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Roche reports good results in 2021

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Eli Lilly nixes Verzenio’s phase 3 HER2-positive early breast cancer trial

On February 3, 2022 Eli Lilly reported that it has made the "difficult decision" to cull a phase 3 study of Verzenio in HER2-positive early breast cancer, Dan Skovronsky, M.D., Ph.D., chief scientific and medical officer at Lilly, said on a call with investors Thursday (Press release, Eli Lilly, FEB 3, 2022, View Source [SID1234607767]).

Details were slim, but Skovronsky blamed the decision on changes in the treatment landscape plus global enrollment challenges.

"Importantly, this decision does not change our commitment to an investment in breast cancer," Lilly’s chief scientist said.

News of the Verzenio trial halt comes a week after Lilly announced it was pulling the plug on Olumiant’s development in lupus. Separately, Olumiant’s application in moderate-to-severe atopic dermatitis could be in jeopardy, thanks to a stalemate with the FDA about the exact patient population, the company said last week. Lilly expects regulatory action on Olumiant’s eczema bid "very soon," Skovronsky said Thursday.

RELATED: CMS’ Biogen decision could spell problems for Lilly, Roche Alzheimer’s drugs, half of surveyed neurologists say

During the call, Lilly shed more light on Olumiant’s regulatory impasse in eczema. Lilly believes Olumiant benefits eczema patients most when used in early treatment, Patrik Jonsson, SVP and president of Lilly immunology and president of Lilly USA, said on the call. The FDA, conversely, "currently has the position of saving Olumiant for the refractory patients, where we see the incremental value of Olumiant to be quite limited."

If that doesn’t change, a complete response letter is likely, Jonsson said.

Lilly has also submitted Olumiant for approval in alopecia, though an analyst on Wednesday’s call questioned whether safety concerns around the JAK-inhibitor class at large could blunt the drug’s ambitions there. Lilly simply said it was "encouraged" by the data it’s seen so far, and it highlighted the immense opportunity in the disease.

"There are currently no treatments approved for alopecia areata," Jonsson said. "We have the opportunity here to be first in disease with Olumiant."

There are about 360,000 patients diagnosed with alopecia in the U.S., some 100,000 of whom would be eligible for treatment with a JAK inhibitor, Jonsson added.

RELATED: UPDATED: Eli Lilly to plow a total of $1.5B into 2 new manufacturing plants

For the fourth quarter, Eli Lilly’s revenue jumped 8% to $7.9 billion. Excluding COVID-19 antibodies, sales for the last three months of the year climbed 6%. Full-year sales increased 15% to $28.3 billion or 10% after subtracting Lilly’s pandemic antibodies from the equation.

Last month, The FDA tweaked its emergency nod for Lilly and Regeneron’s monoclonal antibodies, citing recent data showing the drugs aren’t effective against omicron. The antibodies are now limited to patients who’ve been infected with or exposed to a variant susceptible to the therapies.

Lilly snared $1.1 billion in COVID-19 antibody revenue for the fourth quarter. Lilly says it delivered roughly 435,000 doses out of 614,000 in the last three months of the year, with most of the remaining doses already shipped out last month.

Lilly credited its fourth-quarter momentum to growth drugs like Trulicity, Taltz, Verzenio, Olumiant, Emgality and more.

"Lilly’s margin profile represents "one of the strongest expansion stories in Pharma, in our opinion, with the potential for mid-teens EPS growth," Cantor Fitzgerald analyst Louise Chen wrote in a note to clients Thursday. Her team thinks Lilly is poised to enter a growth period through 2030, helped by multiple readouts for products like donanemab in Alzheimer’s disease and tirzepatide in Type 2 diabetes.

Lilly has forecasted full-year 2022 sales between $27.8 billion and $28.3 billion.

Intellia Therapeutics Announces Acquisition of Rewrite Therapeutics

On February 3, 2022 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage genome editing company focused on developing curative therapeutics leveraging CRISPR-based technologies, reported the acquisition of Rewrite Therapeutics, Inc. (Rewrite), a private biotechnology company focused on advancing novel DNA writing technologies (Press release, Intellia Therapeutics, FEB 3, 2022, View Source [SID1234607765]).

Rewrite has developed promising new tools for genome editing, including DNA writing via CRISPR/Cas9-guided polymerases. Founded by pioneering scientists Shakked Halperin, Ph.D., and Professor David Schaffer, Ph.D., of the University of California, Berkeley and backed by Civilization Ventures and Prefix Capital, Rewrite’s DNA writing technology may enable a range of precise editing strategies. These strategies include targeted corrections, insertions, deletions, and the full range of single-nucleotide changes, which could provide new ways to edit disease-causing genes and broaden the therapeutic potential for genomic medicines. Rewrite also has developed an approach that could improve the efficiency of genome editing in non-dividing cell types, a key challenge for some existing editing platforms. Rewrite’s technology could potentially be delivered using Intellia’s lipid nanoparticle (LNP) technology and adeno-associated virus (AAV) vectors.

"At Intellia, we have built the industry’s broadest and deepest genome editing platform by staying at the forefront of new techniques, while also extending the capabilities of CRISPR/Cas9 editing to make precisely targeted changes to DNA," said Intellia President and Chief Executive Officer John Leonard, M.D. "We could not be more excited to add Rewrite’s additional capabilities to our growing platform, offering us new possibilities and the potential to target diseases beyond those currently being explored in our pipeline."

Dr. Halperin, Rewrite’s President and Chief Executive Officer and the inventor of Rewrite’s gene editing platform, said:

"Since my initial discovery that CRISPR-guided polymerases could help advance genome editing capabilities, I have focused my efforts on developing a suite of genome editing tools that could one day be used to create innovative and potentially curative treatments for patients with life-threatening diseases. I am thrilled that these inventions will now be leveraged by the industry leader, Intellia, so that the full power and potential of genome editing can be harnessed to benefit patients."

