AM-Pharma | September 08, 2021
AM-Pharma B.V., an emerging leader focused on developing therapeutics for severe medical conditions, and Kyowa Kirin Co., Ltd, a global specialty pharmaceutical company that strives to create new value through the pursuit of advances in life sciences and technologies, today announced that they have entered into an exclusive license agreement under which Kyowa Kirin gains the rights to develop and commercialize ilofotase alfa, AM-Pharma’s proprietary recombinant human alkaline phosphatase. Ilofotase alfa is currently being evaluated in the global pivotal REVIVAL Phase III clinical study as the potential first disease-altering treatment for sepsis-associated acute kidney injury (SA-AKI). In July of this year, AM-Pharma announced the enrollment of the first patient in Japan as part of the ongoing REVIVAL trial.
“This is a significant milestone for AM-Pharma as this agreement will optimize the commercialization of ilofotase alfa in the Japanese market and expedite our ability to bring our therapeutic candidate to a substantial patient population in Japan post-approval.”
“Kyowa Kirin is a leading Japanese specialty pharmaceutical company deeply rooted in science that shares our commitment to addressing high unmet medical needs. Based on the number of successful international partnerships they have, they are the ideal partner to support the commercialization of ilofotase alfa in Japan,” stated Erik van den Berg, Chief Executive Officer at AM-Pharma. “This is a significant milestone for AM-Pharma as this agreement will optimize the commercialization of ilofotase alfa in the Japanese market and expedite our ability to bring our therapeutic candidate to a substantial patient population in Japan post-approval.”
Under the terms of the agreement, AM-Pharma will receive EUR 20 million upfront payment, and EUR 30 million related to milestones prior to regulatory submission, and up to EUR 195 million upon submission, NHI price listing and sales milestone payments bringing the overall deal value to EUR 245 million. In addition, AM-Pharma is entitled to tiered double-digit royalties on sales and a drug supply fee. Kyowa Kirin will gain the exclusive right to develop and commercialize ilofotase alfa in Japan. AM-Pharma is responsible for the completion of the REVIVAL pivotal Phase III study, as well as a Phase I pharmacokinetics, safety and tolerability study in Japan and drug supply, whereas Kyowa Kirin will be responsible for the regulatory approval process and commercialization of ilofotase alfa in Japan.
The REVIVAL trial is a Phase III pivotal study evaluating AM-Pharma’s proprietary recombinant alkaline phosphatase, ilofotase alfa, for the treatment of patients with SA-AKI. The primary endpoint of the study is all-cause mortality 28 days post-treatment start with ilofotase alfa at a dose of 1.6 mg/kg. In the Phase II study of ilofotase alfa, the patient group treated with this dose experienced a statistically significant 46% relative reduction in mortality compared to the group treated with placebo (p= 0.022). REVIVAL was initiated in November 2020 and is enrolling up to 1,600 patients in North America, Europe and Japan. As per the study protocol, four interim analyses for futility and/or efficacy will be conducted when enrollment hits certain levels and the first futility analysis will occur when 400 patients have been treated. Up to about 120 clinical sites worldwide, including as many as 11 sites in Japan, will enroll patients into the single global pivotal Phase III REVIVAL trial in SA-AKI patients. The U.S. Food and Drug Administration, European Medicines Agency and Japanese Pharmaceuticals and Medical Devices Agency have all approved the REVIVAL protocol. In addition to the REVIVAL study, the PMDA has approved enrollment into a Phase I pharmacokinetics (PK), safety and tolerability study in healthy Japanese subjects, which is being conducted in parallel to REVIVAL in Japan.
About ilofotase alfa
AM-Pharma’s therapeutic candidate is a proprietary recombinant human Alkaline Phosphatase (AP) constructed from two naturally occurring human isoforms of the AP enzyme. The Company’s compound is highly stable and active and has a dual mechanism of action. The recombinant enzyme displays exquisite activity towards dephosphorylating and detoxifying damage-associated molecular patterns (DAMPs) and pathogen-associated molecular patterns (PAMPs) such as, ATP, ADP, lipopolysaccharide (LPS) and other extracellular substrates that drive acute inflammation, coagulation and microvascular ischemia. Research has shown that ATP dephosphorylation has a double effect in protecting against kidney injury. When the pro-inflammatory ATP is dephosphorylated, the resulting adenosine further reduces inflammation through the activation of the immunosuppressive adenosine A2a receptor pathway (A2aR). AM-Pharma has shown that treatment of patients with ilofotase alfa not only reduces local and systemic inflammation but also protects the kidney, and possibly other organs, against further damage.
