Mapi Pharma News
21 articles
growth-positive
Mapi Pharma to Host a Key Opinion Leader Webinar on Glatiramer Acetate Depot
Mapi Pharma Ltd. will host a webinar to discuss the positive results from its Phase III GA Depot study, which focuses on a potential long-acting injection solution for multiple sclerosis (MS) patients. The webinar will feature key opinion leaders in neurology who will discuss the clinical results and the potential impact on improving standard of care for MS patients. The study showed that GA Depot 40 mg significantly reduced the annualized relapse rate in relapsing forms of MS patients. Mapi Pharma and its partner Viatris plan to work with regulatory authorities to determine next steps. The webinar will also cover the treatment landscape for MS and the unmet medical need for a long-acting monthly injection. Mapi Pharma is a pharmaceutical company focused on developing innovative long-acting depot injectable products.
Customers
growth-positive
Mapi Pharma Announces Positive Top-Line Results from GA Depot Phase III Trial for Relapsing forms of Multiple Sclerosis (RMS)
Mapi Pharma announced positive top-line results from the GA Depot Phase III clinical trial, showing a significant reduction in the annualized relapse rate compared to placebo. The study met its primary endpoint, demonstrating the potential of GA Depot 40 mg as an effective treatment option for relapsing forms of multiple sclerosis. The company plans to commercialize GA Depot in partnership with Viatris. The positive results are seen as a step forward in supporting the needs of the multiple sclerosis community. Mapi Pharma and Viatris will work with regulatory authorities to determine next steps.
Customers
growth-positive
Mapi Pharma to Present Late Breaking Poster Presentation on GA Depot for Treating Primary Progressive Forms of Multiple Sclerosis at CMSC 2022 Annual Meeting
Mapi Pharma will present clinical data on the treatment of Primary Progressive Multiple Sclerosis (PPMS) with GA Depot at the CMSC Annual Meeting 2022. The data suggests that GA Depot is a safe and effective treatment for patients with PPMS. Mapi Pharma plans to evaluate GA Depot in a controlled global double-blind Phase III study. The company is also partnering with Viatris for the commercialization of GA Depot for relapsing forms of multiple sclerosis. Mapi Pharma is a clinical-stage pharmaceutical company focused on introducing innovative long-acting depot injectable solutions for neurological indications.
PartnersInvestment
growth-positive
Mapi Pharma Receives U.S. Patent Covering Methods of Suppressing or Alleviating Primary or Secondary Progressive Multiple Sclerosis with a Sustained Release Glatiramer Acetate Depot
Mapi Pharma Ltd. has been granted a U.S. patent for its long-acting depot injectable solution, GA Depot, for the treatment of primary or secondary progressive multiple sclerosis (PPMS or SPMS). The company is currently in the final stages of a Phase III clinical study for the treatment of relapsing forms of multiple sclerosis (RMS) and is also evaluating GA Depot for the treatment of primary progressive multiple sclerosis (PPMS) in a Phase II study. Mapi Pharma is seeking a partner to support the Phase III development and co-marketing of GA Depot for PPMS. The company will present clinical data on GA Depot at the American Academy of Neurology annual meeting.
PartnersInvestment
growth-positive
Mapi Pharma Signs Agreement with Gaelan Medical Trade LLC to Exclusively Market and Distribute Mapi Products in UAE
Mapi Pharma has entered new Middle Eastern markets with a distribution agreement granting Gaelan Medical Trade LLC exclusive rights to market and distribute Mapi products in the UAE. The partnership is a result of the Abraham Accords Peace Agreement between Israel and the UAE. Gaelan Medical, a part of the Ghassan Aboud Group, has extensive knowledge and experience in specialty generic products and a strong reach into major clinical institutions in the UAE. Mapi Pharma sees this partnership as an opportunity to supply high-quality products to new markets and strengthen ties between the countries in the healthcare sector.
Partners
growth-positive
Mapi Pharma Provides Enrollment Update in Phase III GA Depot Clinical Trial
Mapi Pharma announced that patient enrollment has surpassed 60% in the ongoing Phase III trial for its GA Depot (glatiramer acetate) product for treating multiple sclerosis. The trial is expanded to Israel, with the first clinical site at Tel Aviv Medical Center. Over 60% of the study subjects have been recruited, bringing the total number of patients dosed to over 600. The rights to GA Depot have been exclusively licensed to Viatris (formerly Mylan) to commercialize the product. Viatris commented on the progress of the trial and its plans to bring GA Depot to market. Mapi Pharma is a clinical stage biopharmaceutical company focused on the development of high-value life cycle management products and generic drugs.
