AstraZeneca's Calquence treads on Imbruvica's turf with second phase 3 CLL win

fiercepharma | June 06, 2019

AstraZeneca’s Calquence has been battling it out in mantle cell lymphoma since it won its first approval back in late 2017, but all along, the company has had its eye on another disease: chronic lymphocytic leukemia. And that’s where it’s scored its latest win. In a phase 3 trial, Calquence—combined with Roche’s Gazyva—beat out a regimen of chlorambucil chemotherapy and Gazyva at staving off disease progression in previously untreated CLL patients, AstraZeneca said Thursday. And the trial nailed a key secondary endpoint, too, showing solo Calquence could top the Gazyva-chemo combination at the same feat. The British drugmaker is keeping the details under wraps for now; they’ll debut at a future medical meeting. But in the meantime, later this month, the company plans to unveil full results from another Calquence CLL win that it top-lined in early May.

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This is especially important for sensitive pharmaceuticals, which can be fundamentally compromised when exposed to incorrect temperatures. The effects of this decomposition can vary from lack of therapeutic effect to toxicity and even death.

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This is especially important for sensitive pharmaceuticals, which can be fundamentally compromised when exposed to incorrect temperatures. The effects of this decomposition can vary from lack of therapeutic effect to toxicity and even death.

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BUSINESS INSIGHTS

ERS Genomics and Lepton Pharmaceuticals LTD Enter CRISPR/Cas9 License Agreement

ERS Genomics | July 27, 2022

ERS Genomics Limited is pleased to announce a new license agreement with Lepton Pharmaceuticals LTD. This is a non-exclusive licensing agreement granting Lepton access to the ERS CRISPR/Cas9 patent portfolio for certain applications. ERS, co-founded by Dr. Emmanuelle Charpentier, 2020 Nobel Prize winner for gene-editing, provides access to the foundational CRISPR/Cas9 intellectual property. Over 90 patents are held in over eighty countries. Lepton Pharmaceutical LTD is a biotechnology company developing a proprietary, breakthrough technology to substantially improve adaptive cell-mediated immune response. "We are very pleased to establish this relationship and license agreement with ERS Genomics. It will greatly assist us to develop our innovative Castling technology to significantly improve immune cells efficiency and longevity to fight cancer." Dr. Daniel Zurr, CEO of Lepton Eric Rhodes, CEO at ERS Genomics added: "Lepton's Castling technology has great potential to impact the field of immunotherapies and we are pleased to help enable Lepton in pursuing this exciting approach." The Castling technology is a proprietary, miRNA-based general technology platform, essentially consisting of the manipulation of miRNA expression to achieve enhanced efficacy and longevity (reduced exhaustion) of cell-based therapies. miRNAs are noncoding RNAs that each affects the expression of hundreds of coding genes. The Castling technology allows, in a single gene editing event in the immune cell (either allogeneic or autologous), to impact the expression of a multitude of genes in the immune cells, once such miRNAs penetrate the microenvironment of cancer cells. This technology aims to revolutionize the immune cell cancer therapy field. About ERS Genomics ERS Genomics is a biotechnology company based in Dublin, Ireland. The company was formed to provide broad access to the foundational CRISPR/Cas9 intellectual property held by Dr. Emmanuelle Charpentier. Non-exclusive licenses are available for research and sale of products and services across multiple fields including: research tools, kits, reagents; discovery of novel targets for therapeutic intervention; cell lines for discovery and screening of novel drug candidates; GMP production of healthcare products; companion animal and livestock health; production of industrial materials such as enzymes, biofuels and chemicals; and synthetic biology. About Lepton Pharmaceuticals Lepton Pharmaceuticals LTD. is based in Israel. Lepton focuses on subtle and precise silencing of coding RNA expression by small non-coding RNA molecules, working via the DROSHA/DICER/RISC pathways, small interfering RNA and microRNA (miRNA), to develop products and services to, ultimately, improve therapies for underserved diseases and improve and change patients' lives.

