Schrodinger announced receipt of a milestone payment from Sanofi to mark the advancement into the clinic of an autoimmune therapy discovered as part of a multi-year, multi-target collaboration between the two companies. Under the terms of the collaboration, Schrodinger provides advanced molecular simulation and computational design expertise to Sanofi across multiple stages of drug discovery, from target analysis and lead optimization to identification of a development candidate. The companies are currently advancing programs in oncology and autoimmune disease.
Monday, April 8, 2019
Medtronic: study shows TDD is associated with lower cost for cancer patients
Medtronic announced results of a study published in JAMA Network Open that demonstrates a reduction in health care utilization and cost for cancer pain patients using targeted drug delivery, or TDD and conventional medical management, or CMM, vs. CMM alone. The study found cost savings to payors, with fewer inpatient visits, shorter inpatient length of stay and fewer emergency department, or ED, visits for the TDD and CMM group. Over 12 months, TDD therapy was associated with a significant mean overall cost savings of $63,498 and fewer oral opioid prescriptions per patient. TDD, delivered via the Medtronic SynchroMed II infusion system, is an alternative to oral opioids for patients and provides pain relief at a fraction of the oral dose with fewer side effects and may help reduce the use of oral opioids. The paper reports the results of a retrospective propensity-score matched analysis conducted using a large U.S. claims database comparing mean total commercial payer costs and health care utilization at two, six, and 12 months. Researchers matched commercial insurance beneficiaries with patients with severe uncontrolled cancer pain receiving TDD and CMM or CMM alone. Participants were matched on age, sex, cancer type, comorbidity score and pre-enrollment characteristics. After matching, each group included 268 patients. The study showed that TDD and CMM is a cost-saving therapy to treat cancer pain, and based on these findings, increased use of TDD may have the potential to reduce future health care cost and utilization. As cancer rates continue increasing with the aging population, the authors concluded that considering more patients with significant cancer-related pain for TDD may result in substantial cost savings alongside improved quality of life.
Reveal Biosciences Gets Intel’s Backing on ‘AI-Powered’ Pathology
A 25-person startup developing advanced computing tools to speed up pathology work has raised its first institutional financing from a group of investors led by Intel Capital, the corporate investment arm of the chipmaker.
The San Diego-based company, Reveal Biosciences, is among 14 early-stage companies with business plans that include artificial intelligence, a catchall term for a wide range of “intelligent” computer programs, that the tech giant recently selected to back.
Intel (NASDAQ: INTC) said it invested a total of $117 million in the group of companies as part of a new strategy to make larger, “more strategic” investments in the startups it adds to its portfolio, but didn’t say how much it invested in each. The companies receiving funding were announced at Intel’s annual Global Summit, held this year in Phoenix, AZ.
Reveal isn’t disclosing the amount it raised either. GNI Group, a pharmaceutical company based in Japan, and PP Capital, an Austrian investment company, also invested in the round, CEO Claire Weston said.
Weston, who started Reveal in late 2012, said the Series A round will fund further development of its AI-powered pathology software, called ImageDx, moving it closer toward use in clinical settings. The software, which analyzes images of tissue samples, is intended to provide pathologists with data that can help them characterize and detect disease with greater speed and accuracy, with the subsequent goals of improving both drug development and patient care.
The company to date has been funded by revenue from laboratory services conducted for pharmaceutical and biotech companies. It was one of two healthcare companies included in the latest batch of startups in which Intel Capital announced it would invest.
“These companies are shifting the way we think about artificial intelligence, communications, manufacturing and healthcare—areas that will become increasingly essential in coming years as the linchpins of a smarter, more connected society,” said Wendell Brooks, Intel senior vice president and president of Intel Capital, in a statement.
Under the terms of the Reveal deal, Intel senior director Ranjeet Alexis, who led the investment, will join the company’s board of directors.
Since 1991, Intel Capital has invested about $12 billion in more than 1,500 companies, including big names in the tech world such as Broadcom (NASDAQ: AVGO), Red Hat (NYSE: RHT), and VMware (NYSE: VMW). The division puts $300 million to $500 million annually into emerging companies, according to Intel.
GSK adds to COPD pipeline as Exscientia deal bears fruit
AI drug research firm Exscientia has delivered the first candidate molecule to its partner GlaxoSmithKline following an R&D tie-up signed in 2017.
Under the deal Exscientia will develop small molecule drugs for up to 10 disease targets nominated by GSK, and is worth up to £33 million if all these milestones are met.
The Oxford biotech gave no details about how much it got paid for submitting this first active lead molecule for development by GSK, but said it is a highly potent in vivo molecule targeting a novel pathway for chronic obstructive pulmonary disease (COPD).
Developing new respiratory disease drugs is a priority for GSK, which is under pressure after generics of its ageing blockbuster COPD and asthma inhaler Advair have finally been launched in the US market.
Mylan in February launched its Advair generic at a 70% discount to Advair, and although GSK has a new generation of respiratory drugs on the market, none of them have gained as much traction as Advair.
The company saw sales peak at more than $8 billion in 2013 and still managed to bring in around $3 billion in 2018 despite competition from newly approved competitors.
