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- 2025-12-26 08:56:52
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- Pros and cons of the spin-offs and sales of Big Pharmas
- by Eo, Yun-Ho Jun 08, 2021 06:01am
- Mergers, spin-offs, buying, selling... news shows that global Big Pharmas have been busy constantly changing their shape. In particular, the issue that gained the most attention for the past few years was the companies' spin-offs and sales. Although the companies' made the decision under the premise of ‘focusing on one’s strengths,’ such divisions and sales have brought out both positive and negative views. One thing to note is that these changes have been occurring 'serially' among global pharmaceutical companies. ◆Change in the development trend and surging investment cost = Although it is difficult to pinpoint the root cause of the constant change, a trend is evident. Development of new drugs is difficult, even without specifying the 1 in 10,000 probability of success. Also, successful development does not directly translate to actual sales. And this problem continues to intensify. Hidden within the shadow of the often-discussed ‘open innovation' n the global market. exists the rampant new drug famine. Discovering new substances is difficult and the risk keeps increasing, so ‘sharing’ the burden became the solution. With the field of chronic disease ruled out as ‘drugs in need have already been released,’ the industry's focus is now on anticancer drugs and rare diseases. Also, with the increase of cutting-edge new drugs that have dozens of indications for a single substance, Big Pharmas are now faced with a situation where they would need to spend astronomical amounts just on the Phase III trial of its new drugs. As the direct discovery of candidate substances has become increasingly difficult and buying promising new substances (candidate substances) or venture businesses that own such substances, the companies' investment spending has skyrocketed as well. From the Big pharma’s perspective, this means that their already-high proportion of investments have doubled. Not only Takeda, Pfizer, and MSD, which carried out spin-offs and sales of its business units, but companies that prided in their R&D such as Novartis, Sanofi, and Bayer have announced at least 3-5 acquisitions of drug substances or companies every year. The size of mergers and acquisitions by global companies had already exceeded 400 trillion won in 2019. The advent of the 'age of high-priced drugs’ that is emerging as a social issue is not unrelated to this large amount of investments. A Business Development personnel who returned to the Korean subsidiary after working at its global headquarters said, “Big Pharmas are reducing directly conducted projects that start from substance discovery. The companies have turned their direction to buying promising substances to reduce the investment risk. However, the problem that companies face is that the price of venture businesses that own such substances have also been rising rapidly.” ◆Stock price and stockholders… the BU system and spin-offs = The rise in investment cost and corporate spin-offs may seem unrelated at a glance, but this is also not the case. A company's stock price and its stockholders are currently exerting wider influence on the decision-making process of the Big Pharmas than in the past. For example, when a company maintains its size and only increases investment, investors worry that the stock price will fall due to decreased cash flow. The corporate spin-off is one option that such companies could select in these cases. No matter how promising a new drug may be, investment in its substance eventually affects the financial solvency of the company. Spin-offs allow the company to divide its size and profit structure. In other words, the company can subdivide its business by concept to an investment-focused part and a legacy part – and recreate the company. Equity spin-offs do not burden the company as there is no exercise of appraisal rights. Since the company becomes a legally independent company after the spin-off, the spin-off may go public immediately afterward. Prior to such spin-offs, most multinational pharmaceutical companies first proceed with restructurings that have a split-off tendency that may serve as a foothold for improving the financial solvency of the company or for the sale of its businesses. For example, before Pfizer completed its spin-off of Viatris, it had established a 3-Business Unit system and separated its legacy brand ‘Upjohn,’ then spun-off Upjohn and combined it with Mylan N.V. to form Viatris. The recent MSD’s spin-off of Organon and Takeda’s sale of its diabetes and OTC business, Novartis’ decision to independently operate its pharmaceuticals and oncology division, and Abbott’s separation of ts biopharmaceutical division as Abbvie were all made in the same context. An official from one multinational pharmaceutical company said, “The criticism that the pharmaceutical companies are now acting on behalf of its shareholders rather than their patients also stem from this phenomenon. However, with the proportion of venture capital (VC) investors (financial investors) increasing, the companies do not have many options to choose from with regards to their operations."
