Upadhye Cwik LLP Guides About Innovative Legal Practices On Pharmaceutical and FDA Issues in COVID-19 World

The COVID-19 pandemic continues to turn the world upside down. And when upside down, the legal issues surrounding pharmaceuticals and the FDA become apparent. We identify a few areas that our law firm is working on for clients.

Our patent work remains busy helping clients with rationalizing patent portfolios, conducting infringement-mapping exercises to find potential licensing revenues, and patent litigation to enforce patent rights. Interestingly we see some clients not cutting the pipeline and thus increasing their patent activities to be ready with new products once the economy returns. Other companies are using the 505(b)(2) platform to come up with new products in less costly ways.

The COVID-19 crisis has caused a serious disruption on contracts, from supplying raw materials to end producers, up to the inability to pay for product received due to cash-flow problems. We are seeing clients invoking the Force Majeure clause to get out of contracts and similarly helping clients to force the other party to stay in the contract. The failure to supply may also cause consequential problems such as stock-out penalties, product recalls, or mitigation. We are also drafting new contracts to account for pandemics and other viral/bacterial outbreaks. Nevertheless, business is business and we are helping clients in commercial litigation in order to enforce contracts. Other clients are using commercial litigation to protect market share.

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PHARMACY MARKET

Halozyme Announces Positive Clinical Data of its High-Volume Auto-Injector Demonstrating Successful Rapid Subcutaneous Drug Delivery

PR Newswire | October 19, 2023

Halozyme Therapeutics, Inc. announced positive results of a clinical study demonstrating subcutaneous administration of 10 mL of a representative biologic product co-formulated with its ENHANZE® drug delivery technology, in approximately 30 seconds. In the study, the biologic was delivered with Halozyme's proprietary high-volume auto-injector (HVAI) in healthy volunteers. The injection was delivered successfully to all 23 participants and was well tolerated. "To our knowledge, this is the first clinical study of its kind," said Mike LaBarre, chief technical officer of Halozyme. "Traditional subcutaneous auto-injector delivery methods are typically limited to volumes less than 2 mL or require long delivery times at slow rates for higher volumes. By enabling rapid subcutaneous injection of high volumes of biologic products, our ENHANZE drug delivery technology in combination with our proprietary HVAI has the potential to improve the patient experience for multiple therapies." In the study, a representative biologic, immunoglobulin 10%, was delivered to 23 healthy volunteers. The primary endpoint of the study was achieved with all subjects receiving the completed dose with HVAI, demonstrating that 10 mL of a representative biologic product can be rapidly delivered using Halozyme's ENHANZE® and HVAI technologies. Data Highlights 96% of participants stated that they would be willing to receive the injection again. 90% of participants indicated feeling either no pain or mild pain immediately after injection. Erythema, swelling, and induration were generally minimal to mild and resolved by 90 minutes or less. Biologics delivered subcutaneously through auto-injectors are typically restricted to doses of 1-2 mL. This limitation is caused by hyaluronan, a molecule that inhibits fluid dispersion in the subcutaneous space. Halozyme's ENHANZE® drug delivery technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that locally degrades hyaluronan in the subcutaneous space. This temporarily increases the permeability of the tissue under the skin, allowing space for the biologic to enter, enabling it to be rapidly dispersed and absorbed into the bloodstream. "These results support our continued dedication to providing innovative drug delivery options to patients," said Helen Torley, chief executive officer of Halozyme. "Our ENHANZE drug delivery and HVAI technologies have the potential to rapidly deliver large volume therapeutics subcutaneously with the potential for meaningful clinical benefits." Halozyme's HVAI is available to partners for clinical use. About Halozyme Therapeutics, Inc. Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. As the innovators of the ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the delivery of injected drugs and fluids in order to reduce the treatment burden to patients. Having touched more than 700,000 patient lives in post-marketing use in seven commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, AbbVie, Eli Lilly, Bristol-Myers Squibb, Alexion, argenx, Horizon Therapeutics, ViiV Healthcare and Chugai Pharmaceutical. Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technology that are designed to provide commercial or functional advantages such as improved convenience and tolerability, and enhanced patient comfort and adherence. The Company has a commercial portfolio of proprietary products including XYOSTED®, TLANDO® and NOCDURNA® and partnered commercial products and ongoing product development programs with several pharmaceutical companies including Teva Pharmaceutical, Pfizer and Idorsia Pharmaceuticals.

