Microsoft word - en 4a sandoz.docx
Our Sandoz Division is a world leader in developing,
manufacturing and marketing generic pharmaceutical products,
follow-on biopharmaceutical products and drug substances that are not protected by valid and enforceable third-party patents. As of December 31, 2010, affiliates of the Sandoz Division employed 23 536 full-time equivalents associates worldwide in more than 130 countries. In 2010, our Sandoz Division achieved consolidated net sales of USD 8.5 billion, 17% of the Group’s total net sales.
The Sandoz Division is active in Retail Generics, Anti-Infectives,
Biopharmaceuticals and Oncology Injectables (following the
acquisition of EBEWE Pharma, completed in September 2009).
In Retail Generics, we develop, manufacture and market active ingredients and finished dosage forms of pharmaceuticals, as well as supplying active ingredients to third parties. In Anti-Infectives, we develop and manufacture active pharmaceutical ingredients and intermediates – mainly antibiotics – for use by Retail Generics and for sale to third-party customers. In Biopharmaceuticals, we develop, manufacture and market protein- or other biotechnology-based products (known as biosimilars or follow-on biologics) and sell biotech manufacturing services to other companies. In Oncology Injectables, we develop, manufacture and market cytotoxic products for the hospital market.
The worldwide market for generic pharmaceutical products has
been growing by about 10% annually and is expected by
generic sales, positioned as global leader in Retail
industry analysts to continue at nearly that rate through 2015,
fueled primarily by the growing health needs of an aging
population, opportunities created through patent expiries, increasing access to healthcare and pressures to contain healthcare costs. According to IMS Health, Sandoz is the No. 2 company in worldwide generic sales and is positioned as a global leader in Retail Generics. Sandoz Biopharmaceuticals has emerged as the leading global player in biosimilars, with three marketed medicines, and a pipeline of eight to 10 molecules, including monoclonal antibodies, at various stages of development. In addition, Sandoz remains one of the leading manufacturers of antibiotics worldwide. The acquisition of EBEWE Pharma in 2009 positioned Sandoz among the top four global players in oncology injectables, according to IMS Health.
Sandoz has three strategic priorities: to be first-to-market with
our products as originators’ substance patents expire or become unenforceable; to be cost competitive by leveraging our economies of scale in development and production; and to differentiate Sandoz based on our extensive global reach and our advanced technical expertise in the development, manufacturing and marketing of differentiated generics and biosimilars.
In 2010, Retail Generics benefited from the first-to-market US
launch of Sandoz’s generic enoxaparin sodium (Lovenox®) – the largest-ever launch in the US of a generic hospital medication. Other key US launches included metaxalone (Skelaxin®), and the authorized generics of losartan potassium and losartan potassium-hydrochlorothiazide/HCT (Cozaar® and Hyzaar®), as well as gemcitabine HCI injection (Gemzar®). Key product launches in various European countries included losartan/ losartan HCT, lercanidipine (Corifeo®/Zanidip®), tacrolimus (Prograf®), and Docetaxel
Anti-Infectives experienced continued volume growth, with key
products globally including amoxicillin/clavulanic acid, ceftriaxone, azithromycin and cefdinir, as well as the exclusive US launch of amoxicillin-clavulanic acid ER (Augmentin®).
In Biopharmaceuticals, Sandoz continued to roll out important
follow-on products and to drive its contract manufacturing base business. Recombinant growth hormone Omnitrope,
which was first launched in the EU and US in 2006 and 2007 respectively, received FDA approval for several additional indications, and was launched in 2010 in countries including Taiwan, Argentina, and the Czech Republic. High-dosage oncology formulations of anemia medicine Binocrit
were rolled out in 2010 in countries including France, Spain, Italy and the UK, complementing the base nephrology business. Neutropenia medication Zarzio,
was approved EU-wide in 2009, was rolled out in further countries including Italy, Belgium, Sweden and Switzerland.
In October 2010, just one year after Sandoz completed the
acquisition of Austrian-based oncology injectables specialist EBEWE Pharma, Sandoz announced the successful completion of the integration process and the launch of a new global brand, Sandoz Oncology Injectables. The new business is now fully organized on a global basis and offers customers a broad differentiated portfolio of more than 25 marketed products plus a strong pipeline for future growth.
In April 2010, Sandoz announced a definitive agreement to
acquire Oriel Therapeutics, a privately held US pharmaceuticals company, for an undisclosed sum. The deal was finalized in June, and Oriel has been integrated as a separate development unit within Sandoz. Oriel focuses on developing respiratory products with known pathways as generic alternatives to patented drugs for asthma and chronic obstructive pulmonary disease (COPD). Regulatory approvals of these medicines would enable Sandoz to increase access to affordable, high-quality therapeutic alternatives for these increasingly prevalent medicines. The acquisition also offers Sandoz access to Oriel’s novel FreePath™ drug delivery technology, as well as its proprietary Solis™ disposable dry powder inhaler.
