1/24/2012
Dishman Pharmaceuticals & Chemicals Acquires Creapharm Parenterals
Switzerland-based Carbogen Amcis AG, a leading pharmaceutical process development and API manufacturing company, recently announced the acquisition of Creapharm Parenterals, a subsidiary of France-based Creapharm Group. Creapharm Parenterals (formerly MP5), is a contract development and manufacturing organization (CDMO) specializing in liquid, semi-solid, and injectable aseptic dosage forms. As part of this acquisition, Creapharm Parenterals has changed its name to Carbogen Amcis SAS.
“This exciting transaction further strengthens Carbogen Amcis’ service offerings, enabling us to provide our customers with a complete and reliable manufacturing solution from process development to the supply of pharmaceutical substances and formulated products,” said Mark Griffiths, CEO of Carbogen Amcis.
The acquisition will extend Carbogen Amcis’ comprehensive range of development and manufacturing services by adding complementary formulation, lyophilization services, and sterile GMP capabilities for the fast supply of drug products, including highly potents, for preclinical studies and clinical trials (Phase I, II, and III).
“This move reflects our determination to continue to position Carbogen Amcis as a leading service provider for early phase development projects and niche-scale commercial products within the Dishman Group of Companies,” added Jay Vyas, Managing Director of the Dishman Group and owner of Carbogen Amcis.
Creapharm Parenterals brings over 10 years of expertise in the supply of Investigational Medicinal Products (IMP), with more than 300 batches and 145 clinical batches produced since 2000. The company employs 16 highly qualified specialists and operates a GMP manufacturing site in
Through this acquisition, Carbogen Amcis has added the following services for injectable, liquid, and semi-solid pharmaceutical forms: formulation of new products; optimization of existing formulation; development and optimization of lyophilization cycles; parenterals production of preclinical and clinical batches (Phase I, II, and III); aseptic process validation (Media Fill Testing); GMP capabilities for the development of injectables in liquid or freeze-dried forms; and aseptic filling in vials, syringes, cartridges, and infusion bags
“We believe the combined capabilities and services of our two companies present a one-stop solution to pharmaceutical, biotech, and virtual pharmaceutical companies looking for a single reliable partner that can provide API and drug product development for preclinical and clinical studies,” said Maxime Laugier, Development and Projects Director at Creapharm Parenterals.
Avila Therapeutics, Inc. recently announced it has achieved the first milestone in its Epidermal Growth Factor Receptor (EGFR) Mutant-Selective Inhibitor (EMSI) alliance with Clovis Oncology, triggering a $4-million milestone payment to
The US FDA has allowed an
“We are pleased with the tremendous progress that our partners at Clovis have made in advancing CO-1686 into development, particularly in NSCLC, a disease for which novel treatments are so sorely needed,” said Katrine S. Bosley, CEO of Avila Therapeutics. “With this achievement we have now successfully created two clinical development candidates using our targeted covalent drug platform. This further demonstrates our ability to design and develop innovative medicines using Avilomics.”
EGFR-activating mutations occur in approximately 10% to 15% of NSCLC cases in Caucasian patients and approximately 30% to 35% in East Asian patients. These patients experience significant tumor response to erlotinib (Tarceva) and gefitinib (Iressa), which are first-generation EGFR inhibitors. However, most patients ultimately progress on erlotinib and gefitinib therapy, with approximately 50% of patients developing acquired resistance from a second, or “gatekeeper” mutation, T790M. CO-1686 was designed and developed to selectively target both the initial activating EGFR mutations as well as the T790M mutation, while sparing wild-type, or “normal” EGFR. Because CO-1686 spares wild-type EGFR, it has the potential to cause a lower incidence of skin rash and diarrhea, the primary toxicities associated with other EGFR inhibitors.
Because CO-1686 inhibits the initial activating mutations of EGFR as well as T790M mutations, it also has the potential to effectively treat first-line NSCLC patients. CO-1686 may prevent the T790M resistance from occurring, which could result in responses of greater duration and, because it does not inhibit wild-type EGFR, it may possess a more tolerable side-effect profile. CO-1686 is a targeted covalent, or permanent, inhibitor of EGFR mutations. As a covalent drug, CO-1686 forms a durable bond with its target mutations in a highly directed and controlled manner. Preclinical data presented in late 2011 demonstrated that CO-1686 causes tumor shrinkage in T790M-driven NSCLC xenograft models, and resulted in significant tumor growth inhibition at a variety of doses.
