Sun Pharma to buy Concert, pick up experimental hair loss drug – BioPharma Dive


Concert’s oral drug, called deuruxolitinib, is part of a race to launch more effective treatments for alopecia areata, an autoimmune condition that causes patchy hair loss. Its positive Phase 3 results in May and August came as Eli Lilly and Incyte won Food and Drug Administration approval in June of the first systemic therapy for the condition. Not far behind, Pfizer in September said it expected decisions in 2023 for regulatory reviews of its treatment in the U.S., U.K., Europe, China and Japan.
All three of the drugs work by blocking proteins known as Janus kinases, or JAKS, which are involved in a range of immune disorders. Other JAK inhibitors are approved to treat arthritis, eczema and ulcerative colitis, but the class of drugs also comes with safety risks, and regulators have limited their use or required warnings, including for Lilly and Incyte’s drug for alopecia areata.
Concert was running out of runway to see its drug through approvals. At the end of September, the company said it held about $150 million in cash and investments — enough to meet its needs through mid-2023.
Sun said its immediate focus would be to follow Concert’s plan to submit the drug for approval in the first half of the year. “We are well-positioned to successfully bring this product to market globally,” said Abhay Gandhi, Sun’s North America CEO, in a statement.
The deal’s inclusion of a CVR has been somewhat of a recent trend, according to data compiled by BioPharma Dive. A trio of biotech buyouts last week included the agreements, as did Indivior’s purchase of Opiant Pharmaceuticals in November. Acquisitions last year of Epizyme, Zogenix, Radius Health and Akouos also included CVRs.
Concert investors’ CVR entitles them to receive $1 per share of common stock if deuruxolitinib net sales exceed $100 million by 2027. They would receive another $2.50 per share if sales exceed $500 million by 2029.
Concert reported a net loss of $90.6 million in the first nine months of 2022, with R&D expenses of about $76 million over that period.
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Buoyed by recent approvals, the field faces a pivotal year that’s likely to bring new treatments as well as more challenges.
More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.
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Buoyed by recent approvals, the field faces a pivotal year that’s likely to bring new treatments as well as more challenges.
More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.
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