The exclusive rights to commercialization rights to SRP-9001, the United States based pharma biotech company Sarepta’s investigational gene therapy for Duchenne muscular dystrophy (DMD), will be bought by Basel, Switzerland-based Roche in a $1.15 billion deal. The deal will allow Roche to launch and sell the product outside of the US. Royalties on sales and up to $1.7 billion in regulatory and sales milestones is also included in the deal.
The news of the deal resulted in a 9.4 per cent gain in the shares of the Cambridge, Massachusetts-based Sarepta on the Nasdaq. On the other hand, there was no movement in the shares of Roche that trades on the SIX Swiss Exchange.
A 40-patient, randomized and placebo-controlled Phase II study is currently being conducted for the SRP-9001 therapy which was started about a year ago. It has its protocol page listing sites at the University of California Los Angeles and Nationwide Children’s Hospital in Columbus, Ohio. Two therapies for DMD, both antisense oligonucleotide drugs are currently marketed by the company. These therapies include Exondys 51 (eteplirsen), for DMD involving a gene amenable to exon 51 skipping and Vyondys 53 (golodirsen), which won approval earlier this month for patients in whom the gene is amenable to exon 53 skipping.
Pfizer’s PF-06939926 and Audentes Therapeutics’ AT132 are the other gene therapies in development for DMD. Acquisition of Audentes by Astellas Pharma for $3 billion was announced earlier this month while the decision to acquire another developer of gene therapies for DMD, Exonics Therapeutics, was announced in June by Vertex Pharmaceuticals in a del worth $245 million.
“This collaboration will not only increase the speed with which SRP-9001 could benefit DMD patients outside the United States, but will also greatly expand the scope of territories within which we could potentially launch SRP-9001 and improve and save lives,” Sarepta CEO Doug Ingram said in a statement. “In addition to the validation that comes from joining forces with Roche, this licensing agreement – one of the most significant ex-U.S. licensing transactions in biopharma – will provide Sarepta with the resources and focus to accelerate our gene therapy engine and, if successful, bring SRP-9001 to patients as quickly as possible, potentially transforming the lives of countless DMD patients across the globe.”
The fact that Roche has greater ability to advance SRP-9001’s approval and commercialization much faster than Sarepta would be able to do on its own supports the assumption that the deal “incredibly value creating” for Sarepta, said Cowen analyst Ritu Baral in a note to investors. The note also said that there is a lack of operations or expertise outside the US with the biotech company.
She also mentioned in the note that it is unlikely that Sarepta would be able to launch SRP-9001 abroad in a timely manner or obtain optimal reimbursement for it because of the host of activities that are still required for the therapy ranging from optimizing the manufacturing of the therapy and completing the crucial clinical trials in addition to conducting other clinical trial programs ranging from early-stage to Phase III.
(Source:www.medcitynews.com)
The news of the deal resulted in a 9.4 per cent gain in the shares of the Cambridge, Massachusetts-based Sarepta on the Nasdaq. On the other hand, there was no movement in the shares of Roche that trades on the SIX Swiss Exchange.
A 40-patient, randomized and placebo-controlled Phase II study is currently being conducted for the SRP-9001 therapy which was started about a year ago. It has its protocol page listing sites at the University of California Los Angeles and Nationwide Children’s Hospital in Columbus, Ohio. Two therapies for DMD, both antisense oligonucleotide drugs are currently marketed by the company. These therapies include Exondys 51 (eteplirsen), for DMD involving a gene amenable to exon 51 skipping and Vyondys 53 (golodirsen), which won approval earlier this month for patients in whom the gene is amenable to exon 53 skipping.
Pfizer’s PF-06939926 and Audentes Therapeutics’ AT132 are the other gene therapies in development for DMD. Acquisition of Audentes by Astellas Pharma for $3 billion was announced earlier this month while the decision to acquire another developer of gene therapies for DMD, Exonics Therapeutics, was announced in June by Vertex Pharmaceuticals in a del worth $245 million.
“This collaboration will not only increase the speed with which SRP-9001 could benefit DMD patients outside the United States, but will also greatly expand the scope of territories within which we could potentially launch SRP-9001 and improve and save lives,” Sarepta CEO Doug Ingram said in a statement. “In addition to the validation that comes from joining forces with Roche, this licensing agreement – one of the most significant ex-U.S. licensing transactions in biopharma – will provide Sarepta with the resources and focus to accelerate our gene therapy engine and, if successful, bring SRP-9001 to patients as quickly as possible, potentially transforming the lives of countless DMD patients across the globe.”
The fact that Roche has greater ability to advance SRP-9001’s approval and commercialization much faster than Sarepta would be able to do on its own supports the assumption that the deal “incredibly value creating” for Sarepta, said Cowen analyst Ritu Baral in a note to investors. The note also said that there is a lack of operations or expertise outside the US with the biotech company.
She also mentioned in the note that it is unlikely that Sarepta would be able to launch SRP-9001 abroad in a timely manner or obtain optimal reimbursement for it because of the host of activities that are still required for the therapy ranging from optimizing the manufacturing of the therapy and completing the crucial clinical trials in addition to conducting other clinical trial programs ranging from early-stage to Phase III.
(Source:www.medcitynews.com)
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