About AKI and Sepsis
Acute Kidney Injury (AKI) involves inflammatory processes in the kidney which can lead to complete loss of renal function. Hospital‐acquired AKI affects annually around 3 million patients in the US, Europe, and Japan, and is associated with mortality in roughly 700,000 patients. It occurs in 40-60% of critical care admissions. Depending on the severity and cause of renal injury, mortality occurs in up to 60% of the cases. In the US alone, hospitals spend around $10 billion each year on managing this major medical problem. Sepsis is a condition that is responsible for 1 out of 3 deaths in hospitals and is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. The kidney is the most commonly affected organ, resulting in SA-AKI and significantly increasing the risk for mortality and morbidity in sepsis. No singular effective therapy to alter the progression of these devastating conditions has been approved.4
AM-Pharma's purpose is to save and improve the lives of patients confronted with severe medical conditions. Our initial focus is sepsis-associated acute kidney injury, the cause of death for hundreds of thousands of people hospitalized each year. Our proprietary compound, ilofotase alfa, has the potential to become the first treatment for sepsis-associated acute kidney injury and is now in a global pivotal Phase III clinical trial. We are a dedicated team driven to bring treatment options to severely ill patients, their families and acute care professionals. Find out more about us online at: www.am-pharma.com.
About Kyowa Kirin
Kyowa Kirin strives to create and deliver novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company with a more than 70-year heritage, the company applies cutting-edge science including an expertise in antibody research and engineering, to address the needs of patients and society across multiple therapeutic areas including Nephrology, Oncology, Immunology/Allergy and Neurology. Across our four regions – Japan, Asia Pacific, North America and EMEA/International – we focus on our purpose, to make people smile, and are united by our shared values of commitment to life, teamwork/Wa, innovation, and integrity.
EyePoint Pharmaceuticals | November 20, 2021
EyePoint Pharmaceuticals, Inc. a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders, announced the closing of the previously announced underwritten public offering of 5,122,273 shares of its common stock, which included the exercise in full by the underwriters of their option to purchase an additional 1,095,000 shares of common stock, and pre-funded warrants to purchase up to an aggregate of 3,272,727 shares of its common stock. The shares of common stock were sold at a public offering price of $13.75 per share, and the pre-funded warrants were sold at a purchase price of $13.74 per pre-funded warrant, for aggregate gross proceeds of approximately $115.4 million, before deducting underwriting discounts and commissions and other offering expenses payable by EyePoint. All of the securities were sold by EyePoint.
Cowen and Guggenheim Securities acted as joint book-running managers for the offering. Cantor acted as passive book-running manager for the offering.
EyePoint intends to use the net proceeds from the offering to advance EYP-1901 into and through Phase 2 clinical trials for wet AMD, DR, and RVO, as well as support its earlier stage pipeline development initiatives, and for general corporate purposes.
The securities described above were offered by the Company pursuant to a shelf registration statement on Form S-3 (No. 333-258598) previously filed with the Securities and Exchange Commission (SEC) on August 6, 2021 and declared effective by the SEC on August 11, 2021.
The securities were offered by means of a prospectus supplement and accompanying prospectus relating to the offering that form a part of the registration statement. A final prospectus supplement relating to and describing the terms of the offering was filed with the SEC on November 18, 2021.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About EyePoint Pharmaceuticals
EyePoint Pharmaceuticals (Nasdaq:EYPT) is a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders. The Company's pipeline leverages its proprietary Durasert® technology for sustained intraocular drug delivery including EYP-1901, a potential twice-yearly intravitreal anti-VEGF treatment initially targeting wet age-related macular degeneration. The Company has two commercial products: YUTIQ®, for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye, and DEXYCU®, for the treatment of postoperative inflammation following ocular surgery. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts.
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the use of proceeds for the offering and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause EyePoint’s actual results to be materially different than those expressed in or implied by EyePoint’s forward-looking statements. For EyePoint, this includes stock price volatility and uncertainties relating to the financial markets, the continued impact of the COVID-19 pandemic on EyePoint’s business, the medical community and the global economy, and the impact of general business and economic conditions. More detailed information on these and additional factors that could affect EyePoint’s actual results are described in EyePoint’s filings with the SEC, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as revised or supplemented by its Quarterly Reports on Form 10-Q and other documents filed with the SEC. All forward-looking statements in this news release speak only as of the date of this news release. EyePoint undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Recursion, Vium | July 29, 2020
Recursion, a digital biology company leading in the industrialization of drug discovery, today announced its acquisition of Vium, a digital vivarium company. Vium’s platform combines computer vision, machine learning and sensor technologies to non-invasively collect and derive insights from digital biomarkers in preclinical in vivo research. Recursion’s acquisition of Vium signals continued and rapid integration of advanced technologies to grow its drug discovery pipeline of over 30 programs along with programs developed jointly with large pharmaceutical partners.
“Technology is set to change the pace, scale and cost of drug discovery over the coming decades. At Recursion, we are building a vast machine to rapidly discover drugs through the integration of technology at every step in the process,” said Chris Gibson, Ph.D., co-founder and CEO of Recursion. “Bringing the fantastic team at Vium in-house will enable us to build on our core technology and vision, augmenting our huge in vitro datasets with large, complementary in vivo datasets, and advancing our mission to decode biology to radically improve patient lives.”