- Company
- HPV vaccine market expands 55% midst COVID-19
- by An, Kyung-Jin Jun 07, 2021 06:06am
- The market for the vaccine to prevent cervical cancer has expanded by the greatest amount ever. The increased inoculation rate of the high-priced 'Gardasil 9' has led the total market growth. MSD, which owns two HPV vaccines - 'Gardasil' and 'Gardasil 9' - accounted for 97% of the total market, and boasted its overwhelming influence in the domestic market. According to the industry research institution IQVIA on the 7th, the HPV vaccine market size in Q1 of this year was 22.9 billion won. This was a 55.5% increase from the same quarter of the previous year and the highest-ever quarterly sales record. The COVID-19 outbreak had temporarily slowed down market growth in the first half of last year, but sales turned back upwards in the second half. Since then, the market has been breaking its own record for three consecutive quarters. Compared to the 11.6 billion won in Q1 of 2017, the market size has doubled in 4 years. The high-priced ‘Gardasil 9’ acted as a catalyst in the HPV vaccine’s market growth. In Q1, sales of MSD’s ‘Gardasil 9’ recorded 17.4 billion won, which was a 75.6% YoY increase compared to the 9.9 billion won of the same quarter last year. In the same period, MDS’s other HPV vaccine, ‘Garadsil’ sold 4.8 billion won. Although ‘Garadsil’ also showed a 19.0% YoY increase from the 4.1 billion won in Q1 last year, the market was completely overwhelmed by the surge in sales of ‘Gardasil 9.’ In the same period, GSK’s ‘Cervarix’ sales fell 12.0% in one year to record 0.7 billion won in Q1 this year. Among the three products authorized in the Korean HPV vaccine market, the other two, which are MSD products, account for 97.1% of the domestic HPV vaccine market. In other words, MSD has a monopoly over Korea’s HPV vaccine market. MSD has grasped the lead in Korea’s HPV vaccine market in 2016 with the government selecting ‘Gardasil’ and ‘Cervarix’ as products for Korea’s National Immunization Project, and MSD releasing its follow-up ‘Gardasil 9,’ in the latter half of the same year. After selling 2.5 billion won in the first year of its release, sales of ‘Gardasil 9’ grew rapidly to 15.1 billion won in 2017, and 20.9 billion won in 2018. Since becoming the market leader product in 2019, raising 40.5 billion won in sales, twice the amount compared to the sales of ‘Gardasil,’ it had continued its rise ever since. In Q1 this year, the market share of ‘Gardasil 9’ was 76.0%, which was three times than that of ‘Gardasil.’ ‘Gardasil 9’ is a human papillomavirus virus (HPV) vaccine that was manufactured by adding five HPV serotypes 31, 33, 45, 52, and 58 in addition to the four HPV serotypes 6, 11, 16, 18 already in ‘Garadasil.’ It is being distributed at a high price with the differentiation that it covers the most amount of HPV types among existing HPV vaccines. The cost of inoculation paid by the consumers varies by hospital, but a single shot of 'Gardasil 9' may at most be 100,000 won more expensive than ‘Cervarix.’ Nevertheless, the demand for ‘Gardasil 9’ among adults not subject to NIP increases. News that the vaccine can prevent other HPV-related diseases such as anal cancer, genital warts, premalignant lesion, in addition to cervical cancer had spread through word of mouth, and the ‘couple vaccination’ promotions in obstetrics and gynecology clinics have been increasing the number of male inoculations every year as well. Since last year, the vaccination age for HPV vaccines was expanded to 45 years, and the rate of reinoculations has also increased significantly. One other factor that may have lead to a sales surge in Q1, is the pre-supply orders from hospitals and clinics in preparation for the price hike announced by the pharmaceutical company. MSD Korea has raised the supply price of 'Gardasil 9' and 'Gardasil' by 15% from April this year, citing rising production input costs. MSD Korea has changed its domestic distributor for ‘Gardasil 9' and 'Gardasil' to HK Inno.N this year and has been conducting co-promotion with the company ever since.
