This week, the FDA approved Novartis’ NVS sickle cell disease (SCD) candidate Adakveo (crizanlizumab), AstraZeneca’s AZN leukemia drug Calquence for a new indication - chronic lymphocytic leukemia (CLL) and Pfizer’s PFE Abrilada, a biosimilar version of AbbVie’s ABBV Humira. Meanwhile, Bristol-Myers BMY closed the long pending $74 billion-acquisition of Celgene. While Merck’s MRK late-stage study on heart failure candidate vericiguat met its goal, Bristol-Myers’ late stage melanoma study on Opdivo plus Yervoy combination failed to meet the primary endpoint.
Recap of the Week’s Most Important Stories:
FDA Approves Novartis SCD Drug and AstraZeneca’s Calquence for CLL: The FDA approved Novartis’ crizanlizumab to reduce the frequency of vaso-occlusive crises (VOCs) or pain crises in patients suffering sickle cell disease (SCD). The drug will be marketed by the trade name Adakveo. The regulatory agency’s approval was based on results from the 52-week, randomized, placebo-controlled SUSTAIN study. The nod comes approximately two months ahead of the FDA’s priority review action date.
The FDA also granted approval to AstraZeneca’s BTK inhibitor Calquence for a new indication, chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in frontline and in the relapsed/recurrent disease setting. Calquence is presently marketed for the previously treated mantle cell lymphoma (MCL). The approval for the CLL indication was based on two phase III studies, namely ELEVATE-TN and ASCEND. Data from the studies demonstrated superior progression-free survival post treatment with Calquence across multiple settings while maintaining favourable tolerability. With the approval for this much larger indication, AstraZeneca can gain access to a broader patient population and boost sales of this promising drug.
Bristol-Myers & Celgene Merger Closes: The U.S. Federal Trade Commission finally allowed completion of the impending merger of Celgene with Bristol-Myers after the former agreed to divest its blockbuster psoriasis drug Otezla to Amgen in August. As a result, Bristol-Myers fulfilled all the regulatory requirements under the merger agreement to complete the acquisition of Celgene, which was concluded on Nov 20, 2019.
Meanwhile, Bristol-Myers’ phase III study evaluating a combination of Opdivo plus Yervoy in patients with resected high-risk melanoma failed to show a statistically significant benefit for the co-primary endpoint of recurrence-free survival (RFS). The study was recommended to be continued unmodified by the Data Monitoring Committee.
FDA Approves Pfizer’s Humira Biosimilar, Abrilada: Pfizer’s biosimilar version of AbbVie’s blockbuster drug Humira was approved by the FDA to treat multiple inflammatory conditions. The biosimilar will be marketed by the trade name Abrilada. Pfizer has a non-exclusive licensing deal with AbbVie under which it can launch Abrilada in the United States on Nov 20, 2023. In the EU, Pfizer can launch Humira biosimilar when it gets an approval from the European Medicines Agency.
Merck/Bayer’s Heart Failure Candidate Meets Study Endpoint: Merck and Bayer’s investigational drug vericiguat met the primary endpoint in the phase III VICTORIA study of patients with worsening chronic heart failure with reduced ejection fraction (HFrEF). Data from the study showed that vericiguat lowered the risk of composite endpoint of heart failure, hospitalization or cardiovascular death in such patients compared to placebo when given in combination with available heart failure therapies.
Meanwhile, the European Commission approved Merck’s PD-L1 inhibitor Keytruda for first-line treatment of metastatic or unresectable, recurrent head and neck squamous cell cancer (HNSCC) as monotherapy or in combination with chemotherapy in patients whose tumors express PD-L1. The sBLA was based on data from the phase III KEYNOTE-048 study. A similar approval was granted by the FDA in the United States in June 2019.
CHMP Nod to Roche & Novartis’ Drugs: The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended EU approval of Roche’s RHHBY Kadcyla for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment. The agency also recommended conditional EU nod to Roche’s Polivy for people with previously treated aggressive lymphoma. Polivy was approved in the United States in June this year. Novartis’ Mayzent (siponimod) also got a positive CHMP opinion for the treatment of adult patients with active secondary progressive multiple sclerosis (SPMS). Mayzent was approved by the FDA earlier in March.
Novo Nordisk & AbbVie’s New Deals: Novo Nordisk announced a collaboration deal with Massachusetts-based Dicerna Pharmaceuticals to discover and develop RNAi therapies for liver-related cardio-metabolic diseases using Dicerna’s proprietary GalXC RNAi platform. The companies will discover molecules for targets that may yield multiple potential treatments across disease areas, such as diabetes, obesity, cardiovascular and NASH. Per the deal, Dicerna will get an upfront payment of $175 million while Novo Nordisk will make an equity investment worth $50 million in its stock. Dicerna will also be eligible to receive additional milestone fees and potential royalties on product sales.
AbbVie signed a license and option collaboration contract with Harpoon Therapeutics to advance Harpoon’s pre-clinical candidate HPN217 (BCMA), a TriTAC for the treatment of multiple myeloma. Per the deal, Harpoon granted AbbVie an option to license worldwide exclusive rights to HPN217. Harpoon plans to file an IND application this year to begin a phase I/II study on HPN217 for multiple myeloma. Harpoon will take care of the phase I/II development after completion of which AbbVie can exercise the option. The companies also expanded their existing TriTAC discovery collaboration, formed in October 2017, for up to six additional targets selected by AbbVie. For the two deals, AbbVie will pay Harpoon $50 million upfront and up to $50 million in a contingent milestone payment for the first patient treated with HPN217 in a study.
The NYSE ARCA Pharmaceutical Index rose 1.4% in the last five trading sessions.
Here is how the seven major stocks performed in the last five trading sessions.
Last week, all the stocks were in the green except Bristol-Myers, which declined 2.8%. J&J rose the most (4.2%).
In the past six months, AstraZeneca has risen the most (23.2%) while Pfizer lost the maximum (10.0%).
(See the last pharma stock roundup here: MRK, GSK, ABBV, LLY’s Pipeline & Regulatory Updates)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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Click to get this free report Roche Holding AG (RHHBY) : Free Stock Analysis Report Merck & Co., Inc. (MRK) : Free Stock Analysis Report Pfizer Inc. (PFE) : Free Stock Analysis Report AstraZeneca PLC (AZN) : Free Stock Analysis Report AbbVie Inc. (ABBV) : Free Stock Analysis Report Bristol-Myers Squibb Company (BMY) : Free Stock Analysis Report Novartis AG (NVS) : Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research