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18 July, 2022 |
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Launching a new pharmaceutical product is a complex endeavor, involving a web of interrelated activities from clinical trials through market maturity. Manufacturers can avoid common pitfalls on their commercialization journey when they employ strategic, integrated commercialization solutions. Read the eBook and learn what manufacturers need to know about optimizing everything from clinical trials and payer engagement to patient support and field solutions. |
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Welcome back to our daily pharma newsletter. We hope you had a good weekend. Today's issue features more clarity around a few pharma companies' layoffs, the launch of GSK's Haleon, the return of Khloé Kardashian to pharma marketing, and much more. |
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Zachary Brennan |
Senior Editor, Endpoints News
@ZacharyBrennan
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MIT professor Andrew Lo (Credit: J.T. MacMillan Photography at Endpoints #BIO22) |
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MIT finance professor Andrew Lo has more insider connections than just about any other academic player you’ll find in any industry. And today, if you valued his biotech connections in financial terms, it just spiked. Lo’s QLS Advisors LLC (that stands for Quantitative Life Sciences) has just joined forces with BlackRock Systematic. To put it simply, Lo’s QLS will now put its machine learning approach to determining drug development risk to work with BlackRock execs to guide their targeted strategy for finding biotech winners. |
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Ping Zhu, H3 Biomedicine's president and CSO |
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by Nicole DeFeudis
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Days after announcing a reorganization plan to focus on deep learning and its “most important project,” the Biogen-partnered Alzheimer’s drug lecanemab, Eisai is shuttering its oncology unit H3 Biomedicine. The news comes after H3 revealed in public documents last week that it’s laying off employees at its Cambridge, MA, headquarters. In total, 88 jobs will be affected, a spokesperson said. According to Massachusetts public documents, at least 79 will be laid off by Sept. 15. The cancer unit’s work will be continued under Eisai’s Deep Human Biology Learning department, according to FierceBiotech, which first reported the news. H3 was established back in 2011 to develop precision cancer treatments with the “resource and expertise of a large pharmaceutical company” and the “agility and innovation of a small biotech,” according to the company’s website. Its lead candidate, dubbed H3B-6545, is a small molecule selective estrogen receptor covalent antagonist designed to treat breast cancer patients with estrogen receptor alpha mutations. While that candidate is in Phase II, H3 also has a handful of Phase I programs for hepatocellular carcinoma, non-muscle invasive bladder cancer, advanced solid tumors and other cancers. Back in January, H3 granted Roivant the rights to its small molecule drug H3B-8800, which was in Phase I for myelodysplastic syndromes, acute myeloid leukemia and chronic myelomonocytic leukemia. Last August, the company tapped Novartis Institutes for Biomedical Research veteran Ping Zhu as CSO, and Ross Pettit, who cut his teeth at BeiGene, Otsuka and EMD Serono, as deputy president overseeing business operations. |
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by Zachary Brennan
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The decline and fall of Biogen's controversial Alzheimer's drug Aduhelm — from snap approval to payer coverage denials and now a requirement for more data — has led the company to abandon the drug, and cut staff over the past year, including 331 departures from its Massachusetts-based sites. The layoffs in Cambridge and Weston, first reported by the Boston Business Journal, are part of $1 billion in overall cuts. The company told Endpoints News that currently 2,469 of its employees work in Massachusetts, whereas last August, an industry report said that 2,800 Biogen employees worked in the state, making the company the third largest biopharma employer there. A spokesperson said in a statement: |
We are not providing specificity around the total number of positions that have been reduced given the reductions include open positions that are not being filled, attrition, options to transfer to other positions if qualified, and layoffs...However, with this said, we have shared that we have substantially eliminated the infrastructure supporting Aduhelm. |
