Following Lab Test, Eagle Pharma Looks to Test MH Drug Ryanodex Against COVID-19

BioSpace | April 16, 2020

Following Lab Test, Eagle Pharma Looks to Test MH Drug Ryanodex Against COVID-19
In a controlled laboratory test, Eagle Pharmaceuticals’ malignant hyperthermia treatment Ryanodex (dantrolene sodium) inhibited the growth of SARS-CoV-2, the virus causing the COVID-19 pandemic. Now the company hopes to launch a clinical trial testing the efficacy of the drug in patients. In the in vitro tests, Ryanodex demonstrated antiviral activity and a lack of cytotoxicity. Two days after dosing, the in vitro results showed an absence of cytopathic effects in the infected cells. This morning, New Jersey-based Eagle Pharmaceutical submitted its Investigational New Drug Application to the U.S. Food and Drug Administration to launch a Phase II trial in partnership with Hackensack University Medical Center to evaluate the efficacy of Ryanodex in patients infected with SARS-CoV-2. The company said it has been in contact with the FDA’s Coronavirus Treatment Acceleration Program to request a potential expedited review of the IND application and aims to begin the clinical trial as soon as possible.

Spotlight

This white paper outlines the main benefits of using hard radiation for material analysis studies. X-ray powder diffractometers are generally equipped with X-ray sources using Cu anodes. For specific applications, however, switching to shorter wavelength, ‘harder’ radiation, like obtained from X-ray tubes with Mo or Ag anodes, gives significant improvements over Cu, or even allows experiments that are impossible with Cu radiation, like experiments where a large Q range needs to be probed.

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PHARMA TECH

Gannex Received U.S. FDA Fast Track Designation for Its NASH Drug Candidate ASC42,an FXR Agonist

Gannex | December 14, 2020

Gannex, an entirely claimed organization of Ascletis Pharma Inc. (HKEX:1672) and completely committed to the R&D and commercialization of new medications in the field of NASH, reported today that it got Fast Track assignment from the U.S. Food and Drug Administration (FDA) for its non-alcoholic steatohepatitis (NASH) drug applicant ASC42. The U.S. FDA's Fast Track advancement program is intended to encourage the turn of events and speed up the survey of medications that have capacity to treat genuine or perilous infections or conditions and exhibit the possibility to address neglected clinical necessities with extra clinical advantages to patients. There are no FDA affirmed drugs for NASH sign yet. This Fast Track assignment speaks to FDA's acknowledgment of ASC42's potential in tending to these neglected clinical requirements for NASH patients. Gannex got the investigational new medication application (IND) endorsement for ASC42 from the U.S. FDA in October this year. ASC42 is an in-house developed,novel non-steroidal, specific, intense Farnesoid X Receptor (FXR) agonist with top tier potential. In two NASH creature models, ASC42 showed critical enhancements in liver steatosis, aggravation and fibrosis. The oral tablet plan of ASC42 has been created with the in-house restrictive innovation and is steady at room temperature. "We are excited that the FDA allowed Fast Track assignment for our FXR agonist ASC42 which is found and created by our in-house skilled R&D group," said Dr. Jinzi J. Wu, "This basic acknowledgment by FDA will quicken worldwide advancement of ASC42, a potential top tier FXR agonist."

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PHARMACY MARKET

H.I.G. Capital Acquires Aspire Pharma

Aspire | September 24, 2021

H.I.G. Capital, LLC, a leading global alternative investment firm with $45 billion of equity capital under management, is pleased to announce that one of its affiliates has acquired Aspire Pharma Limited, a leading UK provider of niche generic and branded specialty pharmaceuticals, alongside its founder Graham Fraser-Pye. The financial terms of the transaction have not been disclosed. Aspire licenses and develops niche generic and specialty pharmaceutical products that offer innovative formulations, value for money for payors, and reliable supply arrangements in markets that are often underserved. The business holds leadership positions in urology, ophthalmology, CNS and dermatology, with a highly diversified portfolio of more than 250 products across multiple categories, including branded specialty products and unbranded niche generics. H.I.G., together with the management team, aims to continue Aspire’s strong track record of organic growth and to support new initiatives, such as M&A and international expansion. The existing management team of Aspire Pharma will remain in place, with Graham Fraser-Pye taking the role of Chairman. I am very pleased to welcome H.I.G. as a key investor in the future of Aspire Pharma. Since our foundation in 2009, we have grown rapidly and consistently through our astute strategic choices and extensive development know-how. H.I.G., with its significant financial and geographic reach, will help us maintain our impressive growth trajectory and take Aspire into another exciting phase for its people and customers. We remain committed to the development and supply of innovative products and medicines that offer value to our customers and make a difference to the lives of patients. - Graham Fraser-Pye We are delighted to be supporting Graham and his team to further build upon Aspire’s success. The Company’s track record of identifying, developing and launching niche pharmaceutical products, coupled with H.I.G.’s international presence and history of supporting organic and acquisitive growth in its portfolio companies, underpins an exciting next chapter for Aspire. - John Harper, Managing Director and Head of the H.I.G. Europe Lower Middle Market LBO team in London About Aspire Aspire was founded in 2009. Aspire has an asset-light business model that focuses on R&D, business development and sales and marketing, while outsourcing manufacturing and distribution to specialist third parties. About H.I.G. Capital H.I.G. is a leading global private equity and alternative assets investment firm with $45 billion of equity capital under management.* Based in Miami, and with European offices in London, Hamburg, Madrid, Milan, Paris, and U.S. and Latin American offices in New York, Boston, Chicago, Dallas, Los Angeles, San Francisco, Atlanta, Bogotá, Rio de Janeiro and São Paulo, H.I.G. specializes in providing both debt and equity capital to small and mid-sized companies, utilizing a flexible and operationally focused/ value-added approach

