On February 9, 2022 Global pharma major, Lupin Limited (Lupin) reported that it hasentered into a distribution agreement with Medis for Lupin’sorphan drug NaMuscla (mexiletine) (Press release, Lupin, FEB 9, 2022, View Source [SID1234607945]). Medis will commercialize NaMuscla for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders in Central and Eastern European countries.NaMuscla is the first and only licensed product for this indication .

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

NDM disorders are a group of rare, inherited neuromuscular disorders which is characterized by the inability to relax muscles following voluntary contraction. NaMuscla reduces myotonia symptoms in people with NDM, resulting in a significant improvement in quality of life and other functional and clinical outcomes for patients1. NaMuscla, which has been designated orphan drug status, received EU marketing authorization in December 20182.

Under the agreement announced today, Medis will initially focus on the commercialization of NaMuscla in the Central and East European countries, namely Croatia, Czech Republic, Hungary, Slovakia, and Slovenia in the first phase. Lupin will continue commercialization of NaMuscla in Germany, France, and the UK.

"The distribution agreement representsan important milestone for Lupin as we continue the roll out of NaMuscla across Europe. We know that collaborating with partners which are highly focused in their territories means patients receive medicines in the most efficient way," said Thierry Volle, President EMEA, Lupin.

"At Medis, we are very excited to partner with Lupin and are further committed to using our expertise in comprehensive commercialisation to provide new, innovative treatment options like NaMuscla that address patients’ unmet needs. For us, each patient counts," said Martina Perharič, CEO of Medis. "As a pioneer in full-service pharmaceutical distribution for the CEE region, we have gained extensive knowledge of the complex markets in the region. This allows us to launch NaMuscla quickly and effectively in selected countries and provide excellent support to our partner Lupin."

Today, around 1,000 people in Central and Eastern Europe living with NDM have limited access to a licensed treatment for myotonia that can reduce the daily burden of this disabling, lifelong symptom3-5. Limited access leads to inconsistent medication supply, administrative challenges, and associated financial burdens. Coupled with low awareness and limited clinical experience among healthcare professionals due to the rare nature of the disease, may result in significant harm to patients4.

Lupin has recruited the first study participants in a pediatric trial as part of the pediatric investigation plan for NaMuscla in children (NCT04624750) and a post-authorization study to address long-term safety and treatment effects on patient-reported outcomes in adults (NCT04616807).

Notes for Editors

About Myotonic Disorders and Non-Dystrophic Myotonias (NDM)

Myotonic disorders are a group of heterogeneous, inherited, neuromuscular disorders characterized by a shared symptom called myotonia. Myotonia can be described as an inability to relax a contraction of skeletal muscle which originates from a voluntary muscular contraction such as shaking someone’s hand and blinking, or everyday activities such as walking across a street and climbing stairs.

Non-dystrophic myotonias (NDM) are a sub-set of rare (prevalence of 1:100,0003), inherited, myotonic disorders which are caused by mutations within ion channels in the sarcolemma membrane of skeletal muscles. Non-dystrophic myotonias exhibit both sodium and chloride channelopathies which result in altered membrane excitability6. For patients with NDM, myotonia is the most prominent symptom and demonstrates different phenotypes in subgroups of NDM disorders, and can affect different parts of the body, such as legs, arms, or facial muscles, more severely6.

Myotonia in NDM patients has an onset in childhood and persists across their lifetime. Patients perceive that myotonia increases in severity over time, impacting daily life. Myotonia is described by patients in a variety of ways (stiffness, cramps, pain, difficulty releasing a fist, or difficulty swallowing or eating) which can contribute to substantial delays in diagnosis and treatment, leading to decreased patient quality-of-life and often significant disability4, 7.

About NaMuscla (mexiletine)

NaMuscla is the first and only antimyotonic agent licensed to treat symptomatic myotonia in adults with non-dystrophic myotonic disorders in Europe8. In randomized controlled trials, NaMuscla (167 to 500 mg/day) has been shown to significantly reduce myotonia compared to placebo, reducing skeletal muscle hyperexcitability through its use-dependent, voltage-gated, sodium channel blocking actions which are independent of the cause of channel function. This resulted in an improvement in patient quality-of-life and other functional outcomes, with gastro-intestinal discomfort reported as the most common adverse event, demonstrating NaMuscla to be safe and well tolerated1, 2, 8.

On February 9, 2022 Cardinal Health (NYSE: CAH) reported it will leverage the Kinaxis RapidResponse platform to increase medical product visibility and supply chain agility (Press release, Cardinal Health, FEB 9, 2022, View Source [SID1234607943]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Kinaxis will enhance Cardinal Health’s medical supply chain through concurrent planning and end-to-end network visibility and transparency while factoring in seasonality and pandemic planning; instantly balance demand and supply while accounting for capacity safeguards; and simulate product supply scenarios in seconds to create best-fit solutions for customers. The platform supports fast, confident decisions using advanced insights and analytics in real time.

