Schering-Plough Schering-Plough Corporation Established 1970 2000 Galloping Hill Road Ownership Public Kenilworth Total Staff 30,500 NJ 07033-0530 Research Focus Pharmaceutical USA Total Sales ($US) 8,334.0 (Dec 03) Pharma Sales ($US) 6,672.0 (Dec 03) Scrip Ranking 17 Phone Number +1 908 298 4000 Web Address www.schering-plough.com Principals Chairman & CEO Fred Hassan Elected April 2003. Previously Chairman & CEO, Pharmacia Executive V-P & CFO Robert J Bertolini Appointed November 2003 Executive V-P & President, Carrie S Cox Appointed May 2003 Global Pharmaceuticals Executive V-P, Discovery Catherine Strader Promoted from Senior V-P, Research Discovery Biological Research Senior V-P & President, Dr Cecil B Pickett Promoted May 2004. Previously Schering-Plough Research Senior V-P, Basic Research, Merck Institute Research Labs Senior V-P, Medical Affairs & Dr Robert J Spiegel Previously Senior V-P, Clinical CMO, Schering-Plough Research Research Institute Executive V-P & General Thomas J Sabatino Jr Appointed March 2004. Previously Counsel V-P & General Counsel, Baxter Senior V-P, Global Compliance Brent Saunders Appointed November 2003 & Business Practices Senior V-P, Global Licensing Michael J DuBois Appointed September 2003 Phone: +1 908 298 6720 firstname.lastname@example.org Senior V-P, Global Human C Ron Cheeley Joined July 2003. Previously V-P, Resources Global Compensation, Pharmacia Senior V-P, Global Quality Richard S Bowles Joined January 2001 Operations Senior V-P, Global Business Bruce R Reid Appointed July 2003. Previously, Operations V-P, Global Business Operations, Pharmacia V-P, Investor Relations Alex Kelly Appointed May 2004 V-P & Chief Information Officer Karl D Salnoske Appointed November 2004. Formerly President & CEO, Adaptive Trade and also with IBM V-P, Global Information Christopher Kelly Appointed March 2005. Previously Technology, Global Supply with IBM Chain/Global Quality Operations V-P, Global Project Management Dr Michael Perelman Appointed May 2005 & Global Regulatory Affairs V-P, Global Project Dr Sumant Ramachandra Appointed May 2005. Previously Management, Schering-Plough Group Leader, US Medical Research Institute Oncology Therapeutic Area, Pfizer V-P, Business Development, Nancy Miller-Rich Schering-Plough Consumer Health Care V-P, Strategic Alliances & Dr Thomas Picone Global Licensing Group Head, Global Speciality Raul E Kohan Joined 1984 as Finance Director, Operations & President, Animal Venezuela. Appointed to V-P, Health Finance Operations, Schering- Plough International in 1990 Senior Director, Technology Dr Arthur Bertelsen Phone: +1 908 740 3290 Acquisition & External Fax: +1 908 740 7164 Collaboration email@example.com Manager, Global Licensing Ann Martin Updated by LH on 27/05/2005. Licensing contact Michael J Dubois, Senior V-P, Global Licensing Phone: +1 908 298 6720 E-mail: firstname.lastname@example.org Pharma: Ann Martin, Manager, Global Licensing E-mail: email@example.com Consumer Products: Nancy Miller-Rich, V-P, Business Development, Schering-Plough Consumer Health Care Three Oak Way, Berkeley Heights, NJ 07922-0603 Corporate: Dr Thomas Picone, V-P, Strategic Alliances & Global Licensing Updated by LH on 14/07/2005. The company Schering-Plough is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical and healthcare products worldwide. Pharmaceutical products include prescription drugs and animal health products. Healthcare products include OTC, foot care and sun care products. The company operates in most countries worldwide under the Schering-Plough name. Mergers & acquisitions 1997 June Schering-Plough acquires the worldwide animal health business of Mallinckrodt Veterinary 2000 July Schering-Plough purchases the summit, NJ, research and office facility from Novartis 2005 January Schering-Plough agrees to acquire most of NeoGenesis' assets, subject to normal closing conditions (Press release, Schering-Plough, 20 Jan 2005). COMPLETED FEBRUARY 2005 (Press release, Schering-Plough, 18 Feb 2005) April Faes Pharma acquires the product Lixacol from Schering-Plough (Press release, Faes, 22 Apr 2005) Updated by EW on 07/06/2005. Operating locations/subsidiaries Canji (a research company) DNAX (a biotechnology research company) Essex Chemie Schering-Plough Pharmaceuticals (encompasses global research, development, manufacturing and marketing of human use and animal health pharmaceuticals) Key Pharmaceuticals (specialises in the development of controlled-release forms of ethical drugs) Schering-Plough HealthCare Production (produces OTC goods) Warrick Pharmaceuticals (manufactures generics) Schering-Plough Animal Health Africa Egypt, South Africa Asia China, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Pakistan, Philippines, Singapore, South Korea, Taiwan, Thailand Australasia Australia Europe Austria, Belarus, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Romania, Russia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine, UK North America Canada, Caribbean, Mexico, USA South America Argentina, Brazil, Chile, Colombia, Ecuador, Paraguay, Peru, Uruguay, Venezuela Updated by EW on 06/07/2005. Joint ventures With Location Joint venture YuHan Corporation South Korea as Schering-Plough Korea (Schering-Plough: 90%; YuHan: 10%) Shanghai China as Shanghai Schering-Plough Pharmaceutical Company Pharmaceuticals (Schering: 55%) corporations Merck Unknown as Merck/Schering-Plough Pharmaceuticals Agreements 1996 Dura (Elan) to