Cambridge (United Kingdom) and Indianapolis (United States) – Gilde Healthcare portfolio company Acacia Pharma (EURONEXT: ACPH), a pharmaceutical company commercialising hospital products for US and international markets, announces it has entered into a strategic in-licensing, investment and loan agreement with Cosmo Pharmaceuticals N.V. (SIX: COPN). The agreement includes exclusive US commercialisation rights to ByFavo™ (remimazolam), an equity investment by Cosmo and two loan agreements from Cosmo to finance the marketing efforts of both BARHEMSYS and ByFavo.
ByFavo is an ultra-short-acting and reversible intravenous sedative/anaesthetic designed for use during invasive medical procedures, such as during colonoscopy and bronchoscopy. Approximately 24.5 million such procedures take place annually in the US, of which around 90% used moderate sedation. ByFavo represents a market opportunity estimated to be >$500 million per year. ByFavo’s New Drug Application (“NDA”) is currently under review by the US Food & Drug Administration with a target review (“PDUFA”) date of 5 April 2020.
ByFavo represents a highly complementary commercial fit to Acacia Pharma’s BARHEMSYS®, which is currently awaiting a US approval decision expected by 26 February 2020. The US hospital salesforce of Acacia Pharma is well equipped to execute an effective launch of both products addressing the same commercial call points.
Under the terms of the agreement, Cosmo has made a strategic equity investment in Acacia Pharma of €10 million based on the closing price on 8 January 2020.
In addition, Cosmo will make a new loan facility of up to €35 million available to Acacia Pharma, conditional on specified regulatory milestones:
Under the principal terms of the in-license agreement, Cosmo will be eligible for:
Following the issues of shares Cosmo will own 14.08% of the enlarged share capital. Cosmo will be entitled to appoint one director to the Acacia Pharma Board of Directors.
About ByFavo (remimazolam)
ByFavo is an ultra-short-acting and reversible intravenous benzodiazepine sedative/anesthetic designed for use during invasive medical procedures, such as during colonoscopy and bronchoscopy. Approximately 24.5 million such procedures take place annually in the US, of which around 90% used moderate sedation. This represents a market opportunity estimated to be >$500 million per year.
ByFavo has demonstrated efficacy and safety in an extensive clinical trial programme involving around 2,400 volunteers and patients. Data so far indicate that remimazolam has a rapid onset and offset of action combined with a favorable cardio-respiratory safety profile. ByFavo acts more quickly than the available alternatives of the same pharmaceutical class for the same indication (e.g. midazolam) and is safer than other alternatives for the same indication (e.g. propofol) and can be reversed with flumazenil to rapidly terminate sedation or anesthesia if necessary. The NDA for ByFavo was submitted to the US FDA in April 2019 and has a target review (“PDUFA”) date of 5 April 2020.
About Acacia Pharma
Acacia Pharma is a hospital pharmaceutical company focused on the development and commercialization of new nausea & vomiting treatments for surgical and cancer patients. The Group has identified important and commercially attractive unmet needs in nausea & vomiting and has discovered two product candidates based on the same active ingredient, amisulpride, to meet those needs.
The Group’s lead project, BARHEMSYS® (intravenous amisulpride) for post-operative nausea & vomiting (PONV), has generated positive results in four Phase 3 clinical studies. Its sister project, APD403 for chemotherapy induced nausea & vomiting (CINV), has successfully completed one proof-of-concept and one Phase 2 dose-ranging study in patients receiving highly emetogenic chemotherapy.
Acacia Pharma is based in Cambridge, UK and Indianapolis, IN. The Company is listed on the Euronext Brussels exchange under the under ISIN code GB00BYWF9Y76 and ticker symbol ACPH. For more information, visit the company’s website at www.acaciapharma.com.
About Cosmo Pharmaceuticals
Cosmo is a specialty pharmaceutical company focused in treating selected Gastrointestinal Disorders and Endoscopy. The Company’s proprietary clinical development pipeline specifically addresses innovative treatments for IBD, Colonic Infections and detection of colonic lesions. Cosmo has also developed medical devices for endoscopy and has recently entered into a partnership with Medtronic for the global distribution of its novel Artificial Intelligence device to be used in coloscopies and GI procedures. Further, Cosmo is the licensee for US of the novel agent for procedural sedation, Remimazolam. For additional information on Cosmo and its products please visit the ocmpany’s website at www.cosmopharma.com.
About Gilde Healthcare
Gilde Healthcare is a specialized European healthcare investor managing over €1 billion across two fund strategies: venture & growth capital and private equity. Gilde Healthcare’s venture & growth capital fund invests in fast growing companies active in medtech, digital health and therapeutics. The venture & growth companies are based in Europe and North America. Gilde Healthcare’s private equity fund invests in profitable European lower mid-market healthcare companies with a focus on the Benelux and DACH region. The private equity fund targets healthcare providers, suppliers of medical products and service providers in the healthcare market. For more information, visit the company’s website at www.gildehealthcare.com.