Celgene/Acceleron win speedy FDA review for luspatercept in beta thalassemia; Korean investor out to shake up Aurinia's board
→ As hoped, Celgene $CELG and its partners at Acceleron $XLRN have secured priority review for their red blood cell boosting drug, luspatercept, which has been pegged to eventually generate peak sales of $2 billion. The biologic has been developed to manage anemia resulting from myelodysplastic syndrome (MDS) as well as beta thalassemia. The FDA expects to make its decision on the beta-thalassemia indication by December 4, while the MDS indication will be dealt with by April 4, 2020. The European review of the drug is also underway, the companies said on Tuesday.
→ Aurinia’s $AUPH largest shareholder is skeptical that the company’s leadership team is up to task commercializing its lead drug, voclosporin, as the Canadian biotech revs up late-stage studies in lupus and dry eye disease. Korea-based Iljin has nominated three independent directors to the eight-member board in an attempt to rein in insiders who they say have been placing self-interests above those of investors. Chief among the three nominees is Robert Foster, the ex-CEO of Isotechnika whom Iljin credits for the discovery of voclosporin. The other two, Soon-Yub (Samuel) Kwon and Myeong-Hee Yu, bring regulatory and scientific expertise, respectively. CEO Peter Greenleaf — recently appointed after stints at Cerecor, Sucampo and MedImmune — and chairman George Milne have previously urged investors to reject Iljin’s nominations.
→ In April, the chief medical officer of the embattled biotech Immunomedics $IMMU Robert Iannone said he was leaving the company to work in Pennsylvania to be “close to his family.” On Monday, it was revealed that the former AstraZeneca $AZN executive is headed to Jazz Pharmaceuticals $JAZZ, where he will lead global R&D.
→ Peanut allergy drug maker Aimmune $AIMT presented data from a rollover 28-week study on Tuesday that followed its landmark pivotal study. The results suggested that its treatment, AR101, can help patients tolerate higher doses of peanut protein, thus reinforcing the rationale for continued daily dosing of AR101 beyond one year, as tested in the late-stage PALISADE trial. An FDA approval decision for AR101 is expected in January 2020.
→ In a sign of China’s growing influence on global biotech, BeiGene chief John Oyler has been elected to BIO’s board of directors as well as the organization’s health section governing board.
→ Cambridge, Massachusetts-based Strand Therapeutics — which is focused on gene therapies — has secured a $6 million seed round led by Playground Global with participation from Alexandria Venture Investments, ANRI, and a group of private investors. “This capital will be instrumental to building out and scaling Strand’s mRNA programming technology,” said Jacob Becraft, the company’s co-founder and CEO, in a statement.