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Poseida promotes cell therapy president to CEO; After IPO, Neumora appoints R&D chief

Kristin Yarema
→ The CEO post is changing hands once again at Poseida, as Kristin Yarema gets promoted to the top spot on Jan. 1 and Mark Gergen will…

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Kristin Yarema

→ The CEO post is changing hands once again at Poseida, as Kristin Yarema gets promoted to the top spot on Jan. 1 and Mark Gergen will take on the role of executive chairman. At the conclusion of her seven years with Amgen (2013-20), Yarema was bumped up to VP & therapeutic area head for global product strategy & commercial innovation in hematology-oncology. She then spent more than two years at Atara Biotherapeutics as commercial chief before becoming president of cell therapy at Poseida in April. Gergen, the former CBO at the San Diego CAR-T biotech, succeeded Eric Ostertag as chief executive on Feb. 1, 2022.

Robert Lenz

→ One of the 16 biotech companies to jump on the Nasdaq in 2023 is Bob Nelsen’s “Really Big Neuroscience Company,” Neumora Therapeutics, which started trading the same day as RayzeBio in September. Neumora has also lined up Robert Lenz as R&D chief after appointing AbbVie vet Henry Gosebruch as president and CEO several months ago. Lenz just wrapped up an 11-year career at Amgen and had been serving as the pharma giant’s head of global development. Neumora has a trio of Phase III trials on tap for major depressive disorder, and there won’t be any data out of them until we’re well into 2024.

Tom Garner

→ After a 21-year career at Bristol Myers Squibb, Tom Garner is stepping away from Big Pharma to join Lexicon Therapeutics as chief commercial officer. Lexicon broke through in May with an FDA approval for its heart failure med Inpefa, and Garner has cardiovascular experience as VP and US brand lead for mavacamten, now marketed as Camzyos for obstructive hypertrophic cardiomyopathy. Last year, Garner was elevated to SVP and head of Bristol Myers’ cardiovascular and established brands, a business unit that also has the blood thinner Eliquis in its portfolio, among other products.

Arvin Yang

Arvin Yang is the second Mersana Therapeutics alum in as many weeks to land at another biotech, taking the CMO job at antibody-drug conjugate developer Pheon Therapeutics. A string of setbacks involving patient deaths and a Phase III miss with the ovarian cancer drug upifitamab rilsodotin precipitated Yang’s departure, the retirement of Mersana CEO Anna Protopapas, and several other leadership moves. Last week, ex-Mersana clinical development and operations leader Ellie Im signed on at Centessa. Now led by ex-Vedere Bio chief Cyrus Mozayeni, Pheon hit the scene in September 2022 with $68 million from the likes of Forbion, Brandon Capital and Atlas Venture.

Richie Cunningham

Richie Cunningham has split the uprights with another CEO gig at Anebulo Pharmaceuticals, an acute cannabinoid intoxication biotech that went public during the 2021 IPO boom. Cunningham, a former NFL kicker who had his best season in 1997 as a rookie with the Dallas Cowboys, was CEO of Tyme Technologies from 2020-22. Tyme and the embattled Syros Pharmaceuticals merged last year in a $60 million deal.

→ Dutch biotech VarmX, which has been getting ready to launch a pivotal trial for a reversal agent for blood thinners, has promoted its CSO, Jeffrey Lawson, to the CEO spot, replacing Jan Öhrström. Öhrström will remain as chairman of the company’s board. Before VarmX, Lawson was president and CEO of Humacyte. The CEO change-up comes after the company raised a €30 million Series B2 round in May.

Neil McFarlane

Zevra Therapeutics has tapped UCB and Sanofi Genzyme alum Neil McFarlane as president and CEO, allowing interim chief Christal Mickle to concentrate on her duties as chief development officer. McFarlane ran the show at Parkinson’s biotech Adamas Pharmaceuticals until it was sold to Supernus for $400 million two years ago this week. Zevra bought rare disease player Acer Therapeutics in June and rebranded from KemPharm earlier this year.

