27 July 2015. Pharmaceutical maker Allergan plc is acquiring Naurex Inc., a designer of fast-acting therapies for depression and other neurological disorders, for $560 million. The deal covers Naurex’s products now in clinical trials, with the company’s technology platform and preclinical research spun-off into a new enterprise.
Naurex, a spin-off company from Northwestern University in Evanston, Illinois, develops drugs for diseases of the central nervous system that stimulate N-Methyl-D-aspartate (NMDA) receptors, molecules found in synapses, a part of nerve cells that permit sending and receiving of signals. NMDA receptors help keep synapses flexible, which affects memory, learning, and development of the central nervous system. Naurex uses this platform to discover drugs to treat mood and anxiety disorders, cognitive disorders, neurodegenerative diseases, developmental disorders, neuropathic pain, and addiction.
Naurex’s lead product is rapastinel, being tested as a back-up drug for patients with major depressive disorder not responding to earlier antidepressants. In an intermediate-stage trial, a single dose of rapastinel was tested against a placebo with 300 patients who did not respond to earlier antidepressants. The company says initial findings show the drug acted quickly, within 24 hours, to reduce depression scores on the standard Hamilton Depression Rating Scale, compared to patients receiving the placebo, with results lasting several days.
Naurex says rapastinel is ready for late-stage clinical trials as a once-a-week intravenous therapy. The drug is also in trials as a treatment for obsessive-compulsive disorder.
A more advanced product, code-named NRX-1074, is a follow-on medication to rapastinel, and while chemically similar, is more potent and can be given in oral form as a primary therapy. In January 2015, Naurex reported on an intermediate-stage trial of NRX-1074 in intravenous form, given in doses of 1, 5, and 10 milligrams against a placebo. Tests of the drug as an oral therapy are planned for later.
The results show patients receiving the highest (10 milligram) dose of NRX-1074 had ratings on the standard Hamilton scale 14 points lower than patients receiving the placebo, as soon as 1 day following treatment. According to Naurex, the effect size of the antidepression efficacy — a quantitative measure of strength of a statistical relationship — after 24 hours is more than twice the effect size reported for other antidepression drugs taken in multiple doses over 4 to 6 weeks. In addition, 72 percent of patients receiving the highest NRX-1074 dose reported a reduction of half or more in Hamilton scale scores after 24 hours, compared to 39 percent for patients receiving the placebo.
The agreement gives Allergan ownership of Naurex’s two clinical stage products, but the technology platform designing therapies that stimulate NMDA receptors and Naurex’s preclinical research will be spun-off to a separate, as yet unamed, company. Allergan, however, will collaborate with the new enterprise on discovery of therapy candidates for psychiatric and neurological disorders, and will have first rights to license these candidates from that company.
Under the deal, Allergan is paying Naurex’s shareholders $460 million immediately, and another $100 million by January 2016. Allergan, in Dublin, Ireland, says it is focusing on development of new branded drugs, and also announced yesterday the sale of its generic drug business to Israeli manufacturer Teva Pharmaceutical Industries for $40.5 billion. Earlier this month, Allergan licensed from drug maker Merck therapies for treatment and prevention of migraines for $250 million, plus milestone and royalty payments.
Naurex was founded by Northwestern University biomedical engineering professor Joseph Moskal, who is also the company’s chief scientist. At Northwestern, Moskal is director of the university’s Falk Center for Molecular Therapeutics that calls itself a “new organizational model … to translate discoveries with therapeutic potential into clinically useful compounds.”
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Hat tip: FirstWord Pharma
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