ImmuPharma, Avion ink Lupuzor deal

PharmaTimes | November 28, 2019

ImmuPharma and Avion Pharmaceuticals have signed an exclusive licensing agreement for Lupuzor (rigerimod), ImmuPharma’s lead compound, a peptide therapeutic and a first-in class autophagy immunomodulator for systemic lupus erythematosus (SLE or lupus). Under the terms of the deal, the companies will co-develop Lupuzor to allow registration for marketing in the US, Europe and elsewhere, and Avion will commercialise the drug exclusively for the US. ImmuPharma will also retain all the rights to commercialise Lupuzor outside of the US, either through distribution partnerships or directly by ImmuPharma. Further, Avion is set to fund a new international Phase III trial with costs up to $25 million. Last year Immupharma announced top-line trial results from its pivotal Phase III trial of the drug in lupus, in which it showed statistically significant reductions (71.1% vs 48.8%) in disease activity compared to placebo plus standard of care.

Spotlight

If you want a roller coaster ride full of ups, downs, twists, and turns, move a portion of your portfolio to the pharmaceutical or biotech sector. Every day, including weekends, newswires are full of press releases from these companies outlining the results of clinical trials conducted on new and experimental drugs and compounds.

Spotlight

If you want a roller coaster ride full of ups, downs, twists, and turns, move a portion of your portfolio to the pharmaceutical or biotech sector. Every day, including weekends, newswires are full of press releases from these companies outlining the results of clinical trials conducted on new and experimental drugs and compounds.

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BUSINESS INSIGHTS

MilliporeSigma Invests $ 286 Million in U.S. Drug Safety Testing Capacity

MilliporeSigma | November 16, 2022

MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany, a leading science and technology company, announced that its Life Science business sector is investing more than $ 286 million in its biosafety testing capacity at the company's site in Rockville, Maryland, USA. This will significantly increase the company's ability to conduct biosafety testing and analytical development services. Biosafety testing and analytical development are critical and fundamental requirements of the drug development and commercialization process to ensure the safety of medicines. Global demand for these services is growing at a double-digit rate. "MilliporeSigma is harnessing its broad portfolio of modern technologies and enabling services to help ensure the safety of the world's medicines. These significant investments in Rockville and other sites across our global network will help us meet growing demand for the robust testing studies that biologics manufacturers depend upon to comply with stringent regulatory guidelines. This is a prime example of our focus on sustainable growth in areas with strong underlying upwards dynamics." Belén Garijo, Chair of the Executive Board and CEO of Merck KGaA, Darmstadt, Germany "This is the largest investment in contract testing in Merck KGaA, Darmstadt, Germany's history. Our Rockville campus has a long track record of testing for both traditional and novel therapies. We have been driving innovation in biosafety testing for 75 years and this expansion enables our Life Science business sector to lead in shaping the future of testing," said Matthias Heinzel, Member of the Executive Board of Merck KGaA, Darmstadt, Germany and CEO Life Science. "We thank the State of Maryland and Montgomery County, Maryland, for their collaboration in making this new campus a reality for our employees and clients. Together, we are impacting life and health with science." The BioReliance® contract testing portfolio from MilliporeSigma provides best-in-class biosafety testing and analytical development methods for both traditional and novel therapies. The new state-of-the-art, 250,000-square-foot facility at MilliporeSigma's Rockville site will house biosafety testing, analytical development, viral clearance suites, and cell bank manufacturing services. Currently, about 600 employees work at the site. Over the next four years, the expansion will create more than 500 new jobs. With more than 30 years of drug development, material science and process technology expertise, Millipore® CTDMO Services offerings span pre-clinical development to commercial manufacturing, including testing, across multiple modalities including mAbs, highly potent active pharmaceutical ingredients, antibody-drug conjugates, viral vector therapies, mRNA, and lipid nanoparticle formulation. Contract testing and the newly formed Millipore® CTDMO Services are part of the Life Science Services business unit, which together with the Process Solutions business is one of Merck KGaA, Darmstadt, Germany's "Big 3" growth drivers. The company aims to increase its Group sales to approximately € 25 billion by 2025. Recently, the company's Life Science business sector announced investments in Martillac and Molsheim, France; Shanghai, China; Sheboygan and Verona, Wisconsin, USA; Cork, Ireland; Wuxi, China; Carlsbad, California, USA; Jaffrey, New Hampshire and Danvers, Massachusetts, USA; Buchs, Switzerland; and Darmstadt, Germany. These expansions are part of an ambitious, multi-year program. It aims to increase the capacity and capabilities of Merck KGaA, Darmstadt, Germany's Life Science business sector to support the growing global demand for lifesaving medications and to make significant contributions to public health. About the Life Science business of Merck KGaA, Darmstadt, Germany The Life Science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma in the U.S. and Canada, has more than 26,000 employees and more than 55 manufacturing and testing sites worldwide, with a portfolio of more than 300,000 products focused on scientific discovery, biomanufacturing and testing services. Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and electronics. Around 60,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene-editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2021, Merck KGaA, Darmstadt, Germany generated sales of € 19.7 billion in 66 countries. The company holds the global rights to the name and trademark "Merck" internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company's technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company. All Merck KGaA, Darmstadt, Germany news releases are distributed by email at the same time they become available on the EMD Group website. In case you are a resident of the U.S. or Canada please go to www.emdgroup.com/subscribe to register again for your online subscription to this service as our newly introduced geo-targeting requires new links in the email. You may later change your selection or discontinue this service.