co-promote Uni-Dur (once-daily theophylline) in the US Apogepha for worldwide marketing rights to the urinary incontinence therapy, propiveripine. AMENDED JULY 2004, as UK marketing rights are granted to Amdipharm GlaxoSmithKline (previously whereby GlaxoSmithKline sub-licenses Human Genome Sciences through SmithKline genomic data to Schering-Plough, in return for shared development Beecham) and marketing of any resulting products Biogen Idec (previously for rights to market the multiple sclerosis treatment, Avonex through Biogen) (interferon -1a), in Spain Sequus (Alza) for exclusive marketing rights to Sequus’ Kaposi’s sarcoma therapy, Caelyx (doxorubicin HCl) outside the US, Japan and certain other markets Applied Pharma Research for a licence to a sucralphate suspension Vita-Invest for exclusive marketing rights to commercialise Vita’s OTC products 1997 Oscient Pharmaceuticals to develop new treatments for asthma. EXTENDED 2000 (previously through Genome Therapeutics) University of Toronto, for three years to fund research into the role of two mutated genes, Canada presenilins, in Alzheimer’s disease Novopharm through Warrick to develop, manufacture and market worldwide Novopharm’s generic biopharmaceuticals Myriad Genetics to discover genes which could lead to novel therapeutics for the treatment of prostate and other cancers Dendreon (previously through Dendreon San Diego, to develop and market oral protease through Corvas) inhibitors for the treatment of hepatitis C UCB (previously through to develop oral treatments for asthma and other inflammatory Celltech Chiroscience) diseases based on Celltech Chiroscience’s phosphodiesterase IV inhibitors Reckitt & Colman for exclusive worldwide distribution rights to Reckitt & Coleman’s buprenorphine line of prescription products excluding Japan, Taiwan and South Korea Oscient Pharmaceuticals to discover and develop novel antifungals and to acquire non- (previously through Genome exclusive licence to Genome Therapeutic Corp’s proprietary Therapeutics) sequence database, PathoGenome Aphton whereby Schering-Plough acquires all rights to Aphton's anti- gastrin immunogen for use in animal health applications Zonagen for worldwide rights to Zonagen’s Vasomax (phentolamine) oral erectile dysfunction treatment Sepracor for exclusive global rights to Sepracor’s patents on the active metabolite of the Schering-Plough antihistamine, Claritin (loratadine) 1998 Transgène for five years to develop six gene therapy products using Transgène’s adenoviral delivery platform. Initial development will focus on Schering-Plough’s p53 tumour suppressor gene Genzyme Molecular to develop gene therapy products for cancer, based on Genzyme’s Oncology lipid delivery technology Abgenix to use Abgenix' XenoMouse transgenic mouse technology for the generation of fully human antibodies in the field of inflammation Solvay whereby Solvay acquires US marketing rights to Schering- Plough’s Prometrium (oral progesterone) OncorMed (Gene Logic) whereby OncorMed conducts sample analysis to determine the p53 status of prospective clinical trial candidates for Schering-Plough’s rAd/p53 anticancer gene therapy Novo Nordisk for US co-promotion rights to Novo Nordisk’s insulin drug and device ranges, including the oral antidiabetic, Prandin (repaglinide) Chugai for global exclusive marketing rights, excluding Japan, to Chugai’s vitamin D3 analogue, maxacalcitol (22-oxacalcitriol), for psoriasis Ribi ImmunoChem for global exclusive distribution, marketing and selling rights to Ribi’s Melacine melanoma vaccine Centocor (Johnson & for exclusive rights to Centocor’s monoclonal antibody, Avakine Johnson) (infliximab), for Crohn’s disease and rheumatoid arthritis, in all territories except the US, Japan and other parts of the Far East Sparta to use Sparta’s Spartaject technology to develop a formulation of Schering-Plough’s oral anticancer, Temodal (temozolomide) Immune Response to combine Immune Response’s GeneDrug delivery technology with Schering-Plough’s interferon -2b and another proprietary gene, to develop hepatitis B and C gene therapy products Versicor (previously through to screen Versicor’s microbial compound library against bacterial Biosearch Italia) and fungal test organisms supplied by Schering-Plough Pharmacopeia for five years, whereby Schering-Plough subscribes to Pharmacopeia’s drug discovery and optimisation technologies Incyte Pharmaceuticals for rights to Incyte’s LifeSeq gene sequence and expression database and LifeSeq FL database of full-length genes AstraZeneca whereby Essex Chemie will return marketing rights for Losec (omeprazole), an anti-peptic ulcer drug, and Perfudal/Prevex (felodipine), a calcium antagonist, to AstraZeneca TerraGen Discovery through the Schering-Plough Research Institute, for the discovery and development of novel anti-infective therapeutics derived from microbial organisms to combat emerging strains of antibiotic- resistant pathogens EPIX Pharmaceuticals (previously through NeoGenesis Pharmaceuticals) for the discovery of novel compounds for diagnostic imaging 1999 Medi-Ject whereby Medi-Ject provides the drug injector and Becton Corporation/Becton Dickinson provides the disposable needle-free syringe component Dickinson of a needle-free drug delivery system for the administration of Intron A (interferon alfa-2b, recombinant for injection) Vernalis (previously British to develop and commercialise Vernalis’ matrix metalloproteinase