- Company
- Sales in the herpes zoster market have halved in 2 years
- by An, Kyung-Jin Jun 04, 2021 06:06am
- Sales in the domestic shingles prevention vaccine market, which had been on the mend, fell again. In December last year, sales of two vaccines to prevent shingles fell as the vaccination rate fell in the wake of the third pandemic of COVID-19. According to IQVIA, a pharmaceutical research institute, the size of the vaccine market for shingles prevention in the first quarter was ₩10.9 billion, down 10.8% from ₩12.2 billion a year earlier. It is down 44.5% from ₩19.7 billion. The first quarter of last year was a time when the economy stagnated sharply as COVID-19 pandemic began around the world. South Korea's two vaccines for shingles prevention were competing, but sales fell to the lowest level. This year's sales declined from the first quarter of last year, further slowing down. Two types of shingles prevention vaccines are being sold in Korea, including MSD's Zostavax and SK Bioscience's Sky Zoster. It was monopolized by Zostavax, but it continued to grow rapidly with the advent of Sky Zoster in late 2017. The successful shingles prevention vaccine market has worsened in the face of an unexpected infection crisis. Its fourth quarter sales increased to ₩27.9 billion and halved to ₩12.2 billion in the early stages of COVID-19 crisis. Although its second quarter sales recovered to ₩22.6 billion, but decreased again to ₩20.3 billion in third quarter and ₩17.3 billion in fourth quarter. Until the first quarter of this year, quarterly sales have fallen for three consecutive quarters, and have rarely recovered. The industry believes that the vaccine market for shingles prevention is more easily affected by factors such as the epidemic of infectious diseases than other drug markets prescribed for chronic diseases. Since it is a vaccine to prevent diseases, not treatments used in urgent situations, the inoculation rate will inevitably fall if patients avoid visits to medical institutions. The fact that the COVID-19 vaccination, developed by Pfizer and AstraZeneca since early this year, has also had some impact on the decrease in the number of other vaccinations. The market for adult vaccines is sluggish, with the exception of pneumococcal vaccines that benefited from COVID-19. Both Zostavax and Sky Zoster have drawn similar quarterly sales distributions since last year. Sales of Zostavax in the first quarter were ₩6.5 billion, down 10.9% from a year earlier. This is a 40.6% decrease from $10.9 billion (10.9 billion KRW) in previous quarter.Sky Zoster posted sales of ₩4.4 billion in the first quarter, down 10.6% from a year earlier. Compared to the previous quarter, it decreased by 30.6%. As sales of the two products showed similar ups and downs, market share was similar. Sky Zoster's share in the first quarter stood at 40.4%, no significant difference from 40.3% a year earlier. There is another variable in the domestic shingles prevention vaccine market. GSK reportedly applied to the MFDS for the approval of Shingrix earlier this year. Starting with FDA approval in 2017, Shingrix is a product that has been sold in major countries around the world. Demand was high enough to cause scarcity overseas. Market competition is expected to intensify if GSK starts selling Shingrix in Korea.
- Company
- Roche Korea conducts the voluntary retirement program
- by Jun 03, 2021 05:56pm
- Roche Korea conducts the Early Retirement Program (ERP). In the first half of this year alone, many multinational pharmaceutical companies, including Viatris, Astellas, and GSK, started reducing the number of people. According to pharmaceutical industry on the 3rd, Roche Korea is currently conducting ERP for reorganization. The first target is the sales department. At the end of last year, Roche reportedly conducted ERP for some manager-level employees in the sales department. It is heard that specific size and conditions of ERP are under discussion. Industries estimate that it will be about 20% of 60-70 employees in sales department. It is heard that ERP will be carried out for desk job departments in second half of this year. In the first half of this year alone, five to six multinational companies conducted ERP to reorganize or sell their business units, including Viatris, Astellas, GSK, Zuellig Pharma, Jansen, and Roche. Viatris, which split from Pfizer and merged with Mylan, operated ERP as part of its global headquarters' massive restructuring plan. In the process, several managers appear to have resigned. GSK also conducted ERP to some sales and marketing executives while reorganizing its business structure. In particular, as telecommuting and non-face-to-face marketing have increased due to COVID-19 outbreak, and the reporting system has changed, management executives are mainly on the ERP list. The reason for the implementation of Astellas Pharma and Zuellig Pharma's ERP is the deterioration of management. In order to overcome the situation in which patents of major items expire or are damaged in the long term, restructuring has begun. Astellas said its goal is to reduce its total staff by 40%. Zuellig announced it would restructure about 80% of its 100 sales staff. It posted operating losses for the third consecutive year last year, with a debt ratio of 30,000%. Janssen is different from other companies. Janssen, which sold its Hyangnam plant to Whanin, added ERP as an option in the process of redeploying its employees. Employees who want to stay will be transferred to the Songdo plant in Incheon. Retention of employment is a fundamental principle. Employees who do not want this can choose the ERP. Meanwhile, Sanofi and Lilly also conducted ERP late last year due to the COVID-19 crisis.