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PHARMACY MARKET

Eyenovia's Novel Optejet® Dispenser Puts People's Eyes First

Eyenovia | September 06, 2022

Eyenovia, Inc. an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics, brings human-centric design to ophthalmology with its novel Optejet® dispenser. Traditional eye drops normally overdose the patient's eye with medication and preservatives. Eyenovia's easy-to-use, novel Optejet® dispenser administers precisely 8µL of medication to the eye, effectively treating the patient's condition while creating a more gentle dosing experience. "The unique delivery mechanism of the Optejet® will fundamentally change how we think about eye medication. Right now, traditional eye drops can result in significant dose-related side effects for the treatment of chronic illnesses like glaucoma. The Optejet® dispenser is designed for patients to experience easier administration and fewer side effects with similar efficacy." Michael Rowe, CEO of Eyenovia The Optejet® dispenser administers ophthalmic solutions horizontally using Eyenovia's proprietary Microdose Array Print (MAP™) technology. The system functions similar to an inkjet printer, delivering accurate microdoses through a precision spray. Traditional eye drops deliver four to five times larger volume than the human eye can actually hold, which causes eye drops to roll down the face and overdose the eye with preservatives. Poor delivery of eye drops is more than an inconvenience; it can prevent patients from using necessary medication because of the side effects. For example, with medication to help dilate the pupils for eye exams, up to 23% of patients experienced stinging and burning with the eye drops, causing patients to forgo eye exams. In Eyenovia studies, less than 1% of patients experienced stinging and burning. "Medications only work if patients take them, and with the Optejet, we have designed a way for patients to benefit from an easy-to-use, appropriate, lower dose spray that results in similar efficacy. We're excited for physicians and providers to be able to offer this revolutionary technology in the near future to patients who deserve a more positive experience," said Rowe. Eyenovia's first marketed invention is expected to be MydCombi™, a first-in-class drug-device combination microdose for in-office pupil dilation. This potentially will help save physician's chair time, eliminating the traditional three eyedrops used for a patient's eye exam. Other exciting innovations in the Eyenovia pipeline include MicroLine and MicroPine. About Eyenovia, Inc. Eyenovia, Inc. is an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics. Eyenovia is currently focused on the late-stage development of microdosed medications for mydriasis, presbyopia, and myopia progression.

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BUSINESS INSIGHTS

NeuroBo Pharmaceuticals, Inc. and Dong-A ST Co. Ltd. Announce Strategic Collaboration