Cardinal Health will focus initial implementation efforts of Kinaxis RapidResponse within the Cardinal Health at-Home Solutions business, the largest direct-to-home supplier of disposable medical supplies, with an expected completion date of Summer 2022. A full implementation of the RapidResponse platform across the Cardinal Health medical business is anticipated for completion by the end of calendar year 2023.

"Integrating Kinaxis RapidResponse allows us to view our entire supply chain in real time to proactively mitigate and minimize potential impacts to our customers – and ultimately, their patients," said Paul Rodio, SVP Global Planning at Cardinal Health. "Kinaxis is a key enabler to driving optimization in our end-to-end global planning process."

With the addition of RapidResponse, Cardinal Health will standardize medical planning within one platform, further improving overall planning, supplier management, risk management and inventory capabilities.

"Kinaxis RapidResponse is the world’s first and only concurrent planning platform," said John Sicard, Kinaxis CEO. "We’re excited to collaborate with Cardinal Health to bring this advanced planning to healthcare customers and increase accessibility to the products they need most."

On February 9, 2022 Mevion Medical Systems and Proton International reported the selection of the MEVION S250i Proton Therapy System with HYPERSCAN Pencil Beam Scanning (PBS) to equip the UT Health San Antonio Proton Therapy and Research Center (Press release, Mevion Medical Systems, FEB 9, 2022, View Source [SID1234607941]). It will be the first proton therapy system in San Antonio and South Texas to provide this advanced alternative to conventional radiation therapy for cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Proton therapy targets cancer cells more precisely than traditional x-ray photon therapy, and results in less damage to surrounding healthy tissue and sensitive organs such as the brain, heart, spine, and lungs. This provides a significant reduction in acute adverse events and hospitalization along with a decreased risk of secondary malignancies when compared to traditional x-ray photon therapy. It is the preferred modality for treating pediatric patients, who are particularly susceptible to the potential side effects of radiation therapy.

"Bringing the most advanced technology to serve our patients with the highest quality care is essential," said Mark Bonnen, MD, chief medical officer of the Mays Cancer Center. The MEVION S250i with HYPERSCAN has advanced the benefits of proton therapy by enabling faster and sharper delivery of therapeutic radiation. The system’s leading-edge clinical capabilities, combined with its compact, affordable design, industry-leading ramp-up time, and environmentally friendly energy use have helped expand access proton therapy to patients worldwide. The new proton center will be built adjacent to The University of Texas Health Science Center’s Greehey Children’s Cancer Research Institute and the world-renowned, NCI-designated Mays Cancer Center that will provide clinical and research expertise in the new center and oversee all research and academic training.

"Mevion is honored to partner with UT Health San Antonio and Proton International to bring our life-saving technology close to home for patients in South Texas," said Tina Yu, Ph.D., chief executive officer and president of Mevion. "In the past 5 years, proton therapy has moved away from large multi-room centers to single-room systems and with this system, our seventh NCI-designated center partnership, it solidifies our 62% market leadership in the U.S. compact proton therapy market."

"The Proton International team is pleased to be working with our partners to bring this important technology to the citizens of San Antonio and the surrounding region. Our collective vision is to assure this technology will be available in the fight against cancer and will make a real difference in patients’ lives" said Chris Chandler, CEO of Proton International.

On February 9, 2022 Cyclica Inc. ("Cyclica"), a neo-biotech with the vision to advance the most robust and sustainable drug discovery pipeline, reported that launches Perturba Therapeutics Inc. ("Perturba"), a spin out from the Stagljar Lab at the University of Toronto, Donnelly Centre for Cellular and Biomolecular Research (Press release, Cyclica, FEB 9, 2022, View Source [SID1234607940]). Perturba is advancing a rich pipeline of assets from undrugged protein-protein interactions (PPIs) .

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Only a small subset of biologically important drug targets are currently being explored within the pharma industry. Perturba is taking this challenge on by integrating Cyclica’s comprehensive AI-augmented proteome-wide drug design technology with two first-in-class live cell-based assays from the Stagljar Lab. With this integrated AI-augmented drug design and empirical phenotypic approach, Perturba is developing precision therapies that modulate PPIs and PPI-mediated biological processes with a focus on difficult-to-treat cancers. Perturba will initially focus on advancing two EGFR triple mutant inhibitors for non-small cell lung cancer, and four programs targeting small GTPases for various intractable cancers.

Naheed Kurji, Co-Founder, CEO and President of Cyclica indicates that "More than half of all human disease-related proteins are considered undruggable using conventional approaches. As a result, patients suffering from life threatening diseases are left waiting for treatment. What others view as "undruggable", we see as potential. Perturba represents an important franchise in the pursuit of our cancer strategy. We’re so excited to partner with Professor Stagljar and the world class Stagljar Lab in driving forward our shared vision."