RaNA Therapeutics Emerges With $20.7 Million Start-Up Financing
RaNA Therapeutics, Inc. recently announced it has completed a $20.7 million round of financing co-led by Atlas Venture, SR One, and Monsanto, with participation of Partners Innovation Fund. The company is developing a technology platform to enable selective activation of target genes and expression of therapeutic factors by targeting a type of regulatory RNA called long non-coding RNA.
“Our proprietary platform is based on a new therapeutic approach to selectively up-regulating the expression of genes,” explained Arthur Krieg, MD, RaNA President and CEO. “After conducting in vitro and in vivo experiments, we believe the potential therapeutic applications for this technology would be relevant to an extremely broad range of diseases.”
RaNA Therapeutics was founded based on technology developed in the laboratory of Scientific Founder Jeannie T. Lee, MD, PhD, and is exclusively licensed from Massachusetts General Hospital (MGH). Dr. Lee, a Howard Hughes Medical Institute Investigator at MGH, and co-workers discovered a large number of long non-coding RNA regions that interact with a regulatory complex called PRC2, and showed that it is possible to activate single gene expression by specifically blocking this interaction.
RaNA was co-founded by Atlas Venture, Arthur Krieg, and Dr. Lee, and was seed-funded by Atlas Venture last year. The Series A funds will be used to accelerate R&D efforts across a range of disease areas, expand RaNA’s broad IP estate in the field of long non-coding RNA, and expand the core team.
In connection with the financing, Brian M. Gallagher, Jr., PhD, Partner at SR One, and Stephen Padgette, PhD, Vice President at Monsanto, have joined the RaNA Board of Directors; which includes Jean Francois Formela, MD, a Partner at Atlas Venture as Chairman, Ankit Mahadevia, MD, a Principal at Atlas Venture, and RaNA CEO Arthur Krieg.
Only 2% to 3% of the genome consists of genes encoding proteins; the remainder had been considered “junk DNA” with no role. Recent research has revealed that the majority of the genome is not “junk,” but is actively transcribed into long non-coding RNAs (lncRNA) that serve a critical epigenetic gene-regulating function. These regulatory lncRNAs control the process of development and can lead to disease when aberrantly expressed. By regulating these regulators, RaNA believes it can correct defective gene expression, thereby restoring health in many classes of disease.
Patheon Adds Soft Gel Capsule Capabilities Through New Partnership
Patheon and PROCAPS
“This exclusive agreement is part of our recently announced strategy to strengthen our core operations and product offerings,” said Jim Mullen, Patheon’s CEO. “By combining PROCAPS’ manufacturing capabilities and proprietary technology with our global experience, reach, and customer service, we are positioned to provide our customers royalty-free soft gel capsule solutions for their products.”
“PROCAPS is pleased to enter into this agreement with Patheon, one of the leading providers of contract development and manufacturing services in the world,” added Ruben Minski, PROCAPS CEO. “This partnership truly provides us with a great opportunity to leverage our quality soft gel capabilities across the globe through Patheon’s customers and beyond.”
“The addition of commercial-scale soft gel capacity to our full offering of dosage forms, which includes parenteral, solid, and liquid technologies, creates a more comprehensive array of options for our clients,” explained Michael Lytton, Executive Vice President, Corporate Development and Strategy & General Counsel. “Soft gel oral drug delivery offers many advantages to some of the more challenging compounds being developed by the pharmaceutical industry today, and the collaboration with PROCAPS builds on Patheon’s successful SoluPath solution set for compounds with solubility challenges. We look forward to partnering with our current and future customers to provide them with P-Gels soft gel capability.”
The capabilities Patheon gains via the P-Gels offering include large-scale commercial supply of prescription soft gel capsules for the North American, European, and Asian markets. PROCAPS is an established, multinational company with over 3,000 employees and rich history of providing quality products in food supplements, as well as OTC and Rx pharmaceuticals. PROCAPS has been developing and manufacturing soft gel capsules since 1977 and currently has capacity to manufacture up to 9 billion capsules per year.
