IHS Global Insight Perspective | |
Significance | Novartis's TOBI Podhaler, Tasigna, and Aflunov vaccine have all been approved by the European Medicines Agency's Committee for Medicinal Products for Human Use. Meanwhile, SOM230 met its primary endpoint in a late-stage trial. |
Implications | The European Commission will now consider whether to grant final approval for the three products. SOM230 was shown to reduce urinary free cortisol levels, an important aspect of Cushing's disease. |
Outlook | The anticipated approval of TOBI Podhaler and Tasigna offers Novartis an important life-cycle management strategy, with existing treatment options currently marketed by the company due to face generic competition in the next five years. Regulatory submissions are now planned for SOM230 by the end of the year. |
CHMP Nods for Three Products
Swiss pharmaceutical giant Novartis has reported that the European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of three of its products: TOBI Podhaler (tobramycin inhalation powder), Tasigna (nilotinib), and Aflunov vaccine.
TOBI Podhaler, a dry powder form of TOBI (tobramycin inhalation solution) is recommended as a suppressive therapy for chronic Pseudomonas aeruginosa (Pa) infections in patients with cystic fibrosis, aged six and over. According to Novartis, the recommendation was based on data showing that TOBI Podhaler and TOBI offer the same efficacy to patients; however, the former's incorporated PulmoSphere technology offers an improved delivery mechanism that means treatment can be completed in five-to-six minutes, as opposed to TOBI, which utilises a nebulizer delivery mechanism.
Tasigna has been recommended for the treatment of newly diagnosed patients with Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML). The approval was granted based on positive clinical data from the ENESTnd Phase III trial, which compared Tasigna with current standard of care Glivec/Gleevec (imatinib). According to the results of the trial, Tasigna produces deeper levels of molecular and cytogenetic response, as well as being more effective at slowing disease progression. Data from this trial have been published in the New England Journal of Medicine, and additional data from an 18-month follow-up study were also presented at this year's American Society of Clinical Oncology conference.
In the final regulatory-related development, Novartis's investigational pre-pandemic influenza vaccine Aflunov also secured a recommendation for immunisation against the H5N1 (bird flu) subtype of the Influenza A virus in adults aged 18 and older. Results from clinical trials showed that 85% of subjects vaccinated with two doses of Aflunov developed antibody titres that were considered to be protective against the H5N1 virus. In addition, when subjects received a single dose of Aflunov six-to-eight years after having received two doses of a different surrogate H5 vaccine, with the H5N3 strain, high and rapid serological response was achieved. Aflunov contains the MF59 boosting adjuvant.
SOM230 Performs Well in Phase III
In research and development-related news, Novartis's SOM230 (pasireotide) met its primary endpoint of reducing urinary free cortisol (UFC) levels from baseline for patients taking the 900-mg dose of the drug in a late-stage trial. The Phase III trial, known as PASPORT-CUSHINGS, has been reported to be the largest study of its kind for Cushing's disease. According to the results, 88.3% of patients treated with the drug reported a reduction in UFC from baseline. After six months of treatment, median UFC was reduced by 48% in patients taking SOM230 900 mg and 600 mg. In the 900-mg group, UFC levels were normalised in 26% of patients.
Outlook and Implications
Novartis continues to score major regulatory wins. Although regulatory developments have been less active in the European market, in the United States, Novartis has secured U.S. FDA approval for Tasigna for first-line Ph+ CML, and just last week, for oral multiple sclerosis (MS) drug Gilenya (fingolimod; see Switzerland: 18 June 2010: Tasigna Obtains Thumbs Up from FDA in Newly Diagnosed Ph+ CML and Switzerland: 22 September 2010: Novartis Wins Final FDA Nod for Oral MS Drug). In terms of Tasigna, Novartis is employing a global strategy to ensure that the drug is in a good position to assume Glivec's position as the standard of care in Ph+ CML, while ensuring maximum revenues following Glivec's patent expiration, which is expected to bite Novartis from 2015. The recommendation of TOBI Podhaler is also a major development for the firm in terms of managing the life cycle of TOBI. TOBI was originally approved in 1997, and is due to face generic competition soon. This new formulation offers a significant improved delivery mechanism, cutting the treatment administration time by 74%. Furthermore, Novartis has said that a study has shown higher patient satisfaction levels with the new drug. Other attributes of TOBI Podhaler that make it a more preferable product include the use of a disposable device, which reduces the risk of potential contamination associated with TOBI, while its simplicity could potentially improve patient adherence to treatment. The recommendation of Aflunov will provide a boost to Novartis's vaccine portfolio. The H5N1 virus has not shown much activity in humans, with only 500 cases being reported in humans, and 300 associated deaths. Despite this, the availability of the vaccine remains an important pandemic preparedness tool. Rival vaccines for H5N1 include U.K. drug firm GlaxoSmithKline's (GSK's) Prepandrix, which won approval in 2008 (see United Kingdom: 19 May 2008: GSK Wins EU-Wide Approval for H5N1 Pre-Pandemic Vaccine Prepandrix). These recommendations are expected to translate into final approvals from the European Commission over the next three months.
The positive clinical data for SOM230 brings the investigative compound a step closer to the regulatory stage. Novartis has said that it expects to make the first regulatory submissions for the drug by the end of the year. SOM230 has already been rewarded orphan drug status in the United States and European Union. Novartis is keen to further explore the speciality-drugs avenue, a route many of its competitors are currently employing in the search for a "niche buster" drug. The potential market for Cushing's disease is small, with the condition only affecting 10–15 patients in every 1 million each year.