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- “Evenity is effective in patients at very-high-risk of OP"
- by May 07, 2021 06:01am
- The strategic paradigm for osteoporosis treatment has shifted. Compared to the past where not many patients were treated for osteoporosis and those who were treated used bone resorption inhibitors like bisphosphonate, a more aggressive treatment paradigm has landed in the field of osteoporosis treatment. The development of new drugs had triggered such changes in the treatment trend. Unlike bone resorption inhibitors, the only option patients used to have as a bone-forming agent was teriparatide; however, the introduction of Amgen’s ‘Evenity (romosozumab)’ brought all the difference. Evenity is the first and only bone builder with a dual mechanism of action that increases bone formation and inhibits bone resorption. With the introduction of this promising new drug, the American Association of Clinical Endocrinology∙American College of Endocrinology (AACE∙ACE) newly defined a Very-high-risk group for osteoporosis fractures by revising the 2020 guidelines for the diagnosis and treatment of postmenopausal osteoporosis, to recommend aggressive drug treatment from early on. Dailypharm met with Dr. Felicia Cosman, professor of Medicine at Columbia University Vagelos College of Physicians and Surgeons, to hear about the latest advances and trends in the treatment of osteoporosis. Professor Felicia Cosman. Dr. Cosman is explaining the latest advances in the treatment of osteoproosis in a virtual webinar held on the 4th. (Pic. From the virtual interview) -- Last year, the international guideline newly defined the 'very-high-risk group for osteoporosis fracture' and presented different treatment strategies according to the patient’s level of risk. Could you tell us the background and specifics of the revised guideline? =Academic societies in Korea and abroad have newly defined patients with high risk of fractures as a ‘very-high-risk group for osteoporosis fracture’ and recommends bone-forming agents to be more effective in increasing bone strength. These group of patient can be considered ‘at emergency of osteoporosis’ and are at high risk of experiencing fractures in the near future. The international osteoporosis foundation defined the very-high-risk group for osteoporosis fracture as ‘patients with a 10% or higher probability of experiencing fractures within 2 years.’ Also, according to a retrospective cohort study by Professor Balasubramanian that researched 377,561 women that are 65 years or older who recently experienced fractures, the cumulative risk of subsequent fractures in these women were 10% and 18% in 1 and 2 years, respectively. One notable fact is that the risk and area of subsequent fractures varied according to the initial fracture site. Patients with initial vertebral fracture had the highest risk of refractures at 14%, and those with initial ankle fracture had the lowest risk at 5%. However, as the 2-year risk of refracture in patients with ankle fractures was also 10%, these patients were also categorized as a very-high-risk group. Multiple fracture patients are also classified as a very-high-risk group, regardless of their recent fracture events. This very-high-risk group should use bone-forming agents from early on for rapid bone formation. In the past, bone resorption inhibitors were considered as the first treatment option for these patients; however, the paradigm has shifted to using bone-forming agents from early on. -The new guidelines recommended 4 kinds of treatment strategies for the very-high-risk group. Evenity, which shows a dual effect to increase bone formation and inhibit bone resorption, was also first recommended in the revised guidelines. What is your opinion on this, and how should we devise treatment strategies using the recommended therapies? =As I mentioned before, the paradigm has changed to acknowledge that starting treatment with bone-forming agents like Evenity, followed by bone resorption inhibitors may be more effective for bone formation. This is why Evenity was also included as an option in the new guideline. There aren’t many head-to-head studies on Evenity and teriparatide; however, there is one that was published on NEJM in 2014. The Phase II trial that studied women aged 55 to 85 with low bone mineral density showed that Evenity had improved the BMD in hip, femoral neck and spine more than teriparatide. Evenity also had a higher effect in increasing bone density compared to teriparatide in the hip and spinal area a follow-up study, In practice, the approach needs to be set differently for each patient. For example, a patient in his/her 60s who had experienced spinal fracture may have a low BMD in his/her spine, but a normal BMD in the hip area. If the patient has no other risk factors, he/she may choose to use teriparatide. -As the lead author of the Phase III FRAME (FRActure study in postmenopausal woMen with ostEoporosis) trial, you found that Evenity-Prolia was more effective in reducing the risk of fracture than placebo-Prolia. =The FRAME study compared patients treated with Evenity and placebo for 1 year, both followed by Prolia for 1 year to assess the risk of fractures. Study results showed that at month 12, Evenity reduced the risk of new vertebral and all clinical fracture risk by 73% and 38%, respectively, compared to placebo. Also, patients treated with Evenity saw a mean percent increase