Biotech) inhibitors, including marimastat and BB-3644, for the treatment of cancer in all territories excepting Japan and the Far East Duramed whereby Duramed acquires rights to Schering-Plough’s progesterone AtheroGenics to develop and commercialise drugs for the treatment and prevention of restenosis, including AtheroGenics’ AGI-1067 lead compound for post-percutaneous coronary intervention restenosis. TERMINATED Millennium (previously to collaborate on the study of the antiplatelet agent Integrilin in through Cor)/Genentech combination with the new single bolus fibrinolytic, TNKase, in patients with acute myocardial infarction Hemispherx whereby Hemispherx acquires rights to use Schering-Plough’s Puerto Rican production facility to manufacture its Ampligen chronic fatigue syndrome/myalgic encephalitis product Biovail (previously through whereby DJ Pharma acquires US marketing rights to Schering- DJ Pharma) Plough’s Cedax (ceftibuten) oral cephalosporin. TERMINATED AUGUST 2004, whereby Shionogi USA begins marketing and distributing Cedax in the US (Press release, Schering-Plough, 27 Aug 2004)) Curis (previously through (previously through NeoGenesis Pharmaceuticals) for access to Creative BioMolecules) Neogenesis’ diverse library of small molecules to identify lead compounds for the treatment of chronic degenerative disorders 2000 Drug Royalty for a 14-year deal whereby Drug Royalty acquires royalty interests in worldwide sales of Schering-Plough’s antihistamine, Claritin Bristol-Myers Squibb to co-promote Bristol-Myers Squibb’s new fluoroquinolone antibiotic, Tequin (gatifloxacin), in the US for the treatment of respiratory tract infections Oscient Pharmaceuticals whereby Genome Therapeutics will generate high-quality DNA (previously through Genome sequence information in support of gene discovery projects at Therapeutics) Schering-Plough. Genome Therapeutics will employ its proprietary sequencing techniques, automation, bioinformatics and quality control procedures to generate sequence reads and provide analysis of the sequenced regions Oscient Pharmaceuticals to extend an existing alliance, to identify and develop novel anti- (previously through Genome infectives for drug-resistant bacteria including Staphylococcus Therapeutics) aureus, a leading cause of hospital-acquired infections; the extended agreement carries the alliance to 30 September 2001. CONCLUDED Merck & Co to develop and market two potential blockbuster fixed-dose combination products in the cholesterol-lowering and respiratory categories in the US Valeant (previously ICN) for a long-term strategic collaboration for the licensing of drugs for the treatment of hepatitis C and other indications. Schering-Plough has the right of first and last refusal to license two antiviral drugs currently in the Valeant research pipeline, levovirin and viramidine, and other compounds that Valeant may develop in infectious and other diseases Yuhan for exclusive South Korean distribution rights to Schering-Plough’s oncology product, ulexin (flutamide), Intron-A (interferon-α), Ethyol (amifostine)/antihypersensitive products, Renormyl (spirapril HCL) Texas Biotechnology for a worldwide development and marketing deal, involving a new class of orally active asthma compounds, VLA-4 antagonists, worth up to $87 million to Texas Biotechnology Ono for exclusive development and marketing rights in Central and South America to the leukotriene antagonist, pranlukast. Schering- Plough will develop capsule and dry syrup formulations of the product for asthma, with Ono being responsible for all manufacturing Merck & Co (previously through NeoGenesis Pharmaceuticals) to identify and optimise chemical compounds for new drug discovery leads against multiple targets selected from important protein families across a broad range of therapeutic areas 2001 Genetech/Millennium to co-promote Integrilin for non-ST-segment acute coronary (previously through Cor) syndromes, as well as TNKasea (Tenecteplase) and Activase (Alteplase, recombinant) for acute ST-segment elevation myocardial infarction in hospitals across the US. In June 2004, Millennium reacquires the European marketing rights for Integrilin. Schering-Plough will continue to co-promote Integrilin with Millennium in the US and retains rights to the product in other territories outside of Europe (Press release, Schering-Plough, 23 Jun 2004) Shionogi whereby Shionogi will co-market Schering-Plough's non-sedating once-daily antihistamine, Claritin (loratadine) in Japan Medarex to collaborate on the development of fully human antibody therapeutics for the treatment of chronic conditions, using Medarex's UltiMAb technology to generate antibodies against disease targets identified by Schering-Plough Roche for a cross-licensing deal designed to settle all patent disputes over the two companies' peginterferon products for the treatment of hepatitis C NeoGenesis Drug Discovery to use NeoGenesis’ Automated Ligand Identification System (ALIS) to identify new small-molecule drug candidates Dainippon for the co-marketing in Japan of a metered-dose inhaler formulation of the anti-asthmatic, Qvar (beclometasone dipropionate) AtheroGenics whereby AtheroGenics re-acquires all rights to its lead candidate, AGI-1067, a small-molecule product with potential in the prevention and treatment of post-angioplasty restenosis Cognia Corporation whereby Cognia licenses its Transpath Professional database to Schering-Plough Trine Pharmaceuticals (previously through NeoGenesis Pharmaceuticals) to discover and (formerly Essential develop new classes of antibiotics utilising a specified number of Therapeutics (previously proprietary bacterial in vivo essential gene targets from Microcide's through Microcide)) VALID microbial genomics platform, together with NeoGenesis' proprietary ALIS screening system and its mass-coded NeoMorph small molecule libraries to identify and optimise chemical compounds with antibacterial activity UCB (previously through (previously through NeoGenesis Pharmaceuticals) whereby Celltech (previously through Celltech will provide a large number of potential protein targets it Oxford GlycoSciences)) has identified and NeoGenesis will apply its high-throughput integrated technologies for chemistry, screening and computational biology to search for lead compounds Biogen Inc (previously through NeoGenesis Pharmaceuticals) for a multi-year, multi-target research deal where NeoGenesis will assist on drug discovery across a broad range of therapeutic areas and Biogen will commercialise and market any drugs that result from the collaboration UCB (previously through (previously through NeoGenesis Pharmaceuticals) whereby Celltech) NeoGenesis will use its proprietary chemical genomics technology to identify and optimise new chemical compounds as novel drug discovery leads against multiple disease targets within Celltech's core therapeutic areas. Celltech will be responsible for the commercialisation of all products arising from the collaboration Mitsubishi-Tokyo (previously through NeoGenesis Pharmaceuticals) to discover Pharmaceuticals small-molecule drug candidates for a high value therapeutic area. Mitsubishi-Tokyo Pharmaceuticals will pay NeoGenesis for discovery as well as traditional milestones and royalties on products resulting from the collaboration. In September 2002, NeoGenesis earns a milestone payment by successfully delivering high quality lead molecules for a difficult target provided by Mitsubishi Pharma. EXPANDED SEPTEMBER 2002 whereby NeoGenesis will further optimise the lead compounds Tranzyme (previously through NeoGenesis Pharmaceuticals) in the areas of gene expression and protein function discovery which will utilise Tranzyme's recently introduced TExT (Trans Expression Technology) in support of the chemical genomics program at NeoGenesis. EXPANDED NOVEMBER 2003 to include additional genes of therapeutic interest Amgen (previously through (previously through NeoGenesis Pharmaceuticals) to discover small Tularik) molecule drug candidates in multiple therapeutic areas where Tularik will provide disease targets to which NeoGenesis will apply its drug discovery technologies. The companies will share equally in the development and potential profits from future drug candidates that they jointly discover against certain targets Immusol (previously through NeoGenesis Pharmaceuticals) to discover small molecule drug candidates for the treatment of HIV whereby Immusol will provide novel, biologically validated HIV cellular drug targets to which NeoGenesis will apply its drug discovery technologies 2002 Exelixis for a collaboration to create customised compound libraries for use in the two companies' internal research programmes. Exelixis will use its chemistry technology to generate the libraries of compounds, which will be jointly designed by the two parties Gene Logic for a GeneExpress CustomSuite database access deal for use in its pharmaceutical research and development operations. In addition, Schering-Plough Research Institute and Gene Logic will engage in a pilot toxicity study Human Genome Sciences whereby Schering-Plough acquires exclusive rights to develop and commercialise two human antibodies from Human Genome Sciences’ technology. Human Genome Sciences will receive milestone payments and royalties on sales from products that may result from research on each of the two antibodies Amsterdam Molecular whereby AMT licenses rights to Schering-Plough's interleukin-10 Therapies (AMT) patent intending to use the patent portfolio to expand the scope of its IL-10 ex vivo gene therapy for the maintenance of remission in Crohn's disease Enzon whereby Enzon is entitled to royalties on worldwide sales of Peg- Intron. Schering-Plough holds an exclusive worldwide license to Peg-Intron Affymetrix for an EasyAccess Silver program under which SPRI will gain broad access to Affymetrix' standard and custom GeneChip arrays, instrumentation and software to monitor gene expression for use in biopharmaceutical research and development activities Novartis whereby Schering-Plough gains the marketing and distribution rights to Leucomax (molgramostim) and the licensing rights to Foradil Aerolizer (formoterol fumarate inhalation powder) ALK-Abello in October, to conduct a clinical trial of an ALK-Abelló tablet- based immunotherapy for the treatment of allergy symptoms caused by grass pollens. Schering-Plough will co-develop the grass-pollen allergy tablet and all other non-injectable allergy products in ALK- Abelló’s research pipeline. TERMINATED DECEMBER 2003 whereby ALK-Abelló reacquires the exclusive worldwide rights to these products (Press release, Schering-Plough, 16 Dec 2003) Triad Therapeutics to discover new antifungal compounds whereby Triad will use its technologies to generate small-molecule drug candidates based on the oxidoreductase gene family to inhibit a target provided by SPRI. SPRI will pay Triad