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- Kolon Life Science faces 88.5-billion-won damage lawsuits
- by Kim, Jin-Gu Nov 18, 2019 10:21pm
- Kolon Life Science is facing a series of damage lawsuits asking for 88.5 billion won as compensation for the Invossa incident. Kolon Life Science stated in the third quarter report that the company’s properties have been seized by Mitsubishi Tanabe and outstanding contract payment from Mundipharma has been suspended. It is facing number of damage lawsuits filed by individuals and insurance companies since last May. 1,572 individuals and companies from home and abroad demanding 88.5 billion won As of last Oct. 31, 1,572 individuals have filed litigation cases against Kolon Life Science. Most of them are shareholders of Kolon Life Science and Kolon TissueGene. Some of patients who had been taking Invossa are claiming the damage as well. Other 19 corporations, including Kyobo Life Insurance Company, KB Insurance, and Meritz Fire & Marine Insurance, have also decided to sue Kolon Life Science. Their total litigation value adds up to 58.4 billion won. Meanwhile, Japan-based Mitsubishi Tanabe has submitted a request for arbitration to International Chamber of Commerce (ICC). The Japanese company demands the Korean company to return the upfront payment of JPY 2.5 billion (about 26.9 billion won) and to pay about 300 million yen (3.2 billion won) for damage. Regarding the issue, Kolon Life Science explained “The company received 2.5 billion yen as an upfront payment, without a return condition, when Mitsubishi Tanabe and Kolon Life Science signed the technology transfer deal in 2016. But in December 2017, Mitsubishi Tanabe requested for contract cancellation and return of contract payment, and in last May, the company submitted a request for arbitration to ICC against Kolon Life Science as it added another grounds for the contract revocation”. As a result, Kolon Life Science faces litigation value of about 88.5 billion won from companies in and out of Korea. List of damage lawsuits filed against Kolon Life Science 14.4 billion won-worth property frozen, 15 billion won contract payment suspended The third quarter report also disclosed the fact Kolon Life Science’ property worth 14.4 billion has been put under provisional attachment by Mitsubishi Tanabe. Kolon Life Science headquarter building seized by Mitsubishi Tanabe Mitsubishi Tanabe requested Korean courts to attach three of Kolon Life Science’ real estate properties under provisional attachment, and Daegu, Cheongju, and Seoul Southern District Courts ruled seizure of Kolon Life Science’ assets. Accordingly, land and building of Second Gimcheon Plant (valued at around 3.3 billion won), land and building of Chungju Plant (valued at around 7.8 billion won), and Magok headquarters building (valued at around 3.3 billion won) have been seized. Also the outstanding contract payment from Mundipharma has been put on hold. Kolon Life Science may have to return the already received 15 billion won. Previously, Kolon Life Science and Mundipharma signed a license deal worth of 30 billion won in November, 2018. Mundipharma agreed to pay the Korean company 15 billion won each in the third and fourth quarter of this year. The company has received 15 billion won from the global company in the past third quarter as stated on the agreement. But in last May, Kolon Life Science agreed on signing Mundipharma as pledge of movables for collateral security, which in result suspended the outstanding fourth-quarter payment of 15 billion won. And when the pledgee’s condition is activated, Kolon Life Science may have to return the received 15 billion won.
