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AstraZeneca Gets FDA Nod for New Breast Cancer Drug Enhertu
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AstraZeneca (AZN - Free Report) and its Japan-based partner Daiichi Sankyo Company announced that the FDA has granted accelerated approval to their antibody drug conjugate candidate, trastuzumab deruxtecan for metatstaic breast cancer. The drug will be available as monotherapy for unresectable or metastatic HER2-positive breast cancer in patients who have received two or more prior anti-HER2 based regimens in the metastatic setting. The drug will be marketed by the trade name of Enhertu.
The approval to Enhertu came much earlier than expected. It is the first approval for the antibody drug conjugate in any indication. In October, the FDA had granted priority review to the biologics license application seeking approval for Enhertu. A decision was expected in the second quarter of 2020. Earlier-than-expected approval for the drug was presumably due to impressive results in a clinical study.
The approval was based on data from registrational phase II DESTINY-Breast01, which evaluated Enhertu in HER2-positive unresectable and/or metastatic breast cancer patients who have received prior treatment with Roche’s (RHHBY - Free Report) Herceptin (trastuzumab), Kadcyla (trastuzumab emtansine) or Perjeta (pertuzumab). Data from the study showed that 60.3% of the patients treated with Enhertu achieved confirmed objective response rate. While 4.3% patients achieved complete response, 56% patients had partial response. The patients also achieved a median progression-free survival of 16.4 months.
We remind investors that AstraZeneca acquired joint development and commercialization rights to this promising cancer candidate from Japan’s Daiichi Sankyo in April this year for approximately $6.9 billion. AstraZeneca will have to pay $125 million in milestone payment to Daiichi Sankyo, following the approval. Following the launch of Enhertu, Daiichi Sankyo will recognize future sales of the drug and AstraZeneca will report its share of gross profit margin from the sales in the United States as collaboration revenues.
The drug is currently under review in Japan. Apart from breast cancer, trastuzumab deruxtecan is also being developed to treat other HER2-expressing cancers including gastric cancer, advanced colorectal cancer and lung cancer.
AstraZeneca’s stock has rallied 32.8% this year so far compared with the industry’s rise of 11.8%.
In a separate press release, AstraZeneca announced that it has agreed to divest commercial rights to breast cancer drug, Arimidex, and prostate cancer drug, Casodex, in a number of European, African and other countries to French company, Juvise Pharmaceuticals for $181 million upfront payment. The company has lost compound patent protection for these drugs in these regions. The divestment is a part of the company’s broader strategy of reducing itsportfolio of mature medicines to reallocate resources towards developing the pipeline of new medicines. It had divested its rights to these drugs in the United States in 2017.
Glaxo’s shares have risen 23.8% this year so far. Its earnings estimates for 2020 have gone up 4% in the past 60 days.
Merck’s shares have gained 19.9% this year. Its earnings estimates have increased 2.6% for 2019 over the past 60 days.
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Image: Bigstock
AstraZeneca Gets FDA Nod for New Breast Cancer Drug Enhertu
AstraZeneca (AZN - Free Report) and its Japan-based partner Daiichi Sankyo Company announced that the FDA has granted accelerated approval to their antibody drug conjugate candidate, trastuzumab deruxtecan for metatstaic breast cancer. The drug will be available as monotherapy for unresectable or metastatic HER2-positive breast cancer in patients who have received two or more prior anti-HER2 based regimens in the metastatic setting. The drug will be marketed by the trade name of Enhertu.
The approval to Enhertu came much earlier than expected. It is the first approval for the antibody drug conjugate in any indication. In October, the FDA had granted priority review to the biologics license application seeking approval for Enhertu. A decision was expected in the second quarter of 2020. Earlier-than-expected approval for the drug was presumably due to impressive results in a clinical study.
The approval was based on data from registrational phase II DESTINY-Breast01, which evaluated Enhertu in HER2-positive unresectable and/or metastatic breast cancer patients who have received prior treatment with Roche’s (RHHBY - Free Report) Herceptin (trastuzumab), Kadcyla (trastuzumab emtansine) or Perjeta (pertuzumab). Data from the study showed that 60.3% of the patients treated with Enhertu achieved confirmed objective response rate. While 4.3% patients achieved complete response, 56% patients had partial response. The patients also achieved a median progression-free survival of 16.4 months.
We remind investors that AstraZeneca acquired joint development and commercialization rights to this promising cancer candidate from Japan’s Daiichi Sankyo in April this year for approximately $6.9 billion. AstraZeneca will have to pay $125 million in milestone payment to Daiichi Sankyo, following the approval. Following the launch of Enhertu, Daiichi Sankyo will recognize future sales of the drug and AstraZeneca will report its share of gross profit margin from the sales in the United States as collaboration revenues.
The drug is currently under review in Japan. Apart from breast cancer, trastuzumab deruxtecan is also being developed to treat other HER2-expressing cancers including gastric cancer, advanced colorectal cancer and lung cancer.
AstraZeneca’s stock has rallied 32.8% this year so far compared with the industry’s rise of 11.8%.
In a separate press release, AstraZeneca announced that it has agreed to divest commercial rights to breast cancer drug, Arimidex, and prostate cancer drug, Casodex, in a number of European, African and other countries to French company, Juvise Pharmaceuticals for $181 million upfront payment. The company has lost compound patent protection for these drugs in these regions. The divestment is a part of the company’s broader strategy of reducing itsportfolio of mature medicines to reallocate resources towards developing the pipeline of new medicines. It had divested its rights to these drugs in the United States in 2017.
AstraZeneca PLC Price
AstraZeneca PLC price | AstraZeneca PLC Quote
Zacks Rank
AstraZeneca currently carries a Zacks Rank #3 (Hold). Some better-ranked large cap drug stocks are GlaxoSmithKline (GSK - Free Report) and Merck (MRK - Free Report) . Both the companies carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Glaxo’s shares have risen 23.8% this year so far. Its earnings estimates for 2020 have gone up 4% in the past 60 days.
Merck’s shares have gained 19.9% this year. Its earnings estimates have increased 2.6% for 2019 over the past 60 days.
Just Released: Zacks’ 7 Best Stocks for Today
Experts extracted 7 stocks from the list of 220 Zacks Rank #1 Strong Buys that has beaten the market more than 2X over with a stunning average gain of +24.6% per year.
These 7 were selected because of their superior potential for immediate breakout.
See these time-sensitive tickers now >>