BioIndiana Hotbed: Home to a Thriving Biopharma Industry
The state of Indiana may be generally known for its limestone quarries, corn, soybeans, wide-open prairies and as the birthplace of famed basketball legend Larry Bird, but it’s also home to a thriving biotech and pharmaceutical industry.
Part of the region known as BioMidwest, BioIndiana is home to approximately 1,700 life sciences companies including biopharmaceutical companies, agricultural science companies, device and diagnostic companies. Combined, these companies and institutions have a $78 billion economic impact, according to BioCrossroads, which serves as a catalyst to create life sciences partnerships in Indiana’s life sciences industry.
Highlights of BioIndiana:
When it comes to Indiana, the first company that probably comes to mind is Indianapolis-based pharma giant Eli Lilly. The company is certainly a stalwart of innovation in the state as it continues to develop treatments for a variety of diseases such as cancer and diabetes.
Recently, the company announced strong clinical trial results for its cyclin-dependent kinase inhibitor Verzenio. At the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Eli Lilly announced Verzenio plus fulvestrant significantly extended life to a median of 46.7 months vs. 37.3 months compared to fulvestrant alone. Data from the MONARCH 2 trial showed statistically significant results for women whose disease progressed following endocrine therapy, the company announced during its presentation. Overall survival results were consistent across subgroups, including in women with poor prognostic factors -- whose cancer quickly returned or spread to their organs, such as liver or lungs, the company added.
Also in September, the company showcased positive data for a drug it gained through its $8 billion acquisition of Loxo Oncology earlier this year. One of the assets, LOXO-292, hit the mark as a monotherapy for the treatment of RET fusion-positive non-small cell lung cancer in a Phase I/II trial.
But BioIndiana isn’t measured by Eli Lilly alone. Across the Hoosier State pharmaceutical companies have been flexing their muscles. U.K.-based Acacia Pharma Group, which has its U.S. footprint in Indianapolis, recently announced that the U.S. Food and Drug Administration has given it a PDUFA date of Feb. 26, 2020 for potential approval of Barhemsys (amisulpride injection), a treatment for post-operative nausea and vomiting. That’s a significant step forward for the company as it reeled from a Complete Response Letter for Barhemsys earlier this year following the discovery of continuing deficiencies at the contract manufacturer of amisulpride, the active pharmaceutical ingredient used in the Acacia medication. The company resubmitted its New Drug Application to the FDA with a new supplier of amisulpride who has successfully undergone regular inspections by regulatory authorities.
The Regenstrief Institute is also moving forward with plans to test the feasibility and usability of a revised version of the Brain CareNotes mobile application. Daniel Bateman, a research scientist with the Indianapolis-based institute, received a federal grant to test the technology in hopes of improving care for people with Alzheimer’s disease and dementia. Bateman, a geriatric psychiatrist, believes the app could help ease some of the problems associated with the behavioral and psychological symptoms associated with the disease. Approximately 97% of patients with dementia experience some of these symptoms, which can include depression, anxiety, hallucinations, agitation, apathy among others. The BrainCare Notes app, which was designed by the Regenstrief Institute, will have patients fill out a symptom questionnaire after being prompted by the app. If the answers reach a designated threshold of concern, the patient’s care providers will be notified and will follow up through a phone call, a message, or other form of communication, the institute said. Bateman’s study will be conducted over a five-year period.
Research conducted at Indiana University-Purdue University Indianapolis (IUPUI) is also showing promise in BioIndiana. In August, a research team from the college is exploring a potential treatment that could be the “gold standard of care” in treating hydrocephalus, known more commonly as "water on the brain.” Hydrocephalus, a buildup of cerebrospinal fluid, can occur for a number of reasons and can lead to developmental delay, neurological decline, blindness, impaired motor function, dementia or even death. The team from IUPUI is conducting preclinical studies using a blocker of an electrolyte channel called TRPV4 in hydrocephalic rats and mice. So far, the results are promising and the research team is hoping a pharmaceutical company will come along to continue the development of the asset.
West Lafayette, Indiana-based OnTarget Laboratories is anticipating top-line data from its Phase II trial for OTL38 in the detection of lung cancer nodules in lung cancer patients during surgery in early 2020. OTL38 is an imaging agent consisting of a folate receptor targeting ligand linked to a highly fluorescent near-infrared dye. OTL38 targets folate receptors overexpressed in multiple cancers.
In August, Warsaw, Indiana-based Zimmer Biomet received approval from the FDA for The Tether, a treatment of scoliosis, which provides a fusion-less alternative for young patients requiring surgery. According to the company, Zimmer Biomet’s Tether uses a strong, flexible cord, as opposed to metal rods, which “pull on the outside of a scoliosis curve to initially straighten the spine, while the inside of the curve is left free to grow.”
These are only a smattering of the innovations taking place in BioIndiana. BioSpace will keep you up to date with data shared by these companies and organizations, as well as job opportunities in the region.