Market Newsdesk

– Appointment strengthens leadership team as the Company readies for potential global odevixibat launch and progresses multiple clinical development programs –

– Deep experience spanning drug development, manufacturing, quality and supply chain –

BOSTON, April 13, 2021 (GLOBE NEWSWIRE) — Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage rare liver disease company developing novel bile acid modulators, today announced the appointment of Joan Connolly as Chief Technology Officer and key member of the Albireo Enterprise Team. In this new role, Connolly will be responsible for overseeing drug substance and product development, clinical supply distribution, commercial supply chain and quality.

“Joan joins Albireo at an exciting time, bringing expertise that spans from early drug development through product launches, which is key as we prepare for a potential launch of odevixibat, while progressing clinical programs for Alagille syndrome, biliary atresia and adult liver diseases,” said Ron Cooper, President and Chief Executive Officer of Albireo. “As we continue to progress our pipeline and prepare for the market, Joan’s deep expertise and experience in end-to-end drug development and commercialization is invaluable for Albireo and the patients we serve.”

Connolly’s career spans more than 25 years of experience in manufacturing management, regulatory filings (CMC), and product commercialization, as well as supply chain, logistics and sourcing and procurement. Most recently, Connolly was the Senior Vice President, Technical Operations at Stemline Therapeutics where she was responsible for taking their lead product from the IND stage through to commercialization. Previously, Connolly held senior roles at ImClone Systems and Bristol-Myers Squibb.

“I am excited to join Albireo at this pivotal time, as the company is transitioning from a clinical-stage biotech to a fully commercialized global company,” said Connolly. “With the potential of an upcoming launch and an entire clinical program of drug candidates that could impact the lives of patients and families managing the burden of life-threatening cholestatic liver diseases, I am eager to join Albireo in their mission as we prepare for a potential launch and expand into adult cholestatic liver diseases.”

Ms. Connolly will receive inducement grants of stock options exercisable for an aggregate of 23,000 shares of Albireo’s common stock and restricted stock units representing the opportunity to acquire 5,000 shares of Albireo’s common stock. The exercise price for the inducement grants will be the closing price of Albireo’s common stock as of April 12, 2021 and were granted as inducements material to Ms. Connolly’s acceptance of employment with Albireo in accordance with Nasdaq Listing Rule 5635(c)(4). The inducement grants have a 10-year term and vest over a four-year period, subject to Ms. Connolly’s continued service with Albireo through the applicable vesting dates. The vesting schedule for the inducement grants is 25 percent on the one-year anniversary of Ms. Connolly’s start date with Albireo and 75 percent in 12 equal quarterly installments thereafter. The inducement grants are subject to the terms and conditions of Albireo’s 2020 Inducement Equity Incentive Plan.