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PHARMA TECH

Silverback Therapeutics and ARS Pharmaceuticals Announce Merger

Silverback Therapeutics and ARS Pharmaceuticals | July 22, 2022

Silverback Therapeutics, Inc. and ARS Pharmaceuticals, Inc. announced that the companies have entered into a definitive agreement under which ARS will merge with Silverback in an all-stock transaction. The combined company will focus on the potential regulatory approval and commercialization of neffy, ARS’s investigational epinephrine nasal spray for the treatment of Type I allergic reactions including anaphylaxis. The combined company is expected to have approximately $265M in cash, cash equivalents and marketable securities at closing. Upon stockholder approval, the combined company is expected to operate under the name ARS Pharmaceuticals and trade on the Nasdaq Capital Market under the ticker symbol “SPRY.” The merger is currently expected to close in the fourth quarter of 2022. Type I severe allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. While epinephrine autoinjectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. There are approximately 25 million people in the United States who experience Type I severe allergic reactions. Of those, only 3.3 million currently have an active epinephrine autoinjector prescription, and of those, only half consistently carry their prescribed autoinjector. Even if patients or caregivers carry an autoinjector, more than half either delay or do not administer the device when needed in an emergency. ARS designed neffy to provide injection-like absorption of epinephrine, in a small, easy-to-carry, easy-to-use, rapidly administered, and reliable nasal spray device. With its needle-free administration, neffy may help eliminate the anxiety and hesitation associated with using an autoinjector. “We are extremely pleased to announce this proposed merger with Silverback, which we believe enables ARS to maximize the paradigm-changing opportunity of neffy. neffy is on the cusp of achieving what has not been possible before – the ability to deliver epinephrine with comparable pharmacokinetics to an intramuscular injection, but with a simple to administer nasal spray. We have completed a comprehensive registration program with neffy and based on a favorable pre-NDA meeting with the U.S. Food and Drug Administration (“FDA”), we are preparing to submit our New Drug Application (“NDA”) in the third quarter of 2022. This merger positions ARS and our experienced team to execute on the potential launch of neffy in 2023 by providing the requisite capital needed for launch. ARS was founded with a mission of solving many of the issues that patients and caregivers express about their epinephrine autoinjectors. Today is an important step toward bringing this novel treatment to patients and caregivers to improve their treatment options for these serious and potentially life-threatening allergic reactions.” Richard Lowenthal, M.Sc., MSEL, co-founder and chief executive officer of ARS Data across three registration studies supports that neffy should meet all clinical endpoints recommended by regulators and that its pharmacokinetics are within the range of approved efficacious epinephrine injection products. In addition, neffy has been well-tolerated to date with more than 500 individuals having received at least one dose, and many with repeat administration. The majority of adverse events in clinical trials were mild in nature and comparable to injection products. Based on the totality of data, ARS is preparing to submit its NDA for neffy for use in adults and pediatric patients who are 30 kg or greater in the third quarter of 2022. If approved, ARS is planning to launch neffy in the United States in 2023. “This transaction represents the result of a thorough and thoughtful strategic review process by Silverback,” said Laura Shawver, Ph.D., chief executive officer of Silverback. “ARS is an exciting late-stage company with compelling clinical data demonstrated with neffy, a path to near-term commercialization in a large and dissatisfied market, and an expert team with proven experience in launching and commercializing market-leading nasal spray products, such as NARCAN. I believe we have found the optimal partner to provide value for our stockholders, and even more so, the potential to transform treatment for millions of people with or at-risk for Type I severe allergic reactions.” About the Proposed Merger Under the terms of the merger agreement, assuming that Silverback’s net cash at closing is $240 million, Silverback equity holders are expected to own approximately 37% of the combined company and pre-merger ARS equity holders are expected to own approximately 63% of the combined company on a fully-diluted basis on a treasury stock method. The percentage of the combined company that Silverback’s equity holders will own as of the close of the transaction is subject to certain adjustments as described in the merger agreement, including the amount of Silverback’s net cash at closing. Upon closing of the transaction, Silverback will be renamed ARS Pharmaceuticals, Inc. and will be headquartered in San Diego, California. Richard Lowenthal, M.S., MBA, will serve as chief executive officer and president of the combined company. The merger agreement provides that the Board of Directors of the combined company will be comprised of ten members, including seven from ARS and three from Silverback. The merger agreement has been approved by the Board of Directors of each company, and the transaction is expected to close in the fourth quarter of 2022, subject to approvals by the stockholders of each company and other customary closing conditions. About Silverback Therapeutics, Inc. Silverback Therapeutics, Inc. is a biopharmaceutical company focused on leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered and tissue targeted therapeutics for the treatment of chronic viral infections, cancer, and other serious diseases. Silverback’s platform enables the strategic pairing of proprietary payloads that modulate key disease modifying pathways with monoclonal antibodies directed at specific disease sites. Silverback Therapeutics is located in Seattle, Washington.

