FDA grants priority review to tumour drug selumetinib

Pharmaceutical Technology | November 15, 2019

The US Food and Drug Administration (FDA) has awarded priority review status for AstraZeneca and MSD (Merck)’s selumetinib to treat neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibromas (PNs) in children. If approved, selumetinib would be the first drug for paediatric patients aged three years and above with NF1 plexiform neurofibromas, said the companies. Selumetinib inhibits the MEK enzyme involved in the RAS/MAPK cell-signalling pathway, which is linked to cancer cell growth and proliferation in a variety of tumour types. AstraZeneca and MSD agreed to jointly develop and commercialise the drug worldwide. The new drug application (NDA) submitted to the FDA is supported by positive data from the SPRINT Phase II Stratum 1 clinical trial, which was funded under the National Cancer Institute (NCI) Cancer Therapy Evaluation Programme (CTEP).

Spotlight

Alzheimer’s disease (AD) is the most well-known and most common type of age-related dementia. Amyloid deposition and hyperphosphorylation of tau protein are both pathological hallmarks of the AD. Using a triple-transgenic mouse model (3xTg-AD) that develops plaques and tangles in the brain similar to the human AD, we provide evidence that active full-length DNA amyloid-β peptide 1–42 (Aβ42) trimer immunization leads to the reduction of both amyloid and tau aggregation and accumulation.

Spotlight

Alzheimer’s disease (AD) is the most well-known and most common type of age-related dementia. Amyloid deposition and hyperphosphorylation of tau protein are both pathological hallmarks of the AD. Using a triple-transgenic mouse model (3xTg-AD) that develops plaques and tangles in the brain similar to the human AD, we provide evidence that active full-length DNA amyloid-β peptide 1–42 (Aβ42) trimer immunization leads to the reduction of both amyloid and tau aggregation and accumulation.

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BUSINESS INSIGHTS

Halozyme Completes Antares Pharma Acquisition

Halozyme Therapeutics, Inc. | May 30, 2022

Halozyme Therapeutics, Inc. announced the successful completion of its acquisition of Antares Pharma, Inc. The tender offer for all of the outstanding shares of Antares common stock expired as scheduled at one minute after 11:59 p.m., Eastern Time, on Monday, May 23, 2022. The minimum tender condition and all of the other conditions to the offer have been satisfied and on May 24, 2022, Halozyme accepted for payment and will promptly pay for all shares validly tendered and not validly withdrawn. Following its acceptance of the tendered shares, Halozyme completed its acquisition of Antares through the merger of a wholly owned subsidiary of Halozyme with and into Antares, pursuant to Section 251(h) of the General Corporation Law of the State of Delaware, with Antares continuing as the surviving corporation and becoming a wholly owned subsidiary of Halozyme. In connection with the merger, all Antares shares not validly tendered in the tender offer have been converted into the right to receive the same $5.60 per share in cash, without interest thereon and net of any applicable withholding taxes, that would have been paid had such shares been validly tendered in the tender offer. As of May 24, 2022, Antares common stock will cease to be traded on the NASDAQ Global Select Stock Market. BofA Securities, Inc. and Wells Fargo Securities LLC acted as financial advisors to Halozyme and Weil, Gotshal & Manges LLP acted as legal advisor. Jefferies LLC acted as financial advisor to Antares and Skadden, Arps, Slate, Meagher & Flom LLP acted as legal advisor. About Halozyme Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has touched more than 600,000 patient lives in post-marketing use via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, AbbVie, Eli Lilly, Bristol-Myers Squibb, Alexion, argenx, Horizon Therapeutics, ViiV Healthcare and Chugai Pharmaceutical. Halozyme derives revenues from these collaborations in the form of milestones and royalties as Halozyme's partners make progress developing and commercializing their products being developed using ENHANZE®. Halozyme is headquartered in San Diego.

