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Thursday, January 9, 2020

Lilly launches new robotic drug discovery laboratory

Eli Lilly (LLY +1.7%), in collaboration with lab automation developer Strateos, announces a new San Diego-based robotic laboratory, called the Lilly Life Sciences Studio Lab, designed to accelerate the drug discovery process.
The 11,500 sq. ft. studio lab, operated by Strateos, physically and virtually integrates several areas of the drug discovery process—including design, synthesis, purification, analysis, sample management, and hypothesis testing—into a fully automated platform.
Strateos will use the lab’s robotic cloud platform to enable access of this remote-controlled lab to other drug discovery companies and research scientists via its secure cloud-based platform.

Amarin says no change to Vascepa status at UnitedHealth

Amarin (NASDAQ:AMRN) investor relations says there’s no indication of a change to UnitedHealthcare’s 2020 coverages of Vascepa vs. 2019.
A story yesterday based on this document said the drug had been moved to “non-preferred” status.

Kaleido Bio teams up with J&J to identify microbiome metabolic candidates

Kaleido Biosciences (KLDO -4.4%) will collaborate with Johnson & Johnson (JNJ +0.2%) unit Janssen Biotech to explore the potential of Kaleido’s Microbiome Metabolic Therapies (MMT) to prevent childhood allergies and other atopic immune and metabolic conditions via driving specific features of the microbiome that support the maturation of the infant immune system.
A primary focus will be leveraging Kaleido’s proprietary ex vivo screening platform to identify promising MMT candidates.
Financial terms are not disclosed.

Regenxbio updates on key programs; shares up

REGENXBIO (RGNX +5.5%announces key milestones/events for 2020:
RGX-314: Initiate pivotal program of subretinal delivery in wet AMD in H2. Start Phase 2 studies of suprachoroidal delivery in wet AMD in H1. File IND in H1 for suprachoroidal delivery in diabetic retinopathy followed by the launch of a Phase 2 study in H2.
RGX-121: Release additional interim data from Phase 1/2 study in MPS II this quarter. Report interim data from cohort 2 mid-year. H2: accelerated approval pathway possible, contingent on analysis interim data.
RGX-501: Release interim data on LDL-C levels from Phase 1/2 study in HoFH in H1.
Hereditary angioedema: Select lead candidate in H1.
RGX-181: IND to be filed in H2 for CLN2 disease.
Zolgensma: Regulatory decision in Europe expected this quarter and in Japan in H1. Novartis is the licensee ($175M in sales through Q3 2019).

Pharmacy chains sue Ohio doctors over role in opioid epidemic

Retail pharmacy operators Walgreens (WBA -1.5%), CVS Health (CVS +0.2%), Walmart (WMT +0.4%) and Rite Aid (RAD -2.7%) have filed litigation against over-prescribing doctors in Ohio who operated “pill mills” responsible for up to 60% of the opioids dispensed in the area. The trial is set to begin on October 13.

Bayer, Evotec In Agreement to Develop PCOS Treatments

Bayer AG said Thursday that it will partner with Evotec SE to develop therapies for polycystic ovary syndrome, a common hormone disorder that affects women.
Under the terms of the five-year collaboration agreement, German drug discovery company Evotec is eligible for 16.5 million euros ($18.4 million) in research payments as well as more than EUR330 million in milestone payments, plus royalties generated from sales of treatments that enter the market.
Bayer and Evotec will collaborate in the early development stage, while Bayer will be responsible for clinical trials and commercialization, it said.
The two companies have previously signed collaboration deals to develop drugs targeting endometriosis and kidney disease.

FARE, J&J Fund Research Grant to Discover Food Allergy Biomarkers

Food allergies are fairly common, but for millions of people they are life-threatening. While there are treatments in development for allergies to nuts, milk and others, Johnson & Johnson is launching a program focused on identifying novel food allergy biomarkers.
On Tuesday, Janssen, J&J’s pharma division, received a $250,000 grant from Food Allergy Research & Education (FARE) to help discover and validate those biomarkers in order to boost research into food allergies and potentially develop therapies for them. Johnson & Johnson matched that grant with another $250,000. In a statement to BioSpace, FARE said the biomarker research project, which will be conducted at Janssen’s World Without Disease Accelerator, “has the potential to make a real and significant impact for the 32 million Americans living with food allergies.”
Currently, there are limited treatment options for most people with food allergies. They, and their loved ones, must typically be on guard about what foods are around them and, many walk around with epinephrine auto-injectors and antihistamines in case of accidental exposure, which can lead to anaphylactic shock or, in the worst cases, death. According to recent FARE-supported research, medical claims with diagnoses of life-threatening anaphylactic food reactions rose nearly 400% nationwide between 2007 and 2016. Peanut allergy is the most common food allergy in children and that number has been rising. From 2010 to 2017 the number has increased 21 and almost 2.5% of children in the U.S. are thought to have a peanut allergy, according to the American College of Allergy, Asthma, and Immunology.
Those rising numbers are what makes the biomarker research so critical. It has the potential to change the lives of those millions of Americans, FARE said. Childhood-onset food allergy, a complex disease involving multiple body systems, still requires much more research to fully understand its root causes. Such research will accelerate innovation in food allergy treatment, whether by prevention to stop disease onset, interception to arrest disease development, or with a cure to eliminate food allergy completely and restore health, the organization added. FARE said it will launch a formal request for applications to the Biomarker Research Grant in early 2020.
Janssen’s World Without a Disease Accelerator is an R&D organization that is focused on building collaborative teams to study diseases and point toward an interception of disease, meaning they want to discover ways to arrest the disease before it leads to illness. The research can also lead to better treatment options or a potential cure. The accelerator is focused on areas that include microbiome, immunosciences, predictive analytics and behavioral science.
Lisa Gable, chief executive officer of Virginia-based FARE, said the $500,000 grant to J&J supports the organization’s goal of gaining a better understanding of food allergies. Also though, the grant can help lead to the development of promising new treatments and, hopefully, a potential cure, she said.
“We are proud to work with Janssen on this initiative and look forward to our collaborative effort working towards changing the face of food allergy research,” Gable said in a statement.