Podcast: Perspectives from CPhI Worldwide PharmTech's Patricia Van Arnum discusses strategies in optimizing API syntheses and manufacturing with experts from Aptuit, Cambridge Major Laboratories, and UBM.
Merck Resolves Claims Related to Vioxx for $950 Million
The justice department announced that Merck has agreed to pay $950 million to resolve criminal charges and civil claims related to its promotion and marketing of the painkiller Vioxx.
Gilead Acquires Pharmasset for $11 Billion
On Nov. 21, 2011, Gilead Sciences agreed to acquire Pharmasset for $137 per share in cash, or a total of approximately $11 billion. Pharmasset’s board of directors unanimously approved the transaction, which is expected to close during the first quarter of 2012.
Elan, University of Cambridge Launch New Research Center
Elan and the University of Cambridge have launched a center for innovation and drug discovery that will focus on translational research into therapies for Alzheimer’s and Parkinson’s diseases. The Cambridge–Elan Center will be located at the University of Cambridge, and the agreement between the two will last for 10 years.
Membrane binds contaminants at high conductivities
The Sartobind STIC PA membrane from Sartorius Stedim Biotech uses free primary-amino ligands at high density to bind contaminants at high conductivities through ion exchange. Unlike traditional quaternary ammonium membranes, the Sartobind STIC PA membrane does not require the cation ion-exchange pools to be diluted to bind the negatively charged contaminants. This characteristic can help users reduce buffer consumption and buffer-tank costs. The Sartobind membrane also removes host-cell proteins, DNA, viruses, and endotoxins at salt conditions as high as 20 mS/cm.
The series of membranes includes six capsule sizes from 0.08 mL to 1.6 L. All of the membranes are suitable for flow-through polishing, and users can maintain a 4-mm bed height to scale up to larger devices. The membrane-adsorber capsules are plug-and-play devices that can be used like filters. Personnel can discard the materials after a single use, thus reducing validation costs.
Aeterna Zentaris and Hikma Pharmaceuticals have signed an exclusive commercialization and licensing agreement for the registration and marketing of perifosine, Aeterna Zentaris’ lead anticancer compound for the MENA (Middle East and North Africa) region. Perifosine, a novel oral Akt inhibitor, is currently in two Phase III programs for the treatment of colorectal cancer and multiple myeloma in the United States and Europe. Under the terms of the agreement, Aeterna Zentaris is entitled to receive an upfront payment and additional payments upon achieving certain pre-established milestones in the aggregate of $2 million. Furthermore, Aeterna Zentaris will be supplying perifosine to Hikma Pharmaceuticals on a cost–plus basis and is entitled to receive double-digit royalties on future net sales of perifosine in the MENA region. Hikma Pharmaceuticals will be responsible for the registration and commercialization of perifosine in the MENA territory.
Advertisement: Powerful Solutions for Any HPLC Environment
Utilizing the modular nature of its Prominence HPLC/UFLC and Nexera UHPLC systems, Shimadzu can build a system designed to address your specific application. From conventional, multidimensional and high temperature LC to preparative, ultrafast and high resolution, Shimadzu systems deliver superior data quality, speed, reproducibility, resolution, robustness, and versatility. Learn more.
Amgen has announced the issuance of US Patent No. 8,063,182 related to Enbrel (etanercept). This patent is owned by Roche and exclusively licensed to Amgen. Immunex Corporation (acquired by Amgen in 2002) originally licensed this patent application from Roche in 1999, and in 2004, Amgen paid Roche a one-time payment and obtained an exclusive, fully paid-up license to the application. The patent has a term of 17 years from Nov. 22, 2011.
Advertisement: Introducing Waters ACQUITY UPSFC System −The world's first UPLC-based system for SFC. This normal phase chromatographic solution uses CO2 as the main mobile phase−reducing solvent and increasing opportunities. Now you can run normal phase chiral and achiral applications with superior sensitivity, resolution, and speed. waters.com/upsfc.
Asahi Kasei Pharma has acquired all shares in Artisan Pharma, making it a wholly owned subsidiary. The company name has been changed to Asahi Kasei Pharma America, and the new subsidiary will serve as a base for the development of pharmaceuticals in the United States. Additionally, Asahi Kasei Pharma is constructing a new research complex in its pharmaceutical research center in Shizuoka, Japan, to advance research on new drugs, with operations scheduled to begin in fiscal 2013.
