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- 2025-12-25 15:34:14
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- ‘Brilinta’ generic to be released next month
- by Kim, Jin-Gu Oct 25, 2021 05:50am
- Pic. of Brilinta Generics of AstraZeneca’s oral antiplatelet therapy Brilinta will be released next month. However, only 6 of the 25 companies that received first generic exclusivity will be releasing actual products. The small number of releases is interpreted to be caused by the domestic companies' declining interest in Brilintagenerics. According to industry sources on the 22nd, the substance patent for Brilinta will expire on the 20th next month. In other words, generics that had avoided the formulation patent of Brilintawill be allowed to be released from the 21st next month. Currently, 25 companies have successfully avoided Brillinta’s formulation patent and acquired first generic exclusivity. However, only 6 of these companies will be releasing actual generics. The companies are Chong Kun Dang, Samjin Pharm, Genuone Sciences, Alvogen Korea, and Hana Pharm. The other 19 companies including Hanmi Pharmaceutical and Boryung Pharmaceutical are adjusting their schedules for its release. The companies, which already own other antiplatelet therapies with different ingredients are in no rush to release the generics. This is in stark contrast to 2015 when generic companies competitively challenged Brillinta’s patent. At that time, the ticagrelor market showed promise to expand significantly. This was why around 30 companies in Korea had challenged the substance, formulation, and crystalline form patent of Brilinta. According to the market research institution UBIST, outpatient prescriptions for Brilinta, which recorded 4.8 billion won in 2014, then rose to 7 billion won in 2015. The market continued to grow until 2019 when it peaked at 10.8 billion won. However, sales fell to 9.8 billion won last year. And 4.3 billion won’s worth was prescribed in the first half of this year. At this trend, it is likely that outpatient prescriptions of Brilintamay see a decline for 2 consecutive years. The industry pointed to the existence of strong competitors such as aspirin, clopidogrel, sarpogrelate, and the introduction of new oral anticoagulants (NOACs) that have coinciding indications that quickly gained popularity, as the reason why Brilintais performing less than expected. Also, the relatively high price of ticagrelor APIs is one reason why generics are hesitant to produce their generics. An official from a company that postponed their generics’ release said, “The bottom line is, marketability is low and the price of its API is high, so the generic is not very profitable. That is why we decided to wait and see how the companies that first enter the Brilinta market do then enter the market as latecomers.”
- Company
- Boryung Pharmaceutical acquired Zyprexa's domestic rights
- by Kim, Jin-Gu Oct 25, 2021 05:49am
- Boryung announced on the 21st that it has signed an asset transfer contract with Eli Lilly for the schizophrenia treatment "Zyprexa (Olanzapine)." Through this contract, Boryung will take over all rights from Eli Lilly, including domestic copyrights and permits for Zyprexa. Zyprexa is the world's most prescribed treatment for schizophrenia since its launch in 1996. It is a drug used for schizophrenia and bipolar disorder and controls the imbalance of Dopamine in the brain. According to IQVIA, a pharmaceutical market research firm, Zyprexa generated 14 billion won in sales in Korea last year. It occupies about 50% of the domestic Olanzapine market. Boryung plans to further strengthen its central nervous system (CNS) treatment business through the acquisition of Zyprexa. Boryung has CNS drugs such as Buspar (mental inhibitor), Prozac (central stimulant), and Strattera (behavioral disorder). Boryung's goal is to add Zyprexa to achieve 50 billion won in annual sales in the CNS sector by 2025. The contract was made as part of the Legacy Brands Acquisition (LBA) strategy announced by Boryung in July. LBA refers to the acquisition of original medicines that maintain a certain level of sales and market share even after patent expires. It acquired the domestic rights of the anticancer drug Gemzar (Gemcitabine) from Lilly in May last year. CEO of Boryung Jang Doo-hyun said, "The acquisition of Zyprexa has provided an opportunity for a new leap forward in the CNS treatment business." "In order to continue to acquire products that can contribute to Boryung's growth in the future, we are considering a number of products that are leading the domestic and foreign treatment markets," he said.
