Novartis generics arm files for MS biosimilar, challenging Biogen; Pluristem shortens name
Novartis’ generics arm Sandoz said it has submitted applications for a multiple sclerosis and Crohn’s disease biosimilar.
The drug is a biosimilar for Biogen’s Tysabri, known generically as natalizumab. According to Sandoz, in patients with relapsing-remitting MS, the biosimilar matched Tysabri in both efficacy and safety. Its BLA for the biosimilar has been accepted by both US and EU authorities, Sandoz said.
Tysabri was first approved in 2004 for relapsing forms of MS, and then approved in 2008 for Crohn’s disease. The drug is one of the earliest in Biogen’s suite of MS therapies. Biogen is also facing sliding sales for its backbone MS drug Tecfidera due to generic competition, and in March was denied a rehearing after it lost its appeal for a Tecfidera patent late last year.
In 2021, Biogen made just over $2 billion on Tysabri sales, and $1.95 billion in Tecfidera sales, down from $3.8 billion the year before.
Sandoz said it would be pursuing all indications in which Tysabri is approved for its biosimilar version, which was developed by Polpharma Biologics.
In other news, earlier this month, a Sandoz spokesperson addressed rumors that Novartis might spin off its generic arm, telling Endpoints News that Novartis would make that decision by the end of the year. — Lei Lei Wu
Two weeks after failing late-stage muscle injury trial, Pluristem rebrands as Pluri
A winding road of attempting to regenerate muscles after hip fracture surgery, treat respiratory issues in patients with Covid-19, and address a host of other diseases and hematological deficiencies has led an Israel-based biotech to switch up its name.
The rebranding comes at Pluristem Therapeutics, or Pluri, as it now wants to be known by. Two weeks ago, the company’s intramuscular administration of allogeneic PLX-PAD cells failed to meet the primary endpoint in a Phase III study attempting to treat muscle injury after hip fracture operation.
The biotech also flamed out in the lung condition acute respiratory distress syndrome, in association with Covid-19 patients, in a mid-stage study late last year.
Going forward, Pluri will trade on Nasdaq as $PLUR instead of $PSTI. The reasoning? Pluri is positioning therapeutics as just a portion of its plans — food-tech, agri-tech, biologics and other medical research all fall under the company’s ambitions. That’s inclusive of partnerships aimed at “global wellbeing and sustainability,” including teaming up with Israel food producer Tnuva Group in February to create cell-based products in the field of cultured meat via a new company 84% owned by Pluristem.
“Like our new logo’s dot-connecting arch suggests, it is time for Pluri to move from this single point to next generation products across a range of fields,” CEO Yaky Yanay said in a statement. — Kyle LaHucik