Advertisement:
Tune in to see the benefits of using a 12mm twin-screw extruder and a co-extrusion set-up in your pharmaceutical & medical device design research. ‘Hot Melt Extrusion from API to Medical Device Design’ webinar covers how to use pharmaceutical hot melt extrusion at the laboratory scale to make controlled release dosage forms. This informative webinar is proudly sponsored by C.W. Brabender® Instruments, Inc. Click Here
AstraZeneca has agreed to invest an additional $100 million to its venture-capital arm, MedImmune Ventures, increasing the total capital under management to $400 million. MedImmune Ventures is a venture-capital fund that focuses on equity investments in private companies in the areas of biopharmaceuticals and medical and healthcare technology.
Advertisement:
IMPORTFAB is a well-established contract manufacturer, specializing in the manufacturing and packaging of semi-solid and
liquid products. Our objective is to maintain our position as a reliable reference point in the manufacturing of quality pharmaceutical products: essentially, a benchmark for modern, efficient production, assured through the use of highly performing equipment. IMPORTFAB is cGMP compliant by the FDA and Health Canada. www.importfab.com
BioMarin Pharmaceutical announced that it has received FDA-approval for its proposed manufacturing facility expansion in Novato, California. The facility will support up to $1 billion in revenue for BioMarin’s growing enzyme replacement therapy portfolio, which is comprised of complex glycoprotein products produced by mammalian cells.
Advertisement:
At Solvay Chemicals, we manufacture BICAR® Sodium Bicarbonate and Soda Ash IPH to meet the exacting specifications of the US and EP Pharmacopeias and National Formulary. Produced according to cGMP, these are the products of choice for API or excipient applications requiring effervescent or desiccant properties. Solvay Chemicals, Inc. is part of the Solvay Group, the leading global producer of sodium bicarbonate and soda ash. www.solvaychemicals.us/marketsapplications/marketshidden/0,,40615-2-0,00.htm
The CRO GVK Biosciences (GVK BIO) has entered into a drug-discovery alliance with the Moulder Center for Drug Discovery Research at Temple University in Philadelphia. As part of the multiyear drug-discovery collaboration, GVK BIO will be responsible for the target validation, identification, and optimization of small molecules in selected therapeutic areas, including cardiovascular, metabolic, and central nervous system disorders.
Mylan received a Warning Letter from FDA for “significant violations” of GMP for finished pharmaceuticals at the company’s facility in Caguas, Puerto Rico. FDA cited the company for not having appropriate laboratory determination of satisfactory conformance to final specifications for every batch of drug product prior to release. Some specific violations were failure to complete a content uniformity test for a particular product and not providing sufficient scientific rationale for out-of-specification (OOS) results. FDA issued the letter on Oct. 13, 2011.
The specialty pharmaceutical company Par Pharmaceutical Companies has completed its acquisition of Anchen Pharmaceuticals, a privately held, specialty pharmaceutical company focused on developing and commercializing extended release and niche generic products. The $410-million purchase price was financed with cash on hand and a $350-million term loan.
Pfizer has agreed to acquire the biotechnology company Excaliard Pharmaceuticals. The acquisition is expected to close before the end of 2011. While specific financial terms are confidential, Pfizer will provide to Excaliard an upfront payment and contingent payments if certain milestones are achieved.
The Sanford Consortium for Regenerative Medicine opened a new collaborative research facility dedicated to stem-cell science on Nov. 29, 2011. The collaborative laboratory, named the “collaboratory,” will bring together leading biomedical research institutions to pursue collaborative research projects that advance the search for breakthrough cures. The collaboratory is located in La Jolla, California.
Shire, a biopharmaceutical company, has submitted regulatory filings with FDA and EMA for the production of VPRIV (velaglucerase alfa) in its Lexington, Massachusetts, manufacturing facility. Subject to regulatory approval, which is anticipated in early 2012, Shire expects the new plant to significantly increase manufacturing capacity and allow for increased global supply of VPRIV. These approvals will also make available further capacity for the manufacture of Replagal (agalsidase alfa) at Shire’s Alewife facility, which is located in Cambridge, Massachusetts, where both VPRIV and Replagal are currently manufactured.
