Novartis: Challenging Times, Novel Approaches

Many medications lost patent exclusivity at the end of 2011, and more drugs will face the same fate throughout 2012. With the explosion of biosimilars flooding the market, pharmaceutical companies are looking at how to recoup the revenue lost to generics.
Novartis stands out among the pharmaceutical giants as having a novel approach to this challenge. The company plans to adapt their business strategy and focus on patients with “unmet medical needs,” rather than on spearheading a first-to-market drug launch. Novartis plans to invest in the clinical development of its drugs, move products through their respective clinical phases more efficiently, and create successful patient outcomes. Of Novartis’ business alliances, more than 60% are specialty-focused companies.
Novartis is slated to produce numerous drug candidates in the specialty drug category. The company estimates that by 2015, 75% of their sales will be from specialty and oncology drugs; the company has mapped out a prospective clinical pipeline up to the year 2015 with approximately 50 potential new products filed. The majority of these products have a specialty focus and represent drugs in various stages of synthesis (either in the form of a new molecule, a new indication, or a new formulation). The specialty treatments for the next 3 years focus on the following specialty disease states: breast cancer, acromealgy, gastric cancer, liver transplantation, lymphoma, Alzheimer’s disease, multiple sclerosis, HCV, psoriasis, and melanoma.
Novartis takes note that it has surpassed many of its industry competitors when it comes to supporting and developing the drugs in the field of specialty pharmacy. According to the Novartis Web site, “Novartis has received more approvals in the US and EU for new molecular entities than our competitors.”
Novartis is designing clinical trials and backing Patient Assistance Programs (PAPs) using a patient-centered approach to medication therapy management. The following programs are addressing the needs of patients:
Access to Specialty Medicines Initiative
  • Gilvec International Patient Assistance Program (GIPAP) and Tasigna International Patient Assistance Program (TIPAP)
Novartis created PAPs focusing on patient outcomes for the drugs Glivec and Tasigna, which treat chronic myeloid leukemia and gastrointestinal stromal tumors, respectively. The company has helped more than 37,000 patients obtain treatment who could not otherwise afford the drugs. Additionally, Novartis has helped promote medication adherence for these drugs by implementing GlowCap, in association with Vitality and the specialty pharmacy Apothecary Shop Wholesale, Inc. GlowCap alerts the patient about dosage time with glowing and ringing functions. Should the dosage not be administered within 2 hours, the patient’s telephone will ring, and he or she will receive a recorded reminder. If all of these methods fail to make the patient compliant, a pharmacist will “personally intervene with a call to the patient and practictioner.”
  • ExtraCare
This PAP provided by Novartis—designed to improve MS patients’ compliance and retention—provides instructions to patients and caregivers for medications and drug delivery methods, access to a nurse, a call center, and online resources.
  • Targeted Patient Outcomes
Patients have treatments tailored to them based on their genetic makeup. Some drug therapies do not cause any response in patients, whereas others can cause severe adverse reactions.
  • Novartis Institutes for BioMedical Research (NIBR)
Novartis researchers use proof-of-concept trials with small molecule drugs or antibodies to target key nodes within molecular signaling pathways to help identify the most promising drug candidates.
  • Molecular Diagnostics Unit (MDx)
Novartis launched this program in an effort to develop diagnostic tests which identify patient subgroups that have positive responses to treatment and to monitor disease response and progression. Diagnostic tests are made with the use of biomarkers, and MDx identifies those “who may positively respond to new medicines and develop companion diagnostics to complement new drugs.”
These programs incorporate an integrated approach to patient care by working with various health professionals—including specialty pharmacists—to optimize patient outcomes.

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