- Company
- Supreme court to finally rule on ‘Galvus’ patent dispute
- by Kim, Jin-Gu Oct 22, 2021 05:45am
- The 4-year long patent dispute over the patent of the anti-diabetic DPP-4 inhibitor ‘Galvus (vildagliptin)’ will finally come to an end at the Supreme Court on the 28th. Industry officials believe that the Supreme Court’s decision may affect and modify the overall patent strategies of generic companies in the coming future. If the Supreme Court rules in favor of Ahn-Gook Pharmaceuticals, this will greatly increase the number of challenges filed on substance patents of original drugs, which have been considered impregnable. ◆Will the first ‘invalidation of substant patent extension’ case be born? According to industry sources on the 20th, the Supreme Court issued a notice that it will rule on the Galvus patent dispute between Ahn-Gook Pharmaceutical and Novartis on the 28th. The issue, in this case, is how much of the "extended duration" of the drug substance patent will be considered invalid. The industry anticipates that the Supreme Court’s decision may affect and modify the overall patent strategies of generic companies that will be made. Until now, there has never been a case in which a generic company has overcome the extended term of a drug substance patent.” If the supreme court rules in favor of the generic company and renders even one day of the extended patent term invalid, this will may trigger a series of challenges on substance patents of original drugs, an area that has been considered impregnable. On the other hand, if the Supreme Court accepts Novartis’ claim and recognizes the entire extended period as is, generic companies are expected to maintain their current patent strategy. ◆Mixed rulings at 1st and 2nd trial… what will the Supreme Court’s ruling be? Patent rights are usually protected for 20 years from the filing date. For pharmaceutical products, the time taken for clinical trials and regulatory approval is added to the term. Depending on the recognized period, patent protection for a drug can last 21 years or even 22 years. The same applied to Novartis when applying for Galvus’s patent in Korea. The company requested the patent term for Galvus to be extended to make up for the time spent on clinical trials and for the regulatory review by the Ministry of Food and Drugs Safety. The Korean Intellectual Property Office accepted the request and extended the term by 2 years, 2 months, and 23 days (1068 days). Pic. of GalvusAhn-Gook Pharmaceutical claimed that ‘187 days’ of the extended term for Galvus’s substance patent was invalid. Hanmi Pharmaceutical later joined in the fight. The court ruled in favor of Ahn-Gook Pharmaceutical in the first trial. The Patent Court of Korea accepted Ahn-Gook’s claim and ruled the 187 days invalid. With the ruling, Ahn-Gook Pharmaceutical received the right to release its generic 187 before the expiry of Galvus’s substance patent. Novartis got a partial win in the second trial. The Intellectual Property Trial and Appeal Board had overturned the first instance judgment and ruled that only 55 of the 187 days are invalid. Despite the reduced period, the ruling still rendered a part of the period invalid. As a result, Ahn-Gook did lose the suit but reaped the rewards. Novartis once again appealed, and the case is now being reviewed by the Supreme Court. Novartis is claiming that not a single day should be rendered invalid. The Supreme Court's ruling is expected to be one of the three – recognizing the ‘187 days invalid’ by accepting the ruling of the first trial; recognizing the ’55 days invalid’ by accepting the ruling of the second trial, or accepting Novartis’ claim and not recognizing any part of the term invalid.