NeuroBo Pharmaceuticals, Inc. | September 16, 2022

NeuroBo Pharmaceuticals, Inc. and Dong-A ST Co., Ltd. announced that they have entered into a conditional exclusive license agreement for NeuroBo to develop and commercialize DA-1241 and DA-1726, which are currently being evaluated for the treatment of nonalcoholic steatohepatitis obesity and type 2 diabetes. DA-1241 is a novel G-Protein-Coupled Receptor 119 agonist, which promotes the release of key gut peptides GLP-1, GIP and PYY, which, in turn, play an important role in glucose metabolism, lipid metabolism and weight loss. DA-1241 is a synthetic, selective small molecule, suitable for oral administration and has been shown to be well tolerated in phase 1 studies. Further, its multimodal mechanism appears to induce strong anti-NASH effects, supported by potential best-in-class efficacy, as demonstrated in pre-clinical studies. DA-1726 is a novel oxyntomodulin analogue functioning as a glucagon-like peptide-1 receptor and glucagon receptor dual agonist. OXM is a naturally-occurring, 37-amino acid peptide hormone that is released from the gut after ingestion of a meal, activating both the GLP-1 and glucagon receptors, prompting reduced food intake as well as an increase in energy expenditure, potentially resulting in superior body weight loss compared to selective GLP-1 receptor agonists. The beneficial effects of this dual mechanism of DA-1726 on weight loss compared to selective GLP-1 activity has been demonstrated in animal models. Additionally, DA-1726 has shown the ability to improve hepatic steatosis, inflammation and fibrosis when compared to the GLP-1 agonist, semaglutide in these same models. Under the license agreement, NeuroBo will be responsible for global development, regulatory and commercial activities other than for certain Asian-Pacific geographies. Dong-A will manufacture clinical supplies and initial commercial supplies of the product at its manufacturing facility in Korea. "The acquisition of these two cardiometabolic assets marks a seismic shift for NeuroBo, providing us with a highly promising, diversified pipeline with several upcoming value inflection points in the NASH and obesity space -- areas with enormous market opportunity," stated Gil Price, M.D., President and Chief Executive Officer of NeuroBo. "Through this agreement, Dong-A, one of our largest shareholders, has reaffirmed its commitment to remain a long-term strategic partner of NeuroBo. Dong-A is dedicated to our success and we are grateful it has also committed to provide continued support to facilitate the clinical development of the licensed assets. Once the transaction has closed, which is contingent upon certain closing conditions, we will be uniquely positioned to initiate a phase 2a study of DA-1241 in NASH in the first half of 2023, with data expected in the second half of 2024. We also intend to initiate a phase 1a safety study of DA-1726 in the first half of 2023, for which data is expected in the second half of 2023. We are truly excited about the prospects of NeuroBo as we transition to a cardiometabolic company across the large and growing markets of obesity and NASH." "We are highly enthusiastic about this opportunity to accelerate development of our novel treatments in partnership with NeuroBo. Dong-A plans to continue to strengthen its R&D capability and to seek additional collaboration opportunities to establish ourselves in the US market", Min Young Kim, Chief Executive Officer of Dong-A About the Proposed Licensing Transaction Under the terms of the license agreement, Dong-A will receive an upfront payment of $22 million in Series A convertible preferred stock, which will automatically convert into common stock upon receipt of requisite stockholder approval, and will be eligible to receive commercial- and regulatory-based milestone payments, dependent upon the achievement of specific regulatory and commercial developments. Dong-A will also be entitled to single digit royalties on net sales of the two assets. Dong-A has also agreed to commit $15,000,000 toward financing the assets, subject to NeuroBo's ability to obtain additional financing under the terms of the license agreement. The license agreement has been approved by the board of directors of NeuroBo. The transaction is expected to close in the third quarter of 2022, subject to obtaining third party financing for development of the assets and other customary closing conditions. About NeuroBo Pharmaceuticals NeuroBo Pharmaceuticals, Inc., is a clinical-stage biotechnology company historically focused on therapies for neurodegenerative, infectious, and, upon closing of the license agreement, cardiometabolic diseases. Its therapeutics programs currently include ANA001, an oral niclosamide formulation, which is in Phase 2/3 clinical trials to treat patients with moderate coronavirus disease (COVID-19); NB-01 for the treatment of painful diabetic neuropathy; NB-02 for the treatment of symptoms of cognitive impairment and to modify the progression of neurodegenerative diseases associated with the malfunction of tau protein; and gemcabene currently being assessed as an acute treatment for COVID-19 in combination with ANA001. NeuroBo Pharmaceuticals, Inc. is headquartered in Boston, Massachusetts. About Dong-A Dong-A ST Co. is a leading healthcare company in South Korea with a business focus on developing, manufacturing and distributing pharmaceutical products and medical devices worldwide. Dong-A has successfully developed and marketed several products globally and continues to develop prospective clinical candidates. Dong-A also provides licensed-in and licensed-out drugs, and medical devices, including high-technology medical devices, custom-made products, and sets of artificial cardiac circuits for use in open-heart surgery. Dong-A has over 5,500 employees including 2,300 in the pharmaceutical sector. Dong-A was founded in 1932 and is headquartered in Seoul, South Korea.

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