PledPharma and Solasia enter license agreement to develop and commercialize PledOx® in Asia
Stockholm, 2017-11-20 07:30 CET (GLOBE NEWSWIRE) --
Stockholm, Sweden / Tokyo, Japan, November 20th 2017 - PledPharma AB (“PledPharma”) (STO: PLED) and Solasia Pharma K.K. (“Solasia”) (TSE: 4597) today jointly announce that they have entered a license agreement pertaining to the clinical development and commercialization of PledOx® in Japan, China, Hong Kong, Macau, South Korea and Taiwan.
Under the terms of this agreement, PledPharma grants exclusive development and commercialization rights to PledOx® in the territories mentioned and Solasia will pay upfront, development, regulatory and sales milestones of up to ~USD 83 million (SEK 700 million)*. In addition, Solasia will pay industry standard royalty rates on sales applicable for a deal pertaining to an in-licensed asset in Phase III development. Solasia will also fully finance an expansion of the Phase III program to include Asian patients subject to regulatory consultations.
The license agreement is initially focused on the use of PledOx® as prevention of chemotherapy induced peripheral neuropathy in colorectal cancer patients. The agreement with Solasia facilitates an expansion of the recently announced global Phase III-program for PledOx® with Asian patients, subject to regulatory consultations, aiming to gain sufficient documentation for regulatory approvals in the major Asian markets. In addition, a Phase I study in Japanese and Caucasian Healthy Volunteers with focus on safety, tolerability and pharmacokinetics will be conducted. Following potential regulatory approvals, Solasia will be responsible for the commercialization of PledOx® in Japan, China, Hong Kong, Macau, South Korea, and Taiwan.
“We are very excited to announce our partnership with Solasia – an ideal partner during the development, regulatory process and commercialization of PledOx in this very important region. The collaboration will ensure an optimized expansion of the Phase III program to include Asian patients, aiming at further realising the global commercial potential of our drug candidate,” said Nicklas Westerholm, Chief Executive Officer and President, PledPharma.
“We are convinced that PledOx, as a novel first in class therapy, will play an important role in fulfilling the significant unmet medical need of preventing chemotherapy induced peripheral neuropathy. Solasia is ideally equipped to support PledPharma during the remaining clinical development and local regulatory processes in Japan, and to effectively launch the product in key Asian markets,” said Yoshihiro Arai, President and Chief Executive Officer, Solasia.
As PledPharma announced earlier in November, following interactions with the regulatory authorities, EMA and FDA, the company has finalized the design of the global Phase III program for the drug candidate PledOx®. The Phase III studies are anticipated to be initiated at the end of 2017 with top line results expected during 2020.
* The total value of upfront and milestone payments is up to JPY 9.3 billion. The amount given in USD and SEK is subject to exchange rate.
Invitation to corporate presentation
PledPharma will attend the Redeye Life Science Seminar on November 24 at 11:00 CET where PledPharma will provide a company update and an overview of the license agreement with Solasia. The event will be live streamed from Redeyes website www.redeye.se. After the event, the presentation will be available on PledPharma's website.
PledOx® is a “first in class” drug candidate developed to provide patients, that are treated adjuvantly or for metastatic colorectal cancer, prevention against the nerve damage that can occur in conjunction with chemotherapy treatment. The side-effects of chemotherapy can lead to a reduction of the planned dose or, in worst case, treatment discontinuation. Unfortunately, it appears that the chemotherapy can induce permanent nerve damage. Patients may, for example, experience discomfort and numbness in the hands and feet, difficulty with balance with risk of falling and problems with sensation that can last for the rest of their lives.
About chemotherapy induced peripheral neuropathy (CIPN)
Peripheral neuropathy symptoms are caused by damages to sensory nerves, most commonly in hands and feet. Certain chemotherapies, including oxaliplatin, can cause such damages, which is then called chemotherapy induced peripheral neuropathy (CIPN). This can be a debilitating adverse reaction of the cancer treatment and may occur at any time after the initiation of chemotherapy. The symptoms often increase as the chemotherapy treatment continues and may often causes discontinuation of the chemotherapy. In many patients, the symptoms are resolved after discontinuing the chemotherapy, but up to 20-30% of the patients have sustained symptoms such as numbness, tingling and pain in hands and feet. Patients with CIPN may have difficulties with fine motor skill, such as buttoning buttons, challenges using a computer key board and become hypersensitive to cold. The sensory loss in the feet’s may increase the risk of falls. There is currently no approved drug to prevent or treat CIPN.
