1. In Vivo
  2. >>Leadership

Stryker Misses the Goal with OP-1

Analysts watching the progress of Stryker's OP-1, the first orthobiologic device to deliver a manufactured bone growth-inducing protein, have long been aware that the design for the product's pivotal clinical trial had its shortcomings. Nonetheless, a US approval appeared likely, especially after the CPMP unanimously recommended the product for European approval on January 3. But three weeks later, FDA sent Stryker a not-approvable letter. As it turned out, however, the OP-1 news, coincident with the company's announcement of strong financial results for 2000, barely put a dent in its stock price.

Analysts watching the progress of Stryker Corp. 's OP-1, the first orthobiologic product to deliver a manufactured bone growth-inducing protein, have long been aware that the design for the product's pivotal clinical trial had its shortcomings. Only 100 patients were enrolled, the label indication—for the treatment of tibial nonunion fractures—was narrow, and both the treatment and control arms of the study used nails to fix the fractures, making it more difficult to ascribe any clinical benefit directly to OP-1.

Nonetheless, a US approval appeared likely, especially after the CPMP unanimously recommended OP-1(osteogenic protein-1, also known as bone morphogenetic protein-7...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on In Vivo for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Leadership

Rising Leaders 2025: Doxie Jordan, From UNC Graduate To Global Market Strategist

 
• By Jo Shorthouse

Bristol Myers Squibb executive Doxie Jordan discusses his path to global commercial leadership and the principles guiding pharmaceutical market strategy

Podcast: Brain+ CEO Discusses “Groundbreaking” Potential Of CST Assistant For Dementia Patients

 
• By Anabel Costa-Ferreira

Devika Wood, CEO of Brain+, explains the importance of developing health tech solutions for dementia and the growing need to both raise awareness and improve overall access to nondrug interventions like CST.

Behind The Buyout: Dispatches From The Dealmaking Table

 
• By Jo Shorthouse

In a challenging funding environment for biopharma, strategic dealmaking has become a critical growth engine. In Vivo explores what it truly takes to navigate high-stakes acquisitions and partnerships, drawing on insights from seasoned industry leaders.

Rising Leaders 2025: Ovid’s Meg Alexander On Neurology’s Next Frontier

 
• By Jo Shorthouse

Ovid Therapeutics' president and COO Meg Alexander is leading the company’s strategic pivot toward innovative neurological treatments, potentially creating a new class of medicines for rare neurological disorders.

More from In Vivo

Crisis Or Opportunity? US MFN Policy Could Test Japan’s Appetite For Reforms

 
• By Lisa Takagi

While the adoption of most favored nation drug pricing in the US stands to affect Japanese biopharma firms now heavily reliant on this market, it might also present an opportunity for pricing and policy reforms at home.

Rising Leaders 2025: Ovid’s Meg Alexander On Neurology’s Next Frontier

 
• By Jo Shorthouse

Ovid Therapeutics' president and COO Meg Alexander is leading the company’s strategic pivot toward innovative neurological treatments, potentially creating a new class of medicines for rare neurological disorders.

The Goldilocks Isotope: Perspective Therapeutics’ ‘Just Right’ Alpha Radiotherapeutic

 
• By David Wild

Thijs Spoor's bet on lead-212 is paying off as Perspective Therapeutics advances three clinical programs with promising early efficacy signals and a comprehensive manufacturing strategy.