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This week, Merck’s (MRK - Free Report) investigational vaccine for Ebola Zaire disease, V920, received approval in Europe. While Roche and Glaxo (GSK - Free Report) announced positive data from pivotal studies, Pfizer’s (PFE - Free Report) late-stage gastric cancer study on its PD-L1 inhibitor, Bavencio, failed. AbbVie (ABBV - Free Report) , Bristol-Myers (BMY - Free Report) , Merck, AstraZeneca (AZN - Free Report) and Lilly (LLY - Free Report) provided FDA updates.
Recap of the Week’s Most Important Stories:
EU Approval for Merck’s Ebola Vaccine & AstraZeneca’s New Diabetes Tablet: The European Commission' has granted conditional marketing approval to Merck’s investigational vaccine for Ebola Zaire disease, V920, which will be marketed by the trade name of Ervebo. Ervebo is under priority review in the United States with a FDA decision expected on Mar 14, 2020.
The European Commission also granted marketing approval to AstraZeneca’s Qtrilmet modified-release tablets for type II diabetes. Qtrilmet is a combination of AstraZeneca’s other diabetes drugs Farxiga (dapagliflozin) and Onglyza (saxagliptin) plus metformin. It was approved by the FDA with the trade name of Qternmet XR in May.
Meanwhile, the FDA accepted and granted priority review to Merck & AstraZeneca’s new drug application (NDA) for MEK 1/2 inhibitor selumetinib pertaining to the treatment of neurofibromatosis type 1 (NF1)-related plexiform neurofibromas, an incurable genetic condition that affects newborns. The FDA’s decision is expected in the second quarter of 2020.
Roche’s SMA Candidate Sees Success: Roche’s pivotal study (SUNFISH) on spinal muscular atrophy (SMA) candidate, risdiplam, met its primary endpoint. Data from the study showed that treatment with risdiplam, an oral SMN2 splicing modifier, led to statistically significant improvement in the overall study population with type 2 or 3 SMA (patients aged 2-25 years) compared to placebo. Roche plans to submit the data to the FDA to get risdiplam approved for which it has partnered with PTC Therapeutics.
Meanwhile, a phase II study evaluating Roche’s Gazyva (obinutuzumab) for adults with proliferative lupus nephritis, met the primary endpoint. Data from the phase II NOBILITY study showed that Gazyva, in combination with standard of care, more than doubled the percentage of lupus nephritis patients achieving complete renal response, compared to standard of care alone. Notably, 40% of patients treated with Gazyva plus standard of care achieved complete renal response at Week 76, compared to 18% of patients treated with placebo plus standard of care.
Pfizer’s 2nd Gastric Cancer Study on Bavencio Fails: Pfizer and partner Merck KGaA announced that a phase III study evaluating their PD-L1 inhibitor, Bavencio (avelumab), for the treatment of gastric cancer as a first line maintenance therapy following induction chemotherapy, failed to meet the primary endpoint. Top-line data from the study showed that treatment with avelumab did not result in superior overall survival compared with the standard of care in the overall intent-to-treat population or the PD-L1–positive population, thereby failing to meet the primary endpoint of the study. In November 2017, another study gastric cancer study evaluating avelumab monotherapy in the third-line setting had failed to meet the primary endpoint.
Meanwhile, Pfizer and Mylan announced that the name of the new generic pharmaceutical company to be formed by the merger of Pfizer’s Upjohn unit and Mylan will be Viatris. The transaction, which was announced in July, is expected to close in mid-2020.
Glaxo’s Nucala Study Meets Primary Endpoint: Glaxo announced its asthma drug Nucala led to significant reduction in flares for patients with Hypereosinophilic Syndrome (HES), per data from a pivotal study evaluating the drug for this rare disease. The study met its primary endpoint with 50% fewer patients treated with Nucala experiencing a HES flare, compared to placebo, when added to standard of care treatment over the 32-week study period. Based on this data, Glaxo plans to file regulatory applications seeking approval of Nucala for HES in 2020.
AbbVie Files sNDA for Imbruvica+Rituxan Combo for First-Line CLL/SLL: AbbVie announced that it has submitted a supplemental NDA to the FDA seeking label expansion approval of Imbruvica in combination with Roche’s Rituxan for the treatment of previously untreated, younger adults with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The application is being reviewed under the FDA's Real-Time Oncology Review pilot program and is based on data from the phase III E1912 study. If approved for the combination use, this will be the11th FDA approval for Imbruvica across six distinct disease areas.
FDA Accepts Bristol-Myers’ sBLA for Opdivo/Yervoy Combo: Bristol-Myers’ (BMY - Free Report) supplemental biologics license application (sBLA) application seeking approval of Opdivo plus Yervoy combo regimen for previously-treated advanced hepatocellular carcinoma, a form of liver cancer, was accepted by the FDA. With the FDA granting a priority review designation to the sBLA, a decision is expected on Mar 10, 2020. Meanwhile, the FDA granted Opdivo plus Yervoy Breakthrough Therapy status for this potential indication.