Recently launched products
Sandoz launched a number of important products in 2010, including:
a generic version of the best-selling anti-
thrombotic Lovenox®, was launched as the sole generic in the US.
a generic version of muscle relaxant Skelaxin®, was
launched with generic market exclusivity in the US.
Losartan potassium and losartan potassium-
authorized generic versions of
Cozaar® and Hyzaar®, were launched in the US; “early entry” versions of both products were also introduced in Germany, followed by generic versions in other European markets.
Amoxicillin-clavulanic acid ER,
a generic version of broad-
spectrum antibiotic Augmentin®, was launched with market exclusivity in the US.
a generic version of the kidney and liver
transplantation medicine Prograf®, was launched in several European markets including Germany, Portugal, Netherlands, Austria, Belgium, Switzerland, and the UK.
a generic version of Corifeo®/Zanidip®, was
launched in European markets including France, Italy, Spain, the Netherlands, Austria, Belgium, and Portugal.
a generic version of cytotoxic Taxotere®, was
launched in several European countries as well as in New Zealand.
a follow-on version of the recombinant human
growth hormone Somatropin®, was launched in Taiwan, Argentina, and the Czech Republic.
a follow-on version of the recombinant human protein
Eprex®/Erypo®, was launched in higher dosage pre-filled syringes for patients suffering from chemotherapy-related anemia in countries including France, Spain, Italy and the UK.
a follow-on version of the recombinant human
granulocyte colony-stimulating factor filgrastim (G-CSF), was launched in countries including Italy, Belgium, Sweden, and Switzerland.
These materials contain forward-looking statements that can be identified by terminology such as “proposed,” “pipeline,” “momentum,” “should,” “will,” “opportunity,” “proposes,” “strategy,” “expected,” “would,” “promising,” “opportunities,” “commitment,” “committed,” “opportunities,” “potential,” “priority review,” “promise,” “suggested,” “intent,” “planned,” “expect,” “outlook,” “potentially,” “likely,” “plan,” “expects,” “seek,” “strategic,” “anticipate,” “expectations,” “launch,” “on track,” “pursuing,” “set,” “due,” “intend,” “to be,” or similar expressions, or by express or implied discussions regarding potential new products, potential new indications for existing products, or regarding potential future revenues from any such products; or regarding potential growth opportunities from the acquisition of a 77% majority ownership in Alcon, Inc. or regarding the expected merger with Alcon, or the potential impact on Alcon or Novartis of the expected merger; or regarding potential future sales or earnings of the Novartis Group or any of its divisions as a result of the expected merger or otherwise, or of Alcon, or any potential synergies, strategic benefits or opportunities as a result of the expected merger; or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of the Group regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that any new products will be approved for sale in any market, or that any new indications will be approved for existing products in any market, or that such products will achieve any particular revenue levels. Nor can there be any guarantee that the expected merger with Alcon will be completed in the expected form or within the expected time frame or at all. Nor can there be any guarantee that Novartis will be able to realize any of the potential synergies, strategic benefits or opportunities as a result of either Novartis' acquisition of a 77% majority ownership in Alcon, Inc., or as a result of the expected merger with Alcon. Nor can there be any guarantee that the Novartis Group, or any of its divisions, or Alcon will achieve any particular financial results, whether as a result of the merger or otherwise. In particular, management's expectations could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including additional analyses of existing clinical data or unexpected new clinical data; the Group's ability to obtain or maintain patent or other proprietary intellectual property protection; disruptions from the Alcon 77% implementation and the expected merger making it more difficult to maintain business and operational relationships, and relationships with key employees; unexpected product manufacturing issues; uncertainties regarding actual or potential legal proceedings, including, among others, litigation seeking to prevent the merger from taking place, product liability litigation, litigation regarding sales and marketing practices, government investigations and intellectual property disputes; competition in general; government, industry, and general public pricing and other political pressures; uncertainties regarding the after-effects of the recent global financial and economic crisis; uncertainties regarding future global exchange rates and uncertainties regarding future demand for our products; uncertainties involved in the development of new pharmaceutical products; the impact that the foregoing factors could have on the values attributed to the Group's assets and liabilities as recorded in the Group's consolidated balance sheet; and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Novartis is providing the information in these materials as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.
All product names appearing in italics are trademarks licensed to or owned by Novartis Group companies.
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