This week Pfizer PFE announced a definitive deal to buy Array BioPharma to strengthen its cancer portfolio. In other news, Merck’s MRK blockbuster PD-L1 inhibitor, Keytruda won approval for previously treated advanced small cell lung cancer (SCLC) while AstraZeneca AZN and Roche RHHBY gained approval in Japan for their investigational medicines. Meanwhile, AstraZeneca and Merck’s Lynparza was approved in EU and Japan for first-line maintenance treatment of BRCA-mutated advanced ovarian cancer.
Recap of the Week’s Most Important Stories
Pfizer to Buy Array BioPharma: In a bid to strengthen its cancer portfolio, Pfizer announced a definitive agreement to buy Array BioPharma for $48 per share in cash for a total enterprise value of approximately $11.4 billion. Array, which makes targeted small molecule drugs for treating cancer, launched its only commercial medicine, Braftovi plus Mektovi, as a treatment for BRAF-mutant melanoma, last year. The combination medicine is also being evaluated in label expansion studies for other cancer types including metastatic colorectal cancer (mCRC) with BRAF mutation. The acquisition will bring to Pfizer a large portfolio of royalty-generating out-licensed medicines. The transaction has been approved by the boards of both the companies and is expected to close in the second half of the year.
FDA Approves Merck’s Keytruda for SCLC: The FDA granted accelerated approval for label expansion of Keytruda as a monotherapy for previously treated advanced small cell lung cancer (SCLC). The approval was based on clinical response data from SCLC cohorts of the phase Ib KEYNOTE-028 and phase II KEYNOTE-158 studies. While Keytruda already holds a strong position in the non-small cell lung cancer market, this is the first approval for the drug in the SCLC indication, which accounts for 10% to 15% of all lung cancers.
Several Approvals for AstraZeneca’s Drugs: AstraZeneca/Merck’s PARP inhibitor Lynparza was granted approval in EU and Japan for first-line maintenance treatment of BRCA-mutated advanced ovarian cancer. It was approved in the United States for the indication in late 2018. With the latest approval, Lynparza can now be used as a maintenance monotherapy for the treatment of advanced ovarian cancer patients with BRCA1/2 mutation who have achieved complete or partial response, following first-line standard platinum-based chemotherapy. The regulatory filing was based on data from the phase III SOLO-1 study.
AstraZeneca also won approval from Japan’s regulatory body for PT010, its investigational triple-combo inhaler and Bevespi Aerosphere, its fixed-dose LABA/LAMA inhaler, both to treat COPD. PT010 will be marketed by the trade name of Breztri Aerospher. Japan marks the first global regulatory approval for Breztri Aerospher while the candidate is under review in the United States and EU.
Roche’s Personalized Medicine Entrectinib Gets Approval in Japan: Japan’s regulatory authority granted marketing approval to Roche’s personalized medicine entrectinib for adult and pediatric patients with NTRK fusion-positive advanced recurrent solid tumors. Japan became the first company to approve this tumor-agnostic medicine, which will be marketed by the trade name of Rozlytrek. It is under priority review in the United States with the FDA’s decision expected in August.
Novo Nordisk Gets EU Approval for Esperoct: The European Commission granted marketing approval to Novo Nordisk’s NVO Esperoct for the treatment of haemophilia A in adult patients and children. The drug is indicated for prophylaxis and on-demand treatment of bleeding as well as for surgical procedures in adolescents and adults with hemophilia. A. Esperoct is expected to be launched in the EU in the second half of 2019. The drug was approved in the United States in February.
Sanofi/Regeneron’s Asthma Candidate Succeeds in Study: Sanofi SNY and partner Regeneron Pharmaceuticals announced that a phase II study evaluating their investigational IL-33 antibody REGN3500 (SAR440340) in asthma met the primary endpoint. Data from the study showed that REGN3500 (SAR440340) monotherapy significantly reduced loss of asthma control (primary endpoint) and improved lung function compared to placebo. However, the REGN3500 plus Dupixent treatment arm failed to demonstrate increased benefit compared to Dupixent.
The NYSE ARCA Pharmaceutical Index rose 2.1% 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, all the stocks were in the green with AstraZeneca recording the highest gain (4.3%).
In the past six months, Merck has been the biggest gainer (18.9%) while Bristol-Myers BMY has recorded the least gain (0.3%).
(See the last pharma stock roundup here: MRK Buys Small Cancer Biotech, RHHBY, MRK Drugs Get FDA Nod
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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