Brand Institute Partners on Brand Name Development for Treatment of Relapsed or Refractor Peripheral T-Cell Lymphoma Now Approved by Ministry of Health, Labour and Welfare (Japan)

On July 5, 2022 Brand Institute reported its work with Solasia Pharma K.K. ("Solasia") in developing the brand name DARVIAS (Press release, Brand Institute, JUL 5, 2022, View Source [SID1234616487]).

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DARVIAS, an organoarsenic compound with anticancer activity, is a novel mitochondrial-targeted agent being developed for the treatment of various hematologic and solid tumors. DARVIAS provokes cell cycle arrest and apoptosis through disruption of mitochondrial functions and increased production of reactive oxygen species in tumor cells. DARVIAS is expected to exert an anticancer effect by inducing cell cycle arrest and apoptosis.

DARVIAS has been approved for relapsed or refractory Peripheral T-Cell Lymphoma by Japan’s Ministry of Health, Labour and Welfare (MHLW). Japan is the first country in the world where DARVIAS has been approved. DARVIAS has been granted orphan drug designation in the US and EU.

"The entire Brand Institute and Drug Safety Institute team congratulates Solasia on the MHLW approval of the DARVIAS injection," said Brand Institute’s Chairman and C.E.O., James L. Dettore.

Skyhawk Announces Collaboration Agreement with Sanofi for Oncology and Immunology Targets

On July 5, 2022 Skyhawk Therapeutics, Inc. reported the signing of an exclusive worldwide collaboration agreement with Sanofi to discover and develop novel small molecules that modulate RNA splicing for challenging oncology and immunology targets (Press release, Skyhawk Therapeutics, JUL 5, 2022, View Source [SID1234616486]).

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Frank Nestle
Global Head of Research and Chief Scientific Officer, Sanofi
"We look forward to this collaboration with Skyhawk, a pioneer in developing novel small molecules that modulate critical RNA splice sites. Skyhawk’s SkySTAR platform integrating proprietary computational biology tools, kinetic models, and conformational structural models of RNA, offers an exciting opportunity to build drugs that treat disease targets which today have limited or no therapeutic options."

Bill Haney
Chief Executive Officer, Skyhawk Therapeutics
"Sanofi is a global leader in the development and commercialization of innovative therapies, and we look forward to working with their talented team to build novel small molecule therapeutics that modify RNA splicing for the treatment of critical diseases of high unmet need. We are excited to develop drugs for challenging targets with Sanofi and look forward to working together on these potentially first- and best-in-class programs."

Terms of the Agreement
Under the collaboration agreement, Sanofi will pay Skyhawk $54 million upfront. Skyhawk will grant Sanofi exclusive licenses to worldwide intellectual property rights to candidates discovered and developed under the collaboration that are directed to program targets. Following DC status, Sanofi will assume responsibility for further development and commercialization. Skyhawk is also eligible to receive over $2 billion in potential milestone payments, as well as potential royalties on future sales.

Exelixis to Webcast Fireside Chat as Part of the William Blair Biotech Focus Conference

On July 5, 2022 Exelixis, Inc. (Nasdaq: EXEL) reported that company management will participate in a pre-recorded fireside chat at the William Blair Biotech Focus Conference 2022, which will be available to view on-demand beginning Monday, July 11, 2022 (Press release, Exelixis, JUL 5, 2022, View Source [SID1234616484]).

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To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentations to ensure adequate time for any software download that may be required to listen to the webcasts. Replays will also be available at the same location for at least 30 days.

Boehringer Ingelheim, Evotec and bioMérieux launch Aurobac, a joint venture to fight Antimicrobial Resistance

On July 5, 2022 Boehringer Ingelheim, a leading research-driven biopharmaceutical company, the life science company Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) and bioMérieux, a world leader in in vitro diagnostics, reported that they have formed a joint venture to create the next generation of antimicrobials along with actionable diagnostics to fight Antimicrobial Resistance (AMR) (Press release, Boehringer Ingelheim, JUL 5, 2022, View Source [SID1234616482]).

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The resulting company, Aurobac Therapeutics SAS, will combine the best capabilities of the three founding companies towards developing a new precision medicine approach, from diagnosis to cure. The aspiration is to succeed in the fight against AMR, which is a major public health threat. Having routine surgery such as caesarean sections or hip replacements may become life threatening, and complications from common diseases such as diabetes and injuries or cuts will become harder to manage because of growing resistance to antibiotics in patients.

"The rise of antibiotic-resistant infections – also called antimicrobial resistance, or AMR – is indeed a looming global crisis," said Michel Pairet, Head of Boehringer Ingelheim’s Innovation Unit and Member of the Board of Managing Directors. "Antibiotic resistance kills about 1.27 million people globally every year1 and it has been estimated that by 2050, as many as 10 million worldwide deaths could result from AMR2, making it potentially deadlier than cancer."