→ Cincinnati-based Blue Water Biotech is going through a C-suite shakeup, bringing on Neil Campbell as president and CEO and Bruce Harmon as CFO. Campbell formerly served in a number of roles at IGEN International, Celera Genomics and Abbott Laboratories. Meanwhile, Harmon replaces Jon Garfield for the chief finance spot. Harmon has also served in this role at Marizyme and bioAffinity Technologies.

Shannon Sullivan

Shannon Sullivan has been named chief commercial officer at Milan-based Dompé farmaceutici, which also has offices in the Bay Area and scored the first FDA approval for neurotrophic keratitis with its eye drop Oxervate. Sullivan had numerous roles in 22 years at Amgen, and for the last year she’s been in charge of the Tavneos franchise as VP, general manager of vasculitis for the inflammation business unit. Amgen picked up Tavneos in its $4 billion acquisition of ChemoCentryx last summer.

Sonia Poli

→ Another company based in Italy, protein degradation player Sibylla Biotech, has recruited Sonia Poli as CSO. Poli is the ex-VP of translational science at AC Immune who rose to chief scientist during her 13 years with Addex Therapeutics. Sibylla raised €23 million for its Series A last fall.

Glycomine, a California biotech focused on sugar processing disorders, has installed Rose Marino as CMO. Marino had been VP, clinical development rare disease at Ipsen and was senior medical director for the fibrodysplasia ossificans progressiva programs at Clementia. Glycomine’s lead drug, GLM101, is in Phase II for phosphomannomutase 2-congenital disorder of glycosylation (PMM2-CDG).

Medicenna Therapeutics has recruited Humphrey Gardner as CMO. Gardner has prior CMO experience from his time at Harbour BioMed and Silicon Therapeutics. Gardner’s résumé also has such roles as CMO in residence at Roivant, chief, medical oncology at Evelo Biosciences and SVP clinical development at Karyopharm Therapeutics.

Sakura Minami

→ Redwood City, CA-based Ashvattha Therapeutics has introduced two new leaders: Sakura Minami (VP of translational medicine and nonclinical development) is the former senior director, nonclinical development and translational sciences at Grifols subsidiary Alkahest. Meanwhile, Five Prime and Global Blood Therapeutics alum Sarah Thayer (head of clinical operations) previously held this title at lipid nanoparticle delivery startup ReCode Therapeutics.

Alexander Egeberg

→ Denmark’s Leo Pharma has welcomed Alexander Egeberg as its head of global medical affairs. A dermatology professor at the University of Copenhagen, Egeberg also had a two-year stint at Pfizer in medical affairs. In March, Leo Pharma decided to split its R&D unit into two different teams, with CSO Jacob Pontoppidan Thyssen handling research and early development, and Kreesten Meldgaard Madsen taking over as chief development officer.

According to an SEC filing, Alnylam director Marsha Fanucci resigned on Sept. 29, and the RNAi specialist won’t seek a 13th board member to replace her. Although one analyst said the FDA’s rejection of Onpattro for ATTR cardiomyopathy “isn’t hugely surprising,” Alnylam CEO Yvonne Greenstreet expressed her surprise about the decision in an investor call.

Alethia Young

→ Non-opioid pain management specialist Pacira BioSciences has added four board members: Ventus Therapeutics president and CEO Marcelo Bigal; Rapport Therapeutics chief Abraham Ceesay; ex-ViaCyte president and CEO Michael Yang; and Bicycle Therapeutics CFO Alethia Young. Pacira is still looking for a CEO to succeed the retiring Dave Stack.

Auvelity maker Axsome Therapeutics has elected former Lilly Oncology president Sue Mahony to the board of directors. Mahony has board seats at Zymeworks and Assembly Biosciences, and she was on Horizon’s board before Amgen finally completed its $28 billion buyout.

