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.
CPD AND LEARNING
Miravo Healthcare | March 16, 2023
Nuvo Pharmaceuticals Inc., which operates as Miravo Healthcare (Miravo), and Searchlight Pharma Inc., a Canadian specialty firm, have recently announced the closing of the previously announced plan of arrangement of Miravo with Searchlight. As per the arrangement terms, Searchlight acquired all the outstanding common shares of Miravo in exchange for $1.35 per share in cash, and the Miravo common shares will be removed from the Toronto Stock Exchange. Miravo will also apply to cease being a reporting issuer in each of the Canadian provinces.
The registered shareholders of Miravo must complete, sign and return the letter of transmittal and share certificate(s) to TSX Trust Company, the depositary, to receive their compensation under the arrangement. Non-registered shareholders will receive their compensation through their intermediary.
Before the Arrangement, Searchlight did not possess any Company Shares. Searchlight bought 11,388,282 Company Shares, representing 100% of the issued and outstanding Company Shares, for $1.35 per Company Share in conjunction with the arrangement.
Searchlight Pharma Inc., President and CEO, Mark Nawacki, commented, "Today marks the beginning of a new chapter for Miravo as it officially combines with Searchlight and continues as a private company." He further emphasized, "Searchlight plus Miravo will be a diversified, large and strong company – based on IQVIA CDH sales data, we will rank in the top three of Canadian specialty pharma companies – and this positions us well to continue to execute our successful business model and to deliver on our leadership objective in the sector. On behalf of the Searchlight team, I express our thanks to all Miravo stakeholders for their cooperation throughout this acquisition process, and I warmly welcome our new Miravo colleagues to the Searchlight family."
(Source – Business Wire)
About Miravo Healthcare
Miravo Healthcare, formerly known as Nuvo Pharmaceuticals Inc., is a Canadian specialty pharmaceutical company that focuses on developing and commercializing innovative therapies. Its mission is to improve patient's quality of life by providing them with safe and effective treatments for chronic conditions such as pain, inflammation, and addiction. Miravo Healthcare's portfolio includes a range of prescription drugs, over-the-counter products, and medical devices used in various therapeutic areas, including pain management, dermatology, and women's health. The company's flagship product is Pennsaid, a topical non-steroidal anti-inflammatory drug (NSAID) used to treat knee osteoarthritis. It is committed to sustainability and social responsibility, and the company's initiatives include reducing its environmental footprint, supporting local communities, and promoting diversity and inclusion. With a focus on innovation and patient care, it continues making significant contributions to the pharmaceutical industry in Canada and beyond.
RESEARCH, PHARMA TECH
Ambrx | February 21, 2023
Ambrx Biopharma Inc., recently released positive preliminary results from its current Phase 1 trial, APEX-01 (NCT04662580), which is examining ARX517, Ambrx's patented anti-PSMA ADC, in patients with prostate cancer.
Patients with advanced prostate cancer who have progressed on at least two prior FDA-approved treatments are enrolled in the Phase 1, first-in-human, open label dose escalation and dose expansion experiment known as APEX-01. In the US, APEX-01 is the only clinical trial that uses an ADC to treat PSMA. The trials revealed
• No grade ≥3 treatment-related adverse events (AEs) or drug-related serious adverse events (SAEs) have been reported in the 22 individuals who were evaluable for safety. ARX517 was well-tolerated otherwise with grade 1 or 2 treatment-related adverse events were observed. It is yet to reach the maximum tolerated dose (MTD) • Starting with the second to lowest dose of 0.64 mg/kg, PSA reductions of > 30% have been seen in Cohorts 2-5 • 3 (100%) patients in Cohort 6 (2.0 mg/kg dosage) had a PSA level reduction of at least 50%. PSA levels were reduced by more than 90% in 2 out of 3 patients. At the initial on-treatment scan, soft tissue measurable disease was found in 1 of the 3 patients, and showed a partial RECIST v1.1 response • In Cohort 7, three patients received doses with no DLTs
Daniel J. O’Connor, CEO of Ambrx, said, “While recent advances have considerably reduced the number of men who die from prostate cancer, it remains the second-most common form of death from cancer in the United States. Approximately 1 man in 41 will die of prostate cancer. Thus, there remains an urgent need for better treatments, in particular for men with advanced prostate cancer.” He further added, “We are very pleased to see a significant reduction of greater than 50% in PSA levels in the first three patients at 2.0 mg/kg, two of which went on to see a greater than 90% PSA level reduction, without any serious drug-related adverse events.”
(Source – Business Wire)
Ambrx Inc., is a clinical-stage biopharmaceutical company. It develops precision biologics using an extended genetic code. Synthetic amino acids are incorporated into proteins using Ambrx technology, which is carried out entirely within a living cell. Precision Biologics, a novel therapeutic class with significant potential uses these synthesized amino acids.