FDA: Most Firms Meeting Postmarketing Study Timelines
More than 80% of pharmaceutical and biologics companies are completing their postmarketing studies and regulatory obligations in a timely manner.

Dainippon Sumitomo Pharma to Acquire Sepracor
In a move designed to increase its position in North America, Dainippon Sumitomo Pharma agreed to acquire the specialty pharmaceutical company Sepracor for $2.6 billion.

FDA Seeks Data for Sentinel Initiative
The US Food and Drug Administration plans to begin collecting information for its Sentinel Initiative, according to a Sept. 4 Federal Register announcement.

EC Backs Nanotechnology with EUR 1 Billion
The European Commission has made EUR 1 billion available for new projects involving micro and nanotechnology.

Controlled-Release Formulations a Popular Strategy for Generic-Drug Companies
Generic-drug companies are increasingly viewing the development of controlled-release formulations as a way of obtaining a competitive edge, according to a report published by Espicom Business Intelligence in late August 2009.

Cell Biosciences (Santa Clara, CA), a company focused on protein and biomarker research, agreed to acquire Alpha Innotech (San Leandro, CA), a developer of digital imaging and detection systems, for $1.50 per share, or approximately $17.9 million in cash. The combination of the two companies would create a global protein analysis business.

Covidien (Dublin, Ireland), a provider of healthcare products, formed agreements to sell its Sleep Diagnostics and Oxygen Therapy product lines and has proposed to sell its sleep therapy product line. Embla (Broomfield, CO) agreed to acquire Covidien’s sleep diagnostics products, including design/development, sales administration, technical service, and shipping facilities in Ottawa, Canada, as well as global sales and service functions. This includes several products sold under the Sandman brand. Financial terms were not disclosed. Separately, Chart Industries (Garfield Heights, OH) will acquire Covidien’s oxygen therapy products, including the design, manufacturing, sales, and service functions worldwide. This includes products sold under the Companion and Helios brands. Financial terms were not disclosed. Completion of the two product-line sale transactions is subject to customary closing conditions, with closing expected by the end of 2009. The company intends to sell its sleep therapy product line. This includes several products sold under the Sandman, DreamFit, GoodKnight and Breeze brands.

Facet Biotech (Redwood City, CA) rejected Biogen Idec's (Cambridge, MA) unsolicited proposal of $14.50 per share for Facet’s outstanding shares, calling the offer “inadequate and not in the best interests of Facet Biotech's stockholders,” according to a company press release. Facet confirmed it received a letter outlining Biogen’s offer on Sept. 4, 2009.

LEO Pharma (Ballerup, Denmark), a pharmaceutical company focused on dermatology, will acquire all outstanding securities of the specialty pharmaceutical company Peplin (Brisbane, Australia) for approximately $287.5 million in cash, or $16.99 per common share of Peplin stock. The boards of directors of both companies unanimously approved the transaction.

MDS (Toronto), a provider of products and services to the global life sciences markets, agreed to sell its MDS Analytical Technologies business to Danaher (Washington, DC) for $650 million in cash, and that it currently intends to return approximately $400 million to $450 million of the sale proceeds to its shareholders. The completion of the sale is subject to shareholder and regulatory approval. MDS also intends to sell its MDS Pharma Services business, a provider of innovative drug discovery and early-stage development solutions. Upon completion of these transactions, the company would focus solely on its MDS Nordion business, a provider of medical isotopes for molecular and diagnostic imaging, radiotherapeutics and sterilization technologies.

The European Medicines Agency (EMEA) has issued a reminder that the electronic Common Technical Document (e-CTD) format will be mandatory for marketing authorization applications for medicinal products for human use from Jan. 1, 2010. The mandate is part of EMEA's phased introduction of e-CTDs into the centralized procedure. The agency first began accepting electronic-only submissions, with no additional requirements for paper copies, in July 2008, and on Jan. 1, 2009, EMEA strongly recommended that all submissions be electronic.

Akela Pharma (Austin, TX), and its subsidiary, PharmaForm, appointed Greg McKee as its CEO and Robert Rieder as its chairman. McKee will remain a member of Akela's board of directors. Before joining Akela, he served as president and CEO of Nventa Biopharmaceuticals, which merged with Akela in May of 2009.

Celldex Therapeutics (Needham, MA), a biopharmaceutical company, appointed Larry Ellberger as its chairman of the board of directors. Ellberger has been an independent member of the Celldex board since the merger in March 2008 between Celldex and AVANT Immunotherapeutics, and has been a member of the AVANT board since 2003.

Enzo Biochem (New York) appointed Mohan Chellani vice-president of scientific affairs at its Enzo Clinical Labs subsidiary. Chellani will oversee aspects of the company’s molecular diagnostic’s strategy and implementation.

GENova Biotherapeutics (New York), a biotechnology company, named John Savin as its vice-president. Savin will work with CEO Aaron Whiteman to direct GENova's growth in its business of identifying and acquiring potential drug targets and then subsequently outsourcing them to partners who can successfully usher them through clinical trials and then bring them to market. 

The specialty pharmaceutical company company KV Pharmaceutical (St. Louis, MO) named Thomas McHugh, the company's vice president of finance and corporate controller, as its interim chief financial officer. McHugh replaced former CFO Ronald J. Kanterman on Sept. 2, 2009. Kanterman continues to serve as a member of the KV Pharmaceutical board. The company has formed a committee to search for a CFO.

Lannett (Philadelphia, PA), a manufacturer of generic pharmaceuticals, appointed Stephen J. Kovary vice-president of operations, reporting to Arthur Bedrosian, president and chief executive officer. Kovary succeeds Bernard Sandiford, who retired.

Roche (Basel) announced its new corporate executive committee and management changes that will take effect on Jan. 1, 2010. Among some of the changes are: William M. Burns, CEO of the pharma division, Juergen Schwiezer, CEO of the diagnostics division, and Jonathan Knowles, head of group research, will resign from the corporate executive committee; Ian Clark will be CEO of Genentech; Pascal Soriot, currently Genentech’s CEO, will be chief operating officer (COO) of the pharma division; Daniel O’Day, currently head of Roche Molecular Diagnostic, will be COO of the diagnostics division. For the full details of the corporate executive committee, see the press release.