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Pharmacy Market

Evolution Health Announces Revolutionary Technology Platform to Transform Stakeholder Engagement and Actively Measure Their Impact for Pharmaceutical

prnewswire | September 01, 2023

Evolution Health Group (EHG), a leading name in medical communications, pharmaceutical strategic marketing, and digital solutions, unveiled its game-changing technology platform, 360Connex®, set to redefine the landscape of stakeholder engagement. The primary objective of this robust platform is to enable enterprises to scale and target their engagement initiatives effectively. With a focus on efficiency, transparency, and actionable insights, organizations can now make data-driven decisions and foster stronger relationships with their stakeholder communities. This state-of-the-art platform is geared towards three core functionalities Management, Monitoring, and Measurement of Stakeholder Engagement: Through an intuitive interface and innovative technologies, enterprises can now efficiently manage, track, and measure the impact of their interactions with their key stakeholders, streamlining the collaboration process and helping teams focus their resources and strategies to ensure maximum impact on the business. Facilitation of Speaker Programs: The platform offers tools that will not only simplify the coordination and execution of speaker programs, but also ensure they meet the highest standards of content delivery and engagement. Application of Advanced Analytics: By harnessing the power of artificial intelligence, machine learning, and advanced automation technologies, EHG's 360Connex® platform offers unprecedented insights and optimization opportunities. This ensures that engagement activities are not only scaled, but also aligned with the dynamic needs of the stakeholder community. The platform is designed to meet the differing needs of emerging organizations through the largest of enterprises. "The healthcare community is rapidly evolving, and traditional methods of engagement are no longer sufficient. Our new technology platform bridges the gap, empowering enterprises to create more impactful, meaningful, and measurable interactions with their key stakeholders in a cost-effective way that ensures ongoing transparency and accountability," commented Carolyn Vogelesang Harts, one of the Managing Partners of Evolution Health Group. The unveiling of 360Connex® comes at a pivotal moment in the healthcare industry. As interactions between enterprises and healthcare professionals become increasingly intricate, there is a pressing need for systems that simplify processes and provide actionable insights. EHG's 360Connex® platform is the answer to this pressing demand. This innovation is poised to usher in a new era of insight-driven engagement, ensuring that healthcare companies not only keep pace with, but also anticipate the needs of, their diverse professional audiences. About Evolution Health Group Founded in 2005 and based in Pearl River, NY, Evolution Health Group stands at the forefront of pharmaceutical strategy, marketing, and digital solutions for global healthcare companies. EHG provides distinctive services through three main divisions; Evolution Medical Communications for medical and scientific strategy, blulava, for technology and digital solutions, and Maestro360 for speaker program logistic management.

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PHARMACY MARKET

Iambic Therapeutics Announces Close of Oversubscribed $100 Million Series B Financing to Advance AI-Discovered Therapeutics into Clinical Development