in BMD over placebo of 13.3% at the lumbar spine, 6.8% at the total hip, and 5.2% at the femoral neck. This is a superior increase in BMD compared to both mono and dual therapies. Based on such results, the researchers were able to reconfirm that Evenity is the top priority treatment option for patients at very high risk of fractures as it quickly reduces the risk of fractures while increasing bone formation. In particular, Evenity is more suitable for patients with a low BMD in the hip and nonvertebral areas, as well as the vertebrae area. -Despite Evenity’s potency, why do patients need to switch to Prolia after 1 year? Could patients who saw much benefit from Evenity extend their treatment period? =The treatment period reflects the results of the Phase II trial on Evenity. In the Phase II trial, Evenity showed a very high bone-forming effect for 1 year. After that, its effect was comparable to those of bone resorption inhibitors. While no additional benefits were seen in the second year of Evenity treatment, such as an increase in bone mass, patients who switched to Prolia after 1-year of Evenity treatment saw the better effect. Based on such findings, the 1-year treatment period was deemed reasonable considering the administration cycle and number. -- What are your thoughts on the risk of adverse cardiovascular events that were added to the indications in Europe, U.S., and Korea? =The only clinical study on Evenity that presented adverse cardiovascular events was the Phase III ARCH trial that compared Evenity with alendronate. In the study, a higher rate of major adverse cardiac events (MACE), which is defined as the composite of cardiovascular deaths, myocardial infarction, or stroke, was reported at week 12 in patients treated with Evenity (2.0%, 41/2,040 participants) compared to those treated with alendronate (1.1 %, 22 /2,014 participants). However, when including heart failure events, there was no significant difference in MACE between the two groups. In conclusion, the risk and benefits that each patient may see from using Evenity need to be analyzed and compared. Of course, the decision must comply with the recommendations set in the approval process. In the U.S., use of Evenity is restricted for patients that are at very high risk of experiencing cardiovascular events. This includes patients who have experienced strokes or myocardial infarction within 1 year. -In Korea, the reimbursement standards directly affect treatment strategy. In consideration of the reimbursement standards currently set for Evenity in Korea, what areas do you think require further discussion? = When I saw Korea’s reimbursement criteria for Evenity, I wondered whether its application after 2 or more fractures was appropriate. As I have mentioned before, there is ample evidence to support the validity of prescribing Evenity even after just a single fracture. Also, the criteria that first requires the use of bisphosphonates is quite similar to the pre-revised international guideline. The problem is that prescribing bone-forming agents after the use of bisphosphonates doesn’t provide as good an effect in reducing fractures. Korea also needs to consider the paradigm shift in osteoporosis treatment that has already begun. In the past, the global consensus was to first use bisphosphonate; however, this has completely changed now. With the introduction of Evenity, it has been recognized that the right time to use bone-forming agents for optimal effect is in the early stages when patients are identified to be at very-high-risk of fractures.
- Company
- Why SK and GC's deal for Xarelto exclusivity right misfired
- by Kim, Jin-Gu May 06, 2021 06:07am
- SK Chemicals's discussions with GC Pharma on handing over the exclusivity rights of Xarelto (rivaroxaban) had broken down in the end. The reason is known to be that the scope of the patent avoided by SK Chemicals does not match the composition of the generic developed by GC Pharma. According to industry sources on the 5th, the sale of the exclusivity rights of Xarelto between SK Chemicals and GC Pharma ended in misfire. The two companies had been discussing selling the exclusivity rights of Xarelto. GC Pharma's intent to enter the generics market 9 months earlier than other companies seemed to be in line with SK Chemicals's intent to sell its exclusivity rights. However, the discussion ended in a misfire. Officials from both companies stated, “It is true that there had been discussions, but the deal was broken off.” The industry points to the scope of a patent avoidance that SK Chemicals owns as the cause of the breakdown. SK Chemicals, along with Hanmi Pharmaceutical, succeeded in avoiding the composition patent for Xarelto 2.5mg. After winning the first trial in November 2015, the companies obtained the exclusivity right through the first Marketing Authorization Application (MAA) in July of the following year. However, the scope of the exclusivity right the two companies have obtained was limited to the 2.5mg dosage. The component patent of the remaining doses of Xarelto, 10mg, 15mg, and 20mg, had not been registered by Bayer in the first place. When filing for patent avoidance of Xarelto's composition patent, the argument of SK Chemicals and Hanmi Pharmaceutical was that its "manufacturing process was different from the original.” The original tablet is manufactured through a wet granulation process after suspending rivaroxaban in a hydrophilic