The Biotech Beat: 2.26-3.3.24

by Joey Bose

??Upshot

?? Game Changer: Teva and Alvotech's Simlandi Shakes Up the Humira Biosimilar Market. Can this new biosimilar succeed where other Humira biosimilars have failed and capture the $15B market for TNF-alpha inhibitors?

???♂? The Weight of Innovation: Obesity Drugs Take Aim at MASH in a Battle Beyond Pounds. The obesity drug market is rapidly expanding beyond weight loss to target metabolic dysfunction-associated steatohepatitis (MASH).

?? Amtagvi: Iovance's Melanoma Breakthrough Sets the Stage for TIL Therapy Revolution. Amtagvi has staked its claim as the first and only cell therapy indicated against solid tumors with 20 patients treated in since its very recent FDA approval.

?? Persistence Pays: Eli Lilly's Journey from Alzheimer's Doubt to Donanemab's Breakthrough. The pharma giant's three-decade journey with Alzheimer's research is on the verge of a major breakthrough with the anticipated FDA approval of its drug, donanemab.

?? Novo Nordisk and Neomorph's $1.46 Billion Deal: A New Era for 'Undruggable' Targets. Novo's licensing agreement with Neomorph, worth up to $1.46 billion, is ushering in a new class of therapeutics called "molecular glue degraders" to target intractable molecular mechanisms.

?? Viking's Feast: VK2735's Impressive Weight Loss Results Set the Obesity Market Ablaze. Viking's GLP-1 and GIP dual agonist has demonstrated remarkable weight loss results in a Phase 2 trial, causing their stock to soar 80% and inducing a resurgence in sector-wide investment.

?? Biotech's Bull Run: XBI Index Surges Past $100, Fueling Optimism in the Drug Development Sector. Spurred on by Viking Therapeutics' recent success, the biotech market's key stock index ($XBI) has soared past the $100 mark, marking a significant rebound from its October lows.

?? Pfizer's Oncology Odyssey: Betting Big on Cancer to Regain Market Dominance. After its shares plummeted by 44% last year, Pfizer acquired Seagen for $43 billion aiming to bolster its oncology portfolio with antibody-drug conjugates

?? A Game-Changer for Humira: Teva and Alvotech's Interchangeable Biosimilar Hits the US Market. Teva and Alvotech have received approval for their Simlandi biosimilar of AbbVie's Humira, marking the first fully interchangeable high-concentration version of the drug in the US.

?? Sarepta's Duchenne Gene Therapy Approval: An Exceptional Case in the FDA's Accelerated Pathway. The FDA's top official for cell and gene therapy, emphasized that the narrow approval of Sarepta's Duchenne muscular dystrophy gene therapy, Elevidys, should not be seen as a typical example of accelerated approval.

?? Lawmakers Challenge Biden's Plan to Use March-In Rights for Drug Price Control. A bipartisan group of 28 senators and members of Congress has sent a letter to President Joe Biden, criticizing his administration's proposal to use march-in rights to control drug prices, citing concerns over innovation and incentives.

??? Debating the Future of Medicare Price Negotiations: Lawmakers Consider Amendments to the Inflation Reduction Act. The bipartisan ORPHAN Cures Act aims to broaden exemptions for orphan drugs, while the MINI Act proposes delaying negotiations for "advanced drug products."

?? Research, Development & Drug Approvals ??

?? Game Changer: Teva and Alvotech's Simlandi Shakes Up the Humira Biosimilar Market

The Facts

Teva and Alvotech have finally won approval for their Humira biosimilar, Simlandi, after overcoming manufacturing hurdles that led to multiple rejections. Set to launch imminently, Simlandi enters a competitive market with several other biosimilars vying for a share of Humira's $14.4 billion sales. Despite being late to the market, Teva's CEO Richard Francis remains optimistic, citing the low penetration of biosimilars in 2023 and the potential to capture market share from Humira, which has only lost about 2% of its market share so far. The price of Simlandi is yet to be disclosed, but competitors have launched at discounts up to 86% off the brand-name product.