Business Wire | October 10, 2023

Iambic Therapeutics a biotechnology company developing novel therapeutics from its unique generative AI discovery platform, today announced the closing of an oversubscribed $100 million Series B financing co-led by Ascenta Capital and Abingworth, and also including new investors NVIDIA, Illumina Ventures, Gradiant Corporation, and independent board member Bill Rastetter. Existing investors also participated, including Nexus Ventures, Catalio Capital Management, Coatue, FreeFlow, OrbiMed, and Sequoia Capital. As part of the Series B, Iambic is delighted to welcome two new board members, Evan Rachlin, M.D., from Ascenta Capital and Kurt von Emster from Abingworth. “At Iambic, our world-class team has combined physics and AI to create a differentiated drug discovery platform that achieves a step-change in the speed and success rate for delivering best-in-class and first-in-class development candidates to clinic,” commented Tom Miller, Ph.D., Co-founder and Chief Executive Officer of Iambic. “With the Series B funding, we intend to advance multiple AI-discovered candidates into the clinic and expand our pipeline, demonstrating how the Iambic platform can deliver better therapeutics to patients in less time, with optimized target product profiles for greater likelihood of clinical success.” “We were struck by the originality of these molecules, offering distinctive approaches in both deeply validated and more novel biological pathways,” added Evan Rachlin, M.D., Co-founder and Managing Partner of Ascenta Capital. “Iambic’s platform enables a more creative and expansive exploration of how to treat diseases with profound unmet needs. We are delighted to partner with Tom and his extraordinary team in translating these thoroughly tested medicines into humans.” “Abingworth is proud to support the remarkably talented team at Iambic in its drive to revolutionize drug discovery and speed to the market with highly selective drugs,” said Kurt von Emster, Managing Partner and Head of Life Sciences at Abingworth. “AI-driven technologies, including methods that Iambic and NVIDIA researchers have built together, are charting a new path for researchers in the discovery of new therapeutic candidates,” said Rory Kelleher, Director of Healthcare and Life Sciences at NVIDIA. “NVIDIA-accelerated computing and software are helping industry pioneers like Iambic drive scientific breakthroughs and our continued collaboration aims to speed innovation in drug discovery.” “We believe technology innovations powered by advanced computing and omics-derived data insights will transform drug discovery and pave the way for the next wave of groundbreaking medicines,” said Ron Mazumder, Ph.D., MBA, Partner of Illumina Ventures. “Iambic’s physics-informed machine learning approach has yielded promising lead candidates with superior profiles in record time.” Since its 2021 Series A financing, Iambic has rapidly built its AI-driven discovery platform, which unifies state-of-the-art, physics-informed machine learning and experimental automation, and has demonstrated the platform’s success in identifying therapeutic candidates with differentiated drug profiles. In addition to building out a deep bench of AI and drug-discovery experts, Iambic has discovered two candidates to advance into the clinic: IAM-H1, a highly selective and brain-penetrant inhibitor of HER2 and its oncogenic mutants, and IAM-C1, a potential first-in-class selective dual CDK2/4 inhibitor to address unmet needs in terms of therapeutic window and treatment resistance in cell-cycle-driven cancers. Further, Iambic has extended its leadership position in the AI community, creating methods such as NeuralPLexer and OrbNet to drive its discovery platform. With the funds raised in the Series B, Iambic intends to advance multiple candidates into clinical development, expand its pipeline with additional candidates with best-in-class and first-in-class potential, and continue to innovate and build next-generation AI and automation technologies for drug discovery. It plans to leverage NVIDIA technology such as the NVIDIA DGX Cloud AI supercomputing platform and the NVIDIA BioNeMo cloud service to accelerate discovery. The company retains the technology created under its prior name of Entos Inc., adopting the new name of Iambic Therapeutics to reflect its transition to a company with the additional capability of clinical development of candidates identified through its AI-driven discovery platform. About the Iambic Therapeutics Physics-Informed AI-Driven Discovery Platform The Iambic Therapeutics AI-driven platform was created to address the most challenging design problems in drug discovery, incorporating the most current AI technologies and purpose-built tools from Iambic. The integration of physics principles into the platform’s AI architectures improves data efficiency and allows molecular models to venture widely across the space of possible chemical structures. The platform’s algorithms enable identification of new chemical mechanisms for engaging difficult-to-address biological targets, discovery of defined product profiles that optimize therapeutic window, and exploration of the chemical space to discover candidates for development with highly differentiated properties. Through close integration of AI-generated molecular designs with automated experimental execution, Iambic completes design-make-test cycles on a weekly cadence. About Iambic Therapeutics Founded in 2019 and headquartered in La Jolla, California, Iambic Therapeutics is disrupting the therapeutics landscape with its unique AI-driven drug-discovery platform. Iambic has assembled a world-class team that unites pioneering AI experts and experienced drug hunters with strong track records of success in delivering clinically validated therapeutics. The Iambic platform has been demonstrated to deliver high-quality, differentiated therapeutics to clinic with unprecedented speed and across multiple target classes and mechanisms of action. The Iambic team is advancing an internal pipeline of clinical assets to address urgent unmet patient needs.

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