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Sunday, January 6, 2019

Samsung Bioepis Partners with 3SBio to Expand Biosimilar Business into China


  • Samsung Bioepis’ rapidly growing biosimilar business to expand into Chinese market through partnership with 3SBio, bringing together Samsung Bioepis’ proven development platform with 3SBio’s strong commercialization platform
  • Partnership with 3SBio follows successful biosimilar commercialization partnerships in the European and US markets with Biogen and Merck, also known as MSD outside of the United States and Canada.
Samsung Bioepis Co., Ltd. today announced that its rapidly growing biosimilar business will expand into mainland China through a licensing agreement with 3SBio Inc. The agreement covers multiple biosimilar candidates from Samsung Bioepis, including SB8, a biosimilar candidate referencing AVASTIN® 1 (bevacizumab).
Under the agreement, Samsung Bioepis and 3SBio will collaborate across a number of areas, including clinical development, regulatory registration and commercialization in China. Samsung Bioepis will receive upfront and milestone payments, as well as royalties on sales. Additional financial details were not disclosed.
“We are very excited to expand our biosimilar business into China, where we hope to see our biosimilars play an important role in widening patient access to high-quality healthcare. We are confident we will achieve this goal through our partnership with 3SBio, which brings together Samsung Bioepis’ proven development platform with 3SBio’s strong commercialization platform,” said Christopher Hansung Ko, President and Chief Executive Officer, Samsung Bioepis. “At Samsung Bioepis, we will continue to demonstrate our enduring commitment to biosimilars by further strengthening our pipeline and widening their availability for patients and healthcare systems across the world.”
Established in February 2012, Samsung Bioepis currently has four biosimilars approved and marketed across Europe, which include the anti-TNF trio of BENEPALI™ (etanercept), FLIXABI™ (infliximab) and IMRALDI™ (adalimumab), as well as an oncologic biosimilar, ONTRUZANT® (trastuzumab). In the United States, the company has one biosimilar approved and marketed, RENFLEXIS® (infliximab), with both SB5 (adalimumab) and SB3 (trastuzumab) biosimilar candidates currently under regulatory review.
In total, over 100,000 patients across the world are currently under treatment with Samsung Bioepis’ biosimilars, with over 6 million doses administered.
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Gates backs Schrödinger’s $85M for computational drug discovery platform


Computational chemistry in drug discovery is nothing new — the idea that more precise molecular design can speed up and optimize R&D is always appealing to an industry desperate for a higher return of investment — but it might just be gaining steam again. Just look at the list of investors in Schrödinger’s latest round.

Deerfield Management, Baron, Qiming Venture Partners, and GV (formerly Google Ventures) all chipped into the $85 million Series E, co-led by two of Schrödinger’s big believers: Bill Gates, who’s supported previous rounds; and WuXi AppTec, which launched a drug discovery joint venture with the company just weeks ago.
A storied shop that’s been selling software to biopharma companies since 1990, Schrödinger has been wading deeper into therapeutics in the past decade. With a suite of molecular simulation tools, it has helped launch splashy biotechs like Nimbus Therapeutics and Morphic Therapeutic and convinced Takeda last year to take a try on its in silico platform for $170 million per program in neurodegenerative diseases and schizophrenia. That followed a similar partnership with Sanofi, which wanted to look into autoimmune diseases and oncology.
“The investment will allow us to continue to advance our technology platform to help our users accelerate their work in life sciences and materials design,” said Schrödinger CEO Ramy Farid. “We are also excited to expand our drug discovery efforts, leveraging our platform to grow our pipeline and discover new medicines more efficiently.”
The company didn’t specify what area its discovery programs will focus on. Its worldwide team of around 400 currently covers an extensive range of therapeutic areas, from antifungal and fibrosis to metabolic diseases and type 2 diabetes.
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Galapagos initiates NOVESA Phase 2a trial in patients with systemic sclerosis


Galapagos NV expands its clinical study program with GLPG1690 in systemic sclerosis, following the recent start of the ISABELA Phase 3 program with ‘1690 in IPF. NOVESA is a double-blind, placebo-controlled Phase 2a trial evaluating the efficacy, safety and PK/PD of ‘1690 in patients with systemic sclerosis. NOVESA is planned to recruit 30 patients with diffuse cutaneous SSc, an autoimmune disease involving multiorgan fibrosis, which has one of the highest mortality rates among rheumatic diseases. One of the most visible manifestations is hardening of the skin. In diffuse cutaneous SSc, skin thickening affects several body areas, and patients have a higher risk of developing fibrosis of various internal organs, such as the lung. Currently, there are no approved drugs for this disease. SSc affects approximately 90,000 patients in the US and Europe, with a predominance of female patients. The primary endpoint of NOVESA is the modified Rodnan skin score at 24 weeks. mRRS measures the skin thickness as a surrogate measure of disease severity and mortality, with an increase in thickness associated with involvement of internal organs and increased mortality. Secondary objectives and exploratory endpoints include FVC, HRCT, quality of life as measured by QoL-Q, and CRISS, a SSc disease composite score.
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Syros announces strategic priorities, milestones ahead of JPMorgan conference


