8/22/2012
United Drug Acquires Leading Clinical Trials Materials Business
United Drug plc recently announced it has reached an agreement to acquire the
“The Bilcare acquisition is another very important step in the development of United Drug as we focus on margin expanding, international opportunities,” said Liam FitzGerald, Chief Executive of United Drug. “This business fits well alongside our existing packaging businesses in the
Listed on the Stock Exchanges in
Avantor Names New President & CEO
Avantor Performance Materials recently announced the appointment of John M. Steitz as President and Chief Executive Officer. Mr. Steitz assumes these roles from Avantor Chairman Rajiv L. Gupta, who had been serving as the company’s CEO. Mr. Gupta remains Chairman of the Board of Avantor, which is owned by an affiliate of New Mountain Capital.
Mr. Steitz, 54, brings more than 30 years of experience in the field of specialty chemical manufacturing to his new role at Avantor. Most recently, he served as President and Chief Operating Officer at Albemarle Corporation, a global chemical manufacturing company based in
“We’re pleased at the opportunity to have John and his capabilities in this key role at Avantor,” Mr. Gupta said. “He is a proven leader who has demonstrated throughout his career an exceptional ability to manage growth initiatives and work with employees to serve customers, improve operations, and maximize profitability. His leadership, business management, and administration experience will be a great asset to Avantor’s development as a world-class supplier and partner with our customers.”
“We look forward to working with John as we continue to support an aggressive growth strategy for Avantor. The company is well positioned for long-term success, and we are enthusiastic about the possibilities under John’s leadership,” added Matt Holt, Managing Director of New Mountain Capital.
In his role as President and CEO, Mr. Steitz will oversee all aspects of Avantor’s global operations in its four business areas: Laboratory Products, Pharmaceuticals, Electronic Materials, and Diagnostics. He will be based at Avantor’s global corporate headquarters in
Regulus Therapeutics Files for Multi-Million IPO
Regulus Therapeutics Inc., a biopharmaceutical company founded by Alnylam Pharmaceuticals and Isis Pharmaceuticals, recently announced it has filed a registration statement on Form S-1 with the US SEC relating to a proposed initial public offering of shares of its common stock. All shares of the common stock to be sold in the offering will be offered by Regulus. The number of shares to be offered and the price range for the offering have not yet been determined.
Lazard Capital Markets LLC, Cowen and Company, LLC, and BMO Capital Markets are acting as joint book-running managers for the offering. Needham & Company, LLC and Wedbush PacGrow Life Sciences are acting as co-managers. The offering will be made only by means of a prospectus. When available, copies of the preliminary prospectus relating to and describing the terms of the offering may be obtained from Lazard Capital Markets LLC.
Regulus Therapeutics is a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs. Regulus is using a mature therapeutic platform based on technology that has been developed over 20 years. Regulus is advancing microRNA therapeutics toward clinical development in several areas, including oncology, fibrosis, hepatitis C and metabolic diseases. For more information, visit www.regulusrx.com.
TG Therapeutics; Rhizen Pharmaceuticals Ink $250-Million Agreement
TG Therapeutics, Inc. and Rhizen Pharmaceuticals SA recently announced the companies have entered into an exclusive global agreement to collaborate on the development and commercialization of Rhizen’s lead product candidate, a novel PI3K delta inhibitor, TGR-1202 (previously referred to as RP5264). The companies will jointly develop the product on a worldwide basis, excluding
TG Therapeutics will make up-front licensing payments and milestones based on early clinical development, and will be responsible for the costs of clinical development of the products through Phase II, after which TG Therapeutics and Rhizen will be jointly responsible for all development costs of the product. TG Therapeutics and Rhizen will each maintain an exclusive option, exercisable at specific times during development, for TG Therapeutics to license the rights to TGR-1202, in which case Rhizen would be eligible to receive upfront, development, and commercialization milestone payments in addition to milestone payments and royalties tied to net sales of the product, the aggregate of which could exceed $250 million. Rhizen shall maintain rights to manufacture and supply the product to TG Therapeutics, and TG Therapeutics will be responsible for all clinical and regulatory development for TGR-1202 globally.
