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- 2026-03-18 11:39:01
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- Betadine, disposes of 3 months of advertising suspension
- by Nho, Byung Chul Apr 08, 2021 05:55am
- Mundipharma's Betadine Throat Spray (Povidone Iodine) was suspended from advertising by the MFDS. Mundipharma recently sent a notice regarding administrative disposition to pharmacies that handle the product, and requested cooperation in the removal of Betadine advertising installations in pharmacies. The advertisement business suspension period is from the 29th of this month to the 28th of June. Betadine's suspension of advertising business is a result of the recognition of inappropriate advertisements due to the lack of ad review in the press release posted on the Betadine Throat Spray product website in December of last year. Mundipharma's Betadine was controversial about false hype around October last year. Sales representatives of Kwang Dong, who are in charge of sales, provided small billboards (POPs) with contents such as 'Povidone = 99.9% death of COVID-19' to pharmacies at the end of 2019, and the MFDS launched an investigation of false hype. According to pharmaies, the POP at the time contained contents such that Povidone kills 99.9% of COVID-19, inactivating within 30 seconds, Povidone was recommended as an interim guideline for the World Health Organization, and the content that gargle solution mixed with Povidone is effective in suppressing COVID-19 was included. Povidone's recently announced anti-COVID-19 inhibitory effect is a cell experiment conducted in a laboratory. According to Article 68(5) of The Pharmaceutical Affairs Law, advertisements on the name, manufacturing method, efficacy or performance of pharmaceuticals, etc. are not allowed unless permission has been obtained or a report has been filed. Povidone Throat Spray obtained only indications for sore throat. However, no punitive administrative measures were taken by the health authorities, and it was replaced by retraining sales staff, collecting and disposing of POP promotional materials, promising to prevent recurrence, and posting an apology. Mundipharma said, "Sales of Betadine are the same as before. However, it is impossible to display advertisements and promotional materials in the pharmacy for the product for the next three months. We will sincerely answer inquiries through the sales representative in charge."
- Company
- Zytiga listed as a prostate cancer selective benefit
- by Apr 08, 2021 05:55am
- Janssen announced on the 7th that it will be applied as a first-line treatment for patients with high-risk metastatic prostate cancer with hormone-responsiveness from the 1st. Zytiga, as a CYP17 inhibitor, was approved by the MFDS in July 2012 as a treatment for metastatic castration-resistant prostate cancer, and added hormone-responsive high-risk metastatic prostate cancer treatment indications in June 2018. With this amendment, Zytiga can be used in patients newly diagnosed with hormone-responsive high-risk metastatic prostate cancer (mHSPC). If two or more of the three conditions are satisfied, such as visceral metastasis (excluding lymph node metastasis), which can be confirmed by imaging tests such as MRI, Prednisolone and Androgen blockade therapy (ADT) are applied in combination. Metastatic hormone-sensitive prostate cancer (mHSPC) is a stage that still shows a therapeutic response to hormone therapy or androgen blockade (ADT) among stage 4 prostate cancers that cannot be operated because metastases to other organs have already been confirmed. After this stage, if it progresses to the stage of metastatic castration-resistant prostate cancer that no longer responds to hormone therapy, it is difficult to cure it and the survival period is only 1-2 years. Zytiga significantly improved overall survival (OS) in a newly diagnosed hormone-responsive high-risk metastatic prostate cancer (mHSPC). Accordingly, the National Cancer Network (NCCN) recommended Zytiga as a treatment option first. Seong-il Seo, a professor of urology at Samsung Medical Center, said, "Through the application of Zytiga's insurance benefits, hormone-responsive high-risk metastatic prostate cancer (mHSPC) patients can receive treatment while reducing the economic burden. We look forward to improving our quality of life.”