FDA Panel Votes Against Lilly’s Jardiance Label Expansion: An FDA advisory committee voted against the label expansion of Lilly/Boehringer Ingelheim’s type II diabetes medicine, Jardiance,2.5 mg, for type I diabetes. The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14-2 that the benefits of Jardiance 2.5 mg do not outweigh the risks to support approval for the indication. The companies are seeking approval for Jardiance, 2.5 mg for type I diabetes under a separate brand name.
Meanwhile, Lilly and partner Boehringer Ingelheim initiated the first ever study to evaluate its SGLT2 inhibitor, Jardiance in patients with and without type II diabetes hospitalized for acute heart failure who have been stabilized. The aim of the study, EMPULSE, is to understand whether Jardiance has the potential to improve outcomes in this patient population. It is the sixth phase III study in the Jardiance heart failure program.
Novartis’ Sandoz Strengthens Presence in Japan’s Generic Market: Novartis’ generic subsidiary, Sandoz, announced an agreement to acquire Aspen Global Incorporated’s (“AGI”) Japanese operations and associated assets. Sandoz will make an initial cash payment of 300 million euros to AGI on closing of the deal. The deal will expand Novartis’ presence in Japan, which is the world’s third-largest generics market. Aspen’s portfolio in Japan consists primarily of off-patent branded medicines with focus on anesthetics and specialty brands, which will complement Sandoz broad hospital portfolio and pipeline in Japan.
The NYSE ARCA Pharmaceutical Index rose around 1% in the last five trading sessions.
Watch out for regular pipeline and regulatory updates next week.
Free: Zacks’ Single Best Stock Set to Double
Today you are invited to download our just-released Special Report that reveals 5 stocks with the most potential to gain +100% or more in 2020. From those 5, Zacks Director of Research, Sheraz Mian hand-picks one to have the most explosive upside of all.
This pioneering tech ticker had soared to all-time highs and then subsided to a price that is irresistible. Now a pending acquisition could super-charge the company’s drive past competitors in the development of true Artificial Intelligence. The earlier you get in to this stock, the greater your potential gain.
Image: Bigstock
Pharma Stock Roundup: MRK, GSK, ABBV, LLY's Pipeline & Regulatory Updates
This week, Merck’s (MRK - Free Report) investigational vaccine for Ebola Zaire disease, V920, received approval in Europe. While Roche and Glaxo (GSK - Free Report) announced positive data from pivotal studies, Pfizer’s (PFE - Free Report) late-stage gastric cancer study on its PD-L1 inhibitor, Bavencio, failed. AbbVie (ABBV - Free Report) , Bristol-Myers (BMY - Free Report) , Merck, AstraZeneca (AZN - Free Report) and Lilly (LLY - Free Report) provided FDA updates.
Recap of the Week’s Most Important Stories:
EU Approval for Merck’s Ebola Vaccine & AstraZeneca’s New Diabetes Tablet: The European Commission' has granted conditional marketing approval to Merck’s investigational vaccine for Ebola Zaire disease, V920, which will be marketed by the trade name of Ervebo. Ervebo is under priority review in the United States with a FDA decision expected on Mar 14, 2020.
The European Commission also granted marketing approval to AstraZeneca’s Qtrilmet modified-release tablets for type II diabetes. Qtrilmet is a combination of AstraZeneca’s other diabetes drugs Farxiga (dapagliflozin) and Onglyza (saxagliptin) plus metformin. It was approved by the FDA with the trade name of Qternmet XR in May.
Meanwhile, the FDA accepted and granted priority review to Merck & AstraZeneca’s new drug application (NDA) for MEK 1/2 inhibitor selumetinib pertaining to the treatment of neurofibromatosis type 1 (NF1)-related plexiform neurofibromas, an incurable genetic condition that affects newborns. The FDA’s decision is expected in the second quarter of 2020.
Roche’s SMA Candidate Sees Success: Roche’s pivotal study (SUNFISH) on spinal muscular atrophy (SMA) candidate, risdiplam, met its primary endpoint. Data from the study showed that treatment with risdiplam, an oral SMN2 splicing modifier, led to statistically significant improvement in the overall study population with type 2 or 3 SMA (patients aged 2-25 years) compared to placebo. Roche plans to submit the data to the FDA to get risdiplam approved for which it has partnered with PTC Therapeutics.
Meanwhile, a phase II study evaluating Roche’s Gazyva (obinutuzumab) for adults with proliferative lupus nephritis, met the primary endpoint. Data from the phase II NOBILITY study showed that Gazyva, in combination with standard of care, more than doubled the percentage of lupus nephritis patients achieving complete renal response, compared to standard of care alone. Notably, 40% of patients treated with Gazyva plus standard of care achieved complete renal response at Week 76, compared to 18% of patients treated with placebo plus standard of care.