- Company
- Amgen speeds up commercialization of its KRAS drug
- by Eo, Yun-Ho Jun 03, 2021 06:12am
- Amgen is rapidly working to commercialize its KRAS targeted anticancer therapy in Korea. Industry sources have said that Amgen Korea has submitted an application for the marketing authorization of the first-ever KRAS-targeted anticancer therapy, ‘Lumakras (sotorasib),' on the 28th to the Korean Ministry of Food and Drug Safety (MFDS) immediately after receiving accelerated approval from the U.S. FDA. Amgen's actions seem to be an attempt to solidify Lumakras's position as a first-in-class treatment. As the drug had already received orphan drug designation from the Korean Ministry of Food and Drug Safety in March, the approval process is expected to go smoothly unless there is a special reason for its disqualification. Lumakras is the first-ever drug to be introduced since the KRAS gene was discovered about 40 years ago. Its indication is for non-small cell lung cancer (NSCLC), and patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy may use Lumakras. The KRAS gene was first discovered in a lung tumor in 1982. About 25% of Western patients and 10-15% of Asian patients with lung adenocarcinomas are found to have the KRAS mutation. In Korea, 5-8% of patients have the KRAS mutation. As there had been no suitable targeted therapy for the KRAS mutation, taxane-based chemotherapy was used for its treatment. But Amgen’s CodeBreak 100 trial results showed that the 124 KRAS G12C-mutated NSCLC patients who received Lumakras 960mg had an ORR of 36%, and their median duration of response was 10 months. Despite continuous efforts to develop a KRAS targeted therapy, none had shown promising results in clinical trials. The discovery of the signaling pathway of KRAS afterward led to the development of more specific targeted therapies for various subtypes of KRAS such as G12C, G12D, G12F, etc. Among these, Sotorasib targets the KRAS G12C mutation, which is known to be the most common mutation in lung cancer. Multinational pharmaceutical companies including Amgen, Mirati Therapeutics, and Boehringer Ingelheim have been attempting to develop therapies targeting KRAS, among which Amgen became the first to produce tangible results.
- Company
- Awareness of multiple sclerosis should increase
- by Jun 03, 2021 06:12am
- Today (26th) is World MS Day. Although the treatment environment has improved significantly with the release of more new drugs for multiple sclerosis compared to the past, early diagnosis is not easy due to the low awareness of the disease. The same is true of overseas situations. In response, the International Association for Multiple Sclerosis (MSIF) has designated the last Wednesday of May every year to raise awareness of the disease. This year's theme is 'Connection'. The goal is to challenge the social obstacles and isolation experienced by multiple sclerosis patients and establish relationships for patients' better lives. Multiple sclerosis is a chronic disease in the central nervous system, including the brain, spinal cord, and optic nerve, and an autoimmune disease caused by the immune system attacking healthy cells and tissues. If myelin, which surrounds and protects nerve fibers in the central nervous system, is damaged, unregulated inflammatory reactions cause wounds in various areas such as the brain and spinal cord, leading to diseases that interfere with nerve transmission. Multiple sclerosis has a wide variety of conditions and symptoms depending on where it occurs. Sensory abnormalities, visual impairment, fatigue, motor impairment, balance abnormalities, bowel and bladder problems, sexual dysfunction, and pain are combined, which are characterized by repeated recurrence and remission. In the early stages of the outbreak, it improves without a disorder after a recurrence, but it is also a rare incurable disease that does not fully improve over time and remains disabled as the recurrence repeats. The incidence of women is more than 50% higher than that of men, and it often occurs in young people aged 20 to 40 who are actively engaged in social activities. The number of patients in the country is about 2,500. Rare diseases have low awareness, making it difficult for patients to suspect multiple sclerosis. Difficulties in diagnosis also make early diagnosis difficult. This is because there is no specific test method to confirm multiple sclerosis so far. The doctor should observe various symptoms, medical history, and image findings that the patient appeals to and then determine the disease clinically. It usually applies McDonald standards. Progressive multiple sclerosis is classified as primary and secondary progressive. Primary progression is slow to manifest, while secondary to continuous recurrence and recovery continue to deteriorate over a long period of time. In general, about 50% of patients with recurrent palliative multiple sclerosis progresses to secondary progression within 10 years, and 90% of patients switch to secondary progression after more than 25 years. There is no cure for multiple sclerosis, but treatment options have increased. In the early 1990s, when there was no cure at all, the prognosis of patients was poor, but in 1993, the first multiple sclerosis drug appeared, and the prognosis of patients began to improve. In addition, the half-life of the injection has been extended significantly. Currently, multiple sclerosis treatment relieves the disease with steroids during the acute period, and in the long run, the disease is managed with interferon-like injections and oral drugs (DMT). It is important to curb recurrence so that it does not develop into a permanent disability. Reimbursement standards are also improving. As a representative example, the reimbursement clause of Aubagio, an oral primary treatment drug, has been expanded since February this year, allowing oral formulation to be used from the beginning of treatment. Aubagio is the first oral drug to be launched in Korea, and has more than 16 years of long-term safety data to date, along with features that inhibit recurrence and maintain immune action. As there are more options to choose from depending on the patient's life pattern and condition and the benefit is improving, it is important to find and manage medications that can be conveniently treated by the patient themselves. However, there are still diagnostic and therapeutic limitations that arise from unclear causes of the outbreak. Experts say that improving awareness of the disease is urgently needed to elicit early diagnosis. Multiple sclerosis should be suspected if sensory disorders and muscle weakness occur over several days in situations where symptoms of multiple sclerosis are nonspecific, but there is no pain in the neck or back. In particular, if vision disorders accompanied by sudden eye pain are accompanied by young people aged 20 to 50, optic neuritis and spinal cord, which can be seen as before multiple sclerosis, can be suspected. "Multiple sclerosis is possible to slow down the progress of the disease and maintain daily life without disability when appropriate treatment is started in the early stages of the outbreak," said Kim Byung-joon, chairman of the Korean Society of Neuroimmunology. Early diagnosis by professional neurologists is a very important disease, and medical and social understanding and interest in multiple sclerosis need to be improved to maintain continuous treatment by selecting appropriate treatments.