an up-front payment and may make further milestone and royalty payments if it chooses to develop any compounds discovered Pharmagene for two years, whereby SPRI will gain access to the Pharmagene TargetEvaluator database and will also be able to nominate genes for profiling in specific human-diseased tissues from a range of patient types on an exclusive basis Insert Therapeutics through Canji, for a research collaboration for the targeted delivery of therapeutic genes to cancer cells in vivo CIMA LABS (Cephalon) for a product development, licence and supply deal for a prescription product that will utilise CIMA's OraSolv fast-dissolve drug delivery system Sanofi-Aventis (previously (previously through NeoGenesis Pharmaceuticals) for a multi-year through Aventis) collaboration to attempt to identify novel therapeutic agents for the treatment of infectious diseases. NeoGenesis will use its Chemical Genomics technologies to attempt to identify compounds that exhibit a high degree of binding affinity for Aventis' drug targets and will optimise and validate any biologically active compounds identified through the collaboration Active Pass (previously through NeoGenesis Pharmaceuticals) to discover and develop drugs that target ABC transporters Massachusetts General (previously through NeoGenesis Pharmaceuticals) to discover and Hospital develop new drugs that target cancer and inflammatory diseases. MGH will supply NeoGenesis with proteins believed to play important roles in oncology and inflammatory diseases. NeoGenesis will apply its NeoMorph 10 million compound libraries and its proprietary Automated Ligand Identification System (ALIS) to these targets to discover small molecule drug-like compounds exhibiting high affinity and selectivity against the target proteins Pfizer (previously through NeoGenesis Pharmaceutials) to discover and develop new drugs that target certain human diseases. Pfizer will supply NeoGenesis with proteins believed to play important roles in human disease. NeoGenesis will apply its NeoMorph compound libraries and its proprietary Automated Ligand Identification System (ALIS) to these targets with the goal to discover and optimise small molecule drug-like compounds exhibiting high binding affinity and selectivity for the target proteins. Pfizer will manage all development activity for drug leads identified by NeoGenesis 2003 Pharmagene to grant SPRI access to its target validation technology, TargetEvaluator. SPRI will be able to use the human tissue-based gene expression database for the next two years to validate its own targets as well as nominating genes for profiling in specific human diseased tissues from a range of patient types Three Rivers in February, whereby Schering-Plough licenses US patents on its Pharmaceuticals ribavirin hepatitis C therapy, Rebetol Teva Pharmaceuticals in March, to grant a non-exclusive, non-sublicensable licence to its US ribavirin patents. Teva will pay Schering Plough a royalty on their respective ribavirin sales Geneva Pharmaceuticals in March, to grant a non-exclusive, non-sublicensable licence to its US ribavirin patents. Geneva will pay Schering Plough a royalty on their respective ribavirin sales Novartis in April, to jointly develop and market worldwide a combination of Asmanex (mometasone furoate) and Foradil (formoterol fumarate) in a single inhalation device for the treatment of asthma and chronic obstructive pulmonary disease Amgen (previously through NeoGenesis Pharmaceuticals) in August, for a multi-year research and discovery collaboration focusing on the discovery of small molecule drugs aimed at certain human diseases, including cancer, neurodegenerative and inflammatory diseases. NeoGenesis will use its drug discovery technologies, including its proprietary ALIS (Automated Ligand Identification System) platform, NeoMorph compound libraries and lead optimisation technologies to discovery drug candidates against selected targets (Scrip Daily Online, 8 Aug 2003, S00811608) Pharmacopeia in September, whereby Pharmacopeia uses its internal compound library to identify new drug candidates against multiple therapeutic targets from Schering-Plough's R&D programs. In October 2004, a research milestone is triggered after Schering-Plough initiates preclinical development of a drug candidate (Press release, Schering-Plough, 5 Oct 2004). In November 2004, a research milestone is reached in the oncology therapeutic area, triggering a payment to Pharmacopeia (Press release, Schering-Plough, 30 Nov 2004). In April 2005, a research milestone is triggered after Schering-Plough initiates preclinical development of a novel small molecule drug candidate (Press release, Schering-Plough, 13 Apr 2005) Helsinn Healthcare in October, whereby Schering-Plough acquires exclusive rights in Latin America, Australia, New Zealand and the Caribbean to develop and commercialise Helsinn’s palonosetron, for the prevention of nausea and vomiting in chemotherapy patients. Schering-Plough will be responsible for product commercialisation and will pay Helsinn an upfront licence fee, royalties on sales and subsequent milestone payments (Scrip Daily Online, 3 Oct 2003, S00818594) Andrx in October, to settle patent litigation related to Andrx's generic version of Schering-Plough’s Claritin-D 24 Hour Extended Release Tablets. Under terms of the agreement, Schering-Plough has provided a licence to a relevant patent pertaining to Claritin-D 24 Hour Extended