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Pharma Stock Roundup: FDA Blow for AGN, Label Expansion Nod for MRK, BMY Cancer Drugs


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This week, while Allergan's AGN uterine fibroids candidate was rejected by the FDA on safety concerns, Merck MRK and Bristol-Myers' BMY PD-L1 inhibitors, Keytruda and Opdivo, respectively were approved for label expansions by the agency. AstraZeneca's AZN lung cancer drug Tagrisso gained approval in Japan in the first-line setting. Novo Nordisk NVO bought a small U.K. biotech company to accelerate its development of glucose responsive insulins

Recap of the Week's Most Important Stories

FDA Gives CRL to Allergan's Esmya NDA: Allergan faced a key pipeline setback this week. The FDA issued a complete response letter (CRL) to the new drug application (NDA) for its pipeline drug Esmya/ulipristal acetate for the treatment of abnormal uterine bleeding in women with uterine fibroids. The FDA has requested additional information, citing safety issues in outside U.S. markets. The rejection could negatively impact Allergan's plan to divest its Women's Health franchise to which Esmya belongs. (Read more: Allergan Falls on FDA's Rejection of Uterine Fibroids Drug )

Merck Gets FDA Nod to Include Key Study Data on Keytruda Label: Merck's regulatory application to include overall survival data from a key late-stage lung cancer study, KEYNOTE-189 study, on the label of its PD-L1 inhibitor, Keytruda, was approved by the FDA. The study evaluated Keytruda in combination with Eli Lilly's LLY Alimta (pemetrexed) and platinum chemotherapy (cisplatin or carboplatin) for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), regardless of PD-L1 expression.

Notably, in May 2017, this combination therapy was granted an accelerated approval by the FDA for the aforementioned indication. The approval was based on tumor response rate and PFS data from the phase II KEYNOTE-021 study. The positive readouts from the KEYNOTE-189 confirmatory study helped the company get the accelerated approval converted to a continued approval for the combo therapy, further reinforcing its position in the lung cancer market.

Merck and Japanese partner Eisai's tyrosine kinase inhibitor, Lenvima was approved by the European Commission (EC) for the first-line treatment of unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer. Lenvima was approved for this indication in the United States last week.

Bristol-Myers Opdivo Gets FDA Approval for SCLC: The FDA also approved a label expansion for Bristol-Myers's PD-L1 inhibitor, Opdivo, a key competitor to Keytruda. The FDA granted approval to Opdivo for a new cancer indication - metastatic small cell lung cancer (SCLC) in patients whose cancer has progressed after two or more prior lines of therapy. Both Opdivo and Keytruda are currently approved in several countries including the United States, the EU and Japan for several cancer indications.

In another news, Bristol-Myers' regulatory application looking for label expansion of its cancer drug, Empliciti in combination use for relapsed/refractory multiple myeloma, was granted priority review by the FDA. Accordingly, the FDA is expected to give its decision on December 27 this year.

Tagrisso Gets Approval in Japan in First-Line Setting: AstraZeneca's lung cancer drug Tagrisso gained approval in Japan for the first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR mutations. A similar label expansion application was approved in the United States in April and in EU in June. Until now, Tagrisso was approved in the United States, European Union, Japan and China as a second-line treatment option for patients with EGFR mutation-positive NSCLC.

On the second-quarter call held last month, the company said it saw an encouraging start to the first-line launch in the United States, which contributed to Tagrisso's sales growth of 77% in the second quarter. The approvals in Japan and EU should drive sales of Tagrisso higher in future quarters.

AstraZeneca also announced top-line data from a phase III AERISTO study, which showed that its LABA/LAMA inhaler, Bevespi Aerosphere was non-inferior to Glaxo's Anoro Ellipta in improving lung function in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). The improvement in lung function was measured by trough forced expiratory volume in one second (FEV1). However, the inhaler failed to demonstrate superiority on peak FEV1 or non-inferiority on trough FEV1.

Novo Nordisk Buys Ziylo: Novo Nordisk announced a deal to buy University of Bristol spin-out company, Ziylo, which will accelerate its development of glucose responsive insulins. The acquisition will give Novo Nordisk full rights to Ziylo's glucose binding molecules which have the potential to lead to the development of glucose responsive insulins, a next-generation of insulins. These glucose responsive insulins do away with the risk of hypoglycaemia, a key risk associated with the use of insulins, and thereby help better control diabetes. (Read more: Novo Nordisk Buys Ziylo to Develop Glucose Responsive Insulin )

Pfizer Amends Protocols of Xtandi Late-Stage Studies: Pfizer PFE along with partner Astellas announced that it is amending the protocols of two phase III studies evaluating their prostate cancer drug, Xtandi for an expanded patient population - hormone-sensitive prostate cancer (HSPC). Xtandi is presently marketed for the treatment of castration-resistant prostate cancer.

The amendment is aimed to accelerate the anticipated primary completion dates for the two studies - ARCHES and EMBARK. Xtandi was added to Pfizer's portfolio through the 2016 acquisition Medivation. (Read more: Pfizer Amends Xtandi Study Protocols to Speed Up Completion )

AbbVie's Elagolix Succeeds in Uterine Fibroids Extension Study: AbbVie and Neurocrine Biosciences' announced that a phase III extension study evaluating elagolix in the uterine fibroids indication met the primary endpoint. The ELARIS UF-EXTEND study was evaluating elagolix for reducing heavy menstrual bleeding in premenopausal women with uterine fibroids. Data from the study demonstrated that elagolix (300 mg twice daily), in combination with low-dose add-back therapy, reduced heavy menstrual bleeding in 87.9% of women with uterine fibroids at month twelve.

Two pivotal phase III studies evaluating elagolix for reducing heavy menstrual bleeding in premenopausal women with uterine fibroids have already succeeded. Data from all these studies will support regulatory application for elagolix in the uterine fibroids indication, which is anticipated to be filed next year

Elagolix was approved just last month by the FDA for the management of pain associated with endometriosis, a common gynecologic disorder. Elagolix will be marketed by the trade name of Orilissa. AbbVie believes the drug has multi-billion dollar sales potential. (Read more: AbbVie Posts Positive Data on Elagolix for Uterine Fibroids `)

The NYSE ARCA Pharmaceutical Index rose 1.1% in the last five trading sessions.

Large Cap Pharmaceuticals Industry 5YR % Return

Large Cap Pharmaceuticals Industry 5YR % Return



Here is how the seven major stocks performed in the last five trading sessions:

While Bristol-Myers declined the most (1.3%), J&J recorded the highest gain of 0.5% in the last five trading sessions.

In the past six months, Lilly has been the biggest gainer (30.7%) while Bristol-Myers declined the most (12.5%).

(See the last pharma stock roundup here: Blow for Bayer, FDA Nod for MRK Cancer Drug in New Indication )

What's Next in the Pharma World?

Watch out for several pipeline and regulatory updates next week

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Novo Nordisk A/S (NVO): Free Stock Analysis Report

Bristol-Myers Squibb Company (BMY): Free Stock Analysis Report

Allergan plc (AGN): Free Stock Analysis Report

Pfizer Inc. (PFE): Free Stock Analysis Report

AstraZeneca PLC (AZN): Free Stock Analysis Report

Merck & Co., Inc. (MRK): Free Stock Analysis Report

Eli Lilly and Company (LLY): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.



This article appears in: Investing , Business , Stocks
Referenced Symbols: NVO , BMY , AGN , PFE , AZN



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