- Company
- COVID antibody kits are entering the market of clinics
- by Kim, Jin-Gu Oct 22, 2021 05:44am
- Although the sale of COVID-19 antibody diagnostic kits to pharmacies has been banned, diagnostic kit companies are speeding up into the market, especially in hospitals and clinics. It is explained that the industry's impact from the government's measures is not significant because it has focused on the hospital and clinic markets rather than pharmacies in the first place. Although it is said that there is a limit to accurately confirming the effectiveness of the COVID-19 vaccine, related companies are expecting to expand the market in the future due to the increase in vaccination rates. ◆The impact of banning the sale of pharmacies will be limited to some companies According to the diagnostic kit industry on the 20th, the government's ban on selling antibody diagnostic kits at pharmacies is not expected to have a significant impact on the entire antibody diagnostic kit market. This is because most companies have focused on the hospital and hospital markets, not pharmacies. Industry officials say that only a small number of companies have supplied products to pharmacies. According to the MFDS, 14 products from 11 companies were approved as antibody diagnostic kits as of the end of last month. However, about two of them were distributed to pharmacies. ◆The vaccination rate is close to 70%. The demand for antibody diagnostic kits is increasing On the contrary, some companies are expressing expectations in that demand for on-site is expanding as the vaccination rate increases. As of midnight on the 20th, the complete COVID-19 vaccination rate in Korea reached 66.7%. It is expected to exceed 70% within this month. In particular, it is reported that the demand for the vaccine effect has increased further recently as the effect of the COVID-19 vaccine has dropped sharply within two to six months. It is confirmed that front-line hospitals are using antibody diagnosis kits as non-reimbursed items for confirmation of vaccine effects. ◆Pharmaceutical companies are expressing regret over the government's position of "not being able to confirm the vaccine effect" However, the fact that the government reiterated that "there is a lack of medical evidence for the purpose of confirming the vaccine effect" is a common concern among diagnostic kit companies. The diagnostic kit industry has focused on exploring related markets around the time when the domestic complete vaccination rate exceeded 10%. They expected the market for neutralizing antibody diagnostic kits to confirm vaccine effects to grow explosively. However, in July, the government said, there was a lack of medical evidence for the purpose of confirming the effectiveness of the vaccine. The government reaffirmed its position by banning the sale of pharmacies. ◆It is impossible to determine the vaccine effect by simply producing neutralizing antibodies There are three types of domestic approved diagnostic kits. It is a PCR, antigen, and antibody diagnostic kit. PCR and antigen diagnostic kits are used to confirm suspected COVID-19 patients. Antibody diagnostic kits are used to determine if people have been infected with COVID-19. People who have been infected with COVID-19 develop binding antibodies, which is the principle that antibody diagnosis kits check whether or not binding antibodies are produced. The diagnostic kit industry focused on the fact that it can also check whether neutralizing antibodies are produced with antibody diagnostic kits. Neutralizing antibodies are antibodies that occur after vaccination. They have argued that their own clinical results can determine whether neutralizing antibodies are produced with 90% accuracy. The government is in a position that it is difficult to determine the effectiveness of the vaccine simply by producing neutralizing neutralizing antibodies are produced. This is because in order to check the vaccine effect, it is necessary to determine how much neutralizing antibodies are formed in the body.
- Company
- Q3 exports of Biopharmas 'Good’ Diagnostic kits ‘Slow'
- by Kim, Jin-Gu Oct 21, 2021 05:13am
- While pharmaceutical exports in Q3 increased slightly compared to the same period of the previous year, the performance of biopharmaceuticals and chemical drugs have shown mixed results. Export of biopharmaceuticals increased 13% YOY and continued on its strong flow from last year, however, export of chemical drugs fell 13%. Also, diagnostic kits, which rose as an export ‘cash cow’ after the COVID-19 outbreak, saw a decline in export value amount despite the large increase in export volume. The analysis is that this may be due to the continued decline in its export unit price. ◆Earned ₩6.8 trillion in Q3 exports….will the industry exceed last year’s ‘largest ever’ record? According to Korea Customs Service on the 15th, the domestic export value of pharmaceuticals in Q3 was $1.86 billion (approx.. ₩2.2 trillion). This is a 6% YOY increase from the $1.76 billion (approx.. ₩2.07 billion) in Q3 last year. The cumulative amount of exports by Q3 has increased 26% from $4.60 billion (approx. ₩5.44 trillion) last year to $5.77 billion (approx. ₩6.82 trillion) this year. If this trend continues, the industry may break the all-time