Pfizer and Lilly Announce Top-Line Results From Long-Term Phase 3 Study of Tanezumab in Patients With Osteoarthritis

Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today
announced top-line results from a Phase 3 study evaluating tanezumab 2.5
mg and 5 mg. The objective of the study was to compare the long-term
joint safety and 16-week efficacy of tanezumab relative to nonsteroidal
anti-inflammatory drugs (NSAIDs) in patients with moderate-to-severe
osteoarthritis (OA) of the hip or knee. The tanezumab 5 mg treatment arm
met two of the three co-primary efficacy endpoints, demonstrating a
statistically significant improvement in pain and physical function
compared to NSAIDs at the 16-week analysis, while patientsa?? overall
assessment of their OA was not statistically different than NSAIDs.
Patients who received tanezumab 2.5 mg did not experience a
statistically significant improvement in pain, physical function or
patientsa?? overall assessment of their OA at 16 weeks compared to NSAIDs.
In the safety analysis, there was a higher rate of joint safety events
in the tanezumab arms compared to NSAIDs at 80 weeks; the difference was
statistically significant. Joint safety was a composite measure
consisting of adjudicated outcomes of rapidly progressive osteoarthritis
(RPOA) type 1 or type 2, subchondral insufficiency fracture,
osteonecrosis or pathological fracture. Tanezumab is a monoclonal
antibody that is part of an investigational class of non-opioid chronic
pain medications known as nerve growth factor (NGF) inhibitors.

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"We are analyzing these findings in the context of the recent Phase 3
results as we assess potential next steps for tanezumab,a?? said Ken
Verburg, tanezumab development team leader, Pfizer Global Product
Development. "We plan to review the totality of data from our clinical
development program for tanezumab with regulatory authorities.a??

"Lilly and Pfizer recognize the significant unmet needs for patients
living with osteoarthritis,a?? said Christi Shaw, president, Lilly
Bio-Medicines. "We are committed to understanding these results for
people who suffer from chronic pain.a??
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