- Company
- One-on-one briefing sessions with doctors are not allowed
- by Apr 08, 2021 05:55am
- It is expected that MSD Korea will in principle ban one-on-one product presentations for individual doctors from May. Business restrictions are much stronger than the industry's 'fair competition rules'. According to the pharmaceutical industry on the 7th, MSD Korea announced plans to improve CP to its employees on the 5th. From May, it will prohibit one-on-one product presentations between doctors and sales staff. This is a measure according to the global headquarters' criticism that the cost used for one-on-one product presentations is excessive and the cost-effectiveness is low. MSD Korea emphasized that one-on-one product presentations are not allowed in principle, but they gathered the opinions of each sales team, saying that special exceptions can be considered. The company will review the opinions gathered by mid-April and finalize the new regulations, and it is expected to take effect from May. However, employees point out that the company's claim that one-on-one product presentations are not allowed in principle does not comply with not only the Pharmaceutical Affairs Act but also the industry's voluntary fair competition regulations. Under the current the pharmaceutical affairs law, food and beverages can be provided within ₩100,000 at product presentations. In addition, in Article 10 of the 'Fair Competition Regulations and Detailed Operation Standards for Pharmaceutical Transactions' published by the KRPIA, which MSD Korea belongs to, in the case of a product briefing session that explains its own medicines by visiting individual nursing institutions, member companies provide food and beverage and A small amount of promotional materials can be provided with the company name or product name entered, and in this case, it must be ₩100,000 per day for food and beverages (limited to 4 times a month) and less than ₩10,000 for promotional materials.' The '2021 CP Guidebook' published by the KRPIA on the 1st also contained the same content. Multinational and domestic pharmaceutical companies are conducting one-on-one product presentations within the limit of ₩100,000 per person for food and beverage in accordance with these CP regulations. The CP regulation of MSD Korea follows Article 10 of the KRPIA regulation, and the explanation for one-to-one product-related explanation (PRE) is also clearly stated. 'One-on-one PRE is not included in small meetings (product presentations for 2 to 25 people), but must comply with the KRPIA rules.' Considering that the average cost per person for a one-on-one product presentation at MSD Korea is about ₩60,000, the evidence that the cost is excessive is insufficient. Some employees criticized the company's decision as a one-sided measure that did not take into account the business environment. The competition situation with other pharmaceutical companies and the sales target suggested by the company remain unchanged. However, it is argued that limiting meetings, which are allowed by other pharmaceutical companies, is overpressing the business environment. One MSD Korea employee said, "It is also said that the regulations will be strengthened in the so-called Simple PRE, in which an employee eats light meals of less than ₩10,000, such as coffee or sandwiches, with a doctor." He said, "There is a lot of anxiety that the company is in the process of changing its business to online rather than offline and further reducing the organization drastically." In response, MSD Korea said, "MSD always prioritizes transparent and legitimate business execution based on high ethical standards. Current issues are closely monitored internally and externally, this is a part of reflecting them in internal regulations, and there is no clear decision yet."