binder. On the other hand, the generics developed by SK Chemicals and Hanmi Pharmaceutical are made by first spray drying the lactose hydrate and hypromellose+solvent solution into fine powder instead of granules, then adding excipients for tablet manufacturing, followed by compression and tableting. The Intellectual Property Trial and Appeal Board (IPTAB) and the court acknowledged the significant difference in manufacturing and ultimately ruled that SK and Hanmi's generic does not violate the original’s scope of patent. However, the problem was that this manufacturing method was different from the method used in the generic that was self-developed by GC Pharma. As GC Pharma's generic was manufactured in a different way than the one that was acknowledged as 'different from the original drug' by IPTAB, GC Pharma would not be able to exercise the exclusivity rights even if they purchased it. So, GC Pharma either had to develop a new generic with the method through which SK Chemicals avoided the original patent or give up the deal. GC Pharma's decision was to give up the deal. “The two companies started negotiations without specific knowledge of the scope of the exclusivity right, so the deal eventually ended up nowhere,” explained a pharmaceutical industry official. On whether to proceed with the sale of exclusivity rights of Xarelto with other companies, an official from SK Chemicals said, “We haven’t yet made other deals after discussions with GC Pharma had broken down.” According to the pharmaceutical market data research firm UBIST, the outpatient prescription sales of Xarelto recorded 50 billion won last year. This was a 1% decrease from the 50.8 billion won in 2019. In the first quarter of this year, 11.9 billion won worth was sold. In the new oral anticoagulant (NOAC) market, Xarelto stands in second place after Lixiana and is followed by Eliquis and Pradaxa.
- Company
- Moderna’s next steps in Korea…vaccine production scenarios
- by Kim, Jin-Gu May 06, 2021 06:07am
- The establishment of Moderna’s Korean subsidiary has begun. Moderna's business team from its U.S. headquarters had visited a factory of a domestic pharmaceutical company. The company's actions are adding strength to the speculation that domestic production of Moderna's vaccines is imminent. The factory that the business team had visited the previous month is expected to act as an outpost for Moderna’s vaccine production. On this, various scenarios on whether Moderna will directly take charge of vaccine production in Korea or will contract a domestic company to produce the vaccine are being raised in the industry. ◆'Establishment of ‘Moderna Korea’ … why enter Korea? According to industry sources on the 3rd, Moderna had posted an announcement on its website to hire a GM (General Manager) for Korea. Industry officials interpret this as the company's first step into establishing subsidiaries in Korea, Japan, and Australia as stated by the compnay on the 15th last month. The most likely purpose for entering Korea is to produce COVID-19 vaccines. Moderna has been producing 500 million doses of its vaccine annually at its U.S. and European plants. However, the whole amount of the vaccines produced by the two plants are being supplied locally. The production amount of the two plants is said to be tight and is just enough to meet the local demand. Therefore, vaccines for other regions must be produced in other factories. This is also true for the 20 million doses that the company agreed to supply to Korea. Moreover, in the case of the United States, the Defense Production Act fully controls the export of raw materials and equipment used in the production of COVID-19 vaccines, which gives strength to the theory that Moderna will produce vaccines in Korea. Moderna had posted a job announcement on its website to hire a GM for Korea. ◆Why Moderna’s business team visited A Pharmaceutical’s plant In mid-April, a business team from Moderna headquarters visited a plant of a domestic pharmaceutical company, A Pharmaceuticals. "I know that Moderna 's HQ visited and inspected A Pharmaceutical's plant and manufacturing facilities around 2 weeks ago,” said an industry official. However, whether the company has visited plants of other pharmaceutical companies remains unknown. Some are interpreting the visit as Moderna's move to secure a base for the domestic production of its vaccine. However, whether Moderna will be directly producing the vaccine, or will consign its production to a domestic company has not been decided yet. ◆Direct manufacturing or CMO… three possible scenarios The industry has been pushing three scenarios based on the two facts mentioned above. The first scenario is where Moderna takes over the A company’s plant to directly produce its vaccine. mRNA vaccines are largely manufactured in three steps. raw material manufacturing → lipid nanoparticle coating → finished product manufacturing. The key technology in the production of mRNA vaccines lies in the lipid nanoparticle coating process. When injected, mRNA quickly degrades in the body, therefore, the technology that surrounds it with lipid nanoparticles to keep it intact for a long period of time is important. Moderna has been known to pay extreme attention to the security of this technology. It has been using the direct production method to prevent technology leakage in the U.S. and Europe. On the surface, the company has signed a CMO deal with Lonza, a Swiss-based