Outsourcing Articles

Greenwich, CT-based Aptuit, Inc. has cemented its presence in Europe with the acquisition of the Chemical and Pharmaceutical Development (CPD) business of Evotec AG, which is comprised of an active pharmaceutical ingredient (API) facility in Oxford, England, and an established, recently-expanded parenteral fill/finish facility in Glasgow, Scotland. The venture, which gives Aptuit access to more than 80 clients, is projected to generate revenue upwards of $40 million this year alone.

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Contract research organizations (CROs) are playing increasingly vital roles on behalf of manufacturers in the global drug development process, conducting Phase I safety testing all the way to Phase IV postmarket studies (see Figure 1). Traditionally, CROs focused on providing additional capacity and expertise to facilitate drug development and reduce R&D costs, while maintaining quality standards. More recently, they have begun highlighting their capacity to support drug safety efforts for products on the market and compounds in the pipeline.

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According to the FDA's Critical Path initiative, biomarkers offer a key opportunity to improve the development process by increasing safety and establishing efficacy. The Critical Path Initiative is the FDA's effort to stimulate and facilitate a national effort to modernize the scientific process through which a potential human drug, biological product, or medical device is transformed from a discovery, or "proof of concept," into a medical process. Some predict that within the next 10 years, biomarkers will be a standard aspect of drug development for any new candidate.

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Today's biopharmaceutical pipeline promises treatments that were unimaginable just a few years ago. As biotechnology grows in importance, the science and engineering of primary packaging for injectable biopharmaceuticals has taken on new prominence. For reasons of safety, packaging design, integrity, and materials are therefore reviewed by the FDA as stringently as the products themselves. We shall discuss the science, engineering, and regulation of primary packaging for injectable biotech drugs by exploring the issues that can make or break a product's regulatory submission. This information is presented in light of FDA's June, 1999 Container Closure Guidance.

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Quality tops the list of pharma's expectations from an analytical testing provider, according to industry insiders. Whether it's method validation, microbiological testing, tech transfer or method development, analytical labs -- estimates indicate about 100 in the U.S. -- are enlisting top-tier scientists and sophisticated equipment to address industry needs, from virtual organizations to Big Pharma.

"Quality results are what pharma wants; rarely do we hear complaints about cost," said Michael Crowley, Ph.D., M.S., B.S., vice president business development for PharmaForm, a full-service analytical support CRO.

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OSG Norwich Pharmaceuticals, a pharmaceutical outsourcing manufacturing and packaging provider, was recently purchased by AFI Partners, a private equity group based in New York, NY. The new company is known as Norwich Pharmaceuticals, Inc.

The terms of the deal were not disclosed. According to Christopher R. Calhoun, president of Norwich Pharmaceuticals, operations at OSG's Norwich, NY, facility will continue uninterrupted. The current leadership team will remain in place and will continue to manage the business. All current employees will also remain with the new company.

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Merck & Co., of Whitehouse Station, NJ, recently announced that it will acquire San Diego, CA-based NovaCardia, Inc., a privately held clinical-stage pharmaceutical company focused on cardiovascular diseases, for $350 million. The acquisition gives Merck access to NovaCardia's adenosine A1 receptor antagonist, KW-3902, an Phase III compound for use in patients with acute congestive heart failure (CHF).

According to Merck's Richard Kender, vice president of business development and corporate licensing, the acquisition furthers the company's aspiration to deliver on its strategy of targeted acquisitions in areas of "unmet medical need in the therapeutic areas of strategic importance for Merck," one of which is cardiovascular diseases.

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Boston, MA-based Parexel International Corp. has opened a new office in Hyderabad, India, to manage aspects of its clinical research and data management. The office is located in the country's sixth largest metropolis and is a burgeoning biotechnology hub. The new office comes on the heels of last year's joint venture arrangement with Synchron, an India-based clinical research organization, that formed Parexel International Synchron Private Limited, which provided Paraxel with the opportunity to offer a range of Phase II-IV clinical research services.

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It is curious to see the rather silent drug discovery scene in India turn increasingly noisier by the day. Traditionally a hotbed of intense generic activity, the Indian drug industry hardly figured in the global atlas of the so-called innovators. Even then, quite a few companies -- both big and small -- are putting the R&D arena on fire through some big-ticket deals.

Most of these collaborations are long-term pacts with discovery-led drug behemoths. The deal signed between Eli Lilly Suven Life Sciences on G-protein coupled receptors for CNS disorders is a striking example. A small-time player based in southern India, Suven got European patent (EPO) for a class of selective 5-HT compounds useful in treating neuro-degenerative disorders. Suven will receive milestones as well as downstream payments from Lilly if the identified candidates are selected for further development. GPCR based drugs constitute some of the top-selling medicines today.

Warts and all, Amgen remains at the apex of the Top 10 Biopharma rankings. The first half of 2007 was none too kind to the top gun, but Amgen still has a comfortable lead over its competitors on this list.
Speaking of which, there are a pair of new entries at #3 and #4! After putting Novo Nordisk on the Top 20 Pharma list last year, I decided that it would be more suited to the Top Biopharma ranks, especially since it announced that it was closing down all small molecule R&D. And UCB Group made its way onto our list after last year's edition came out and members of the company called to explain (patiently) why UCB should truly be considered a Biopharma (a lot of companies misuse the term, in my opinion). Their argument made enough sense for me to add them to this year's ranks.

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