Solasia is a specialty pharmaceutical company based in Asia, with a mission of "Better Medicine for a Brighter Tomorrow". In order to address the unmet medical needs within the oncology area, we develop innovative medicines to contribute to the patient's healthy living and to provide treatment options for the healthcare providers. Additional information is available at http://www.solasia.co.jp/en/
PledPharma develops new drugs that protect the body against oxidative stress – a potentially debilitating and sometimes life-threatening condition that can be caused by chemotherapy treatment and following acetaminophen (paracetamol) overdose. The company's most advanced project PledOx® is being developed to reduce nerve damage associated with chemotherapy. A phase IIb study has been conducted and will serve as the basis for the continued development. The drug candidate Aladote® is being developed to reduce the risk of acute liver failure associated with acetaminophen poisoning. PledPharma (STO: PLED) is listed on Nasdaq First North. Erik Penser Bank is the company’s Certified Adviser (tel +46 8 463 80 00). For more information, see http://www.pledpharma.se/
For further information, please contact:
Nicklas Westerholm, Chief Executive Officer, PledPharma AB
Tel. +46 73 354 20 62
Rie Toyoda, Investor Relations, Solasia Pharma K.K.
Tel. +81 3 6721 8332
This information is information that PledPharma AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 07:30 CET on November 20, 2017
Om Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York
+1 212 401 8700http://www.nasdaqomx.com
NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.
Følg saker fra Nasdaq GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Nasdaq GlobeNewswire
Feelunique–Europe’s largest online beauty retailer–expands partnership with Moovweb13.12.2018 03:28 | Pressemelding
Feelunique will introduce a new App-like Mobile Site powered by Moovweb SAN FRANCISCO, Dec. 12, 2018 (GLOBE NEWSWIRE) -- Feelunique, Europe’s largest online beauty retailer, announced today that it has expanded its long-standing partnership with Moovweb, by building an innovative Progressive Web App (PWA) with The Moovweb Experience Delivery Network (XDN) that powers modern mobile experiences for the world’s leading brands. The company’s new eCommerce experience will allow shoppers to browse, checkout and purchase items as fast as an app in their mobile browser without requiring a mobile app download. Powered by The Moovweb XDN, the new web experience will dramatically speed up mobile shopping–search, browsing and buying products–leveraging PWA technology. Now that page load speed is a key factor for SEO thanks to new rules that rank which mobile sites appear first on Google, best-in-class eCommerce brands are utilizing PWA technology. With PWAs, follow-up pages are pre-cached giving t
Chvaletice Manganese Project Mineral Resource Update, 2018 Metallurgical Testwork Program Update and Preliminary 2019 Plans13.12.2018 03:03 | Pressemelding
HIGHLIGHTS: Successful 2018 Drilling Program results in updated Mineral Resource Estimate with 98.3% of Resource classified in Measured Category. Drilling Program confirmed outstanding consistency of manganese grade and mineralogy. Successful Metallurgical Testwork Program and Pilot Plant Test runs, indicating manganese can be extracted from Chvaletice tailings using a combination of proven commercial technologies. Testwork Program confirmed the proposed hydrometallurgical process can produce Ultra-High-Purity Manganese Products meeting or exceeding customer specifications. Plan to build and commission a Demonstration Plant in 2019 to produce multi-tonne, Ultra-High-Purity Manganese Product samples for customer testing and qualification. Project timeline remains on track, with Preliminary Economic Assessment targeted for release in early 2019. Targeting production of both electrolytic manganese metal and manganese sulphate monohydrate, focusing principally on Europe's rapidly emerging
Quantenna and Telefónica Reinforce Strategic Partnership with New Portfolio of 8x8 MIMO Wi-Fi 6 Products12.12.2018 23:00 | Pressemelding