global CMO company, but then directly invested 70 million francs (about 86 billion won) and 40 million francs (about 49 billion won), in the U.S. and Swiss factory respectively. The industry views it as no different from direct production. In the same way, Moderna may start direct production of its vaccine by acquiring a share of a plant in Korea. The second scenario is that Moderna will make a CMO deal with a domestic company to produce the vaccine. Usually, global pharmaceutical companies do not use their own factories when establishing Korean subsidiaries. Most of the companies receive ‘import permits’ rather than ‘ manufacturing permits’ upon their establishment. Rather, in recent years, the trend has been for the subsidiaries to withdraw the already-established factories. Most recently, Janssen, as well as Bayer, Novartis, Abbott, Pfizer, Boehringer Ingelheim, Roche, and MSD previously had also withdrawn operation of their plants. This is why some believe that Moderna, like other companies, will not set up a factory in Korea. For Moderna, which owns only one type of vaccine, the factory is likely to remain a nuisance after COVID-19 ends. Accordingly, some speculate that the vaccine will be developed under a CMO deal with a domestic company. However, whether Moderna will make a technology transfer deal or participate in production by acquiring some of the domestic company’s shares is unknown. The third scenario is that Moderna will dualize the manufacturing process. Moderna will take charge of the core process, and then consign a domestic company for the last step, the fill&finish process. GC Pharma is a prominent candidate for Moderna's filling and packaging process. GC Pharma has already been selected as a CMO for COVID-19 vaccines by CEPI (Coalition for Epidemic Preparedness Innovations), a global private organization, in October last year. GC Pharma's manufacturing will take place in its Ochang plant, and the company plans to fill and finish more than 500 million doses. In addition, GC Pharma already has ties with Moderna. It has already signed a contract for the domestic approval and distribution of the Moderna vaccine. In this scenario, after the raw material is manufactured by Moderna and A Pharmaceutical company, filling, finishing and domestic distribution of the finished product would likely be handled by GC Pharma based on the relationship already established between the two companies.
- Company
- Eli Lilly applies for reimbursement of Emgality in Korea
- by Eo, Yun-Ho May 04, 2021 05:55am
- The new migraine treatment ‘Emgality’ is seeking reimbursement benefits in Korea. According to industry officials, Eli Lilly Korea has recently submitted a reimbursement application for its calcitonin gene-related peptide (CGRP)-targeted migraine prevention therapy ‘Emgality (galcanezumab).’ Emgality, the first CGRP-targeted migraine prevention treatment to be introduced in Korea, selectively binds to CGRP, a substance known to be a key cause of migraine, and blocks its binding to the receptor. The drug was designated as an orphan drug in April of last year and approved in September of the same year. Recently, Emgality was additionally approved by the FDA as a treatment for episodic cluster headaches. Emgality had received much attention as a promising drug in the field of migraine along with ‘botulinum toxin.’ However, as a non-reimbursed drug, the demand for better access to the drug has been rising. If approved, the reimbursement is expected to have a significant impact on the migraine market. Emgality had passed the drug committee (DC) in major general hospitals in Korea including the Seoul National University Hospital and Severance Hospital. Lilly Korea and SK Chemicals have been co-promoting Emgality in Korea. With ‘Ajovy (fremanezumab),’ another CGRP-targeted therapy, soon to enter the Korean market, attention is on how the migraine treatment market will be reorganized in the future. The approval was based on results of the EVOLVE-1 and EVOLVE-2 trials which involved 1,773 patients with episodic migraines for 6 months, and the REGAIN trial which involved 1,113 patients with chronic migraines (at least 15 headaches a month for at least three months) for 3 months. Results of the two trials on episodic migraine patients comparing the MHDs per month over a 6-month period showed that compared to baseline (Emgality group 9.2 and placebo group was 9.1), Emgality demonstrated efficacy over placebo in treating migraines. In particular, in the EVOLVE-2 trial that involved Korean patients, the mean MHDs per month was reduced by 2 more days during the 6-month period in the Emgality group (226 patients) compared to the placebo group (450 patients) (Emgality 4.3 days vs. placebo 2.3 days). Also, 59% of patients treated with Emgality (compared to 36% in the placebo group) saw a 50% reduction in MHDs over the 6-month period. 34% (18% for the placebo group) saw a 75% or more reduction, and 12% (6% for the placebo group) saw a 100% reduction in MHDs. “Emgality showed a migraine prevention effect from the first week. Episodic migraines patients who experienced migraines 4 to 14 days a month have experienced a reduction by half compared to before treatment, and 1 in 7 patients showed a 100% response rate,” said Professor Min-kyung Joo of the Severance Hospital. “The drug may bring a big difference to patients who have been struggling to maintain their daily and social life due to migraines.”