- Company
- AI-driven Drug Discovery is already signigicantly high level
- by Kim, Jin-Gu Nov 18, 2019 04:47pm
- Global pharmaceutical companies are showing great interest in the development of new drugs using artificial intelligence (AI). It is expected that AI will drastically reduce the time and costs associated with finding a candidate substance through clinical trials and approvals before entering the market. What about the perspective of the computer science industry, not the pharmaceutical industry? Prof. Kang, Jaewoo, Dept. of Computer Science and Engineering, Korea University, explained that AI-driven Drug Discovery is already coming to reality at 'BIOplus 2019' held at COEX in Seoul on Nov 12. Prof. Kang presented as a speaker at a session called ''AI Medicine: Data-driven Drug Discovery. He expects AI to be particularly strong in clinical trials including Drugs Pipeline discovery & verification. In addition, he introduced cases of this and added his experience of winning the global competition continuesly, According to him, the most prominent step in AI development is Drugs Pipeline discovery. At present, the discovery of candidate materials is mainly done by manual method through document retrieval like Pub Med, the world's largest medical thesis site, reads related articles and formulates hypotheses. However, the number of new articles published in Pub Med is 5000 conservatives a day. It is impossible for a person to check one by one. AI can contribute to this, Professor Kang explained. He focused on AI's "human language learning ability." He succeeded in creating a program called 'BioBERT' last January based on Google's 'deep learning' technology. AI will answer it. if you enter the medical question you want in the program. It is an expansion of the pharmaceutical bio sector of 'BERT' which Google disclosed earlier. Google learned Wikipedia's language with deep learning and created a program called BERT. Data was entered as Wikipedia's language. Instead of Wikipedia, BioBERT learned the language of Pub Med and PMC (another medical article search site). 16 billion words were entered as data. BioBERT's capabilities have been recognized globally. He won first place in BioASQ, one of the AI bio competitions in the pharmaceutical bio sector. Google was in second place. It came with Google's model and reborn as a better program than Google. He said,“It was a test to see how accurate the program would answer, and we can significantly reduce time and effort to find candidates (via BioBERT)." Next step is to verify it once you formulate a hypothesis. Prof. Kang also explained that AI contributes a lot. He added real experience. It was a competition called 'IDG-DREEM' this year. When professors at Mount Sinai Medical School in New York presented their hypothesis as a problem, AI experts around the world searched for answers. Professor Kang won the championship for two consecutive years. He became a co-winner this year. It is in the same position as Illinois State University, China National University of China, and North Carolina State University. The problem was that 'find ZINC15 (Pharmaceutical Bio-Sector Compound DB)' to determine what is most effective when combined with certain drugs in thyroid cancer. In the case of drugs with different structures and similar mechanisms, Prof. Kang's group trained machine learning models to recognize as similar drugs. As a result, It was successful to find 10 substances. Seven of these substances were also confirmed to have related papers. AI could also help with clinical trials, Pro. Kang predicted. "We can predict which patients will be particularly effective for which patients or for which biomarkers," he said. In 2016, AstraZeneca held a contest with Sanger. After revealing the patient's genetic information and the effects of the drug, the problem was predicting which cancer would be most effective. Prof. Kang said that more data is required than the previous stage of finding and verifying candidates. Even though it was the latest professional computer at that time, it took over 20 hours to solve a problem on its own. Eventually, 20 more computers were purchased and the processing speed was increased by 20 times and then reduced to 1 hour. Prof. Kang's group, who first entered the competition, placed second . The following year, he was ranked No. 1 in a competition hosted by the National Cancer Institute (NCI) in 2017. "In 2016 and 2017, we were able to succeed because we used the good quality of patient information that was organized in advance by the organizer." "It is very important to reine data for AI and Even in the field, quality & quantity of information is very important.“ "AI also learns from data… the more the better" In the subsequent presentation, the importance of the data was emphasized. Ph.D Shin, Hyun-jin, who is in charge of AI drug development at Takeda Pharmaceuticals, said, "I feel like I'm floating in the ocean. It's water everywhere but there's no water to drink." There is a lot of data, but no useful data available. "In order for machine learning to evolve, standardized data must be available. However, different data formats are difficult to use these days.“ “Dissemination is the most important to win the war in the long run”he said. "It is same as AI drug development. Both the quantity and quality of the data is important. lower quality may result in lower accuracy, while lower quantities may result in biased results“ He emphasized.
