PHARMA TECH

Feds rebuff Pfizer's pleas to speed up supplies of COVID-19 vaccine raw materials

Pfizer | December 21, 2020

Since the time Pfizer was fixed to partake in the U.S. government's Warp Speed exertion to get COVID-19 antibodies to showcase, the organization has made it very clear it didn't have to take any bureaucratic cash to build up the immunization.

In any case, did that refusal of R&D subsidizing add to Pfizer's failure to produce more dosages of its mRNA antibody for the U.S. market?

Pfizer could give more than the 100 million portions it guaranteed in its unique agreement with the U.S. government in the main portion of one year from now—however just if Trump organization authorities request that providers of crude materials rapidly satisfy the organization's requests. Furthermore, CEO Albert Bourla, Ph.D., is approaching the public authority to utilize the Defense Production Act to do precisely that.

The Trump organization hasn't done as such yet on the grounds that they've zeroed in on giving those materials to antibody producers that took government R&D subsidizing, as Moderna, as indicated by anonymous sources who addressed The New York Times.

A representative for Pfizer declined to remark, refering to the privacy of conversations with the U.S. government. Yet, Bourla said during a CNBC meet that the organization is in exchanges to sell an extra 100 million dosages of Pfizer's COVID-19 immunization to the U.S. government.

"We can give a ton of that in the second from last quarter. The U.S. government needs it in the subsequent quarter," Bourla said in the Monday meet. "We are working cooperatively to attempt to discover an answer and have the option to apportion those 100 million [doses] in the subsequent quarter if conceivable, or a ton of them."

Pfizer mentioned almost immediately that the public authority grant it "supported status" with providers of crude materials, however authorities were anxious about the possibility that that would harm contending immunization programs that took government R&D cash, as per the Times report. Among those organizations is Moderna, which is required to win crisis use approval from the FDA for its mRNA immunization this week—and last Friday, inked an arrangement to add 100 million additional portions to its underlying U.S. request.

Spotlight

Can the therapeutic development timeline be improved and accelerated by addressing challenges and developing opportunities? This infographic from the Institute of Medicine examines those challenges and opportunities. Read more in two workshop summaries: Improving the Utility and Translation of Animal Models for Nervous System Disorders and Improving and Accelerating Therapeutic Development for Nervous System Disorders.

Spotlight

Can the therapeutic development timeline be improved and accelerated by addressing challenges and developing opportunities? This infographic from the Institute of Medicine examines those challenges and opportunities. Read more in two workshop summaries: Improving the Utility and Translation of Animal Models for Nervous System Disorders and Improving and Accelerating Therapeutic Development for Nervous System Disorders.

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PHARMACY MARKET

Kedalion Therapeutics Secures Series B Funding and Announces Signing of Option to Acquire Agreement

Kedalion Therapeutics, | November 16, 2021

Kedalion Therapeutics is pleased to announce the completion of its Series B financing led by Novartis and involving a combination of new and existing investors. The Novartis investment includes an Exclusive Option to Acquire the company and its AcuStream™ technology. This agreement follows a Feasibility Study agreement with the AcuStream™ technology signed earlier this year. The subsequent feasibility study has been completed with successful results. Collaboration between the two parties is ongoing. The financial and other terms of this transaction are not disclosed. Kedalion’s AcuStream™ platform is a highly innovative, digitally connected, electromechanical topical ocular delivery device that aims to address a potential unmet need for a convenient, user-friendly device that reliably, accurately, and comfortably delivers topical ocular therapy with improved efficiency and patient comfort, and reduced reliance on patient skill and instillation technique when administered by a physician.1 The multi-dose, preservative-free platform strives to enable intended aim, potential for a comfortable patient experience, micro-dosing capability, and in phase 1 proof of concept studies, has shown a potential for a reduction in delivery dose of an intended therapy.1-4 Kedalion will continue to move forward with the development of the AcuStream™ platform across multiple disease categories, drug classes and compositions, including the treatment of presbyopia. The AcuStream™ technology has a potential to enhance the patient experience and optimize treatment outcomes of the company’s highly advanced portfolio of topical ocular drug products in development. The company looks forward to the opportunity to collaborate with Novartis Innovative Medicines as a valued investor and partner in developing our technology platform and therapeutic targets. “At Novartis, we are committed to reimagining medicine and investigating innovative approaches that have the potential to address unmet patient needs. The AcuStream™ technology is a novel platform with broad applicability in ophthalmics and we envisio that it could help us deliver transformative solutions to the patients who rely on our therapeutics to treat a range of eye conditions.” Jill Hopkins, Global Development Unit Head, Ophthalmology, Novartis Pharmaceuticals Dr. Mark Blumenkranz, the Chairman and Chief Executive of Kedalion Therapeutics, commented that “this transaction and associated further studies will help us accomplish our goal of revolutionizing the way drugs are delivered to the eye. The AcuStream™ technology, which strives to enable easier aiming, micro-dosing capability, and a potential for a reduction in delivery dose of an intended therapy, has the potential for a comfortable patient experience for patients worldwide.1 The platform could potentially provide convenience and enable micro-dosing capability for various ocular diseases.1 We see our capabilities coupled with the scientific and market leadership of Novartis in ophthalmics to be a winning formula for both organizations.” About Kedalion Therapeutics Kedalion Therapeutics is a venture-backed, clinical-stage biotechnology company whose mission is to bring to market transformative topical ophthalmic therapies for new and existing indications. Kedalion’s proprietary AcuStream™ platform technology delivers topical drugs to the eye in a precise and accurate manner that enables comparable effect with up to an 80% reduction in dose compared to standard eye drops. Kedalion is based in Menlo Park, CA.