- Company
- Hanmi launched a new challenge for patent of Entresto
- by Kim, Jin-Gu May 03, 2021 05:54am
- EntrestoHanmi took a new challenge in patenting the heart failure treatment Entresto (Sacubitril/Valsartan). It was already challenging other patents and requested an invalidation trial for a more difficult patent. If Hanmi succeeds in overcoming its patent on its own, it is expected that it will be able to release generics earlier than other companies. According to the pharmaceutical industry on the 3rd, Hanmi filed a trial against Novartis on the last day of last month for invalidation of composition and use patent of Entresto. This patent is known to be the most difficult to overcome among the four patents listed as Entresto. Patents registered as Entresto are ▲use/composition patent expiring in July 2027 ▲crystalline patent expiring in September 2027 ▲composition patent expiring in November 2028 ▲composition patent expiring in January 2029. The use/composition patent that expire first are in fact playing the role of product patent. Entresto is a heart failure treatment with the addition of Valsartan, an ARB-series hypertension treatment, and Sacubitril, an NEP inhibitor series, another treatment for hypertension. With the expiration of each patent, Novartis conducted a clinical trial by combining the two active ingredients, and was licensed as a treatment for heart failure. The reason that Hanmi newly challenged the most difficult patents to overcome is to preoccupy the generic market. Earlier, 20 companies, including Elyson, have requested a trial to confirm the scope of passive rights for a crystalline patent that expires in September 2027. This included Hanmi. If they overcome the patent, it was possible to release generics after July 2027. If Hanmi additionally overcomes the patent, it will receive generic for exclusivity, and will be exclusive for 9 months regardless of the success of challenges such as Elyson. The key is whether other companies will join the challenge. if an invalidation trial is filed within 14 days like Hanmi, a generic for exclusicity can be jointly secured after the successful challenge. Elyson's Rx performance has been increasing rapidly since its launch in Korea in October 2017. According to UBIST, Elyson has grown more than three times in two years to ₩20.3 billion last year after it produced ₩6.3 billion in 2018, the first year of its release. In the first quarter of this year, prescriptions amounted to ₩5.8 billion, the highest quarterly prescription amount ever.
- Company
- Dong-A ST’s Nesp biosimilar export exceeds ₩10 bil.
- by An, Kyung-Jin May 03, 2021 05:53am
- Pic of the Darbepoetin-α product being sold in Japan The cumulative export sales of Dong-A ST’s biosimilar anemia treatment have exceeded 10 billion won. After entering the Japanese market through a partner company at the end of 2019, the sales of Dong-A ST's biosimilar have shown steady growth based on the increasing product recognition and favorable policies set on biosimilars by the Japanese government. According to Dong-A ST on the 1st, its overseas sales of ‘Darbepoetin-alfa’ during the first quarter of this year was 2.9 billion won, a 326.6% increase from the same period of the previous year. ‘Darbepoetin-alfa’ is a biosimilar of the second generation anemia treatment ‘Nesp (darbepoetin-α)’ that was co-developed by Amgen and Kyowa Kirin. Its mechanism of action allows erythropoietin (EPO) to stimulate erythroblasts and accelerate red blood cell production and is used to treat patients with anemia from chronic renal failure or from chemotherapy. The overseas sales of ‘Darbepoetin-alfa’ are solely accrued from its Japan exports. After conducting the Phase I clinical trial on’ Darbepoetin-α,’ Dong-A ST signed a licensing-out agreement on the development and sale of its drug to Sanwa Kagaku Kenkyusho (SKK). Based on a Phase III trial conducted in Japan that compared the efficacy and safety of ‘Darbepoetin-α’ to the original ‘Nesp,’ SKK received marketing approval from Japan's Ministry of Health, Labor and Welfare in September 2019 and released the drug from November of the same year. Dong-A ST exports the finished products that were produced by DM Bio, a biosimilar company under Dong-A Socio Group, to SKK, after which SKK is solely responsible for its local sales. After recording 0.1 billion won in sales in the first year of its release, ‘Darbepoetin-alfa' started making real profit from last year. After exceeding 2 billion won in sales in the second quarter of last year, it has been selling around 3 billion won’s worth every quarter. The cumulative export sales of ‘Darbepoetin-alfa’ since its launch in 2019 to the first quarter of this year amounts to 11.8 billion won. Chong Kun Dang has also launched a Nesp biosimilar in the same market. The company had received marketing approval for its Nesp biosimilar ‘Nesbell’ at a similar period with Dong-A ST and released its product in December of the same year. The Japanese subsidiary of U.S. global pharmaceutical company, Mylan N.V., is in charge of its sales in Japan, however, Chong Kun Dang has not disclosed the individual sales performance of ‘Nesbell’ in Japan. An official from Dong-A ST said, “It has been three years since we released our ‘Darbepoetin-alfa' in Japan, and brand recognition of our product has been increasing. The advantage that our product is cheaper than the original drug, and the subsidies provided by the Japanese government to hospitals that use biosimilars, have also added to our continued positive increase in sales.”
