Mar 14, 2017
InteRx, Lumosa to Launch Naldebain
InteRx, Lumosa to Launch Naldebain
Following the TFDA approval of Naldebain®, a novel long-acting analgesic injection (LT1001) on March 4 2017, Lumosa Therapeutics (Lumosa, 6535.TWO) and InteRx Biomedical Co., Ltd. (InteRx), a subsidiary of Amed Co., Ltd. (Amed), announced the marketing plan for Naldebain® jointly today. InteRx has obtained the right of manufacturing and marketing of Naldebain® in Taiwan from Lumosa in December 2015. The market for moderate/severe analgesic in Taiwan values approximately NT$13.7 billion (US$ 443 million), and InteRx will initially focus on pain relief after orthopedic, gynecological, abdominal and non-abdominal surgeries; including joint replacement, gastroenterological and hepatological surgeries, hemorrhoidectomy, etc. Market for post-operative pain relief of these procedures are estimated to be up to NT$ 4.46 billion (US$143.8 million).
Lumosa was invited to participate in an investor conference sponsored by Yuan Fu Securities on March 14, 2017. Lumosa invited its marketing partner for the new long-acting analgesic injection, InteRx, to jointly present the marketing strategy for Naldebain® in Taiwan.
Lumosa’s Naldebain® was approved by Taiwan Food and Drug Administration (TFDA) on May 6, 2017, and the product launch in Taiwan by InteRx is planned in April. Yao-Chien Wan, Chairman of AMED expressed great expectation in Naldebain®’s success upon launch, as there are more than 2 million cases of moderate to severe surgeries in Taiwan each year per statistics released by TFDA; “pain relief after these surgeries will be the potential market for Naldebain®,” he said.
The analgesic effect of Naldebain® is comparable to other common prescribed opioids but with much better safety profile. As demonstrated in the phase 3 clinical trial, a pre-operative dose of Naldebain® would provide 7 days of analgesic relief for severe pain. InteRx pointed out that Naldebain® provides great convenience to care takers because it doesn't require the use of additional devices for post-operative pain management and it facilitates patients’ recovery for early discharge. Currently, self-pay analgesic occupies 40% of analgesic market, which will be the targeted by InteRx initially. Self-pay analgesic is covered in most medical insurances, which may substantially increase the willingness of patients in Taiwan to use Naldebain®, even though they need to pay out-of-pocket. The commonly used patient-controlled analgesia (PCA) is self-paid and costs NT$6000~8000 (US$193.5~258.1) for 2~3 days of analgesic effect. InteRx will continue developing new indications with the assistance from Lumosa to expand market share.
Dr. Wendy Huang, CEO of Lumosa expressed her confidence that that, Amed has a wonderful track record for its research and development and manufacturing of wound dressing products that has been marketed globally under the brand “A+Med,” and has years of experience in marketing. Its subsidiary, InteRx, has an 80-person sales team of extensive experience and reach to medical professionals and products related to surgery and wound care. It has complete sales network that covers medical centers, regional hospitals, large community hospitals, clinics, and pharmacies.
Lumosa’s LT3001, a novel drug for acute ischemic stroke, has also attracted much attention recently with the scientific presentation in 2017 International Stroke Conference. Dr. Huang indicated that its Investigational New Drug (IND) will be submitted to the US Food and Drug Administration (FDA) in the first half of 2017, as scheduled.
Dr. Huang also stated that Lumosa continues to make great progress with its pipeline project. New indications and formulations are under development for Naldebain®, which will increase investment returns and expand the product out-licensing opportunities. Company is actively seeking new drug candidates with novel therapeutic approach and highly differentiated target product profile to enrich Lumosa’s pipeline and expand future profit sources.
Following the TFDA approval of Naldebain®, a novel long-acting analgesic injection (LT1001) on March 4 2017, Lumosa Therapeutics (Lumosa, 6535.TWO) and InteRx Biomedical Co., Ltd. (InteRx), a subsidiary of Amed Co., Ltd. (Amed), announced the marketing plan for Naldebain® jointly today. InteRx has obtained the right of manufacturing and marketing of Naldebain® in Taiwan from Lumosa in December 2015. The market for moderate/severe analgesic in Taiwan values approximately NT$13.7 billion (US$ 443 million), and InteRx will initially focus on pain relief after orthopedic, gynecological, abdominal and non-abdominal surgeries; including joint replacement, gastroenterological and hepatological surgeries, hemorrhoidectomy, etc. Market for post-operative pain relief of these procedures are estimated to be up to NT$ 4.46 billion (US$143.8 million).
Lumosa was invited to participate in an investor conference sponsored by Yuan Fu Securities on March 14, 2017. Lumosa invited its marketing partner for the new long-acting analgesic injection, InteRx, to jointly present the marketing strategy for Naldebain® in Taiwan.
Lumosa’s Naldebain® was approved by Taiwan Food and Drug Administration (TFDA) on May 6, 2017, and the product launch in Taiwan by InteRx is planned in April. Yao-Chien Wan, Chairman of AMED expressed great expectation in Naldebain®’s success upon launch, as there are more than 2 million cases of moderate to severe surgeries in Taiwan each year per statistics released by TFDA; “pain relief after these surgeries will be the potential market for Naldebain®,” he said.
The analgesic effect of Naldebain® is comparable to other common prescribed opioids but with much better safety profile. As demonstrated in the phase 3 clinical trial, a pre-operative dose of Naldebain® would provide 7 days of analgesic relief for severe pain. InteRx pointed out that Naldebain® provides great convenience to care takers because it doesn't require the use of additional devices for post-operative pain management and it facilitates patients’ recovery for early discharge. Currently, self-pay analgesic occupies 40% of analgesic market, which will be the targeted by InteRx initially. Self-pay analgesic is covered in most medical insurances, which may substantially increase the willingness of patients in Taiwan to use Naldebain®, even though they need to pay out-of-pocket. The commonly used patient-controlled analgesia (PCA) is self-paid and costs NT$6000~8000 (US$193.5~258.1) for 2~3 days of analgesic effect. InteRx will continue developing new indications with the assistance from Lumosa to expand market share.
Dr. Wendy Huang, CEO of Lumosa expressed her confidence that that, Amed has a wonderful track record for its research and development and manufacturing of wound dressing products that has been marketed globally under the brand “A+Med,” and has years of experience in marketing. Its subsidiary, InteRx, has an 80-person sales team of extensive experience and reach to medical professionals and products related to surgery and wound care. It has complete sales network that covers medical centers, regional hospitals, large community hospitals, clinics, and pharmacies.
Lumosa’s LT3001, a novel drug for acute ischemic stroke, has also attracted much attention recently with the scientific presentation in 2017 International Stroke Conference. Dr. Huang indicated that its Investigational New Drug (IND) will be submitted to the US Food and Drug Administration (FDA) in the first half of 2017, as scheduled.
Dr. Huang also stated that Lumosa continues to make great progress with its pipeline project. New indications and formulations are under development for Naldebain®, which will increase investment returns and expand the product out-licensing opportunities. Company is actively seeking new drug candidates with novel therapeutic approach and highly differentiated target product profile to enrich Lumosa’s pipeline and expand future profit sources.