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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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Everest Medicines Announces Commercial Launch and First Prescription for XERAVA® in China

PRNewswire | July 27, 2023

Everest Medicines a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, announced today XERAVA® (eravacycline) has been successfully launched in China with its first prescription issued at Huashan Hospital affiliated to Fudan University. The commercialization of XERAVA® in China marks Everest's transformation into a commercial-stage innovative biopharmaceutical company. XERAVA® is the world's first fluorocycline antibiotic for the treatment of infections caused by susceptible gram positive, gram negative and anaerobic pathogens including multidrug resistant ("MDR") isolates. It was approved by the National Medical Products Administration ("NMPA") of China for the treatment of complicated intra-abdominal infections ("cIAI") in adult patients in March 2023, and has been recommended by multiple treatment guidelines in China and globally, based on its broad bacterial spectrum coverage and high potency against multidrug-resistant bacterial infections. "The commercialization of XERAVA® in China is a significant milestone for Everest as a company, as this marks the beginning of Everest as a commercial-stage biopharma company. I want to thank everyone involved in bringing XERAVA® to a successful launch," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "After the commercial launch, we will accelerate patient access to XERAVA® with a lean commercial team, following a highly efficient commercial strategy. The company will continue to advance the approval and commercialization of other first-in-class or best-in-class drug candidates such as Nefecon to further address urgent unmet needs in China and the rest of Asia." "Eravacycline has broad antibacterial spectrum and high potency against common clinical multi-drug resistant bacteria such as ESBL-producing bacteria, CRE, CRAB, MRSA and VRE," said Dr. Zhu Duming, leader and chief physician of the Critical Care Department at Zhongshan Hospital Affiliated with Fudan University. "It has been recommended by authoritative guidelines at home and abroad for the treatment of MDR Gram-negative bacterial infections. The launch of eravacycline in China will help doctors tackle the challenges of clinical drug resistance." "Patients with malignant hematological diseases have a high incidence of neutropenia and fever caused by radiotherapy, chemotherapy, and hematopoietic stem cell transplantation. Antibacterial treatment is very important for patients with neutropenia and fever as MDR/Carbapenem-resistant Organism ("CRO") infections have high mortality rates," said Sun Aining, chief physician at the First Affiliated Hospital of Soochow University. "As the world's first fluorocycline antibiotic, eravacycline has completed phase II/III clinical trials and multiple real-world studies around the world to demonstrate that it has good clinical efficacy and safety profiles. It is an innovative choice for the treatment of MDR/CRO infections." In addition to XERAVA®, Everest anticipates the launch of three additional innovative drugs in China over the next two years, including Nefecon, the first-in-disease treatment for adults with primary immunoglobulin A nephropathy (IgAN) and expected to be approved in China in the second half of this year. In the infectious disease space, Everest is actively developing other important drug candidates to meet the urgent demand for innovative antibacterial treatment. The company plans to file New Drug Application for cefepime-taniborbactam in China this year for complicated urinary tract infection. In immunology, etrasimod is a next-generation, oral selective sphingosine 1-phosphate (S1P) receptor modulator with a differentiated efficacy and safety profiles. The company aims to submit NDA in Everest territories as soon as possible. About XERAVA® XERAVA® is a novel, fully synthetic, fluorocycline intravenous antibiotic for the treatment of infections caused by susceptible gram-positive , gram-negative and anaerobic pathogens including those multidrug resistant ("MDR") isolates. XERAVA® is currently approved for the treatment of complicated intra-abdominal infections in the US, EU, GB, Singapore, mainland China, Hong Kong and the medicine is currently under review for cIAI in Taiwan region. XERAVA® was licensed from Tetraphase Pharmaceuticals, Inc., a wholly owned subsidiary of Innoviva, Inc. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders.

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Business Insights, PHARMACY MARKET

