Regenerons Sanofi deal finally turns a profit, thanks to Dupixent

FiercePharma | August 06, 2019

More than 10 years after Sanofi and Regeneron joined forces in a high-profile antibody drug partnership, the tie-up has recorded its first-ever profits no thanks to the PCSK9 laggard Praluent, but with big bouquets for hard-driving Dupixent. Fueled by Dupixents 557 million dollars in second-quarter sales, Regeneron on Tuesday reported that its Sanofi antibody partnership posted a 39 million dollars profit, a big turnabout from the same period last year, when it cost Regeneron 69 million dollars. Sanofi and Regeneron first joined forces way back in 2007, agreeing to split U.S. profits and losses 50-50 and ex-U.S. proceeds on a sliding scale. Along the way, Regeneron has opted to co-promote Dupixent, now approved to treat severe eczema, asthma and nasal polyps; cholesterol-fighter Praluent and the rheumatoid arthritis med Kevzara in the U.S. Sanofi recorded $557 million in Dupixent sales worldwide in Q2, plus $74 million for PCSK9 cholesterol drug Praluent and $56 million for rheumatoid arthritis med Kevzara. Dupixent and Kevzara beat analyst expectations, while Praluent fell short. SVP of commercial operations Marion McCourt said about 80% of asthma patients starting Dupixent haven’t taken a biologic before, while the rest are switches from rivals such as GlaxoSmithKline's Nucala. Both asthma and atopic dermatitis—a.k.a. eczema—were “major drivers” for the quarter, she added.

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PHARMACY MARKET

Alpha Cognition Announces Positive Neuroprotection Data from Pre-Clinical Study of ALPHA-1062 for Traumatic Brain Injury

Alpha Cognition Inc. | February 23, 2022

Alpha Cognition Inc. a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating neurodegenerative disorders, is pleased to announce histology data from their intranasal ALPHA-1062 Traumatic Brain Injury (TBI) program. ALPHA-1062 treatment was neuroprotective, preserving hippocampal structure, reducing cell loss and promoting neurogenesis compared to no treatment. Functional recovery data released in December demonstrated statistically significant improvement in motor, sensory and cognitive functioning in all measures. Today’s histological results, combined with positive functional data released previously, strongly support the further development of ALPHA-1062 for the treatment of TBI. “These data, together with the data released previously, demonstrate that ALPHA-1062 exhibits both neuroprotection and enhances restoration of sensory, motor, and cognitive performance in this model of moderate traumatic brain injury. We are very encouraged by the preclinical data which gives us confidence in the potential of ALPHA-1062 to become an effective treatment for TBI. We plan to meet with the FDA to discuss our clinical development plan in the coming months.” Denis Kay, the Company’s Chief Scientific Officer In a rodent model of TBI, ALPHA-1062 or vehicle was administered intranasally, with treatment initiated 2 hours after injury and continued twice daily for 35 days. A sham cohort of animals was also used for comparison. Compared to vehicle treatment, ALPHA-1062 Demonstrated statistically significant reduction in lesion size measured at 35 days after injury. Preserved greater hippocampal structure. The hippocampus plays a critical role in learning, memory formation, and spatial coding and damage to hippocampus can lead to memory disorders like AD, amnesia, and depression. Demonstrated statistically, significant reduction in neuronal cell loss. The number of neurons in the ALPHA-1062 treated animals were equivalent to those in the uninjured cohort of animals at the end of treatment. Statistically significantly enhanced neurogenesis as evidence by an increase in the number of neuron precursor cells and new neurons in the dentate gyrus, which plays a critical role in learning, information processing, and mood regulation. Lauren D’Angelo, the Company’s Chief Commercial Officer, commented: “Traumatic brain injury is a highly prevalent and increasingly common condition, with nearly 3 million diagnosed events in the United States in 2019, with no FDA approved treatment. There is a significant unmet need for effective therapies to help patients who suffer a traumatic brain injury, and we are encouraged by the commercial opportunity for ALPHA-1062 in this indication.” About Alpha Cognition Inc. Alpha Cognition Inc. is a clinical stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer's disease and Amyotrophic Lateral Sclerosis (ALS), for which there are limited treatment options. ALPHA-1062 is a patented new chemical entity being developed as a new generation acetylcholinesterase inhibitor for the treatment of Alzheimer's disease, with expected minimal gastrointestinal side effects. ALPHA-1062's active metabolites are differentiated from donepezil and rivastigmine in that they bind neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer's dementia and as an intranasal formulation for traumatic brain injury.

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BUSINESS INSIGHTS

Optomed signs an industrial partnership with a French AI company OphtAI

Optomed Oyj | March 21, 2022

Optomed and a French artificial intelligence company OphtAI have signed a commercial collaboration agreement, where both parties sell OphtAI artificial intelligence for screening of most common eye diseases together with Optomed Aurora handheld cameras as a complete solution for eye screening. The agreement is focusing mostly on European countries and Canada, where OphtAI has a strong presence. OphtAI offers artificial intelligence for detection of diabetic retinopathy, glaucoma and AMD, which is CE-marked for use in Europe and also regulatory authorization for commercialization in Canada. This collaboration supports both companies in their goals to provide more accessible and easier screening of various eye diseases. "The partnership with OphtAI supports Optomed's vision to bring AI enabled eye screening to primary care. We are happy to work with OphtAI who have a strong clinical validation and existing market approvals for EU and Canada." Optomed Vice President Devices, Laura Piila OpthAI CTO, Bruno Lay, comments: "This partnership with Optomed will bring OphtAI to the next level of its growth. OphtAI has been successfully integrated in the Optomed Aurora camera and the software suite, validated by key ophthalmologists, and it is now used on a daily basis for mass screening of diabetic retinopathy. This portable solution is easy to use, intuitive, and quite powerful for end-users. We are really excited to work with the leading company of portable cameras".

