biOasis Technologies Ord Shs V.BTI.H

RE:Chiesi receives positive CHMP opinion this morning:

[G1945V]

prophetoffactz wrote: Chiesi has been trying to build a strategic position in Lysosomal Storage Disorders. This week it became the the first company to have FDA approval for an enzyme to treat alpha-mannosidosis. Being able to offer Lysosomal Storage Disorder products that no other company has would potentially give Chiesi a strategic advantage with its overall Lysosomal Storage Disorder portfolio. Today Chiesi has further received a positive CHMP opinion from European regulators for its key Fabry asset. Chiesi has signed a potential billion dollar deal with Protalix for this opportunity that could be the emerging standard-of-care in the multi-billion dollar Fabry market globally. I believe that there is a very high correlation between a positive CHMP opinion from the European regulators and ultimate approval in both Europe and the US. Chiesi may now be well on its way to becoming a strategic player in Lysosomal Storage Disorders. The FDA PDUFA date is May 9, 2023 which is now only about 2 1/2 months away.

Lysosomal Storage was one of the key focus areas for Chiesi as it builds its rare diseases division. With Denali potentially not having access to Chiesi's Fabry asset and Chiesi also having the only FDA approved enzyme for alpha-mannosidosis Chiesi's strategic interest in xB3 may have become that much more important this week as the industry rushes to treat the brain too for these disorders. Rathjen licensed only 4 LSD opportunities to Chiesi and kept the rest of the opportunity including the large Hunter opportunity and the largest Lysosomal Storage opportunity of all Gaucher's. BTI anticipated releasing Hunter data in Q2 in a Biodexa presentation. BTI also controls xB3-004 and has talked about its potential for Fabry in the past. BTI's strategic focus has been Lysosomal Storage Disorders, inflammation, and neurodegenration. Given Chiesi's emerging strategic interest in Lysosomal Storage and its potential increasing strategic interest in xB3 a second deal between BTI and Chiesi could be interesting. This could be of additional significance given Chiesi's work on xB3 since signing its US$138 million deal plus royalties for xB3 over 2 1/2 years ago. How close is it now to an xB3 IND given its work on xB3 to date? BTI's Mei Mei, Rathjen, and Saltarelli have been on Chiesi's xB3 Advisory Board and Lysosomal Storage Disorders, inflammation, and neurodegeneration have emerged as BTI's strategic focus. Saltarelli has stayed with BTI. Midatech was also highly positive on BTI's partnerships recently. BTI has had to try to give birth to a horse that it could ride given the difficulties with Herceptin. Lysosomal Storage Disorders, inflammation, and neurodegeneration may now be increasingly validated. Cresence's Phase II ready EGF assets also treat inflammation and neurodegeneration.

Chiesi has recognized the potential for xB3 beyond just Lysosomal Storage Disorders previously.

BTI news release:

“With this collaboration, we are taking our commitment to bringing innovative therapies to rare disease patients, including those living with LSDs, to an entirely new level,” said Giacomo Chiesi, Head of Chiesi Global Rare Diseases, a business unit of Chiesi Group. “The unique delivery method of their xB3 platform has the potential to overcome a significant challenge in the treatment of many neurological disorders, which is the ability to cross the blood brain barrier. We look forward to working closely with the Bioasis team in advancing several new LSD clinical development programs using this technology platform.”

“We are very pleased to have entered into this agreement and excited to be working with Chiesi Group, a global company with a strong commitment to bringing innovative treatments to patients with LSDs,” said Deborah Rathjen, Ph.D., Bioasis’ Chair and Chief Executive Officer. “Neurological complications of LSDs remain largely untreatable when peripheral symptoms of disease respond to enzyme replacement therapy. Our xB3 BBB drug delivery platform has the potential to significantly advance the treatment of LSDs and the use of enzyme replacement therapy, solving one of the major unmet needs and improving the lives of patients.”

pof/fact: Can you please show a dated origin of what you posted for some of us that don't follow BTI that closely.

TIA
G1945V