MedinCell’s Partner Teva Announces Successful Launch of UZEDY™

Businesswire | August 03, 2023

MedinCell During today’s Q2 earnings call, Richard Francis, President and CEO of Teva, and Eric Hughes, Executive Vice President, Global R&D & Chief Medical Officer, commented the US launch of UZEDY since May 2023 and the olanzapine Long-Acting Injectable (LAI). About UZEDY Richard Francis said1 “We are actually right on plan or slightly ahead of our market access strategy targets and we are very happy with the launch.” “The newest member of our innovative family is said risperidone, our long-acting treatment for schizophrenia. Now, to remind everybody, this is a $4 billion market and we've only just launched UZEDY, but we're very pleased with the feedback we're getting from healthcare professionals. And they're confirming that the product profile that we have is unique and advantageous. Now we're seeing this in the fact that our NBRX2 is 40%, so already we're getting 40% of the risperidone long-acting market. We're also seeing hospitals look to use our free samples and free trial requests, and we're having good discussions with our payers. So once again, I think excitement around UZEDY early days, but initial feedback is very positive.” UZEDY, a long-acting injectable (LAI) risperidone for the treatment of schizophrenia in adults, is the first FDA-approved product based on MedinCell’s BEPO technology. MedinCell is eligible for up to $105m commercial milestones and for royalties on net sales. About LAI olanzapine (mdc-TJK), initiated in January 2023 Eric Hughes said1 “Our Olanzapine Phase 3 study is actually enrolling very quickly.” “Olanzapine as an oral agent account for 20% of the patients being treated today, but only less than 1% of patients on the long-acting form are being using that product. And that's primarily because of the safety profile3.” Richard Francis, said1 “With olanzapine, I've already highlighted the fact that it's a $4 billion market. But if we do manage to bring this to the market with a favorable safety profile, I think we have a real opportunity to have a significant product on our hands here.” mdc-TJK is an investigational long-acting injectable olanzapine also based on BEPO technology. If approved, it could be the first olanzapine LAI with a favorable safety profile offering a valued treatment option as a complement to UZEDY for severe schizophrenia patients. MedinCell is eligible for $12m left out of $17m of development milestones, for up to $105m commercial milestones and for royalties on net sales. About MedinCell MedinCell is a commercial-stage technology pharmaceutical company developing long-acting injectable drugs in many therapeutic areas. Our innovative treatments aim to guarantee compliance with medical prescriptions, to improve the effectiveness and accessibility of medicines, and to reduce their environmental footprint. They combine already known and used active ingredients with our proprietary BEPO® technology which controls the delivery of a drug at a therapeutic level for several days, weeks or months from the subcutaneous or local injection of a simple deposit of a few millimeters, entirely bioresorbable. The first treatment based on BEPO technology, intended for the treatment of schizophrenia, was approved by the FDA in April 2023, and is now distributed in the United States by Teva under the name UZEDY™.

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Pharmacy Market

AIS Healthcare’s Advanced Infusion Care Announces Opening of Cockeysville, Maryland Pharmacy

Businesswire | August 16, 2023

Advanced Infusion Care (AIC), a division of AIS Healthcare, today announced the opening of a new pharmacy location in Cockeysville, Maryland. This continued expansion to the Northeast provides a platform for the company to serve more patients and physicians in the region. The Maryland pharmacy is AIC’s sixth location from which the company dispenses essential medications and personalized care to patients across the United States with complex medical conditions like immune deficiency diseases. The newly opened pharmacy is strategically positioned and designed to cater to the unique needs of patients and providers in the Mid-Atlantic. With a firm commitment to elevating the patient experience, AIC aims to make medications and home infusion services more accessible to those in need of care solutions. "We are thrilled to open a pharmacy location in Maryland. This expansion is a testament to AIC’s unwavering dedication to our patients and our vision of providing best-in-class healthcare services with a personal touch. By opening this location, we aim to streamline the medication fulfillment process, enhance convenience, and ultimately improve the lives of our patients,” said Jud Hall, President at AIC. With a focus on efficiency and compassion, AIC is committed to addressing the unique medication needs of each patient and fostering strong relationships with healthcare providers in the area. The fully operational pharmacy in Maryland has started dispensing its extensive inventory of prescription medications, over-the-counter products, and specialty medications to patients. The location utilizes cutting-edge technology and a team of highly skilled pharmacists and healthcare professionals to serve patients. The facility also features a state-of-the-art USP797-compliant cleanroom, which is critical to ensuring sterility and quality in the medications. In recent months, AIC announced further expansion into the New England market and the grand reopening of a newly designed pharmacy in Valdosta, Georgia. AIC also made medications like GAMMAKED™ and LEQEMBI™ available to patients through its locations in Valdosta, Georgia; Birmingham, Alabama; Clinton, Mississippi; Panama City, Florida; and Dallas, Texas. About AIS Healthcare As the leading provider of targeted drug delivery and infusion care solutions, AIS Healthcare is committed to doing more of what matters. From pharmacies that put patient safety first to comprehensive services that enhance the entire care experience, we go beyond the expected in everything we do.

