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News from Europe's pharmaceutical manufacturing industry coupled with upcoming events, and exclusive articles and interviews from industry experts.
Mergers, acquisitions, and restructuring
Basel, (July 2)— Novartis completed the sale of its medical nutrition business to Nestlé for $2.5 billion, one of the company's final steps in a divestment program to focus its strategy on healthcare, with pharmaceuticals at the core. The final step of this process, the previously announced divestment of Gerber baby foods for $5.5 billion, is expected to be completed this year.
Albany, NY (July 2))— Albany Molecular Research, Inc. (AMRI) completed its previously announced acquisition of two pharmaceutical manufacturing sites, along with additional land for expansion, in Aurangabad and Navi Mumbai, India for approximately $11 million in cash. AMRI acquired from the Runwal Group (Mumbai, India) the assets of Ariane Orgachem Pvt. Ltd. in Aurangabad and Ferico Laboratories Ltd. in Navi Mumbai. The facilities currently manufacture pharmaceutical intermediates and bulk active ingredients. AMRI also obtained additional land in Aurangabad and plans to invest approximately $15 million to expand and upgrade manufacturing capabilities over the next three years. In addition to expansion and improvement of intermediates and active pharmaceutical ingredient manufacturing capabilities, investments will include upgrades to existing environmental and safety systems and procedures, and improvements to wastewater treatment facilities.
Los Angeles (July 2)— Abraxis BioScience, Inc. plans to separate its hospital-based product business, Abraxis Pharmaceutical Products (APP), from its proprietary products businesses, Abraxis Oncology and Abraxis Research, to form two public companies. Abraxis Pharmaceutical Products will become APP Inc., and Abraxis Oncology and Abraxis Research will become the new Abraxis BioScience.
"Strategic initiatives executed over the past few years, including the acquisition of global rights to Abraxane and the nab technology platform, the acquisition of the AstraZeneca anesthesia/analgesic portfolio, and the acquisition of the Pfizer manufacturing facility in Puerto Rico, have accelerated the growth of two robust businesses with more than 1900 employees and combined revenues that are expected to approach $1 billion by the end of 2007," outlined Patrick Soon-Shiong, chairman and CEO of Abraxis BioScience, in a company release.
Following the separation of the businesses, each current shareholder will own one share of Abraxis Pharmaceutical Products, Inc., and one share of the new Abraxis BioScience, for each share previously held. The transaction is expected to be completed in the fourth quarter of 2007, subject to customary closing conditions, obtaining of a private-letter ruling from the Internal Revenue Service (Washington, DC) that that the separation will be tax-free to Abraxis BioScience and its shareholders, and other regulatory approvals.
Abraxis has received commitments for $1.45 billion of senior credit facilities comprised of a funded $1.3-billion term loan and an unfunded $150 million revolving credit facility. A portion of the proceeds raised through the debt financing will be used to repay the current company's existing debted and approximately $1.0 billion will be transferred to the new Abraxis BioScience immediately prior to the separation. Detailed information about the separation of the businesses will be provided when the company files a Form 10 registration statement for the new Abraxis BioScience, which is expected to be filed in the third quarter of 2007.
Following the separation, APP will be one of the largest stand-alone publicly traded companies focused on injectable pharmaceuticals, according to the company, and will have approximately 1400 employees. APP expects to generate revenue growth in 2007 in the mid-teens over 2006 revenue of $583 million. The headquarters of APP will remain in Schaumburg, Illinois.
Soon-Shiong will remain as chairman and will serve as CEO of APP. Thomas H. Silberg will continue to lead APP as president. Frank Harmon will remain as executive vice-president and chief operating officer of APP. Key executive officer positions, as well as the board of directors, will be named prior to, or at the time of, the close of the transaction.
In 2006, APP had 10 abbreviated new drug application (ANDA) approvals. From 2001 to 2006, APP had 55 ANDA approvals. It has 29 ANDAs pending with US Food and Drug and Administration (Rockville, MD) and more than 60 product candidates in various stages of development, according to the company.
The key technology platform of the new Abraxis Bioscience is its "nab" (nanoparticle-albumin bound) technology platform. The technology is commercialized in a nab-based form of the anticancer therapy paclitaxel.
Abraxis Bioscience is developing other nab-based products, which include nab-docetaxel (ABI-008), mTOR inhibitor nab-rapamycin (ABI-009), and the HSP90 inhibitor nab-17AAG (ABI-010). The investigational new drug application (IND) for ABI-009 is the third investigational product based on the company's nab technololgy. Abraxis anticipates filing two additional IND submissions over the next 12 to 18 months for ABI-010 and nab-thiocolchicine dimer (ABI-011).
Soon-Shiong, who will remain chairman and CEO of the new Abraxis BioScience, envisions that the new company will be positioned in personalized medicine. "The era of personalized medicine has arrived, and with the financial and scientific resources created as a result of this transaction, the new Abraxis BioScience will be uniquely positioned to forge new paradigms of drug discovery and personalized drug development," he said in a company release.
The new Abraxis BioScience, as a stand-alone publicly traded company, will have its headquarters in Los Angeles, California and employ more than 500 people. The executive committee of Abraxis BioScience will remain in their current positions. The new board of directors for this business will be determined prior to, or at the close of, the transaction.
Milton Keyes, UK (June 27)— Bespak plc will begin a consultation process with employees involved inthe production of an inhaler for "Exubera," the inhaled insulin product of Nektar Therapeutics (San Carlos, CA) and Pfizer, Inc. (New York). Based on a slow take-up for the product, Bespak expects lower production for the Exubera inhaler and redundancies among the 160 employees at Bespak's production facility in Milton Keynes. The costs of the staff reductions are recoverable by Bespak under the terms of its contract with Nektar Therapeutics. During the consultation process, Bespak will remain in detailed discussions with Nektar on potential strategies to address the short to medium-term supply issues.
Hafnarfjordur, Iceland (June 22)—The board of the generic-drug manufacturer Actavis recommended that Actavis's shareholders accept a revised offer for the company from Novator (London), an investment firm led by Bjorgolfur Thor Bjorgolfsson, chairman of Actavis.Under the terms of Novator's revised offer, Actavis shareholders would receive EUR 1.075 per share. This represents a premium of 19.6% over Actavis's share price on May 9, 2007, the day immediately prior to Novator's announcement of its initial offer, which was subsequently published on June 1, 2007. The revised offer represents an additional 10.6% increase above the initial offer of EUR 0.98 per share. The revised offer also contains a clause by which existing Actavis shareholders are entitled to receive an additional payment in the event that Novator sells 10% or more of its common equity interest in Actavis within 12 months of the revised offer closing.
Basel, Switzerland (June 25)—Roche made a tender offer to acquire Ventana Medical Systems Inc. (Tucson, AZ) for $75 dollars per share in cash, or roughly $3 billion. Ventana specializes in histopathology (tissue-based diagnostics). Roche says its entry into tissue-based diagnostics is an important step in its strategy of delivering personalized healthcare solutions.
Roche made multiple efforts to engage in discussions with Ventana's chairman and board concerning a negotiated transaction, but Ventana declined. Roche decided to commence a tender and remains willing to discuss a negotiated transaction agreed to by both parties, as this route continues to be Roche's preferred option.
Roche will operate Ventana as a dedicated business within the Roche Diagnostics Division, and will retain Ventana's headquarters in Tucson, Arizona. On July 11, Ventana Medical Systems' board of directors recommended to the company's shareholders not to accept Roche's offer.
Los Angeles, CA (June 20)— Auriga Laboratories, Inc. formed a new division, Advanced Topical Solutions (ATS Pharmaceuticals). ATS will focus on gastroenterology and dermatology.
Somerset, NJ (June 21)— Catalent Pharma Solutions, formerly Cardinal Health Pharmaceutical Technologies and Services, was officially launched as an independent company. Catalent was acquired by The Blackstone Group in April 2007. The company provides technology, development, manufacturing, and packaging solutions for pharmaceutical, biotechnology, and consumer healthcare companies.
Houston, TX (June 25)—Encysive Pharmaceuticals Inc. is restructuring to refocus its resources. The company will reduce its US workforce by approximately 70% and eliminate the position of chief operating officer.
Paris (June 18)— Groupe SNPE Inc. sold its American subsidiary Isochem, Inc. (Lockport, NY) to Buckingham Capital Partners II, LP. Isochem manufactures phosogene derivatives used as intermediates for the fine chemicals market. The company will be renamed VanDeMark Chemical Inc.
Branford, CT (June 19)—Curagen Corp. is closing its pilot manufacturing plant and reducing its workforce by approximately 40 employees. The closure was partially attributed to the company's decreased emphasis on internal manufacturing capabilities. The facility was used for pilot-scale production of proteins and antibodies.
Agawam, MA (June 19)— Microtest Laboratories Inc. and Texcel Medical (East Longmeadow, MA) formed a strategic alliance to help pharmaceutical manufacturers and biotechnology companies bring combination products to market. The alliance brings together Microtest's testing facilities and regulatory experience and Texcel's manufacturing infrastructure and engineering expertise.
Greenwich, CT (June 18)— Aptuit,Inc. and Laurus Labs Limited (Hyderabad, India) are forming a new contract drug-development company to be called Aptuit Laurus Inc.. The new company will be based in Hyderabad and provide integrated services, technologies, and manufacturing capabilities for the entire drug-development process. Aptuit Laurus will comprise a 160,000-ft2 research and development facility in Hyderabad, a large-scale manufacturing plant that is currently under construction in Vishakhapatnam, and Aptuit's existing informatics development and support group in Bangalore. Aptuit will invest approximately $100 million during the next four years to build on Aptuit Laurus's development, manufacturing, and informatics capabilities.
Boca Raton, FL (June 18)– Nabi Biopharmaceuticals plans to eliminate 32 jobs, approximately 5% of its workforce, as it forms Nabi Biologics and Corporate Shared Services groups. In addition, the company is engaging in discussions for the sale of all or a significant part of the company.
Heerlen, Netherlands (June 15)— DSM is restructuring its anti-infectives business in an effort to make it more profitable. DSM plans to make the DSM Anti-Infectives business group a separate entity. In addition, DSM is partnering with North China Pharmaceutical Corporation Ltd. (Hebei Province, China) to create a joint venture for the production and marketing of anti-infectives in China. The restructuring is expected to result in the loss of around 100 jobs in 2007 and 2008.
St. Louis, MO (June 14)— KV Pharmaceutical Company acquired all the technologies, assets, and related intellectual property of Particle and Coating Technologies Inc.(PCT, St. Louis). KV hopes the acquisition will augment the development of its advanced drug-delivery product pipeline. PCT uses proprietary processes to develop products for the pharmaceutical industry that include novel particle coatings, controlled release, inhalable particle delivery, and fast-dissolving tablets.