export record that it made last year. The total pharmaceutical exports last year amounted to $6.89 billion (approx. ₩8.15 trillion). However, exports last year were concentrated around Q4. In Q4 last year, the industry earned $2.30 billion (approx. ₩2.71 trillion), accounting for 33% of the total amount of exports of the whole year. ◆Biopharmaceuticals increase 13% · Chemical drugs decrease 13% … shows clear difference between areas In detail, the export between biopharmaceuticals and chemical drugs have shown mixed results. In Q3, export sales of biopharmaceuticals amounted to $1.4485 billion (approx. ₩1.71 trillion) and increased 13% YOY. The analysis is that the export of biopharmaceuticals is continuing to show good flow. The share of biopharmaceuticals contributing to the total pharmaceutical exports also rose 5%p from 73% in Q3 last year to 78% in Q3 this year. Export of biopharmaceuticals has soared over the past 2 years, mainly around biosimilars from Celltrion and Samsung Biologics. Biopharmaceutical exports doubled from $430.17 million (approx. ₩510 trillion) in Q1 2019 to $868.95 million (approx. ₩1.03 trillion) in Q1 2020 and doubled once more to $1.81 billion (approx. ₩2.14 trillion) in Q1 this year. On the other hand, the export of chemical drugs fell 13% from $467.81 million (approx. ₩550 billion) in Q3 last year to $408.8 million (approx. ₩480 billion) in Q3 this year. ◆Export volume of diagnostic kits the greatest-ever… however value earned falls 5% in one year Also, the export performance of diagnostic kits that soared after the COVID-19 outbreak has been slowing down recently. In Q3 this year, exports of domestic diagnostic kits amounted to $570.37 million (approx. ₩670 billion), which is 5% lower than the $600.41 million (approx. ₩710 billion) in Q3 of last year. By each quarter, sales of diagnostic kits increased steadily until Q4 last year, and then was showing signs of stagnation entering this year. This is due to the worldwide COVID-19 vaccinations that began earlier this year, and the falling unit price of the kits due to intensified competition between global diagnostic kit companies. By export volume, quarterly exports of diagnostic kits set a new record of 2,517 tons in Q3 this year. This is much larger than the export volume in Q3 last year - 1,467 tons. In other words, the export value fell 5% despite a 72% increase in exports export volume in the same period.
- Company
- Pfizer applies for reimbursement of 3rd-gen ALKi Lorviqua
- by Eo, Yun-Ho Oct 20, 2021 05:56am
- Pfizer is aiming to introduce a second ALK inhibitor after ‘Xalkori’ into Korea’s prescription market. According to industry sources, Pfizer Korea has recently submitted a reimbursement listing application for its anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI), ‘Lorviqua (lorlatinib),’ which is in progress. Pfizer received the orphan drug designation for Lorviqua last March, then in July, the drug was approved as monotherapy to treat adult patients with ALK-positive advanced non-small-cell lung cancer (NSCLC) whose disease has progressed after - Alecensa (alectinib) or Zykadia (ceritinib) as the first ALK tyrosine kinase inhibitor (TKI) therapy; or Xalkori (crizotinib) and at least one other ALK TKI. Lorviqua is a third-generation drug that arose as an alternative option in patients who developed resistance to the first-generation drug Xalkori and the second-generation drugs Zykadia, Alecensa, or Alunbrig. In other words, patients who used Xalkori first-line may use second-generation drugs as second-line, then use Lorviqua; patients who used second-generation drugs as first-line may use Lorviqua as second-line treatment. Until now, patients who developed resistance to the drugs in the second-line had no available targeted therapies and therefore had to opt for chemotherapy in later-line treatments. ALK G1202R solvent front mutation is the most common ALK resistance mutation after being treated with second-generation drugs, and other ALK mutations also occur by drug, such as F1174L(Zykadia), I1171T/N/S(Alecensa), E1210K(Alunbrig), etc. Lorviqua (lorlatinib) has shown to be effective against all known resistance mutations. With such strengths to resistance, Lorviqua is expected to quickly attract prescriptions if listed for reimbursement. Whether Pfizer, the pioneer of ALK targeted anticancer therapy, will be able to increase its share in the market remains to be seen. Meanwhile, the approval of Lorviqua was based on an open-label, single-arm, multinational, multicenter Phase II study that was conducted on various 275 NSCLC patients with ALK-positive and ROS1-positive advanced NSCLC, from treatment-naïve patients to those who had been treated with up to three ALK inhibitors. In the study, the ORR (Objective response rate) - the primary endpoint - of patients who have been previously treated with 1 or more ALK inhibitors including second-generation ALK inhibitors was 47%, and the patients’ intracranial objective response rate (IC-ORR) was 63%. The median duration of response was yet to be reached at the time of analysis, as 63 out of 93 patients with a confirmed response at the time of analysis showed a continued response. The lower bound of the 95% confidence interval for the response period was 11.1 months.