Release Tablets to Andrx ViroPharma in November, to license ViroPharma's intranasal formulation of the antiviral compound pleconaril to Schering-Plough for the treatment of the common cold in the US and Canada. Schering-Plough will pay ViroPharma an upfront option fee of $3 million. EXTENDED AUGUST 2004 (Scrip Daily Online, 27 Aug 2004, S00855342). In December 2004, Schering-Plough assumes responsibility for all future development and commercialisation of pleconaril and pays ViroPharma an initial licence fee of $10 million (Press release, Schering-Plough, 3 Dec 2004). In January 2005, Schering-Plough purchases the existing inventory of pleconaril bulk drug substance for $6 million (Press release, Schering-Plough, 12 Jan 2005) 2004 Toyama in June, for a definitive licence for garenoxacin (T-3811), Toyama's proprietary quinolone antibacterial agent. Toyama grants to Schering-Plough exclusive rights to develop, use and sell garenoxacin worldwide, excluding Japan, Korea and China (Press release, Schering-Plough, 22 Jun 2004) Achaogen (previously through NeoGenesis Pharmaceuticals) in August, for a research and discovery collaboration whereby NeoGenesis will use its unique drug discovery technologies, including its proprietary ALIS (Automated Ligand Identification System) platform, NeoMorph compound libraries, and lead optimisation technologies to discover drug candidates against selected targets (Press release, Schering-Plough, 26 Aug 2004) Shionogi USA in August, to market and distribute Cedax in the US (Press release, Schering-Plough, 27 Aug 2004) Bayer in September, whereby Schering-Plough acquires exclusive rights to market, sell and distribute Bayer's primary care products Avelox (moxifloxacin HCl) and Cipro (ciprofloxacin HCl) in the antibiotics category and will undertake on behalf of Bayer the US commercialisation activities for the erectile dysfunction medicine Levitra (vardenafil HCl) under Bayer's co-promotion agreement with GlaxoSmithKline. Bayer will support the promotion of certain Schering-Plough oncology products in the US and key European markets for a defined period of time (Press release, Schering- Plough, 13 Sep 2004) Shionogi in November, to jointly market Claritin RediTabs Tablet, a rapidly- disintegrating tablet used in the treatment of allergy on a nationwide scale (Press release, Schering-Plough, 16 Nov 2004) Themis Medicare in December, with Schering-Plough’s animal health business unit, for a new drug delivery system. Themis transfers patent rights to Schering and provides its "technical know-how" and raw materials for developing products which will be marketed in other countries (Press release, Schering-Plough, 3 Dec 2004) 2005 PediaMed in February, to co-promote a respiratory treatment to the paediatric medical community in the US (Press release, Schering-Plough, 22 Feb 2005) Southern Research Institute in May, to discover novel compounds as potential new products to treat infectious disease (Press release, Schering-Plough, 9 May 2005) ViroLogic in July, through Schering-Plough Research Institute, to use ViroLogic's novel HIV resistance testing technology to support Schering-Plough's drug discovery and development programmes in a deal worth $4.8 million (Press release, ViroLogic, 6 Jul 2005) Migenix in July, whereby Schering-Plough supply Pegetron (peginterferon alfa-2b powder for solution plus ribavirin 200 mg capsules) and provide certain technical and laboratory support and other services for Migenix' upcoming MX-3253 Phase II combination study in chronic HCV patients. Schering-Plough also receive limited periods of exclusivity for data review of clinical trial results (Press release, Migenix, 13 Jul 2005) Updated by LH on 14/07/2005. Financial figures Summary (US$ million) Year ended Dec 2005(3m) 2004 2003 2002 2001 2000 Net sales 2,369.00 8,272.00 8,334.00 10,180.00 9,802.00 9,815.00 R&D expenditure 384.00 1,607.00 1,469.00 1,425.00 1,312.00 1,333.00 Net income (loss) 127.00 (947.00) (92.00) 1,974.00 1,943.00 2,423.00 EPS 0.07 (0.67) (0.06) 1.34 1.32 1.64 Total assets 14,921.00 15,911.00 15,102.00 14,136.00 12,174.00 10,805.00 Net Sales by Major Therapeutic Category (US$ million) Year ended Dec 2005(3m) 2004 2003 2002 2001 Global pharmaceuticals 1,846.00 6,417.00 6,672.00 8,788.00 8,369.00 Other pharmaceuticals 430.00 1,522.00 597.00 764.00 656.00 Foot Care 84.00 331.00 275.00 290.00 310.00 Over-the-counter (OTC) 162.00 578.00 563.00 275.00 188.00 Sun Care 84.00 176.00 127.00 193.00 208.00 Key Product Sales (US$ million) Year ended Dec 2005(3m) 2004 2003 2002 2001 1 Intron franchise 143.00 881.00 1,851.00 2,736.00 1,447.00 Remicade 220.00 746.00 540.00 337.00 166.00 * * Clarinex 144.00 692.00 694.00 598.00 - Nasonex 183.00 594.00 500.00 523.00 524.00 PEG-Intron 170.00 563.00 - - - Temodar 131.00 459.00 324.00 278.00 180.00 Integrilin 75.00 325.00 306.00 304.00 231.00 Claritin Rx 111.00 321.00 370.00 1,260.00 2,285.00 Intron A 73.00 318.00 - - - Caelyx 43.00 150.00 111.00 - - # # Proventil 125.00 128.00 230.00 1 * # Includes PEG-Intron and Intron A Clarinex / Aerius Figures unavailable In March 2000, Schering-Plough completed a $1 billion share repurchase program and initiated a new $1.5 billion share repurchase program. In November 2003, the company completed the offering of $1.25 billion aggregate principal amount of 5.3% senior noted due 2013 and $1.15 billion aggregate principal amount of 6.5% senior notes due 2033 in an underwritten registered public