Bayer, Elanco could lock up animal health merger next week

FiercePharma | August 08, 2019

When rumors emerged nearly a year ago that Bayer might be planning to exit the animal-health business, Eli Lilly spinoff Elanco was not at the top of any market-watchers list of potential buyers especially not after it became clear that several private equity players were interested in the asset. Turns out Elanco was interested, and the two companies could announce an agreement to merge as soon as next week, Reuters reports, citing unnamed sources. Elanco would pay for the deal partly in stock, and it could be aiming to time the announcement with its quarterly report next week, the sources said. A spokesperson for Elanco declined to comment to FiercePharma. A spokesperson for Bayer said in an email that the company is “on track” to exit animal health. “Following a strategic review of exit options, the primary focus is on a sale. However, Bayer also continues to consider all value-maximizing options,” he said. Although combining two companies would create an animal-health giant rivaling Pfizer spinoff Zoetis and Merck’s animal health business, Elanco isn’t in the best shape financially to execute a big deal. It did pull off an upsized $1.5 billion initial public offering last September, but it’s still carrying a lot of debt—$2.5 billion, according to its most recent annual report. The report warned that Elanco may not be able to generate enough cash to service that debt.

Spotlight

A cutting-edge technique called cellular barcoding has been used to tag, track and pinpoint cells responsible for the spread of breast cancer from the main tumor into the blood and other organs. The study could help to inform new targeted treatments for breast cancer, the most common cancer to affect women.

Spotlight

A cutting-edge technique called cellular barcoding has been used to tag, track and pinpoint cells responsible for the spread of breast cancer from the main tumor into the blood and other organs. The study could help to inform new targeted treatments for breast cancer, the most common cancer to affect women.

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BUSINESS INSIGHTS

Health Canada Approves Ipsen’s Sohonos™ (palovarotene capsules) as the First Approved Treatment for Fibrodysplasia Ossificans Progressiva

Ipsen | January 24, 2022

Ipsen announced the Health Canada approval of Sohonos, an oral selective retinoic-acid receptor gamma agonist indicated to reduce the formation of heterotopic ossification in adults and children aged 8 years and above for females and 10 years and above for males with fibrodysplasia ossificans progressiva.1 Sohonos is approved for the treatment of patients with FOP for both chronic use, and for flare-ups, in these patient populations. This decision marks the first approval for Sohonos worldwide. “FOP is a progressive and debilitating condition which has such a profound impact on patients, and their families. Until today, there was no approved medicine, and we are proud to bring this important new medicine to the FOP community.” Dr. Howard Mayer, Executive Vice President and Head of Research and Development, Ipsen FOP is characterized by new bone formation outside of the normal skeletal system, like in soft connective tissues, a process known as heterotopic ossification,2 which can be preceded by painful soft tissue swelling or “flare-ups.”2 Flare-up episodes are common and are a substantial contributor to the formation of new bone, however bone can also form in the absence of a flare-up. Once formed, it is irreversible and leads to loss of mobility and shortened life expectancy.2 It is an ultra-rare genetic disorder with an estimated prevalence of 1.36 per million individuals; however, the number of confirmed cases varies by country.3,4. As part of the ongoing commitment to the FOP and rare disease community, Ipsen plans to file in the US in H1 2022 and is in discussions with other regulatory authorities around the world. About the MOVE clinical program This approval is based on data from the ongoing MOVE trial, the first global multi-center Phase III trial in FOP. MOVE is an open-label, single-arm trial, evaluating the efficacy and safety of a chronic/flare-up dosing regimen of palovarotene in decreasing new annualized HO volume in patients with FOP. About Sohonos Sohonos is an oral, selective RARγ agonist developed as a treatment for people living with the debilitating ultra-rare genetic disorder, FOP. The treatment was acquired by Ipsen through the acquisition of Clementia Pharmaceuticals in April 2019. It is a member of the retinoid class of drugs that is associated with birth defects in humans. Sohonos must not be used by patients who are, or intend to become, pregnant due to the risk of teratogenicity. To minimize fetal exposure, Sohonos is to be administered only if all conditions for pregnancy prevention are met. Sohonos has been shown to cause premature physeal closure in growing children with FOP; periodic monitoring is recommended. About Ipsen Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience; it also has a well-established Consumer Healthcare business. With total sales of over €2.5bn in FY 2020, Ipsen sells more than 20 medicines in over 115 countries, with a direct commercial presence in more than 30 countries. The Company’s research and development efforts are focused on its innovative and differentiated technological platforms located in the heart of leading biotechnological and life-science hubs: Paris-Saclay, France; Oxford, U.K.; Cambridge, U.S.; Shanghai, China. Ipsen has around 5,700 colleagues worldwide and is listed in Paris and in the U.S. through a Sponsored Level I American Depositary Receipt program.

