(News Bulletin 247) – The American Medicines Agency has given the green light to the marketing in the United States of the product developed by Medincell to treat schizophrenia, based on a prolonged-release formulation of risperidone.

Medincell and Teva get their revenge. In April 2022, the two partners had been refused by the Food and Drug Administration (FDA), the latter having declined the marketing application submitted with a view to approving their extended-release version of risperidone, a treatment for schizophrenia.

This time, the biotech from Lune has just obtained the green light for a commercial launch on the North American market under the name of Uzedy. This approval by the US health agency is the “long-awaited news” for Invest Securities. It is rewarded on the stock market by a rebound in the title of 16%, to return to its annual peaks, on 10 euros.

It is therefore a new innovative treatment in the field of schizophrenia which will benefit North American patients. Uzedy is the first long-acting subcutaneous formulation of risperidone that uses SteadyTeq, Medincell’s proprietary copolymer-based technology that controls the steady release of risperidone. This formulation achieves therapeutic plasma concentrations within 6 to 24 hours after administration of a single dose. Once the tolerance to oral risperidone has been determined in the patient, the doctor decides on the interval of administration, either once a month or once every two months.

Avoid missed treatment

The interest of this approach is to eliminate the need to swallow your dose of tablets every day, significantly improving the effectiveness of treatments while poor compliance (more or less involuntary forgetfulness) of long-term treatments for chronic diseases is considered by the WHO to be a major problem.

In the field of schizophrenia, this gradual release injection technology is suitable for this pathology. Patients are usually not able to become aware of their disease and its consequences. Compliance with treatment is therefore low, leading to significant direct and indirect social medical costs. Uzedy also reduced the risk of relapse by up to 80% compared to placebo.

Medincell points out that around 80% of patients with schizophrenia experience numerous relapses during the first five years of treatment, most often due to a lack of compliance with treatment with oral antipsychotics. “Each relapse carries a biological risk of loss of function, resistance to treatment, and mutation in brain morphology,” the company adds.

A “list” price between 1232 and 3080 dollars

Uzedy will be available in the next few weeks in the United States, before the end of the first semester according to the indicative schedule unveiled by Teva during a meeting last February. The Israeli-American giant also “unveiled a target of 20% of the American long-acting schizophrenia treatment market (estimated at $4 billion),” recalls TP ICAP Midcap in its note of the day.

The product will be sold to wholesalers at a price between $1232 and $3080 per month depending on the dosage. Medincell specifies that actual costs to patients should be less than the list price, which does not take into account additional discounts and rebates that may apply.

Teva should extend marketing authorization requests to other territories, Invest Securities said. The potential market is significant for both partners as it is estimated that 1% of the world’s population will develop schizophrenia during their lifetime, a severely disabling mental disorder affecting the way patients think, feel and act, can appear at any age but generally between adolescence and young adulthood.

According to WHO data cited by Invest Securities, schizophrenia is a serious mental disorder that affects approximately 24 million people worldwide, or 1 in 300. Currently, the vast majority of people with schizophrenia in the world do not benefit from mental health care. “Schizophrenia is diagnosed in about 50% of people hospitalized in psychiatry, and only 31.3% of people with psychosis receive specialized mental health care,” adds the research office.

A major step for both partners

Today’s announcement will also benefit Medincell financially. The French company will receive royalties from the first sales and may also receive up to 105 million dollars in commercial milestones in the years to come. In the short term, this approval triggers the payment by Teva of 4 million dollars to MedinCell and allows access to the third tranche of the loan from the European Investment Bank in the amount of 10 million euros.

TP ICAP Midcap also recalls that Medincell will receive “the share of the results generated on the sale of the polymers used for the manufacture of the products (Medincell, 50% shareholder of the JV CM Biomaterials alongside Corbion, in charge of the supply of the polymers specific to the Uzedy product)”.

The two companies set up a multi-product partnership agreement in 2013. In this context, three other products are in the development phase with Medincell technology. “A project already in phase III (last stage of clinical trials before possible marketing, editor’s note) since mid-2022, which also addresses schizophrenia but on the basis of the molecule Olanzapine, and which could thus offer a solution to patients treated with this molecule (often the most serious patients)”, recalls the design office. In the scenario established by Claire Deray of TP ICAP Midcap, a commercial launch of this product is expected in early 2026.

The analyst also points out that this new stage “is very likely to attract other players interested in extended modes of action, thus fueling the future newsflow [flux d’actualités, NDLR]”, a prospect that reinforces her opinion on the purchase on the file. As for the target price, this is raised from 15 euros to 16.9 euros on the title of the French company, the analyst explaining that it no longer applies a discount to the value for Medincell of the Uzedy product to take into account the commercial launch of this treatment.

In a note written at the end of March, Oddo indicated that a return from the FDA to Uzedy would mark MedinCell’s “transition from an R&D biotech to a commercial company, but will also give its BEPO platform all the more credibility for obtaining new partnerships”.