Our Opinion

The approval of Simlandi is a significant development for the biotech industry, signaling a shift towards more affordable alternatives for blockbuster drugs like Humira. The entry of another biosimilar could intensify competition, drive down prices, and increase accessibility for patients. For the economy, this could mean substantial healthcare cost savings. The successful resolution of manufacturing issues also highlights the importance of robust quality control and collaboration in the biopharmaceutical sector.

Your Turn

Why have biosimilars failed to capture market share from Humira and what strategies can companies like Teva and Alvotech employ to increase biosimilar adoption among healthcare providers and patients?

???♂? The Weight of Innovation: Obesity Drugs Take Aim at MASH in a Battle Beyond Pounds

The Facts

The obesity drug market is expanding beyond weight loss to target metabolic dysfunction-associated steatohepatitis (MASH), with about 23 of the 105 obesity treatments in development or on the market being investigated for this severe liver disease. Companies are competing to prove their drugs' unique benefits, with treatments like Novo Nordisk's Wegovy and Eli Lilly's Zepbound showing potential in addressing MASH. The market opportunity for MASH treatments is significant, given its prevalence and lack of approved therapies. The FDA's requirement for liver biopsies in trials poses challenges, but advancements in obesity drugs targeting both weight loss and liver health offer hope for more effective MASH treatments.

Our Opinion

The convergence of obesity and MASH treatments represents a pivotal shift in the biotech industry's approach to metabolic diseases. By targeting the root cause of obesity, these drugs offer a dual benefit that could revolutionize treatment paradigms. This strategy not only broadens the market potential for obesity drugs but also addresses a critical unmet need in liver disease management. The biotech industry's focus on multifunctional therapies reflects a deeper understanding of the interconnected nature of metabolic disorders and underscores the importance of innovative, holistic approaches in drug development.

Your Turn

Given the heterogeneity of the MASH patient population, how could personalized medicine approaches be integrated into the development and prescription of obesity drugs to optimize treatment outcomes for different patient subgroups?

?? Amtagvi: Iovance's Melanoma Breakthrough Sets the Stage for TIL Therapy Revolution

The Facts

Iovance Biotherapeutics' advanced melanoma treatment, Amtagvi, has made a promising start, signing on 20 patients just 12 days after receiving FDA accelerated approval. As the first US-approved T cell therapy for solid tumors, Amtagvi is now being manufactured in-house and by WuXi Advanced Therapies. With plans to onboard 50 authorized treatment centers in the US by the end of May and projections of $180 million in full-year sales, Iovance is also preparing for submissions in the EU, UK, Canada, Australia, and other countries in 2024 and 2025.

Our Opinion

Amtagvi's rapid launch and early demand signify a pivotal moment for the biotech industry, showcasing the potential of tumor-infiltrating lymphocyte (TIL) therapy in treating advanced melanoma. This breakthrough not only opens new avenues for cancer treatment but also highlights the importance of innovative manufacturing and distribution strategies in bringing novel therapies to market. As Iovance expands globally, the impact of Amtagvi on the industry and patient care will be profound, setting a new standard for T cell therapies in solid tumors.

Your Turn

How does the mechanism of action of TIL therapy, like Amtagvi, differ from traditional chemotherapy, and what implications does this have for patient outcomes in advanced melanoma?

?? Persistence Pays: Eli Lilly's Journey from Alzheimer's Doubt to Donanemab's Breakthrough

The Facts

Eli Lilly's nearly three-decade journey with Alzheimer's research is on the verge of a major breakthrough with the anticipated FDA approval of its drug, donanemab. The drug, which targets amyloid plaques in the brain, has shown a 35% slowing of cognitive decline over 18 months in pivotal trials. This success comes after multiple failures and a steadfast belief in the amyloid hypothesis, despite industry skepticism. Lilly's strategic investments in research, including the acquisition of Avid Radiopharmaceuticals for PET scan technology, have been crucial in bringing donanemab to the brink of approval.