- Company
- Moderna Korea speeds up group organization
- by Oct 20, 2021 05:56am
- Moderna Korea, which had shown little activity for almost 6 months after establishing its Korean subsidiary, is busy recruiting members in secrecy. With the active hiring and imminent production of Moderna vaccines, officials predict that the company will be starting its official activity soon. According to industry sources on the 19th, Moderna Korea has completed hiring executives for some of its departments including those for Medical, Pharmacovigilance, and Regulatory Affairs. For the PV Head, an official with global CRO experience has moved to Moderna Korea in July, and a former BMS official has been serving as the Quality Head since last August. The company has been speeding up its organizational process, recruiting executives and employees for various departments including the Supply Chain, Customer Services and Logistics, and Commercial Legal. The General Manager (GM) for the Korean subsidiary has also been appointed, however, who the GM is remains unknown. Only rumors that the GM is a vaccine expert from a specific multinational pharmaceutical company are abound. A representative of a multinational pharmaceutical company who wished to remain anonymous said, “Under the premise that the GM was already hired, it is possible that the new head may have been recruited from a different country since so little is still known.” Over 60 candidates had applied for the position, and although most were residing in Korea some have applied from other regions such as Hong Kong, etc. Looking at Moderna Korea’s organization chart, the Korean subsidiary’s role is expected to be concentrated around the supply and quality control of its products. An industry official said, “Looking at the areas in hiring, I believe the company’s work will focus on drug-related tasks such as the side effects of its vaccines rather than drug development. However, as Moderna is one of the few companies that can implement mRNA products as a platform, what role the branch will play remains to be seen.” This adds strength to expectations that Moderna Korea will start its official activities in line with Samsung Biologics' consignment production of the Moderna vaccines. According to the remarks made by the Minister of Food and Drug Safety Gang-lip Kim at the NA’s Health and Welfare Committee audit, Samsung Biologics is expected to receive GMP certification within this month. Samsung Biologics has begun production of the Moderna COVID-19 vaccine in line with this. After Moderna Korea finishes organizing its group, the company is expected to be in charge of the regulatory procedures necessary to supply the Moderna products produced by Samsung Biologics to Korea and the Asia Pacifica region.
- Company
- Hugel’s Geodu BTX plant completes EMA inspection
- by Lee, Seok-Jun Oct 19, 2021 06:00am
- [Hugel announced that the European Medicines Agency completed the on-site inspection of its ‘Geodu plant’ in Chuncheon on the 18th. The Geodu plant has a fully automated state-of-the-art system that can manufacture over five million botulinum toxin vials a year. EMA conducted an on-site inspection on the Geodu plant’s manufacturing facilities and quality control system for 3 days, from the 12th to the 14th, to verify whether the facility complies with the EU-GMP standards. With the on-site inspection complete, the company expects to acquire the EU GMP certification soon. The company had previously completed FDA’s on-site inspection for cGMP in August. A Hugel official said, “ With the recent inspection of EMA’s Geodu plant complete, the company expects to be able to soon emerge into the European market in addition to its entry into the Chinese market last year. By entering the European market this year, and the US market next year, we aim to continue our endeavors to become a global company that covers 95% of the world’s botulinum toxin market. The European market, combined with the US market accounts for 70% of the world’s botulinum toxin market. With the aim to emerge into the European market, Hugel completed its Phase III clinical trials(Bless 1 and Bless 2) in Poland and Germany with an Austrian medical aesthetics pharma company ‘Croma,’ and submitted an application for marketing authorization in June 2020.