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BUSINESS INSIGHTS

Hikma strengthens US Injectables business through acquisition of Custopharm

Hikma Pharmaceuticals USA Inc. | September 27, 2021

Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company and one of the largest suppliers of generic injectable medicines in the US, today announces that it has agreed to acquire Custopharm Inc. ('Custopharm') from Water Street Healthcare Partners ('Water Street'). Hikma will pay an initial cash consideration of $375 million on a debt and cash-free basis, with a further $50 million in contingent consideration payable upon the achievement of certain commercial milestones. Custopharm, a US-based generic sterile injectables company with a differentiated product portfolio and R&D pipeline, currently markets its products in the US through its commercial arm Leucadia Pharmaceuticals. Since partnering with Water Street in 2015, Custopharm has received 13 US FDA approvals, with four first-to-market Abbreviated New Drug Application (ANDA) approvals - including one with Competitive Generic Therapy (CGT) designation - and one novel 505(b)(2) NDA approval. Based in Carlsbad, California, Custopharm has 39 employees. With this acquisition, Hikma will have a differentiated US portfolio of close to 130 injectable medicines a more than fivefold increase over the last decade. Through this broad portfolio and by combining Custopharm's strong R&D capabilities with our high-quality and extensive manufacturing footprint, we will be in an excellent position to better serve the growing needs of hospitals, doctors and patients. I look forward to welcoming the team at Custopharm and Leucadia to Hikma as we continue to grow and strengthen our Injectables business. - Riad Mishlawi, President of Hikma Injectables We're excited to become part of Hikma, a global leader that shares our deep commitment to bringing generic products to market and into the hands of patients who need them. Water Street has been an outstanding partner in working with us to build an exemplary portfolio of complex generic products. We're looking forward to building on this success. - William C. Larkins, Ph.D., CEO of Custopharm and Leucadia Terms of the transaction and financial impact: The up-front consideration of $375 million is on a cash-free, debt-free basis and is being funded from Hikma's existing cash resources. The acquisition constitutes a Class 2 transaction pursuant to the UK Listing Rules.The gross assets of Custopharm at 31 December 2020 were $43 million. Losses before tax in the year to 31 December 2020 were $7.5 million. About Hikma Hikma helps put better health within reach every day for millions of people around the world. For more than 40 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across the United States (US), the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 8,600 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. About Custopharm Custopharm is a leader in the generic injectables market. Its goal is to provide important new generic injectable products to the acute and specialty markets and to reach people and communities with underserved conditions. Custopharm invests significantly in developing and acquiring new products, including through strategic partnerships. It also launches newly approved products through its nationally recognized commercial organization, Leucadia Pharmaceuticals. Custopharm features a portfolio of highly differentiated generic products, including four first-to-market products: Calcitonin Salmon Injection, USP, Synthetic, Dihydroergotamine Mesylate Nasal Spray, Sodium Tetradecyl Sulfate (STS) Injection, 3%, and Valrubicin Intravesical Solution, USP. Headquartered in Carlsbad, California, Custopharm is a company of Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry. About Water Street Water Street is a strategic investor focused exclusively on health care. The firm has a strong record of building market-leading companies across key growth sectors in health care. It has worked with some of the world's leading companies on its investments including Humana, Johnson & Johnson, Medtronic and Walgreen Co. Water Street's team is comprised of industry executives and investment professionals with decades of experience investing in and operating global health care businesses. The firm is headquartered in Chicago.

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Spotlight

This white paper outlines the main benefits of using hard radiation for material analysis studies. X-ray powder diffractometers are generally equipped with X-ray sources using Cu anodes. For specific applications, however, switching to shorter wavelength, ‘harder’ radiation, like obtained from X-ray tubes with Mo or Ag anodes, gives significant improvements over Cu, or even allows experiments that are impossible with Cu radiation, like experiments where a large Q range needs to be probed.