- Company
- Pfizer’s Upjohn changed in business name to Viatris
- by Eo, Yun-Ho Nov 18, 2019 06:23am
- Pfizer's Upjohn is expected to be reborn as a complete independent corporation, or one pharmaceutical company, next year. According to the relevant industry, Pfizer and Mylan decided to change the name of the company to Viatris in 2020 after the merger of the patent expiry division. This means complete company separation. Currently, Pfizer’s Upjohn is still operating under Pfizer's name under Pfizer Pharmaceutical. In fact, Pfizer Korea general manager, Oh Dong-wook is also in charge of the two subsidiaries. As Mylan has not entered the Korean market yet, the Pfizer’s Upjohn’s business division will be operated under Pfizer's control for the time being, but in the end, independence will be achieved if all the matters are prepared with the name’s change in the next year. In particular, due to the nature of the domestic market, the sales volume of expired patented drugs is not small, and Pfizer's Upjone has big items such as Lipitor (Atorvastatin calcium), Norvasc (Amlodipine besylate), and Celebrex (Cerecoxib). So, Pharmaceutical company of a certain scale is expected to be established. Compared to global corporations, the number of employees in Korean subsidiaries is also overwhelming. CEO Dong-wook Oh reorganized the company's internal corporate structure into Pfizer Korea Pharmaceutical which specializes in innovative drugs based on the development of new drugs, and Pfizer Korea Upjohn with concentrating on off-patent brands and generic drugs. He said, "We look forward to growth potential to be better realized in each area“ He said, "We will focus on improving the quality of life by providing timely treatments to more patients based on the various drug pipelines and medicines in each business division. It is the stage to discuss which direction to take, and also, Employees' roles and responsibilities remain unchanged in this process. ”
- Company
- Combination therapy dominates in DPP-4 inhibitor market
- by Chon, Seung-Hyun Nov 17, 2019 05:35pm
- While dipeptidyl peptidase-4 (DPP-4) inhibitor products are currently leading the Korean oral diabetic treatment market, combination drugs reaffirmed its dominance over the DPP-4 market taking up two-thirds of the pie. Even compared with monotherapy prescription volume, MSD’s combination drug with DDP-4 inhibitor and metformin, Janumet outdid other products. On the other hand, Boehringer Ingelheim’s Trajenta topped the monotherapy market. According to the pharmaceutical research frim, UBIST on Nov. 13, outpatient prescription sales of DPP inhibitor class diabetes treatment grew by 7.2 percent than the same time year before, reaching the total of 398.6 billion won. The figure includes both monotherapy and combination therapy. DPP-4 inhibitor medicine outpatient prescription sales trend (unit: KRW 1 million) Source: UBISTSince the launch of MSD’s Januvia in 2008, total of nine DPP-4 inhibiting products have been released. The products aim to treat diabetes by blocking the action of DPP-4 enzyme breaking down secreted insulin. The type of medicine has the biggest pie in the oral diabetes treatment market in Korea. Apparently, the medicine adequately controls the blood glucose level, while it lowers the risk of adverse events like hypoglycemia and increased body weight than any other medicine. Also, there are other DDP-4 inhibitor-based combination therapies available with metformin and pioglitazone. The Korean market has been heated up as six out of nine DPP-4 inhibitor products launched in the market are co-promoted by two companies. ◆Januvia and Janumet top market share, Tenelia and Suganon leap forward Individual sales-wise, Januvia and Janumet kept their top prescription sales in the third quarter with accumulated sales of 117.4 billion won. The figure was increased by 3.0 percent than the previous year. MSD and Chong Kun Dang are co-promoting Januvia products in the Korean market. Trajenta and Trajenta Duo, co-promoted by Boehringer Ingelheim and Yuhan Corporation, had a 5.1 percent growth than the previous year reaching accumulated prescription sales of 