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Pharmacy Market

Everest Medicines Announces Commercial Launch and First Prescription for XERAVA® in China

PRNewswire | July 27, 2023

Everest Medicines a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, announced today XERAVA® (eravacycline) has been successfully launched in China with its first prescription issued at Huashan Hospital affiliated to Fudan University. The commercialization of XERAVA® in China marks Everest's transformation into a commercial-stage innovative biopharmaceutical company. XERAVA® is the world's first fluorocycline antibiotic for the treatment of infections caused by susceptible gram positive, gram negative and anaerobic pathogens including multidrug resistant ("MDR") isolates. It was approved by the National Medical Products Administration ("NMPA") of China for the treatment of complicated intra-abdominal infections ("cIAI") in adult patients in March 2023, and has been recommended by multiple treatment guidelines in China and globally, based on its broad bacterial spectrum coverage and high potency against multidrug-resistant bacterial infections. "The commercialization of XERAVA® in China is a significant milestone for Everest as a company, as this marks the beginning of Everest as a commercial-stage biopharma company. I want to thank everyone involved in bringing XERAVA® to a successful launch," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "After the commercial launch, we will accelerate patient access to XERAVA® with a lean commercial team, following a highly efficient commercial strategy. The company will continue to advance the approval and commercialization of other first-in-class or best-in-class drug candidates such as Nefecon to further address urgent unmet needs in China and the rest of Asia." "Eravacycline has broad antibacterial spectrum and high potency against common clinical multi-drug resistant bacteria such as ESBL-producing bacteria, CRE, CRAB, MRSA and VRE," said Dr. Zhu Duming, leader and chief physician of the Critical Care Department at Zhongshan Hospital Affiliated with Fudan University. "It has been recommended by authoritative guidelines at home and abroad for the treatment of MDR Gram-negative bacterial infections. The launch of eravacycline in China will help doctors tackle the challenges of clinical drug resistance." "Patients with malignant hematological diseases have a high incidence of neutropenia and fever caused by radiotherapy, chemotherapy, and hematopoietic stem cell transplantation. Antibacterial treatment is very important for patients with neutropenia and fever as MDR/Carbapenem-resistant Organism ("CRO") infections have high mortality rates," said Sun Aining, chief physician at the First Affiliated Hospital of Soochow University. "As the world's first fluorocycline antibiotic, eravacycline has completed phase II/III clinical trials and multiple real-world studies around the world to demonstrate that it has good clinical efficacy and safety profiles. It is an innovative choice for the treatment of MDR/CRO infections." In addition to XERAVA®, Everest anticipates the launch of three additional innovative drugs in China over the next two years, including Nefecon, the first-in-disease treatment for adults with primary immunoglobulin A nephropathy (IgAN) and expected to be approved in China in the second half of this year. In the infectious disease space, Everest is actively developing other important drug candidates to meet the urgent demand for innovative antibacterial treatment. The company plans to file New Drug Application for cefepime-taniborbactam in China this year for complicated urinary tract infection. In immunology, etrasimod is a next-generation, oral selective sphingosine 1-phosphate (S1P) receptor modulator with a differentiated efficacy and safety profiles. The company aims to submit NDA in Everest territories as soon as possible. About XERAVA® XERAVA® is a novel, fully synthetic, fluorocycline intravenous antibiotic for the treatment of infections caused by susceptible gram-positive , gram-negative and anaerobic pathogens including those multidrug resistant ("MDR") isolates. XERAVA® is currently approved for the treatment of complicated intra-abdominal infections in the US, EU, GB, Singapore, mainland China, Hong Kong and the medicine is currently under review for cIAI in Taiwan region. XERAVA® was licensed from Tetraphase Pharmaceuticals, Inc., a wholly owned subsidiary of Innoviva, Inc. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders.

