Company and People Notes: MannKind to Purchase Pfizer Facility; Catalent Appoints President and CEO; More...

March 12, 2009
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, Penn Pharma to expand; stem cell research funding ban lifted; Bristol-Myers Squibb made senior appointments; more...

Company Notes

Acsis (Marlton, NJ), a provider of solutions for supply-chain security, announced the availability of the Acsis Optimization Platform, a package of solutions geared toward optimizing supply-chain initiatives by reducing costs and labor requirements through improved supply-chain execution, visibility, and control. Acsis launched its Shipment Execution Optimization Solution (SEOS), a shipment execution and verification module that enables the efficient and accurate processing of deliveries, which is available on the Acsis Optimization Platform.

American Pacific (Las Vegas, NV) announced that its wholly owned subsidiary, AMPAC Fine Chemicals (AFC, Sacramento, CA), inaugurated a new kilogram-scale, CGMP, batch/continuous processing development facility. The new facility can accommodate either batch reactors (20 to 50 L) or AFC's continuous zone reactor technology using up to seven reactors of 0.25–1 L.

Bristol-Myers Squibb (BMS, Princeton, NJ) formed a pact with Nissan Chemical Industries (Tokyo) and Teijin Pharma (Tokyo) for the development and commercialization of NTC-801, a selective inhibitor of the acetylcholine-activated potassium ion channel (IKACh). The compound is currently in Phase I development in Japan for the maintenance of normal sinus rhythm in patients with atrial fibrillation. Under the terms of the agreement, Nissan Chemical and Teijin Pharma will grant to BMS exclusive rights for the development and commercialization of NTC-801, and certain backup compounds, worldwide, excluding Japan. BMS will provide an upfront cash payment of $40 million, development milestone payments of up to $170 million, sales milestone payments of up to $175 million, and royalties on net sales for licensed products.

Lonza (Basel, Switzerland) and the drug-development company Opsona (Dublin, Ireland) entered into an agreement for the production of the monoclonal antibody OPN-305 developed by Opsona. Under the agreement, Lonza will provide process development and manufacturing services, following current good manufacturing practices, for preclinical and Phase I studies using Lonza’s GS Gene Expression System. Financial details of the agreement were not disclosed.

MannKind (Valencia, CA) entered into an agreement with Pfizer (New York) to purchase Pfizer's insulin facility at Industriepark Hoechst in Frankfurt, Germany, and assets related to the production of bulk insulin, including the property rights, production equipment, a quantity of bulk insulin, and a license to manufacture bulk insulin for use in pulmonary delivery. The aggregate purchase price is $33 million, subject to certain adjustments. At MannKind's option, up to $30 million worth of the company's common stock may be issued to Pfizer at closing and applied toward the full purchase price. MannKind intends to retain more than half of the current workforce, subject to consultation with the works council and employee codetermination rights.

On Mar. 6, 2009, Roche (Basel, Switzerland) increased its offer price for all the outstanding publicly held shares of Genentech (South San Francisco, CA) to $93 per share and extended the offer to March 20, 2009. All other terms and conditions of the tender offer remain unchanged. Genentech issued a press release on Mar. 6 urging shareholders to take no action until the board of directors takes an official position on the offer. Roche’s previous offers to acquire the company were rejected by Genentech, including its most recent offer of $86.50 per share on Feb. 9, 2009.

Penn Pharma (Tredegar, South Wales) will launch a major expansion program over the next five years to extend its current facilities at Tafarnaubach Industrial Estate, Tredegar, South Wales. The £12.2 million ($16.9 million) expansion will extend the company’s manufacturing, storage, and development capacity. The company expects the expansion will create 133 jobs.

Vertex Pharmaceuticals (Cambridge, MA), a biotechnology company developing the hepatitis C virus (HCV) protease inhibitor telaprevir, will add two polymerase inhibitors to its HCV drug-development portfolio through a definitive agreement to acquire privately held ViroChem Pharma (Laval, Canada) in a stock-and-cash transaction. ViroChem shareholders are to receive $100 million in cash and 9.9 million shares of Vertex common stock. The transaction is subject to customary preclosing conditions.