- Company
- Yungjin won patent dispute on Abilify after 6 years
- by Kim, Jin-Gu May 03, 2021 05:53am
- Yungjin won the patent dispute between Otsuka and Yungjin over Abilify (Aripiprazole), a treatment for schizophrenia and bipolar disorder, in six years. This added Abilify's indication for bipolar disorder. Yungjin, which won the dispute, relieved the burden of compensation for damages caused by patent infringement. ◆Generic release as an indication for schizophrenia after product patent expiration On the 29th, the Supreme Court reaffirmed the court's decision in the Abilify patent invalidation lawsuit between Otsuka and Yungjin and dismissed the appeal. It has been six years since the conflict began. In 2014, when Abilify's product patents expired, domestic companies entered the generic market one after another. There are five indications of Abilify: schizophrenia, bipolar disorder, major depressive disorder, autism disorder, and Tourette syndrome. Among them, only the indication for schizophrenia was applied due to the expiration of the product patent. Indications for bipolar disorder and major depressive disorder have been expanded as Otsuka's use patent (expired in 2022) was listed. Considering that Abilify is used for both schizophrenia and bipolar disorder, it was beneficial to launch it in both indications. In March 2015, Yungjin filed a trial claiming that the use patent for bipolar disorder was invalidated. However, the Intellectual Property Trial and Appeal Board took the side of the original company Otsuka in October 2016. Otsuka pushed generic companies in all directions by requesting a trial to verify the scope of their rights and sending out certification of contents. Eventually, generic companies sold only as schizophrenia, excluding bipolar disorder, as an indication. ◆Yungjin, including indications for bipolar disorder However, Yungjin was an exception. Yungjin continued fighting against the defeat of the first trial. It filed a lawsuit with the Patent Court of Korea to cancel the trial decision. The Patent Court of Korea overturned the first trial decision. In July 2017, on the side of Yungjin, he ruled that the patent for use with bipolar disorder was invalid. Otsuka objected. Through an appeal, the case was taken to the Supreme Court. A fierce legal dispute ensued in the Supreme Court. The conclusion came out after 3 years. As with the second trial, a ruling was handed over to Yungjin's side. The ruling included Abilify's indications for bipolar disorder, allowing Yungjin as well as other generics to add indications for bipolar disorder to schizophrenia. It can be added immediately after the trial for reversal of revocation in the Patent Court is concluded with a final judgment. Yungjin escaped the crisis of large-scale counterindemnity. If the Supreme Court ruled in favor of Otsuka, it was because Yungjin had to hand over a significant portion of the sales revenue of generics over the past five years to Otsuka. An official from Yungjin said, "Yungjin had a dispute alone. It was defeated in the first trial, but under the judgment that the logic of invalidity was certain, the second trial was enforced and finally won." He predicted that "Otsuka is also in the process of action against infringement of patent, apart from this lawsuit. It is currently in the process of winning the first trial and in the patent court. In line with this Supreme Court decision, the action against infringement of patent will also be finalized." Patent Attorney Park Jong-hyuk, who represented Yungjin, said, "Unlike composition patents and formulation patents, it is not easy to obtain an invalidation judgment. The Supreme Court recently sided with the patentee, but it means that a ruling to invalidate the use patent was made.” He explained "Bipolar disorder is a recurrent disease of two opposing conditions, mania and depression. It is the judgment of the Supreme Court that if there are no experimental data that clearly show the therapeutic effect of both diseases, it is invalid as a description." According to UBIST, a pharmaceutical market research institute, the amount of Aripiprazole's outpatient prescription last year was ₩25.3 billion. Among them, the generic prescription amount is ₩1.3 billion. However, considering that the prescription of Aripiprazole is 40% to 50% for schizophrenia, 30% to 40% for bipolar disorder, and 20% to 30% for the rest of major depressive disorders, the addition of indications for bipolar disorder will increase the prescription performance of generic companies. It is expected to work positively.