The soft gel dosage form provides important advantages for drug delivery and consumer experience. It offers rapid and consistent absorption of drugs and consistent delivery of highly potent drugs that require small dosages. In many cases, soft gels can be used to improve the solubility of drugs that pose bioavailability challenges. Consumer advantages include reliable delivery, taste-masking, ease of swallowing, and rapid onset. Patient feedback surveys consistently rate soft gels as the preferred dosage form.
B. Braun Becomes First to Deliver FDA-Approved 2-g Cefazolin
B. Braun Medical Inc. recently announced it received US FDA approval for 2-g Cefazolin for Injection USP and Dextrose Injection USP in B. Braun’s DUPLEX Drug Delivery System. The FDA approval makes B. Braun the first company to deliver an FDA-approved 2-g Cefazolin dose to hospitals and other healthcare settings, where it is a frequently prescribed antibiotic.
The arrival of 2-g Cefazolin is welcome news. Until now, Cefazolin had only been available in 1-g IV and multi-dose vials. The 2-g Cefazolin in the DUPLEX system can be stored, ready to use wherever and whenever it is needed, which means faster, safer, and more accurate administration of 2-g Cefazolin to patients.
“B. Braun heard physician and pharmacist calls for a 2-g Cefazolin dose, and we’ve responded,” said Rob Albert, Vice President, Pharma Marketing for B. Braun. “2-g Cefazolin will be the latest in an expanding DUPLEX portfolio, which is designed to provide fast, safe, convenient, and Joint Commission and USP Chapter <797> compliant products that improve the practice of healthcare professionals while advancing patient safety and outcomes.”
B. Braun will offer 2-g Cefazolin delivered via its DUPLEX Delivery System, a ready-to-use two-compartment flexible plastic IV container that stores pre-measured drug and diluent doses. Healthcare workers administering DUPLEX simply squeeze the container and shake it to mix pharmaceuticals and diluent.
The DUPLEX system saves time, labor, and speeds dispensing because it can be stored right in emergency and operating rooms until it’s needed and is ready immediately. The DUPLEX container is not manufactured with latex, PVC, or DEHP. A barcode that references the final admixture, lot number, and expiration date helps reduce medication errors, automate patient charting, track inventory, and facilitate reimbursement tracking.
With the addition of 2-g Cefazolin to its drug delivery portfolio, B. Braun will expand its broad spectrum of intravenous cephalosporin antibiotic therapies for the hospital setting: Cefepime, Ceftazidime, Cefoxitin, CefTRIaxONE, Cefazolin, CefUROXime, and Cefotetan.
Aptalis Pharma Announces NDA Approval of Oral Powder Formulation of Viread
Aptalis Pharma recently announced the US FDA has approved an NDA for Gilead Sciences, Inc.’s Viread (tenofovir disoproxil fumarate) oral powder in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients ages 2 to 5. Co-developed by Aptalis and
“We are delighted to have the opportunity to use our Microcaps proprietary technology to co-develop the oral powder formulation of Viread with Gilead, which was the result of an Aptalis program referred to as EUR-1030,” said John Fraher, President of Aptalis Pharma.
The Aptalis microencapsulation technology, known as Microcaps, employs versatile and precise coating techniques to encapsulate individual drug particles using solvent- and aqueous-based coacervation. This includes taste- and odor-masking, customized release profiles, conversion of liquids to solids, and the separation of incompatible materials. Microcaps can also be combined with the Aptalis AdvaTab technology to provide an orally disintegrating tablet with superior mouth-feel attributes.
Aptalis Pharma Inc. is a privately held, leading specialty pharmaceutical company providing innovative, effective therapies for unmet medical needs, including cystic fibrosis and gastrointestinal disorders. Aptalis, formed from the recent combination of Axcan Pharma and Eurand, has manufacturing and commercial operations in the US, the European Union, and Canada, and its products include ZENPEP, CANASA, CARAFATE, PYLERA, LACTEOL, DELURSAN, PANZYTRAT, and SALOFALK. Aptalis also formulates and clinically develops enhanced pharmaceutical and biopharmaceutical products for itself and others using its proprietary technology platforms, including bioavailability enhancement of poorly soluble drugs, custom-release profiles, and taste-masking/orally disintegrating tablet (ODT) formulations.
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