87.4 billion won in the third quarter. The total sales figure may be lower than Januvia, but it had a greater growth. LG Chem’s Zemiglo and Zemimet accumulated prescription sales of 71.3 billion won until the third quarter, soaring 13.0 percent than last year. After launching Zemiglo in 2012, LG Chem partnered with Sanofi to co-promote the product but it resigned the partnership deal with Daewoon Pharmaceutical instead in 2016. Daewoong Pharmaceutical has been cumulating expertise in diabetes treatment sales for eight years since 2008 with the first DPP-4 inhibitor drug, Januvia. Combined sales experience and knowledge, Daewoong Pharmaceutical has been evaluated to have led the prominent sales power of Zemiglo in recent days. Tenelia and Suganon jumped into the game late but their performances so far have been notable. Along with Tenelia M, Handok’s Tenelia generated accumulated outpatient prescription sales of 25.9 billion won by the end of September. The figure has surged by 18.9 percent than the same time last year. Dong-A ST’s Suganon and Sugamet generated 62.0 percent growth from the year before, recording 10.9 billion won this September. However, Galvus and Galvus Met were a few that showed a decrease in prescription than last year among DPP-4 inhibitor medicines. ◆Janumet undoubtedly tops combination therapy market, Trajenta leads monotherapy Comparing DPP-4 inhibitor monotherapy and combination therapy, the combination therapy products had a steeper growth. Accumulated prescription sales of DPP-4 inhibitor monotherapy were 144 billion won in the third quarter, recording 5.1 percent growth from the year before. But, DPP-4 inhibitor in combination with metformin and pioglitazone generated prescription sales of 254.6 billion won, surging about 8.4 percent from last year. Making a steeper growth than monotherapy, combination therapy took over 63.9 percent of the whole market share. Within the DPP-4 inhibitor combination therapy market, Janumet, a combination of sitagliptin (Januvia) and metformin, dominated the market share. Janumet and Janumet XR swallowed up 33.0 percent of the whole combination therapy market with accumulated prescription sales of 84.9 billion won in the third quarter. Another combination therapy, Zemimet followed right behind with 46.4 billion won prescription sales, beating Trajenta Duo. Meanwhile, monotherapy market showed a contrasting trend. Accumulated prescription sales of Trajenta reached 43.9 billion won and topped the market share, when Januvia’s figure only reached 32.6 billion won. Trajenta was ranked on the third place in the combination therapy market, but the medicine still remains strong in the monotherapy market. Galvus was the fourth most selling medicine in the combination therapy market, but its rank in monotherapy market dropped to sixth after Tenelia and Nesina.
- Company
- Prosecution combs vaccine companies for alleged collusion
- by Kim, Jin-Gu Nov 16, 2019 06:29am
- The prosecution set out to investigate on a suspicion of pharmaceutical companies colluding together when supplying vaccine to government. According to pharmaceutical industry on Nov. 14, the prosecution combed ten alleged pharmaceutical companies and distributors on Nov. 13. Companies like GC Pharma, Kwangdong Pharmaceutical, Boryung Pharmaceutical and Korea Vaccine, and distributors like Wooin Meditech, and Pharm World were reportedly on the search and seizure list. Allegedly, the companies have fixed bidding prices of vaccine products submitted to Public Procurement Service when supplying the products to national healthcare institutes. The suspicion not only accuses them for price fixing, but also for supplying products without reporting vaccine’s adverse reaction. In fact, the authority apparently found documents related to vaccine bidding and supply as prosecutors and investigators were searching their offices in the afternoon of Nov. 13. Meanwhile, seven pharmaceutical companies, including Boryung Biopharma, SK Chemical and GC Pharma and CJ have been caught by Fair Trade Commission for colluding vaccine prices in 2005 to 2009. As a result, the companies were fined by the court’s decision.