- Company
- SGLT-2 inhibitor combos drive sales in diabetes market
- by Kim, Jin-Gu Apr 30, 2021 06:10am
- The domestic sales of sodium-glucose transport protein-2 (SGLT-2) inhibitors in the diabetes treatment market have repeatedly marked rapid growth. The outpatient prescription sales of SGLT-2 inhibitors in Q1 this year increased by 14% from the previous year, continuing its double-digit growth. The growth is driven by combination therapies. Prescriptions of the two combo therapies ‘Xigduo’ and ‘Jardiance Duo’ have increased by 2.3 times over the past two years. ◆2.3 times increase in prescription of combo drugs… market share also jumps from 27%→39% According to pharmaceutical market research firm UBIST on the 29th, the SGLT-2 inhibitor class of antidiabetic treatments has recorded a total of 32.1 billion won in outpatient prescription sales in Q1 this year. This is a 14% increase from Q1 of the previous year. The SGLT-2 inhibitor market has been increasing quarter by quarter since AstraZeneca’s ‘Forxiga (dapagliflozin) was first introduced to the market in June 2014. Following AstraZeneca, Astellas Pharma’s ‘Suglat (ipragliflozin),’ Boehringer Ingelheim’s ‘Jardiance (empagliflozin),’ MSD’s ‘Steglatro (ertugliflozin),’ also entered the market. Prescription sales of SGLT-2 inhibitors for the last 2 years have been 20.9 billion won in Q1, 23 billion won in Q2, 24.2 billion won in Q3, and 26.1 billion won in Q4 of 2019, and 28.1 billion won in Q1, 29.2 billion won in Q2, 32 billion won in Q3 and 32.1 billion won in Q4 of 2020. The recent market growth has been driven by combination therapies. The SGLT-2 inhibitor combos, AstraZeneca’s ‘Xigduo’ and Boehringer Ingelheim’s ‘Jardiance,’ are in fierce competition. Both drugs are combination therapies that have added metformin to each company’s SGLT-2 inhibitor. At first, total prescription sales of the two products amounted to a mere 5.6 billion won in Q1 2019, with their combined market share being 27%. However, sales have increased over twofold over the next 2 years to reach 12.7 billion won, and their market share also expanded to reach 39%. By each product, Xigduo sold 7.7 billion won, and Jardiance Duo sold 5 billion won in Q1 of this year. The growth surge is more notable in Jardiance Duo, with a 58% increase from Q1 of the previous year. Xigduo also saw a 19% growth during the same period. ◆Forxiga·Jardiance both record ₩9.1 billion… market expected to increase with indication expansion Among monotherapies, Forxiga and Jardiance have recorded 9.1 billion won each. This is an 8% increase for Jardiance and a 4% increase for Forxiga compared to the previous year. Despite the market’s rapid growth, Suglat and Steglatro, however, has shown reduced performance. The prescriptions sales of Suglat and Steglatro recorded only 0.8 billion won and 0.5 billion won in Q1 this year. This was a 4% and 19% respective decrease compared to the Q1 of last year. Industry officials expect the growth of Forxiga and Jardiance to continue for a while. The biggest reason being their expanded indication. In December last year, Forxiiga succeeded in adding a chronic heart failure indication in Korea. As a result, the drug may be used for heart failure, with or without diabetes. Jardiance also has submitted an application for the same indication and is awaiting approval. One variable that might hinder this growth is the release of follow-on drugs by domestic pharmaceutical companies. Currently, Dong-A ST is the only company to have successfully avoided Forxiga's substance patent (to expire in April 2023). The second and third trial remains, however, the company has met the requirements to release a follow-on drug. If wishing to do so, Dong-A ST could release a follow-on drug within this year. Also, Daewoong Pharmaceutical has been speeding up the development of its new drug 'Enavogliflozin.' With Phase III clinical trials currently underway, Daewoong aims to roll out its drug in 2023.