- Company
- Tumor-agnostic ‘Rozlytrek’ seeks PE exemption
- by Eo, Yun-Ho Apr 07, 2021 06:03am
- Discussions will begin for the listing of Roche's anticancer drug ‘Rozlytrek,’ which may be prescribed regardless of cancer type if specific conditions are met. According to industry sources, 2 types of anticancer drugs by Roche Korea – Rozlytrek (entrectinib) and Polivy (polatuzumba) – will be up for deliberation by the Review Committee for Cancer Disease of the Health Insurance Reimbursement and Assessment Service (HIRA) tomorrow on the 7th. Among the two drugs, Rozyltrek, which targets the neurotrophic tyrosine receptor kinase (NTRK), is expected to take the pharmacoeconomic evaluation (PE) exemption track. Rozlytrek’s approval was based on a single-arm study that did not involve a control group. As it already meets subparagraph 2 of the PE exemption criteria, it is likely that the drug will have not much difficulty in receiving the exemption once the committee deems the remaining conditions to be met. Rozlytrek, which was approved as an orphan drug in April last year, is currently indicated for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have an NTRK gene fusion without a known acquired resistance mutation, and for adult patients with locally advanced ROS1-positive or metastatic NSCLC. This means Rozlyterk may be used in virtually all cancer types confirmed with an NTRK gene. In addition, the listing of ‘Polivy,’ an antibody-drug conjugate(ADC) used in combination with the standard BR therapy (rituximab-cyclophosphamide) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), will also be first discussed by the committee on the same day. Considering the fact that Roche submitted the application for Polivy's reimbursement listing this year, the schedule for deliberation by the Review Committee for Cancer Disease has been set relatively quickly. Diffuse large B-cell lymphoma (DLBCL), the most common form of non-Hodgkin lymphoma (NHL), is an aggressive (fast-growing) type of lymphoma that requires immediate treatment. Although DLBCL is generally responsive to treatment and over half of the patients reach remission, 30% to 40% of the patients do not respond to the standard-of-care, R-CHOP, or experience relapse after first-line treatment. Polivy, the first ADC that targets CD79b, a protein expressed in B-cells, binds to the CD79b to induce apoptosis. This drug was also designated as an orphan drug last October. Meanwhile, Roche has been continuously expanding its rare disease pipeline. Last year, it had received approval for ‘Evrysdi (Risdiplam),’ for the treatment of spinal muscular atrophy (SMA). Also, the approval process for Roche’s ‘Enspryng (satralizumab),’ a competitor of ‘Soliris (eculizumab)’ is also currently underway.
- Company
- Beovu heats up the AMD treatment market with its ease of use
- by Apr 07, 2021 06:01am
- Novartis has jumped into the competition in the macular degeneration treatment market with ‘Beovu.’ Emphasizing its longer treatment interval, the new drug is fiercely chasing the market leader ‘Eylea.’ Beovu (brolucizumab) is a treatment for wet (neovascular) age-related macular degeneration (AMD) launched by Novartis as a successor to its ophthalmology drug ‘Lucentis.’ The prefilled syringe formulation of Beovu was approved in Korea last July and is being reimbursed from this month. The biggest benefit of Beovu is its longer treatment interval. Beovu is administered once every 4 weeks for the first three doses, followed by once every 12 weeks. Bayer’s Eylea is also administered monthly like Beovu for the first 3 doses, however, the following doses for Eylea are administered every 8 weeks. In other words, patients who had to visit the hospital every 2 months will be able to increase the interval to every 3 months with Beovu, which may improve convenience and the possibility of patient compliance. At the Beovu press conference held by Novartis Korea on the 5th, Sang-jin Kim, a professor of ophthalmology at Samsung Medical Center, said, “ In macular degeneration, the number of injections administered is highly correlated to vision maintenance. However, many AMD patients fail to continue treatment due to that burden of treatment, which results in reduced vision improvement effects. Therefore, the unmet need that existed for a treatment that can maintain its efficacy while reducing the number of injections and hospital visits may be satisfied with the introduction of Beovu." Beovu demonstrated its non-inferiority in head-to-head clinical trials with Eylea. In the Beovu HAWK and HARRIER clinical trials conducted by Novartis, the Beovu-treated group showed non-inferiority in the best-corrected visual activity (BCVA), the primary endpoint, compared to the Eylea-treated group at week 48. The therapeutic effect lasted until week 96. Also, the Beovu-treated group showed superior improvement in intra-retinal fluid and sub-retinal fluid compared to the Eylea-treated group. The reason Beovu produces a similar effect despite the longer dosing interval is due to its molecular characteristics. Beovu’s single-chain antibody fragment (ScFv) is engineered to deliver a higher concentration of molecules compared to other treatments with multiple chains. With the higher molar concentration, the agent potently inhibits vascular endothelial growth factor A (VEGF-A) isoforms, has better tissue penetration, and clears more rapidly from systemic circulation. However, why vision gains with Beovu at week 96 is similar to that of Eylea even with stronger effects may be yet questionable. “Opinions have been divided among doctors on the reason behind the matter. Personally, I would say that anatomical changes such as exudates often precede functional changes. However, it is true that in the long-term, the possibility of degeneration happening in photoreceptor cells, etc. is high as the period exudate remains is prolonged.” Kim added, “Although there was no difference in vision gains during the 96-week study period, I believe there will be a difference in the long-term.” Also, another hidden competitor to note is the anticancer drug ‘Avastin,.' Since Avastin has the same mechanism as Lucentis but is relatively cheaper than Lucentis or Eylea, off-label prescription of Avastin for the treatment of AMD is known to be quite active in the treatment of macular degeneration. The price of the newly reimbursed Beovu is similar to that of Eylea, and this higher price compared to Avastin is an obstacle. On this, the company stated that "Beovu was approved for the same indication as with other macular degeneration treatments, so we do not foresee big changes in the current market. We would have to wait and see in the long run as patients who have a lot of remaining exudate, or those who wish to reduce more exudate may choose Beovu over other competitors.” According to data from IQIVA, Eylea made 63.6 billion won, and Lucentis 36.9 billion won in sales last year.
