Lonza to continue narsoplimab manufacture for Omeros

By Vassia Barba contact

- Last updated on GMT

(Image: Getty/4X-image)
(Image: Getty/4X-image)

Related tags: Lonza, Omeros, Partnership, CDMO

Lonza extends its deal with Omeros for the commercial manufacture of a treatment for thrombotic microangiopathy, ahead of filing with the US FDA and the EMA.

Seattle, US-based Omeros Corporation has developed OMS721 (narsoplimab), a human monoclonal antibody (mAb) targeting mannan-binding lectin-associated serine protease-2 (MASP-2), for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).

The deal extends Lonza’s multi-year manufacturing agreement with Omeros, in which the former provides the clinical supply of narsoplimab.

The two companies have now decided to extend the partnership for the product’s commercial manufacture, ahead of anticipated regulatory approvals.

Omeros will submit a biologics license application (BLA) and a marketing authorization application (MAA) to the US Food and Drug Administration (FDA) and to the European Medicines Agency (EMA), respectively.

To date, there is no approved product for the treatment or prevention of HSCT-TMA, and narsoplimab is the only drug in development for the treatment of HSCT-TMA filed for FDA’s designation.

The company has reached an agreement with the FDA regarding the primary endpoint of the product’s trials, with the company suggesting​ it is ‘confident’ that its study and treatment will be able to meet.

According to the company, the primary endpoint requires the investigational drug to show both a beneficial effect on the underlying HSCT-TMA disease and a meaningful improvement in patients’ clinical status. It also includes laboratory measures and markers of organ function, as well as platelet and red blood cell transfusion burden.

The drug product is also currently being investigated by Omeros as a potential treatment for immunoglobulin A (IgA) nephropathy, atypical hemolytic uremic syndrome (aHUS), lupus nephritis and other renal diseases.

The company has previously commercialized Omidria (phenylephrine and ketorolac intraocular), which is indicated for the prevention of intraoperative floppy iris syndrome (IFIS),

While Lonza has been investing in its drug substance production, with its most recent announcement to be the expansion​ of its bioconjugation facility in Visp, Switzerland producing antibody-drug conjugates.

Regarding monoclonal antibody (mAb) manufacture, the contract development and manufacturing organisation (CDMO) has also recently agreed​ to provide manufacturing for Alector’s Phase I drug candidates for neurodegenerative diseases.

Related news

Show more

Related products

show more

Seasonal Vaccine Manufacturing

Seasonal Vaccine Manufacturing

Baxter BioPharma Solutions | 10-Feb-2021 | Technical / White Paper

The production of seasonal vaccines, such as those for influenza, presents unique challenges to manufacturers due to the necessary time constraints resulting...

Consideration and Options for Prefilled Syringes

Consideration and Options for Prefilled Syringes

Baxter BioPharma Solutions | 10-Feb-2021 | Technical / White Paper

Convenience, product differentiation, and less waste are great reasons for developing a product in a prefilled syringe. Baxter’s whitepaper describes the...

Rapid Biosafety Testing Enables the Future of Manufacturing

Rapid Biosafety Testing Enables the Future of Manufacturing

Viral Safety for mAb: Prevent, Detect, Remove | 23-Nov-2020 | Technical / White Paper

This white paper explores the factors driving the evolution toward faster biosafety testing and describes rapid approaches for adventitious agent testing...

Related suppliers

Follow us

Products

View more

Webinars