- Company
- Otsuka recently signed a co-promotion contract with Boryung
- by Apr 30, 2021 06:09am
- Otsuka Otsuka will co-promote with Boryung to maintain IMD Mucosta SR in the Rebamipide market. The gastrointestinal drug Rebamipide market, worth ₩100 billion, has recently been fiercely competitive. In December of last year, Yuhan (Recomid SR), GC Pharma (Mucotect SR), Daewoong Pharmaceutical (Mucotra SR), and Daewon Pharmaceutical (Bidreba SR) were approved for IMD of Rebamipide. While Rebamipide is taken three times a day, these IMDs are taken twice a day. A competitive drug has been released in the existing market where generics have been the only so far. The launch of IMDs affected Mucosta's sales, which account for about 10% of Otsuka's total sales. Mucosta recorded ₩17.3 billion in outpatient prescriptions based on UBIST last year. It was down 5.5% from the previous year. Last year's prescription for Bamedin by Samjin was ₩4.6 billion. In order to maintain the No. 1 position in market share, Otsuka was also approved for an IMD Mucosta SR in January after 30 years. Four domestic companies, including Yuhan, are the same through joint development, but Otsuka, which was developed independently, shows a slight difference from the products of the four companies. Otsuka recently signed a co-promotion contract with Yuhan. The original Mucosta could be replaced with a company's product rather than IMD by other companies. The two companies' co-promotion contracts were announced later. In particular, Boryung is expected to play an active part in the highly competitive clinics. Boryung is also in charge of selling Otsuka's antithrombotic drug Pletaal. Domestic pharmaceutical companies were not interested in Rebamipide. This is because the growth trend was insignificant even after 30 years of launch. However, the situation has changed starting with the Ranitidine Incident in September 2019. After Ranitidine was expelled, it affected the growth of Rebamipide. The Rebamipide market, which was only growing at an annual average of around 4%, increased 14.8% year-on-year to ₩110.6 billion in 2020. Existing Rebamipide trend by item
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- Will SK hand over Xarelto generic exclusivity rights to GC?
- by Kim, Jin-Gu Apr 29, 2021 06:09am
- Pic. of Xarelto SK Chemicals may decide to hand over the hard-won generic exclusivity for its generic version of ‘Xarelto (rivaroxaban) 2.5mg’ to GC Pharma. If GC Pharma takes over SK Chemicals’ generic exclusivity, the company will be able to enjoy market exclusivity for the low-dose Xarelto generic with Hanmi Pharmaceutical from this October to July next year. According to industry sources on the 28th, SK Chemicals and GC Pharma have been actively reviewing the possibility of making a deal for SK Chemicals’ generic version of Xarelto 2.5mg. Currently, SK Chemicals and Hanmi Pharmaceuticals own generic market exclusivity for Xarelto 2.5mg. The products that receive the benefit are Hanmi Pharmaceuticals’ ‘Riroxban Tab. 2.5mg’ and SK Chemicals’ ‘SK rivaroxaban Tab. 2.5mg.’ The exclusivity will apply from the date Xarelto’s substance patent expires, October 4th, to July 3rd next year. After successfully avoiding the formulation patent infringement for Xarelto 2.5mg in November 2015, the two companies obtained generic exclusivity by being the first to file for generic approval in July of the following year. The companies finally won the long patent dispute that went up to the Supreme Court in December 2020 and was allowed to exercise their right to generic exclusivity without the burden of a reversal ruling. However, the generic exclusivity owned by the two companies only applies to the 2.5mg dose, as Bayer had not registered a formulation patent for other doses of its Xarelto (10mg·15mg·20mg). In other words, from October, when Xarelto’s substance patent expires, all companies will be allowed to release 10mg·15mg·20mg generics of Xarelto. Still, experts interpret GC Pharm’s deal with SK Chemicals as an attempt to preoccupy the market and gain an advantage. For the other doses, 56 companies have obtained approval for 146 products and are awaiting their release in October. In this context, releasing the product 9 months earlier than the other competitors may provide an advantage in securing brand recognition, distribution, and positioning. Experts explain that the deal also meets the needs of SK Chemicals well. SK Chemicals has not applied for the approval of doses other than the 2.5mg, which suggests that SK Chemicals may not intend to enter the supersaturated market. Officials from GC Pharm and SK Chemicals have said that they cannot confirm or deny issues that are currently being discussed. According to the pharmaceutical market data research firm UBIST, the outpatient prescription sales of Xarelto recorded 50 billion won last year. This was a 1% decrease from the 50.8 billion won in 2019. In the first quarter of this year, Xarelto sold 11.9 billion won. In the new oral anticoagulant (NOAC) market, Xarelto stands in second place after Lixiana, and is followed by Eliquis and Pradaxa.