Dr. Igor Stagljar, Professor at University of Toronto’s Temerty Faculty of Medicine and Principal Investigator at the Donnelly Centre, shares, "over the past two years, my lab has developed two high impact, live cell-based technologies for studying protein-protein interactions and identifying novel drug molecules – MaMTH-DS and SIMPL. Combining these two technologies with Cyclica’s world-class AI-drug design approach will usher in a new way to conduct drug discovery for highly intractable targets in an unprecedented way at scale. I’ve known Naheed and the team at Cyclica for years and jointly have shown multiple proof points using our platforms with a program targeting an osimertinib resistant EGFR triple mutant that we will be progressing in Perturba, and a program targeting an oncogenic KRAS in a separate collaboration that gave us confidence to target other small GTPases in Perturba."

Seasoned drug developer Rick Panicucci, PhD, SVP at BridgeBio Pharma and a long time advisor at Cyclica has been appointed as non-executive Chairman of Perturba to help oversee the company’s strategy. Su Dharmawardhane Flanagan, PhD, Tony Hunter, PhD and Ming Tsao, MD, have been appointed to Perturba’s Scientific Advisory Board. Cyclica will provide initial funding for Perturba and will seek external funding from strategic partners as required.

"I’ve been involved in drug discovery & development for over 25 years. What I can say with certainty is that the way things will be done going forward is going to be very different from how it was done before. I’ve been an advisor at Cyclica for 6 years and have witnessed first hand the power of AI and data-first approaches to drive drug discovery fast and with quality. Now, with Perturba and integrating AI drug design and phenotypic assays opens a whole new way of design-make-test-analyze at scale for target classes that have been ignored for too long," shares Panicucci.

On February 9, 2022 Imagia Cybernetics, an AI-healthcare company that accelerates oncology solutions generated from real world data, reported its merger with Canexia Health (Press release, Canexia Health, FEB 9, 2022, View Source [SID1234607939]). Canexia is an oncology innovator that streamlines complex cancer genomic information which allows oncologists to identify optimal treatment selection and patient monitoring. The merger includes C$20 million funding with participation from: BDC Capital’s Women in Technology Venture Fund, Desjardins Capital, and PacBridge Capital. Combined, Imagia and Canexia will increase access to precision oncology at the community level. In addition to working with four leading pharmaceutical companies, Imagia and Canexia are integrated with 20 hospital systems and reference labs around the world. Their expertise in genomics, oncology, artificial intelligence, and informatics will enable health systems to bring testing in-house, delivering precision oncology to patients no matter where they live.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

While 85 percent of all cancer treatments in the United States are administered at community cancer centers and local hospitals, only 15 percent of patients are routinely screened for targeted treatment selection that can improve outcomes threefold1. The new company, Imagia Canexia Health, improves accessibility through cost-effective local testing, thereby reducing expenses and generating faster results. This integrated solution leverages AI-based informatics for treatment selection, patient monitoring, and provides clinical laboratories support to bring testing in-house. The result is a new ability to integrate patient clinical and genomic data which achieves more effective treatment decisions by oncologists.

"Combating cancer is what Imagia set out to accomplish through advanced AI technology, and merging with Canexia speeds up our momentum to realize that goal," said Imagia CEO Geralyn Ochab, who will lead the new company. Ochab spent over 20 years on technology’s cutting-edge in healthcare creating durable business partnerships in previous roles at Toshiba, GE Healthcare, and Resonant Medical. During that time, she orchestrated market expansions, built high performance teams, and spearheaded full scale corporate restructures. "Imagia’s EVIDENS platform, with its distributed model providing onco-clinical solutions generated from real world data, is critical to our joint ecosystem’s ability to provide earlier treatment selection and recurrence monitoring."

Aligning resources, the merger now enables expanded access to precision-guided cancer management. Imagia’s robust data insights technology preserves cancer healthcare data privacy via federated learning and Canexia’s end-to-end solution tests, validates, and delivers the analysis directly to the oncologist. Together, they will provide faster and more comprehensive insights.

"Targeted cancer therapies transform access to cancer treatment, patient outcomes, and health system effectiveness. Through Imagia Canexia Health these precision treatments can be available to physicians and patients around the world," said Canexia Health Board Chair Sue Paish, who will also chair the new company. "This merger with Imagia will greatly enhance access to life saving cancer treatments and improve health equity."

"This merger realizes new revenue streams from integrated workflow solutions, and more services that bring therapeutics to where patients need them most," said Michael Ball, Canexia Health CEO.

"Combining two advanced technology companies to bring affordable access to the best cancer treatments closer to the patient is exactly the kind of opportunity that we want to invest in," said Michelle Scarborough, a Managing Partner at BDC’s Women in Technology Venture Fund.

The transaction is expected to close at the end of February, subject to shareholder approval.