AstraZeneca plc (AZN) received surprising news this week as the Food and Drug Administration approved Calquence, a therapy for mantle cell lymphoma.
The company was hoping to hear from the FDA about the BTK inhibitor sometime in the first quarter of 2018 after AstraZenca received a breakthrough designation in August.
AstraZeneca gained access to Calquence with the acquisition of privately held Acerta Pharma that was completed in 2016 for $ billion. AstraZeneca will pay Acerta shareholders another $1.5 billion thanks to the FDA approval.
How Calquence and Inbruvica match up in the marketplace may be influenced by trial results for the newly approved Calquence, which had an overall response rate of 81% versus 66% for the more established Inbruvica. Inbruvica is just a single dose each day while patients opting for Calquence will need to take two doses daily.
Calquence's entry to the market holds some risk for J&J/AbbVie. Johnson & Johnson reported revenue of $450 million for Inbruvica in the second quarter, up $155 million from the previous year. AbbVie reported $626 million in revenue, a jump of $187 million year over year.
AstraZeneca has priced its newly approved drug at $171,108 annually, undercutting Inbruvica's $177,648 price tag.
While the approval for mantle cell lymphoma, AstraZeneca has its eye on a larger prize, an FDA approval for Calquence as a treatment for chronic lymphocytic leukemia, one of the most common forms of leukemia. The company also hopes to be able to gain eventual approval for the drug to treat Waldenstrom macroglobulinaemia, multiple myeloma, diffuse large B-cell lymphoma and follicular lymphoma.
The good news from the FDA offset some disappointing trial results regarding tralokinumab, a candidate to treat severe asthma. Coming off a failed trial in May, the company hoped that a pair of tests on subpopulations could yield better results. But the drug failed to perform in the Stratos2 and Tropos tests.
Moderna Therapeutics announced a new license agreement with AstraZeneca to co-develop and commercialize RNA therapeutic encoding for Relaxin and the new candidate AZD7970 with a focus on treating heart failure.
AZD7970 is being designed to instruct cells to produce Relaxin, a secreted protein that may directly impact the underlying conditions that can lead to heart failure.
AstraZeneca and Moderna have worked together since 2013 and AZN invested in the privately held company's A and E rounds of financing. The new agreement calls for Moderna to fund preclinical development of AZD7970, AZ will take the reins for early clinical development and both companies will pay for the late-stage work.
Both companies will work to commercialize the candidate and share 50-50 in profits.
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