Adiso Therapeutics has reserved a seat on its board of directors for Robert Lisicki. Lisicki recently served as CEO and a board member of InCarda Therapeutics, and before that, he was chief commercial officer for Arena Pharmaceuticals.

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Four burning questions about the future of the $16.5B Novo-Catalent deal

To build or to buy? That’s a classic question for pharma boardrooms, and Novo Nordisk is going with both.
Beyond spending billions of dollars to expand…

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To build or to buy? That’s a classic question for pharma boardrooms, and Novo Nordisk is going with both.

Beyond spending billions of dollars to expand its own production capacity for its weight loss drugs, the Danish drugmaker said Monday it will pay $11 billion to acquire three manufacturing plants from Catalent. It’s part of a broader $16.5 billion deal with Novo Holdings, the investment arm of the pharma’s parent group, which agreed to acquire the contract manufacturer and take it private.

It’s a big deal for all parties, with potential ripple effects across the biotech ecosystem. Here’s a look at some of the most pressing questions to watch after Monday’s announcement.

Why did Novo do this?

Novo Holdings isn’t the most obvious buyer for Catalent, particularly after last year’s on-and-off M&A interest from the serial acquirer Danaher. But the deal could benefit both Novo Holdings and Novo Nordisk.

Novo Nordisk’s biggest challenge has been simply making enough of the weight loss drug Wegovy and diabetes therapy Ozempic. On last week’s earnings call, Novo Nordisk CEO Lars Fruergaard Jørgensen said the company isn’t constrained by capital in its efforts to boost manufacturing. Rather, the main challenge is the limited amount of capabilities out there, he said.

“Most pharmaceutical companies in the world would be shopping among the same manufacturers,” he said. “There’s not an unlimited amount of machinery and people to build it.”

While Novo was already one of Catalent’s major customers, the manufacturer has been hamstrung by its own balance sheet. With roughly $5 billion in debt on its books, it’s had to juggle paying down debt with sufficiently investing in its facilities. That’s been particularly challenging in keeping pace with soaring demand for GLP-1 drugs.

Novo, on the other hand, has the balance sheet to funnel as much money as needed into the plants in Italy, Belgium, and Indiana. It’s also struggled to make enough of its popular GLP-1 drugs to meet their soaring demand, with documented shortages of both Ozempic and Wegovy.

The impact won’t be immediate. The parties expect the deal to close near the end of 2024. Novo Nordisk said it expects the three new sites to “gradually increase Novo Nordisk’s filling capacity from 2026 and onwards.”

As for the rest of Catalent — nearly 50 other sites employing thousands of workers — Novo Holdings will take control. The group previously acquired Altasciences in 2021 and Ritedose in 2022, so the Catalent deal builds on a core investing interest in biopharma services, Novo Holdings CEO Kasim Kutay told Endpoints News.

Kasim Kutay

When asked about possible site closures or layoffs, Kutay said the team hasn’t thought about that.

“That’s not our track record. Our track record is to invest in quality businesses and help them grow,” he said. “There’s always stuff to do with any asset you own, but we haven’t bought this company to do some of the stuff you’re talking about.”

What does it mean for Catalent’s customers? 

Until the deal closes, Catalent will operate as a standalone business. After it closes, Novo Nordisk said it will honor its customer obligations at the three sites, a spokesperson said. But they didn’t answer a question about what happens when those contracts expire.

The wrinkle is the long-term future of the three plants that Novo Nordisk is paying for. Those sites don’t exclusively pump out Wegovy, but that could be the logical long-term aim for the Danish drugmaker.

The ideal scenario is that pricing and timelines remain the same for customers, said Nicole Paulk, CEO of the gene therapy startup Siren Biotechnology.

Nicole Paulk

“The name of the group that you’re going to send your check to is now going to be Novo Holdings instead of Catalent, but otherwise everything remains the same,” Paulk told Endpoints. “That’s the best-case scenario.”

