BUSINESS INSIGHTS, PHARMACY MARKET
Framework Solutions, LLC | March 02, 2023
On March 1, 2023, Framework Solutions, a leading clinical to commercial solutions provider, announced that it has acquired ONIX Life Sciences, a consultancy focused on regulatory operations services for the life sciences industry. The acquisition will enable both firms to expand their global reach and strengthen their service capabilities by providing clients with a broader range of critical services. ONIX's expertise in eCTD Submissions, Publishing, and eCTD Lifecycle Management has helped clients submit their regulatory documents to health authorities worldwide, including the FDA and EMA.
ONIX, based in the United Kingdom, has successfully completed eCTD submissions for over 100 clients globally across North America, Europe, South America, the Middle East, and Asia Pacific regions. In addition, ONIX is proud of its accomplishment of never having an eCTD technical rejection and never missing a deadline since its inception in 2010.
Frameworks, headquartered in Connecticut, received a growth investment from WestView Capital Partners in 2021 to develop end-to-end solutions for clinical and commercial-stage organizations in the life sciences industry. WestView Capital Partners, a Boston-based growth equity firm, focuses on investing in middle-market companies with a longstanding dedication to the life sciences services industry.
The transaction terms between Framework Solutions and ONIX Life Sciences were not disclosed.
Frameworks CEO Joe Walsh commented, "We are thrilled to welcome Jasbir and the ONIX team to Frameworks." He further emphasized, "ONIX has built an impeccable reputation in the industry and we are excited to bring Regulatory Operations services to our customers. We look forward to working with Jas as we continue to expand our suite of service offerings to best serve the clinical to commercial-stage needs of life sciences clients."
(Source – PR Newswire)
About Framework Solutions, LLC
Framework Solutions is a leading clinical to commercial solutions provider to pharmaceutical and biotechnology companies with the aim of promoting customer success. The company provides both strategic and tactical solutions in various fields, including Regulatory Affairs, Medical Affairs, MLR, and Commercialization. These services are reinforced by the Technology Group, which delivers tech-enabled solutions and integrated enterprise help desk and infrastructure support. Over 100 clients, from emerging biotech to large pharma, have utilized its services. Its operation centers are located in Europe, North America, and Asia, allowing us to provide these services globally.
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BUSINESS INSIGHTS, PHARMACY MARKET
Xeris Pharmaceuticals, Inc. | January 31, 2023
On January 30, 2023, Xeris Biopharma Holdings, Inc., a leading biopharmaceutical company, announced that the Food and Drug Administration (FDA) granted orphan-drug exclusivity (ODE) to its subsidiary Xeris Pharmaceuticals, Inc. for Recorlev® (levoketoconazole) a cortisol synthesis inhibitor for the treatment of endogenous Cushing's syndrome in adult patients for whom surgery is not viable or has not been effective.
levoketoconazole (Recorlev) being the first FDA-approved therapeutic for the treatment of endogenous hypercortisolemia, Xeris Pharmaceutical is permitted to have seven years of orphan-drug market exclusivity beginning from December 30, 2021. The FDA's Orphan Drug Designation program intends to accelerate the development of medications that treat a disease that affects 200,000 or fewer people in the United States each year. This regulatory exclusivity with the patent exclusivity under Xeris' U.S. patents for Recorlev is valid until at least March 2040.
To serve and assist this community, Xeris is dedicated to ensuring that everyone who needs access to their medications receives them. Xeris has developed Xeris CareConnection™ to provide patients and caregivers with a comprehensive program that includes financial support, one-on-one assistance, and educational materials throughout the treatment journey. Additionally, Xeris CareConnection assists healthcare providers and their teams with education on access and reimbursement.
About Xeris Pharmaceuticals, Inc.
Founded in 2005, Xeris is a growth-oriented biopharmaceutical firm dedicated to improving patients' lives via the development and commercialization of novel products in a range of therapies. Its unique technology makes medicines easier to use for patients & caregivers. The company has three commercially available products; Gvoke®, a ready-to-use liquid glucagon for treating severe hypoglycemia (very low blood sugar); Keveyis®, the first and only FDA-approved therapy for primary periodic paralysis; and Recorlev® for the treatment of endogenous hypercortisolemia. In addition, it has an increasingly broad pipeline of research and partnered projects utilizing its unique formulation technology platforms, XeriSol™ and XeriJect™, bringing forward innovative products for the firm and its partners.
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PHARMACY MARKET, PHARMA TECH
Jazz Pharmaceuticals plc and Zymeworks Inc. | December 28, 2022
Jazz Pharmaceuticals plc and Zymeworks Inc. recently informed that the former has chosen to keep its exclusive rights to develop and sell Zymeworks' Zanidatamab in key markets, such as the U.S., Europe, and Japan, as part of the license and collaboration agreement made in October 2022.
A pivotal trial in previously treated HER2-amplified biliary tract tumors (BTC) found that 41.3% (95% CI: 30.4, 52.8) of recruited patients with HER2-amplified and expressing (IHC2+ and 3+) illness achieved an objective response as judged by independent central review. The median response length was 12.9 months (95% CI: 5.95 to not attained). In this trial, Zanidatamab's safety profile was similar to what had been found in previous studies of monotherapy, while no new safety signals were found.
Jazz Pharmaceuticals stated that the compelling top-line clinical data from the pivotal study in patients with BTC demonstrated the transformative potential of Zanidatamab. This big win gives the company more confidence that it can make this medicine better for cancer patients who have big unmet needs. Even though its main focus will be on the ongoing clinical trials for BTC and GEA, these data will add to the growing amount of evidence that Zanidatamab is effective against a wide range of HER2-expressing cancers.
Zymeworks expressed that the collaboration with Jazz is going well, which will speed up the global development of Zanidatamab in many types of cancer and may give patients with hard-to-treat cancers and few treatment options access to a basic HER2-targeted drug.
Jazz will pay Zymeworks $325 million to exercise its option to develop and sell Zanidatamab in all countries except Asia-Pacific in the fourth quarter of 2022.
About Jazz Pharmaceuticals
Jazz Pharmaceuticals, founded in 2003 and located in Dublin (Ireland), innovates to improve the lives of patients and their families. The company transforms biopharmaceutical discoveries into innovative medications to reimagine what's possible.
About Zymeworks
Zymeworks develops next-generation multifunctional biotherapeutics. Zanidatamab is a new Azymetric™ HER2-targeted bispecific antibody being examined in numerous Phase 1, Phase 2, and pivotal clinical trials globally as a targeted therapeutic option for patients with HER2-positive solid tumors. Zanidatamab Zovodotin (ZW49) is a bispecific antibody-drug combination in Phase 1 clinical development. It combines Zanidatamab's unique design and antibody framework with Zymeworks' ZymeLink™ linker-cytotoxin.
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