Prescribers give thumbs up to Biotie/Lundbeck's Selincro
This article was originally published in Scrip
Selincro (nalmefene), the alcohol-dependence drug licensed to Lundbeck from Finnish firm Biotie, is going down well with prescribers, says Andreas Eggert, Lundbeck's senior vice-president of global product strategy & portfolio development. as the company prepares for its imminent launch in in the first markets where it has won reimbursement: the Netherlands and Denmark .
Selincro, which, according to the firms, radically changes the paradigm for treating alcohol dependence, won EU approval earlier this year (scripintelligence.com, 1 March 2013). According to Mr Eggert, the drug offers an alternative to the abstinence only method with a "reduction-based" approach that cuts a patient's urge to drink.
Selincro is a dual-acting opioid system modulator that acts on the brain's motivational system, which is dysregulated in patients with alcohol dependence, Lundbeck says. It is thought to reduce the reinforcing effects of alcohol, and thereby reduces the urge to drink alcohol.
Biotie developed the product until Phase II, then, under a licensing agreement, Lundbeck took charge for Phase III development and commercialization. So far, Lundbeck has launched the drug in some 14 countries, including Finland, Norway, Poland, the UK and most recently Italy. Early October will see launches in the Netherlands, where the drug is to be universally reimbursed and Denmark, where the drug is to be reimbursed on an individual patient basis. This means that Danish prescribers have to fill in individual forms to secure reimbursement for each patient to get the drug. According to Mr Eggert, this type of reimbursement is quite common before authorities award the drug universal reimbursement. In England regional health authorities are reimbursing the drug, but Lundbeck is now submitting to NICE, the HTA institute for England and Wales, and hopes to win universal coverage. Meanwhile, the first health technology appraisal of the drug is due out soon as the Scottish Medicines Consortium is to announce a decision in the coming weeks. Payers are very interested in the product, he said.
It's early days to give any figures on sales or uptake, but the drug has been well received by prescribers, said Mr Eggert. "What I can say is that physicians are very open to the idea of a treatment option that is different to anything that has been available. And feedback from patients who have tried the drug is very positive. The product delivers on what the clinical trials showed," he said. Phase III studies demonstrated alcohol consumption dropped by two thirds over 12 months.
Reduction is an important option that Mr Eggert describes as a "conversation enabler." Patients are more willing to talk about their condition if they know that the doctor won't simply advise them to stop drinking altogether. For many alcohol dependency patients this is an unattainable goal that puts them off discussing their condition with their doctor. In addition, doctors feel more inclined to talk about alcohol dependency if they know there is an alternative to abstinence, said Mr Eggert. "Selincro allows physicians and their patients to engage with each other," he added.
So far Lundbeck's strategy has been to target specialists in brain disease – psychiatrists – so that the firm can establish the need for a new approach to treating alcohol dependence. Then, once that has been achieved, Lundbeck will start targeting general practitioners. According to Dr Timo Veromaa, CEO and president of Biotie, getting the product to primary care doctors, the physicians who have most contact with alcohol dependency patients, will be key to Selincro's success.
In its dealings with doctors, Lundbeck is largely focused on ensuring that doctors and patients understand that alcohol dependence is a brain disease that requires treatment. In addition, the firm highlights the significant burden of the disease on patients and health systems. Then it explains the importance of the reduction concept: Mr Eggert emphasizes that Lundbeck is not pitting Selincro against abstinence, but providing an alternative. For some patients, for example, those with liver cirrhosis, abstinence is the only viable treatment. But for patients with mid-stage dependence and mild-to-moderate health problems, reduction is an important treatment option. And of course the firm highlights Selincro's credentials and Phase III study results.
Selincro costs around €4-€5 per pill in different markets, including pharmacy and wholesaler mark-ups. The ex-factory price is around €3.50-€3.60. Analysts predict peak sales of DK2bn (€340m).
The firm hopes to launch soon in France, and Germany, although the company is waiting to hear more about how German pricing and reimbursement authorities are likely to receive the drug before it goes forward there.
Windfall for Biotie
The most recent launch, in Italy, brings good news for developer Biotie. Under the licensing deal, each launch lands the Finnish firm a €2m milestone payment. This comes on top of the €12m signing payment and then longer-term revenue from royalties on sales.
Selincro was Biotie's most advanced product and will be the first to bring in sustainable revenue for the firm, according to Dr Veromaa. Biotie plans to put the money from Selincro towards furthering two of its key pipeline assets: nepicastat, an orally administered dopamine β-hydroxylase inhibitor for cocaine dependence; and an intranasal form of diazepam to treat epileptic seizures not controlled by oral medication. The latter is in late-stage development and the firm expects a short cut to FDA approval by referring to a rectal formulation of the product and proving bioequivalence. Dr Veromaa does not think the firm will need a partner to commercialize the drug in the US.
A Phase II trial for nepicastat is already underway and is funded by the US National Institute on Drug Abuse, data should be available in the next 18 months. The firm would consider partnering for this drug too, but its early days.
Biotie does not have to worry about using the Selincro revenues to finance its other chief late-stage product: its adenosine A2a receptor antagonist tozadenant for Parkinson's disease, said Dr Veromaa. After a successful Phase IIb trial, Biotie licensed the product to Belgian firm UCB (scripintelligence.com, March 22 2013). UCB will be footing the bill for Phase III development.