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5 December, 2022 |
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Be sure to register for our annual Women in Biopharma virtual event this Wednesday at 2 PM ET. We'll celebrate 20 exceptional scientists who are blazing trails in biopharma R&D, followed by a panel discussion with four experts. It's one you won't want to miss! |
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Nicole DeFeudis |
Editor, Endpoints News
@Nicole_DeFeudis
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Tim Walbert, Horizon Therapeutics CEO (via YouTube) |
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by Paul Schloesser
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Horizon Therapeutics announced last week that it was in talks with three pharmaceutical giants that could take over the company. You can now remove one of them from the equation. J&J's Janssen, after Horizon reported its initial involvement in early discussions to acquire the rare disease biotech, issued a statement Saturday that said Janssen "does not intend to make an offer for Horizon," and that Janssen is bound by restrictions set in Rule 2.8 of the Irish Takeover Rules. These rules are in place for any company interested in taking over Irish companies, with Horizon Therapeutics currently based in Dublin. However, Janssen did not completely closed the door on a buyout offer, adding that it reserves the right to backtrack its statement within six months if the circumstances are right and permitted by Rule 2.8. A Janssen spokesperson declined to comment further to Endpoints News. Horizon confirmed last week that “highly preliminary discussions” were taking place with the companies regarding a potential buyout offer after the Wall Street Journal reported takeover interest. Although the company — commanding a near-$18 billion market cap — iterated that “there can be no certainty that any offer will be made for the Company,” shares HZNP went up more than 30% after Horizon's announcement. Of the parties remaining at the dealmaking table, both Amgen and Sanofi alluded to wanting to use cash. Sanofi chief Paul Hudson issued a statement Friday that any offer from the French pharma — although not guaranteed — “will be solely in cash.” Amgen CEO Robert Bradway alluded to a cash possibility, saying in a statement filed on the London Stock Exchange "that any offer by Amgen for Horizon is, or is likely to be, solely in cash." |
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Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool) |
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by Nicole DeFeudis
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The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment. The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo. While Novartis is keeping the details of the data under wraps for now, it said in a press release that Pluvicto met its primary endpoint by achieving a “statistically significant and clinically meaningful” improvement in radiographic progression-free survival compared to a change in ARPI. In an email, the company declined to share much more information, and said additional data will be revealed at an upcoming meeting. US-traded shares of the company NVS were up 1.12% on Monday, at around $91 per share. The drug is specifically approved for patients who test positive for PSMA, a protein that's found on normal prostate cells but is found in higher amounts on cancerous prostate cells. Approval for use earlier in treatment would more than double the number of patients eligible to get the drug, Novartis said in an email to Endpoints News. The company had no unexpected safety findings to report, and plans to approach regulators next year. |
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by Beth Snyder Bulik
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The cancer drug ads that get oncologists' attention online are informative and use clear, eye-catching designs. That’s ZoomRx's assessment in its most recent tracking survey, and while not necessarily surprising, the details in the research do break a few common misconceptions. One of those is frequency, also known as the number of impressions an ad gets. No matter how many times oncologists saw a particular cancer drug ad, effectiveness prevailed in the survey across five drug brands. ZoomRx measured effectiveness as a combination of most attention-getting, relevant information and improved perception as reported by the doctors. Pfizer’s Xalkori, for example, had among the fewest impressions or views of ads seen by oncologists, yet it ranked as one of the two most effective brands, along with Amgen’s Lumakras. Both ads notched high scores for detailed information, as well as easy-to-read concepts and design. “What we found is that there’s actually no relationship between how many impressions an ad gets, so how frequently it’s viewed, and how effective that ad is perceived to be,” said Ty Harkness, ZoomRx associate director of customer engagement, adding, “What makes them effective is very clear messaging — NCCN recommendations are always very compelling — and they need to be attractive visually.” Another common device used by pharma marketers is linking to more information, because ads can get bogged down by too much of it. However, ZoomRx’s survey finds that drug information is better placed inside the ad. As Harkness noted, banner ad rates have a less than 0.1% click rate across the pharma industry. |
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Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images) |
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by Tyler Patchen
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Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe. The New York-based pharma giant's site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site. The plan also builds on the first phase of MAP investment in Kalamazoo, begun in in 2018 and slated to cost $465 million. “Since 2017, Pfizer has invested $5 billion to support the ongoing growth of our manufacturing leadership in the U.S. This expansion is part of our blueprint to grow our U.S. manufacturing base, create more manufacturing jobs, and help ensure patients everywhere can get the medicines they need,” Pfizer CEO Albert Bourla said in a statement. The second phase of the MAP facility plans to incorporate a “technologically advanced” aseptic manufacturing system, equipment and design into the facility. This includes adding several new modular manufacturing lines. The products being manufactured in the MAP facility will also include mRNA technology, which has been a major part of Pfizer’s business since the height of the pandemic, as well as “ultra-low” temperature storage. Currently, the MAP facility employs 3,000 people inside its 400,000 square feet footprint, according to Pfizer. The facility itself produces more than 144 products including sterile, liquid and “semi-solid” medicines as well as active pharmaceutical ingredients. |