Our Opinion

Eli Lilly's perseverance in the face of repeated failures underscores the importance of long-term investment and faith in scientific hypotheses for the biotech industry. The potential approval of donanemab not only represents a significant advancement in Alzheimer's treatment but also validates the amyloid hypothesis that many had doubted. This breakthrough could open the door to more effective treatments for Alzheimer's and other neurodegenerative diseases, highlighting the critical role of persistence and innovation in drug development.

Your Turn

How does the amyloid hypothesis, which underpins the development of donanemab, challenge the current understanding of Alzheimer's disease, and what implications does this have for future research in neurodegenerative disorders?

?? Investment, M&A, and IPOs ??

?? Novo Nordisk and Neomorph's $1.46 Billion Deal: A New Era for 'Undruggable' Targets

The Facts

Novo Nordisk has entered into a licensing agreement with Neomorph, worth up to $1.46 billion, to discover, develop, and commercialize molecular glue degraders. Neomorph will lead the discovery and preclinical activities for selected targets, while Novo Nordisk will have the option to further pursue clinical development and commercialization. The partnership aims to expand Neomorph's platform beyond oncology and leverage Novo Nordisk's expertise in cardiometabolic and rare diseases to develop transformative treatments.

Our Opinion

This collaboration between Novo Nordisk and Neomorph represents a significant leap forward in the biotech industry's pursuit of treating 'undruggable' targets. Molecular glue degraders have the potential to revolutionize the way we approach complex diseases, offering hope for conditions previously deemed challenging to treat. By combining Neomorph's innovative platform with Novo Nordisk's extensive experience in drug development, this partnership could pave the way for groundbreaking therapies that address unmet medical needs in cardiometabolic and rare diseases.

Your Turn

How do molecular glue degraders differ from traditional small molecule drugs, and what advantages do they offer in targeting 'undruggable' proteins?

?? Viking's Feast: VK2735's Impressive Weight Loss Results Set the Obesity Market Ablaze

The Facts

Viking Therapeutics' GLP-1 and GIP dual agonist, VK2735, has demonstrated remarkable weight loss results in a phase 2 trial, with reductions ranging from 9.1% to 14.7% over 13 weeks, significantly outperforming the placebo group's 1.7% dip. This achievement not only surpasses the internal target of an 8% weight loss but also positions VK2735 competitively against existing obesity treatments like Novo Nordisk's semaglutide and Eli Lilly's tirzepatide. Viking's stock surged by 80% in premarket trading, reaching a market cap of $3.9 billion, as the biotech remains open to business development discussions while focusing on advancing VK2735's clinical development.

Our Opinion

The success of VK2735 in early trials is a game-changer for the obesity treatment landscape and holds significant promise for addressing the global obesity epidemic. Viking Therapeutics' ability to produce a drug with such potent weight loss effects and a favorable safety profile underscores the potential of combining GLP-1 and GIP agonists. This breakthrough not only offers hope for millions struggling with obesity but also highlights the importance of innovative drug development in tackling complex metabolic disorders.

Your Turn

Considering the potential applicability of VK2735 to metabolic dysfunction-associated steatohepatitis (MASH), how could the development of obesity drugs impact the treatment and management of related metabolic disorders?

?? Biotech's Bull Run: XBI Index Surges Past $100, Fueling Optimism in the Drug Development Sector

The Facts

The biotech market's key stock index, the SPDR S&P Biotech ETF ($XBI), has soared past the $100 mark, marking a significant rebound from its October lows. This 5.7% rise on Tuesday is part of a months-long recovery, further boosted by Viking Therapeutics' impressive data readout for its obesity drug. The industry has been on an upward trajectory since the start of the year, with signals of upcoming interest rate cuts and increased M&A activity in Q4 contributing to this momentum. Despite some concerns about the timing of potential interest rate cuts, the biotech sector's total enterprise value worldwide has surged by 21.5% so far this year, according to a report from Stifel.

Our Opinion

The resurgence of the biotech market, as evidenced by the XBI index crossing the $100 threshold, is a testament to the sector's resilience and potential for growth. This rally is not just a reflection of short-term gains but indicates a broader optimism in the drug development industry, driven by breakthroughs in research, strategic mergers and acquisitions, and favorable economic signals. For investors and stakeholders, this upward trend underscores the importance of continued innovation and investment in biotechnology, as it remains a crucial driver of medical advancements and economic prosperity.

