Global Licensing rights builds Aspire’s strategic commitment to develop therapies in the prevention of bronchopulmonary dysplasia (BPD) and retinopathy of prematurity (ROP) in preterm infants

Aspire Pharma Ltd, (Petersfield Hampshire), today announced the successful completion of its global licensing agreement of Retinolx , owned by Orphanix GmbH, a privately held, clinical-stage biopharmaceutical company focussed on the development of novel therapeutic orphan drugs across a range of paediatric therapy areas.

Retinolx brings Aspire a promising therapeutic candidate in BPD and ROP based on retinol (Vitamin A) allowing the option for both intramuscular and intravesical administration, specifically developed for preterm infants in the neonatal intensive care unit.

Orphanix have an approved EU PIP (paediatric investigation plan) and Orphan Designations for the Product in the European Union and in the United States of America in the indication ‘Prevention of bronchopulmonary dysplasia’ and ‘Prevention of retinopathy of prematurity’.

“We are excited to bring Orphanix’s promising investigational preventative treatment for BPD and ROP into our paediatric pipeline at Aspire. This acquisition demonstrates our commitment to advance the science and treatment options for Orphan Drug Designations in vulnerable patient groups. Through our in-house expertise and network of global leaders in these respective fields, we strive to bring breakthrough advances in clinical management” said Richard Condon, Chief Executive Officer of Aspire Pharma.

“Aspire’s investment in Retinolx demonstrates the belief that the Orphanix Management Team, and Board, have held for several years regarding the prevention of BPD and ROP. We look forward to bringing our category expertise to Aspire’s development and commercialisation capability to accelerate the development of this important treatment” said Dr. Philipp Heinrich Novak, Managing Director & Founder of Orphanix GmbH.

Additional Transaction Details

No terms of the financial agreement were disclosed by either party.

About Aspire Pharma

Aspire was established with a simple mission: To make a difference to the lives of patients through development and supply of innovative products and medicines that offer value to our customers.

Aspire is present in the generics, niche generics, branded medicines and medical device sectors. Aspire was majority acquired by H.I.G Capital ‘H.I.G’ in 2021. H.I.G. is a leading global alternative assets investment firm with over $50 billion of equity capital under management. Based in Miami, and with offices in New York, Boston, Chicago, Dallas, Los Angeles, San Francisco, and Atlanta in the USA, as well as international affiliate offices in London, Hamburg, Madrid, Milan, Paris, Bogotá, Rio de Janeiro and São Paulo. For more information, go to

About Orphanix GmbH

The Orphanix GmbH mission is to improve the lives of new-borns with rare diseases by filling blind spots with safe, innovative and readily accessible medical solutions. We are dedicated to fundamentally understand the needs of affected babies and to facilitate innovative opportunities for treatments.

We identify, develop and commercialize innovative orphan drugs across all paediatric indications based on in-depth evaluation of academic and real-world data.

Disclosure Notice

The information contained in this release is as of August 15, 2022. Aspire assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about Aspire’s global licensing agreement of Retinolx, Orphanix’s development candidate in BPD and ROP that involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, risks related to the ability to realise the anticipated benefits of the global licensing agreement, including the possibility that the expected benefits from the global licensing agreement will not be realised; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavourable new clinical data and further analyses of existing clinical data; risks associated with interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when license applications may be filed in any jurisdictions; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, the product(s) will be commercially successful.

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