- Company
- Baculovirus overcomes shortcomings of DNA vaccines
- by Nho, Byung Chul Apr 06, 2021 11:08am
- 김영봉 교수 The development of a COVID-19 ‘DNA and viral vector-based vaccine’ made with 100% domestic technology is well underway. Although in its preclinical stage, the vaccine, once commercialized, is expected to show superior safety and protection over existing COVID-19 vaccines by Pfizer, Moderna, AstraZeneca as well as vaccines from Russia and China. Professor Young Bong Kim of Biomedical Science & Engineering at Konkuk University and his team have recently announced positive results from the preclinical study of their Covid-19 vaccine in development. The study used hamsters to assess the immunogenicity, antibody production, seroconversion rates, and increments in geometric mean concentrations or titers of their Covid-19 vaccine. The key to the COVID-19 vaccine platform being developed by Kim, the world-renown leader in the field of viruses, is the baculovirus. Baculovirus is an insect-derived vector that is considered safe as it is generally non-toxic and non-replicative in human cells. Also, baculoviral-based vaccines have fewer side effects than adenoviral vector-based vaccines. Kim's team constructed a recombinant baculovirus expressing the envelope glycoprotein of human endogenous retrovirus to enhance effective gene delivery into human host cells. In other words, the AstraZeneca vaccine generates an immune response from our body by delivering an adenovirus containing the COVID-19 spike protein to our cells whereas the vaccine developed by Kim’s team inserts the COVID-19 spike protein or its part into a baculovirus that virtually has zero side effects to produce antibodies. This 'baculovirus platform technology' has been patented in Korea in 2010 as well as various other countries including the U.S, the U.K, France, Germany, China, and Japan, and is expected to have high growth potential over the next decade. In particular, the HPV (human papillomavirus) vaccine for cervical cancer requires 2 or more doses for a strong cell-mediated immunity (CMI). The advantage of the platform technology is that neutralizing antibodies to the baculovirus are not generated while baculovirus produces therapeutic antibodies for cervical cancer, enabling patients to receive repeated doses of the vaccine consecutively. In addition to HPV, the efficacy and safety of vaccines using the baculovirus platform has been proven in preclinical trials conducted for MERS and Zika virus. Especially, the ability to actively respond to the rising number of COVID-19 variants is regarded as its greatest strength. “Hamsters vaccinated with two doses of the baculovirus COVID-19 vaccine a week apart showed 99.99% protection against COVID-19 infection, while the control group still showed viral infection," said Kim. He added, “As we are still in our preclinical stages, a large-scale clinical trial will be needed to verify our results. We also need to be prepared for multiple simultaneous outbreaks of infectious diseases, such as MERS and SARS. With various mutations of COVID-19 emerging, we urgently need to secure sovereignty over a more safe and effective vaccine." Meanwhile, the results of the preclinical trial on the MERS-CoV vaccine using the baculovirus platform technology were published on ‘npj Vaccines,’ a sister journal of Nature, and recognized for its academic value.
