Lymphangitis

Dec 12 (Reuters) - Amgen Inc (AMGN.O) on Monday agreed to buy Horizon Therapeutics Plc (HZNP.O) in a deal valued at $27.8 billion, fortifying its rare diseases portfolio in the biggest buyout in the sector this year. The company will pay $116.50 in cash, a premium of nearly 20% to the stock's last close, for each Horizon share. Horizon shares closed up 15% on Monday at $112.36. They had climbed 23.5% through Friday since the company disclosed in late November it was in preliminary talks with Amgen, Sanofi (SASY.PA) and Johnson & Johnson (JNJ.N) for potential offers. Amgen shares dipped less than 1% to close at $276.78. With the deal, Amgen gains two fast-growing drugs, the thyroid eye disease treatment Tepezza and gout treatment Krystexxa. Amgen hopes they can act as a bulwark against rising competition for its blockbuster arthritis drug Enbrel and as other key drugs in its portfolio, such as psoriasis therapy Otezla, face loss of patents over the next few years. Both Horizon medicines have an orphan drug designation, a status granted by the U.S. Food and Drug Administration to encourage development of drugs for rare conditions that comes with a market exclusivity period if the drug is approved. Orphan status also means they would likely not be among the drugs for which the U.S. government's Medicare program can negotiate lower drug prices under the Biden Administration's Inflation Reduction Act (IRA). "We liked this company, even before the IRA," Murdo Gordon, Amgen's head of global commercial operations, said in an interview. "Given the IRA, the strategic importance of being in these kinds of disease areas with biologics primarily, and with products that have low Medicare exposure and orphan designation, makes it even more attractive," he added. Amgen plans to finance the deal through debt and cash, and has entered into a $28.5 billion credit agreement with Citibank (C.N) and Bank of America (BAC.N) Amgen said it expects the deal to close in the first half of next year and add to earnings from 2024. It does not anticipate any "overlaps of concern to regulators." Sales of Amgen's Enbrel tumbled 14% in the latest reported quarter to $1.1 billion. Tepezza, Horizon's largest selling drug, saw sales double to $1.66 billion in 2021 from a year earlier. Analysts forecast Tepezza sales reaching $3.85 billion in 2028, while Enbrel sales are expected to fall to $1.89 billion during the same period, according to Refinitiv data. Horizon's gout treatment Krystexxa brought in sales of $565.5 million last year. They are forecast to reach $1.36 billion by 2028. "The offer clearly brings in a number of growing assets for Amgen," said William Blair analyst Matt Phipps. "However, the deal comes with significant debt," Phipps said, adding that the acquisition stretches Amgen's net debt-to-core-earnings ratio. Amgen is testing a closely watched obesity drug in early trials as it seeks to tap a potential multibillion-dollar market that has excited biotech investors. The Horizon bid follows Amgen's $3.7 billion deal in August for rare blood vessel inflammation treatment maker ChemoCentryx Inc . The offer values Horizon at $27.8 billion on a fully diluted basis, according to the company, which includes ordinary shares to be vested. Based on Reuters calculations, it values Horizon at about $26 billion and gives Horizon a $28.3 billion valuation, including debt. Our Standards: The Thomson Reuters Trust Principles.

