Aachen (Germany) | January 12, 2021 – The Specialty Pharma Company, PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) and its wholly owned subsidiary PAION Deutschland GmbH (collectively PAION), today announce that they entered into an exclusive license agreement with La Jolla Pharmaceutical Company and certain of its wholly owned subsidiaries (collectively La Jolla) for GIAPREZA(TM) (angiotensin II) and XERAVA(TM) (eravacycline). The agreement grants PAION an exclusive license for the commercialization of these two approved products in the European Economic Area, the United Kingdom and Switzerland (the Territories).
GIAPREZA(TM) is approved by the European Commission as a vasoconstrictor indicated for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies. XERAVA(TM) (eravacycline) is approved by the European Commission for the treatment of complicated intra-abdominal infections in adults. Both products are already launched in the U.S. and are showing strong revenue growth and potential.
Dr. Jim Phillips, CEO of PAION AG, commented: “We are excited to now have three attractive hospital products in our portfolio, giving us a strong basis to launch our European commercial organization and to build out our sales and marketing activities. We will be using single, hospital focussed sales teams in each country to commercialize these products in Europe. The licensing agreement announced today puts us on a strong footing to become a leading specialty pharmaceutical company in the fields of anesthesia and critical care. These products have the potential to double PAION’s annual revenues in each of the next 5 years from 2022.”
Larry Edwards, President and Chief Executive Officer of La Jolla added: “Our agreement with PAION marks an important step in our strategic plans to bring innovative therapies that improve outcomes in patients suffering from life-threatening diseases to Europe. We are excited to have PAION as a partner and expect its commercialization expertise will be invaluable in maximizing the value of GIAPREZA(TM) and XERAVA(TM) in Europe.”
Under the terms of the license agreement, PAION has the exclusive right to commercialize GIAPREZA(TM) and XERAVA(TM) in the Territories, while bearing all future associated costs for the development, market authorization and distribution in the Territories.
La Jolla will receive a USD 22.5 million upfront license fee payment. In addition, La Jolla is entitled to receive additional payments of up to USD 109.5 million contingent upon the achievement of certain commercial milestones, the majority of which are predicted upon reaching significant sales revenues. La Jolla is also entitled to royalties on PAION’s own net sales in Europe in the amount of 15% for XERAVA(TM) and between 18% and 24% for GIAPREZA(TM) and a share of revenues from indirect sales.
PAION will use current cash at hand of close to EUR 22 million (as of today) to settle the upfront payment and will draw the first two tranches of the loan facility from the European Investment Bank (EIB) in the amount of EUR 12.5 million. The third tranche from the EIB loan in the amount of EUR 7.5 million is expected to be available shortly.
With the addition of two more hospital products to its commercial portfolio, PAION has made the final decision to build out its own commercial structure in Europe to commercialize GIAPREZA(TM) and XERAVA(TM) together with Byfavo(R) after its potential market approval in Europe.
A Market Approval Application (MAA) for Byfavo(R) for procedural sedation is currently under review by the European Medicines Agency (EMA). PAION expects that the CHMP (Committee for Medicinal Products for Human Use) will publish its recommendation on the MAA by the end of January 2021. The European Commission will review the CHMP recommendation and a final decision is expected in the first half of 2021. PAION plans to have launched all three products by the end of 2021.
PAION will require additional funds to commercialize its product portfolio in selected European markets. The total funds required will depend on the structure of the commercial/distribution setup, as well as the magnitude and timing of incoming milestone and royalty payments from remimazolam licensees. These milestone and royalty payments could partially cover the funding requirements. Furthermore, PAION is looking into complementary financing measures to cover the funds required in the next years.
PAION was advised by Destum Partners and Pinsent Masons LLP on the transaction.
Conference call and webcast
The Management Board of PAION AG will host a conference call (conducted in English) on Wednesday, 13 January 2021, at 2 p.m. CET (8:00 a.m. EST). To access the call, please dial: Germany +49 (0) 30 3001 90612, UK +44 (0) 33 0551 0200 and U.S. +1 212 999 6659. When prompted, please provide the password “PAION”. The conference call will be supplemented by a webcast presentation which can be accessed during the call under the following link: PAION AG – Press Release (world-television.com).
GIAPREZA(TM) (angiotensin II) for injection is approved by the U.S. Food and Drug Administration (FDA) as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. GIAPREZATM is approved by the European Commission for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies. GIAPREZATM mimics the body’s endogenous angiotensin II peptide, which is central to the renin-angiotensin-aldosterone system, which in turn regulates blood pressure. Prescribing information for GIAPREZATM is available at http://www.giapreza.com. The European Summary of Product Characteristics is available on the EMA website: www.ema.europa.eu/en/medicines/human/EPAR/giapreza. GIAPREZA is marketed in the U.S. by La Jolla on behalf of La Jolla Pharma, LLC, its wholly owned subsidiary, and will be marketed in Europe by PAION.
XERAVA(TM) (eravacycline) for injection is a novel fluorocycline of the tetracycline class of antibacterials that is approved by the FDA for the treatment of complicated intra-abdominal infections (cIAI) in patients 18 years of age and older. XERAVATM is approved by the European Commission for the treatment of cIAI in adults. Prescribing information for XERAVATM is available at www.xerava.com. XERAVATM is marketed in the U.S. by Tetraphase Pharmaceuticals, Inc., a wholly owned subsidiary of La Jolla, and will be marketed in Europe by PAION.
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is dedicated to the development and commercialization of innovative therapies that improve outcomes in patients suffering from life-threatening diseases. GIAPREZA(TM) (angiotensin II) is approved by the FDA as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. XERAVA(TM) (eravacycline) is approved by the FDA for the treatment of complicated intra-abdominal infections. For more information, please visit www.ljpc.com.
PAION AG is a publicly listed specialty pharmaceutical company focused on developing and commercializing innovative drugs for out-patient and hospital-based sedation, anesthesia and critical care services. PAION’s lead compound is remimazolam, an intravenous, ultra-short-acting and controllable benzodiazepine sedative/anesthetic. Remimazolam is partnered in multiple territories outside of Europe. Remimazolam is approved in the U.S. and China for procedural sedation and in Japan and South Korea for general anesthesia.
In Europe, PAION is seeking approval of Byfavo(R) (remimazolam) for general anesthesia and for procedural sedation. PAION submitted a Marketing Authorization Application (MAA) for procedural sedation in November 2019. It is planned to commercialize Byfavo(R) once approved in Europe together with GIAPREZA(TM) as a vasoconstrictor indicated for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies, and XERAVA(TM) for the treatment of complicated intra-abdominal infections in adults.
PAION’s mission is to be a leading specialty pharmaceutical company in the fields of anesthesia and critical care by bringing novel products to market to benefit patients, doctors and other stakeholders in healthcare.
PAION is headquartered in Aachen (Germany) with an additional site in Cambridge (United Kingdom).
Director Investor Relations / Public Relations
52062 Aachen – Germany
Phone: +49 241 4453-152
This release contains certain forward-looking statements concerning the future business of PAION AG. These forward-looking statements contained herein are based on the current expectations, estimates and projections of PAION AG’s management as of the date of this release. They are subject to a number of assumptions and involve known and unknown risks, uncertainties and other factors. Should actual conditions differ from PAION AG’s assumptions, actual results and actions may differ materially from any future results and developments expressed or implied by such forward-looking statements. Considering the risks, uncertainties and other factors involved, recipients should not rely unreasonably upon these forward-looking statements. PAION AG has no obligation to periodically update any such forward-looking statements to reflect future events or developments.
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