Pfizer Inc. PFE and Eli Lilly and Company LLY announced that a higher dose of their NGF inhibitor, tanezumab, met the primary endpoint in a phase III study, evaluating it in patients with chronic low back pain (“CLBP”).
In the past six months, shares of Pfizer have risen 1% compared with the industry’s gain of 1.6%.
The phase III study evaluated two dosages – 5 mg or 10 mg – of tanezumab, a non-opioid candidate, subcutaneously administered every eight weeks for 56 weeks in patients with moderate-to-severe CLBP, followed by 24-week safety follow-up period. The eligible patients experienced inadequate relief or are intolerant to analgesics and suffering from the disease for more than three consecutive months.
Top-line data from the study showed that treatment with the 10 mg dose of tanezumab led to a statistically significant improvement in pain compared to placebo after 16 weeks of treatment. Although the lower dose of 5mg demonstrated numerical improvement in pain compared to placebo, it did not achieve statistical significance. Detailed results from the study will be submitted for future scientific publication and presentation.
The company estimates that there are 8 million patients with moderate-to-severe CLBP in the United States, which represents a significant opportunity for the candidate as currently available therapies do not have adequate patient response.
Apart from CLBP, tanezumab is also being developed for other pain indications, osteoarthritis and cancer pain. The companies have successfully completed two late-stage studies evaluating tanezumab in patients with osteoarthritis pain.
Tanezumab works by inhibiting nerve growth factor, which suppresses pain signal in the body. Its approval will provide a safer pain medication for patients in the United States where opioid abuse is widespread and patients are largely underserved by the existing medications.
We remind investors that Regeneron Pharmaceuticals, Inc. REGN and Teva Pharmaceutical Industries Limited TEVA are also developing a NGF antibody, fasinumab for treating osteoarthritis pain.
In a separate press release, Pfizer announced that the European Commission has granted approval to Zirabev (bevacizumab), its biosimilar version of Roche’s cancer drug, Avastin. Zirabev is approved for the treatment of several cancer indications, for which the reference product is approved like colon cancer, metastatic breast cancer, unresectable advanced, metastatic or recurrent non-small cell lung cancer (“NSCLC”), among others.
This is Pfizer’s second oncology biosimilar to be approved in Europe, the first being Roche’s another cancer drug, Herceptin. Meanwhile, Zirabev is also under review in the United States along with biosimilar versions of Rituxan and Herceptin with FDA decisions on all expected in 2019.
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