As Adcetris slows, Seattle Genetics touts early launch figures for bladder cancer med Padcev

FiercePharma | February 07, 2020

It wasn’t long ago when Seattle Genetics shareholders moved past earlier letdowns and cheered strong performance from key cancer drug Adcetris. But now, they might be disappointed again. During the fourth quarter, Adcetris pulled in sales of $166.2 million in the U.S. and Canada, a 26% increase over 2018. Still, the number came below the Street’s expectations of $174.5 million as well as its own third-quarter sales of $167.6 million. The fourth-quarter haul brought the antibody-drug conjugate’s 2019 total to $627.7 million, which was at the bottom end of the company’s guidance provided in October, SVB Leerink analyst Andrew Berens said in a Friday note to clients. Seattle Genetics itself doesn’t predict significant improvement in the near term. For 2020, the company expects Adcetris sales to come in between $675 million and $700 million, under Berens’ previous estimate of around $788 million. The company is only expecting organic sales increases in the single-digit percentages, the analyst noted. Seattle Genetics just raised the drug’s list price by 3.9% in December, he wrote.

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Ex-Biocon team Symbio Generrics completes capital raise from Ascent Capital

Symbio Generrics | November 25, 2022

Symbio Generrics India Private Limited a specialized Active Pharmaceutical Ingredients & Intermediates manufacturing and marketing organization, announced that it has completed an equity capital raise from Ascent Capital, a leading growth-capital focused private equity fund. Symbio was founded by pharmaceutical professionals, Salim Shaikh and Abhijit Kale. They were soon joined by the third promoter, Akash Puranik; all of whom possess decades of experience in the global pharmaceutical industry. Symbio's journey from a sales and marketing organization to a full-fledged vertically integrated manufacturer of specialized APIs has been exemplary. Through a well-developed customer ecosystem, the highly experienced & skilled team at Symbio has established a global footprint for its APIs. Ascent Capital's sizeable investment in Symbio will further accelerate the company's expansion plans and sets the company enroute to emerge as a top-10 manufacturer of APIs in India. The funds raised from Ascent will be utilized towards undertaking strategic acquisitions, establishing a best-in-class R&D facility and ramping up manufacturing capacity. The company's R&D Centre is housed in Bengaluru while the manufacturing plant is located at Dobbaspet, Bengaluru. The Company is in the process of acquiring another manufacturing facility in India. The team is focused on building a high-potential generics API portfolio for the global markets and to this effect, will work towards getting US FDA and other SRA approvals for their recently acquired facilities. "We are glad to be associated with Ascent Capital which has a reputation of partnering with entrepreneurs to build leading businesses in India. The sizeable investment from Ascent Capital will add power to our next growth spurt and enable us to emerge as a top-10 API company in India. We are setting ourselves a medium-term goal of growing rapidly into a sizeable company by leveraging the strength of our team and expanding our horizons to actively serve the global API market." Commenting on the fund raise, Salim Shaikh, Executive Chairman & Founder of Symbio Generrics Akash Puranik, Promoter, MD& CEO of Symbio Generrics, says, "The latest feather in our cap is the influx of resources from Ascent Capital. We have carved strategic alliances and relationships spanning over two decades with leading pharmaceutical entities in regulated and semi-regulated markets and are now keen to expand these synergies further in the global arena. With a well-developed infrastructure, both on the manufacturing and R&D front, we are keen to engage with potential partners for CDMO Business." Mr. Raja Kumar, Founder and MD of Ascent Capital, said, "Ascent Capital has been known to support highly qualified professional teams in niche domains. Continuing with this tradition, we are delighted to partner with the first-generation technocrat founders at Symbio. Collectively, the team at Symbio is one of the best multi-disciplinary teams in the Indian pharma space and has shown an exemplary track record of building global relationships. We look forward to working collaboratively with the Company to ensure that we have another category leader from the Ascent stable, akin to BigBasket, Sequent, Skanray, to name a few." IC Universal Legal's Chennai team led by Senior Partner, Sameena Chatrapathy represented Symbio as the legal counsel for the fund raise from Ascent Capital as well as the follow-on acquisitions. About Symbio Symbio Generrics India Private Limited founded in the year 2010 is a specialized Active Pharmaceutical Ingredients & Intermediates manufacturing and marketing organization with headquarters in Bengaluru. The Company was founded by first generation entrepreneurs coming from a leading pharmaceutical organization, with a combined experience of over 40 years. About Ascent Capital Ascent Capital is a leading India-focused Independent Private Equity Fund Manager. The team at Ascent is one of the most experienced investment teams in India with 150+ years of collective experience in Indian PE and capital markets. Thus far, Ascent has helped more than 60 entrepreneurs build leading businesses across diverse sectors such as Technology, Healthcare, Financial Services, Consumer Brands, etc. It typically invests USD 10-30 MM in fast growing businesses, led by outstanding entrepreneurs, that have the potential to emerge as leaders in its segment thereby delivering exceptional exit outcomes. Ascent is backed by marquee investors, who include long term institutional investors like pension funds, foundations, endowments, fund of funds and large corporations - a vote of confidence in the team's ability to excel and deliver results.