In a worst case, Paulk said she feared the new owners could wind up closing sites or laying off Catalent groups. That could create some uncertainty for customers looking for a long-term manufacturing partner.

Are shareholders and regulators happy? 

The pandemic was a wild ride for Catalent’s stock, with shares surging from about $40 to $140 and then crashing back to earth. The $63.50 share price for the takeover is a happy ending depending on the investor.

On that point, the investing giant Elliott Investment Management is satisfied. Marc Steinberg, a partner at Elliott, called the agreement “an outstanding outcome” that “clearly maximizes value for Catalent stockholders” in a statement.

Elliott helped kick off a strategic review last August that culminated in the sale agreement. Compared to Catalent’s stock price before that review started, the deal pays a nearly 40% premium.

Alessandro Maselli

But this is hardly a victory lap for CEO Alessandro Maselli, who took over in July 2022 when Catalent’s stock price was north of $100. Novo’s takeover is a tacit acknowledgment that Maselli could never fully right the ship, as operational problems plagued the company throughout 2023 while it was limited by its debt.

Additional regulatory filings in the next few weeks could give insight into just how competitive the sale process was. William Blair analysts said they don’t expect a competing bidder “given the organic investments already being pursued at other leading CDMOs and the breadth and scale of Catalent’s operations.”

The Blair analysts also noted the companies likely “expect to spend some time educating relevant government agencies” about the deal, given the lengthy closing timeline. Given Novo Nordisk’s ascent — it’s now one of Europe’s most valuable companies — paired with the limited number of large contract manufacturers, antitrust regulators could be interested in taking a close look.

Are Catalent’s problems finally a thing of the past?

Catalent ran into a mix of financial and operational problems over the past year that played no small part in attracting the interest of an activist like Elliott.

Now with a deal in place, how quickly can Novo rectify those problems? Some of the challenges were driven by the demands of being a publicly traded company, like failing to meet investors’ revenue expectations or even filing earnings reports on time.

But Catalent also struggled with its business at times, with a range of manufacturing delays, inspection reports and occasionally writing down acquisitions that didn’t pan out. Novo’s deep pockets will go a long way to a turnaround, but only the future will tell if all these issues are fixed.

Kutay said his team is excited by the opportunity and was satisfied with the due diligence it did on the company.

“We believe we’re buying a strong company with a good management team and good prospects,” Kutay said. “If that wasn’t the case, I don’t think we’d be here.”

Amber Tong and Reynald Castañeda contributed reporting.

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Petrina Kamya, Ph.D., Head of AI Platforms at Insilico Medicine, presents at BIO CEO & Investor Conference

Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb….

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Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb. 26-27 at the New York Marriott Marquis in New York City. Dr. Kamya will speak as part of the panel “AI within Biopharma: Separating Value from Hype,” on Feb. 27, 1pm ET along with Michael Nally, CEO of Generate: Biomedicines and Liz Schwarzbach, PhD, CBO of BigHat Biosciences.

Credit: Insilico Medicine

Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb. 26-27 at the New York Marriott Marquis in New York City. Dr. Kamya will speak as part of the panel “AI within Biopharma: Separating Value from Hype,” on Feb. 27, 1pm ET along with Michael Nally, CEO of Generate: Biomedicines and Liz Schwarzbach, PhD, CBO of BigHat Biosciences.

The session will look at how the latest artificial intelligence (AI) tools – including generative AI and large language models – are currently being used to advance the discovery and design of new drugs, and which technologies are still in development. 

The BIO CEO & Investor Conference brings together over 1,000 attendees and more than 700 companies across industry and institutional investment to discuss the future investment landscape of biotechnology. Sessions focus on topics such as therapeutic advancements, market outlook, and policy priorities.