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PHARMACY MARKET

KEEP, The Modern Medicine Cabinet, Announces Partnership with McKesson Canada

KEEP Labs Inc. | January 28, 2022

KEEP Labs, the Modern Medicine Cabinet and KARE by KEEP Adherence Platform developers, are pleased to announce a partnership with McKesson Canada to provide a novel solution for Canadians taking specialty medications. A majority of healthcare activities occur in the home, making it a critical place to monitor, engage and support patients. KEEP's state of the art technology and intuitive design allows McKesson Canada to provide an award-winning adherence platform that supports all dosage forms, from oral to injectable therapies. This partnership extends the reach of McKesson Canada's patient engagement capabilities, allowing them to gain greater insight into how to best support patients in real-time. KEEP and McKesson Canada are building the patient experience of the future. Despite notable advancements in new treatment options, adherence rates remain stagnant. Patient support programs have an opportunity to expand their services to drive adherence, capture real world evidence (RWE) and utilize new data sources to intelligently guide which patients can benefit most from specific interventions. "A key function of KEEP is removing friction throughout the entire patient journey and passively capturing daily dosing events through automation in real-time, rather than relying on patients to manually input when doses are taken. When we have full visibility to the last and most important mile of the therapy journey, we have the best opportunity to intervene in a proactive and meaningful way. We're helping to enable the industry to transition from retrospective monthly data points to real-time and actionable intervention capabilities." Jeff Wandzura, RPh, CEO of KEEP Labs KEEP has built an integrated technology ecosystem to support providers with the data they need to make informed decisions. Patient support program providers are confronting the complexity of integrating disparate systems to deliver actionable intelligence to all stakeholders. McKesson Canada's commitment to providing an industry-leading technology stack starts by ensuring that innovative partners, like KEEP, are enhancing and complementing existing technologies through seamless integration. The ability to intervene in real-time via nurse outreach, educational content or behavioural nudges that are configured on a program and patient archetype specific basis allows McKesson Canada to personalize the experience for each patient. These learnings are continually refined over the course of the program (using real world data), providing a first-of-its-kind data set with outcomes reported to partner organizations and members of the care team. ABOUT KEEP LABS KEEP Labs is a Canadian tech company founded by two dads who were looking for a smart way to store prescription medication at home. KEEP Lab's introductory product, KEEP, is a TIME Best Invention of 2020 and CES 2020 Innovation Honoree. KARE by KEEP is the first medication adherence and analytics platform for global life sciences companies, patient support programs and pharmacy networks that integrates both hardware and software for all dosage forms, providing deeper insight into the patient journey at home.

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PHARMA TECH

Sebela Pharmaceuticals Announces U.S. Launch of SUTAB® Tablets, An Alternative to Liquid Colonoscopy Preparation

Sebela Pharmaceuticals | January 06, 2021

Sebela Pharmaceuticals® today announced that SUTAB® (sodium sulfate, magnesium sulfate, and potassium chloride) tablets, the first tablet colonoscopy preparation to receive approval from the U.S. Food and Drug Administration (FDA) in over 10 years, is now available in the United States. SUTAB is a sulfate-based tablet colonoscopy preparation that is taken orally in a split-dose administration starting the evening before a colonoscopy. The tablets offer a safe and effective alternative to liquid colonoscopy preparations, which traditionally require consuming large volumes of poor-tasting solution and can often be a barrier to patients' willingness to undergo colonoscopy screening for colorectal cancer. 1 The American Cancer Society and the U.S. Preventive Services Task Force recommend adults undergo screening for colorectal cancer beginning at age 45.2 Colonoscopy is the gold standard detection method for colorectal cancer, a leading cause of cancer-related deaths that can be more effectively treated if caught early through screening.3 Within the last decade, the rate of colonoscopy procedures has increased significantly with approximately 18 million people now screened annually for colorectal cancer. "Alternative colonoscopy preparations, like SUTAB, can play an important role in encouraging more patients to get screened for colorectal cancer," said Alan Cooke, President and CEO of Sebela Pharmaceuticals. "With the introduction of SUTAB tablets, we hope to take yet another important step toward removing some of the burden often associated with the preparation process – allowing more patients to feel confident in their choice to undergo a colonoscopy." The FDA approved SUTAB on November 10, 2020. The approval was based on positive Phase 3 clinical trials, which evaluated the safety and efficacy of SUTAB compared to FDA-approved preparations in 941 patients, including a traditional polyethylene glycol and ascorbate preparation (PEG-EA) for bowel cleansing prior to a colonoscopy.4

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