Novartis introduces Lucentis® in state of the art pre-filled syringe
Novartis announces the launch in Europe of the Lucentis pre-filled syringe (PFS), which is specifically designed for intraocular injection
The Lucentis PFS can lead to improved patient treatment via a potential reduced risk of adverse events from non-sterile conditions
Retinal specialists and patients benefit from the potential for improved efficiency and dose accuracy offered by this innovation
Basel, March 20, 2014 - Novartis has announced the launch of the Lucentis® (ranibizumab) pre-filled syringe (PFS) in Germany, with other markets to follow throughout 2014. The Lucentis PFS, which received European approval in October 2013, is a new way of administering Lucentis that is specifically designed for intraocular injection to enhance patient safety and convenience for the treating clinician.
"We are pleased to be able to offer a better way to accurately and safely administer Lucentis in the eye," said David Epstein, Division Head, Novartis Pharmaceuticals. "Lucentis PFS brings convenience, safety, and the potential for improved efficiency and dose accuracy to both retinal specialists and patients."
The Lucentis PFS has been specifically designed to reduce the risk of adverse events to patients and to enhance the treatment process in the clinic. This new injection technology offers the potential for improved safety for patients through a reduction in non-sterile preparatory steps and the inclusion of more safety features, such as a non-retractable plunger. Moreover, greater dose accuracy is possible through design features such as a smaller syringe barrel.
These features combined may equate to reduced waiting times and thereby improve the patient treatment experience.
About Lucentis® (ranibizumab)
Lucentis is the first choice to save sight owing to its unsurpassed efficacy and uncompromised safety profile. As an antibody fragment with a short systemic half-life, Lucentis was specifically designed, developed, formulated and licensed for ocular conditions, and is manufactured to the highest standards for intra-ocular use.
Lucentis is licensed in more than 100 countries, for the treatment of wet age-related macular degeneration (wet AMD), visual impairment due to diabetic macular edema (DME) and for visual impairment due to macular edema secondary to retinal vein occlusion (RVO), including both branch- and central-RVO. Also, Lucentis is licensed in 50 countries for the treatment of patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (myopic CNV). In most countries, including those in Europe, Lucentis has an individualized treatment regimen with the goal of maximizing visual outcomes while minimizing under- or over-treating patients.
Lucentis has a well-established safety profile supported by 43 extensive sponsored clinical studies and real-world experience. Its safety profile has been well established in a clinical development program that enrolled more than 12,500 patients across indications and there is more than 2.4 million patient-treatment years of exposure since its launch in the United States in 2006.
Lucentis was developed by Genentech and Novartis. Genentech has the commercial rights to Lucentis in the United States. Novartis has exclusive rights in the rest of the world. Lucentis is a registered trademark of Genentech Inc.
The foregoing release contains forward-looking statements that can be identified by words such as "launch," "can," "potential," "offered," "to follow," "offer," "offers," "possible," "may," or similar terms, or by express or implied discussions regarding potential launches of Lucentis pre-filled syringe in additional markets, and potential future revenues from Lucentis and Lucentis pre-filled syringe. 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 Lucentis or Lucentis pre-filled syringe will be submitted or approved for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that Lucentis or Lucentis pre-filled syringe will be commercially successful in the future. In particular, management's expectations regarding Lucentis and Lucentis pre-filled syringe could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including ongoing pricing pressures; general economic and industry conditions; the company's ability to obtain or maintain proprietary intellectual property protection; the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected manufacturing issues, 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 press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2013, the Group achieved net sales of USD 57.9 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 136,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visithttp://www.novartis.com.
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