| With the departure of Biogen CEO Michel Vounatsos, the cuts are part of the company's decision to significantly reduce global commercial infrastructure supporting Aduhelm as well as other cost reductions that are expected to yield about $500 million in annualized savings, in addition to other, previously announced $500 million in savings. "This brings total expected annualized savings to approximately $1 billion, a portion of which will be reinvested in strategic initiatives over the coming years," Biogen said. The news comes as Biogen and partner Eisai are having a second go at the amyloid plaque theory, with another hopeful accelerated approval for their drug lecanemab. |
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by Nicole DeFeudis
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GSK may regret turning down that offer from Unilever. The pharma giant’s consumer health unit Haleon officially debuted on the London Stock Exchange on Monday — but it did so with a valuation much lower than Unilever’s takeover bid back in January. Haleon HLN started trading at 330 pence, but by mid-morning the stock had fallen to around 317 pence. That leaves the company’s market value around £31 billion (roughly $37 billion), far lower than Unilever’s £50 billion ($68 billion) offer. AJ Bell analyst Danni Hewson noted on Monday morning: |
Haleon has so far got off to a mixed start. Trading started at 330p, but the shares had slipped to 326p in the first half hour of the UK market being open. Soon after they jumped to 337p. With a market value of approximately £31 billion, investors might be wondering why GSK didn’t accept the much higher bid from Unilever. |
| The company’s also launching with about £10.3 billion (more than $12 billion) in debt, GSK confirmed a couple of weeks ago. Barclays analysts have previously called the consumer business, which owns popular brands such as Sensodyne toothpaste and Robitussin cough syrup, the “largest listing in Europe for over a decade.” The split has been in the works for four years, as CEO Emma Walmsley looks to steer a slimmer GSK to new heights. Earlier this year, Walmsley punted multiple unsolicited offers from Unilever, with the company’s board claiming that the offer “fundamentally undervalued” Haleon. |
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Stephen Ubl, PhRMA president and CEO (Photographer: Andrew Harrer/Bloomberg via Getty Images) |
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by Zachary Brennan
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While PhRMA is engaged in a fierce battle on Capitol Hill over new Medicare drug price negotiations, which the top pharma industry lobby argues will take a big cut on innovation, the group also unveiled a new report finding its member companies have spent more than double on US R&D in 2021 (almost $80 billion) when compared to 2012 ($37 billion). But that doubling in US R&D spending, as well as a doubling of worldwide R&D spending in 2021 ($102 billion) when compared to 2013 ($51 billion), has not resulted in a corresponding uptick in new molecular entity (NME) approvals — reflecting both how difficult it is to discover new, meaningful drugs, and how the process is getting more expensive over time. In 2021, 36 NMEs won approval in the US, according to Nature Reviews Drug Discovery, whereas in 2012, 33 NMEs won approval. Those numbers have fluctuated in the intervening years, with no clear correlation between R&D spending and NME approvals. But the approvals and the amount spent don't tell the full story given the extent to which most drugs and biologics fail in the clinic. The PhRMA survey estimates that about 30% of those R&D dollars go to Phase III trials and that it can take developers more than a decade to bring a new drug to the market. However, the new PhRMA survey may end up as grist for the mill for those working on Medicare negotiations in Congress as Democrats rail against the fact that many Americans spend double or triple on medicines that others in Europe and elsewhere do. |
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Actor Patrick Dempsey doubles down on his Amgen collaborations to raise cancer awareness, this time with a StoryCorps campaign. |
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by Beth Snyder Bulik
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Actor Patrick Dempsey is best known for his role as Grey’s Anatomy brain surgeon “McDreamy," but he’s also a longtime cancer care advocate — and an Amgen partner. Dempsey founded the Dempsey Center in 2008 to honor his mother who had ovarian cancer, and around the same time, struck up an association with Amgen that continues today. Dempsey began as an Amgen ambassador for its “Breakaway from Cancer” effort in 2007. Amgen then became a Dempsey Center partner and presenting sponsor of its major annual fundraiser — a run, walk or bike event called Dempsey Challenge that has raised $17 million to date to ensure the center’s cancer support and health services remain free. The newest initiative expands on Amgen’s already running StoryCorps collaboration called “Every Patient Counts, Every Story Matters,” which began in 2019. The effort documents personal cancer stories with patients, caregivers, doctors, nurses and researchers to raise awareness with the nonprofit oral history documenter. The newest episode features Dempsey and cancer survivor Amanda talking about her experience, as well as the center and its founding. “When my mother was newly diagnosed, I felt so helpless. Where do you go? Who do you talk to? And it was like ‘well God, if we’re going through this, how many other people?’" Dempsey says in the audio interview. |