Your Turn

With the XBI index's significant rise, how might this influence the strategies of biotech companies in terms of research and development priorities, as well as merger and acquisition activities?

?? Pfizer's Oncology Odyssey: Betting Big on Cancer to Regain Market Dominance

The Facts

Pfizer's shares plummeted by 44% last year, leaving the pharmaceutical giant with a market capitalization significantly lower than its competitors. In a bold move, Pfizer acquired Seagen for $43 billion, aiming to bolster its oncology portfolio with antibody-drug conjugates. CEO Albert Bourla believes this deal could be as transformative as Merck's acquisition of Organon. Pfizer's strategy involves integrating Seagen's expertise with its existing $11.6 billion cancer business, led by chief oncology officer Chris Boshoff. The combined entity will focus on developing new cancer treatments, with 24 marketed drugs and 17 potential medicines in the pipeline. Pfizer aims to rekindle investor interest by showcasing its oncology strategy and promising pipeline at an upcoming investor briefing.

Our Opinion

Pfizer's aggressive pivot towards oncology reflects a strategic effort to regain its foothold in the pharmaceutical market. The acquisition of Seagen and the emphasis on antibody-drug conjugates could position Pfizer as a leader in cancer treatment, potentially revitalizing its stock performance. However, the success of this strategy hinges on the company's ability to deliver groundbreaking treatments and convince investors of its long-term viability. As Pfizer navigates this oncology odyssey, the industry will be watching closely to see if this bet pays off and restores the company's reputation for innovation and execution.

Your Turn

Given the challenges Pfizer has faced with its pipeline in recent years, what steps should the company take to ensure the success of its oncology strategy and regain investor confidence?

?? Politics & Policy ???

?? A Game-Changer for Humira: Teva and Alvotech's Interchangeable Biosimilar Hits the US Market

The Facts

Teva and Alvotech have received approval for their Simlandi biosimilar of AbbVie's Humira, marking the first fully interchangeable high-concentration version of the drug in the US. This approval allows pharmacists to substitute Simlandi for Humira without a physician's intervention, potentially accelerating the adoption of biosimilar alternatives. Humira, used to treat various immunological diseases, saw its sales drop to $14.4 billion last year due to the emergence of biosimilars. Simlandi's entry into the market, despite being delayed by manufacturing issues, is expected to make significant gains as payers renegotiate formularies, leveraging its interchangeable exclusivity at the high concentration.

Our Opinion

The approval of Simlandi as an interchangeable biosimilar for Humira represents a significant shift in the biopharmaceutical landscape. It not only introduces a cost-effective alternative for patients but also sets a precedent for the future of biosimilar competition and adoption in the US. The ability for pharmacists to substitute biosimilars without prescriber involvement could streamline the process and increase accessibility for patients. Teva and Alvotech's partnership in bringing this product to market demonstrates a commitment to expanding the availability of biosimilars, which is crucial for fostering a competitive and sustainable healthcare system.

Your Turn

Given the slow development of the biosimilar Humira market, what strategies should other biosimilar manufacturers consider to enhance their competitiveness and market penetration?

?? Sarepta's Duchenne Gene Therapy Approval: An Exceptional Case in the FDA's Accelerated Pathway

The Facts

Peter Marks, the FDA's top official for cell and gene therapy, emphasized that the narrow approval of Sarepta's Duchenne muscular dystrophy gene therapy, Elevidys, for boys ages 4 and 5, should not be seen as a typical example of accelerated approval. Despite advocating for faster gene therapy approvals, Marks highlighted the unique circumstances surrounding Elevidys' approval, including the influence of patient advocates and the override of FDA reviewers' recommendations. The therapy's approval process was marked by a contentious advisory committee meeting, where patient testimonials and videos played a significant role in swaying opinions. Internal documents reveal the FDA's internal debate and Marks' insistence on considering patient perspectives. A decision expected in June could potentially expand the therapy's eligibility to a broader range of patients.