Regulatory Roundup

President Obama signed an executive order on Mar. 9, 2009 that reversed embryonic stem cell research funding restrictions put in place by President George W. Bush. The Bush administration’s legislation prevented federal funding for research on human embryonic stem cell lines created after Aug. 9, 2001. Obama said he would "vigorously support" new research.

The US Food and Drug Administration is asking for public comments on proposed information collection through a survey designed to identify potential data sources and/or data environments that could participate in the Sentinel Initiative. The initiative is meant to create a national electronic distributed system, strengthening FDA's ability to monitor the postmarket performance of a medical product. This survey will collect information on the scope, content, structure, quality, and timeliness of data; patient population(s), duration of follow up, and capture of care across all settings; availability, experience, and interest of investigators with knowledge of the data in using it for post-market product safety surveillance as well as plans for further data source enhancements; availability, experience, and interest of investigators with knowledge of the data in participating in a distributed data system; and barriers that exist to including each data source in the Sentinel Initiative.

The US Food and Drug Administration announced a new collaboration with the Houston-based Alliance for NanoHealth (ANH) and its eight member institutions to help speed development of safe and effective medical products in the emerging field of nanotechnology. Under a Memorandum of Understanding, the FDA/ANH Nanotechnology Initiative will work to expand knowledge of how nanoparticles behave and affect biologic systems, and to facilitate the development of tests and processes that might mitigate the risks associated with nanoengineered products. All outcomes from this public-private partnership will be placed in the public domain.

People Notes

ANI Pharmaceuticals (Woodlawn, MD), private specialty generic pharmaceutical company, appointed Arthur S. Przybyl chief executive officer and a member of the company’s board of directors. Most recently, Przybyl was the president and CEO of Akorn (Lake Forest, IL). Przybyl is replacing Tom Anderson, ANI's founding CEO, who is leaving to pursue other opportunities. Anderson will remain on ANI's board of directors.

BioStorage Technologies (Indianapolis, IN), a provider of storage of biomaterials, sample management, and cold chain logistics, promoted Lori Ball to the newly created role of senior vice-president. Ball joined BioStorage in 2007 as vice-president of global sales and marketing. In her new role, Ball will oversee operations, logistics, sample handling and processing, information technology, and new service rollouts.

Bristol-Myers Squibb (New York) recently made senior appointments. Lamberto Andreotti, Elliott Sigal, and Jean-Marc Huet will join James M. Cornelius, chairman and chief executive officer, on the company’s newly formed Executive Committee, which will be the company’s senior strategy and decision-making body. The company also announced that Anthony Hooper was named president, Americas; Beatrice Cazala was named president, global commercialization, and president, Europe; John Celentano was named president, emerging markets and Asia-Pacific; Carlo De Notaristefani was named president, technical operations and global support functions; and Giovanni Caforio was named senior vice president, global and US oncology.

Catalent Pharma Solutions (Somerset, NJ), a provider of development, manufacturing, and packaging services, appointed John Chiminski as president, CEO, and a member of the board of directors, effective Mar. 17, 2009. George Fotiades, who has been serving as interim president and CEO, will step down from the role effective the same date and will continue to serve as chairman of Catalent’s board of directors.

CG Therapeutics (CGT, Seattle, WA), a biotechnology company, appointed Denise Harrison CEO and president. Harrison, who previously held the position of chief financial officer, takes over for Jonathan Green, CGT’s first CEO, in an effort to move the company forward in new directions.

The specialty pharmaceutical company ULURU (Addison, TX) announced the resignation of Kerry P. Gray as CEO of the company effective immediately. Gray will continue to serve as a director of the company. Renaat Van den Hooff was appointed by the board of directors to assume the position of president and CEO. Van de Hooff was previously the company's executive vice-president of operations.