Healthcare Corner: Lens on CSL and Opthea

Healthcare Corner: Lens on CSL and Opthea

Summary

  • University of Queensland’s COVID-19 vaccine candidate, for which biotech player CSL is providing technical assistance, began human trials on 13 July 2020.
  • CSL had earlier announced the acquisition of exclusive global license rights from uniQure to commercialise an adeno associated virus (AAV) gene therapy program, AMT-061, for treating haemophilia B.
  • Ophthalmology- focussed biotech player Opthea’s Positive Phase 2a Trial data for OPT-302 in DME to be presented at the ASRS 2020 annual meeting.

The healthcare sector has been one of the top-performing industries in Australia over the last 12 months. Some healthcare sector players have witnessed an impressive surge in their share price in recent times, despite the COVID-19 pandemic-induced market instabilities.  The crisis has generated opportunities for the sector, including vaccine research & development, COVID-19 test kit manufacturing, and production and supply of masks, sanitisers, and PPEs, among others. Several biotech companies have taken part in developing a treatment/vaccine to combat this life-threatening viral infection.

Let us shed some light on two ASX-listed healthcare sector companies- CSL, OPT.

CSL Limited (ASX:CSL)

Melbourne-headquarters leading biotech Company CSL Limited is into the development and delivery of novel biotherapies as well as influenza vaccines for saving lives and providing support to patients having life-threatening diseases. CSL has its operations in over sixty countries with more than 26k employees across the globe.

Appointment of New Non-Executive-Director

On 16 July 2020, CSL stated that the Company had appointed Mr Pascal Soriot as an Independent Non-Executive Director, effective from 19 August 2020.

Mr Soriot, CEO of UK-based AstraZeneca (LON:AZN), is a highly experienced international business leader and has worked in a variety of senior pharmaceutical management positions in the US, Australia, Japan, France, and Switzerland.

Partnership with Queensland University & CEPI to develop COVID-19 vaccine; Human trials begin

On 13 July 2020, CSL stated that human trials for University of Queensland’s (UQ) COVID-19 vaccine candidate had begun with the first dose being administered to healthy volunteers.

CSL had earlier, in June, announced that it had entered a partnering agreement with UQ and CEPI (Coalition for Epidemic Preparedness Innovations) to fast-track the development, production and the delivery of COVID-19 vaccine candidate.

CSL to Acquire AMT-061 from uniQure

On 25 June 2020, CSL revealed that the Company had agreed to acquire exclusive global license rights from uniQure (NASDAQ:QURE) to commercialise an adeno associated virus (AAV) gene therapy program, AMT-061, for treating haemophilia B.

The AMT-061 program, in Phase 3 clinical trials at present, could possibly be among the first gene therapies to offer potentially long-term benefits to haemophilia B patients.

Under the agreement terms, upon closing the transaction, CSL will have the exclusive global right for commercialisation of AMT-061. uniQure will receive an upfront cash payment of US$450 million. The Company will further receive regulatory and commercial sales milestone payments & royalties. Also, uniQure will complete the Phase 3 clinical trial of AMT-061 and increase its manufacturing for early commercial supply under the agreed plan with CSL.

This acquisition will also improve the capabilities of CSL in its developing gene therapy portfolio.

TO KNOW MORE, DO READ: How is the Global Biotech Player CSL Limited Responding to COVID-19?

Stock Information: On 24 July 2020, CSL stock closed day’s trade at A$277.020 down by 1.912% from its previous close. The market cap of CSL stood at A$128.23 billion with approximately 454.05 million shares trading on the ASX.

Opthea Limited (ASX:OPT)

ASX-listed clinical-stage biologics drug developer Opthea Limited is focused on developing ophthalmic disease therapies. The Company has exclusive rights to a significant intellectual property portfolio around VEGF-C, VEGF-D and VEGFR-3 across the world. The intellectual property of Opthea is held within its wholly-owned subsidiary Vegenics Pty Ltd.

The product development programs of Opthea are focused on the development of OPT-302 for the treatment of wet AMD (age-related macular degeneration) and diabetic macular edema (DME).

Appointment of New Non-Executive Director

On 24 July 2020, Opthea revealed the appointment of Mr Lawrence Gozlan as a Non-Executive Director, effective from 24 July 2020.

The extensive global capital markets experience and in-depth knowledge of Mr Gozlan in the biotechnology industry, adds substantial value to the Board of Opthea as the Company plans to expand its operations and advance OPT-302 into late-stage of clinical development.

Clinical data of OPT-302 in DME to be presented at the ASRS 2020 annual meeting

On 23 July 2020, Opthea Limited revealed that Phase 1b/2a clinical trial findings of OPT-302 in DME patients refractory to anti-VEGF-A therapy would be presented at the forthcoming 2020 Virtual Annual Meeting of American Society of Retina Specialists (ASRS).

Mr Megan Baldwin, CEO and Managing Director, Opthea Limited commented-

Last month, Opthea had declared positive topline findings of its Phase 2a clinical trial evaluating safety as well as the efficacy of OPT-302 administered with Eylea® (aflibercept) in treatment of refractory patients with persistent DME.

The Company had disclosed that OPT-302 combination therapy was well-tolerated with a comparable safety profile to Eylea.

The Phase 2a clinical trial is a double-masked, randomised, sham-controlled, proof-of-concept clinical study conducted at fifty-three sites in the US, Australia, Latvia, and Israel.

Moreover, Opthea disclosed that this trial was performed in a difficult to treat refractory DME patients, and these initial findings support further later stage clinical investigation of OPT-302 in a bigger population of patients with diabetic macular edema.

In addition to the ongoing Phase 2a DME clinical trial, OPT will undertake development for Phase 3 clinical trial program in wet AMD, including regulatory engagement in Europe and the US, and to progress production of its OPT-302 for Phase 3 clinical studies.

Stock Information: Opthea last quoted at A$2.720, up 1.873% on 24 July 2020. With ~269.16 million shares trading on ASX and market capitalisation of OPT stood at A$718.65 million.          

 


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