offering. Updated by EW on 21/04/2005. Number of Projects in R&D (summary) Launched 22 Phase III Clinical Trial 3 Preclinical 15 Registered 1 Phase II Clinical Trial 4 Pre-registration 2 Phase I Clinical Trial 2 Number of Projects in R&D (detail) Drug Name Main therapy Main therapy status Alimentary/Metabolic Products (2) MCH-1 receptor antags, S-P Anorectic/Antiobesity Preclinical PTP-1b inhibitors,Schering-Pl Antidiabetic Preclinical Anti-infective Products (8) ribavirin + \a-interferon, SP Antiviral, other Launched thymalfasin Immunomodulator, anti-infective Launched moxifloxacin Quinolone antibacterial Launched posaconazole Antifungal Pre-registration pleconaril Antiviral, other Phase III Clinical Trial garenoxacin Quinolone antibacterial Phase III Clinical Trial SCH-D Antiviral, anti-HIV Phase II Clinical Trial NMT inhibitors, S-P Antifungal Preclinical Anticancer Products (12) temozolomide Anticancer, alkylating Launched toremifene Anticancer, hormonal Launched amifostine Radio/chemoprotective Launched palonosetron Radio/chemoprotective Launched Sch-57050 Anticancer, hormonal Phase III Clinical Trial lonafarnib Anticancer, other Phase II Clinical Trial Akt-1 inhibitors, S-P Anticancer, other Preclinical fatty acid synthase inhibs,S-P Anticancer, other Preclinical hormone modulators, S-P Anticancer, other Preclinical kinase inhibitors, Schering-Pl Anticancer, other Preclinical PS-095760 Anticancer, other Preclinical transcription factor mods, S-P Anticancer, other Preclinical Biotechnology Products (4) infliximab Monoclonal antibody, chimaeric Launched interferon, Biogen (\b1a) Recombinant interferon Launched interferon gene therapy, Canji Gene therapy Preclinical Pharmaprojects No. 5297 Genomics-based drug discovery Preclinical Drug Name Main therapy Main therapy status Blood and Clotting Products (1) PAR-1 receptor antagonists, SP Antithrombotic Preclinical Cardiovascular Products (2) eptifibatide Antianginal Launched ezetimibe Hypolipaemic/Antiatherosclerosis Launched Formulations (9) interferon, Enzon (\a2b) Formulation, conjugate, pegylated Launched ezetimibe + simvastatin Formulation, fixed-dose Launched combinations mometasone furoate, DPI Formulation, inhalable, dry Launched powder mometasone furoate, nasal Formulation, inhalable, solution Launched doxorubicin, Stealth Formulation, optimized, liposomes Launched progesterone, Schering-Plough Formulation, optimized, Launched microencapsulate loratadine, Zydis Formulation, oral, orally- Launched disintegrating formoterol, SkyePharma Formulation, inhalable, dry Registered powder histamine dihydrochloride,Maxi Formulation, other Pre-registration Genitourinary (including sex hormones) (2) vardenafil Male sexual dysfunction Launched dasantafil Male sexual dysfunction Phase II Clinical Trial Musculoskeletal Products (2) PS-291822 Anti-inflammatory Phase I Clinical Trial CB2 inverse agonists, Schering Anti-inflammatory Preclinical Neurological Products (3) felbamate Antiepileptic Launched Sch-63390 Antiparkinsonian Phase II Clinical Trial BACE inhibitors, S-P Cognition enhancer Preclinical Respiratory Products (4) desloratadine Antiallergic, non-asthma Launched pranlukast Antiasthma Launched PS-938285 Respiratory Phase I Clinical Trial TBC-4746 Antiasthma Preclinical Marketed pharmaceutical products (originated) Drug Name Brand Name Main therapy Anti-infective Products (3) clotrimazole+betameth+gentami Triderm Antifungal Drug Name Brand Name Main therapy isepamicin Isepacin Aminoglycoside antibiotic netilmicin Netromycin Aminoglycoside antibiotic Anticancer Products (1) flutamide Drogenil Anticancer, hormonal Cardiovascular Products (2) ezetimibe Zetia Hypolipaemic/Antiatherosclerosis spirapril Renormax Antihypertensive, renin system Dermatological Products (2) alclometasone dipropionate Delonal Antipruritic/inflamm, allergic mometasone furoate Elocon Antipruritic/inflamm, allergic Formulations (11) clotrimazole + betamethasone Lotriderm Formulation, fixed-dose combinations ezetimibe + simvastatin Zintrepid Formulation, fixed-dose combinations interferon, Schering-P (\a2b) Viraferon Formulation, parenteral, other mometasone furoate, DPI Asmanex Twisthaler Formulation, inhalable, dry powder mometasone furoate, nasal Nasonex AQ Formulation, inhalable, solution naproxen, Key naproxen, Key Formulation, modified-release, other nitroglycerin, Key Nitro-Dur Formulation, transdermal, patch progesterone, Schering-Plough Prometrium Formulation, optimized, microencapsulate ribavirin+PEG-interferon(\a2b) PEG-Intron A + ribavirin Formulation, fixed-dose combinations theophylline, Key Theo-Dur Formulation, modified-release, other theophylline, Schering-Plough Uni-Dur Formulation, other Neurological Products (2) halazepam Paxipam Anxiolytic quazepam Selepam Hypnotic/Sedative Respiratory Products (1) loratadine Clarityn Antiallergic, non-asthma Marketed pharmaceutical products (licensed in) Drug Name Brand Name Main therapy Anti-infective Products (9) ceftezole Alomen Cephalosporin, injectable ceftibuten Cedax Cephalosporin, oral ciprofloxacin Cipro Quinolone antibacterial Drug Name Brand Name Main therapy clotrimazole Lotrimine Antifungal fenticonazole Lomexin Antifungal moxifloxacin Avelox Quinolone antibacterial ribavirin Rebetol Antiviral, other ribavirin + \a-interferon, SP Rebetol Combination Therapy Antiviral, other sisomicin Sisomin Aminoglycoside antibiotic Anticancer Products (4) amifostine Ethyol Radio/chemoprotective temozolomide Temodal