Insilico Medicine is a leading, clinical stage AI-driven drug discovery company that has raised over $400m in investments since it was founded in 2014. Dr. Kamya leads the development of the Company’s end-to-end generative AI platform, Pharma.AI from Insilico’s AI R&D Center in Montreal. Using modern machine learning techniques in the context of chemistry and biology, the platform has driven the discovery and design of 30+ new therapies, with five in clinical stages – for cancer, fibrosis, inflammatory bowel disease (IBD), and COVID-19. The Company’s lead drug, for the chronic, rare lung condition idiopathic pulmonary fibrosis, is the first AI-designed drug for an AI-discovered target to reach Phase II clinical trials with patients. Nine of the top 20 pharmaceutical companies have used Insilico’s AI platform to advance their programs, and the Company has a number of major strategic licensing deals around its AI-designed therapeutic assets, including with Sanofi, Exelixis and Menarini. 

 

About Insilico Medicine

Insilico Medicine, a global clinical stage biotechnology company powered by generative AI, is connecting biology, chemistry, and clinical trials analysis using next-generation AI systems. The company has developed AI platforms that utilize deep generative models, reinforcement learning, transformers, and other modern machine learning techniques for novel target discovery and the generation of novel molecular structures with desired properties. Insilico Medicine is developing breakthrough solutions to discover and develop innovative drugs for cancer, fibrosis, immunity, central nervous system diseases, infectious diseases, autoimmune diseases, and aging-related diseases. www.insilico.com 


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Another country is getting ready to launch a visa for digital nomads

Early reports are saying Japan will soon have a digital nomad visa for high-earning foreigners.

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Over the last decade, the explosion of remote work that came as a result of improved technology and the pandemic has allowed an increasing number of people to become digital nomads. 

When looked at more broadly as anyone not required to come into a fixed office but instead moves between different locations such as the home and the coffee shop, the latest estimate shows that there were more than 35 million such workers in the world by the end of 2023 while over half of those come from the United States.

Related: There is a new list of cities that are best for digital nomads

While remote work has also allowed many to move to cheaper places and travel around the world while still bringing in income, working outside of one's home country requires either dual citizenship or work authorization — the global shift toward remote work has pushed many countries to launch specific digital nomad visas to boost their economies and bring in new residents.

Japan is a very popular destination for U.S. tourists. 

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This popular vacation destination will soon have a nomad visa

Spain, Portugal, Indonesia, Malaysia, Costa Rica, Brazil, Latvia and Malta are some of the countries currently offering specific visas for foreigners who want to live there while bringing in income from abroad.

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With the exception of a few, Asian countries generally have stricter immigration laws and were much slower to launch these types of visas that some of the countries with weaker economies had as far back as 2015. As first reported by the Japan Times, the country's Immigration Services Agency ended up making the leap toward a visa for those who can earn more than ¥10 million ($68,300 USD) with income from another country.

The Japanese government has not yet worked out the specifics of how long the visa will be valid for or how much it will cost — public comment on the proposal is being accepted throughout next week. 

That said, early reports say the visa will be shorter than the typical digital nomad option that allows foreigners to live in a country for several years. The visa will reportedly be valid for six months or slightly longer but still no more than a year — along with the ability to work, this allows some to stay beyond the 90-day tourist period typically afforded to those from countries with visa-free agreements.

'Not be given a residence card of residence certificate'

While one will be able to reapply for the visa after the time runs out, this can only be done by exiting the country and being away for six months before coming back again — becoming a permanent resident on the pathway to citizenship is an entirely different process with much more strict requirements.

"Those living in Japan with the digital nomad visa will not be given a residence card or a residence certificate, which provide access to certain government benefits," reports the news outlet. "The visa cannot be renewed and must be reapplied for, with this only possible six months after leaving the countr

The visa will reportedly start in March and also allow holders to bring their spouses and families with them. To start using the visa, holders will also need to purchase private health insurance from their home country while taxes on any money one earns will also need to be paid through one's home country.

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