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John Rim, Samsung Biologics CEO |
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by Tyler Patchen
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As investments into CDMOs are gaining steam from several South Korean and Japanese conglomerates, Samsung is making a big land grab. On Monday, Samsung Biologics, the CDMO arm of the Korean conglomerate, announced that it has officially signed a land purchase agreement with the Incheon Free Economic Zone to support the build-out of its second bio campus, dubbed Bio Campus II. Samsung stated that the 3.8 million square foot land purchase is valued at about $324 million. The land, which is located within the Songdo Industrial Cluster, will be 30% larger than the company's current campus. Bio Campus II is also designed to support further expansion of large-scale manufacturing capacity along with a plant and an innovation facility. In an interview with Samsung Biologics CEO John Rim at #BIO22, the new campus will be adjacent to their current 60-acre campus in Songdo, South Korea. Rim said the current campus is fully occupied and needs expansion. Rim expects the site be fully staffed within the next decade. According to a report from the Korean news site, Yonhap News Agency, the company is planning to add 400 new jobs following construction, with a total of 4,000 additional jobs added by 2032. “Through continuous investment, we will maintain our position as the best-in-class CDMO partner, fully equipped with the world's largest manufacturing capacity and provide diverse service offerings to our clients to address new emerging diseases and save lives of patients worldwide,” Rim said in a statement. |
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European Commissioner for Health Stella Kyriakides (Francisco Seco/Pool via AP Images) |
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by Paul Schloesser
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The EU is back for more doses of monkeypox vaccines after seeing thousands of more cases. The European Commission announced Monday that it reached a deal with Bavarian Nordic to buy an additional 54,000 doses of the biotech's monkeypox vaccine after a substantial increase in monkeypox cases in the continent. This order and others pushed Bavarian Nordic on Monday to also reup its 2022 revenue guidance, which is now expected to be between $368 million and $396 million (previously it was estimated to be between $314 million and $341 million). European Commissioner Stella Kyriakides expressed concern in a statement over increasing cases of monkeypox in the EU, noting that there are now more than 7,000 cases — about a 50% increase over last week. There are currently more than 12,500 confirmed cases of monkeypox worldwide, according to a CDC tracker — tripling the 4,000 mark reached the last week of June. "We have now secured over 160,000 doses of vaccines to respond promptly to the progression of the spread of this virus," Kyriakides said in a statement. Delivery of these vaccine doses will be done through the rest of 2022 to all EU member states, plus Norway and Iceland, the European Commission said in a statement. This comes just a few weeks after the European Commission reached an initial deal with Bavarian Nordic for 110,000 doses of Jynneos, the US-licensed version of Bavarian Nordic’s Imvanex. Imvanex is currently only authorized in the EU to prevent smallpox in adults, but only “under exceptional circumstances" due to difficulties generating efficacy data. |
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Khloé Kardashian is back again to promote Biohaven migraine med Nurtec ODT in its newest TV and digital campaign (courtesy Biohaven) |
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by Beth Snyder Bulik