Werner Lanthaler, CEO of Evotec added: "The grim prospect of a post-antibiotic era has many causes but only one solution: The development of new, targeted, and effective antimicrobial therapies. We are excited to launch Aurobac together with our partners at Boehringer Ingelheim and bioMérieux, to combine our complementary strengths. By leveraging Evotec’s multimodality approach to infectious diseases, we are confident that Aurobac will be able to generate much-needed progress to tackle the global challenge of AMR."

"bioMérieux has a strong expertise in antimicrobial resistance. We supply the most comprehensive integrated diagnostic solutions to support an appropriate use of antibiotics (antimicrobial stewardship)," said Alexandre Mérieux, bioMérieux Chairman and CEO. "Our role within the joint venture is to develop and commercialize diagnostic tests, including Companion Diagnostics, which deliver rapid, reliable and actionable results. This participation in Aurobac is perfectly aligned with bioMérieux’ full commitment to sustain antibiotic efficacy for future generations."

Aurobac will work to shift the strategy related to antibiotic treatment regimens which at the moment leans heavily on empirical approaches using broad-spectrum and unfocused medicines. The goal is to turn this into a precision approach, using new highly effective and targeted modalities, combined with rapid and actionable diagnostics to quickly identify pathogens and their resistance patterns, and supported by new economic models.

Funded by Boehringer Ingelheim as lead investor with 30 million EUR and by Evotec and bioMérieux with 5 million EUR each, the 40 million EUR joint venture, which has its headquarters in Lyon (France), combines the world leading expertise of Evotec, one of the most active research companies in infectious diseases, with bioMérieux’s market-leading expertise in infectious disease diagnostics and with Boehringer Ingelheim’s broad drug discovery and significant clinical development capabilities.

Three partners committed to combat AMR

Boehringer Ingelheim’s participation in Aurobac is part of a wider so-called pandemic preparedness initiative, which includes a 50 million EUR investment in the AMR action fund by Boehringer Ingelheim. Boehringer Ingelheim Venture Fund has committed to invest up to 12 million EUR in AMR infection companies.

bioMérieux has over 55 years of diagnostics expertise with more than 75 percent of its research and development budget focused on antimicrobial resistance. Moreover, 80 percent of its turnover is related to the fight against AMR through a complete diagnostic solution facilitating antibiotic therapy decision-making, including antibiotic initiation, optimization, and discontinuation.

Evotec has built a world-leading platform to tackle infectious diseases. With a more than 200-strong anti-infective discovery team, the company has proven experience on multiple agent classes. On top of the company’s own pre-competitive pandemic preparedness and rapid response technology platform ("PRROTECT"), Evotec leverages its infectious disease capabilities with many industry, academic and non-profit partners and is active in a variety of networks such as the AMR Accelerator that is part of the EU’s Innovative Medicines Initiative ("IMI").

Urovant Sciences and Pierre Fabre Médicament Enter into Exclusive License Agreement to Commercialize Vibegron for the Treatment of Overactive Bladder in the European Economic Area, UK, and Switzerland

On July 5, 2022 Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., and Pierre Fabre Médicament reported they have entered into an exclusive license agreement for Pierre Fabre to register and commercialize vibegron for the treatment of Overactive Bladder (OAB) in the European Economic Area, UK, and Switzerland, with some option territories, which notably include French-speaking countries of Sub-Saharan Africa, Turkey, and certain Eastern European countries (Press release, Pierre Fabre, JUL 5, 2022, View Source [SID1234616481]). Urovant will retain full rights in the United States and other select markets.

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"We are thrilled to partner with Pierre Fabre, a leader in the international biopharmaceutical space," said Jim Robinson, Chief Executive Officer of Urovant Sciences. "Their experience in the global OAB and Benign Prostatic Hyperplasia (BPH) market make them uniquely suited to deliver vibegron to more patients who need it across Europe and surrounding areas."

Under the terms of the agreement, Urovant Sciences will receive payments up to USD $75 million, based on upfront, regulatory, and sales milestone payments. Additionally, Urovant will receive royalties based on sales performance.

Urovant Sciences and Pierre Fabre will share responsibility for vibegron clinical trials in the pediatric populations in Europe. As part of the transaction, Urovant Sciences will also provide manufacturing services to Pierre Fabre.

"We are delighted to enter into this partnership with Urovant, which will bring effective treatment and improved quality of life to all patients suffering from Overactive Bladder (OAB) in Europe. This partnership confirms Pierre Fabre’s extensive expertise in urology and in women’s health for five decades and the group’s ambitions to offer therapeutic solutions to chronic diseases that are very disabling in everyday life," said Eric Ducournau, group CEO at Pierre Fabre.

About Overactive Bladder

Overactive bladder (OAB) is a clinical condition that occurs when the bladder muscle contracts involuntarily. Symptoms may include urinary urgency (the sudden urge to urinate that is difficult to control), urgency incontinence (unintentional loss of urine immediately after an urgent need to urinate), frequent urination (usually eight or more times in 24 hours), and nocturia (waking up more than two times in the night to urinate).1

While 33 million US adults experience the bothersome symptoms of OAB, approximately 546 million people ≥ 20 years are affected by OAB worldwide. 1,2