational purposes only and nothing herein constitutes investment, legal, accounting or tax advice, or a recommendation to buy, sell or hold a security. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. It should not be assumed that any investments in securities, companies, sectors or markets identified and described were or will be profitable. All information is current as of the date of herein and is subject to change without notice. Any views or opinions expressed may not reflect those of the firm as a whole. Zacks Investment Research does not engage in investment banking, market making or asset management activities of any securities. These returns are from hypothetical portfolios consisting of stocks with Zacks Rank = 1 that were rebalanced monthly with zero transaction costs. These are not the returns of actual portfolios of stocks. The S&P 500 is an unmanaged index. Visit http://www.zacks.com/performance for information about the performance numbers displayed in this press release.