Two missed PDUFA dates in the past two years have come and gone, but now the U.S. FDA has approved Daxxify (daxibotulinumtoxinA-lanm) for treating cervical dystonia in adults nearly a week ahead of its Aug. 19 PDUFA date. Approval of the sBLA for the injectable, peptide-formulated neuromodulator went to Revance Therapeutics Inc. The drug’s original approval was for treating glabellar lines, better known as frown lines, came in September 2022. Daxxify is the first neuromodulator stabilized with Revance’s peptide exchange technology. Revance estimates the cervical dystonia market to be worth about $345 million and the neuromodulator market to be worth about $2.5 billion.
Harmony taking over Zynerba in $200M CVR deal
Harmony Biosciences Holdings Inc. inked a deal to acquire Zynerba Pharmaceuticals Inc. for about $1.10 per share in cash, or $60 million altogether, plus one non-tradeable contingent value right per share, which represents the right to potentially bank additional payments of up to $140 million if clinical, regulatory and sales milestones are hit. Zynerba is developing transdermal cannabinoid therapies for orphan neuropsychiatric disorders, including fragile X syndrome, where Zygel is being evaluated in a pivotal phase III trial called Reconnect. The compound also has shown positive signals in an open-label phase II effort in 22q11.2 deletion syndrome. Shares of Harmony (NASDAQ:HRMY) were trading midday at $31.97, down 6 cents. Stock of Zynerba (NASDAQ:ZYNE), based in Devon, Pa., were selling for $1.29, up 95 cents, or almost 280%.
Prizes in place of Rx patents not the cure needed
A recent bipartisan request for funding of a study on replacing U.S. drug patents with cash prizes is just one more symptom of a larger global malady that makes patents the scapegoat for bigger problems that have nothing to do with intellectual property, David Kappos, board co-chair of the Council for Innovation Promotion, told BioWorld. Other symptoms such as the European Commission’s proposed compulsory licensing initiative and the World Trade Organization’s COVID-19 IP waivers have intensified in the wake of the pandemic, as policymakers blamed patents for inequitable global access to vaccines, tests and treatments. While supply chain problems, pricing and reimbursement issues need to be addressed, they will not be resolved by curtailing patents, Kappos said.
Purdue bankruptcy saga stretches on and on
How long does it take for a U.S.-based biopharma company to complete a bankruptcy? In the case of privately held Purdue Pharma LP, the answer is likely five years or more. The company filed for bankruptcy nearly four years ago in its first step toward reorganizing as a new public benefit company after reaching, in principle, a broad nationwide opioid settlement revolving around its sales of Oxycontin (oxycodone). But the U.S. Supreme Court last week put that plan on hold when it issued a temporary stay and called for oral argument in December.
Kelun’s Trop2 ADC meets primary endpoints in phase III triple-negative breast cancer trial
Kelun-Biotech Biopharmaceutical Co. Ltd.’s Trop2-targeted antibody-drug conjugate, SKB-264, met the primary endpoint of progression-free survival in a phase III trial in patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer, according to an interim analysis. The randomized, controlled, open-label, multicenter phase III trial compared injectable SKB-264 (also known as KL-A264 and MK-2870) vs. investigator-selected regimens in patients who failed second-line or above prior standard-of-care therapies. The trial began in August 2022.
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