- Company
- Hugel's Letybo benefits from FDA delay of Revance's DAXI
- by Nho, Byung Chul Oct 18, 2021 05:54am
- The U.S. Food and Drug Administration’s disclosure of the official document outlining concerns in the DAXI manufacturing plant of the botulinum toxin company, Revance Therapeutics (hereinafter ‘Revance’), raised industry concerns about the uncertainty of the company’s approval. Revance is a new medical aesthetics company that sells botulinum toxin and HA filler products. The company had submitted a Biologic License Application to the FDA for its botulinum toxin product DAXI in 2020 and expected to receive marketing authorization by 2021. The FDA conducted an on-site inspection of the company's manufacturing plant from late June to early July. The document that was disclosed this time had pointed to 4 issues of concern, which includes the issues that the actual manufacturing process is not the same as in the application for the marketing authorization, and the verification of the Working Cell Bank is inadequate. Upon disclosure of such concerns, Revance announced that it still expects to receive approval within the year. However, the industry expects that it would take considerable time before the company can make up for the serious issues discussed by the FDA. Currently, Allergan’s Botox accounts for 75% of the 2 trillion dollar botulinum toxin market, virtually dominating the market. The US market, therefore, has a high need for a new company that has a premium botulinum toxin product with a reasonable price. Companies that have recently submitted a marketing approval to the FDA for their botulinum toxin and underwent review include the US company Revance and Korean company Hugel. An industry official said, “Expectations for Hugel’s entry in the US market is increasing as the competition between the new companies, Revance and Hugel, has fallen apart with the FDA’s document that rendered the date of Revance’s marketing approval uncertain. Hugel has smoothly completed its on-site inspection and mid-cycle meeting. The official added, “Hugel completed submission of the supplementary material requested by the FDA after its inspection and is expected to pass review without issue." The FDA had conducted a cGMP inspection for nine days from August 12-20 to verify the manufacturing facilities and the quality management system of Hugel’s second plant that is in charge of the production of Letybo.
- Company
- Novartis applies for another gene therapy, Luxturna
- by Eo, Yun-Ho Oct 18, 2021 05:54am
- Novartis has applied for the registration of insurance benefits for another new one-shot gene therapy drug. According to related industries, Novartis Korea recently submitted an application for benefits for the Inherited Retinal Dystrophy (IRD) treatment "Luxturna (Voregenene Neparvovec). Luxturna restores its function by replacing the deficiency and defective RPE65 gene, one of the causes of IRD, with a normal gene with just one administration. In other words, fundamental treatment of diseases is possible. The drug was designated by the U.S. FDA as a target for Breakthrough Therapy in 2014, Orphan Drug in 2016, and Priority Review in 2017, and obtained rapid approval in 2017. IRD is a rare refractory disease that causes visual loss due to mutations in genes responsible for retinal optic cell structures and functions. It contains more than 20 various eye diseases and has about 300 causative genes. IRD, caused by RPE65 gene mutation, causes abnormalities in the visual cycle in the retina that converts visual information into neural signals and transmits it to the brain. The RPE65 gene mutation can reduce the RPE65 protein essential for visual circuits and gradually narrow the field of view as retinal cells are destroyed, which can eventually lead to blindness. Kang Se-woong, chairman of The Korean Retina Society (Professor of Ophthalmology at Samsung Medical Center), said, "Luxturna can expect recovery to the extent that independent walking is possible without the help of a guardian with a single injection." Luxturna proved its effectiveness through phase 3 clinical trials conducted in patients with hereditary retinal disease whose double confrontational trait mutation of the RPE65 gene was confirmed. Clinical results show that the patient group who received Luxurna treatment at 1 year of treatment had statistically functional vision than the control group who did not receive treatment. It has improved significantly. As a result of evaluating the average score of the Multi-Luminance Mobility Test (MLMT) at the time of 1 year of treatment as a primary evaluation variable, the score change of the Luxturna treatment group was 1.8 points, 1.6 points higher than the control group's score change of 0.2 points. In the darkest 1lux (Lux), 65% (n=13/20) of the Luxturna treatment group reported the maximum improvement in MLMT scores, while none of the controls passed.