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PHARMA TECH

ArisGlobal Accelerates Growth Announces Executive Evolution

ArisGlobal | September 08, 2022

ArisGlobal, the leading provider of life sciences software that automates core drug development functions with its end-to-end technology platform LifeSphere®, today announces an expansion to its C-suite. James Jarrett is the company's new Chief Financial Officer, Kathleen Turland joins as the first Chief Legal Officer, and Aman Wasan has stepped into the new role of Chief Commercial Officer. The three appointments are happening during a time of significant momentum for ArisGlobal, which has experienced annual recurring revenue growth of 34% in the first half of 2022 YoY. James Jarrett, Chief Financial Officer Jarrett brings over a decade of executive leadership experience driving revenue and cash flow growth. He has partnered with management teams and boards of directors of high-growth, highly leveraged companies undergoing rapid change. Prior to joining ArisGlobal, he served as the CFO for Emergence Health Holdings, Carewell Urgent Care, and ProCure Proton Therapy Center. Kathleen Turland, Chief Legal Officer Turland is a global strategic leader with more than 20 years of legal experience. She brings her broad range of legal and business skills to ArisGlobal, having worked with companies experiencing significant growth and expansion over the years, including General Electric, and FUSE Group. She started her legal career in New York, clerking for a Federal Court Judge, and working at two revered New York law firms. Aman Wasan, Chief Commercial Officer Wasan is an expert in general management and commercial leadership with a deep understanding and knowledge of drug safety and clinical research. Since joining ArisGlobal in 2018, Wasan has excelled in six different positions, most recently as Senior Vice President of Global Commercials, where he managed global enterprise business. Before joining the ArisGlobal team, Wasan worked for Bioclinica as the company's Global Head of Safety and Regulatory Services. "As we continue scaling our business and building new functions to better serve our customer base, expanding our C-suite will help us execute our mission and further drive our success in the life sciences industry. James, Kathleen, and Aman carry a wealth of industry knowledge instrumental in empowering ArisGlobal to further expand its customer pipeline, continue to develop innovative technology, and maintain a role as a trusted leader in the market." CEO Mike Gordon Turland's addition to the company also represents consistent and focused efforts by ArisGlobal to continually put women in positions of leadership. Turland joins ArisGlobal veterans Ritu Shrivastava, Vice President Corporate Development, and Heidi Hattendorf, Vice President of Marketing, on the executive team. Currently, ArisGlobal also has women in core leadership positions across business, product, quality, people, and technology functions. About ArisGlobal ArisGlobal is led by passionate individuals who support life sciences leaders in developing and monitoring breakthrough medicines and therapies. With more than 35 years of expertise in the life sciences industry, ArisGlobal develops technology products within the platform LifeSphere to power pharmaceutical and biotech research and development. Building on our commitment to corporate social responsibility and sustainability initiatives, we give back to the communities where we live and work – in the U.S, Europe, India, Japan, and China.

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VIEWS AND ANALYSIS

Altamira Therapeutics Provides Business Update and First Half 2022 Financial Results

