Gannex | December 14, 2020
Gannex, an entirely claimed organization of Ascletis Pharma Inc. (HKEX:1672) and completely committed to the R&D and commercialization of new medications in the field of NASH, reported today that it got Fast Track assignment from the U.S. Food and Drug Administration (FDA) for its non-alcoholic steatohepatitis (NASH) drug applicant ASC42.
The U.S. FDA's Fast Track advancement program is intended to encourage the turn of events and speed up the survey of medications that have capacity to treat genuine or perilous infections or conditions and exhibit the possibility to address neglected clinical necessities with extra clinical advantages to patients. There are no FDA affirmed drugs for NASH sign yet. This Fast Track assignment speaks to FDA's acknowledgment of ASC42's potential in tending to these neglected clinical requirements for NASH patients.
Gannex got the investigational new medication application (IND) endorsement for ASC42 from the U.S. FDA in October this year. ASC42 is an in-house developed，novel non-steroidal, specific, intense Farnesoid X Receptor (FXR) agonist with top tier potential. In two NASH creature models, ASC42 showed critical enhancements in liver steatosis, aggravation and fibrosis. The oral tablet plan of ASC42 has been created with the in-house restrictive innovation and is steady at room temperature.
"We are excited that the FDA allowed Fast Track assignment for our FXR agonist ASC42 which is found and created by our in-house skilled R&D group," said Dr. Jinzi J. Wu, "This basic acknowledgment by FDA will quicken worldwide advancement of ASC42, a potential top tier FXR agonist."
Pluristem | December 30, 2020
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a main regenerative medication organization building up a foundation of novel natural helpful items, reported today it has gone into a coordinated effort concurrence with Mexican drug organization Innovare R&D to extend its continuous clinical program of PLX cells in the treatment of Acute Respiratory Distress Syndrome (ARDS) related with COVID-19 in Mexico. The Phase II investigation in Mexico is dependent upon the endorsement of neighborhood specialists, with the objective of being led under the U.S. Food and Drug Administration (FDA) cleared convention.
As per the arrangement, Innovare will open clinical destinations and enlist patients for the proposed clinical investigation in Mexico. Innovare will subsidize the examination in Mexico and will buy PLX cells for the investigation from Pluristem. Subject to potential positive clinical investigation results and Mexican administrative endorsement for commercialization, the arrangement awards Innovare restrictive conveyance rights in Mexico to supply PLX cells for treating serious COVID-19 cases confounded by ARDS. All protected innovation and assembling rights stay with Pluristem.
With 1,389,430 cases and 122,855 passings as of December 29, 2020, Mexico's COVID-19 disease and death rates have been expanding. Mexico has the most elevated passings relatively to COVID-19 cases or populace on the planet as of December 28, 2020, as announced by Johns Hopkins University of Medicine.
"We are satisfied to unite with Innovare, a main imaginative organization intending to be important for the answer for battling the COVID-19 pandemic in Mexico," expressed Pluristem CEO and President, Yaky Yanay. "On account of our key upper hand of having in-house producing office, progressed strategic capacities, and a worldwide reach, we can supply PLX cells to clinical bases on the world while broadening our worldwide help for COVID-19 into Latin America. By directing the examination in both the U.S. furthermore, Mexico, in corresponding to the E.U. furthermore, Israel, we are proceeding with our attention on accomplishing clinical achievements and targets, while bringing the expected treatment of PLX cells to those out of luck."
Gerardo Cárdenas Vogel, CEO of Innovare R&D remarked, "As an organization that is looking for overall accomplices indicating clinical guarantee for neglected clinical necessities, we are eager to team up with Pluristem. We anticipate utilizing our clinical and business capacities with Pluristem's high level cell treatment answer for help create and possibly bring a genuinely necessary treatment for ARDS patients related with COVID-19 to Mexico."
Eagle Pharmaceuticals, Inc. | March 29, 2022
Eagle Pharmaceuticals, Inc. reported that it had achieved an agreement with Acacia Pharma Group plc on the parameters of a plan of arrangement under Part 26 of the United Kingdom's Companies Act 2006.
Acacia Pharma's current issued and to be issued, share capital is valued at approximately €94,700,000, or the equivalent of €0.90 per share, under the terms of the proposed transaction. Each Acacia Pharma shareholder would get €0.68 in cash and 0.0049 shares of Eagle common stock in exchange for each Acacia Pharma share owned. Eagle will additionally guarantee about €25.0 million of debt within the Acacia Pharma group under the proposed acquisition terms. In conjunction with the proposed transaction, the Company and Acacia Pharma entered into a collaboration agreement on March 27, 2022, and (ii) certain shareholders and directors of Acacia gave irrevocable undertakings to the Company and Acacia.
The proposed deal has been authorized by the boards of directors of both businesses. It is scheduled to complete in late Q2 2022, subject to shareholder approval, approval by the High Court of England and Wales, and satisfaction of standard closing conditions for transactions of this kind. There is no guarantee that the proposed transaction will be completed on the given terms, on the anticipated schedule, or at all.
The proposed transaction is expected to provide Eagle with two currently marketed acute care hospital products with the potential to disrupt the marketplace:
• BARHEMSYS® is the first and only antiemetic authorized by the Food and Drug Administration (FDA) for the rescue treatment of postoperative nausea and vomiting (PONV) in the absence of prophylaxis. Eagle is now targeting healthcare providers and institutions, which account for more than 70% of the anticipated addressable market potential for BARHEMSYS.
• BARHEMSYS is also licensed for the treatment and prevention of PONV in patients who have not received prophylaxis. The projected yearly addressable market for prophylaxis and rescue in the United States is $2.7 billion.
• BYFAVO® is authorized for the induction and maintenance of procedural sedation in adults having operations lasting 30 minutes or less, with a total addressable market for procedural sedation in the United States estimated at more than $0.4 billion per year.
“We are delighted to announce that we have agreed to terms for the proposed acquisition of Acacia Pharma. This will be a very important acquisition for us, both financially and strategically. In recent years, the pharmaceutical industry has witnessed slower uptake of new products and longer ramp periods. In the face of further challenges brought about by the COVID-19 pandemic, many smaller underfunded companies experienced significant hurdles launching products. We therefore believe that Eagle is well suited to drive uptake of these two new products, building from Acacia Pharma’s established foundation since its launch, through our experienced and specialized hospital-based sales organization with minimal additional infrastructure,”
President and Chief Executive Officer of Eagle Pharmaceuticals, Scott Tarriff
“We have been extremely disciplined in managing our balance sheet over the years, and we believe that the proposed acquisition is a wise use of the cash we have generated. With these two products, together with landiolol, which is on track for an NDA submission to the FDA in May of this year, Eagle will potentially have three NCEs going into their launch phase. We believe these efforts will strengthen our leadership position in the hospital and oncology space and establish a strong foundation for sustainable long-term growth and bring value to our shareholders,” concluded Tarriff.
“We believe that BARHEMSYS and BYFAVO address unmet clinical needs and are nearing usage inflection points, with strong formulary acceptance, and that with our longstanding relationships in the hospital space, we can accelerate uptake and capture the commercial potential of these assets. In doing so, we strive to impact and improve the care of patients undergoing medical treatments such as surgery and invasive procedures. Additionally, their value to anesthesia providers, who are key users, is important, facilitating precision medicine for patients. We see our sales infrastructure as a strategic asset, and as we add to our commercial product portfolio going forward, we plan to expand the size of our salesforce over the next two years,” stated Executive Vice President and Chief Commercial Officer of Eagle Pharmaceuticals, Michael Moran.