- Company
- Novatis Korea, 5 Copyright arrangements including Exelon
- by An, Kyung-Jin Nov 16, 2019 06:28am
- Exelon Capsules Novartis Korea is working copyright control of some central nervous system (CNS) medicines such as Excelon. According to the industry on 14th Novartis Korea is considering selling the copyrights of some of the CNS products sold by the Rx medicine business division. The intention is to clean up less profitable items and focus sales marketing activities on the company's flagship products. The abolition of division in charge of CNS products such as dementia, epilepsy and Parkinson's disease drugs has already been phased out, leaving only official announcements. Novartis' original copyrighted products are sold to domestic pharmaceutical companies, and it is likely to return the original copyrighted products from other industry to the original developer. Novartis will continue to supply products while maintaining product licensing rights, but the overall sales activities, including product promotions and sales manpower, will be handed over to domestic pharmaceutical companies. The contract partner is not yet confirmed. The products sold by the CNS department are five drugs, including anti-intermittent drugs named 'Trileptal' and 'Tegretol', Parkinson's drugs named 'Stalevo' and 'Comtan' and Alzheimer's dementia drugs named 'Exelon'. Parkinson's drugs named Stalevo and Comtan, are two products that Novartis does not own the original copyright and are likely to return to the original developer without re-signing. Drugs under the copyright sale has been a record a sharp decrease in sales after the rebate suspension According to UBIST Data Bank, outpatient prescriptions sales for ‘Excelon’ in 2018 were ₩1.8 billion, 86.7% less than in 2016, before the suspension of reimbursement was imposed. The total sales of five products in the CNS department, including Exelon, dropped 57.3% from ₩51.5 billion in 2013 to ₩21.6 billion in 2018. In this regard, Novartis Korea was found to provide medical workers with illegal rebates and was suspended from the MOHW for six months (Aug 24 2017 ~ Feb 23 2018) for nine items in 2017. At the time, the sales loss was big due to the inclusion of four different doses of Execlon capsules and three different doses of Execlon patches. The company’s stance is that it is just to optimize the CNS portfolio, not related to the rebate case. A Novartis official said, “In the process of optimizing our product portfolio strategy, we are reducing the activity of some older products and increasing the concentration of new drugs. Reducing the domestic sales marketing of some items does not mean we withdraw our business division. "
- Company
- XOSPATA , AML Medicine landing soon in Korea
- by Eo, Yun-Ho Nov 15, 2019 06:28am
- It is anticipated that new AML (acute myeloid leukemia) drugs which are lack of the treatment will be approved . According to the related industry on the 15th, Astellas Pharmaceuticals is in the process of approving from MFDS for 'Acute myeloid leukemia (AML) drug named Xospata (Gilteritinib). The drug is already approved in 2018 in the US and Japan and received European EMA approval last month. The efficacy of Xospata has been demonstrated in phase 3 clinical ADMIRAL studies. XOSPATA delivered superior survival with a median OS(Overall Survival) of 9.3 months vs 5.6 months with salvage chemotherapy during the ADMIRAL trial. XOSPATA more than doubled the 1-year survival rate compared with salvage chemotherapy. The one-year survival rate was 17% with salvage chemotherapy and 37% with XOSPATA. Adverse reactions occurred in more than 10% of patients receiving XOSPATA for 30days were anemia, increased ALT and AST, febrile neutropenia, thrombocytopenia, constipation, fever, and fatigue. AML is the most common form of leukemia, accounting for about 65% of adult acute leukemia. As you get older, the incidence increases. AML is first treated with a combination of two or three drugs such as Anthracycline. The problem is that even after the first chemotherapy, the leukemia cells fall to less than 5% and the degree of complete perception reaches 50-70%, but up to 50% of these relapse. As a result, many big Pharmacuticals are eager to develop new drugs. An official of the Korean Society of Hematology said, "AML is important to reduce cancer cell numbers in the beginning. We look forward to the appearance of options for prescribing older patients and patients who are unable to apply induction therapy." Meanwhile, Janssen's Decitabine named Dacogen has been prescribed as a primary treatment for older AML patients.