About Albireo
Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases. Albireo’s lead product candidate, odevixibat, is being developed to treat rare pediatric cholestatic liver diseases with Phase 3 trials in PFIC, Alagille syndrome and biliary atresia. For PFIC, the FDA recently granted Priority Review and set a PDUFA goal date of July 20, 2021. In Europe, the EMA validated MAA. Odevixibat is the only IBATi granted accelerated assessment by the EMA. The Company has also initiated a Phase 1 clinical trial for A3907 to advance development in adult cholestatic liver disease, with IND-enabling studies moving ahead with A2342 for viral and cholestatic liver disease. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. The Boston Business Journal named Albireo one of the 2020 Best Places to Work in Massachusetts for the second consecutive year. For more information on Albireo, please visit www.albireopharma.com.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements, other than statements of historical fact, regarding, among other things: the plans for, or progress, scope, cost, initiation, duration, enrollment, results or timing for availability of results of, development of odevixibat or any other Albireo product candidate or program; including expectations regarding the impact of the COVID-19 pandemic on our business and our ability to adapt our plans and activities as appropriate; the pivotal trial for odevixibat in biliary atresia (BOLD), and the pivotal trial for odevixibat in Alagille syndrome (ASSERT); the Phase 1 trial for A3907, the target indication(s) for development or approval, the size, design, population, location, conduct, cost, objective, enrollment, duration or endpoints of any clinical trial, or the timing for initiation or completion of or availability or reporting of results from any clinical trial, including the long-term open-label extension study for odevixibat in PFIC, the pivotal trial for odevixibat in biliary atresia, the pivotal trial for odevixibat in Alagille syndrome; the Phase 1 trial for A3907, the potential approval and commercialization of odevixibat; the potential for odevixibat to become the first approved drug for PFIC patients; discussions with the FDA or EMA regarding our programs; the potential benefits or competitive position of odevixibat, A3907, A2342 or any other Albireo product candidate or program or the commercial opportunity in any target indication; the potential effects of odevixibat of the treatment of PFIC patients and its potential to improve the current standard of care; the potential benefits of an orphan drug designation; the potential issuance of a rare pediatric disease priority review voucher; or Albireo’s plans, expectations or future operations, financial position, revenues, costs or expenses. Albireo often uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “planned,” “continue,” “guidance,” or the negative of these terms or other similar expressions to identify forward-looking statements. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to: whether the NDA for odevixibat for the treatment of pruritus in patients with PFIC will be approved by the FDA and whether the MAA for odevixibat in PFIC will be approved by the EMA; whether the FDA or EMA will complete their respective reviews within the target timelines, including the FDA’s PDUFA goal date, as a potential result of the impact of the COVID-19 pandemic or otherwise; the risk that the NDA will not be approved despite the FDA’s acceptance of the NDA for review; whether the FDA will require additional information, whether we will be able to provide in a timely manner any additional information that the FDA requests, and whether such additional information will be satisfactory to the FDA; other potential negative impacts of the COVID-19 pandemic, including on manufacturing, supply, conduct or initiation of clinical trials, or other aspects of our business; whether favorable findings from clinical trials of odevixibat to date, including findings in indications other than PFIC, will be predictive of results from other clinical trials of odevixibat; whether either or both of the FDA and EMA will determine that the primary endpoint for their respective evaluations and treatment duration of the double-blind Phase 3 trial in patients with PFIC are sufficient to support approval of odevixibat in the United States or the European Union, to treat PFIC, a symptom of PFIC, a specific PFIC subtype(s) or otherwise; the outcome and interpretation by regulatory authorities of the ongoing third-party study pooling and analyzing of long-term PFIC patient data; the timing for initiation or completion of, or for availability of data from, clinical trials of A3907 or odevixibat, including the pivotal program in biliary atresia or the pivotal program in Alagille syndrome, and the outcomes of such trials; Albireo’s ability to obtain coverage, pricing or reimbursement for approved products in the United States or European Union; delays or other challenges in the recruitment of patients for, or the conduct of, company’s clinical trials; and Albireo’s critical accounting policies. These and other risks and uncertainties that Albireo faces are described in greater detail under the heading “Risk Factors” in Albireo’s most recent Annual Report on Form 10-K or in subsequent filings that it makes with the Securities and Exchange Commission. As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. Albireo cautions you not to place undue reliance on any forward-looking statement. In addition, any forward-looking statement in this press release represents Albireo’s views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Albireo disclaims any obligation to update any forward-looking statement except as required by applicable law.

Media Contact:

Colleen Alabiso, 857-356-3905, [email protected]
Lisa Rivero, 617-947-0899, [email protected]

Investor Contact:

Hans Vitzthum, LifeSci Advisors, LLC., 857-272-6177

BURBANK, Calif., April 13, 2021 (GLOBE NEWSWIRE) — via NewMediaWire – Medolife Rx, Inc. (“Medolife”), a global integrated bioceutical company with R&D, manufacturing, and consumer product distribution, which is a majority owned subsidiary of Quanta, Inc. (OTC PINK: QNTA), announced today that it has filed its final set of data requested by the US Food and Drug Administration (FDA) for its Pre-Investigational New Drug (PIND #150335) filing on its lead drug candidate Escozine® as a COVID-19 therapeutic. Along with the submission of a batch of Escozine® previously announced specifically produced for the FDA, the Company believes that this will be the last submission necessary in order to receive IND designation from the regulatory body in the United States.