Syros Pharmaceuticals outlined its strategic priorities and expected upcoming milestones. The Company will review these priorities in a presentation at the 37th Annual JPMorgan Healthcare Conference on Thursday, January 10, 2019. The company expects to complete enrollment in mid-2019 in the ongoing Phase 2 study cohort evaluating the safety and efficacy of SY-1425 in combination with azacitidine in RARA and IRF8 biomarker-positive patients with newly diagnosed acute myeloid leukemia who are not suitable candidates for standard chemotherapy. Syros also expects to report updated clinical data in the second half of 2019 on SY-1425 in combination with azacitidine, and report initial clinical data in the fourth quarter of 2019 from the expansion portion of the ongoing Phase 1 trial, which is assessing SY-1365 as a single agent and in combination with standard-of-care therapies in multiple ovarian and breast cancer patient populations. Additionally, the company expects to complete IND-enabling studies to support initiation of a Phase 1 oncology trial in early 2020. Syros also announced that it has made a portfolio prioritization decision not to pursue further development of SY-1425 in combination with daratumumab beyond completion of the ongoing pilot cohort in the Phase 2 trial. Based on its current operating plans, Syros expects that its existing cash, cash equivalents and marketable securities will enable it to fund its anticipated operating expenses and capital expenditure requirements into 2020. Syros had approximately $113.2M in cash, cash equivalents and marketable securities as of September 30, 2018.
https://thefly.com/landingPageNews.php?id=2844141
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Gilead, Yuhan Corp announce collaboration, license agreement


Gilead Sciences and Yuhan Corporation announced that the companies have entered into a licensing and collaboration agreement to co-develop novel therapeutic candidates for the treatment of patients with advanced fibrosis due to nonalcoholic steatohepatitis. Under the agreement, Gilead will acquire global rights to develop and commercialize novel small molecules against two undisclosed targets in all countries, with the exception of the Republic of Korea where Yuhan will retain certain commercialization rights. Yuhan and Gilead will jointly conduct preclinical research, and Gilead will be responsible for global clinical development. Gilead will also be responsible for commercialization worldwide, outside of Yuhan’s rights in the Republic of Korea. In connection with this agreement, Yuhan will receive an upfront payment of $15M and is eligible to receive up to an additional $770M in potential milestone payments upon achievement of certain development and commercial milestones, as well as royalties on future net sales. This agreement builds on the companies’ existing commercial collaboration to support the promotion of Gilead’s medicines in the Republic of Korea.
https://thefly.com/landingPageNews.php?id=2844143
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Biotech week ahead: Jan 7


The new year kick started with a bumper deal in the pharma space, with Bristol-Myers Squibb Co BMY 3.95% agreeing to buy Celgene Corporation CELG 5.58%.
Can the deal infuse some momentum into the space following a down year? Here are some key catalysts of the upcoming week that could provide an answer.

Conferences

  • 6th Annual Dermatology Summit – Jan. 6, in San Francisco, California
  • Biotech Showcase – Jan. 7-9, in San Francisco
  • 37th Annual JPMorgan Healthcare Conference – Jan.7-10, in San Francisco
  • 11th Annual T-cell Lymphoma Forum – Jan. 10-12, in La Jolla, California

Clinical Trials

Axsome Therapeutics Inc AXSM 0.75% is due to release Phase 2 data for AXS-05 which is being evaluated in a study dubbed ASCEND for treating major depressive disorder. The release is scheduled for early January.
Miragen Therapeutics Inc MGEN 21.07% will present updated Phase 1 data for Cobomarsen at the 11th annual T-cell Lymphoma Forum at 6 pm PT Jan. 11. Cobomarsen is being evaluated for a variety of blood cancer types such as chronic lymphocytic leukemia, diffuse large B-cell lymphoma and cutaneous T-cell lymphoma.

IPO Quiet Period Expiry

Hong Kong-based pharma company Aptorum Group Ltd APM 0.19% offered 1.9 million shares in an IPO in December, with the offering priced at $15.80. The shares were listed on the Nasdaq Dec. 18 and closed the debut session at $14.35.
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New mechanism to ‘activate’ the immune system against cancer


A new mechanism for activating the immune system against cancer cells allows immune cells to detect and destroy cancer cells better than before, according to a study published this week in the journal Nature.
The study was led by Prof. Nick Haining, of Harvard Medical School, and co-authored by Prof. Erez Levanon, doctoral student Ilana Buchumansky, of the Mina and Everard Goodman Faculty of Life Sciences at Bar-Ilan University, and an international team.
The focus of the study is a mechanism that routinely serves the cell by marking human virus-like genes in order to avoid identifying them as viruses. Now, Prof. Levanon, together with the Harvard team, has discovered that when inhibiting this mechanism, the immune system can be harnessed to fight cancer cells in a particularly efficient manner, and most effectively in lung cancer and melanoma.
“We found that if the mechanism is blocked, the immune system is much more sensitive. When the mechanism is deactivated, the immune system becomes much more aggressive against the ,” said Levanon.
In recent years, a new generation of cancer drugs has been developed which blocks proteins that inhibit immune activity against malignant tumors. These drugs have shown remarkable success in several tumor types. This year’s Nobel Prize in Medicine was awarded to James Allison and Tasuku Honjo, who discovered the key genes of this mechanism. Despite this achievement, the current generation of drugs helps only a small number of patients, while most of the drugs fail to cause the immune system to attack the tumor. It is hoped that the new discovery will allow enhanced activity of the  to attack . A number of companies have already begun research to screen for drugs that will operate on the basis of this discovery.
 Explore further: Cancer under pressure: Visualizing the activity of the immune system on tumor development
More information: Jeffrey J. Ishizuka et al, Loss of ADAR1 in tumours overcomes resistance to immune checkpoint blockade, Nature (2018). DOI: 10.1038/s41586-018-0768-9
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