- Company
- Tecentriq attempts reimbursement after Keytruda fails
- by Eo, Yun-Ho Jun 02, 2021 06:11am
- ‘Tecentriq’ is attempting what ‘Keytruda’ had failed. Industry sources have said that Roche Korea had submitted an application for the reimbursement of its ‘Tecentriq (atezolizumab),’ as monotherapy in the first-line setting for non-small cell lung cancer (NSCLC) patients whose tumors have a programmed death ligand-1 (PD-L1) expression on at least 50% of tumor cells (TC), or tumor-infiltrating immune cells covering at least 10% of the tumor area. The company received approval for this indication this April. The agenda will be put up for deliberation by the Cancer Drugs Benefit Appraisal Committee of the Health Insurance Review & Assessment Service in July. Accordingly, the possibility is rising for Tecentriq's reimbursement to be discussed together with MSD Korea’s PD-1 inhibitor ‘Keytruda,' which failed to be approved for the 8th time at the meeting held on the 26th last month, at the next Cancer Drugs Benefit Appraisal Committee meeting. The authorities may induce competition among pharmaceutical companies to reduce fiscal spending, however, this would lead to a delay in reimbursement listing. This irony often occurs in the process of listing expensive new drugs or expanding reimbursement in Korea. As drugs are expensive, if pricing competition arises between pharmaceutical companies, the government can take advantage of the net function of the market. Fiscal savings under the National Health Insurance system saved from such competition can create additional opportunities for coverage expansion. However, the issue at hand is its timing. It would be optimal if drugs of the same class are approved at a similar period so that they can apply for reimbursement listing at a similar timeframe, but this is not likely in reality. In general, the period of each company's reimbursement listing application varies by 6 months to even over a year. Of course, factors other than the physical 'application' date also do play a role in the reimbursement delay, but this difference is important because there are patients awaiting the approval. Moreover, most of the drugs in issue are anticancer drugs. Attention is on what the results would be for the 2 anticancer immunotherapies that walked very different journeys that are attempting the long-delayed reimbursement in first-line lung cancer. The NSCLC reimbursement expansion for Keytruda had been discussed since September 2017, and it has already been nearly 4 years. Among the many barriers, the biggest issue was the ‘pharmaceutical company taking the burden of the initial 3 cycles’ worth of administration cost’ requested by the government to companies with immunotherapy agents. Roche, which owned the then-latecomer Tecentriq was the only company to accept the government’s proposal, and 2 types of PD-1 inhibitors – Keytruda and ‘Opdivo (nivolumab)’ were unable to accept the offer.