Anticancer, alkylating toremifene Fareston Anticancer, hormonal vinorelbine Navelbine Anticancer, other Biotechnology Products (5) alteplase Activase Recombinant, other infliximab Remicade Monoclonal antibody, chimaeric interferon, Biogen (\a2b) Intron-A Recombinant interferon interferon, Biogen (\b1a) Avonex Recombinant interferon molgramostim Leucomax Recombinant growth factor Cardiovascular Products (4) eptifibatide Integrilin Antianginal labetalol Normodyne Antihypertensive, adrenergic nifedipine Adalat Vasodilator, coronary propionyl L-carnitine, Sigma Dromos Vasodilator, peripheral Formulations (7) doxorubicin, Stealth Caelyx Formulation, optimized, liposomes interferon, Enzon (\a2b) ViraFeronPeg Formulation, conjugate, pegylated isosorbide mononitrate, Hassle Imdur Formulation, modified-release, <=24hr isosorbide mononitrate, Roche Monosorb Formulation, other loratadine, Zydis Claritin RediTabs Formulation, oral, orally- disintegrating sucralfate, APR Crafilm Formulation, oral, other theophylline, KV theophylline, KV Formulation, modified-release, other Genitourinary (including sex hormones) (3) promestriene Colpotrophine Reproductive/gonadal, general propiverine hydrochloride Detrunorm Urological vardenafil Levitra Male sexual dysfunction Musculoskeletal Products (1) nimesulide Scaflam Anti-inflammatory Neurological Products (3) buprenorphine Temgesic Analgesic, other felbamate Taloxa Antiepileptic Drug Name Brand Name Main therapy selegiline Deprenyl Antiparkinsonian Respiratory Products (4) desloratadine Neoclarityn Antiallergic, non-asthma formoterol Atock Antiasthma pranlukast Azlaire Antiasthma salbutamol Proventil Antiasthma 2003 Additional news July Schering-Plough announces a new organisational structure for its Global Pharmaceutical Business (GPB), consolidating several previously autonomous prescription pharmaceutical business units into a unified, globally integrated operation. The new GPB structure focuses on key products, countries and customer groups. (Press release, Schering-Plough, 7 Jul 2003) August Schering-Plough slashes its quarterly dividend by 68% and plans to cut at least 1,000 jobs. The company also intends to end some executive perks, such as bonuses, in an attempt to boost the company’s financial status. The cost cutting plans are expected to deliver in excess of $200 million in annual savings. (Press release, Schering-Plough, 20 Aug 2003) December Schering-Plough resizes the company based on greater centralisation of certain functions, improving process efficiencies and other actions. These efforts build on previously announced key actions to stabilise and repair Schering-Plough and set a solid foundation for the future. Schering-Plough's Value Enhancement Initiative (VEI), which helps the company save and spend wisely as the company is revitalised, is expected to deliver in excess of $200 million in annual cost savings that will generate funds for reinvestment into the business and help drive earnings. (Press release, Schering-Plough, 4 Dec 2003) 2004 Additional news January Schering-Plough announces that about 170 jobs are to be discontinued at Schering-Plough (Brinny) Company at Brinny, Innishannon, Co Cork, bringing site numbers to 762. The reduction in jobs is due to a decrease in demand for the company's main product, coupled with the recent announcement by Schering-Plough Corporation of a 10% reduction in payroll expenses worldwide. (Press release, Schering-Plough, 7 Jan 2004)l May Schering-Plough announces plans to develop its 88-acre site in Summit for office space and R&D use in conjunction with consolidating several of its other New Jersey facilities. (Press release, Schering-Plough, 26 May 2004) December Schering-Plough KK completes a project to expand its production plant in Shiga, Japan, which supplies Schering-Plough products in Japan. The company has also completed renovation of existing manufacturing buildings. (Press release, Schering-Plough, 20 Dec 2004) 2005 Additional news January Schering-Plough announces the sale of its Madison, NJ office building to Reckson Associates Realty Corp. Schering-Plough says the Madison sale represents a further step in the company's New Jersey real estate strategy and plans to develop its 88-acre site in Summit, NJ. (Press release, Schering-Plough, 14 Jan 2005) February Schering Plough announces up to 240 lay-offs at its three plants in Ireland. Schering Plough has operations in Brinny, Co Cork, and in Bray and Rathdrum in Co Wicklow. (Press release, Schering-Plough 3 Feb 2005) May Schering-Plough creates a new Schering-Plough Biopharma unit. The Biopharma operations will be fully integrated with the core pharmaceutical R&D organisation of the company in order to help assure a seamless and efficient overall product flow process. Schering-Plough Biopharma will be formed through the integration of the company's two West Coast research facilities into one site. The new Biopharma unit will be based at the current DNAX laboratories in Palo Alto. (Press release, Schering-Plough, 3 May 2005) July Schering-Plough opens commercial operations in Korea and Pakistan. The actions are part of a long-term strategy to build strength in its Asia Pacific region. Schering-Plough Korea is now headquartered in the capital city of Seoul, and Schering-Plough Pakistan is now headquartered in Islamabad. (Press release, Schering- Plough, 6 Jul 2005) Updated by EW on 06/07/2005.
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