Read More

Business Insights, PHARMACY MARKET

MedinCell’s Partner Teva Announces Successful Launch of UZEDY™

Businesswire | August 03, 2023

MedinCell During today’s Q2 earnings call, Richard Francis, President and CEO of Teva, and Eric Hughes, Executive Vice President, Global R&D & Chief Medical Officer, commented the US launch of UZEDY since May 2023 and the olanzapine Long-Acting Injectable (LAI). About UZEDY Richard Francis said1 “We are actually right on plan or slightly ahead of our market access strategy targets and we are very happy with the launch.” “The newest member of our innovative family is said risperidone, our long-acting treatment for schizophrenia. Now, to remind everybody, this is a $4 billion market and we've only just launched UZEDY, but we're very pleased with the feedback we're getting from healthcare professionals. And they're confirming that the product profile that we have is unique and advantageous. Now we're seeing this in the fact that our NBRX2 is 40%, so already we're getting 40% of the risperidone long-acting market. We're also seeing hospitals look to use our free samples and free trial requests, and we're having good discussions with our payers. So once again, I think excitement around UZEDY early days, but initial feedback is very positive.” UZEDY, a long-acting injectable (LAI) risperidone for the treatment of schizophrenia in adults, is the first FDA-approved product based on MedinCell’s BEPO technology. MedinCell is eligible for up to $105m commercial milestones and for royalties on net sales. About LAI olanzapine (mdc-TJK), initiated in January 2023 Eric Hughes said1 “Our Olanzapine Phase 3 study is actually enrolling very quickly.” “Olanzapine as an oral agent account for 20% of the patients being treated today, but only less than 1% of patients on the long-acting form are being using that product. And that's primarily because of the safety profile3.” Richard Francis, said1 “With olanzapine, I've already highlighted the fact that it's a $4 billion market. But if we do manage to bring this to the market with a favorable safety profile, I think we have a real opportunity to have a significant product on our hands here.” mdc-TJK is an investigational long-acting injectable olanzapine also based on BEPO technology. If approved, it could be the first olanzapine LAI with a favorable safety profile offering a valued treatment option as a complement to UZEDY for severe schizophrenia patients. MedinCell is eligible for $12m left out of $17m of development milestones, for up to $105m commercial milestones and for royalties on net sales. About MedinCell MedinCell is a commercial-stage technology pharmaceutical company developing long-acting injectable drugs in many therapeutic areas. Our innovative treatments aim to guarantee compliance with medical prescriptions, to improve the effectiveness and accessibility of medicines, and to reduce their environmental footprint. They combine already known and used active ingredients with our proprietary BEPO® technology which controls the delivery of a drug at a therapeutic level for several days, weeks or months from the subcutaneous or local injection of a simple deposit of a few millimeters, entirely bioresorbable. The first treatment based on BEPO technology, intended for the treatment of schizophrenia, was approved by the FDA in April 2023, and is now distributed in the United States by Teva under the name UZEDY™.

Read More

Pharmacy Market

AIS Healthcare’s Advanced Infusion Care Announces Opening of Cockeysville, Maryland Pharmacy

Businesswire | August 16, 2023

Advanced Infusion Care (AIC), a division of AIS Healthcare, today announced the opening of a new pharmacy location in Cockeysville, Maryland. This continued expansion to the Northeast provides a platform for the company to serve more patients and physicians in the region. The Maryland pharmacy is AIC’s sixth location from which the company dispenses essential medications and personalized care to patients across the United States with complex medical conditions like immune deficiency diseases. The newly opened pharmacy is strategically positioned and designed to cater to the unique needs of patients and providers in the Mid-Atlantic. With a firm commitment to elevating the patient experience, AIC aims to make medications and home infusion services more accessible to those in need of care solutions. "We are thrilled to open a pharmacy location in Maryland. This expansion is a testament to AIC’s unwavering dedication to our patients and our vision of providing best-in-class healthcare services with a personal touch. By opening this location, we aim to streamline the medication fulfillment process, enhance convenience, and ultimately improve the lives of our patients,” said Jud Hall, President at AIC. With a focus on efficiency and compassion, AIC is committed to addressing the unique medication needs of each patient and fostering strong relationships with healthcare providers in the area. The fully operational pharmacy in Maryland has started dispensing its extensive inventory of prescription medications, over-the-counter products, and specialty medications to patients. The location utilizes cutting-edge technology and a team of highly skilled pharmacists and healthcare professionals to serve patients. The facility also features a state-of-the-art USP797-compliant cleanroom, which is critical to ensuring sterility and quality in the medications. In recent months, AIC announced further expansion into the New England market and the grand reopening of a newly designed pharmacy in Valdosta, Georgia. AIC also made medications like GAMMAKED™ and LEQEMBI™ available to patients through its locations in Valdosta, Georgia; Birmingham, Alabama; Clinton, Mississippi; Panama City, Florida; and Dallas, Texas. About AIS Healthcare As the leading provider of targeted drug delivery and infusion care solutions, AIS Healthcare is committed to doing more of what matters. From pharmacies that put patient safety first to comprehensive services that enhance the entire care experience, we go beyond the expected in everything we do.

Read More

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