TGR-1202 is a highly specific, orally available, PI3K delta inhibitor, targeting the delta isoform with nanomolar potency and several fold selectivity over the alpha, beta, and gamma isoforms of PI3K. Inhibition of PI3K delta signaling with TGR-1202 has demonstrated robust activity in numerous preclinical models and primary cells from patients with hematologic malignancies. An
The phosphoinositide-3-kinases (PI3Ks) are a family of enzymes involved in cellular functions, including cell proliferation and survival, cell differentiation, intracellular trafficking and immunity. The delta isoform of PI3K is strongly implicated in B-cell related lymphomas. Rhizen has developed novel selective inhibitors of the PI3K delta pathway, believed to be important in the proliferation and survival of B-cell lymphocytes. The lead candidate TGR-1202 has demonstrated activity in preclinical xenograft models and primary cells from patients for hematologic cancers.
TG Therapeutics is an innovative, clinical-stage biopharmaceutical company focused on the acquisition, development, and commercialization of innovative and medically important pharmaceutical products for the treatment of cancer and other underserved therapeutic needs. For more information, visit www. www.tgtxinc.com.
Rhizen is a biopharmaceutical company dedicated to the discovery and development of novel therapeutics to treat cancer and immune disorders. Rhizen has to date created a diverse portfolio of proprietary drug candidates targeting several cancers and immune associated cellular pathways. For more information, visit www.rhizen.com.
The Wistar
DavosPharma recently announced it has signed a collaborative agreement with The Wistar Institute of Philadelphia. This agreement provides DMPK, and preclinical
Since 1972, DavosPharma has serviced the pharmaceutical industry, from preclinical development to commercialization. Over the years, the company has established an excellent reputation in evaluating, coordinating, and delivering drug development through strategic partners. DavosPharma is headquartered in
The Wistar Institute is an international leader in biomedical research with special expertise in cancer research and vaccine development. Founded in 1892 as the first independent nonprofit biomedical research institute in the country, Wistar has long held the prestigious
New Findings Advance Industry Understanding of Standardizing In Vitro Tests for Lipid-Based Formulations
With the push to bring new drugs to market faster, the healthcare industry has made significant advances in utilizing lipid-based drug delivery systems to expedite their development. While lipid-based formulations have proven to be capable of improving bioavailability, while also reducing food effect and intra- and inter-patient variability, many formulation challenges remain. With a very high proportion of the industry’s development pipeline consisting of molecules with poor bioavailability, advances in lipid-based formulation technologies are essential to the future of drug development.
To reduce the hurdles to lipid-based product development, the Lipid Formulation Classification System Consortium (LFCS), a non-profit organization composed of researchers from academia and industry, has been created to conduct research into lipid-based drug delivery systems for the oral administration of poorly soluble drugs with the end goal of developing guidelines that support the development of promising drug candidates. Capsugel is a founding industry member of the Consortium. Today’s findings are the first of a series of research updates that will be published by the Consortium over the next several months.
These new findings, recently published online in the Journal of Pharmaceutical Sciences, were presented for the first time by two key members of the Consortium: Professor Colin Pouton of
“Given the increase in poorly soluble compounds under investigation that have the potential for real patient and consumer benefit, there is a need to standardize in vitro methods for evaluating lipid-based formulations,” said Professor Pouton, working group leader of the Lipid Formulation Classification System Consortium “Our initial findings confirm that using the digestion model is the preferable method for differentiating between formulations.”
Dr. Ross Blundell emphasized during his talk the importance of the LFCS findings for the pharmaceutical industry by stating, “It is difficult to see that an industrial partner working alone could have achieved the same breadth of data in the same time frame as the Consortium. The findings will enable lipid-based formulations to be screened both accurately and rapidly and to move projects more swiftly through the development process.”
In their research paper, the LFCS Consortium team describes the test performance of eight different types of lipid-based formulation models and found good differentiation of formulation performance was possible. Digestion experiments were performed in vitro using a pH-stat device and the compound danazol as the model for a poorly water-soluble drug. Lipid-based formulation digestion and drug solubilization patterns on digestion were examined and experiments were conducted at two sites for consistency to ensure results could be reproduced.
“Researchers at Capsugel have developed lipid-based technologies that are proven to address many of the challenges presented by poorly soluble compounds. We have two world class centers based in
For more information about the LFCS Consortium and its activities, visit www.lfcsconsortium.org.
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