The molecule delivered by Exscientia is light years away from the market, but demonstrates that GSK is focused on trying to get ahead of its competitors in this tough market by finding new ways to treat COPD.
The molecule was developed through the application of Exscientia’s Centaur Chemist AI-driven automated drug discovery platform.
Exscientia said the approach has delivered a lead molecule with fewer compounds synthesised in comparison to conventional industry benchmarks. The in vivo lead was identified de novo from 85 project compounds and was synthesised and tested within five iterative design and screening cycles.
The company uses AI algorithms that learn from a bank of biological and chemistry data resources to design novel molecules, when given exacting criteria by clients.
Exscientia last month signed a $25m cancer drug development deal with Celgene, and is also working with clients such as Roche, Sanofi, and Evotec.
Celltrion Partners with Canada’s iProgen for Biotherapeutics
- Celltrion signs a partnership deal with the Canada-based iProgen Biotech Inc. to bolster its pipeline for novel biotherapeutics.
- The deal aims to co-develop up to 4 ADCs including a novel ADC (Antibody-drug conjugate) that targets breast cancers expressing low levels of HER2 using iProgen’s proprietary antibody drug delivery technology.
On April 8, Celltrion (KRX:068270) and the Canada-based iProgen Biotech Inc. announced to agree to partner for the development of novel ADCs against validated antibody targets, including HER21 and CD202.
The terms of the partnership agreement include: (1) Celltrion manufactures and supplies four recombinant antibodies to iProgen, among which two are HER2 and CD20 targeting, selected by Celltrion, and two additional targets to be selected by iProgen, (2) Celltrion provides supports for the Chemistry, Manufacturing, and Control (CMC) activities for the IND application and the Phase-1 clinical trial, (3) iProgen conducts the Phase-1 clinical trial using these drug candidates, and (4) upon completion of Phase 1, Celltrion has the right of first negotiation on these drug candidates for global in-licensing.
The antibodies encompassing iProgen’s proprietary delivery technology, Antibody Delivery Enhancing Domain (ADED) is expected to increase anti-tumor efficacy by enhancing the drug delivery and internalization to cancer cells. The ADED technology is applied to anti-HER2 ADCs to potentially treat not only the breast cancer patients with high levels of HER2 expression more effectively but also those with low levels with no approved targeted therapies. In addition to HER2, other tumor antigens may be therapeutically targeted by ADCs that embody this technology.
Sun Pharma Launches Ready-to-Infuse Chemo Product in U.S.
INFUGEM™ (gemcitabine in sodium chloride injection) is the first and only chemotherapy product in a premixed, ready-to-infuse formulation
Use of ready-to-infuse bags eliminates steps in the complex chemotherapy preparation process, reducing exposure and mitigating inherent provider and patient safety risks
Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries and/or associate companies) today announced that INFUGEM™ (gemcitabine in sodium chloride injection), for intravenous use, is now commercially available in the U.S. INFUGEM, the first chemotherapy product that comes in a premixed, ready-to-infuse formulation, was approved by the U.S. Food and Drug Administration (FDA) in July 2018 in combination with other drugs for the treatment of breast, ovarian, non-small cell lung cancers, and as a single agent for the treatment of pancreatic cancer.
INFUGEM is an alcohol-free, clear, colorless, sterile solution of 10mg/mL gemcitabine in 0.9% sodium chloride that is supplied to pharmacists in ready-to-infuse bags as a Spike & Go™ package. It involves dose banding practice, whereby standardized doses of intravenous cytotoxic drugs are used for ranges (or “bands”) of doses calculated for individual patients. INFUGEM is the only available gemcitabine formulation that does not require reconstitution and syringe withdrawal prior to intravenous administration. Eliminating these steps reduces complexity and minimizes the inherent risks of hazardous drug exposure, contamination, and medication errors.
Sunday, April 7, 2019
Sanofi, Alnylam conclude research and option phase of 2014 rare disease alliance
Sanofi and Alnylam have agreed to conclude the research and option phase of the companies’ 2014 RNAi therapeutics alliance in rare genetic diseases. The material collaboration terms for patisiran, vutrisiran (ALN-TTRsc02) and fitusiran, as previously announced, will continue unchanged.
As part of this agreement, Alnylam will advance an additional investigational asset in an undisclosed rare genetic disease through the end of IND-enabling studies. Sanofi will be responsible for any potential further development or commercialization of such asset. If this product is approved, Alnylam will be eligible to receive tiered double-digit royalties on its global net sales.
“Our alliance with Alnylam has successfully brought one important medicine to patients with ATTR amyloidosis and it also has spawned a molecule that is in pivotal clinical trials for people with hemophilia,” said John Reed, Global Head of Research and Development at Sanofi. “As we wrap up this phase of our program with Alnylam, we remain committed to advancing therapies for patients with rare diseases and rare blood disorders.”
In addition, Alnylam and Sanofi have agreed to amend certain terms of the companies’ equity agreement, with Sanofi obtaining a release of its lock-up of Alnylam stock holdings, subject to certain trading restrictions, among other provisions.
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