- Company
- The Cancer Committee discusses Tagrisso's first-line therapy
- by Eo, Yun-Ho Apr 06, 2021 06:10am
- #Tagrisso, a third-generation lung cancer targeting anticancer drug, is once again discussed at the Cancer Drugs Benefit Appraisal Committee in about a year. According to related industries, discussions on expanding the benefits of first-line therapy for the third-generation epithelial growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tagrisso (Osimertinib) will be held at the Cancer Drugs Benefit Appraisal Committee, which will be held on the 7th. As Leclaza, a drug of the same class, passed the Cancer Drugs Benefit Appraisal Committee within a month after approval, it is noteworthy whether Tagrisso can pass to expand benefits. Tagrisso was added first-line therapy indications in Korea in December 2018 and aimed to expand benefits in 2019, but in October of the same year, a Phase 3 FLAURA study that confirmed overall survival (OS) in first-line therapy at the Cancer Drugs Benefit Appraisal Committee. It was put on hold that it would have to wait for the full data of the company to be released. Later, along with the additional submission of the full data of the FLAURA study, they expressed their intention to accept most of the fiscal allocation proposals proposed by the government, but the members (specialists) objected that there was a problem with the clinical usefulness. Last May, the expansion of the benefits of first-line therapy was rejected. AstraZeneca's FLAURA China study, which was poster published last year at the online European Society for Medical Oncology (ESMO), added the evidence for confirming OS in Asians. The reason why Tagrisso's first-line therapy benefit extension was rejected was an Asian sub-analysis of FLAURA. Through the study, Tagrisso's OS was 38.6 months, demonstrating 6.8 months improvement compared to the first-generation drugs Iressa (Gefitinib) and Tarceva (Erlotinib). It is the first among EGFR TKIs, and it is encouraging considering that it has admitted the cross-over prescription of patients with confirmed T790M mutations in the first-generation drugs for research ethics. However, it was the Hazard Ratio (HR) of the sub-analysis for Asians. Tagrisso's HR for Asians was only 0.995. The value of 0.995 means that the gap is 0.005 based on 1, meaning that there is no difference from the control group. Based on this, an opinion was raised in academia that Tagrisso's OS is unreliable in Asians to which Koreans belong, and it had a dominant effect on the results of the Cancer Drugs Benefit Appraisal Committee. It is noteworthy what the results of Tagrisso, which added a study on Chinese people, will be produced. Meanwhile, in the FLAURA Chin study using a Chinese cohort, a total of 71 patients were assigned to the Tagrisso group and 65 patients were assigned to the control group. In particular, if the patients in the control group progressed to T790m positive, they could switch to Tagrisso and receive secondary treatment, and 22 out of 65 patients in the control group continued treatment with Tagrisso. As a result, the median OS of the Tagrisso group was 33.1 months, which was 7.4 months longer than 25.7 months of the control group, and the risk of death was reduced by 15.2%.
