Eczema drug from Regeneron tipped for blockbuster statusAnalysts predict first medicine for skin illness will make $6bn in annual sales
When Morgan Burns’ severe eczema cleared up at the age of 13, he thought he had been handed a reprieve from the painful condition that plagued his childhood.
“But in law school it came back with a vengeance and it was all over the place — my hands, elbows, feet, knees, back,” recalls Mr Burns, 47. “No part of my body was spared.”
He embarked on an unsuccessful “20-year quest” to treat his cracked and bloody skin, until one day he secured a place on a trial of a new drug discovered by Regeneron, the New York-based biotech company. The medicine, Dupixent, changed his life.
“Over the next six to eight weeks, there was a continuous improvement until one day my skin was basically clear,” says Mr Burns, a lawyer, who has been injecting himself with the drug each week for the past 14 months.
The US Food and Drug Administration is due to decide whether to approve the new medicine for moderate to severe eczema, or atopic dermatitis, this month, and analysts are predicting blockbuster sales for Regeneron and its commercial partner, French drugmaker Sanofi.
If Dupixent is given a green light, it is expected to be the most lucrative drug launch of the year, with annual revenues of $4.6bn by 2022, according to EvaluatePharma, the research group.
There are no approved medicines for moderate or severe atopic dermatitis, which affects 8.5m adults in the US and EU, so patients must make do with steroid creams and other, sometimes questionable, treatments.
Adnan Butt, analyst at RBC, is forecasting peak annual sales of up to $6bn, a figure predicated on a price tag of roughly $25,000 per patient per year for Dupixent, which patients will probably have to take for life. He says the dearth of options for patients will make it easier for Regeneron and Sanofi to charge such a price.
But some physicians think insurers and pharmacy benefit managers — often referred to as “payers” — could demand steep discounts, or require doctors and patients to jump through several hoops before agreeing to reimburse the drug.
“Payers have their antenna up and . . . they will be aggressive in containing utilisation,” says Dr Peter Bach, a pricing expert at Memorial Sloan Kettering Cancer Center. He points to the difficulty that Amgen, Regeneron and Sanofi have had securing reimbursement for their new cholesterol-lowering drugs, and similar problems for Novartis’ recently launched heart medicine.
Faced with the economics of an older and sicker population, US payers have increasingly been driving a harder bargain with drugmakers. They have been emboldened by the public outcry over egregiously priced medicines such as the $10,000 acne cream and the $750 Aids pill.
Analysts say the launch of Dupixent will be a test of whether drugmakers can convince buyers to foot the bill for new medicines with premium prices. In a sign of the importance of the negotiations, Leonard Schleifer, Regeneron’s chief executive, has handled them personally.
“There is no competition, so from a market perspective we would be free to price the drug at a very robust price,” says Dr Schleifer. “But I feel that we should be responsible, and price the drug responsibly.”
In return, he says, he wants payers to agree to a “grand bargain” where they will reimburse the medicine for patients who need it.
“I’m very optimistic that this formula of working together with a breakthrough product but being responsible in pricing will lead payers to be equally appropriate on how they make the drug accessible,” he says.
Regeneron says there are roughly 300,000 patients in the US who do not have their atopic dermatitis under control, but some analysts think the number could be as high as 500,000.
Before trying Dupixent, Mr Burns attempted lots of treatments, including standing in a sunbed-style lightbox and slathering himself with vegetable oil once a day. “It sort of helps until you realise all your clothes are stained,” he says.
In the most serious cases, doctors use toxic drugs that suppress the immune system such as cyclosporine, which is used in organ transplant patients, and methotrexate, more commonly associated with cancer treatment. Neither medicine has been endorsed by regulators, meaning physicians use them “off label”.
“All of them increase the risk of infections and [cancer] down the road, so they are associated with some pretty heavy baggage,” says Dr Jonathan Silverberg, a dermatologist at Northwestern Medicine in Chicago who conducted trials of Dupixent.
By targeting a biological pathway that triggers atopic dermatitis, Dupixent can control the condition without suppressing other parts of the immune system, meaning it is much safer than drugs such as cyclosporine.
“[Dupixent] is able to target very specifically this inflammation without the collateral damage of hitting other parts of the immune system that are needed to fight off infections,” says Dr Silverberg.
During late-stage clinical trials, around two-thirds of patients taking Dupixent with a steroid cream saw a dramatic improvement in their eczema, while nearly 40 per cent achieved clear or almost clear skin. Participants also reported a marked reduction in itching, the number one complaint among sufferers of atopic dermatitis.
The pathway targeted by Dupixent is also thought to cause several other allergic conditions, and Regeneron is trialling the medicine in people with asthma, nasal polyps, food allergies, as well as children with atopic dermatitis.
Mr Butt describes the product as a “pipeline within a drug”, and compares it to anti-inflammatory agents such as AbbVie’s Humira and Johnson & Johnson’s Remicade. The medicines were first approved for arthritis but went on to become the world’s top-selling drugs after being proven to work in a wide range of illnesses, generating a combined $23bn in sales last year.
Many atopic dermatitis patients also suffer from asthma and other allergic illnesses, and Regeneron and Sanofi are hoping that Dupixent could help control two or more conditions. That would allow the companies to make a “two-for-the-price-of-one” argument when negotiating with cash-strapped healthcare systems.
“If you have one molecule that does two things you essentially have a cost-effective way of doing combination therapies,” says Elias Zerhouni, president of global research and development at Sanofi, likening the approach to “sending a missile with multiple warheads”.
Dr Zerhouni stresses that the drug is intended to be used only in patients for whom there is no effective treatment. “We do not want Dupixent to be used for millions of patients who don’t really need it. We want it to be used for the thousands of patients that really need it.”