Piramal Pharma Solutions, Theratechnologies Inc. | January 25, 2021
Piramal Pharma Limited's Pharma Solutions business, a leading contract development and manufacturing organization (CDMO), today declared that it is giving Theratechnologies Inc. with GMP manufacturing of sterile fill/finish drug item to help their developmental item as it goes into a first-in-people clinical investigation.
The clinical material is being created at the Piramal Pharma Solutions (PPS) manufacturing site in Lexington, Kentucky, which is perceived around the world for its skill in sterile fill/finish administrations. It will be utilized in a Phase I preliminary for TH1902, Theratechnologies' lead peptide-drug conjugate (PDC) (docetaxel conjugate). The Phase I preliminary plan incorporates a portion acceleration study to assess the security, pharmacokinetics, most extreme endured portion (MTD) and fundamental enemy of tumor movement of TH1902 managed once at regular intervals in patients with cutting edge strong tumors headstrong to accessible enemy of malignant growth treatments.
According to Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions, "Our Lexington team went the extra mile to provide solutions to ensure timely formulation development and production of the material. It's yet another example of how we are focused on working with our customers to reduce the burden of disease on patients."
About Piramal Pharma Solutions
Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs and finished dosage forms. We also offer specialized services like development and manufacture of highly potent APIs and antibody drug conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve innovator and generic companies worldwide.
About Piramal Pharma Limited
Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, offers a portfolio of differentiated products and services through end-to-end manufacturing capabilities across 14 global facilities and a global distribution network in over 100 countries. PPL includes an integrated contract development and manufacturing (CDMO) business, Complex hospital generics business, and India Consumer Products business, selling over-the-counter products in India. In addition, it has a joint venture with Allergan, a leader in ophthalmology in the Indian formulations market. In October 2020, PPL received 20% strategic growth investment from the Carlyle Group.
Theratechnologies is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs.
CURE Pharmaceutical Holding Corp. | November 17, 2021
CURE Pharmaceutical Holding Corp. (OTC: CURR), a technology focused, vertically integrated drug delivery and product development company focused on pharmaceutical and health & wellness products, announced today that it received an issue notification from the U.S. Patent Office (USPTO) stating that U.S. Patent No. 11,179,331 (the ’331 patent) is set to issue on November 23, 2021. The ’331 patent, entitled “Oral Soluble Film Containing Sildenafil Citrate,” covers the product CUREfilm Blue™, an oral soluble film of sildenafil citrate (the active ingredient present in Viagra®1) for the treatment of erectile dysfunction (ED). CURE is seeking approval of this product via the 505(b)(2) regulatory pathway.
CUREfilm Blue™ utilizes the Company’s patented and proprietary fast-dissolving drug delivery platform, known as CUREfilm™, to deliver the active pharmaceutical ingredient (API) sildenafil citrate. By innovating beyond the traditional pharmaceutical delivery of pills and solutions, CURE is advancing this uniquely discrete, convenient and portable oral film product for achieving a better patient experience. The ’331 patent highlights several key aspects of the CUREfilm Blue™, such as a balance of performance characteristics (e.g., fast-dissolving and early onset of action) and physical parameters (e.g., large mass and small thickness), while it can be administered with or without water or beverage.
The global erectile dysfunction drug market is projected to grow at a CAGR of 6% and reach approximately USD$6.6 billion by 2025 with sildenafil representing a majority of the market, according to a report by QYR Research.
About CURE Pharmaceutical Holding Corp.
CURE Pharmaceutical® is the pioneering developer of CUREform™, a patented drug delivery platform that offers a number of unique immediate- and controlled-release drug delivery vehicles designed to improve drug efficacy, safety, and patient experience for a wide range of active ingredients. As a vertically integrated company, CURE’s 25,000 square foot, FDA-registered, NSF® and cGMP-certified manufacturing facility enables it to partner with pharmaceutical and wellness companies worldwide for private and white-labeled production. CURE has partnerships in the U.S., China, Mexico, Canada, Israel, and other markets in Europe.
Forward Looking Statement
Statements CURE makes in this press release may include statements which are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (“Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (“Exchange Act”), which are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. CURE intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and is making this statement for purposes of complying with those safe harbor provisions. The forward-looking statements in this press release reflect CURE’s judgment as of the date of this press release. CURE disclaims any intent or obligation to update these forward-looking statements
Quotient Sciences, Arcinova | February 09, 2021
Quotient Sciences, the drug development and manufacturing accelerator, reported that it has procured Arcinova, the U.K.- based multiservice contract development and manufacturing organization (CDMO). With more than 40 years of involvement and 160 representatives, Arcinova gives drug substance, drug item and bioanalysis administrations to more than 200 pharma and biotech clients around the world.
The obtaining expands Quotient's administration portfolio and will empower the incorporation of drug substance, drug item and clinical testing abilities all under one organization broadening the year drug development course of events investment funds previously conveyed by Quotient's flagship platform Translational Pharmaceutics®. By slicing through storehouses and incorporating a scope of capacities, rethought development projects can be additionally improved and quickened, reliable with Quotient's conviction that particles need to become fixes, quick.
“I’d like to congratulate the Arcinova team on building an exciting business, and I am thrilled to be joining forces. Both businesses are similar in culture and aspire to help customers accelerate molecules from candidate selection through development and on to commercial launch,” said Mark Egerton, Ph.D., CEO of Quotient Sciences. “I’d also like to take this moment to thank our private equity partner, Permira, for supporting our ambitious growth plans.”
Professor Ian Shott, CBE, co-founder and executive chairman of Arcinova, said, “Since inception, we set out to build a unique organization that accelerates the development of new medicines for patients in need. We are delighted to move on to the next stage with Quotient as the perfect partner for Arcinova. Deep science, agility, flexibility and the drive for customer service excellence are the cornerstones of both businesses. I look forward to working with the Quotient team and Permira to deliver even greater value for our customers.”
As part of the deal, Arcinova’s minority equity partner, BGF, will exit the business, having backed its growth since 2018. Mark Bryant, BGF, said, “It has been a privilege to support the expansion of Arcinova’s world-leading CDMO facility at such a critical part of its growth journey. We wish the team all the best as it moves to the next stage with Quotient Sciences.”
RBC Capital Markets went about as selective monetary counselor to Quotient Sciences. PwC gave monetary and charge due industriousness administrations and Latham and Watkins gave legal counsel. BGF got legal counsel from Weightmans. KPMG filled in as corporate money guide for Arcinova, and Womble Bond Dickinson gave legal counsel.
About Quotient Sciences
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients. Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
Arcinova is a multiservice contract development and manufacturing organization (CDMO) that serves pharmaceutical and biotechnology companies across the globe in developing their life changing medicines. The company, with decades of experience, combines agility with flexibility to provide an innovative approach to the development and manufacture of pharmaceutical products. Arcinova’s ambition is to save our clients valuable time, enabling them to rapidly bring life-changing medicines to market.