Stevanto, a manufacturer of pharmaceutical packaging, is expanding its plant in Monterrey Mexico. The investment plan will initially open with the amount of EUR 4.5 million ($6 million), which is expected to double early in 2012, and will reach EUR 30 million ($40 million) by the time the plant has been completed. The facility is situated on a 40,000-m2 lot, 20,000 m2 of which will be covered upon completion of the project. It will employ 250 people and will be capable of supplying enough glass containers, ampoules, vials, and cartridges for pharmaceutical use to satisfy demand in North, Central, and South American markets.
Unilife, a developer and commercial supplier of advanced drug-delivery systems, has signed a clinical-development and supply agreement with an undisclosed pharmaceutical company for a device for targeted organ delivery. The proprietary Unilife device is intended to be used in a drug clinical trial that is scheduled to commence in early 2012. The terms of the agreement and the pharmaceutical company are to remain confidential at this time. Unilife will receive $1.4 million in development fees and revenue from initial unit sales of the devices for the clinical trial under the first phase of this program. Upcoming phases of the clinical development program are expected to generate additional revenues for Unilife over the coming year.
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to [email protected]
Coldstream Laboratories, a provider of drug-product research and manufacturing services, has named Vickie Hall as vice-president of manufacturing. She will assume responsibility of Coldstream’s manufacturing, facilities, and warehouse operations.
The CRO ICON has appointed Daniel Tang as general manager of the Asia-Pacific region for the company’s development solutions division. Tang will lead the development of ICON’s early phase activities across the region.
Par Pharmaceutical Companies has appointed Thomas J. Haughey to the role of president and Paul V. Campanelli to the role of chief operating officer, effective immediately. Both executives will continue to report to Patrick G. LePore, chairman of the board of directors and CEO.
MPI Research has appointed Roger N. Hayes as vice-president and general manager of laboratory sciences, effective Nov. 14, 2011.
The EMA brought together European and US expert representatives from regulatory authorities, academia, industry, and a health-technology-assessment agency on Nov. 18, 2011 to discuss the use and importance of subgroup analysis in the assessment of clinical trials. The workshop, the first of its kind, aimed to present the scope and content of a proposed guideline on the topic being prepared by the Committee for Medicinal Products for Human Use (CHMP) and garner feedback on standards and methodology.
The main conclusions drawn from the meeting about the design of trials were that as clinical trial populations are frequently heterogeneous, regulators must examine the risk–benefit balance for subsets of patients that fall outside of traditional demographics (e.g., gender, age, and ethnicity). Therefore, according to the press release, “plans to explore benefits and risks in biologically defined and potentially clinically relevant subgroups should be incorporated into every development program.” The group also agreed that early dialogue between industry and regulators about the most important subgroups to be accounted for was highly valuable and will guide assessment.
In other EMA news, registrations for the eSubmission Gateway pilot, which begins Jan. 9, 2012, are being invited. The three-month trial sees a new electronic submission channel being put into action for centralized marketing authorizations for human medicines, including new applications, supplementary information, variations, and renewals. The gateway will use a secure business-to-business transfer process, which should improve the speed and efficiency of the application process. A web-based submission client is also under development to handle low-transmission volumes that may be more suitable for small- and medium-sized companies; plans will be announced in the first quarter of 2012. Following successful completion of the pilot, which is open to a limited number of applicants, the EMA will consider extending the use of the Gateway to all applicants.
by: Angie Drakulich
Novartis AG and Novartis Pharmaceuticals Corporation have been focusing research efforts on rare diseases since the company was established in 1996.
Coming soon: Don't miss Pharm Tech's special coverage on Regulation and Analytical Testing in the upcoming December issue.
Generic-Drug User Fees
Do you support a generic-drug user fee for industry?
To ensure delivery to your Inbox, please add %%email.list%% to your address book. If you need help doing this,click here.
Advanstar Communications provides certain customer contact data (such as customers' names, addresses, phone numbers and e-mail addresses) to third parties who wish to promote relevant products, services and other opportunities which may be of interest to you. If you do not want Advanstar Communications to make your contact information available to third parties for marketing purposes, simply call (toll free) 1-866-529-2922 at any time, or fax us at 1-218-740-6417. Outside the U.S., please phone 1-218-740-6395. Contact us by mail at Advanstar Communications Inc., 131 West First St., Duluth, MN 55802-2065, USA.
Membrane binds contaminants at high conductivities