Customers
growth-positive
Mapi Pharma in talks to produce Covid-19 vaccine in Israel
Mapi Pharma is in talks with a leading pharmaceutical company to produce a COVID-19 vaccine at its manufacturing facility in Jerusalem. The company aims to dedicate capacity for vaccine production for Israel, the EU, and international markets. This move is expected to help the Israeli government secure a larger amount of the vaccine. Mapi Pharma has state-of-the-art production facilities and is expanding its fill and finish facility to support the global effort in vaccine distribution. The companys lead product is a slow-release generic version of the multiple sclerosis treatment Copaxone. Mapi Pharma is actively communicating with major vaccine developers and governments to collaborate in the fight against COVID-19.
PartnersExpand
growth-positive
Mapi Pharma Presents Glatiramer Acetate Depot (GA Depot) Results at the 8th Joint ACTRIMS-ECTRIMS Meeting MSVirtual2020
Mapi Pharma announced that it will present data from its ongoing Phase II studies of GA Depot for the treatment of relapsing remitting multiple sclerosis (RRMS) and primary progressive multiple sclerosis (PPMS). The data shows that 90% of RRMS patients on GA Depot demonstrated no evidence of disease activity (NEDA) at four years, and GA Depot may also have potential as a PPMS treatment. The study provided evidence of the product’s long-term safety, tolerability, and efficacy in RRMS patients. Mapi Pharma has now dosed more than 300 patients in its ongoing Phase 3 study for RRMS, which is designed to support a New Drug Application (NDA). Mapi Pharma is collaborating with Mylan to bring GA Depot to market and expand access for patients.
CustomersPartners
growth-positive
Mylan invests $20m more in Mapi's monthly Copaxone
Mapi Pharma has received an additional $20 million investment from Mylan to support the continued Phase III clinical study progress of Glatiramer Acetate (GA) Depot, a proposed once-monthly injection for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS). Mapi Pharma aims to manufacture a delayed release version of Copaxone that can be taken once a month instead of three times a week. The Phase III study enrollment has been progressing well, and Mapi Pharma is building capacity at its facility to supply GA-Depot for commercial sale pending FDA approval. Mylan expressed confidence in the development program and the progress of the long-acting GA product.
Investment
growth-positive
Mapi Announces First Patient Enrolled in the Phase III Clinical Trial of GA Depot for Relapsing Multiple Sclerosis (RMS)
Mapi Pharma has enrolled the first patient in its Phase III study with GA Depot for relapsing forms of multiple sclerosis (RMS). GA Depot is a long-acting depot formulation injection of glatiramer acetate, which is expected to provide improved treatment for MS patients. The Phase II trial showed promising results, with 84.6% of patients achieving No Evidence of Disease Activity (NEDA-3). Mapi Pharma aims to develop and launch GA Depot as the best drug for MS, combining the safety of Copaxone with better efficacy and improved compliance. Mylan N.V. is partnering with Mapi Pharma to bring GA Depot to market.
CustomersPartners
growth-positive
Mapi Pharma to launch generic Copaxone next year
Mapi Pharma has leased a Jerusalem plant to manufacture delayed release Copaxone. The company has signed a deal with Mylan for this product, which is due to enter a Phase III trial. Mapi Pharma has raised $130 million to date, with Mylan being the leading investor.
PartnersInvestment
growth-positive
Copaxone-Competitor Developer Mapi Pharma Gets Funding for Jerusalem Plant
Mapi Pharma has received a grant of NIS 9.2 million from the Israeli government to build a production plant in Jerusalem. The plant, with an overall investment of NIS 46 million, will manufacture a multiple sclerosis drug for export. Mapi Pharma develops more efficient versions of existing successful drugs and has a partnership with Mylan NV for its flag product GA Depot, a long-acting equivalent of Copaxone. Mylan has launched a generic version of Copaxone, cutting into Tevas profits. Mapi Pharma plans to enter phase 3 clinical trials for its injection later this year. The company has also received a $10 million investment from Zhejiang Jingxin Pharmaceutical Co. Ltd.
InvestmentPartners
growth-positive
Mapi Pharma to Host Key Opinion Leader Meeting on Long Acting Glatiramer Acetate (GA Depot) for Primary Progressive Multiple Sclerosis and New Treatments for MS
Mapi Pharma Ltd. will host a Key Opinion Leader (KOL) luncheon to discuss its GA Depot, a long-acting depot formulation of glatiramer acetate for Multiple Sclerosis (MS). The luncheon will also cover new horizon treatments for MS. The companys CEO and Chairman will provide an overview of the companys positioning in the MS market, recent clinical data, and pipeline developments. The event is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals. Mapi Pharma is a clinical stage pharmaceutical company focused on the development of high-value life cycle management products and generic drugs. They have partnered with Mylan N.V. for the commercialization of the GA Depot injection product.