- Company
- Janssen’s ‘Tremfya’ approved for psoriatic arthritis
- by Apr 06, 2021 06:08am
- Janssen Pharmaceutical Companies of Johnson & Johnson announced on the 5th that the Korean Ministry of Food and Drug Safety (MFDS) approved its psoriatic arthritis treatment ‘Tremfya (guselkumab)’ on March 29th. With the approval, Tremfya may now be used for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or who have been intolerant to a prior disease-modifying anti-rheumatic drug (DMARD) therapy. Tremfya is the first and only interleukin (IL)-23 inhibitor to be approved for the treatment of active psoriatic arthritis in Korea. Tremfya is administered as a 100 mg subcutaneous injection once every 8 weeks, after starter doses at week 0 and 4. Patients who are at high risk for joint damage may consider 100 mg subcutaneous doses every 4 weeks according to clinical judgment and may consider using Tremfya in combination alone or with other disease-modifying antirheumatic drugs (DMARDs). The approval was based on two Phase 3 clinical trials, DISCOVER-1 and DISCOVER-2, which demonstrated that after 100mg SC injection of Tremfya, patients with psoriatic arthritis who had an inadequate response to conventional treatment showed improved signs and symptoms, including joint symptoms and skin symptoms at week 24. In DISCOVER-1, which evaluated patients who were naive to biologics or had an inadequate response to one or two standard therapies, 52% of the patients who received Tremfya every 8 weeks following two starter doses at week 0 and 4 achieved an ACR20 response at 24 weeks. In addition, 50% and 26% of the patient group achieved Psoriasis Area and Severity Index 90 (PASI 90) and PASI 100 response rates respectively, showing a significant improvement compared to the placebo group. In DISCOVER-2 which studied biologic-naïve patients, 64% of the patients who received Tremfya every 8 weeks achieved an ACR20 response at 24 weeks. Also, 69% and 45% of the Tremfya-treated patient group achieved PASI 90 and PASI 100 response rates respectively, showing a significant improvement compared to the placebo group. Integrated analysis of the two studies showed that Tremfya significantly improved enthesitis and dactylitis. From baseline, 50% of the patients who had enthesitis (114/230) and 59% of the patients who had dactylitis showed symptom improvement at 24 weeks since receiving Tremfya every 8 weeks, which is a significant difference from the 29% (75/255) and 42% (65/154) of the placebo group. “We are pleased to be able to provide a new treatment option to patients suffering from psoriatic arthritis in Korea with the approval of Tremfya,” said Jenny Zheng, Area Managing Director of Janssen Korea. “From plaque psoriasis, palmoplantar pustulosis, to psoriatic arthritis, we hope the extended indication will allow Tremfya to be more widely used in the field of psoriasis.” Previously, Tremfya has been approved in Korea for the treatment of adult patients with plaque psoriasis in 2018, and for the treatment of palmoplantar pustulosis in 2019.
- Company
- Reimbursement expanded for Takeda’s Adcetris and Alunbrig
- by Eo, Yun-Ho Apr 06, 2021 06:08am
- Takeda Korea has achieved continuous success in expanding reimbursement for its anticancer drugs, increasing the company’s hold over the market. According to industry sources, starting from April 1st, the government has decided to grant reimbursement for Takeda Korea’s antibody-drug conjugate ‘Adcetris (brentuximab vedotin)’ as a first-line treatment for Hodgkin and non-Hodgkin lymphoma and its anaplastic lymphoma kinase(ALK) tyrosine kinase inhibitor (TKI) ‘Alunbrig (brigatinib)’ as a first-line treatment for ALK-positive advanced non-small cell lung cancer (NSCLC). Takeda Korea had also previously received approval to expand the scope of reimbursement for its poly ADP-ribose polymerase (PARP) Inhibitor, ‘Zejula (niraparib)’ as maintenance treatment. Specifically, Adcetris can now be prescribed with reimbursement as first-line treatment for patients with previously untreated Hodgkin lymphoma and for patients with previously untreated CD30-positive systemic anaplastic large cell lymphoma (ALCL) who have an IPS (International Prognostic Score) of 4 or higher (If the patient is ALK-positive, those who have an IPS of 2 or higher may be covered) ‘Hodgkin lymphoma (HL)’ and 'systemic anaplastic large cell lymphoma (sALCL),’ a non-Hodgkin lymphoma subtype, are malignant tumors that develop in the lymphoid tissues that make up the immune system. In general, 30% to 40% of stage 3 to 4 HL patients experience treatment failure despite first-line treatment with the existing combination chemotherapy, ABVD (adriamycin+bleomycin+vinblastine+dacarbazine). Also, 26% of the ABVD treated group experienced disease progression, relapse, or death within 5 years. For Alunbrig, a new reimbursement criterion has been added for the first-line treatment of locally advanced or metastatic NSCLC, and the phrase ‘those who have been previously treated with crizotinib’ was removed from the second-line reimbursement criteria. The decision to approve the first-line administration of Alunbrig was based on the government’s review of the NCCN guidelines, where Alunbrig is recommended as category 1 preferred regimen for ALK-positive NSCLC, and that its Phase 3 trial results demonstrated that its clinical utility is comparable to other reimbursed replacements like ‘Alexenza (alectinib)’ and ‘Zykadia (ceritinib).’ However, reimbursement is not approved for patients wishing to change therapies for no specific reason or those receiving Alexenza or Zykadia that wishes to switch to a different ALK inhibitor due to disease progression. Myung-Ju Ahn, a professor of Hematology & Oncology at Samsung Seoul Medical Center said, “In addition to meeting the unmet demand that still remains in the current treatment environment, its ease of medication also provides a therapeutic advantage as it only requires a once-daily intake for disease management."