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RESEARCH

Pluristem Enters Collaboration With Pharmaceutical Company Innovare R&D to Expand Pluristem’s ARDS Associated With COVID-19 Program to Mexico

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."

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PHARMA TECH

Hovione and Zerion Pharma announce a strategic partnership to market the Dispersome® technology platform

Hovione | February 23, 2022

Hovione, the leader in spray drying and particle engineering, announced a strategic partnership with Zerion Pharma to market and commercialize Dispersome®, Zerion´s proprietary solubility enhancement technology platform. Zerion´s innovative Dispersome® technology builds on a new concept of increasing drug solubility by using natural protein-based excipients to formulate APIs into amorphous solid dispersions (ASDs) by spray drying. By combining Dispersome® technology with Hovione's unique spray drying capabilities, experience in development, scale-up and GMP manufacturing, Hovione further strengthens its leadership in amorphous solid dispersions and shows its commitment to innovative solutions to overcome one of the most prevalent challenges faced by the industry: low drug solubility. "We are extremely pleased to have entered into this partnership with Zerion whom we recognize as a very innovative company in the field of oral drug formulations. By joining forces, Zerion and Hovione will be able to bring Dispersome® to the market faster. We look forward to applying the technology in collaboration with our customers and partners in our effort to develop novel drugs with strong benefits to patients. Hovione will continue to pursue opportunities to enhance its offering around core areas of expertise such as particle engineering and inhalation by partnering with companies and research institutions developing innovative drug formulation technologies, like Dispersome®". Jean-Luc Herbeaux, Hovione´s Chief Operating Officer Zerion´s CEO, Ole Wiborg, sees a strong synergy in the partnership and expects it to generate new pharma partnerships. "We consider Hovione the global leader in the field of producing amorphous solid dispersions by spray-drying. More importantly for us, this leadership has resulted in Hovione being, over the last 5 years, the main commercial manufacturer of novel FDA-approved drugs formulated as amorphous solid dispersions. Incorporating these competencies in our offering to the pharma industry both validates the strength of our Dispersome® platform and provides us and our pharma partners immediate access to the highest quality in upscaling and commercial GMP manufacturing." says Ole Wiborg. The announcement of this partnership follows Hovione's communication on a further expansion with an expected investment of $170 million in assets worldwide and shows the company's commitment to also expand its technology platforms. Hovione is investing both in new assets and innovative technologies to meet customer demand for integrated and differentiated services in drug substance manufacturing, particle engineering and most recently drug product manufacturing. About Hovione Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) with a fully integrated offering of services for drug substance, drug product intermediate and drug product. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solution across the entire drug life cycle. In the inhalation area, Hovione is the only independent company offering a complete range of services, from API, formulation development and devices. Hovione is a company with a culture based on innovation, quality and delivery. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards. About Zerion Pharma ApS Zerion has pioneered the Dispersome® technology that greatly enhances the solubility of poorly soluble, oral drugs and improves bioavailability and therapeutic outcomes for the patients. The Dispersome® technology is based on preparing stable amorphous formulations by mixing high loads of the drug compound with beta-lactoglobulin, a sustainable and biodegradable by-product from cheese production. Zerion develops proprietary drug formulations and offers the Dispersome® technology to established pharma companies as a means to solve their most challenging drug solubility problems.

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