Altamira Therapeutics Ltd | December 01, 2022

Altamira Therapeutics Ltd. a company dedicated to developing therapeutics that address important unmet medical needs, today provided a business update and reported its first half 2022 financial results. “We continue to make good progress with the transformation of Altamira into an RNA delivery technology company. We are optimistic of reaching an agreement to divest or partner our Bentrio nasal spray for key markets in North America and Europe by year end. Last month, we agreed to divest part or all of our inner ear therapeutics programs to a European family office. Following some delay and under slightly amended terms, we expect that transaction to close in December. Thomas Meyer, Altamira Therapeutics’ founder, Chairman and CEO “Heading towards 2023, we look forward to focusing exclusively on the many emerging opportunities in the fast-growing RNA therapeutics market. We are increasingly well positioned to advance our RNA delivery technology throughout 2023.” As Altamira is going through the final stages of a major corporate transformation, management intends to hold its next investor call upon finalization of its partnering / divestiture projects. On that call, the Company will also provide its outlook for 2023. RNA delivery platform update Altamira continued to make solid progress with the development of its patented, peptide-based platform for RNA delivery to extrahepatic tissues. In recent months, the RNA team led by Chief Development Officer Covadonga Pañeda, Ph.D., and Chief Scientific Officer Samuel Wickline, MD, have advanced various projects, including selection and optimization of siRNA sequences, formulation, process development and manufacturing. Starting with project AM-401 for the treatment of KRAS-driven tumors, the Company added a second project, AM-411 for the treatment of rheumatoid arthritis. AM-411 nanoparticles comprise siRNA targeting NF-kB a key checkpoint in RA inflammation. The Company is developing both AM-401 and AM-411 with the objective of out-licensing the drug products at a later stage. They serve as a “showcase” for the application of Altamira’s RNA delivery technology; the Company’s strategy will be to out-license the technology to pharma and biotech companies for use with their own RNA molecules. In this context, Altamira has been intensifying its efforts to raise awareness about OligoPhore/SemaPhore within science and industry. In recent months, members of Altamira’s leadership team gave oral presentations at multiple international conferences, highlighting the ability to deliver RNA molecules to extrahepatic tissues and achieve efficient and rapid endosomal release inside target cells. Concurrently, further data on RNA delivered with Altamira’s delivery technology has been published by independent research groups in peer-reviewed scientific journals. Altamira anticipates entering into its first partnering agreements in 2023. Bentrio Update Earlier today, Altamira reported that its licensee and distribution partner Nuance Pharma has launched Bentrio nasal spray in Hong Kong to help provide protection against airborne viruses as well as allergens. This will be the first step to distributing Bentrio in the other Nuance-licensed territories which is comprised of mainland China, Macau and South Korea. As part of its strategy to focus exclusively on RNA delivery, Altamira has been in discussions with several well-established OTC consumer health companies for the partnering of Bentrio. Those discussions intensified following the 510(k) clearance of the product by the FDA and have advanced well, including due diligence by interested parties. The Company anticipates entering into a partnering transaction before year end. In the context of those partnering discussions, Altamira suspended preparations for launching the product in the US on its own as well as pausing major marketing initiatives in Europe. This restraint provides the prospective strategic partner for Bentrio with maximum flexibility to fit the product into its business plan. Beginning in early October, the Bentrio nasal spray was relaunched in Europe for allergic rhinitis. Previously, the Company had ceased marketing the product for the indication of viral infection in the EU and Switzerland although Bentrio’s mode of action is the same regardless of whether it provides a barrier against airborne virus or allergen particles. This had been demonstrated in various relevant in vitro assays. However, certain countries and regions require specifically clinical performance data to clear Bentrio for this indication, in particular related to COVID-19. Such data are expected to become available through the COVAMID trial. In September, Altamira announced that it had reached its extended enrollment target of 160 confirmed subjects in its COVAMID clinical investigation to evaluate the safety, tolerability, and efficacy of its Bentrio nasal spray in patients with acute COVID-19. The read-out of top-line data remains on track for the current quarter. The Company plans to seek an expansion of its product label to also include viral infections in those countries requiring supportive clinical data. In September, the Company also announced that its “NASAR” clinical trial in seasonal allergic rhinitis (SAR) resumed enrollment as the new pollen season started in Australia. The NASAR trial is expected to enroll a total of 100 patients suffering from SAR and is designed to compare the safety and efficacy of Bentrio against a (control) saline nasal spray. The primary endpoint will be the comparison of the reflective Total Nasal Symptom Score under treatment with Bentrio against control. The NASAR trial was initiated in the fall of 2021. It was suspended in spring 2022 as the pollen season came to an end before the enrollment target could be met. Interim data from the trial were used in support of the 510(k) clearance of Bentrio by the US FDA. Unless an interim analysis performed upon reaching 50% of the enrollment target to check the validity of the statistical powering assumptions requires a change to the target size of 100 patients, the Company expects to complete enrollment into the NASAR trial by year-end or in early 2023 with a read-out of top-line data in late 1Q-23.

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BUSINESS INSIGHTS

Iterative Scopes Receives FDA Clearance for AI-Assisted Polyp Detection Device SKOUT™

