Our Sandoz Division is a global leader in developing, manufacturing
and marketing generic pharmaceutical products, follow-on
biopharmaceuticals and drug substances not
biopharmaceutical products and drug substances that are not
protected by valid and enforceable third-party patents. In 2013, Sandoz achieved consolidated net sales of USD 9.2 billion, representing 16% of the Group’s total net sales. As of December 31, 2013, affiliates of the Sandoz Division employed 26,905 full-time equivalent associates worldwide and sell products in over 140 countries.
Sandoz has three strategic priorities: to differentiate Sandoz based on Three strategic priorities its extensive global reach and advanced technical expertise in the development, manufacturing and marketing of differentiated generics and biosimilars; to be first-to-market as originators’ substance patents expire or become unenforceable; and to be cost-competitive by leveraging economies of scale in production and development. According to IMS Health, Sandoz is the second-largest company in worldwide generic sales and is the global leader in biosimilars, with three marketed medicines accounting for over half of all biosimilars in the combined regions of North America, Europe, Japan and Australia. In addition, we have a pipeline of several biosimilar molecules, including biosimilar rituximab (sold by Roche under the brand names Rituxan®/MabThera®) and biosimilar etanercept (sold by Amgen and Pfizer under the brand name Enbrel®).
In 2013, Sandoz launched 31 new products in the US – twice as many 31 new products in the as in 2012 – including first-to-market launches of candesartan cilexetil US in 2013 tablets (AstraZeneca’s Atacand®) and metronidazole 1% topical gel (Galderma Labs’ Metrogel®) as well as authorized generics of Merck’s temozolomide (Temodar®) and Celgene’s azacitidine (Vidaza®).
Key product launches in various European countries include
montelukast (Merck’s Singulair®), sildenafil (Pfizer’s Viagra®),
memantine (Lundbeck’s Ebixa®/Merz Pharmaceuticals’ Axura®), escitalopram (Lundbeck’s Cipralex®), methylphenidate (Janssen-Cilag’s Concerta®), mometasone (Merck’s Nasonex®), and diclofenac (an authorized generic version of our Pharmaceuticals Division’s Voltaren
In Biopharmaceuticals, Sandoz continued to strengthen its global
leadership in biosimilars and to drive its contract manufacturing base biosimilars business. All three Sandoz biosimilar products continue to occupy the number one biosimilar position in terms of market share in their
respective markets. According to IMS data, recombinant growth
was the fastest growing hGH treatment globally
in terms of volume. Omnitrope
, which is now marketed in over 40
countries, was also among the top three products of Sandoz in terms
of sales. In 2013, Sandoz also introduced an innovative device that
provides patients with a simple and secure way to inject Omnitrope
Anemia medicine Binocrit
continued to demonstrate strong growth in
several European countries as a short-acting erythropoietin
stimulating agent (ESA). According to IMS, Sandoz G-CSF biosimilar, Zarzio,
became the first biosimilar to overtake its reference product
(Amgen’s Neupogen®), as well as market leader (Chugai’s
Granocyte®), and is now the most prescribed daily G-CSF by volume in
Europe and the number one daily G-CSF biosimilar globally.
Sandoz made significant progress in its biosimilar pipeline in 2013,
with the start of Phase III clinical trials for biosimilar etanercept (Amgen’s Enbrel®) and biosimilar adalimumab (AbbVie’s Humira®). Sandoz now has six molecules in Phase III trials, including a biosimilar version of the originator compound rituximab (Roche’s Rituxan®/MabThera®), which is currently in Phase III clinical trial for the treatment of follicular lymphoma and Phase II trial for rheumatoid arthritis. Some of the other molecules undergoing Phase III testing are biosimilar versions of pegfilgrastim (Amgen’s Neulasta®), filgrastim for US registration (Amgen’s Neupogen®) and epoetin alfa (Janssen’s Procrit®).
Sandoz received its first European approvals in Denmark in December
2013 and other countries including Germany and Sweden in January
2014 for its AirFluSal Forspiro
respiratory inhaler for asthma and
chronic obstructive pulmonary disease (COPD) patients, which offers
the proven combination of salmeterol (a long-acting inhaled beta2-
agonist) and fluticasone (an inhaled corticosteroid) in an innovative
new inhalation device. The product’s safety, efficacy and equivalence
have been proven in multiple clinical trials. These approvals of AirFluSal Forspiro
are a key element of Sandoz’s strategy to introduce
differentiated generic medicines.