- Company
- Samsung Bioepis CEO notes 3 reasons why CAR-T struggles
- by Kim, Jin-Gu Nov 14, 2019 09:07am
- Ko Hang-Seung, CEO of Samsung Bioepis Co., picked three reasons CAR-T cell therapy (“CAR-T”) is struggling – price, patient size and productivity. On Nov. 12, CEO Ko shared his opinions about CAR-T and other next generation treatment options during his keynote speech at BIOplus 2019 in COEX, Seoul. “Data was fairly good when CAR-T first came about. The U.S. Food and Drug Administration (FDA) approved the treatment only with a handful of data. But never did we think that it would be so unprofitable. Apparently, Novartis is making about one-third of initially projected sales,” said CEO Ko. As the first reason, Ko pointed out the existing alternative option. Among others, rituximab (brand name Mabthera) is the most famous case. He explained CAR-T is vulnerable in price competition with rituximab out in the market. “When first rituximab was release, many commented how extremely expensive it was. But the price got notably lower after CAR-T was launched. CAR-T is inevitably expensive due to its production process. The manufacturer has to extract a patient’s blood sample and reprogram extracted T-cell first to finally infuse it back to the patient.” The second reason is limited patient size. The approved indication of CAR-T at the moment is limited to patients with hematologic malignancies. But as patient size of the cancer is significantly smaller than that of solid cancer, CAR-T sales figures are also low. Small patient size also negatively affects clinical trials. This also includes price issues. The CEO commented, “Clinical trial for CAR-T is full of obstacles as it has small patient size and its production cost is off the chart. This adds to the issue of generating statistically meaningful evidence for another indication and having it approved”. The third reason is productivity. Ko claimed “Some think pharmaceutical manufacturing is the easy part of the drug development. But mass manufacturing of a product in consistently satisfying quality is easier said than done”. “Production is one of the reasons Novartis is struggling with CAR-T. As the treatment is based on individually customized production, mass manufacturing is impossible and consistent quality control is difficult”, said the CEO. Lastly, he noted “Circumstances are quite similar with cell therapy and gene therapy sector that many of startups are jumping into these days. If they don’t tackle the quality control aspect in manufacturing stage fast, the market would unlikely to grow further”.
- Company
- Merck Korea vs GM employee feud sees no end
- by An, Kyung-Jin Nov 14, 2019 09:07am
- KDPU Merck Korea chapter picketing during morning rush hour After licensing out antihypertensive and anti-diabetic treatments, Merck Korea is finally, and completely, shutting down its General Medicine (GM) division. However, an intense conflict with labor union has deepened as more than a half of the employees have not reached an agreement with the company’s management. The company offering early retirement program (ERP) became highly controversial as it technically asked a certain group of employees to leave the company “voluntarily”. According an industry insider on Nov. 13, imminent shutdown of Merck Biopharma Korea’s GM division is causing increasingly heated labor-management strife with the GM division employees. Merck Korea has officially announced the closing of the GM division by the end of this month as it has sold off local sales rights of two prescription drugs to Korean pharmaceutical companies within a month. On Oct. 11, the company closed a deal with GC Pharma to sell the sales right in Korea for an anti-diabetic drug, Glucophage. And shortly after on Nov. 5, the company and Daewoong Pharmaceutical signed a deal over a sales right of an antihypertensive drug Concor. The signed deals provide Merck Biopharma Korea to maintain the item permit, while GC Pharma and Daewoong Pharmaceutical would initiate marketing and sales activities of the products from the beginning of next year. The decision was made based on the Merck headquarters’ intention to focus on accelerating growth of specialty care sector. “Merck now has a new aim to strengthen specialty care pipelines on oncology, infertility and neurology sectors to become a global specialty innovator. By supplying Merck’s drug products to GC Pharma and Daewoong Pharmaceutical, we would continue to contribute in improving lives of Korean patients,” said Merck Biopharma Korea General Manager Javed Alam. The GM division has about two weeks left to complete the closing, but more than a half of employees and Merck Korea have not settled on a middle ground for their employment condition. Representative of Merck Korea chapter of Korea Democratic Pharmaceutical Union (KDPU) informed that the management has offered ERP compensation to pay out eight month’s wage, in addition to two month’s wage times by a number of years of service. Including a manager-level employee, nine out of 35 employees from GM division have applied for ERP, and other 26 are demanding the management to provide more options of employment security, such as reassignment of position. According to the division shutdown schedule, offices in Gwangju, Daejeon, Daegu, Busan and other regions are also preparing to shut down and reassigning employees to Seoul office from next month, regardless of their unimaginable intercity commute. Merck Korea plans to offer the employees an ERP package, and also to provide opportunities to transfer position within or out of the company. Moreover, the management is offering financial support of maximum 40 million won for up to two-year MBA or master’s degree graduate school programs, and it informed there would be another call for ERP applicant. However, the union claims the management asking one specific department to apply for early retirement is not so far off from them picking on a particular group of employees. The union explains the ERP should be offered to everyone in the company and employees who wish to stay should get a chance to be reassigned to another department. Beginning from Sept. 30, Merck Korea’s labor union has been protesting against the management’s decision to downsize in front of their office building. And to this date, the union members are picketing during the busy commuting time every morning. Head of Merck Korea chapter of KDPU, Cho Young-seok reproached, “The union has attempted to convince the management to postpone the sales right deal and to seek mutually sustainable means for the both parties, but our proposition has been denied. Besides the sales license, the company should at least give employment opportunities to those who want to stay. Relocating employees from closed regional offices to Seoul office is technically pushing them over to the edge to leave the company”. About the issues addressed, Merck Biopharma Korea official stated, “As GM division’s regional offices are closing down soon, their employees have been reassigned to Seoul office. The headquarters’ intention is to discuss various options including ERP. Although the feasible number of employees cannot be specified at this moment, we plan to offer opportunities for them apply for transition to Korean pharmaceutical companies with the sold drug sales rights, or even to other divisions in the company”.