Great strides have been made over the last few decades that see more women and men surviving breast cancer, but the journey leaves survivors with physical, mental and emotional impacts that can take years to recover from or to learn to cope with the often disabling new realities. For Dr. Nandini N. Kulkarni, medical director of surgical oncology at New Jersey-based Inspira Health Network, technologies that provide early detection to prevent chronic conditions, increase accuracy for biopsies and lumpectomies and elevate surgical outcomes improve survivorship. Preventing lymphedema with early intervention Kulkarni called bioimpedance spectroscopy a game changer andwas eager to share the progress that's been made in ongoing surgical care. Finding subclinical lymphedema much sooner than clinical manifestations "allows me to refer the patients in a much more timely and aggressive fashion to physical therapy than I would have in the past," she said. Lymphedema can quickly develop to chronic stages, and it's functionally debilitating and potentially deadly with a risk of lymphangitis infection and the development of sarcomas over time. Some women have higher risk factors to develop lymphedema, but even those who have had sentinel node biopsy and no further lymph node dissection as part of their cancer treatment run a 6-12% risk, she said. "The risk doesn't nullify five, seven, ten years down the line. There can be delayed lymphedema," Kulkarni said. And only in the early stages can lymphatic dysfunction be reversed. Catching lymphedema early to improve the quality of life and reduce down-the-line diseases is where this patient data collection tool is so attractive for preventive care for breast cancer programs. "This is going to become a fairly vital tool in every surgeon's repository," she said. Before the L-Dex Beginning ideally with diagnosis, breast cancer patients are scanned as part of their regularly scheduled appointments at their surgeon's office, said Kulkarni. Of the 261 Inspira Health breast cancer patients scanned post-treatment between January 2021 and October 12 across two cancer centers, nearly 15% met the threshold and were referred for physical therapy. "The alternative to bioimpedance spectroscopy was the tape measure. You know, kind of actual physical limb circumference measurements, which as you can imagine is a fairly cumbersome process because it has to be standardized," Kulkarni explained. There was a lot of variability in the measure depending on the technician. However, Impedimed's SOZO platform calibrates itself, making sure the patient is positioned correctly to get the most accurate Lymphedema Index (L-Dex) score. "That has been extremely helpful, I don't have to worry that these measurements are not accurate," she said. While patients must avoid exercise and liquids prior to their L-Dex scans and remove jewelry, socks and shoes, results from the 30-second test are available immediately. Patients simply stand on the device, and low-level electrical signals pass through the body providing a precise picture of fluid status and tissue composition. As part of the New Jersey-based non-profit health system's "prehab to rehab" program, patients are measured and monitored up to five years after surgery. Studied and in use in Australia since the early 2000s, there are more that 700 SOZO devices in use. Practitioners there advocate for widespread L-Dex monitoring of all breast cancer patients for early detection of disease progression. While it is too soon for Kulkarni to report statistically significant results, it's clear that the surveillance and early intervention program is reducing the incidence of chronic lymphedema in clinical practice at Inspira Health. "Anecdotally, it's definitely made a difference. I have seen patients where a greater than six rise in their fluid index score has triggered a physical therapy appointment, and I can see that number go back down," she said. Patients that had their L-Dex numbers rise up to almost the point of clinical lymphedema are able to start treatment with manual compression devices and reverse their scores, said Kulkarni. "I've seen that number go back into the green and stay in the green," she said. Going wireless with localizing Kulkarni also uses SAVI SCOUT – wireless localization tags from Merit Medical that increase patient comfort, decrease the number of steps before breast cancer surgery and improve the accuracy of lumpectomies and lymph node dissections. The size of a grain of rice, the tags are also used to locate biopsied lymph nodes for greater accuracy in dissection. "The localization is far superior than you know, kind of estimating where that wire went based on mammography images. Now I have a probe telling me exactly what the distance from the probe to the clip is. There's no guesses here. And it allows me to put my incision in a much more cosmetic fashion," she explained. The tags can safely be placed prior to the day of surgery. According to the manufacturer's website, they can even be placed during the initial biopsy after detection. Oncoplastic device sharpens radiation field A bioabsorbable spiral scaffolding product embedded with radiation clips serves a dual purpose is also one of her favorite tools, said Kulkarni. The scaffolding provides a more precise 3-D view of where the tumor was for targeted radiation treatment. "It really hones down the area they have to boost during radiation," she said. The second advantage the Hologic Biozorb provides is filling the loss of volume that a lumpectomy creates, allowing Kulkarni to connect the adjacent breast tissue and improve the overall cosmetic result of the surgery. The bioabsorbable device dissolves over a period of two years, just leaving the clips behind, having bridged the cavity so it doesn't sink in. Andrea Fox is senior editor of Healthcare IT News. Email: afox@himss.org Healthcare IT News is a HIMSS publication.