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BUSINESS INSIGHTS

Astorg to Acquire Global Medical Communications and Market Access Platform OPEN Health From Amulet Capital Partners

Astorg and Amulet Capital Partners | June 01, 2022

Astorg and Amulet Capital Partners announce that they have signed a binding agreement whereby Astorg will acquire OPEN Health, a leading global provider of scientific communications and market access services to the pharmaceutical industry. Established in 2011 and headquartered in London, UK, OPEN Health is a key partner to its customers in helping them develop strategies for evidence generation and data communication by leveraging their extensive scientific knowledge and relentless focus on quality. Together, this approach consistently delivers best-in-class scientific communications, health economics and outcomes research (HEOR) and market access services to an ever-increasing audience. OPEN Health has more than 1,000 employees in 15 locations and six countries, across North America, Europe and Asia. OPEN Health serves over 170 life sciences customers, including 48 of the top 50 pharmaceutical companies. OPEN Health’s existing management team, led by CEO Rob Barker, will continue to lead the organization, building on a strong track-record of organic growth and strategic acquisitions. "We are excited to build on the momentum across our business and to continue executing with our new partners at Astorg on a shared long-term vision to bring deep scientific solutions that support our clients in driving positive health outcomes. We are grateful for the strong partnership of the Amulet team over the last three and a half years and for all that we have accomplished in expanding our industry-leading capabilities across disciplines. We continue to be very well positioned to drive innovation and growth, and we look forward to embarking on this next chapter for OPEN Health." Rob Barker, CEO, OPEN Health Building on OPEN Health’s leading service offerings, Astorg will invest in the development of the business across its main existing offerings, and beyond, to continue delivering best-in-class scientific content to OPEN Health’s customer base and help them harness the full value of their most important assets. "OPEN Health is a very impressive company. We have been following the development of the medical affairs space for a long time as the function evolved from a supportive to a central role and identified OPEN Health as a global leader in the making. We have been impressed with its outstanding reputation and the trust it benefits from its customer base,” said Judith Charpentier, Partner and Head of Healthcare, Astorg. “We look forward to supporting Rob and the OPEN Health management team in continuing to build a global leading scientific focused medical affairs platform, expanding the platform through both organic initiatives and additional strategic acquisitions,” said Olivier Lieven, Director, Astorg. Ramsey Frank, President and Managing Partner of Amulet, said, “OPEN Health was built around Amulet’s investment thesis in medical affairs: the current generation of drugs is fundamentally different from prior generations, and these therapies need to be brought to market with the support of high science communications and data analytics. We brought OPEN Health together very intentionally via three acquisitions to create a purpose-built suite of services to meet pharma’s evolving needs.” Amulet Partner Nick Amigone continued, “We could not be more grateful to Rob Barker and his team for the outstanding job they have done in building a true industry leader.” The terms of the transaction were not disclosed. The transaction is subject to customary regulatory approvals. Houlihan Lokey served as financial advisor to OPEN Health and Rothschild & Co advised Astorg on the transaction. About OPEN Health OPEN Health brings together deep scientific knowledge, global understanding, and broad specialist expertise to support our clients in improving health outcomes and patient wellbeing. We are united as one flexible organization, harnessing the power of the collective to solve complex challenges. About Astorg Astorg is a European private equity firm with over €17 billion of assets under management. Astorg works with entrepreneurs and management teams to acquire market leading global companies headquartered in Europe or the US, providing them with the strategic guidance, governance and capital they need to achieve their growth plans. Enjoying a distinct entrepreneurial culture, a long-term shareholder perspective and a lean decision-making body, Astorg has valuable industry expertise in healthcare, software, technology, business services and technology-based industrial companies. Astorg has offices in London, Paris, New York, Frankfurt, Milan and Luxembourg. About Amulet Capital Partners, LP Amulet Capital Partners, LP is a middle-market private equity investment firm based in Greenwich, CT, focused exclusively on the healthcare sector. Amulet seeks to achieve long-term capital appreciation through privately negotiated investments in companies. Amulet Capital Partners focuses on those segments it believes have the most attractive long-term fundamentals with a target investment size generally between $25 million to $150 million.

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