Roche Reveals New Hemlibra Data, Extends Spark Merger Deadline

Roche Holdings AG RHHBY announced new data on hemophilia drug from multiple studies at the International Society on Thrombosis and Haemostasis (ISTH) 2019 Congress on Jul 6-10 in Melbourne, Australia.

The new analyses from phase III HAVEN studies support Hemlibra’s sustained efficacy, safety and quality of life benefit in patients suffering from hemophilia A, with and without factor VIII inhibitors.

A high proportion of patients experienced zero treated bleeds on Hemlibra, per the updated data from the pooled HAVEN studies (HAVEN 1, HAVEN 2, HAVEN 3 and HAVEN 4; n=400) in patients of all ages suffering from hemophilia A, with and without factor VIII inhibitors. Moreover, this was maintained over a median of 83 weeks. More than 87% of participants had no treated joint bleeds (either spontaneous or due to injury/trauma) and more than 92% of participants experienced no spontaneous bleeds in each interval from week 25 across all studies.

Updated data from the HAVEN 3 and HAVEN 4 studies demonstrated that Hemlibra prophylaxis offers a clinically meaningful improvement in long-term health-related quality of life versus previous episodic or prophylactic factor VIII treatment in people with hemophilia A, with and without factor VIII inhibitors as measured by the Haem-A-QoL questionnaire.

Data showed that across all four HAVEN studies, Hemlibra’s established safety and tolerability profile was maintained.

Moreover, results from the first interim analysis of the phase IIIb STASEY study in 88 patients reinforce the safety profile of Hemlibra as observed in the HAVEN 1 study.

We note that Hemlibra is approved in the United States and the EU for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients suffering from hemophilia A with factor VIII inhibitors based on the results of the pivotal HAVEN 1 and HAVEN 2 studies.

The new analysis of pivotal data suggests that additional factor treatment may not be needed for patients on Hemlibra undergoing certain minor surgeries.

The uptake of the drug has been encouraging so far and further diversified Roche’s portfolio. The company is currently looking to diversify its portfolio in wake of stiff competition from biosimilars for key drugs, such as Avastin, Rituxan and Herceptin from Novartis NVS and Amgen AMGN.

The stock has gained 11.6% in the year so far compared with the industry's 1.9% growth.

 

Meanwhile, Roche and Spark Therapeutics ONCE have agreed to extend the date of the completion of their merger by three months to Apr 30, 2020. Both the companies had earlier expect to complete the merger by Jan 31, 2020. This will provide the companies with additional time to satisfy the regulatory conditions. The acquisition was announced earlier in the year.

Zacks Rank

Roche currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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