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March 4, 2010 PharmTech.com

News

Merck KGaA Agrees to Buy Millipore for $7.2 Billion
Merck KGaA agreed to acquire Millipore for EUR 5.3 billion ($7.2 billion). Click Here to Read More

FDA and NIH Collaborate to Speed the Introduction of New Medicines
The US Food and Drug Administration and the National Institutes of Health unveiled plans for a Joint Leadership Council to address important public-health issues, including accelerating the availability of new medical therapies to patients.
Click Here to Read More

Big Pharma Faces Major Slowdown
Top pharmaceutical and biotech companies should expect a major slowdown in sales growth between 2008 and 2014, according to Datamonitor.
Click Here to Read More

FDA and EMA Allow Single Annual Report for Orphan Drugs
FDA and EMA are implementing a streamlined process to help regulators better identify and share information regarding orphan-drug and biologic products.
Click Here to Read More



Product Spotlight

Product image hspace=Instrument requires small sample volumes
Malvern’s (Malvern, England) Zetasizer µV uses dynamic and static light-scattering techniques to characterize proteins. The instrument is designed to provide high sensitivity and yield rapid, accurate, and repeatable protein-size and molecular-weight data. The Zetasizer µV requires samples of only 2 µL, and a sample can be recovered fully after the measurement. Because of the small sample size required and the unit’s high sensitivity, the instrument can analyze small quantities of protein. For example, the Zetasizer µV can measure 40 ng of bovine serum albumin.

The unit’s software is designed for ease of use and allows scientists to export data in various formats. Operators also can set up reports and establish standard operating procedures to ensure that measurement procedures are consistent. The instrument also includes a programmable temperature control that enables automated measurements as a function of time at a fixed temperature, as well as temperature-trend measurements.


Company Notes
Astellas Pharma (Tokyo) issued an unsolicited offer of $3.5 billion for outstanding shares of biopharmaceutical company OSI Pharmaceuticals (Melville, NY). OSI acknowledged receipt of the offer and advised stockholders to take no action at this time.

AstraZeneca (London) informed Merck & Co. (Whitehouse Station, NJ) it would obtain Merck's interest in AstraZeneca's non-proton, pump-inhibitor products. Merck will receive a payment of $647 million from AstraZeneca.

Biopharmaceutical company ARYx Therapeutics (Fremont, CA) retained Cowen and Company to explore strategic options. ARYx will explore the possibility of capturing full near-term value for its three lead programs rather than pursuing other licensing deals.

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Global healthcare company Baxter International (Deerfield, IL) will acquire the outstanding equity of ApaTech (London), an orthobiologic products company, for up to $330 million. The transaction is expected to close in the first quarter of 2010.

Cephalon (Frazer, PA) acquired Ception Therapeutics (Malvern, PA) following release of positive data from a clinical study in adults with eosinophilic asthma. Ception's lead compound, CINQUIL (reslizumab), in 106 patients demonstrated improved asthma control in adult patients with moderate to severe asthma and eosinophilic airway inflammation.

Eli Lilly (Indianapolis, IN) and Covance (Princeton, NJ), a contract research organization, expanded their research and development collaboration. Covance will now also test Lilly’s developmental biologics.

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GlaxoSmithKline (London) responded to the US Senate Committee on Finance report on the company's antidiabetes drug Avandia (rosiglitazone), saying it failed to present an accurate, balanced, or complete view of the currently available information on Avandia. In a press release, GSK denied allegations in the report that it concealed safety information or otherwise acted inappropriately; In other news, the US Food and Drug Administration and GSK announced joint efforts to investigate the theft of products that were stolen during transport from the distributor to wholesalers in Puerto Rico on January 29, 2010.

Merck & Co. (Whitehouse Station,NJ) announced that its new pipeline, following the recent merger with Schering-Plough (Kenilworth, NJ), includes more than 20 candidates in Phase III or under regulatory review, and more than 20 candidates in Phase II development.

NanoGuardian (Skokie, IL) and Capsugel (Morris Plains, NJ) agreed to collaborate to fight counterfeiting and illegal diversion. Capsugel will use NanoGuardian’s overt, covert, and forensic-security features directly on capsules, tablets, vial caps, and single-use syringes.

PPD (Wilmington, NC) opened its contract research facility in Athlone, Ireland. The new facility includes an 18,000-square-foot, analytical-testing laboratory and clinical-supplies business.

The contract development and manufacturing company Ricerca Biosciences (Concord, OH) has agreed to acquire the discovery and preclinical business MDS Pharma Services, which has facilities in Bothell, Washington; Lyon, France; and Taipei, Taiwan. Ricerca’s headquarters will remain in Concord, Ohio. The transaction is expected to close within the next two months.

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Regulus Therapeutics (Carlsbad, CA) agreed to collaborate with GlaxoSmithKline (London) to develop and commercialize microRNA therapeutics targeting microRNA-122 in all fields with hepatitis C as the lead indication. Regulus will receive upfront and early-stage milestone payments with the potential to earn more than $150 million in miR-122-related combined payments.

Watson Pharmaceuticals (Morristown, NJ) agreed to divest its equity ownership of approximately 31% in the contract research and development company ScinoPharm (Taiwan). Watson, which expects the transaction to close during the first half of 2010, plans to use proceeds from the sale for general business purposes and future strategic business-development initiatives.

Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com


People Notes

Pfizer (New York) announced the retirement of William Ringo, senior vice-president of worldwide business development, strategy and innovation. Ringo’s retirement will be effective Apr. 30, 2010. Ringo will be succeeded by Kristin Peck, senior vice-president of worldwide strategy and innovation.

Cytovance Biologics (Oklahoma City, OK) named Molly S. McGlaughlin vice-president of sales and business development, international, and William Dull as vice-president of sales and business development, North America.

Cook Pharmica (Bloomington, IN) named Veda Walcott vice-president of quality and corporate compliance officer. Walcott will be responsible for leading Cook Pharmica’s quality and compliance programs and will oversee regulatory and validation-support activities.

Genzyme (Cambridge, MA) received notice from Icahn Partners and certain affiliates of their intention to nominate Carl C. Icahn, Steven Burakoff, Alexander J. Denner, and Richard Mulligan to Genzyme’s board of directors. In a press release, Genzyme said it would evaluate the nominees and make a recommendation to its shareholders.

PharmTech Talk blog
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Pfizer Outlines Postacquisition Manufacturing Strategy

Following its $68-billion acquisition of Wyeth (Madison, NJ), Pfizer (New York) is integrating its manufacturing and outsourcing activities. In a joint podcast with its sister publication BioPharm International, Pharmaceutical Technology discusses Pfizer's plans for manufacturing integration with Tony Maddaluna, senior vice-president of strategy and supply-network transformation at Pfizer Global Manufacturing. Click Here to Read More

Coming Soon: James Agalloco and James Akers address the myth called "sterility" in PharmTech's March supplement on sterile manufacturing and bioprocessing.

The Opportunities, Challenges, and Trends in Biomanufacturing
By Patricia Van Arnum
Nigel Darby, vice-president of biotechnologies at GE Healthcare Life Sciences and speaker at the Drug, Chemical, and Associated Technologies Association (DCAT) upcoming educational program on biologics, offers insight into the current and future state of upstream and downstream processing of biologics. Click Here to Read More


 

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