- Company
- Improved reg. allow price succession of transfer products
- by Chon, Seung-Hyun Jun 02, 2021 06:10am
- Drug price succession in transferred pharmaceutical products has been increasing. As the stepped pricing system is no longer applied to drugs that are relisted due to change of licensees, companies have been actively engaged in the transfer of their products. Some products have seen a twofold increase in their price compared to when the stepped pricing system was applied. According to the Ministry of Health and Welfare (MOHW) on the 30th, Organon Korea’s ‘Ezetrol tab.’ will be listed at a ceiling price of 744 won. Ezetrol (ezetimibe) originally used to be owned by MSD Korea. As the license holder was changed to Organon Korea, a new spin-off of MSD Korea, the drug had to be newly listed on the health insurance benefit list. MSD Korea’s Ezetrol will be removed from the reimbursement list from next month and its license will be transferred to Organon Korea. In January this year, a drug price succession regulation for transferred products was newly added, which allowed Ezetrol to maintain its previous maximum ceiling price of 744 won. In July last year, the drug pricing system was revised to add a stepped-pricing system that reduces the price of drugs that are listed late. The key point of the system was to reduce the price of later entrant generics by 15% when the number of products exceeds 20. In other words, if there are more than 20 drugs listed of the same ingredient, the drug price is set at ‘85% of the drug price of products that does not satisfy the two qualifications’ or ‘85% of the lowest price among the previously listed drugs,’ whichever is lower. Under the system, an unexpected issue arose as the drug products transferred between businesses were being listed at the lowest price among all products in the same category due to the application of the stepped pricing system. In transfers where the license of a pharmaceutical product is handed over to another company, the product needs to undergo a removal and relisting process. Even products that were previously listed are regarded a newly listed product after removal from the benefits list and is inevitably applied the stepped pricing system. The industry had pointed out that it was unreasonable to list transferred products the same as newly listed products, and the MOHW agreed to improve the system. From January, MOHW had made a partial amendment to the ‘Criteria for Decision or Adjustment on Drugs,’ so that in cases ▲where the manufacturer’s position was succeeded; ▲ where the same company switches its license from manufacturing and marketing to import authorization; or ▲ where the company withdraws its license due to business conversion, etc. and receives relicensing for the same product; the product’s price will be calculated at the same ceiling price that was previously set for the removed product. The regulation allows for the succession of the previous drug price in process of removal and relisting the same products in product transfers, etc. 42 ezetimibe products are currently listed in the reimbursement list, and their prices range from 480 won to 746 won. If Organon Korea’s Ezetrol was to be regarded as a newly listed product, its price may not have exceeded 408 won, which is 85% of the lowest listed price of 480 won. However, with the amendment, the company was able to maintain Ezetrol’s price at its previous listing price of 744 won. Recently, the drug price succession is actively being carried out among transferred drug products. In only this month, 4 products succeeded their previous drug price and were newly listed on the reimbursement benefits list. Daewoong Bio’s amlodipine and Valsartan combination ‘V-Forge Tab 10/160mg’ was newly listed at a ceiling price of 1,128 won on the 1st of this month. 1,128 won is the highest price among all products in its category and dose, and is a price 60% higher than the lowest price, which is 699 won. 81 products of the 10/160mg dose Amlodipine and Valsartan combination are currently listed in Korea. Under the stepped pricing system, newly listed products may not exceed a price of 594 won, which is 85% of the lowest price of 699 won among the same products. However, V-Forge Tab 10/160mg was a transferred product from Cosmax Pharma. By entering the market through a transfer, Daewoong Bio was able to be listed at a price that was twice higher than that of newly authorized products. Alvogen Korea’s ‘Maxgrel-A,’ which was newly listed from this month, received a ceiling price of 1,209 won. This is the highest price among the same products. With 35 Maxgrel-A products already listed, the price of a newly listed product in the same class would have had received a price discount through the stepped pricing system. However, Maxgrel-A was able to maintain its highest price by being newly listed through a transfer. If Maxgrel-A was a newly licensed product, its price would not have been able to exceed 732 won, which is 61.4% of the highest listed price. Celltrion Pharm’s ‘Celltrion Neopa,’ and Albogen Korea’s ‘Lutsnal Cap. 0.4mg’ would also have been applied the stepped drug pricing system, receiving a price that is ‘85% of the lowest price’ or ’61.4% of the highest price.’ However, the drugs were able to maintain their previous price as a transfer product.
