Sanofi and GSK say they could have a coronavirus vaccine next year
Sanofi, working with technology from GlaxoSmithKline, said it intends to have vaccine for the novel coronavirus that will be ready for regulatory review in 2021.
Are we sure this cholesterol drug is a blockbuster?
Yesterday, the investment giant Blackstone paid $1 billion for a cut of inclisiran, a twice-a-year treatment for high cholesterol that convinced Novartis to part with $9.7 billion last year. With all those 10-figure votes of confidence, it’s worth remembering: No one’s positive inclisiran will be a success.
The treatment, invented by Alnylam before getting spun out into another company, is an RNAi drug that targets PCSK9, a protein involved in the clearance of bad cholesterol from the blood. In clinical trials, it has lowered cholesterol about as well as the PCSK9 antibodies from Regeneron and Amgen, with the added convenience of dosing every six months instead of monthly or bimonthly.
But it’s worth remembering that, after five years on the market, those PCSK9 antibodies have made little commercial noise. In the fourth quarter, Amgen’s Repatha brought in $200 million, while Regeneron’s Praluent made just $83 million.
Back to inclisiran. For Blackstone to just break even on its $1 billion investment, the drug would need to generate $10 billion in revenue over the 14 years of patent life it has left. And that’s assuming the treatment wins FDA approval next year, as Novartis expects. If the agency holds off until Novartis completes an ongoing study on outcomes, inclisiran’s launch would be delayed into 2024, making its blockbuster window even narrower.
The treatment, invented by Alnylam before getting spun out into another company, is an RNAi drug that targets PCSK9, a protein involved in the clearance of bad cholesterol from the blood. In clinical trials, it has lowered cholesterol about as well as the PCSK9 antibodies from Regeneron and Amgen, with the added convenience of dosing every six months instead of monthly or bimonthly.
But it’s worth remembering that, after five years on the market, those PCSK9 antibodies have made little commercial noise. In the fourth quarter, Amgen’s Repatha brought in $200 million, while Regeneron’s Praluent made just $83 million.
Back to inclisiran. For Blackstone to just break even on its $1 billion investment, the drug would need to generate $10 billion in revenue over the 14 years of patent life it has left. And that’s assuming the treatment wins FDA approval next year, as Novartis expects. If the agency holds off until Novartis completes an ongoing study on outcomes, inclisiran’s launch would be delayed into 2024, making its blockbuster window even narrower.
Amarin could use some good news
Amarin CEO John Thero used a conference call last night to tell investors that sales of the company's heart drug, Vascepa, totaled $150 million in the first quarter, a performance that handily beat Wall Street projections.
The problem, as you might recall from last month, is that a federal judge ruled key patents covering Vascepa were invalid, opening the market to generic competition. Investors aren’t likely to care very much about how much Vascepa sales are growing if its market exclusivity may soon come to an end.
So, what’s Amarin going to do now? Appeal the judge’s verdict, of course, Thero said. Unfortunately, appeals take time and are hard to win, so what else? It’s possible Vascepa might help patients with Covid-19, he said. Amarin’s shares rose 7% after hours.
The problem, as you might recall from last month, is that a federal judge ruled key patents covering Vascepa were invalid, opening the market to generic competition. Investors aren’t likely to care very much about how much Vascepa sales are growing if its market exclusivity may soon come to an end.
So, what’s Amarin going to do now? Appeal the judge’s verdict, of course, Thero said. Unfortunately, appeals take time and are hard to win, so what else? It’s possible Vascepa might help patients with Covid-19, he said. Amarin’s shares rose 7% after hours.
When will biotech get back to buying things?
There’s only so much you can get done on a videoconference, and negotiating a multibillion-dollar pharmaceutical merger might be one degree too complicated for Zoom.
As STAT’s Adam Feuerstein points out, high-dollar deals have been largely unheard of in biotech since over the past month, as the industry’s many scouts and negotiators have been operating from home. Furthermore, the pandemic-related delays to clinical trials have scuttled timelines across the industry, making it that much more difficult to pinpoint a given company’s true value.
But, as Baird analyst Brian Skorney notes, the world’s largest drug companies are still sitting on huge quantities of cash, and with interest rates no virtually nonexistent, it’s incredibly cheap to amass capital at the moment. That means once society returns to normal or something that approximates it, there could well be a bolus of deals reflecting pent-up demand.
Read more.
As STAT’s Adam Feuerstein points out, high-dollar deals have been largely unheard of in biotech since over the past month, as the industry’s many scouts and negotiators have been operating from home. Furthermore, the pandemic-related delays to clinical trials have scuttled timelines across the industry, making it that much more difficult to pinpoint a given company’s true value.
But, as Baird analyst Brian Skorney notes, the world’s largest drug companies are still sitting on huge quantities of cash, and with interest rates no virtually nonexistent, it’s incredibly cheap to amass capital at the moment. That means once society returns to normal or something that approximates it, there could well be a bolus of deals reflecting pent-up demand.
Read more.
More reads
- Zai Lab targets blood cancers in deal with Regeneron. (STAT Plus)
- How a premier U.S. drug company became a virus ‘super spreader.’ (New York Times)
- Brazilian lawmakers propose compulsory licensing for Covid-19 products. (STAT)
- The tension between public health and patents in the era of Covid-19. (STAT)
As STAT’s Matthew Herper reports, Sanofi’s announcement means it effectively leapfrogs the other traditional vaccines programs in the pipeline. Newer technologies, like Moderna Therapeutics’ mRNA vaccine, are further along in the process but come with the caveat that they’ve never before been FDA approved.
Sanofi is employing the same technology it uses to make flu vaccines, which uses a genetically modified version of a virus to create proteins that train the immune system to react. The company is combining its approach with GSK’s proprietary adjuvant, an additive that makes vaccines more potent.
Read more.
Sanofi is employing the same technology it uses to make flu vaccines, which uses a genetically modified version of a virus to create proteins that train the immune system to react. The company is combining its approach with GSK’s proprietary adjuvant, an additive that makes vaccines more potent.
Read more.
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