News briefing: Amarin's panel could put Vascepa patents in jeopardy; Santhera nabs a Duchenne drug
Amarin’s fish oil empire may be slipping out of its grasp.
On Wednesday, in the latest twist in a long legal battle, the appeal panel of judges was announced for the patent dispute between Amarin with two generic drugmakers that are looking to make off-brand decision. No ruling has yet been made — the hearing starts at 10:30 this morning — but analysts believed that the decision could come down to which judges were chosen, and that these judges may be unlikely to decide in Amarin’s favor. The stock fell 17% pre-market.
In a note, Stifel’s Derek Archila said the judges’ view on Amarin was mixed, but given that a low percentage of such disputes are reversed on appeal, the selection did not bode well. “Given the low rates of success for a reversal in these types of cases (10-20%), we think this doesn’t improve the odds,” he wrote.
SVB Leerink’s Ami Fadia struck a similar tone. “Bottom line: Overall, we don’t believe this 3-judge panel improves Amarin’s chances at winning the Vascepa patent litigation appeal.” And Jefferies’ Michael Yee may have been the bluntest: “Judge panel looks mixed at best,” he wrote.
Last December, the FDA opened a path for Amarin’s fish oil drug Vascepa to become a blockbuster, expanding its approval to include prevention of heart attacks and stroke. But just four months later a federal judge ruled that Amarin’s patents on the drug were invalid, setting up Hikma Pharmaceuticals and Dr. Reddy’s to market generic alternatives. Amarin appealed, leading to today’s hearing. — Jason Mast
Santhera wheels and deals its way to global Duchenne rights
In a three-way deal, Santhera has picked up global rights to the Duchenne drug it signed onto two years ago.
The drug, known as vamorolone, is a steroid that is designed to have the same effects as the corticosteroids Duchenne patients now take to slow disease progress but without the systematic side effects those steroids cause. ReveraGen developed the compounds and signed an option agreement with Actellion in 2016. Two years later, Actellion — now known as Idorsia — sold the option to Santhera.
So far, only Phase IIa data comparing patients on the drug to natural history comparators have come out. Santhera’s option allowed them to wait until Phase IIb data emerged, but they chose to act early, giving Idorsia 366,667 shares and an exchangeable note for 10 million CHF ($11 million) to restructure the deal. Reveragen, in turn, will receive $7 million — given in monthly installments of $500,000 to continue development.
With Santhera trading at $7.35, Idorsia’s new shares are worth about $2.7 million. — Jason Mast
Small Israeli pain biotech finds scant purchase for IPO
As the biotech boom surged in the US, the Israeli biotech PainReform sought to get in on the action and raise $25 million to advance their topical post-op pain drug. The company, though, has struggled to find buyers. They officially filed to raise $23 million by selling shares between $8 and $10, but yesterday announced they priced on the low end, ultimately netting $20 million.
That should still be enough, though, to cover the cost of clinical trials. In their F-1, the cited $16 million as the estimated cost of two pivotal trials for their lead drug, ropivacaine. — Jason Mast
Clene NanoMedicine SPACs its way to public markets
Clene Nanomedicine, a company researching the use of gold nanocrystals for neurodegenerative diseases, has announced plans to go public. The company is going the SPAC route, earning a $542.5 million valuation and netting a $25 million payment from Tottenham Acquisition I Limited in the process.
Wednesday’s news comes on the heels of a $42.5 million Series D round last week. Thus far, ALS has been Clene’s lead indication, as the company was recently selected to participate in the first-ever platform trial for the disease. Pitting its CNM-Au8 against two other ALS candidates and placebo, the Phase III study began enrolling patients last month. Clene has also seen signs that the same candidate could potentially treat patients with multiple sclerosis and Parkinson’s disease. It is running concurrent Phase II trials in those indications, as well as ALS. — Max Gelman