(Health Korea News / Lee Chung-man) Hanlim Pharmaceutical is starting a full-scale clinical trial of its improved new drug ‘Hanxetine Tablet’ (ingredient: Vortioxetine Hydrochloride) for the antidepressant ‘Brintellix’ (ingredient: Vortioxetine Hydrobromide). According to our newspaper’s investigation, Hanlim Pharmaceutical began recruiting trial participants for the phase 1 clinical trial evaluating ‘Hanxetine Tablet’ on the 5th.
The test is to compare the safety and pharmacodynamic characteristics of 20 mg of ‘Hansetin tablets’ and 20 mg of ‘Brintellix’ administered to 40 healthy adults. The conducting institution is Gwangmyeong Hospital of Chung-Ang University. The test consists of 1 screening, 2 hospitalizations (2 nights and 3 days), and 13 outpatient visits (until November of this year).
The original of ‘Hansetin tablets’, ‘Brintellix’, is a multi-action antidepressant developed by Lundbeck in Denmark. It is a mechanism of treating depression by directly controlling serotonin receptors involved in depression and inhibiting serotonin reuptake. The Ministry of Food and Drug Safety approved ‘Brintellix’ in August 2014.
Existing antidepressants such as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) only have single or dual effects, but ‘Brintellix’ is characterized by increasing the activity of various neurotransmitters as well as serotonin, thereby balancing the neurotransmitters in the brain.
This drug had a minimal presence in the domestic market until 2019, but has been growing rapidly in recent years. As of 2022, Brintellix’s domestic sales (based on IQVIA data) exceeded 10 billion won, and its overall antidepressant market share rose to 3rd place.
Accordingly, companies that had a large sales share in the portfolio of psychiatric and neurological disease drugs are moving to attack the generic version of ‘Brintellix’. Representative examples include Myungin Pharmaceutical, Unimed Pharmaceutical, Samchundang Pharmaceutical, and Hwanin Pharmaceutical. Among them, Myungin Pharmaceutical obtained approval for the first generic, ‘Bocetin Tablet’, from the Ministry of Food and Drug Safety in April 2023.
On the other hand, Hanlim Pharmaceutical is targeting the ‘Brintellix’ market with a non-generic salt-changed improved new drug. ‘Brintellix’ is a compound that combines vortioxetine with hydrobromide hydrate, but Hanlim Pharmaceutical’s ‘Hansetin Tablet’ adds hydrochloride to vortioxetine.
This is interpreted as an intention to slightly advance the market entry of ‘Brintellix’, which is blocked by a patent, through salt change.
These four companies, which are targeting the generic version of ‘Brintellix’, received a decision to establish the claim in an invalidation trial filed in January 2023 for the purpose patent of ‘Brintellix’. The patent in question was set to expire in 2028.
However, ‘Brintellix’ still has a remaining material patent that expires in May 2027. As a result, even if the generic product receives approval from the Ministry of Food and Drug Safety, it cannot be launched before May 2027. Accordingly, it is interpreted that Hanlim Pharmaceutical is trying to avoid the patent by developing a salt-modified new drug.
The key question is whether Hanlim Pharmaceutical’s strategy of developing improved new drugs by changing the salt content is still valid.
In the past, domestic pharmaceutical companies used a strategy of avoiding patents by changing the salt before the patent expired. As the original company extended the monopoly period of the drug by 6 months to 3 years, generic companies released their products early by changing the salt of the drug to avoid the patent.
However, since the Supreme Court ruled in 2019 not to recognize patent evasion for salt-altering drugs, the salt-altering improved new drug strategy is no longer considered a viable method.
Accordingly, attention is being paid to what strategy Hanlim Pharmaceutical will employ to launch ‘Hansetin Tablet’ into the market after obtaining approval from the Ministry of Food and Drug Safety.
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Source: www.hkn24.com
