Denmark's Gubra to collaborate with Bayer on peptides; Samsung and Biogen receive FDA approval for Lucentis biosimilar
Danish biotech Gubra announced a research collaboration and license agreement with Bayer to develop peptide therapeutics to treat cardiorenal diseases. The collaboration will utilize Gubra’s peptide drug discovery platform to identify potential candidates.
This is not the first time Gubra has partnered with a company on peptide therapeutics — they partnered with Boehringer Ingelheim back in 2017 to create peptide therapeutics to treat obesity.
“We are very pleased to enter this research collaboration and license agreement with Bayer,” said Gubra CEO Henrik Blou in a statement. “We are pleased that the potential of our technology is being recognized by such a qualified partner capable of advancing innovative medicines into the clinic.”
As part of the agreement, Gubra will receive an undisclosed payment upfront, as well as up to $253 million for reaching development and commercialization milestones.
Samsung and Biogen receive FDA approval for Lucentis biosimilar
Samsung Bioepis and Biogen announced today that the FDA has approved Lucentis biosimilar Byooviz for three indications:
- Neovascular (wet) age-related macular degeneration (AMD)
- Macular edema following retinal vein occlusion (RVO)
- Myopic choroidal neovascularization (mCNV)
While Byooviz is the first ophthalmology biosimilar approved in the United States, this approval was likely a matter of time as CHMP had recommended the drug’s approval back in June.
Byooviz was approved in Europe on August 18 and in the UK on August 31.
“We are very excited to be able to open a new chapter with the approval of Byooviz in the US,” said Biogen SVP and global head of biosimilars Ian Henshaw in a statement.
How much will BYOOVIZ cost? Biogen spokesperson Allison Parks declined to say.
“Because we’re not launching until June, it’s too preliminary to announce pricing,” Parks told Endpoints News. “We will work in partnership with external stakeholders, including payers and providers to ensure a predictable and sustainable access position is developed for BYOOVIZ.”
Synlogic unveils data from multiple clinical studies on PKU
Massachusetts biotech Synlogic announced positive data from clinical studies looking at two engineered microbes to treat phenylketonuria, or PKU — SYNB1618 and SYNB1934.
SYNB1618 showed reductions of phenylalanine (Phe) at different dose levels, across multiple time points, in an interim analysis of a Phase II SynPheny-1 study. SYNB1934, an optimized strain evolved from SYNB1618, showed two-fold higher activity than SYNB1618 in a head-to-head Phase I study in healthy volunteers, as measured by biomarkers of Phe metabolism.
Based on these clinical data, Synlogic will start planning a pivotal Phase III study.
“These events mark a major milestone for Synlogic’s Synthetic Biotic platform. We look forward to completing our Phase 2 SynPheny-1 study and advancing the PKU program into a pivotal study,” said Synlogic president and CEO Aoife Brennan in a statement.
GlaxoSmithKline to embark on clean energy investment
As GSK CEO Emma Walmsley participated at the opening event for New York Climate Week, GSK announced major updates on efforts to achieve certain environmental goals, including major new investment in renewable electricity at manufacturing sites in the UK and US.
There is also a new initiative to reduce greenhouse gas emissions from its metered dose asthma inhalers, which account for almost half of the company’s carbon emissions.
“For GSK, our sustainability commitments are an integral part of our strategy, making our business more resilient, protecting our operations and ultimately helping us to achieve health impact on a global scale while delivering returns for our shareholders,” said Walmsley.
GSK said these investments also coincided with confirmation of the global pharmaceutical and medical technology sector reaching the Race to Zero ‘breakthrough’ target of 20% of major companies (by revenue) committing to net zero carbon emissions by 2050.
FDA accepts Marinus’s NDA on epilepsy seizure treatment
Marinus Pharmaceuticals announced today that the FDA accepted Marinus’ NDA for the use of ganaxolone in the treatment of seizures associated with rare genetic epilepsy CDKL5 deficiency disorder.
The NDA was granted priority review and the FDA assigned a PDUFA action date of March 20, 2022. In its acceptance letter, the FDA indicated that it is not currently planning to hold an advisory committee meeting to discuss the application.
“We believe that ganaxolone has the potential to provide meaningful clinical benefit for patients and we look forward to working closely with the FDA during the review process,” said Marinus CEO Scott Braunstein in a statement.
Ganaxolone received orphan drug designation and Rare Pediatric Disease (RPD) designation for CDD in June 2017 and July 2020, respectively.
The acceptance of the NDA for filing enables the biotech to draw $30 million under its May 2021 financing agreement with investment firm Oaktree Capital Management, based on certain conditions described in the credit agreement. If the NDA is approved by the end of next year, an additional $30 million is available under the agreement.