Symbio Confirms Treakisym’s In-House Commercialization Post Patent Expiration in 2020e

Asia Healthcare Analyst, Pathology Associates Limited

Dion Stéfan Büchner M.D., FCAP

Asia Healthcare Analyst

Pathology Associates Limited

Equity Bottom-Up

Symbio Pharmaceuticals / Equity Bottom-Up

Announcement – <a href="https://www.smartkarma.com/entities/10456" target="_blank" data-smartkarma-citation="entities:10456:1">Symbio Pharmaceuticals (4582 JP)</a> on September 27, 2018, announced that it has filed a partial change application for marketing approval of Treakisym (bendamustine hydrochloride) as a pre-treatment to regenerative medical products (<a href="https://www.symbiopharma.com/news_e/20180927e.pdf" target="_blank">link</a>).Our Take – It is yet another positive development relating to Treakisym and instils further confidence in its ability to drive topline and earnings growth for Symbio over the medium to long term.<ul>
<li>
Kymriah ( <a href="https://www.smartkarma.com/entities/26851" target="_blank" data-smartkarma-citation="entities:26851:1">Novartis AG (NOVN SE)</a>, filed April 2018) is well on its way to becoming the first CAR-T therapy to be approved in Japan for R/R ALL and R/R DLBCL</li>
<li>The announcement implies that Symbio’s Treakisym could be used as a pre-treatment to Kymriah.</li>
<li>We anticipate Kymriah approval in 1Q FY19 and as such Treakisym could start generating revenue in R/R DLBCL much earlier than our expectation (expected launch in FY21e).</li>
<li>However, given Kymriah’s limited target population (late stage R/R ALL and R/R DLBCL patients), we estimate only incremental contribution from Treakisym until it gets MHLW approval for R/R DLBCL indication in around FY21e</li>
<li>Having said that, the announcement (despite having only incremental financial impact in the short term), adds to a series of positive news related to Treakisym recently, including: <ul>
<li>approval in combination w/ CD-20 antibodies,</li>
<li>inclusion as Standard of Care therapy for malignant lymphoma by JSH (Japan Society of Hematology)</li>
</ul>
</li>
</ul>

Announcement – Symbio Pharmaceuticals (4582 JP) on September 27, 2018, announced that it has filed a partial change application for marketing approval of Treakisym (bendamustine hydrochloride) as a pre-treatment to regenerative medical products (link).Our Take – It is yet another positive development relating to Treakisym and instils further confidence in its ability to drive topline and earnings growth for Symbio over the medium to long term.

Kymriah ( Novartis AG (NOVN SE), filed April 2018) is well on its way to becoming the first CAR-T therapy to be approved in Japan for R/R ALL and R/R DLBCL
The announcement implies that Symbio’s Treakisym could be used as a pre-treatment to Kymriah.
We anticipate Kymriah approval in 1Q FY19 and as such Treakisym could start generating revenue in R/R DLBCL much earlier than our expectation (expected launch in FY21e).
However, given Kymriah’s limited target population (late stage R/R ALL and R/R DLBCL patients), we estimate only incremental contribution from Treakisym until it gets MHLW approval for R/R DLBCL indication in around FY21e
Having said that, the announcement (despite having only incremental financial impact in the short term), adds to a series of positive news related to Treakisym recently, including: 
approval in combination w/ CD-20 antibodies,
inclusion as Standard of Care therapy for malignant lymphoma by JSH (Japan Society of Hematology)




Treakisym to Be Used as a Pre-Treatment To CAR-T Therapy