Geneva, Switzerland, 23 April 2018
RELIEF THERAPEUTICS Holding SA (“Relief”, “the Company”) announces that it has granted to Seren Clinical (“Seren”), a privately held clinical development company based in the UK, an option to license the development and commercial rights on Relief’s proprietary patent protecting the use of inhaled Aviptadil for the treatment of the orphan indication pulmonary Sarcoidosis and Acute Lung Injury. The exercise of the option by Seren is subject to certain provisions that may eventually lead Relief to granting a final license on the Company’s proprietary Intellectual Protections. This agreement is in line with Relief’s strategy announced in the 2016 Annual Report published on April 28, 2017.
The pre-negotiated financial terms of the putative future licensing agreement were not disclosed but will eventually include upfront, milestone and royalty payments by Seren.
Given the global increase in the number of sarcoidosis patients and the significant unmet need in this disease, facilitating the development stages remaining until marketing authorization is achieved for Aviptadil through this option agreement represents a substantial opportunity for Relief to gather funding for the development of the remaining medicinal product candidates (MPC) in its portfolio, including those recently acquired from Genclis SA (see press release from April, 9, 2018).
Gael Hedou, CEO of Relief comments: “Seren Management has a strong and convincing track record of success in both funding and development of Medicinal Product Candidates. It is a great pleasure and opportunity to rely on their expertise for the development of Aviptadil for these underserved diseases. While we remain committed to support the endeavor of Seren, we wish them all success in their endeavors.”
Nigel Trim, CEO of Seren adds: “We are delighted to have this opportunity to work with our colleagues at Relief. Aviptadil fits perfectly with our vision to develop a pipeline of late stage MPCs for rare and orphan diseases, and we believe this will be the start of a productive relationship with Relief .”
RELIEF THERAPEUTICS Holding AG is a clinical-stage biotechnology company with a portfolio of drug candidates derived from natural human origins. Its two first candidates are Aviptadil for the treatment of sarcoidosis (to enter Phase III) and low dose interleukin-6 (Atexakin alfa) for the treatment of peripheral neuropathy (to enter Phase II). Aviptadil development in sarcoidosis addresses the orphan disease market, in which European regulators have indicated that a single pivotal Phase III trial would be sufficient to support approval. Atexakin alfa is the subject of an exclusive worldwide development and commercialization agreement with Merck KGaA, The current priority indication for Atexakin is to alleviate peripheral diabetic neuropathy, a market that is estimated to reach $4.1 billion in 2019 (source Datamonitor).
Seren is a clinical development company comprising leading experts in the development and commercialization of pharmaceutical and biopharmaceutical assets. Seren is focusing on rare and orphan diseases where there is a clear unmet medical need.
Aviptadil (Vasoactive Intestinal Peptide – VIP) is an abundant biologically active endogenous human peptide acting as a ligand on specific G-protein coupled transmembrane receptors. It is one of the signal molecules of the neuroendocrine-immune network comprising anti-proliferative, anti-inflammatory, and immune-regulatory features. Its predominant biological activity is performed in the lungs, and a vast body of experimental, pharmacological and clinical evidence suggests Aviptadil to be an attractive candidate for the treatment of pulmonary affections including sarcoidosis and acute lung injury. A phase II trial in sarcoidosis patients has demonstrated a striking suppression of inflammatory mechanisms of the lung and amelioration of dry cough and of exertional dyspnea. The compound is positioned to enter a phase III clinical trial campaign (Avisarco II). The sole market of sarcoidosis, which is internationally recognized as an orphan indication, is estimated to peak at more than €150 million in Europe only.
RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and is headquartered in Geneva, Switzerland.
This communication expressly or implicitly contains certain forward-looking statements concerning Relief Therapeutics Holding AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Relief Therapeutics Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Relief Therapeutics Holding AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.