Our Opinion

The FDA's approval of Elevidys underscores the complex interplay between regulatory rigor, patient advocacy, and the urgent need for innovative treatments. While the decision reflects the FDA's willingness to adapt its processes for groundbreaking therapies , it also raises questions about the balance between scientific evidence and emotional appeals. As the FDA navigates future approvals, it must continue to prioritize patient safety and efficacy while acknowledging the valuable insights that patient advocates bring to the table.

Your Turn

What role should patient advocacy groups play in the regulatory review process, and how can their input be effectively integrated without compromising the objectivity of the decision-making?

?? Lawmakers Challenge Biden's Plan to Use March-In Rights for Drug Price Control

The Facts

A bipartisan group of 28 senators and members of Congress has sent a letter to President Joe Biden, criticizing his administration's proposal to use march-in rights to control drug prices. The proposal, announced in December, suggests that the government could take over patents for drugs developed with federally-funded research if prices are deemed too high. The lawmakers argue that this interpretation misrepresents the Bayh-Dole Act of 1980 and could have a minimal impact on prescription drug prices, as only a small fraction of FDA-approved drugs would be subject to march-in rights. They also express concern that using march-in rights in this way could deter collaboration between the NIH and the pharmaceutical industry.

Our Opinion

The debate over the use of march-in rights highlights the complex intersection of innovation, public investment, and drug affordability. While the intention to lower drug prices is commendable, the lawmakers' concerns about the potential impact on research collaboration and the limited scope of the proposal raise important questions. Striking a balance between ensuring affordable access to medications and fostering a conducive environment for medical research and development is crucial for the long-term health of both the public and the pharmaceutical industry.

Your Turn

How does the Bayh-Dole Act of 1980 shape the relationship between federally-funded research and patent rights, and what are the implications for drug pricing?

??? Debating the Future of Medicare Price Negotiations: Lawmakers Consider Amendments to the Inflation Reduction Act

The Facts

In a recent House Committee on Energy and Commerce hearing, US lawmakers discussed potential amendments to the Inflation Reduction Act (IRA), focusing on the implementation of Medicare price negotiations and exemptions for certain drugs. The bipartisan ORPHAN Cures Act aims to broaden exemptions for orphan drugs, while the MINI Act proposes delaying negotiations for "advanced drug products." The hearing revealed deep divisions among lawmakers, with some advocating for changes to preserve innovation and access to life-saving cures, while others warn against undermining the IRA's intent to negotiate fair drug prices. The debate reflects the ongoing tension between controlling drug costs and encouraging pharmaceutical innovation.

Our Opinion

The discussions surrounding the ORPHAN Cures Act and the MINI Act highlight the delicate balance between ensuring affordability and fostering innovation in drug development. While it's essential to prevent drug developers/manufacturers from exploiting loopholes to avoid fair price negotiations, it's equally important to maintain incentives for developing treatments for rare diseases and advanced drug products. As lawmakers consider these amendments, they must carefully weigh the potential impacts on patient access, drug pricing, and the future of medical research.

Your Turn

Considering the mixed opinions on the IRA's impact on innovation, what measures can be taken to ensure that price negotiations do not deter investment in research and development for new drugs?

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Disclaimer: The contents of this article are not to be construed with investment advice. The information presented in this article is a compilation of current events, technical analyses, corporate press releases, and the author's personal viewpoints about the biotechnology industry. While efforts have been made to provide accurate and timely information, there may be inadvertent errors, omissions, or inaccuracies. Therefore, investment decisions should not be made solely based on the content of this article. The article may contain statements that are forward-looking in nature, encompassing predictions and future expectations that are subject to inherent risks and uncertainties; as such, actual outcomes may significantly deviate from those expressed or implied herein. This article serves purely as an informational and entertainment resource, and should not be construed as an endorsement to purchase or sell any financial securities. Prior to engaging in any investment activities, it is imperative that you conduct comprehensive due diligence and consult with a qualified financial advisor.