- Company
- Rolontis®to get ₩11.6 billion upon FDA's approval
- by An, Kyung-Jin Nov 14, 2019 03:25am
- The royalty scale of Rolontis® was first revealed. Hanmi Pharmaceuticals will receive rayalty of nearly ₩ 12 billion upon final FDA approval. After the release, Hanmi Pharmaceuticals will also likely receive a certain percentage of revenue annually, depending on sales. Spectrum Pharmaceuticals, Hanmi Pharmaceutical’s partner, recently filed quarterly report SEC. Spectrum Pharmaceuticals noted in its report that it has completed reauthorization application process on Oct 24. The company rescinded its initial BLA for the reason of the FDA’s request for more CMC data in March. The company resubmitted the biologics license applications (BLA) for Rolontis® to the FDA after 7 months. Spectrum pharmaceuticals said with confidence ,“Rolontis® demonstrated safety and efficacy in 643 early breast cancer patients with neutropenia following myelosuppressive chemotherapy. The two phase III clinical trials showed non-inferiority in terms of the duration of neutropenia compared with Pegfilgrastim during the four cycles of chemotherapy.”It expects to enter the Pegfilgrastim market generating $ 4 billion in revenue annually, if approved. According to the report, Spectrum pharmaceuticals agreed to pay $ 10 million milestones to Hanmi Pharmaceuticals upon FDA’s approval. After launch, Spectrum pharmaceuticals will pay a certain percentage of royalties annually based on the net sales. Rolontis® is a biological new drug with long-acting that utilizes Hanmi’s Labscovery platform technoloy. In 2012, Hanmi Pharmaceuticals signed a licensing agreement with Spectrum Pharmaceuticals, giving the global rights for Rolontis® except for Korea, China and Japan. Hanmi Pharmaceuticals and Spectrum Pharmaceuticals did not disclose the total contract size, including the upfront fee and the technology at the time of contract. According to Spectrum Pharmaceuticals, a certain deposit was paid to Hanmi Pharmaceuticals when they signed the contract initially. In September 2014, after confirming the positive phase II clinical results and deciding to proceed with phase III clinical trials, they said the terms of the contract, such as milestones and sales royalties were modified. Spectrum Pharmaceuticals first paid Hanmi Pharmaceuticals $1.9 million milestones when it started the ADVANCE study in the first quarter of 2016. Spectrum pharmaceuticals issued 318,750 common shares for Hanmi pharmaceuticals in April of the same year. Considering the stock price at that time, it was worth $ 2.3 million in cash. , Currently, Hanmi pharmaceuticals owns 0.29 percent of Spectrum pharmaceuticals shares. Joseph W. Turgeon, CEO of Spectrum, who attended the conference call on July 7, said, “Spectrum pharmaceuticals submitted theRolontis®BLA to the FDA last month with a strategic decision considering management priorities.” We plan to introduce the Rolontis® Phase III clinical integration data which was released at the 2019 ASCO conference, at the San Antonio Breast Cancer Symposium (SABCS) in Texas, USA next month“.