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PHARMA TECH

iXensor Receives Strategic Investment from Rohto Pharmaceutical with A Separate Technology Licensing Agreement

iXensor | April 28, 2022

iXensor, the pioneer of mobile health, announced that Rohto Pharmaceutical Co., Ltd, a multinational pharmaceutical corporation headquartered in Japan, has become the new strategic partner and shareholder. iXensor received Rohto Pharmaceutical's strategic investment to expand its mobile health business globally and accelerate its PixoTech® platform licensing business. Building on this strategic partnership, Rohto Pharmaceutical will deploy iXensor's patented PixoTech® technology to digitize its new products through a separate technology licensing and joint development agreement, thereby providing Rohto Pharmaceutical's consumers with innovative self-testing portfolios including women's health and infectious diseases in Japan market. iXensor's first product, PixoTest® Glucose Monitoring System, developed based on its PixoTech® platform, is the world's first US FDA-approved smartphone camera-based blood test dated in 2017. The PixoTech®, currently protected by more than 70 international patents, is iXensor's core technology platform that transforms smartphones into in vitro diagnostic instruments for biomedical analysis in point-of-care testing and self-testing. PixoTech® controls smartphones' camera sensing modules and screen lighting emissions with multiple wavelengths to analyze all types of immunoassay and enzymatic tests through the proprietary algorithm. "By investing in iXensor, we can deepen our joint efforts on a series of new product developments, thus expanding our testing and diagnostic business through a wave of digital transformation. As the first step, we will receive a technical license for smartphone-based diagnostic devices and apps from iXensor to develop and sell innovative self-testing products." Mr. Hidetoshi Segi, Chief Strategy Officer of Rohto Pharmaceutical Dr. Carson Chen, CEO of iXensor, expressed, "This partnership represents the unlimited potential and technical advantage of the PixoTech® platform to transform smartphones into precision medical diagnostic devices. The licensing business of PixoTech® technology started shifting in as the new engine to drive iXensor's growth." In the post-pandemic era, iXensor endeavors to accelerate the growth of the at-home self-testing market and empower the evolution of the digital health ecosystem through licensing the PixoTech® technology. Thanks to that, PixoTech® can be flexibly applied to the digitalization of various lateral flow tests. In addition, it can shorten the lead time for IVD manufacturers venturing into the digital health business. It can also be applied to develop companion diagnostic or remote monitoring tools for pharmaceuticals to prove the efficacy of new classes of medications with actual test results collected from patients' smartphones with comfort at home. About Rohto Pharmaceutical Founded in 1899, Rohto Pharmaceutical is a renowned Japanese company that has successfully commercialized its research and development of consumer and pharmaceutical products worldwide. Rohto Pharmaceutical has established a robust product portfolio, including eye care, skincare, gastrointestinal medicines, and functional foods. Within the test drug business, the novel coronavirus antigen rapid test for medical institutions was launched in response to the global epidemic in addition to the existing pregnancy test, ovulation test, and flu rapid test products. About iXensor iXensor, the pioneer of mobile health, turns smartphones into lab-grade mobile medical diagnostics. In 2017, iXensor introduced the PixoTest® Blood Glucose Monitoring System as the world's first US FDA-approved smartphone camera-based blood test. Based on the PixoTech® platform, iXensor has ventured into at-home self-testing and clinical point-of-care diagnostics across infectious diseases, women's health, diabetes, and cardiovascular diseases.

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BUSINESS INSIGHTS

Ascletis Announces Submission of Marketing Authorization Applications for Ritonavir in Multiple European Countries

Ascletis Pharma Inc. | February 14, 2022

Ascletis Pharma Inc.announces that it has submitted marketing authorization applications for ritonavir in Germany, France, Ireland and United Kingdom through its agent in Europe. It is expected that more marketing authorization applications for ritonavir in certain other countries, including the ones in Europe, North America and Asian Pacific will soon be submitted. Ascletis has been in discussion with both domestic and international companies, including major multi-national pharmaceutical companies, for the commercial supplies of ritonavir in China and globally. Oral ritonavir tablet is a pharmacokinetic booster of multiple oral antiviral drugs targeting viral proteases and a component of oral antiviral drug Paxlovid. Ascletis aims to be one of the global commercial suppliers of oral ritonavir tablets. Ascletis owns the only authorized oral ritonavir tablet in China, which passed bioequivalence study. Ascletis' oral ritonavir tablet was approved in September 2021 by China National Medical Products Administration. Ascletis has been applying sophisticated formulation technology to significantly increase human bioavailability of ritonavir which has a very poor solubility and successfully achieved human bioequivalence with the oral ritonavir tablets produced by the originator, AbbVie. On January 3, 2022, Ascletis announced that oral ritonavir tablet annual production capacity has been expanded to 100 million tablets and can be further rapidly expanded based on market demand. About Ascletis Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange, a global platform covering the entire value chain from discovery and development to manufacturing and commercialization. Ascletis is committed to developing and commercializing innovative drugs in the areas of viral diseases, NASH/PBC, and cancer to address unmet medical needs both in China and globally. Led by a management team with deep expertise and a proven track record, Ascletis targets those therapeutic areas with unmet medical needs from a global perspective, and efficiently advances the developments of pipelines with an aim of leading in global competition. To date, Ascletis has three marketed products and 20 robust R&D pipelines of drug candidates with global competitiveness, and is actively exploring new therapeutic areas.

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Spotlight

Pharma biotech companies requiring entirely new or updated on-boarding or annual cGMP training programs turn to NSF International for an innovative approach and the very latest regulatory information and trends to ensure employees are gaining valuable cGMP knowledge which will help them in their work. Watch this brief video to learn more.

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