PartnersCustomers
growth-positive
Mapi Pharma Ltd. Announces Closing of $10 Million Investment by Zhejiang Jingxin Pharmaceutical Co.
Mapi Pharma has completed an equity investment of $10 million by Zhejiang Jingxin Pharmaceutical Co., Ltd., a Chinese pharmaceutical company. The funds raised will support Mapis future development and enable the expansion of the companys pipeline. Mapi has developed a cooperation model with Chinese companies, leveraging both parties strengths. Jingxins investment entails a product development agreement, and Mapi will develop a product exclusively for Jingxin. Mapi will hold the global IP and marketing rights.
Investment
growth-positive
Mylan buys rights to Mapi Pharma's slow release Copaxone
Mylan N.V. and Mapi Pharma are partnering on the development and commercialization of GA Depot, a long-acting Glatiramer Acetate product for the treatment of multiple sclerosis. Mylan is acquiring global marketing rights to the product. The once-monthly injection would provide a more convenient treatment option for patients with relapsing-remitting multiple sclerosis. Mapi Pharma has strong research capabilities in long-acting depot injections, while Mylan brings regulatory expertise and a global commercial platform. The partnership is subject to approval by the Israeli Innovation Authority. Mapi Pharma had planned an IPO in 2015 but later withdrew.
Partners
Israeli drug developer Mapi-Pharma officially withdraws $50 million US IPO
growth-positive
Mapi Pharma Closes in on IPO
Mapi Pharma has registered with the SEC for its IPO, with an expected pricing range of $15 to $17 per share. The company is a clinical stage pharmaceutical company focused on developing improved extended-release versions of existing drugs. Their lead product candidate is Glatiramer Acetate Depot for the treatment of multiple sclerosis. The net proceeds from the IPO will be used to expand the clinical development program and for general corporate purposes.
Public Trading
growth-positive
Mapi Pharma sets terms for $50m Nasdaq IPO
Israeli drug developer Mapi Pharma is planning a $50 million Nasdaq IPO at a company value of $194 million. The company is developing extended-release formulations of existing drugs, including Tevas multiple sclerosis treatment Copaxone. Mapi Pharma previously filed for an IPO in 2014 and 2015 but postponed the offering. Despite difficult market conditions, the company is now moving forward with the IPO.
Public Trading
growth-positive
Mapi Pharma files for third Nasdaq IPO attempt
Biomedical company Mapi Pharma is making its third attempt at an IPO on Nasdaq. The company is developing a delayed release version of Tevas Copaxone and wants to raise $57.5 million. Mapi Pharma recently announced a $10 million financing round. Its delayed release Copaxone is in a Phase II clinical trial. The company is also developing versions of Pfizers Lyrica drug and Johnson & Johnsons Risperdal Consta.
Public Trading
growth-positive
MS treatment developer Mapi Pharma raises $10m
Mapi Pharma, a company developing a version of multiple sclerosis drug Copaxone, has raised $10 million in funding. The funding round was led by Shavit Capital Fund. Mapi Pharmas version of Copaxone is administered once a month, compared to the current version by Teva Pharmaceutical Industries, which is administered several times a week. The company plans to use the funding to complete its Phase II trial and begin a Phase III trial. If successful, the product could reach the market in 2019. Mapi Pharma has also signed joint drug development and marketing agreements with major pharmaceutical companies, and is likely to see initial revenue in 2017. The company has not disclosed the names of the companies it has partnered with. Mapi Pharma attempted a Nasdaq IPO in the past but was unsuccessful.
InvestmentPublic Trading
growth-positive
Mapi Pharma again considers Nasdaq IPO
Mapi Pharma, a company that develops delayed release drugs, is considering raising $10-30 million through an IPO or private placement in the first quarter of 2015. The company is currently conducting a trial on the effectiveness of its delayed release version of Teva Pharmaceutical Industries Ltd.s Copaxone. Mapi attempted an IPO in 2014 but was unable to raise the desired amount. The company has signed three agreements with other companies for joint development of delayed release generic drugs, with the first product expected to reach the market in 2017. Mapi believes it is well positioned for an offering in 2018, as the Copaxone market is projected to be worth over $1 billion.
Investment
