Leading developer of allogeneic (off-the shelf) cellular medicines, Mesoblast Limited (ASX: MSB) has provided the corporate review of the company, following which the share price of the company increased by 4.519 percent as on 28 December 2018.
In the corporate review, the company’s Chief Executive Dr. Silviu Itescu told that Mesoblast is going to enter 2019 with the most mature cell therapy product pipeline and technology platform in the regenerative medicine industry. The company’s two commercial products have already been approved and marketed by the Company’s licensees JCR Pharmaceuticals Co, Ltd in Japan and Takeda Pharmaceutical Company in Europe.
Recently, the company entered into a strategic cardiovascular partnership for China with Tasly Pharmaceutical Group and is in advanced and active discussions with various potential global commercialization partners to maximize the value proposition of each of its blockbuster cell therapy candidates. He also informed that the Company is having enough cash to achieve key commercial milestones.
In the first quarter of 2019, Mesoblast is planning to start the Food and Drug Administration (FDA) process of filing a Biologics License Application (BLA) for market authorization of remestemcel-L in the United States which will further support the company’s confidence in the U.S. market access plan.
In Japan, the company is already having a licensee JCR Pharmaceuticals which markets TEMCELL®1 HS Inj. for children and adults with aGVHD. TEMCELL has achieved substantial adoption rates in just over 2.5 years, and this achievement further underpins the Mesoblast’s market access plan in the U.S.
The company is already in the process of establishing a focused sales team that will target the principal U.S. transplant centers as soon as the company gets the FDA Approval.
In the first half of 2019, the company is planning to meet with the US FDA authority to discuss a potential approval of its product Revascor (MPC-150-IM) as this product has demonstrated meaningful outcomes in the trials by reducing major GI bleeding episodes by 76% and associated hospitalization events by 65%. In a meeting in 2018, the FDA has advised Mesoblast that reduction in major GI bleeding in left ventricular assist device (LVAD) patients is considered a clinically meaningful outcome by the FDA and an acceptable endpoint for product approval.
Further, Mesoblast also believes that its product candidate MPC-06-ID could fulfill the US need of a therapy that can offer both a durable reduction in pain and improvement in function without the risk of opioid addiction. MPC-06-ID’s Phase 2 data outcomes are supporting the ongoing Phase 3 trial which has already demonstrated that intra-discal injection of MPC-06-ID could reduce pain and improve function in patients. The company is intending to select and secure an ideal strategic partner to maximize the value creation potential inherent in MPC-06-ID.
In the last six months, the share price of the company decreased by 29.25 percent as on 27 December 2018. MSB’s shares traded at $1.087 with a market capitalization of circa $517.26 million as on 28 December 2018 (AEST 12:47 pm).
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