As part of this transaction, Intellia will pay the Rewrite shareholders $45 million in an upfront payment and an additional $155 million in pre-specified research and regulatory approval milestones through a mix of Intellia common stock and cash. Additional financial details were not disclosed.

Goodwin Procter, Latham & Watkins and Finnegan acted as Intellia’s legal counsel. Arnold & Porter Kaye Scholer and Wilson, Sonsini, Goodrich & Rosati acted as Rewrite’s legal counsel.

EVERSANA and Integra Connect Form Strategic Partnership to Advance Next Generation Oncology Commercialization Services Propelled by Real-World Evidence & Technology Platforms

On February 3, 2022 EVERSANA, the pioneer of next generation commercial services to the global life sciences industry, reported a strategic partnership with Integra Connect, LLC, designed to support life sciences companies as they develop and commercialize new oncology treatments (Press release, EVERSANA, FEB 3, 2022, View Source [SID1234607764]). EVERSANA and Integra Connect, the leading provider of value-based, precision medicine technologies and services for specialty care, will contribute market-leading expertise, real-world data and technologies to create a comprehensive longitudinal oncology patient database. Once available, life sciences companies will be able to leverage the database to optimize their decision-making across a product’s entire life cycle.

Currently, life sciences companies are working to make commercial decisions based on value-based, precision medicine principles but struggle to effectively gather and apply high-quality, real-world oncology data. This is because commercialization insights are limited by multisite care and a complex care ecosystem with disparate data assets. The EVERSANA and Integra Connect solution will give life sciences companies greater visibility into variables that may impact commercial success by combining real-world data (RWD) from sources such as electronic health records (EHRs) and expert analyses from EVERSANA’s value and evidence team. Together, these capabilities will help life sciences leaders to substantiate the product’s value across the commercialization ecosystem, including evidence development strategy, reimbursement submissions and payer marketing. The combined solution will be available on the Integra Connect’s value-based, precision medicine platform.

Specifically, to accelerate the development of new therapies and evidence-based commercialization, EVERSANA will leverage its internationally recognized HEOR and data science as well as Integra Connect’s platform to provide curated RWD and research support. The real-world data of the combined solutions will characterize baseline patient attributes, disease progression and treatment-based outcomes for patients; and will model customized commercialization models, including EVERSANA’s real-time patient services available from its patient service hub.

"Together with Integra Connect, we are transforming oncology commercialization services with the power of real-world data and evidence throughout the product and patient journeys," said Jim Lang, CEO, EVERSANA. "The combination of scaled clinical data, with expert curation, and a scaled HEOR and data science capability will give life sciences partners the ability to accelerate clinical programs and validate therapeutic impact for all stakeholders, especially patients and caregivers."

"The partnership is an important step in enabling life sciences companies to successfully bring forth oncology treatments that are beneficial to patients and viable in a value-based, precision medicine environment," said Charles Saunders, MD, CEO of Integra Connect. "Additionally, I am proud of Integra Connect’s continued leadership in creating new innovations and strategic partnerships that will help make value-based precision medicine a reality for patients, providers and populations."

Valneva Reports Full Year 2021 Revenue and Cash; Provides First 2022 Guidance

On February 3, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) a specialty vaccine company, reported its revenue and cash balance for the full year 2021 and provided full year 2022 revenue guidance (Press release, Valneva, FEB 3, 2022, View Source [SID1234607744]). The Company will report its 2021 audited consolidated financial statements in March 2022.

Peter Bühler, Valneva’s Chief Financial Officer, commented, "2021 was an exceptional year for Valneva, marked by the EC COVID-19 supply agreement, our successful Nasdaq listing and the great progress made across our R&D pipeline. We reported positive Phase 3 results for two vaccine candidates (COVID-19 and chikungunya) and we expect both vaccines, if approved, to make a positive change to people’s lives. With close to €350 million in cash, we entered 2022 in a strong position and will continue to focus on gaining regulatory approvals and preparing market entry for our key late stage programs."

Revenues
Valneva’s total revenues were €348.1 million in 2021 compared to €110.3 million in 2020, an increase of 216%.
Product sales decreased by 4.5% to €63.0 million in 2021 compared to €65.9 million in 2020 as the travel industry continued to be impacted by the COVID-19 pandemic. On a constant exchange rate (CER) basis, product sales also decreased by 4.5% in 2021 as compared to 2020.
IXIARO/JESPECT sales decreased by 6.9% (5.7% at CER) to €45.1 million in 2021 compared to €48.5 million in 2020. The impact of the COVID-19 pandemic was mitigated by sales to the U.S. Government’s Department of Defense (DoD) during the period.
DUKORAL sales declined by 81.7% (82.4% at CER) to €2.4 million in 2021 compared to €13.3 million in 2020.
Third Party product sales grew by 271.3% to €15.4 million in 2021 from €4.2 million in 2020. The increase in Third Party product sales was driven by incremental sales related to Valneva’s distribution agreement with Bavarian Nordic for the sales of Rabipur/RabAvert and Encepur, which commenced in certain territories in 2021.
Other Revenues, including revenues from collaborations, licensing and services, amounted to €285.1 million in 2021 compared to €44.4 million in 2020. This increase was attributable to revenues recognized in relation to the terminated UK COVID-19 vaccine supply agreement for non-refundable payments received during the duration of the contract.

Liquidity
Cash and cash equivalents increased to €346.7 million as of December 31, 2021, compared to €204.4 million as of December 31, 2020, and included $209.6 million of combined gross proceeds from the two successful equity offerings the Company completed in 2021 as well as pre-payments for future COVID-19 vaccine deliveries to the EC.