Iterative Scopes | September 23, 2022

Iterative Scopes, a pioneer in precision medicine technologies for gastroenterology, and Provation, the premier software and SaaS provider of clinical productivity and workflow automation solutions, announced that SKOUT™ has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for adults undergoing colorectal cancer screening or surveillance. SKOUT, a real-time computer-aided polyp detection device developed by Iterative Scopes, uses advanced computer vision technology designed to recognize suspicious tissue and provide real-time feedback to gastroenterologists. The device was evaluated in the largest U.S.-based multicenter clinical study for a computer aided polyp detection (CADe) device completed to date, which determined that SKOUT significantly improved overall adenoma detection in screening and surveillance colonoscopy compared to standard colonoscopy.1 In March 2021, Provation and Iterative Scopes entered a partnership focused on delivering artificial intelligence-based solutions to healthcare providers and researchers. Provation is a market leader in gastrointestinal (GI) documentation, with more than 3,500 customer facilities including 80% of the top academic and large health systems, and the company will act as an exclusive distributor of SKOUT to help broaden the technology’s reach among the country’s top GI-focused organizations. Colorectal cancer is the second leading cause of cancer-related deaths in the United States and Europe,2 3 due in part to the high volumes of adenomas – approximately 26%4 – that endoscopists miss when conducting a colonoscopy. In its registration trial, SKOUT was found to improve adenoma detection, as measured by adenomas per colonoscopy (APC). Furthermore, increased detection was not limited to diminutive polyps. Higher APC rates have been shown to lead to improved patient outcomes; a recent study showed that the incidence of colorectal cancer within three years of examination decreases with higher APC rates.5 “Even among the best endoscopists, there is room for improvement in adenoma detection, which can impact patient outcomes. We are enthusiastic about the fact that even gastroenterologists with an already high baseline rate of adenoma detection demonstrated an improvement with SKOUT. Now that SKOUT is FDA-cleared, clinicians will be able to better detect adenomas with more efficiency, and ultimately change the standard of gastrointestinal care.” Sloane Allebes Phillips, VP of Clinical Operations at Iterative Scopes SKOUT is indicated as a computer-aided detection tool to assist qualified and trained endoscopists in identifying potential colorectal polyps during colonoscopy examinations in adult patients undergoing colorectal cancer screening or surveillance. SKOUT demonstrated a 27% relative increase in the detection of adenomas per colonoscopy, with an average of one additional adenoma resected for every 4.5 patients examined. Importantly, in the proximal colon, SKOUT demonstrated a 44% relative increase in 5-9 mm polyp detection, and a 29% relative increase in 5-9 mm polyp detection overall.1 These results validate the need for technological advancements that can help improve colonoscopies, and SKOUT’s artificial intelligence capabilities position it to do so. “Knowing that patients can walk away from their appointment with the confidence that they received a high quality and detailed colonoscopy is what excites us most about SKOUT’s FDA clearance,” said Aasma Shaukat, MD, MPH, Robert M. and Mary H. Glickman Professor of Medicine and Gastroenterology at NYU Grossman School of Medicine, and a primary investigator on the SKOUT registration study. “Confidence and peace-of-mind on behalf of providers and patients alike will allow clinicians to provide stronger recommendations and solutions for their patients.” “We are thrilled that our partner Iterative Scopes has received FDA clearance for their AI-Assisted Polyp Detection device, SKOUT. We have been very impressed with its study results and are eager to share our vision for integrating this technology into our solutions,” said Daniel Hamburger, CEO at Provation. “SKOUT is a true game-changer for the field of gastroenterology, and we can’t wait to start seeing its impact on patient care.” SKOUT’s intuitive user interface seamlessly integrates with existing clinical workflows and does not increase total procedure or withdrawal time.1 When a potential polyp is detected, the system calls attention to the polyp on the procedure monitor by drawing a blue bounding box around it and tracking the polyp as it moves on the screen. If a medical tool enters the frame, the bounding box automatically disappears to avoid obstructing the physician’s view during polyp removal. About Iterative Scopes Iterative Scopes is a pioneer in the application of artificial intelligence-based precision medicine for gastroenterology with the aim of helping to optimize clinical trials investigating treatment of inflammatory bowel disease (IBD). The technology is also designed to potentially enhance colorectal cancer screenings. Its powerful, proprietary artificial intelligence and computer vision technologies have the potential to improve the accuracy and consistency of endoscopy readings. Iterative Scopes is initially applying these advances to impact polyp detection for colorectal cancer screenings and working to standardize disease severity characterization for inflammatory bowel disease. Longer term, the company plans to establish more meaningful endpoints for GI diseases, which may be better predictors of therapeutic response and disease outcomes. Spun out of MIT in 2017, the company is based in Cambridge, Massachusetts. About Provation Provation is a leading provider of healthcare software and SaaS solutions for clinical productivity, care coordination, quality reporting, and billing. Our purpose is to empower providers to deliver quality healthcare for all. Provation’s comprehensive portfolio spans the entire patient encounter, from pre-procedure through post-procedure, with solutions for physician and nursing documentation anesthesia documentation patient engagement, surgical care coordination, quality reporting, and billing capture order set and care plan management and EHR embedded clinical documentation. Provation has a loyal customer base, serving more than 5,000 hospitals, surgery centers, and medical offices, and 700 physician groups globally, including 19 of the top 20 U.S. hospitals. In 2021, Provation was acquired by Fortive Corporation, a Fortune 1000 company that builds essential technology and accelerates transformation in high-impact fields like workplace safety, engineering, and healthcare.

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Lung Cancer is the leading cause of cancer death. It claims more lives each year than do colon, prostate, ovarian and breast cancers combined. ISR explores risk factors, treatment, and drug development in this infographic.

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