- Company
- The FDA's final decision on Rolontis remains
- by An, Kyung-Jin Jun 01, 2021 06:11am
- View of Hanmi The FDA's due diligence on the domestic manufacturing facilities of Rolontis, a drug that Hanmi exported technology, has entered the final stage. The final process for obtaining final FDA approval has been completed as scheduled. Hanmi's partner Spectrum is rushing to prepare to enter the U.S. market worth about ₩3 trillion in preparation for FDA approval within this year. According to an industry on the 1st, FDA pre-approval inspection of Hanmi's Pyeongtaek Bio Plant, which produces undiluted liquid of Rolontis (Eflapegrastim), is underway. The schedule, which was scheduled from the end of last month to the beginning of this month, is progressing smoothly. "We cannot reveal the specific schedule," a source at Hanmi said. The FDA's due diligence has been carried out as scheduled. The due diligence of the Pyeongtaek Bio Plant is the final step for Rolontis' FDA sales license. "Rolontis' remaining procedures related to BLA have been completed," said Spectrum Pharmaceuticals, a U.S. partner of Hanmi. In the aftermath of COVID-19 infection, we were forced to proceed with due diligence at the Pyeongtaek plant," he said, stressing several times that final approval is possible once due diligence is completed." Rolontis is up to the FDA's decision. It is predicted that it will be able to obtain FDA's permission as early as this year. "If there was a problem with the clinical data, the FDA would have sent a CRL in October last year after completing the review of Rolontis," said Joe Turgeon, CEO of Spectrum Pharmaceuticals. "I'm confident that the rest of the process was fine. We are looking forward to FDA approval." Rolontis is a bio-new drug that Hanmi Pharmaceutical Co. transferred to Spectrum in Spectrum in 2012. Cancer patients subject to myelosuppressive chemotherapy are administered for treatment or prevention of neutrophilia. It is a family of "G-CSF" (grain globular stimulators) that stimulates granulocytes to increase the number of neutrophils, similar to Amgen's blockbuster drug "Neulasta" (Pegfilgrastim). If "Rolontis" receives FDA's final approval, Hanmi will release its first bio drug to the U.S. market that combines Labscovery platform technology that increases the duration of bio-medicine in the body. Given that Pyeongtaek Bio Plant has passed the FDA's strict due diligence standards, it can also enjoy the achievement of recognizing biopharmaceutical manufacturing technology. It is estimated that long-term G-CSF markets in the U.S. are worth ₩3 trillion. Amgen's "Neulasta" accounts for about 70%, Mylan's "Fulphila" and Coherus' "Udenyca" account for the remaining 30%. Spectrum has been conducting new global clinical trials since March last year, apart from "Rolontis" licensed clinical trials. It is a study that administers Rolontis on the day of myelosuppressive chemotherapy (Docetaxel+Cyclophosphamide). Existing treatments in the G-CSF family are difficult to administer on the same day as anti-cancer drugs, so patients have to be hospitalized or visit the hospital again the next day. Spectrum is conducting a reaction evaluation by administering Rolontis for 30 minutes, 3 hours, and 5 hours after chemotherapy to ease this hassle. Its strategy is to secure differentiation from competitive drugs by maximizing convenience of patients. Spectrum's management team said at a recent conference call, "Patients' enrollment on the same day of Rolontis is going smoothly. We expect to be able to announce research results by the end of this year. It will serve as data that can differentiate itself from competitive drugs after market release." Hanmi did not disclose specific terms of the contract regarding the transfer of Rolontis technology at the time of the initial contract with Spectrum. However, it is possible to estimate the size of the contract through a report submitted by Spectrum to the U.S. securities and exchange commission (SEC). Spectrum agreed that "If Rolontis obtains FDA's final sales license, Spectrum will pay Hanmi $10 million (about ₩1.9 billion) in technical fees." After its release, it pays an additional percentage of royalties each year depending on net sales.
- Company
- 3-way race between ultra-expensive new orphan drugs to start
- by Jun 01, 2021 06:11am
- With Novartis’s gene therapy ‘Zolgensma’ approved, 3 new drugs have been introduced into the Korean spinal muscular atrophy (SMA) market, a market that previously had virtually no treatment available. The introduction of 3 new drugs in just 3 years marked the start of a full 3-way race between the new SMA treatments in Korea. In the U.S. where the race had already started, Spinraza’s share in the market has been decreasing. As to whether the situation would be the same in Korea is gathering attention. The Ministry of Food and Drug Safety (MFDS) has approved Novartis’ ‘Zolgensma (onasemnogene abeparvovec-xioi)’ as the second advanced biological product in Korea. Zolgensma can be used in SMA patients with a double allelic mutation in the SMN1 gene who have been ▲ clinically diagnosed as SMA Type 1 or ▲ has three or fewer copies of the SMN2 gene. Zolgensma’s different mechanism of action works as a strength over to Spinraza or Evrysdi SMA is a serious rare disease in which muscles gradually degenerate as motor nerves are damaged due to a gene defect in the survival motor neuron 1 (SMN1) gene. One out of every 10,000 infants around the world are diagnosed with SMA, and in Korea, around 30 patients (per 300,000 infants) are diagnosed with SMA every year. The severity of SMA is deeply associated with the number of copies of the “backup” SMN2 gene. The SMN2 gene may produce and compensate at most 10% of the SMN protein unable to be produced by SMN1. Patients with Type 1 SMA that have only 1-2 SMN2 copy genes may experience 95% loss of their motor neurons, and 90% of the patients die before reaching age 2. In Korea, there had been no SMA treatment available until 2017. Biogen’s ‘Spinraza’ was the first to be approved in December 2017, opening up a new treatment paradigm. 