Pfizer’s 2nd Gastric Cancer Study on Bavencio Fails: Pfizer and partner Merck KGaA announced that a phase III study evaluating their PD-L1 inhibitor, Bavencio (avelumab), for the treatment of gastric cancer as a first line maintenance therapy following induction chemotherapy, failed to meet the primary endpoint. Top-line data from the study showed that treatment with avelumab did not result in superior overall survival compared with the standard of care in the overall intent-to-treat population or the PD-L1–positive population, thereby failing to meet the primary endpoint of the study. In November 2017, another study gastric cancer study evaluating avelumab monotherapy in the third-line setting had failed to meet the primary endpoint.
Meanwhile, Pfizer and Mylan announced that the name of the new generic pharmaceutical company to be formed by the merger of Pfizer’s Upjohn unit and Mylan will be Viatris. The transaction, which was announced in July, is expected to close in mid-2020.
Glaxo’s Nucala Study Meets Primary Endpoint: Glaxo announced its asthma drug Nucala led to significant reduction in flares for patients with Hypereosinophilic Syndrome (HES), per data from a pivotal study evaluating the drug for this rare disease. The study met its primary endpoint with 50% fewer patients treated with Nucala experiencing a HES flare, compared to placebo, when added to standard of care treatment over the 32-week study period. Based on this data, Glaxo plans to file regulatory applications seeking approval of Nucala for HES in 2020.
AbbVie Files sNDA for Imbruvica+Rituxan Combo for First-Line CLL/SLL: AbbVie announced that it has submitted a supplemental NDA to the FDA seeking label expansion approval of Imbruvica in combination with Roche’s Rituxan for the treatment of previously untreated, younger adults with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The application is being reviewed under the FDA's Real-Time Oncology Review pilot program and is based on data from the phase III E1912 study. If approved for the combination use, this will be the11th FDA approval for Imbruvica across six distinct disease areas.
FDA Accepts Bristol-Myers’ sBLA for Opdivo/Yervoy Combo: Bristol-Myers’ (BMY - Free Report) supplemental biologics license application (sBLA) application seeking approval of Opdivo plus Yervoy combo regimen for previously-treated advanced hepatocellular carcinoma, a form of liver cancer, was accepted by the FDA. With the FDA granting a priority review designation to the sBLA, a decision is expected on Mar 10, 2020. Meanwhile, the FDA granted Opdivo plus Yervoy Breakthrough Therapy status for this potential indication.
FDA Panel Votes Against Lilly’s Jardiance Label Expansion: An FDA advisory committee voted against the label expansion of Lilly/Boehringer Ingelheim’s type II diabetes medicine, Jardiance,2.5 mg, for type I diabetes. The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14-2 that the benefits of Jardiance 2.5 mg do not outweigh the risks to support approval for the indication. The companies are seeking approval for Jardiance, 2.5 mg for type I diabetes under a separate brand name.
Meanwhile, Lilly and partner Boehringer Ingelheim initiated the first ever study to evaluate its SGLT2 inhibitor, Jardiance in patients with and without type II diabetes hospitalized for acute heart failure who have been stabilized. The aim of the study, EMPULSE, is to understand whether Jardiance has the potential to improve outcomes in this patient population. It is the sixth phase III study in the Jardiance heart failure program.
Novartis’ Sandoz Strengthens Presence in Japan’s Generic Market: Novartis’ generic subsidiary, Sandoz, announced an agreement to acquire Aspen Global Incorporated’s (“AGI”) Japanese operations and associated assets. Sandoz will make an initial cash payment of 300 million euros to AGI on closing of the deal. The deal will expand Novartis’ presence in Japan, which is the world’s third-largest generics market. Aspen’s portfolio in Japan consists primarily of off-patent branded medicines with focus on anesthetics and specialty brands, which will complement Sandoz broad hospital portfolio and pipeline in Japan.
The NYSE ARCA Pharmaceutical Index rose around 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.
Last week, while Merck rose the most (2.0%), Lilly lost the maximum (1.2%).
In the past six months, AstraZeneca has risen the most (25.3%), while Pfizer lost the maximum (12.3%).
(See the last pharma stock roundup here: AGN, NVO Q3 Earnings, FDA Nod to SNY & NVS’ Products)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
Free: Zacks’ Single Best Stock Set to Double
Today you are invited to download our just-released Special Report that reveals 5 stocks with the most potential to gain +100% or more in 2020. From those 5, Zacks Director of Research, Sheraz Mian hand-picks one to have the most explosive upside of all.
This pioneering tech ticker had soared to all-time highs and then subsided to a price that is irresistible. Now a pending acquisition could super-charge the company’s drive past competitors in the development of true Artificial Intelligence. The earlier you get in to this stock, the greater your potential gain.
Download Free Report Now >>