- Company
- SK Biopharm's new epilepsy drug licensed in Europe
- by An, Kyung-Jin Apr 06, 2021 06:08am
- #SK Biopharmaceuticals announced on the 31st that Cenobamate, a new epilepsy drug, has obtained sales permission from the EC on the 30th (local time). It has been about two months since it received a recommendation for marketing approval from CHMP under the European Medicines Agency (EMA) last month. Through this sales permit, SK Biopharm has secured a total of 1232.2 million dollars (about 140 billion won) worth of technology fees from partners. In addition to the $110 million milestone for European permits received from Angelini Pharma, which is responsible for local sales in Europe, the company will receive an additional $13.22 million milestone for each phase from the sale of its first contract partner, Arvelle Therapeutics. SK Biopharmaceuticals signed a Cenobamate technology transfer contract with Arvelle Therapeutics in February 2019.As Arvelle Therapeutics was acquired by Angelini Pharma earlier this year, it transferred 12% of its existing Arvelle stake to Angelini Pharma. At that time, it secured $31.76 million, a portion of the sale proceeds. SK Biopharmaceuticals expects earnings to improve as sales of'Cenobamate' begin in Europe within this year. Angelini Pharma, a European partner, announced that Cenobamate will be released in 41 countries in Europe from the third quarter of this year under the product name'ONTOZRY'. Starting with major countries such as Germany, France, Italy, Spain, and the UK, it is planned to be released sequentially to Iceland, Norway, and Liechtenstein, which are the signatories of the European Free Trade Agreement. Since May last year, SK Biopharm has started selling three Cenobamate under the product name Xcopri through SK Life Science, a US subsidiary. Unlike the US, the European market has a structure to receive royalties from sales by implementing a commercialization strategy through partners. When the commercialization of'ONTOZRY' begins in earnest, SK Biopharm can secure up to $585 million as a milestone linked to sales performance. Since royalties from sales are separately received, the scale of revenue can be expanded according to the sales volume. The company is confident in its marketability as there has been high interest in'ONTOZRY' in Europe before the approval. At the time of the contract in 2019, SK Biopharm recorded the highest record in exports of central nervous system (CNS) drug technology to Europe. In August of last year, it was selected as a promising innovative treatment by MHRA in the UK, and in December of the same year, as the clinical results were announced at the annual conference of the European Academy of Neurology, it was evaluated as the best-in-class drug in the same category. As the partner company changed from Arvelle to Angelini Pharma, its sales and marketing capabilities have also strengthened. Angelini Pharma is one of the top three pharmaceutical companies in Italy and has a product line specialized in the CNS field, such as pain, depression, and schizophrenia. “Our efforts to provide breakthrough treatments to patients with epilepsy in Europe are paying off,” said SK Biopharm's President Jo Jung-woo. "We will continue to develop new treatment options for patients with the central nervous system and fulfill our role as a global comprehensive pharmaceutical company," he said. Pierluigi Antonelli, president of Angelini Pharma, said, "We expect ONTOZRY to be a new hope for epilepsy patients suffering from unexpected seizure symptoms. We will build an innovative product portfolio to meet the needs of CNS patients."
