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2020-01-16| Manufacturing

JP Morgan Healthcare Conference 2020 Updates

by Rajaneesh K. Gopinath
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By Rajaneesh K. Gopinath, Ph.D.

Although major merger or acquisition announcements have eluded the 38th Annual JP Morgan Healthcare Conference so far, several companies have shared important updates and collaboration deals. We handpicked a few of them here.

 
NHS Strikes Inclisiran Deal with Novartis

One of the four healthcare providers in the UK announced an “innovative” collaboration deal with Novartis. Lord Prior, chairman of the National Health Services (NHS) England, revealed plans to conduct a large-scale clinical trial involving the investigational cholesterol-lowering drug inclisiran. The Swiss pharma giant gained control of the PCSK9 targeting siRNA inhibitor following their acquisition of The Medicines Company. The trial is to be conducted in atherosclerotic cardiovascular disease (CVD) patients who are non-responsive to statins.

Under the terms of the agreement, Novartis will provide free bi-annual injections in exchange for the five-year clinical trial data. Inclisiran is yet to be approved by the European Medicines Agency. Following approval, the drug is expected to also be scrutinized for cost-effectiveness by the National Institute for Health and Care Excellence (NICE) by 2021. NHS officials claim that if inclisiran is administered to 300,000 patients each year, it could prevent 55,000 cases of heart attacks and strokes, saving up to 30,000 lives in the next decade.

“Novartis has a unique opportunity with Inclisiran to use innovative population-based approaches to open up a new chapter for the treatment of cardiovascular disease, the world’s leading cause of mortality and disability.” said Vas Narasimhan, the CEO who likened the treatment to that of a vaccine against CVD. “Novartis is excited to partner with the UK government to leverage innovative models that could potentially lead to generating leading scientific evidence, accelerate access for patients and ensure continuous improvement in manufacturing efficiency and optimization”.

 

Illumina Announces Partnership with Roche

Illumina has played a key role for close to two decades in the DNA sequencing market and has been instrumental in lowering the cost down to the figure of US$ 1000. Continuing with the trend of providing high-quality sequencing information at lower costs for small and medium-sized research labs, Illumina announced the NextSeq™ 1000 and NextSeq 2000 Sequencing Systems at the JP Morgan Conference on Monday.

Secondly, Illumina CEO, Francis deSouza, announced a 15-year, non-exclusive collaboration agreement with Roche. “We are excited Roche has selected Illumina’s sequencers as their platform of choice to accelerate the adoption and broaden the reach of oncology-based, distributable IVD tests into clinical care,” he said. “This partnership complements and strengthens our strategy to establish TSO 500 as a comprehensive NGS panel for cancer therapies by expanding the supported set of CDx claims on this universal panel. Building on the momentum of other recently established diagnostic and pharmaceutical partnerships, together we aim to advance critical access to NGS testing to improve patient outcomes”. Roche will also get to develop and distribute in-vitro diagnostic tests on Illumina’s NextSeq 550Dx and the NovaSeqDx sequencer in the future.

The third biggest announcement was that of TruSight software suite v1.0 developed in combination with the Mayo clinic and other KOLs. The combination of this software with Illumina’s Novaseq and TruSeq DNA PCR-Free offers a complete whole-genome sequencing analysis workflow which he firmly believes will help to establish whole genome sequencing to become the standard of care in undiagnosed diseases.

“The NextSeq 1000 and 2000 Sequencing Systems, TruSight Software and our partnership with Roche, will accelerate the adoption of research and clinical sequencing for the benefit of humanity.” deSouza said.

 

Alnylam Expects Top 5 Status in 2020

CEO John Maraganore expressed delight over the progress of Alnylam in the previous decade. The company ended 2019 on a high with two products on the market, two in registration, 11 programs in the clinic including six in late stages. Besides, it boasts of a product engine that delivers 2-4 new IDs per year. “We believe that in this decade, Alnylam will emerge as one of the top 5 biopharma companies” Maraganore said.