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Reality star, businesswoman and brand boss Khloé Kardashian is back on TV for Biohaven’s migraine brand Nurtec ODT. The mega-influencer is leading the charge for Biohaven’s consolidated “All in One” marketing strategy and message. The new 15- and 30-second Kardashian TV ads, along with revamped marketing across the Nurtec TV and digital portfolio of real patient ambassadors, includes its latest branding element — a white pill with “All in One” across the top and “Treat & prevent” on the bottom. Nurtec ODT was first approved in February 2020 to treat acute onset of migraine, and nabbed a second indication as a preventative in May 2021. “The first thing we did when we launched was just get people aware about this new mechanism that works for acute,” Biohaven CEO Vlad Coric said. “Then we got the prevention and the focus was on raising prevention awareness. Now the next stage is to highlight the one pill that does both.” Kardashian sports a more serious business look in the new ad, departing from her last Nurtec TV ad appearance as a mom on the couch with her daughter, and opens the ad saying, “There’s nothing glamorous about migraines.” She’s promoting the new work in media interviews and across her social channels. Along with celebrity Kardashian, Nurtec “real-life” spokespeople including college student Ellie and military veteran Greg will also be featured in ads running on network, cable and connected TV and on its website and in digital and social media with the new consolidated message. |
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Canadian Prime Minister Justin Trudeau (Justin Tang/The Canadian Press via AP) |
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by Tyler Patchen
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While Covid-19 and monkeypox manufacturers are getting more ontracts, the Canadian government is still concerned with the flu, especially as its season will soon be upon North America in a few months. Last Friday, GSK announced an agreement with the Canadian government to manufacture pandemic and seasonal influenza vaccines. The four-year agreement, which extends through March 2026, includes GSK supplying as many as 80 million doses of Arepanrix, an adjuvanted pandemic flu vaccine, in case there is an influenza pandemic. The deal will also have GSK produce a minimum of 4 million doses per year of the seasonal flu vaccine Flulaval Tetra. Both vaccines will be manufactured at its 230,000-square-foot facility in Sainte-Foy, Quebec. The financial terms of the deal were not disclosed. According to GSK, the agreement follows earlier agreements between the Canadian government and GSK. The company has been supplying both vaccines since 2001. "COVID-19 has shown the world the importance of immunization and pandemic preparedness. This agreement reserves future production and delivery of pandemic and seasonal influenza vaccines allowing for a rapid response to help protect Canadians,” said Roger Connor, president of GSK Vaccines. This deal in Canada comes as GSK plans to distribute 50 million doses of flu vaccines in the US in preparation for flu season. GSK’s facility in Quebec, however, did receive a warning letter from the FDA in 2014. According to Fierce Pharma, the letter raised concerns about issues related to certain quality control and manufacturing procedures at the facility. |
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Wisconsin Governor Tony Evers (AP Photo/Andy Manis, File) |
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by Tyler Patchen
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Merck KGaA’s MilliporeSigma is again expanding its facilities near Wisconsin’s capital, now with the federal government contract in tow. The company kicked off the expansion at its Sheboygan location as the company is building its first lateral flow membrane production facility in the US. Lateral flow membranes are a key component in rapid diagnostic test kits for a variety of applications, including Covid-19 testing. According to the company, the new facility is supported by a $136.7 million contract awarded to MilliporeSigma from the DOD on behalf of HHS. The contract, which was awarded last year, will see the company specifically produce nitrocellulose membrane production capacity, which is a key component in Covid-19 rapid tests. However, the facility will also serve other in-vitro diagnostic manufacturing customers. Other financial details or the size of the location were not disclosed. "Our purpose is to positively impact life and health with science, and today's ground-breaking exemplifies this commitment by adding physical capacity and expanding our regional network to meet the growing needs of our customers and ensure supply chain security," said Matthias Heinzel, member of the executive board of Merck KGaA, Darmstadt, Germany, and CEO Life Science. According to Wisconsin Governor Tony Evers, the expansion will also create 60 jobs. However, this is not the first time MilliporeSigma has expanded in Sheboygan. In 2017, the company expanded the location to 80,000 square feet and received a tax credit of $1.25 million from the Wisconsin Economic Development Corporation over three years. That project cost MilliporeSigma $47 million according to the local news site the Sheboygan Press. |
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Worldwide made. Thanks for reading.
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