The Company assembled detailed information regarding the manufacturing of Escozine®, clarity on dosing, as well as both previous and new safety and efficacy data derived from an on-going human study taking place in the DR. The study has been conducted on over 500 participants and intends to demonstrate the safety and efficacy of Escozine®. Escozine® is a polarized solution of the Rhopalurus princeps scorpion peptide owned by Medolife, which has been filed with the FDA under the IND regulatory pathway as well as the Ministry of Health in the DR where the Company is seeking product registration. Previous clinical data was submitted to the FDA including preliminary results of the safety study, which has now been expanded upon. This data, as well as the batch of Escozine® that was produced specifically for the FDA, has now been submitted. After the review of the data and barring any further inquiries or requests, the FDA will designate IND status for Escozine®, essentially allowing the drug to be distributed in the US. After such designation, the Company will pursue other clinical applications of Escozine®, including as a potential cancer therapeutic where the Company has already released positive clinical results.

“The FDA-approved therapeutic drug market is the gold standard globally and should we receive IND designation from the FDA, it would catapult our other research across the world,” said Medolife CEO Dr. Arthur Mikaelian. “Submission to the FDA is never easy, but we are generating such positive clinical trial results that we are confident the regulatory body will take notice. They have been reviewing our submission for some time, requesting various other information that we have now submitted. I believe this could be the last request ahead of approval, which would be tremendous not only for our Company, but for patients who are in need of a solution where one does not currently exist. An approval from the FDA would also propel interest from the scientific community on the potential therapeutic benefits of the natural peptides we are studying, including investment and partnership interest.”

The Company has conducted extensive clinical studies on Escozine® as a therapeutic for both COVID-19 and multiple forms of cancer in the US and globally. It is seeking product registration in the DR for treatment of COVID-19 through its exclusive relationship with the Ministry of Health. Escozine® utilizes a patented polarization technology developed by Dr. Mikaelian that increases the potency of single molecules and complex compounds.

About Medolife Rx

Medolife Rx, Inc. is a global biotechnology company with operations in clinical research, manufacturing, and consumer products. Medolife Rx was created through the merger of Medolife, a private company founded by Dr. Arthur Mikaelian who pioneered the unlaying polarization technology that makes the Company’s portfolio of pharmaceutical and nutraceutical products so effective, and Quanta, Inc., a direct-to-consumer wellness product portfolio company. The Company’s lead clinical development programs include Escozine®, a proprietary formulation consisting of small molecule peptides derived from Rhopalurus princeps scorpions which is amplified by the Company’s polarization technology and is being researched as a treatment of various indications, including COVID-19 and cancer. The Company has completed preclinical safety and efficacy research on Escozine® and is pursuing product registration and drug approval in various countries, including the United States and throughout Latin America. 

Through its subsidiary QuantRx, Medolife manufactures and distributes consumer wellness and nutraceutical products in high-impact consumer areas such as pain relief, beauty, and general wellness. QuantRx products are designed using Dr. Mikaelian’s polarization technology which applies advances in quantum biology to increase the potency of active ingredients. Currently, QuantRx supports product formulations in pain management, anti-inflammation, skincare, agriculture, nutritional supplements, and plant-based consumables. Ultimately, Quanta’s mission is to deliver better, more effective ingredients to elevate product efficacy, reduce waste, and facilitate healthier, more sustainable consumption.

Beyond its own clinical and consumer applications, the polarization technology used by Medolife and its subsidiaries has many potential applications. From potentiating bio-ingredients, to producing more-effective carbon-trapping plants, to transformative anti-aging solutions, Medolife has the opportunity to upend how commercial and pharmaceutical products are made and increase their benefits, while decreasing their chemical concentration.

 Forward-Looking Statements

Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995: This release contains statements that are forward-looking in nature which express the beliefs and expectations of management including statements regarding the Company’s expected results of operations or liquidity; statements concerning projections, predictions, expectations, estimates or forecasts as to our business, financial and operational results and future economic performance; and statements of management’s goals and objectives and other similar expressions concerning matters that are not historical facts. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “estimate,” “plan,” “project,” “continuing,” “ongoing,” “expect,” “we believe,” “we intend,” “may,” “will,” “should,” “could,” and similar expressions. Such statements are based on current plans, estimates and expectations and involve a number of known and unknown risks, uncertainties and other factors that could cause the Company’s future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. These factors and additional information are discussed in the Company’s filings with the Securities and Exchange Commission and statements in this release should be evaluated in light of these important factors. Although we believe that these statements are based upon reasonable assumptions, we cannot guarantee future results. Forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

Contacts:

Phil Sands
https://ir.quantrx.com/
818-659-8052

Kyle Porter
[email protected]
858-264-6600