자료: 각사 Spinraza is an RNA-based treatment. It is an antisense oligonucleotide splicing modulator that promotes protein production by binding to the pre-mRNA sequence of the SMN protein produced by SMN2. After Spinraza, Roche also received approval for its RNA-based treatment, ‘Evrysdi.’ Unlike Spinraza, which is an injection formulation, Evrysdi is an oral formulation and is cheaper. However, this oral drug needs to be taken every day. Evrysdi has not yet been released in the Korean market. Zolgensma’s mechanism of action is completely different from the two drugs that were previously approved. Unlike Spinraza and Evrysdi, which use the “backup” SMN2 gene to increase the production of proteins, Zogensma completely replaces the function of the missing SMN1 gene to produce SMN proteins. When the replacement, made with a recombinant AAV adeno-associated virus (AAV9), is given to an infant by intravenous infusion, it works as an SMN1 gene and produces proteins. It is also called a 'dream cure' as patients can expect to be completely cured with just a single treatment. As a “one-shot treatment,’ the cost of the drug is also ultra-expensive. The cost of a single Zolgensma infusion costs 2.5 billion won. This is 25 times higher than the cost of Spinraza. However, Novartis explains that the cost-effectiveness of Zolgensma is quite high considering that Spinraza or Evrysdi would cost 0.3-0.5 billion won every year. Spinraza’s sales falter and Evrysdi strong in the U.S…. how about Korea? The SMA market in Korea is currently dominated by Spinraza. Based on IQVIA, Spinraza sold 72 billion won in sales last year. However, with the entry of Zolgensma and the yet-to-be-introduced Evrysdi, the market dominion in Korea is expected to change. Changes in the U.S. SMA market that is already in the 3-way race, can be used as a reference to predict the future of the Korean market. In the U.S. Spinraza’s sales have been showing a decline with the introduction of Zolgensma and Evrysdi. After selling 233 million dollars (approx. 257.3 billion Korean won) in Q1 2019, its sales had started falling from Q2 2020. The sales fell to under 200 million dollars in Q3 2020 to record 183 million dollars (approx. 202.1 billion won), then to 149 million dollars (approx. 164.5 billion won) in Q1 last year. This was a 36% decline in sales over the past 2 years. On the other hand, Zolgensma’s sales have shown a similar record every quarter since its introduction, since Zolgensma is a one-shot treatment that does not accumulate patients. After recording 150 million dollars (165.6 billion won) in Q3 2019 when it started to be prescribed in earnest, its sales have stayed steady in the 100 million to 130 million dollar range (143.5 billion won) every quarter. Evrysdi, which was introduced last in the U.S. market, has been relatively rapidly gaining its share compared to the other two competitors. After receiving approval in August 2020, Evrysdi sold 9 million dollars (9.9 billion won) in Q3 of the same year, which increased to 51 million dollars (56.3 billion won) in Q4, then to 87 million dollars (96.1 billion won) in Q1 this year. It may have had the lowest sales record, but its sales growth is the fastest among the three products. Based on the trend, U.S. experts expect Evrysdi to record the highest sales in 2026 based on its low-cost and oral formulation. Of course, the U.S.’s case may not apply 100% to Korea, as the Korean market is most strongly influenced by whether the drug is reimbursed as well as the reimbursement criteria. However, Spinraza’s sole lead in the Korean market is expected to continue for the time being, until reimbursement is approved for Evrysdi and Zolgensma. Also, there is criticism that the current insurance policy structure makes it difficult to accommodate ultra-expensive drugs like Zolgensma. The various clinical trials ongoing with Spinraza are also a variable. Spinraza has been conducting various clinical trials to maintain its lead in the SMA market; one of which is on asymptomatic infants. This study investigates whether administering Spinraza in advance to infants that have been genetically diagnosed with SMA helps to maintain a normal level of motor function in the patients. If Spinraza is approved for the indication to treat infants with confirmed SMN1 gene defect or mutation prior to diagnosis, Spinraza will be available at the very front-end, before any other treatment. In addition, Biogen has started more aggressive trials as well. The Phase IV RESPOND trial studies the benefit of switching to Spinraza in patients who showed a suboptimal clinical response to Zolgensma. Biogen identified cases of some patients who received Zolgensma but were insufficiently treated and found that switching to Spinraza may bring additional benefits to these patients. A long-term follow-up study showed that 4 out of 10 patients that had previously received Zolgensma have switched to Spinraza to continue their treatment.