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by Nicole DeFeudis
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As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil. The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs. Most IPF patients suffer with a dry cough, and breathing can become difficult. Ifenprodil, also known as NP-120, is an N-methyl-D-aspartate (NMDA) receptor antagonist. NMDA receptors are found on many tissues, including lung cells, and are targets among painkillers and anesthetics. However, Algernon touts ifenprodil as a potential first-in-class option for IPF and chronic cough. According to updated Phase IIa data released back in July, ifenprodil helped reduce patients’ mean 24-hour cough counts by 32% at 4 weeks (p = 0.023) and 39.5% at 12 weeks (p = 0.001) compared to baseline. “We appreciate the U.S. FDA’s decision to grant ODD status to Ifenprodil for IPF, a disease for which prognosis remains dismal, with 50% mortality expected within 3-4 years,” Algernon CEO Christopher Moreau said in a news release. The news comes as the FDA is “not currently finalizing ODE determinations” because of the “far-reaching implications” of a recent court case involving Catalyst and Jacobus. A US appeals court overturned a prior FDA court win, ruling that the agency shouldn't have approved a rare disease drug because a previously approved (and more expensive) one with the same ingredient had orphan drug exclusivity. |
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by Tyler Patchen
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Innoforce is off to the races at its new site in the city of Hangzhou, China. The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ. The company said it's investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces. Innoforce plans to bring on over 300 employees at the site by the end of next year. "Building on existing capabilities, including our outstanding workforce, scale, and modern technology platforms, we are well-positioned to help clients overcome common pain points and bring revolutionary advanced therapies to market. We believe our platform can support clients to reduce cycle times, increase efficiency, and ensure supply reliability that meets international regulators' requirements," Min Zhu, SVP of CDMO operations at Innoforce, said in a statement. Innoforce has been hard at work on the facility. Just last year, it reeled in another $96 million which went straight to construction, with blueprints for a new monoclonal antibody manufacturing facility coming through a partnership with Thermo Fisher Scientific. |
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by Tyler Patchen
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A biotech centered on treating fibrosis — born out of Mass General and Brigham and Women's Hospital — has received a financial boost. According to an SEC filing, the company has raised $31,761,186 in its latest funding round, which includes 17 investors. The filing lists six names attached to the company, including Meredith Fisher, a partner at Mass General Brigham Ventures and Mediar’s acting CEO. Other names in the filing include Peter Parker, the managing general partner at Mission BioCapital, and Michael Baran, a partner at Pfizer Ventures, who are members of Mediar’s board. Nandita Shangari, managing director of the Novartis Venture Fund; Maina Bhaman, a partner at Sofinnova Ventures; and Andreas Jurgeit, a partner at Gimv, were also listed on the document. Endpoints News has reached out for more information on the funding. In an email, Fisher said that Mediar is not commenting at this time. Mediar, which was founded by Mass General Brigham Ventures and researchers from the institution in 2019, is still in the preclinical stage. The biotech is developing candidates to try and halt or reverse fibrosis by using the cell known as the myofibroblast. The biotech raised a seed extension in 2021, which brought on Pfizer Ventures and Ono Venture Investment as new members to bring the total backing to $20 million. Mass General Brigham Ventures led the initial seed round in 2019, along with other investors, to support a discovery platform and the development of antibody treatments. |
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by Kyle LaHucik
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While NBC ran "The Biggest Loser" for 17 seasons, deemed toxic by critics for the reality show's punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data. Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen's AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon. Novo's Wegovy is already a Hollywood darling and uptaken by the likes of Elon Musk since getting a 2021 label expansion after a 2017 diabetes nod (Ozempic), and Lilly is within quarters of completing its submission for tirzepatide, which is on the path to a fast-tracked approval after securing marketing authority earlier this year as Mounjaro for Type I diabetes. Known for drugs like Otezla and more recently notching first in the KRAS race with Lumakras, Amgen is wading into the obesity treatment market with a drug that attacks two pathways, like Eli Lilly. Instead of hitting the gas pedal on both pathways like Lilly, Amgen is ramping up one (GLP1) and taming the other (GIP) based on a genetic study that its subsidiary helped conduct — in which "Mother Nature’s experiment" showed inhibition, rather than stimulation, did the trick, Amgen VP Narimon Honarpour told Endpoints News. |
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John Carroll
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Editor & Founder
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Arsalan Arif
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Publisher & Founder
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Igor Yavych
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Chief Technical Officer
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Valentin Manov
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Creative Director
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Drew Armstrong
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Executive Editor
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Melissa Nazzaro
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Sales Director
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Julie Notario
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Sales Director
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Amanda Florez
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Chief of Staff
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Kari Abitbol
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Director, Studio
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James Cherrick
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Controller
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Worldwide made. Thanks for reading.
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