SAN JOSE, Calif., Dec. 12, 2018 (GLOBE NEWSWIRE) -- Quantenna Communications, Inc. (NASDAQ: QTNA) is further strengthening its strategic partnership with Telefónica. Through a long history of cooperation, the two companies have developed multiple generations of best-in-class products including gateways, repeaters and set-top boxes deployed in Europe and Latin America. Leveraging Quantenna’s 8x8 QSR10GU-AX, Telefónica is delivering a new portfolio of high-end fiber gateways and repeaters. The Wi-Fi 6 compliant QSR10GU-AX provides integrated dual-band, dual-concurrent 2.4GHz and 5GHz functionality in the same chipset, supporting up to a maximum speed of 10Gbps and 12 simultaneous streams. Thanks to its “Always-On DFS” feature, the QSR10GU-AX offers enhanced radar detection and spectrum analyzer capabilities with wide frequency range analysis. The QSR10GU-AX also supports advanced MU-MIMO, allowing for transmission to multiple devices at the same time, and providing higher throughput, inc
Improved Accuracy and Speed for Disease Research, Two Genomic Companies Integrate Kits and Software to Enable Deep Exploration of Epigenetic Data12.12.2018 21:16 | Pressemelding
OnRamp’s ROSALIND and Active Motif offer an improved ChIP-Seq data analysis experience for researchers with state-of-the-art dynamics track plots and advanced collaboration capabilities SAN DIEGO, Dec. 12, 2018 (GLOBE NEWSWIRE) -- OnRamp BioInformatics, a genomics company focused on scientist-friendly bioinformatics software solutions, today announced they are working with Active Motif to improve accuracies in data analysis for ChIP-Seq experiments. OnRamp’s flagship software, ROSALIND, provides a point-and-click experience to speed up and simplify the process of genomic data analysis from experiment setup to QC and interactive data visualization to interpretation. With this integration, researchers will now benefit from an optimized analysis that includes the unique characteristics of Active Motif kits and antibodies, including Unique Molecular Identifiers (UMI) and spike-in solutions. Active Motif customers will now be able to rapidly interpret their data with ROSALIND’s identificati
Markforged launches H13 tool steel for high-strength, high-temp tooling applications12.12.2018 15:00 | Pressemelding
New material for Metal X 3D printing system is first of many WATERTOWN, Mass., Dec. 12, 2018 (GLOBE NEWSWIRE) -- Markforged, the Boston-area 3D printer company transforming manufacturing, today announced the launch of H13 tool steel for the Metal X, the world’s leading desktop-sized metal printer with over 150 systems shipped since March 2018. The expansion into H13 will enable customers to print parts in high-strength, high-temperature applications such as metal forming tools, dies and punches, and hardened inserts for fixtures, and even injection molds with conformal cooling channels. To learn more about H13 tool steel and place an order, please visit http://markforged.com/h13 “We designed the Metal X system to change the way things are made, and the launch of H13 is the next step down that path,” said Jon Reilly, Markforged VP of product. “For manufacturers of high-volume plastic parts this is a game changer, significantly accelerating the speed at which they can bring new products
XBiotech’s Results from Phase 2 Atopic Dermatitis Study Suggest New Drug to Treat Skin Disease12.12.2018 14:30 | Pressemelding
Bermekimab Therapy Rapidly and Significantly Reduces Disease AUSTIN, Texas, Dec. 12, 2018 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ: XBIT) announced today that its open label, proof of concept, multicenter study using bermekimab to treat patients with moderate to severe atopic dermatitis (AD) has completed and the study met all primary and secondary endpoints. Thirty eight patients in two treatment groups received a low (n=10) or high (n=28) dose of bermekimab once weekly for either a 4 or 7-week treatment regimen, respectively. Statistically significant improvement was seen for all efficacy endpoints in the high dose group; and a significant dose response for the high dose compared to low dose group was observed for key endpoints, including the Eczema Area and Severity Index (EASI), Global Individual Sign Score (GISS), Patient Oriented Eczema Measure (POEM), Hospital Anxiety and Depression Scale (HADS), and SCORing Atopic Dermatitis (SCORAD). While clinically and statistically significant
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom