ΚΑΤΑΣΤΑΣΗ ΤΩΝ ΜΕΓΑΛΥΤΕΡΩΝ GENERIC ΦΑΡΜΑΚΕΥΤΙΚΩΝ ΕΤΑΙΡΕΙΩΝ ΣΤΙΣ ΗΠΑ A/A COMPANY NAME, ADDRESS, PHONE, FAX 1. Baxter International Inc. 1 Baxter Pkwy. Deerfield, IL 60015-4625 United States 2009 SALES (MIL. $) 12,562 EMPLOYEES OVERVIEW CONTACT 49,700 Why choose between making drugs and making medical equipment? Baxter International does it all. The company makes a wide variety of medical products across its three divisions, including drugs and vaccines, dialysis equipment, and IV supplies. Its BioScience segment makes protein and plasma therapies to treat hemophilia and immune disorders, as well as vaccines and biological sealants used to close surgical wounds. Baxter is a leading maker of intravenous (IV) supplies and systems via its Medication Delivery segment; the segment also makes infusion pumps and inhaled anesthetics. Baxter's Renal division makes dialyzers and other products for the treatment of end-stage renal disease (ESRD). Ludwig Hantson Phone: 847-948-2000 Fax: 847-948-2016 www.baxter.com Corporate VP and President, International Baxter has sold off some underperforming units, including the majority of the services portion of its Renal division. It also spun off its Transfusion Therapies business, which made blood-collection and storage products, into a new company called Fenwal in 2007. Fenwal, which still accounts for some of Baxter's annual income, is owned by investment firm Texas Pacific Group. The company's BioScience segment accounts for roughly 45% of sales, most of which comes from the sale of recombinant 1 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 proteins and plasma products used to treat hemophilia and immune disorders. Recombinant proteins are useful because they are derived from DNA that is manufactured in the laboratory (meaning greater access to supply). Recombinant DNA does not exist naturally, but is created by combining DNA sequences that would not normally occur together. Among Baxter's BioScience products are hemophilia therapy Advate and Aralast NP, a plasma-derived drug for hereditary emphysema. The company increases sales of Advate and Aralast NP by pushing for greater adoption of the technology used to make them through aggressive marketing and educational campaigns. However, a glut of plasma-derived products from Baxter and its competitors combined with the highprice of obtaining such medications has caused a bit a of market-slowdown which Baxter intends to fight with a renewed marketing push aimed at physicians and hospitals in the US. The BioScience unit also makes vaccines for infectious diseases, such as tick-borne encephalitis and meningococcal meningitis. Baxter received authorization from the European Commission in 2009 to market its pandemic influenza vaccine Celvapan H1N1 in Europe. The vaccine uses Baxter's Vero cell technology which allows rapid production and delivery of pandemic vaccines. Much of the company's R&D efforts are focused in the BioScience segment. It has an ongoing collaboration with Nektar 2 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Therapeutics, for example, to development blood-clotting proteins using Nektar's PEGylation technology. And it is working on other products in areas such as regenerative medicine and adult stem cell therapies. To jump into the bone grafting market, the company spent some $330 million to acquire UK-based ApaTech in 2010. ApaTech's bone grafting materials are already approved and sold in the US and Europe. The deal gave Baxter manufacturing and research facilities in Germany, the UK, and the US. Baxter's second largest division, Medication Delivery, makes intravenous drug delivery systems, infusion pumps, and anesthesia products. Products include inhaled and injectable anesthetics, as well as premixed drugs and parenteral nutrition products that are administered intravenously. The Medication Delivery segment has continued to see strong growth as demand for IV solutions and nutritional products has not seen any signs of slowing, especially in international markets. In 2009 Baxter expanded its infusion systems portfolio by entering into an agreement to distribute medical device maker SIGMA's SPECTRUM large volume infusion pumps domestically and internationally. The deal also gave Baxter a 40% stake in the company (with the option to buy the rest of SIGMA over a three-year period) as well as access to future products under development. Along with dialyzers -- dialysis equipment used primarily in hospitals or clinics -Baxter's Renal division makes home-use 3 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 dialyzers that use a technology called peritoneal dialysis. The company is betting on the growth of peritoneal dialysis and other home-use technologies, especially in developing markets that don't have the medical infrastructure needed for clinically administered dialysis. To that end, it entered an agreement with HHD and DEKA Research and Development to produce next generation home dialyzers. Baxter expanded further in renal therapies when it acquired the hemofiltration (renal replacement therapy) product line of Edwards Lifesciences in a $65 million deal in 2009. The Renal division is also a leading supplier of heparin, an anticoagulant used during dialysis and in critical care situations such as heart surgery. In 2008 Baxter halted production of heparin, however, after hundreds of bad reactions (including several deaths) occurred in patients using the drug. Subsequent investigations focused on raw heparin supplied to Baxter by a Chinese factory, which apparently added a cheaper ingredient into the drug which contaminated it. The heparin recall as well as the end of a marketing and distribution deal for generic propofol with Teva Pharmaceutical Industries caused the company to take a hit in sales in 2008. With manufacturing operations in more than two dozen countries and sales operations all over the world, Baxter International gets more than half of its revenue outside the US. Continued international expansion is key to the company's growth strategy. It is 4 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 particularly keen on the possibilities of growing sales of its renal products in developing countries. It has also set up a joint venture in China to sell its parenteral nutrition 2. Novartis Corporation 608 5th Ave. New York, NY 10020 United States n/a 30,186 Phone: 212-307-1122 Fax: 212-246-0185 www.us.novartis.com 3. Mylan Inc. 5,092.8 15,500 1500 Corporate Dr. Canonsburg, PA 15317 United States Phone: 724-514-1800 Fax: 724-514-1870 www.milan.com Novartis Corporation has what the doctor ordered. As the North American headquarters of Switzerland-based Novartis AG, the unit handles administration, sales, and marketing for a vast product line of prescription drugs, consumer health products, vaccines, and veterinary products. But wait, there's more! Novartis Corporation also oversees the Novartis Institutes for Biomedical Research, which is headquartered in the US, and charged with the job of discovering new medicines to add to the company's ever-expanding pipeline. Novartis Corporation also headlines dozens of other US business units including CIBA Vision, Novartis Pharmaceuticals, and the US operations of its Sandoz generics business Mylan knows you may not recognize the names of their drugs, but it hopes you'll appreciate their prices. Through Mylan Pharmaceuticals, Generics (UK), and other subsidiaries, the company is a global manufacturer of prescription generic drugs, holding a top 5 position in terms of sales, in more than a dozen of its worldwide markets. Mylan's pharmaceutical cabinet holds antibiotics, antidepressants, anti-inflammatories, and laxatives. The company's Mary Lou Mumford General Manager Didier Barret President, Europe, Middle East, and Africa 5 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 customers include wholesalers, distributors, retail drugstore chains, and government agencies. Another Mylan division, Matrix, is a top producer of active pharmaceutical ingredients (APIs) for generic drugs. Mylan is led by CEO and chairman of the board Robert Coury. Mylan makes branded specialty pharmaceutical products through its Dey division. The biggest seller in the Dey segment is the company's EpiPen Auto-Injector, used in the treatment of severe allergies. EpiPen is an epinephrine auto-injector and is the #1 prescribed treatment for severe allergic reactions, with a US market share of more than 95%. Mylan's generic pharmaceutical business is conducted primarily in North America, Europe, the Middle East, Africa, Australia, and the AsiaPacific region. In the generics segment, 2008 sales to McKesson and Cardinal Health represented 12% and 10% of total sales. The company's Mylan Technologies subsidiary develops and manufactures generic transdermal patch products. Another unit, UDL Laboratories, puts generic drugs into unit-dose packaging for hospital and institutional use. The API business is conducted principally through Matrix Laboratories in India. 6 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Docpharma, which is a subsidiary of Matrix Laboratories, is primarily a distributor of pharmaceutical products in the Benelux region of Europe. Mylan is involved in proprietary drug development through subsidiary Somerset Pharmaceuticals. Somerset Pharmaceuticals' primary products are Eldepryl, a drug for the treatment of Parkinson's disease; and Emsam, a transdermal patch for major depressive disorder that is marketed by Bristol-Myers Squibb. It was with an eye on global expansion that Mylan acquired control of Matrix Laboratories and created the new division to hold it. With 10 manufacturing facilities, it is one of the largest companies in India and is the world's largest supplier of generic antiretroviral pharmaceutical ingredients used to treat HIV/AIDS. Additionally, by having its own API producer in-house, Mylan hopes to gain an edge over competitors, who must obtain their ingredients from outside manufacturers. A key piece of Mylan's strategy is to be the first to file with the FDA to manufacture generic versions of popular drugs as they become fair game. Being first in line gives a manufacturer a three-month window of exclusivity, while its competitors have to wait before they can produce an equivalent product. 7 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 In its biggest deal yet, Mylan spent nearly $7 billion to acquire Generics (UK) Ltd. from Merck. Mylan won out in a bidding war that included its major rivals Actavis Group and Teva, with the prize being a business almost twice Mylan's size. Following the acquisition, the company changed its name from Mylan Laboratories to just plain Mylan. Akin to a frog swallowing a salmon, Mylan estimated it will take two to three years to fully realize the benefit of the deal that closed in late 2007. In 2009 Mylan formed a partnership with Indian biotech firm Biocon to expand into the growing field of generic biotech drugs. The two companies will co-develop and market biologic therapies in numerous countries 4. Hospira, Inc. 3,879.3 13,500 275 N. Field Dr. Lake Forest, IL 60045 United States Phone: 224-212-2000 Fax: 224-212-3350 www.hospira.com Hospira helps hospitals help the hurting. The company, a spinoff of drug manufacturer Abbott Laboratories, makes specialty injectable pharmaceuticals (primarily generics) and drug delivery equipment. Its medication delivery systems include drug pumps, infusion therapy devices, and related medication management software. Its injectable drugs include cardiovascular, anesthesia, and antiinfective therapies. In addition, Hesperia provides contract manufacturing services for Ron Squarer Chief Commercial Officer 8 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 injectable pharmaceuticals. A good portion of Hospira's sales are to group purchasing organizations (GPOs), including Broadlane, Novation, and Premier. Global acquisitions remain a key part of the company's strategy for future growth, and in early 2010 it acquired the generic injectable drug business of India-based Orchid Chemicals for $400 million. The purchase included a manufacturing and research facility in India and a long-term exclusive agreement with Orchid to supply Hospira with active pharmaceutical ingredients (APIs). The company has also announced plans to acquire drug developer Javelin Pharmaceuticals. The purchase (worth about $145 million) will give Hospira access to a new pain medication Dyloject, which has been submitted to the FDA for approval. The deal hit a stumbling block in mid-2010 when Javelin filed suit against Hospira and the unit formed to acquire Javelin, Discus Acquisition Corp., alleging that the two failed to accept and pay for Javelin shares that had already been tendered and also breached terms of the two companies' original loan agreement (under which Hospira was to lend Javelin $2 million). The suit seeks to compel Hospira and Discus to complete the acquisition. In 2008 Hospira acquired Sculptor Developmental Technologies, the bar-code 9 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 medication management software business of St. Clair Health. Hospira continues to use the St. Clair Hospital in Pittsburgh as a testing and development site for its medication administration products. The purchase contributed to Hospira's efforts to beef up product offerings in the areas of patient safety (avoiding medication errors) and clinician efficiency in health care facilities. In addition, the company acquired Australian pharmaceutical maker Mayne Pharma for about $2 billion a few years ago. The purchase positioned Hospira as the world's largest generic injectable drug manufacturer and significantly expanded its roster of oncology treatments. Hospira had acquired another Australian firm, BresaGen, the previous year; BresaGen conducted biotechnology therapeutic research. Hospira's research and development efforts are focused on creating new generic pharmaceuticals, as well as new and improved medication management including IV infusion pumps and software to control their function. Hospira has about 15 manufacturing facilities globally after closing a few to concentrate manufacturing in other locations, and outsourcing some production to third-party suppliers. Its North Carolina, Texas, Kansas, Costa Rica, and Australia (Victoria) locations account the majority of output. In 2009 the company announced corporate 10 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 streamlining measures, including a 10% workforce reduction by the end of the year. Hospira also laid out plans to trim its product line and review options for noncore operations. Later that year it sold its critical care product line, with full marketing rights, to ICU Medical for $35 million. The critical care business already operated under a manufacturing partnership between ICU Medical and Hospira. In early 2010 the company sold its brain function monitoring business to SEDLine, a private research firm backed by Masimo Corporation 5. Perrigo Company 2,006.9 7,250 515 Eastern Ave. Allegan, MI 49010 United States Phone: 269-673-8451 Fax: 269-673-9128 www.perrigo.com Perrigo makes its name by making sure you never see it. One of the US's largest manufacturers of generic and private-label over-the-counter pharmaceuticals and supplements, Perrigo makes products that use similar packaging and discount pricing to compete with leading national brands. The company makes more than 1,300 products, including pain relievers, cough and cold remedies, dietary supplements, and smoking cessation products -- some of which are sold under its own Good Sense brand. It also makes more than 250 generic prescription products for other companies. Its Active Pharmaceutical Ingredients (API) division manufactures the raw materials used by generic and branded pharmaceutical companies worldwide. John Hendrickson EVP Global Operations and Supply Chain Perrigo's international consumer health care product subsidiaries Quimica y Farmacia (Mexico) and Wrafton (UK) offer over-the-counter and store-brand 11 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 pharmaceutical products. Perrigo manufactures generic prescription drugs at facilities in the US and Israel, and subsidiary Chemagis makes APIs in Israel, Germany, and China. In 2010 the company divested its consumer products operations (but not its manufacturing operations) in Israel. The business primarily sold consumer products to the Israeli market, including cosmetics, toiletries, and detergents. Perrigo has grown its pharmaceuticals business through acquisitions of product lines it either doesn't have or that would complement its existing businesses. For example, in 2008 it expanded its manufacturing operations by acquiring US contract OTC drugmaker J.B. Laboratories for $44 million and Unico Holdings, a US maker of nutrition and hygiene products, for $49 million. Both companies have been integrated into the Perrigo organization. In a departure from all things pharmaceutical, in 2010 Perrigo purchased PBM Holdings, a US-based private manufacturer and marketer of store-brand infant formulas and baby foods. The $808 million acquisition took advantage of Perrigo's existing private-label relationships with retailers, and gave it a deeper presence in the OTC consumer products market. To expand internationally, the firm has made purchases abroad including the acquisition of UK company Galpharm Healthcare, a manufacturer of store brand products, in 2008. It then bought Mexican drugmaker Laboratorios Diba for $25 12 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 million to expand its manufacturing capacity. In 2010 the company agreed to acquire Australian OTC products maker Orion Laboratories for $48 million. Perrigo's ongoing efforts to introduce a generic version of Mucinex (guaifenesin) have been stymied by Mucinex maker Adams Respiratory, which has filed a blizzard of patent infringement lawsuits seeking to protect its lucrative market niche. The company won the rights to begin selling a version of Johnson & Johnson's Monistat vaginal infection product after a similar series of lawsuits. It plans to begin marketing the products in 2010. Along with snapping up other company's products, Perrigo has its own in-house research and development team that whips up generic formulations of name brand products, as well as responds to changes in existing national brand products by reformulating existing company products. Perrigo's clients include such retailers as Wal-Mart, CVS, and Walgreen and such wholesalers as SUPERVALU and McKesson. Wal-Mart is its largest customer, however, and accounts for more than 20% of sales. The company's consumer healthcare segment has its own sales force to work with its largest customers. Vice Chairman Moshe Arkin owns about 10% of Perrigo, and director Michael Jandernoa holds just over a 3% stake 6. Boehringer n/a 6,000 As the US headquarters of German drug maker Boehringer Ingelheim, Boehringer Peter Hansbury 13 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Ingelheim Corporation Ingelheim Corporation oversees about half a dozen stateside subsidiaries that produce and sell drugs (both prescription and overthe-counter), animal health products, and chemicals for the US market. It sells its prescription and OTC products through its largest unit Boehringer Ingelheim Pharmaceuticals. Additionally, the firm's Roxane Laboratories makes generic drugs and its Ben Venue Laboratories is a contract pharmaceutical manufacturer and provides drug development services to other pharmaceutical companies 900 Ridgebury Rd. Ridgefield, CT 06877 United States Phone: 203-798-9988 Fax: 203-791-6234 www.us.boehringeringelheim.com 7. Watson Pharmaceuticals, Inc 2,793 5,830 311 Bonnie Cir. Corona, CA 92880-2882 United States Phone: 951-493-5300 Fax: 973-355-8301 www.watsonpharm.com Watson Pharmaceuticals tries to have the best of both worlds, with operations in the US generics market and the higher-profitmargin branded drug business. The company's broad generics portfolio of about 140 products includes treatments for hypertension and pain, as well as smoking cessation products, antidepressants, and oral contraceptives. Its line of about 30 branded drugs focuses on urology and nephrology; it markets its branded products, including treatments for iron deficiency anemia and overactive bladder, to specialist physicians in the US. Additionally, Watson distributes its own and third-party products to independent pharmacies and health care providers through its Anda and Valmed subsidiaries. General Manager, Contract Manufacturing Division Thomas Russillo EVP Global Generics and Global Operations Watson Pharmaceuticals' bread and butter is its generics line, accounting for about 60% of sales. An important part of the company's generics business is its generic oral contraceptive line. Watson has a 14 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 leading position in the US in generic oral contraceptives with roughly two dozen different oral contraceptive products and about a 35% market share. Its top five oral contraceptives TriNessa, Low-Ogestrel, Necon, Lutera, and Microgestin, account for almost 50% of the total Watson oral contraceptives portfolio. The generics business overall has struggled with the loss of a key product and the general decline of generics revenue over time. The big loss came a few years ago when a distribution agreement with Purdue Pharma for oxycodone HCl (generic OxyContin) ended. Name-brand drug companies sometimes authorize an "official" generic form when a drug goes off-patent, in order to recoup some losses that inevitably result from generic competition. Watson had distributed the authorized generic of OxyContin since the drug lost patent protection in 2005, and the drug was a big contributor to the company's revenue. Watson's strategy for combating declining sales (as well as the loss of the OxyContin deal) is to develop and acquire new products to beef up its pipeline. In 2009 alone the company launched about a dozen new products including Metoprolol ER to treat angina, emergency contraceptive NextChoice, and Galantamine for the treatment of Alzheimer's disease. The previous year Watson introduced a generic version of Biovail's antidepressant Wellbutrin XL, Johnson & Johnson's Duragesic pain patch and its Alzheimer drug Razadyne, Duramed's Mircette oral 15 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 contraceptive, and GSK's Nicorette smoking cessation gum. Additionally, the company co-promotes AndroGel, a male hormone replacement therapy, with Unimed and distributes an authorized generic of Merck's Fosamax. To pick up a few more products, expand its development pipeline, and broaden its geographic presence, Watson spent about $1.75 billion to acquire privately held Arrow Group in 2009. Arrow develops and manufactures generic pharmaceuticals in Canada, Malta, and Brazil and distributes its products in more than 20 countries. Major products in the company's branded drug segment include prostate therapies Trelstar and Rapaflo. Watson is building its branded product line through several partnerships and joint ventures, as well as through acquisitions of later-stage drug candidates. Because it relies on partnerships to augment its product line, the company's bottom line is also vulnerable to the expiration of those deals. For example, Watson lost a key product in 2009 when its license agreement with Sanofi-Aventis for anemia drug Ferrlecit ended. To stave off losses related to losing licenses, Watson has been trimming costs by consolidating some operations and moving some manufacturing operations overseas. It established a plant in Goa, India, for example, and has announced the closures of some US facilities, including the planned closure of a facility in Carmel, New York (it will transfer these operations to Goa). It owns or has invested in plants in 16 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 China and other parts of India and plans to continue its overseas growth; however, Watson divested its interest in an API (active pharmaceutical ingredient) plant in Taiwan in 2010 after deciding that the operation was not key to the company's long-term growth strategy 8. Forest Laboratories, Inc 4,192.9 5,200 909 3rd Ave. New York, NY 10022-4731 United States Phone: 212-421-7850 Fax: 212-750-9152 www.frx.com Forest Laboratories doesn't just blend in with the trees. The company develops and manufactures name-brand as well as generic prescription and over-the-counter pharmaceutical products. The company's central nervous system (CNS) pharmaceutical line includes antidepressants Celexa and Lexapro, as well as Namenda, which treats Alzheimer's disease. Other products include treatments for thyroid disease, hypertension, respiratory ailments, and pain. Forest Laboratories markets directly to doctors, hospitals, drugstore chains, managed care organizations, and distributors through its own sales force in the US; it also has affiliated and independent sales representatives in the UK and Ireland. David F. Solomon VP Business Development and Strategic Planning Subsidiary Inwood Laboratories promotes the company's generic products. Nearly 90% of the company's sales revenues come from large pharmaceutical distributors McKesson, Cardinal Health, and AmerisourceBergen, which deliver Forest's products to customers on a wholesale basis. Despite fierce competition from other established brands, Forest Laboratories has found a niche in the antidepressant market. 17 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 With Celexa's recent conversion to generic status, however, the company has become more dependent on sales of Lexapro, which accounts for around two-thirds of the company's revenues. In 2009 Lexapro received FDA approval for use to treat depression in adolescents, neatly extending the brand's potential profitability. Namenda is another top seller in the CNS field, accounting for about a quarter of Forest's sales. The firm is working to develop and release new drug candidates that it hopes will make up for any decline in sales seen from generic competition. Recent releases include Bystolic for hypertension treatment in 2007 and Savella for fibromyalgia in 2009. Its pipeline includes potential drugs to treat neuropathic pain, gastrointestinal disorders, asthma, and schizophrenia; many of the company's development programs are collaborative efforts with other pharmaceutical companies. To bolster its biopharmaceutical research capabilities, Forest Laboratories purchased private biotech firm Cerexa for about $494 million in early 2007. Cerexa brought with it a series of injectable antibiotics under development to combat bacterial infections including MRSA (methicillin-resistant Staphylococcus aureus). The company ended a co-promotion agreement with Daiichi Sankyo in 2008 for the hypertension drug Axor to focus on sales efforts for its other commercial products. The two companies have historically marketed antihypertensive drug Benicar together; Forest continues to 18 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 receive royalties from the agreement but has stopped actively marketing the drug. 9. Falcon Pharmaceuticals, Ltd n/a 3,000 6201 South Fwy. Fort Worth, TX 761342099 United States Phone: 817-293-0450 Fax: 800-777-2799 www.falconfharma.com 10. Mylan Pharmaceuticals, Inc Falcon Pharmaceuticals has a keen eye for alternatives. The company specializes in making generic equivalents of ophthalmic drugs that treat a range of eye conditions, as well as otic (ear) and nasal ailments. Its lead product, Timolol GFS, is a generic equivalent of Merck's glaucoma treatment Timoptic-XE gel. The company also offers anti-infective, steroid, anti-viral, antiallergy, and anesthetic pharmaceutical products without the markup typically associated with brand names. Falcon Pharmaceuticals is a subsidiary of eye care products company Alcon. Mike Hemrick VP The company manufactures about 30 generic formulations of name-brand drugs, including glaucoma treatment brimonidine, eye inflammation treatment prednisolone, and otic and ophthalmic suspensions of hydrocortisone. Falcon Pharmaceuticals regularly looks for opportunities to develop additional products as patented drugs reach their expiration dates. Alcon formed the subsidiary in 1994 to develop and market generic versions of Alcon's and other drugmakers' products n/a 2,000 781 Chestnut Ridge Rd. Mylan Pharmaceuticals isn't a snob when it comes to labels -- the company is the generic research and development, manufacturing, marketing, and distribution division of Mylan. Mylan Pharmaceuticals offers more than 200 generic prescription products developed in-house and through Larry Salmon Manager 19 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Morgantown, WV 26505 United States Phone: 304-599-2595 Toll Free: 800-826-9526 Fax: 304-598-3232 www.mylanpharms.com distribution agreements with other pharmaceutical companies. Mylan devotes most of its research and development efforts to the creation of extended oral dosages. Its sister company Mylan Technologies develops transdermal and polymer film patches. Its products are sold to pharmaceutical wholesalers, distributors, mail order pharmacies, and drugstore chains. Mylan Pharmaceuticals is hoping to take full advantage of its manufacturing capacity of some 35 million doses as an aging population combined with efforts to reduce health care costs, and the resultant reliance on less-expensive generics continue to fuel demand in that industry. The company is also focused on filling a niche by bringing generics to the US market that are difficult to formulate or manufacture, or for which the ingredients are difficult to obtain. Past examples of such drugs are pain medication fentanyl, epilepsy treatment levetiracetam, psychiatric drug divalproex, and overactive bladder medication oxybutynin. Those drugs (and others like them) continue to contribute to the company's bottom-line, even several years after their initial launch, because competition remains limited due to their high barriers to entry 20 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 11. Endo Pharmaceuticals Holdings Inc 1,460.8 1,487 100 Endo Blvd. Chadds Ford, PA 19317 United States Phone: 610-558-9800 Fax: 610-558-8979 www.endo.com Endo Pharmaceuticals wants the pain to end, preferably through the drugs it acquires and markets. The pharmaceutical company has a portfolio of both branded and generic prescription products for pain management. Its best-selling drug is Lidoderm, a lidocaine patch that treats nerve pain caused by shingles; it accounts for about two-thirds of the company's revenue. Endo also sells well-known pain meds Percodan and Percocet, as well as migraine therapy Frova. Its generics include morphine and oxycodone tablets. The company markets its drugs in the US through its own domestic sales force; however, it outsources almost everything else, from manufacturing to distribution to clinical development acitivities. Sandeep Gupta VP Eschewing the integrated business model favored by most pharmaceutical companies, Endo has built its business on alliances with other firms. It in-licenses or acquires drug candidates and uses contract research organizations to implement the clinical development programs it designs. It also outsources manufacturing (largely to Novartis Consumer Health and Teikoku Seiyaku) and warehouse and distribution activities(to UPS Supply Chain Solutions). Although the pain management market is at its core, Endo Pharmaceuticals made a move to expand into other therapeutic areas, specifically endocrinology, oncology, and urology, through its acquisition of Indevus Pharmaceuticals, a maker of therapies for ailments including overactive bladder, hormone disorders, and prostate 21 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 cancer. The 2009 deal cost the company $370 million, plus potential additional milestone payments of $267 million. Endo also gained drug delivery technologies through the acquisition. One of the drugs that came with Indevus was VALSTAR, an approved treatment for an aggressive form of bladder cancer that had been shelved years earlier due to formulation problems. Endo immediately set to relaunching the product for a quick return on its investment. In 2010 the company moved to expand further in the field of urology when it agreed to purchase HealthTronics through a $258 million tender offer and debt transaction. The acquisition will strengthen Endo's offering of urological therapies and expand its operations into the new area of non-pharmaceutical treatments. HealthTronics, which will become a wholly owned subsidiary of Endo, offers medical equipment including kidney stone lithotripters, cryosurgery (freezing of tissue), and diagnostics for prostate enlargement and cancer, as well as other urological conditions. The purchase will also widen Endo's customer base of urological professionals. The company's branded prescription pharmaceuticals, which heavily outweigh its generics in sales, are marketed to physicians in anesthesiology, neurology, oncology, urology, pain management, primary care, and surgery. It also targets retail pharmacies throughout the US. Endo Pharmaceuticals was created in 1997 22 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 through the management buyout of a pharmaceutical joint venture between DuPont and Merck 12. APP Pharmaceuticals, LLC n/a 1,375 1501 E. Woodfield Rd. Ste. 300 E. Schaumburg, IL 601735837 United States Phone: 847-413-2075 Toll Free: 888-386-1300 Fax: 800-743-7082 www.appdrugs.com Your eyes are getting heavy. You're getting sleepy. No hypnotist here, just APP Pharmaceuticals, a company that develops, makes, and markets anesthetics and other injectable drugs. Specializing in generics, APP's critical care products segment includes market-leading general anesthetic Diprivan and blood thinner Heparin. Other product segments focus on injectable oncology treatments and drugs that fight ear, heart, respiratory tract, skin, and sinus infections. APP markets through a direct sales force and often sells through group purchasing organizations to customers that include hospitals, long-term care facilities, and clinics in North America. The company is a subsidiary of German medical firm Fresenius. Steve Weltler Manager The German health care group purchased APP Pharmaceuticals in 2008 to expand its global generic injectables business and to gain entry into the US drug market. Following the acquisition, APP became part of the company's Fresenius Kabi division, which makes infusion therapy and clinical nutrition products. At the close of 2009 APP Pharmaceuticals CEO Thomas Silberg retired, and Fresenius Kabi executive John Ducker was appointed to the post. In addition to its marketed generics, APP Pharmaceuticals has a steady stream of new drug applications awaiting regulatory approval and more than 70 product 23 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 candidates in development across its core oncology, anti-infective, and critical care categories. Its US research and development facility focuses on pharmaceutical formulation, analystical chemistry, and drug delivery. American Pharmaceutical Partners Inc. merged with American BioScience in 2006 to form Abraxis BioScience. In 2007 Abraxis spun off the generic injectables business as APP Pharmaceuticals, leaving Abraxis to focus on developing a patented oncological drug 13. Ben Venue Laboratories, Inc n/a 1,103 300 Northfield Rd. Bedford, OH 44146-4650 United States Phone: 440-232-3320 Fax: 440-439-6398 www.benvenue.com Ben Venue Laboratories prides itself on having products that are clean, clear, and cold. A subsidiary of German drug firm Boehringer Ingelheim, the company provides contract manufacturing services, including product and process development and regulatory compliance services. The company specializes in manufacturing liquid and lyophilized (freeze-dried) pharmaceuticals. Ben Venue's Bedford Laboratories division provides contract manufacturing of generic injectable pharmaceuticals. Customers include multinational drugmakers, small biotech development firms, and government agencies. Peter Hansbury General Manager, Contract Manufacturing Division The company's Bedford Laboratories division has expanded its operations as a contract developer and manufacturer of generic sterile pharmaceuticals through internal research and development efforts. Its products include generic versions of injectable oncology pharmaceuticals sold 24 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 under the Bedford brand 14. Amphastar Pharmaceuticals, Inc 300 1,040 11570 6th St. Rancho Cucamonga, CA 91730 United States Phone: 909-980-9484 Toll Free: 800-423-4136 Fax: 909-980-8296 www.amphastar.com Amphastar Pharmaceuticals wants to help drugs help themselves. A maker of injectable and inhalant drugs and drug delivery systems, the company focuses on drugs that are difficult to manufacture or can be improved with new delivery systems. Amphastar's products include Amphadase (increases absorption and dispersion of injected drugs), Duocaine (anesthetic for eye surgery), Cortrosyn (tests for adrenal gland disorders), and prefilled disposable pipettes (single-dose dispenser for liquids, creams, and other forms). The company also offers contract manufacturing services, including labeling and packaging, cold storage, and aseptic filling. Peter Langosh VP Operations The company's Massachusetts-based Armstrong Pharmaceuticals subsidiary manufactures metered dose inhalers used to administer respiratory drugs for asthma and obstructive pulmonary disease. Along with generic prescription inhalers and nasal sprays the company also manufactures the branded asthma drug Primatene Mist, which is sold over the counter. Amphastar's California-based International Medication systems subsidiary manufactures pre-filled syringes and vials with injectable and topical drugs. Its products range from lidocaine and morphine used in emergency medicine to Vitamin K administered to newborn babies 25 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 15. Teva Pharmaceuticals USA n/a 1,025 1090 Horsham Rd. North Wales, PA 194541090 United States Phone: 215-591-3000 Fax: 215-591-8600 www.tevausa.com When the pharmacist asks you if a generic equivalent is acceptable, Teva hopes you'll say "yes." Teva Pharmaceuticals USA, the US subsidiary of massive Israeli generic drug maker Teva Pharmaceutical Industries, develops, manufactures, and markets both generic and branded pharmaceuticals. The company is the largest manufacturer of generic drugs in the US; its product roster boasts more than 400 generic equivalents of prescription drugs in a wide variety of therapeutic categories, including cardiovascular, antiinflammatory, anti-infective, oncology, central nervous system, and dermatological. Robert Jernick Manager Teva Pharmaceuticals USA (along with its cousin to the North, Teva Canada Ltd.) accounts for about 60% of its parent company's sales. Teva Pharmaceuticals USA itself gets about half of its revenues from direct sales to drugstores and a third from drug wholesalers; other customers include mail-order pharmacies, distributors, and hospitals. Its production capabilities include a variety of dosage forms, such as tablets, capsules, ointments, creams, liquids, injectables, and inhalants. The company expects US demand for generics to continue to grow as the population ages and as the nation continues to look for ways to reduce escalating health care costs. To meet that expected demand and to solidify its position in the US market, Teva acquired US generics maker Barr Pharmaceuticals for $7.5 billion in 2008. Barr's operations were later integrated into the Teva organization, 26 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 upping Teva Pharmaceuticals USA's annual prescriptions to about 600 million or more than 20% of all US generic prescriptions written. Teva Pharmaceuticals USA also seeks to keep its pipeline pumping out generics and to that end, the company has more than 200 new generic drugs awaiting FDA approval. Along with performing its own research and development, the company forms alliances with other pharmaceutical firms to license and market generic versions of their branded drugs. Teva Pharmaceuticals USA has one such agreement with Biovail, which expires in 2011, to market three of its hypertension treatments (Adalat CC, Cardizem CD, and Procardia XL). The company's roots go back to Lemmon Pharmaceutical Company, founded in 1945. Lemmon Pharmaceutical was acquired by Teva Pharmaceutical Industries in 1981 16. Dey, L.P. n/a 1,000 2751 Napa Valley Corporate Dr. Napa, CA 94558 United States Phone: 707-224-3200 Fax: 707-224-9264 www.dey.com Dey helps people breathe easier. The company, a subsidiary of generic drugmaker Mylan, makes prescription drugs for the treatment of allergies and respiratory diseases. Dey markets EpiPen autoinjectors, used by patients to selfadminister epinephrine for severe allergic reactions. Its premeasured unit-dose inhalation products include treatments for asthma and chronic obstructive pulmonary disease (COPD). These treatments, called bronchodialators, are used in air-driven breathing devices called nebulizers and include branded DuoNeb and Perforomist Garry L. Michaud SVP Operations 27 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 products. It also offers several non-branded generic nebulizer treatments. A direct sales force markets Dey's products to doctors, pharmacies, and wholesalers. EpiPen, the company's top product accounting for more than half of sales, is the most-prescribed treatment for severe allergic reactions in the US. Dey launched its Perforomist inhalation solution for the treatment of COPD, chronic bronchitis, and emphysema in 2007. The company plans to pursue the development and commercialization of additional product lines. In late 2007 former parent Merck KGaA sold certain generic and specialty businesses, including Dey, to Mylan for a whopping $6.7 billion. Merck was looking to reduce debt from previous acquisitions, while Mylan boosted its already-stable position in the global generics market through the acquisitions. Mylan explored strategic options for Dey in 2008, but decided to keep the business later that year. Mylan plans to restructure Dey's operations. Dey started out in 1978 as a purely generic drug maker, but has expanded over the years to include branded products. Dey uses existing respiratory treatments to develop its patented products using its drug delivery technologies. It has also directed R&D efforts towards new dosage and drug delivery innovations. Dey is facing some federal and state lawsuits over alleged false drug-price 28 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 reporting 17. Roxane Laboratories, Inc n/a 1,000 1809 Wilson Rd. Columbus, OH 43216-6532 United States Phone: 614-276-4000 Fax: 614-279-5517 www.roxane.com Mark Edmonds This Roxane isn't being wooed by Cyrano. VP Operations Roxane Laboratories, a US-based subsidiary of Germany's Boehringer Ingelheim, oversees the development, manufacturing, and marketing of its parent company's generic drug business in the US. It markets more than 75 medications in some 250 package sizes, focusing on oral liquids, sustained-release and controlledrelease tablets, cancer drugs, and nasal sprays. It also distributes narcotics, such as meperidine (generic Demerol) and methadone. Products developed and marketed by Roxane are manufactured by its sister company, Boehringer Inghelheim Roxane, also located in Columbus, Ohio. Roxane depends on a continual flow of new drug approvals to refresh its product lineup. Its research and development operations aim to file a steady stream of abbreviated new drug applications with the FDA. Such applications simply demonstrate the company's ability to make functionally equivalent versions of existing drugs, and requesting permission to do so. Recent approvals included a version of GlaxoSmithKline's Valtrex (herpes 29 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 simplex, 2010 18. Sandoz Inc. 135.2 850 506 Carnegie Center Ste. 400 Princeton, NJ 08540-6243 United States Phone: 609-627-8500 Fax: 609-627-8659 www.us.sandoz.com Sandoz, Inc. makes it easier to swallow the cost of prescription medicines. As the US arm of Swiss giant Novartis' generic Sandoz International division, the firm is one of the largest generic drug makers in the US, manufacturing more than 200 generic oraldosage drugs. The company's product portfolio includes drugs to fight infections, arthritis pain, cardiovascular and gastrointestinal disorders, and central nervous system disorders. Sandoz markets its products to wholesalers, drug stores, government agencies, HMOs, and hospitals. The company operates two manufacturing facilities in the US. Sharon Jones Director Sandoz does more than just manufacturing of its parent's drugs. It is active in the research and development of new generics, shepherding them through testing and FDA approval, and finally handling the manufacturing, packaging, and distribution of the drugs. Don DeGolyer was appointed CEO of Sandoz, Inc. in 2010. He replaced Christine Mundkur who held the position for barely a year, but steered the company through the turbulence of the economic recession. Formerly named Geneva Pharmaceuticals, the company was brought under the Sandoz name in 2003 as Novartis sought to consolidate its generics businesses. Novartis acquired Eon Labs in 2005 and integrated it into Sandoz, Inc. to further strengthen its position in the US generic 30 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 pharmaceutical market. 19. Impax Laboratories, Inc. 358.4 801 30831 Huntwood Ave. Hayward, CA 94544 United States Phone: 510-476-2000 Fax: 510-471-3200 www.impaxlabs.com IMPAX Laboratories hopes that its combination of generic and branded pharmaceuticals will make an impact on its financial health. The company makes specialty generic pharmaceuticals, which it markets through its Global Pharmaceuticals division and through marketing alliances with other firms, including Teva. It concentrates on controlled-release versions of branded pharmaceuticals and niche pharmaceuticals that require difficult-toobtain raw materials or specialized expertise. The company's branded pharmaceuticals business (called IMPAX Pharmaceuticals) is developing drugs that target Parkinson's disease, epilepsy, and other central nervous system disorders. Peter R. Terreri Director The company's Global Pharmaceuticals division sells its generic products to wholesalers, chain drug stores, and mail order pharmacies. IMPAX also works through strategic alliances; its deal with Teva, for instance, gives the generics giant US rights to some versions of its generic Claritin, Wellbutrin SR, and Prilosec products 20. Actavis U.S. n/a 740 60 Columbia Rd. Bldg. B Morristown, NJ 07960 United States Keeping its parent active in the US is Actavis US. As its name implies, the company is the US manufacturing and marketing unit of global generics firm Actavis. As such it makes a variety of generic equivalents of both prescription and OTC drugs, in a number of forms, including liquids, tablets, creams, and suppositories. Ken Hunt Manager 31 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Phone: 973-993-4500 Fax: 973-993-4303 www.actavis.us Among other consumer and specialty drugs, it makes anxiety, depression, and pain medications. Actavis US has manufacturing facilities in Maryland, New Jersey, and North Carolina, from which it ships its own products and provides contract manufacturing services to third parties. Overseeing the US market for its parent is no small feat, since it comprises about one third of Actavis' sales. Some of Actavis US' notable drug releases have included Kadian, an extended release pain medication, the generic form of the antidepressant Wellbutrin XL, and Levetiracetam, a generic form of Keppra, an epilepsy drug. Actavis US ran into some trouble at its facility in Towata, New Jersey, in 2008 after the FDA found some manufacturing violations. The plant issued a voluntary recall of about 60 medications and worked with the FDA to meet all of its requirements before restarting production in 2009. The company marked the opening by reintroducing one of its biggest sellers, pain medication oxycodone, in the US. In 2010 Actavis consolidated its New Jersey manufacturing operations into its Elizabeth plant, which resulted in the closure of the Towata plant. The move came as part of the company's efforts to cut expenses and improve operational efficiencies. Actavis entered North America and created its US subsidiary in 2005 with three acquisitions: Amide Pharmaceuticals, Abrika Pharmaceuticals, and the Human Generics division of Alpharma 32 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 21. Caraco Pharmaceutical Laboratories, Ltd. 337.2 667 1150 Elijah McCoy Dr. Detroit, MI 48202 United States Phone: 313-871-8400 Fax: 313-871-8314 www.caraco.com Caraco Pharmaceutical Laboratories is cooking up cheaper versions of prescription drugs in the Motor City. The Detroit-based drug company makes generic knock-offs of a wide variety of pharmaceuticals, producing about 60 prescription products in various strengths and dosages. Its product lineup includes treatments for high blood pressure, cancer, nervous system conditions, diabetes, allergies, and pain. Indian drugmaker Sun Pharmaceutical Industries owns about 75% of the firm and licenses US marketing rights to Caraco for more than two dozen drugs. Caraco markets its products throughout the US and Puerto Rico, selling primarily to pharmaceutical wholesalers. The fast-growing company has added to its product list by focusing on hard-to-make drugs, as well as therapies that cater to niche markets such as epilepsy. However, it is increasingly challenging the validity of brand-name drug patents, hoping to be the first to file generic applications with the FDA, a status that gives drugmakers a period of market exclusivity. A majority of the development work for the company's products is performed at laboratories in Mumbai and Vadodara, India operated by Sun Pharmaceuticals. Sun Pharmaceuticals also supplies Caraco with a substantial portion of its raw materials for drug-making. Along with pharmaceutical wholesalers, Caraco's products are marketed toward a wide range of other customers including 33 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 buying groups, retail pharmacies, distributors, and hospitals. The company's three largest customers -- AmerisourceBergen, McKesson, and Cardinal Health -combined account for nearly half of its total sales. Though the company has experienced pretty steady growth within its product lines, it hasn't been without problems. In 2009, the FDA seized more than three dozen different types of generic drugs from three manufacturing plants in Michigan due to what it said were violations of manufacturing standards having to do with the size of the tablets being made. The affected drugs included generic versions of certain antidiabetic agents, high blood pressure medicines, and anti-anxiety medications. Following the move by the FDA, Caraco signed a consent decree by which the company cannot resume manufacturing its products until it gets written notification independent experts and the agency. The stoppage led the company to layoff more than 400 employees in two phases late in the year. Jitendra Doshi became interim CEO of the company in 2009 following the resignation of Daniel Movins. Doshi previously served as Caraco's interim CEO for nearly two years between 2003 and 2005, prior to the appointment of Movins 22. Par 1,193.2 616 Par Pharmaceutical Companies is your insurance company's resource for cheaper drugs. The company markets about 70 34 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Pharmaceutical Companies, Inc. 300 Tice Blvd. Woodcliff Lake, NJ 07677 United States Phone: 201-802-4000 Fax: 201-802-4600 generic drugs in more than 240 dosages; its generic product line focuses on central nervous system, cardiovascular, and antiinflammatory medications, as well as infectious disease. Par manufactures some of its own products, but in many cases it distributes drugs manufactured by strategic partners. The company is moving into the branded pharmaceutical market as well by developing updated versions of off-patent drugs. Its first marketed brand-name product, Megace ES, treats anorexia and severe weight loss associated with AIDS; the drug is a version of a compound owned by Bristol-Myers Squibb. In addition to its own portfolio of off-patent generics, Par Pharmaceutical sells some authorized generics, which are off-brand versions of drugs that are sanctioned by the patent holders. Par has sold an authorized generic version of diabetes drug Glucophage, under contract with Bristol Myers Squibb; it has had other authorized generic contracts with GlaxoSmithKline for Flonase and Zantac and with AstraZeneca for Toprol XL. In conjunction with a reduction of its generics business, the company is seeking to expand its branded products division, Strativa Pharmaceuticals. To that end it acquired the rights to develop Nascobal, a vitamin B-12 nasal spray, in 2009. It anticipates future company growth will come from this sort of in-licensing deal. In 2008 Strativa partnered with Alfacell, acquiring the US commercialization rights to that company's investigational cancer drug, Onconase. The following year it 35 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 signed a similar deal with MonoSol for its chemotherapy-induced nausea treatment. Strativa also has an ongoing marketing relationship with Solvay's for its testosterone replacement product Androgel. Par sells mainly to wholesalers and retail pharmacy chains; its largest customers, which account for just over half of revenues, include drug distributors McKesson, Cardinal Health, and AmerisourceBergen 23. Nycomed US Inc. 257 575 60 Baylis Rd. Melville, NY 11747 United States Phone: 631-454-7677 Fax: 631-454-6389 www.altanainc.com Nycomed US is the US specialty pharmaceutical business of Switzerland's Nycomed International. It operates through three divisions and is focused on making and selling drugs for dermatological and ophthalmic conditions. Its largest division E. Fougera & Co. primarily makes generic topical steroids, antibiotics, and antifungals. It makes both prescription and over the counter products for use in hospitals and sale through retailers. Fougera's sister division PharmaDerm develops, manufactures, and markets branded prescription dermatology products. Nycomed US' Savage Laboratories makes prescription emergency medicines including antivenin for snake bites and an antidote for digitalis poisoning. Ann Bryant VP Business Development Nycomed US operates a manufacturing facility in New York and two distribution centers in Arizona and Pennsylvania. In 2008 parent Nycomed acquired Bradley Pharmaceuticals, another US-based niche player with a focus on dermatology. 36 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Nycomed integrated Bradley's operations -which include sales of branded and generic drugs -- into Nycomed US's Fougera and PharmaDerm units. Formerly owned by ALTANA AG, the company was bought by Nycomed in 2006, along with ALTANA AG's other pharmaceutical operations. The company had previously grown with the acquisition of the US dermatology business of GlaxoSmithKline Consumer Healthcare. Through the deal, PharmaDerm added corticosteroid Aclovate, antiinflammatory Cutivate, and antibiotic Emgel, among other products 24. Upsher-Smith Laboratories, Inc n/a 550 6701 Evenstad Dr. Maple Grove, MN 55369 United States Phone: 763-315-2000 Fax: 763-315-2001 www.upsher-smith.com Upsher-Smith Laboratories (U-S) makes drugs for us all. Its products include generic prescription and over-the-counter medications, focused primarily on the therapeutic areas of cardiology, dermatology, and women's health. Among its cardiology products are folic acid supplement Folgard, anticoagulant Jantoven, and heart arrhythmia treatment Pacerone. It also sells several moisturizers and cleansers under the AmLactin and Clenia brand names. The company is also moving into treatments for diseases of the central nervous system. Founded in 1919, U-S maintains manufacturing facilities in Minneapolis and Denver. Tom Burke EVP Commercial Operations Looking to expand beyond its traditional generic market, the company has taken a small stake in Proximagen Neuroscience, a British firm that is developing a treatment for Parkinson's disease. U-S spent about $6 37 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 million for a 7% stake in the company in hopes of bringing its drug, PRXI, to market. Its a first step in fulfilling U-S' plans to introduce four new proprietary drugs by 2017. The family-owned firm may see its future plans in jeopardy, however. One more victim of scam-investor Bernie Madoff, both the controlling Evenstad family (father and son Ken and Mark, chairman and CEO, respectively run the firm) and the company's profit-sharing fund were heavily invested in Madoff's Ponzi scheme that collapsed in late 2008. The FBI froze all investments when Madoff was arrested. 25. Paddock Laboratories, Inc 120 375 108.7 375 3940 Quebec Ave. North Minneapolis, MN 55427 United States Phone: 763-546-4676 Fax: 763-546-4842 www.paddocklabs.com 26. Hi-Tech Pharmacal Co., Inc Paddock Laboratories can help you corral all sorts of pharmaceutical goodies. The company develops and manufactures bioequivalent generic pharmaceuticals and OTC specialty products. Paddock's product line includes suppositories, diabetes treatments, topical powders, enemas, injectables, and dermatological offerings, as well as compounding bases and charcoal products. Its manufacturing facilities are located in Minneapolis, Minnesota. In addition to the US market, some of Paddock's products are sold in Europe and the Asia/Pacific region through distributors. The company was founded in 1977 by Chairman Bruce Paddock Hi-Tech Pharmacal combines imitation with innovation, making and distributing dozens of liquid and semi-solid prescription, overthe-counter (OTC), and nutritional products. The company primarily produces generic forms of prescription drugs, Ed Maloney VP Business Development Eyal Mares VP Operations 38 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 369 Bayview Ave. Amityville, NY 11701 United States Phone: 631-789-8228 Fax: 631-789-8429 www.hiteckpharm.com including off-brand versions of antibiotic Bactrim (made by Roche) and allergy medicine Flonase (from GlaxoSmithKline), as well as prescription skin creams, mouthwashes, and pediatric multivitamins. Hi-Tech also makes branded over-thecounter products, including a line of products for diabetes patients and the Zostrix line of pain and arthritis medications. In addition, the company has a handful of branded prescription products. Hi-Tech's expertise is with difficult-tomanufacture liquid and semi-solid dosage products, including ophthalmic and inhaled pharmaceuticals. It provides contract manufacturing services to other drug firms needing this specialty. The company's products are marketed across the US through large retailers and wholesale distributors. Sales of generic drugs bring in about threefourths of Hi-Tech's revenue, and the company wants to speed up R&D and regulatory submissions in order to expand its core prescription drug line. Its generic product line focuses on oral solutions and suspensions, creams and ointments, and nasal sprays, including cough and cold products and prescription vitamins. The company also expands its generic business through acquisitions. The company widened its product line when it purchased privately held ECR Pharmaceuticals for $5.1 million in 2009. ECR manufactures branded specialty prescription drugs (allergy, headache, and dermatitis) and promotes them through an in-house force of sales representatives 39 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 active in the mid-Atlantic and southern US. The firm's Health Care Products division, which handles its branded OTC business, targets diabetes sufferers with such products as DiabetiSweet (sugar substitute) and DiabetiDerm (moisturizing lotion). It intends to continue developing new products for its niche diabetes market, possibly expanding into complementary areas such as podiatry. The family of the company's founder Bernard Seltzer (who died in 2007), including CEO David Seltzer, own about a quarter of the firm 27. Akorn, Inc. 75.9 329 1925 West Field Court Suite 300 Lake Forest, IL 60045 United States Phone: 847-279-6100 Fax: 800-943-3694 www.akorn.com Akorn works hard to grow roots in several segments of the pharmaceutical industry. The company makes and sells specialty therapeutic and diagnostic pharmaceuticals in categories including ophthalmology, rheumatology, and anesthesia. Akorn's ophthalmic segment includes antibiotics, glaucoma treatments, lubricating ointments, diagnostic stains and dyes, and contact lens accessories. The firm's injectable segment includes drugs for rheumatoid arthritis and pain management. Akorn's products are sold nationally to hospitals, physicians, pharmacies, and wholesalers. Akorn also provides contract manufacturing services for other drugmakers. Chairman John Kapoor controls about a third of the company. Steven J. Meyer Director The company has internal development operations, but many of its products are generic drugs licensed from external sources. Akorn has teamed with three 40 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 Indian pharmaceutical firms -- Strides Arcolab, Cipla, and Serum Institute of India -- to make available to Akorn certain products (including an oral anti-infective and some oncology drugs) it can sell to hospitals and retailers in the US and Canada. With the launch of its Tetanus-Diptheria (Td) vaccine, the company formed a new operating segment dubbed biologics and vaccines. The Td vaccine is licensed from Massachusetts Biologic Laboratories. Following the successful launch of the Td vaccine, the company began to market and distribute an influenza virus vaccine Afluria (which it licensed from CSL Biotherapies). Both vaccines are marketed directly to hospitals and doctors, as well through wholesalers and distributors. The company's three biggest customers account for about half of its sales revenue. Top customers are Cardinal Health (which is also one of Akorn's biggest suppliers), McKesson, and AmerisourceBergen. Chairman Kapoor is the company's largest shareholder with a 32% stake, while Pequot Capital Management owns a 29% interest in Akorn. When Arthur Przybyl resigned as CEO in 2009, CFO Jeffrey Whitnell briefly served as interim CEO before choosing to leave the company. The board then appointed newcomers Raj Rai as interim CEO (and later gave him the position on a permanent basis) and Timothy Dick as CFO in mid-2009 41 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 28. Lannett Company, Inc. 119 277 9000 State Rd. Philadelphia, PA 191361615 United States Phone: 215-333-9000 Fax: 215-333-9004 www.lanett.com Lannett banks on the designation of "bioequivalent" for its products. The firm manufactures and markets generic prescription drugs such as painkillers (including two versions of Novartis' migraine treatment Fiorinal), anticonvulsants for epileptics, and Digoxin for congestive heart failure (a version of Lanoxin). The company has also developed a generic version of Abbott Laboratories' Synthroid. While it manufactures some of its products, Jerome Stevens Pharmaceuticals manufactures a significant portion of Lannett's inventories. Lannett prefers to focus on products with few generic competitors. Chairman William Farber and his family own more than half of the company. Stephen J. Kovary VP Operations Formed in 1942, Lannett is one of the oldest generics manufacturers in the US. While the company manufacturers and/or distributes over 20 different generic drugs, four formulas account for more than 75% of its sales. Most of its products are sold as generics, but some receive private labeling with a customer's name. Its customers include the big wholesale US pharmaceutical distributors as well as group purchasing organizations, chain drug stores, and other pharmaceutical companies. Its largest single customer, Walgreens, accounted for more than 35% of sales in 2007. Lannett holds supply and development agreements with a handful of domestic and foreign companies, including Banner Pharmacaps. It also has agreements for new product formulation and development 42 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 with other companies, but it intends to conduct its own manufacturing of any such products. The company's 2007 acquisition of Cody Laboratories expanded its manufacturing capacity and it has been steadily beefing up its product development staff to bring more products through the FDA approval process 29. Momenta Pharmaceuticals, Inc. 20.2 176 675 W. Kendall St. Cambridge, MA 02142 United States Phone: 617-491-9700 Fax: 617-621-0431 www.momentapharma.com Momenta Pharmaceuticals looks to increase momentum for its drug candidates. The biotech company specializes in engineering complex sugars to improve versions of existing drugs, as well as to discover moreeffective new drugs. By analyzing complex sugars, the company provides a more comprehensive picture of the roles sugars play in cell function, disease, and drug action. Momenta has several products in the pipeline, including M-Enoxaparin, a generic version of heparin drug Lovenox from Sanofi-Aventis to treat patients with deep-vein thrombosis and acute coronary syndromes. The company is also developing a generic version of multiple sclerosis treatment Copaxone (marketed by Sanofi-Aventis and Teva). Barbara Rosengren VP Novartis and its generics arm Sandoz have teamed with Momenta to develop and market M-Enoxaparin. This partnership has been the source of all of the company's revenues. The two companies are working to get the drug approved by the FDA. The company is also developing a proprietary anticoagulant candidate to treat cardiovascular ailments including acute coronary syndromes. Another discovery 43 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 stage program is exploring the role of complex sugars in cancer treatment. Momenta Pharmaceuticals was founded in 2001. Novartis owns a 13% stake in the company 30. Spectrum Pharmaceuticals, Inc 38 158 157 Technology Dr. Irvine, CA 92618 United States Phone: 949-788-6700 Fax: 949-788-6706 www.spectrumpharm.com Spectrum Pharmaceuticals sees a rainbow of opportunities in its drug development pipeline. The drug firm, which focuses on anti-cancer therapies, won FDA approval in 2008 for its injectable LEVOleucovorin for use with some osteosarcoma patients; the drug reduces the toxic effects of a certain type of chemotherapy. Another investigational candidate, EOquin, is being studied as a bladder cancer treatment. Spectrum has licensed global rights to a third anti-cancer compound, satraplatin, to GPC Biotech. Additionally, in 2008 the company sold to Par Pharmaceutical its share of profits for the authorized generic of GlaxoSmithKline's migraine drug Imitrex; Par had been Spectrum's marketing partner for the drug. Michael Adam SVP Pharmaceutical operations Spectrum has a number of other investigational drugs in its pipeline, most of which are focused in the areas of cancer and urology. And it continues to add candidates to the mix, usually through inlicensing compounds in later stages of development. In 2007, for instance, it licensed ortataxel, a potential cancer treatment, from Italian drug developer Indena. The company has been building its sales and marketing organization to launch LEVOleucovorin in the US in 2008. The 44 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010 drug, which the company is also developing for additional indications such as colorectal cancer, is already sold outside the US by Pfizer (through its acquisition of Wyeth) and Sanofi-Aventis. Spectrum works and plays well with others. It formed a collaboration agreement with Allergan for the development of EOquin for bladder treatment in 2008. The two companies will work together to develop and commercialize the drug; the deal will earn Spectrum $42 million plus a potential additional $304 million in milestone payments. That same year Spectrum formed RIT Oncology, a joint venture with Cell Therapeutics to market that company's drug Zevalin, a treatment for nonHodgkin's lymphoma. In 2009 Cell Therapeutics exercised its option to sell the remaining interest in RIT Oncology to Spectrum 45 Γραφείο Οικονομικών & Εμπορικών Υποθέσεων Σικάγο, Ιούνιος 2010