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BUSINESS INSIGHTS

Pharma Tech Holdings SA Obtains a Capital Commitment Agreement of CHF 30 million from Global Investor LDA Capital

Pharma Tech | August 09, 2022

Pharma Tech Holding SA announced it has secured a CHF 30 million investment to support its portfolio investments from LDA Capital Ltd, a global investment group with expertise in cross border transactions including the agriculture, Agri-tech, and CBD industries. Established in 2019, PTH is a Swiss based holding company, which invests into innovative businesses with high technological value and scalability potential, mainly in Switzerland and Europe, with a focus on the health-tech, Agri-tech, and functional food. This investment will allow PTH to mainly invest and support its portfolio company Blue Sky Swisse SA a JV between PTH and listed company IGEA PHARMA NV IGPH - ISIN NL0012768675. BSS focuses on the extraction of natural active principles from vegetable matrices, vegetable waste, and renewable sources to deliver B2B products under the form of CBD oil, Terpenes and Waxes. The factory located in Biasca, will be built to the state of art of extraction technology by super critical CO2 and will be energy self-sufficient through the use of solar photovoltaic panels and district heating. BSS will grant for highest CBD quality also due to a proprietary extraction process, starting from the farming performed under strict control and culminating with the immediate freezing of the flowers after harvest, with the target to also sell “all natural” formulations to increase bioavailability thus enhancing the possible applications. Last, but not least, BSS will invest in the agricultural raw material chain and will create an aeroponic green house in Ticino, to deliver a high quality GMP Pharmaceutical CBD oil. LDA Capital agreed to commit an amount of up to CHF 30 million in cash within a maximum of three years. This Capital Commitment will be released based on drawdowns by PTH, that PTH has the right to exercise at its sole discretion. “We’re thrilled with this partnership and are so glad that LDA Capital recognizes the value of PTH and its portfolio company, with the aim of creating one of the most innovative hub for health-tech, agri-tech and functional food,” Sabina Del Nigro, CEO at PTH About Pharma Tech Holding Pharma Tech Holding SA is a holding company based in Lugano, Switzerland, which invests into innovative businesses with high technological value and scalability potential, mainly in Switzerland and Europe, with a focus on the health-tech, Agri-tech, and functional food. About LDA Capital LDA Capital is a global alternative investment group with expertise in cross border transactions worldwide. Our team has dedicated their careers to international & cross border opportunities having collectively executed over 250 transactions in both the public and private middle markets across 43 countries with aggregate transaction values of over US$11 billion.

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PHARMACY MARKET

Vipergen and LEO Pharma Partner for DNA Encoded Library (DEL)-Based Drug Discovery for Dermatology Indications

Vipergen | June 20, 2022

Vipergen, a leading provider of small-molecule drug discovery services based on DNA-encoded library technologies, announced a multi-target drug discovery partnership with LEO Pharma focused on novel treatments for dermatology indications. Under the terms of the agreement, Vipergen will apply its high-fidelity DNA-encoded library (DEL) screening technologies, including its new in-living-cell DEL platform, to discover novel small-molecule compounds that bind to selected LEO Pharma targets. LEO Pharma will select hits for potential development into innovative drugs for dermatology applications. LEO Pharma will retain exclusive rights to globally commercialize any products resulting from the collaboration. Financial details of the agreement were not disclosed. "Driving our mission to rapidly bring better treatments to people with skin conditions, we continue to explore ways to discover novel small-molecule compounds for innovative and challenging targets while shortening development timelines. Partnering with Vipergen gives us access to the only technology capable of screening DEL libraries inside living cells, under physiologically relevant conditions. We look forward to a productive partnership." Thorsten Thormann, Vice President of Research & Early Development at LEO Pharma "We are very pleased to partner with LEO Pharma in its mission to develop first-in-class and best-in-class treatments for the millions of patients around the world suffering with psoriasis, eczema, acne, skin infections, and other serious skin conditions," said Nils Hansen, PhD, Chief Executive Officer of Vipergen. "We look forward to applying our full suite of DEL screening technologies to accelerate and advance LEO Pharma's efforts to discover novel, high-quality small molecules for development into innovative new treatments." About Vipergen ApS Vipergen is a world-leading provider of small-molecule drug discovery services based on DNA-encoded library technologies and is the first and only company capable of screening DELs inside a living cell. Vipergen provides its proprietary suite of leading-edge DEL technologies through funded discovery partnerships with leading pharmaceutical and biotechnology companies, including top pharmaceutical companies in the U.S., EU, and Japan.

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