Alnylam brought the first RNAi drug, Onpattro to the market and has received regulatory approvals in the US, Europe, Japan, Canada, Japan, and Switzerland. In 2020, they expect to increase this number including approval in Brazil. In the fourth quarter of 2019, the drug registered a revenue of US$ 56 million, bringing the net tally to US$ 116 million. By 2021, they expect to bring Onpattro to the broader cardiomyopathy setting including wild-type ATTR, an indication that would provide a multibillion-dollar worth product for Alnylam. He also shared the company’s plans for bringing Vutrisiran to the market around the same time frame in the polyneuropathy area.

Givlaari, the second RNAi drug got an earlier than expected FDA approval for the treatment of acute hepatic porphyria (AHP) recently. Maraganore said they would like to follow Onpattro’s model for the drug launch and leverage the global capabilities built previously. The biggest boon for patients though is Alnylam’s new framework of value-based agreements (VBAs) with payers. According to this framework, payers will pay the full value for the drug when it delivers patient outcomes similar to clinical trials. Secondly, if the number of patients covered by the payer exceeds current estimates for AHP, a Prevalence-Based Adjustment (PBA) additional feature will offer rebates to payers.

Alnylam has more to look forward to in 2020 with lumasiran on its way to an FDA approval and fitusiran enrolling in late-stage trials. Besides, if inclisiran gets authorized, the company’s revenue will increase with 20% royalties from Novartis.

 

Guardant Health, Amgen to Develop Companion Diagnostic

The CEO of Guardant Health, Helmy Eltoukhy said that their biopharma opportunity is estimated at over 2 billion dollars, which is a substantial portion of the 6-billion-dollar therapy selection market. They have continued to make major strides in deepening their relationships with around 60 pharma companies in the areas of prospective screening, prospective analysis, companion diagnostic development, and commercial collaboration opportunities.

On Monday, he announced yet another strategic collaboration with Amgen to develop and commercialize a companion diagnostic (CDx) test named Guardant360® CDx, based on liquid biopsy. The CDx is for the treatment of metastatic non-small cell lung cancer (NSCLC) patients with G12C mutation in the KRAS oncogene. Amgen’s oral therapy, AMG 510 is a first-in-class KRAS G12C inhibitor that has received the FDA’s Orphan Drug Designation and Fast Track Designation for this indication and is currently on trials. According to the agreement, Guardant will pursue regulatory approvals for the CDx including FDA Pre-Market Approval, Japan Pharmaceutical and Medical Device Agency Approval, and European CE-Mark.

“In a recent head-to-head study of liquid versus tissue testing, Guardant demonstrated that advanced non-small cell lung cancer patients are not consistently receiving adequate genotyping results from tissue,” said Amir Ali Talasaz, Ph.D., Guardant Health President. “We believe that the development of Guardant360 CDx will lead to consistently delivered guideline-complete genotyping results along with other important genomic information to patients and their providers through blood, which will ultimately increase the number of patients who are identified as eligible for targeted therapies, including AMG 510, and thus improve access to these potentially life-changing treatments”.

 

Biogen Optimistic About Aducanumab

As expected, Michel Vounatsos, the CEO continued to express high hopes for aducanumab, the Biologics License Application (BLA) of which Biogen is currently working towards. In the breakout Q&A session, he mentioned that they are constantly engaged with the FDA in the US and having “positive discussions” with regulatory bodies in Europe and Japan as well.

Alfred Sandrock, head of R&D also shared similar optimism while saying that they have a good chance of getting approved. He conceded that it going to be a difficult decision for the FDA but opined that the datasets from EMERGE and ENGAGE, which demonstrated a significant reduction of clinical decline in early Alzheimer patients would be one of the factors it might get approved. He expects that apart from the safety and mechanism of action, the FDA will also weigh in the fact that Alzheimer’s is a serious, fatal disease with no alternative treatments.

When asked how Biogen will go about the pricing of the drug if approved, Michel Vounatsos said they are very early in the process but they are starting to engage with different stakeholders like pharmacoeconomists, thought leaders and customers in order to start to prepare. But according to him, the ultimate goal is for the patients to gain access to the drug.

 

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