Sandoz also accelerated its efforts in 2013 to build a leading,
sustainable and lasting presence across Sub-Saharan Africa, where it is already the number one provider of generics medicine across French West Africa. A strong product portfolio, including anti-infectives, tuberculosis treatments and maternal and child health products, support the objective to expand on the continent and
address the needs of African patients. In 2013, Sandoz opened offices in Senegal (regional office for West Africa), Kenya, Ethiopia, Nigeria, Ghana, and Zambia. Sandoz also continued its ongoing work through several corporate responsibility projects, including efforts to develop “Health Shops” in Zambia in collaboration with the Zambian Ministry of Health to improve access to essential medicines in rural areas and a collaboration with Ethiopian authorities to set up a regional bioequivalence laboratory in Ethiopia. Sandoz is developing plans to expand its production capacity in Sub-Saharan Africa to address a growing demand for high-quality drugs.
The Sandoz Division has activities in Retail Generics
and Biopharmaceuticals & Oncology Injectables
Anti-Infectives and Biopharmaceuticals & Oncology Injectables
In Retail Generics, Sandoz develops, manufactures and markets active ingredients and finished dosage forms of pharmaceuticals to third parties. Retail Generics includes the specialty areas of Dermatology, Respiratory and Ophthalmics. In Anti-Infectives, Sandoz manufactures active pharmaceutical ingredients and intermediates – mainly antibiotics – for internal use by Retail Generics and for sale to third-party customers.
In Biopharmaceuticals, Sandoz develops, manufactures and markets protein- or other biotechnology-based products (known as biosimilars or follow-on biologics) and provides biotechnology manufacturing services to other companies. In Oncology Injectables, Sandoz develops, manufactures and markets cytotoxic products for the hospital market.
Recently Launched Products
In 2013, Sandoz launched a number of important products in various
cream (Bristol Myers Squibb’s Mycolog-II®)
− Candesartan cilexetil
tablets (AstraZeneca’s Atacand®)
− Zoledronic acid
(authorized generic version of our Pharmaceuticals
in 5% dextrose (Pfizer’s Cleocin Phosphate® in
(Boehringer Ingelheim’s Micardis®)
(Lundbeck’s Ebixa®/Merz Pharmaceuticals’ Axura®)
tablets (Takeda Pharmaceuticals’ Actoplus
1% topical gel (Galderma Lab’s Metrogel®)
for injection (Celgene’s Vidaza®)
This presentation contains forward-looking statements that can be identified by words such as “potential,” “expected,” “will,” “planned,” or similar terms, 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; potential shareholder returns or credit ratings, the potential outcome of the share buyback being
initiated; or regarding potential future sales or earnings of the Novartis Group or any of its divisions; or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking 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 any existing products in any market, or that any approvals which are obtained will be obtained at any particular time, or that any such products will achieve any particular revenue levels. Nor can there be any guarantee that shareholders will achieve any particular level of shareholder returns or regarding the potential outcome of the share buyback being initiated. Neither can there be any guarantee that the Group, or any of its divisions, will be commercially successful in the future, or achieve any particular credit rating. In particular, management's expectations could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; the potential that the strategic benefits, synergies or opportunities expected from the divestment of our former blood transfusion diagnostics unit may not be realized or may take longer to realize than expected; the inherent uncertainties involved in predicting shareholder returns or credit ratings; the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; the Company’s ability to obtain or maintain other proprietary intellectual property protection, including the ultimate extent of the impact on the Company of the loss of patent protection and exclusivity on key products which commenced in prior years and will continue this year; unexpected manufacturing and quality issues, including the final resolution of the Warning Letters previously issued to us with respect to Sandoz and Consumer Health manufacturing facilities; global trends toward health care cost containment, including ongoing pricing pressures; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, government investigations and intellectual property disputes; general economic and industry conditions; uncertainties regarding the effects of the persistently weak global economic and financial environment, including the financial troubles in certain Eurozone countries; uncertainties regarding future global exchange rates; uncertainties regarding future demand for our products; uncertainties involved in the development of new healthcare products; and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this presentation 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 owned by or licensed to Novartis Group Companies.
Number Title Composer 22 Nutcracker Suite. Dance of the Automatons55 Jewels of the Madonna, Intermezzo, No.156 Sonata, No.1, Op.42, 2nd Mvt, Pastorale. 77 Athalia, War March of the Priests. 84 Tristan & Isolde, Love Death. 101 Die Meistersingers. Dance of the Apprentices130 Cavalleria Rusticana, Prelude & Siciliana139 Samson & Delilah - My Heart at Thy Sweet Voice142 Moon
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