Year Established: 1996
Revenues: $51,900 (+6%)
Pharma Revenues: $44,751 (+6%)
Net Income: $12,614 (+64%)
R&D: $9,074 (+1%)
TOP SELLING DRUGS
|Cosentyx||Psoriasis, ankylosing spondylitis and psoriatic arthritis||$2,837||37%|
|Lucentis||age-related macular degeneration||$2,046||8%|
|Tasigna||chronic myeloid leukemia||$1,874||2%|
|Gleevec||Leukaemia, chronic myeloid (CML)||$1,561||-20%|
|Promacta||Thrombocytopaenic purpura, idiopathic (ITP)||$1,174||35%|
With pharmaceutical sales of nearly $45 billion, Novartis slid into second just ahead of Roche in this year’s report—up four spots from last year’s sixth place ranking. Under the leadership of new chief executive, Vasant Narshimhan, 2018 saw Novartis involved in several deals that has the Swiss pharma giant focused more on medicines.
First it inked an $8.7 billion deal to acquire gene therapy company AveXis as part of its neuroscience strategy. AveXis is conducting several clinical studies for the treatment of spinal muscular atrophy, or SMA, an inherited neurodegenerative disease caused by a defect in a single gene. Their gene therapy candidate AVXS-101 has the potential to be the first one-time gene replacement therapy for SMA according to Novartis, and it currently has orphan drug designation from the U.S. Food and Drug Administration for the treatment of SMA.
The deal followed shortly after Novartis sold its stake in its consumer health-care joint venture to GlaxoSmithKline for $13 billion. The company also decided to spin off its Alcon eye-care unit and sold parts of its Sandoz generic-drugs unit, specifically the Sandoz U.S. dermatology business and generic U.S. oral solids portfolio, to Aurobindo Pharma USA for $800 million.
The Sandoz U.S. portfolios to be sold to Aurobindo include approximately 300 products as well as additional development projects. The sale includes the Sandoz U.S. generic and branded dermatology businesses as well as its dermatology development center. As part of the transaction, Aurobindo will acquire the manufacturing facilities in Wilson, NC, and in Hicksville and Melville, NY.
In another acquisition, Novartis bought cancer-drug maker Endocyte for $2.1 billion. Endocyte is a U.S. company developing a new treatment for prostate cancer. It specializes in radiopharmaceuticals, a new class of drug that carries radioactive substances directly to cancer cells so they can kill tumor cells at close range. It uses drug conjugation technology to develop targeted therapies with companion imaging agents, including 177Lu-PSMA-617, a potential first-in-class investigational radioligand therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC).
The prostate cancer drug bolsters its capability in the field, which it expects to be a key growth driver moving forward, and joins another late-stage radiopharmaceutical directed at a rare form of gut cancer, acquired when it bought Advanced Accelerator Applications S.A. for $3.9 billion at the end of 2017.
Expanding manufacturing capacity
At the end of 2018, Novartis announced it had made an offer for the French contract development and manufacturing organization (CDMO), CellforCure, from its parent, LFB. CellforCure is one of the first and largest CDMOs producing cell and gene therapies in Europe.
The deal has subsequently closed for an undisclosed amount and includes the cell and gene manufacturing facility located in Les Ulis, France. CellforCure is now a wholly owned Novartis manufacturing site, joining the network of cell and gene therapy sites including Morris Plains, NJ in the U.S. and Stein, Switzerland, where construction continues to progress on the €79 million facility.
The deal builds on a previously signed agreement in July 2018. Novartis signed a deal with CellforCure to produce CAR-T cell therapies including Kymriah (tisagenlecleucel), the first CAR-T cell therapy approved by the U.S. Food and Drug Administration (FDA) and indicated for two distinct, difficult-to-treat cancers in the U.S., EU, Switzerland, Canada and Australia. Novartis and CellforCure have successfully completed technology transfer and Kymriah clinical supply production is expected to begin by mid-2019.
In addition to the CellforCure deal, Novartis has made several steps to strengthen and expand its cell and gene manufacturing, including signing a strategic licensing, collaboration and share purchase agreement with Cellular Biomedicine Group (CBMG) to manufacture and supply Kymriah in China; expanding an alliance with the Fraunhofer Institute in Germany to support manufacturing for clinical trials and post approval manufacturing; and a contract manufacturing collaboration in Japan.
Partnership for virtual trials
Novartis formed an alliance with Science 37 to initiate up to 10 new clinical trials over the next three years. The studies will blend virtual and traditional models, with increasing degrees of decentralization towards a mostly “site-less” model. Novartis was an early investor in Science 37 and together have already initiated virtual trials for cluster headache, acne and nonalcoholic steatohepatitis (NASH).
The new decentralized trials in the U.S. will focus on dermatology, neuroscience and oncology, leveraging Science 37’s proprietary Network Oriented Research Assistant (NORA) technology, which enables patients to participate in studies using mobile devices and telemedicine services. Through this alliance, the companies plan to apply Science 37’s customized enterprise software to some of the leading clinical development programs of Novartis.
According to the Center for Information & Study on Clinical Research Participation (CISCRP), only 2% of the eligible population in the U.S. participate in clinical trials. Those who do participate attend an average of 11 trial site visits in six months, representing a significant burden for both patients and trial centers. By bringing the trial to the patient, Novartis aims to decrease the burden of clinical trial participation on patients and trial centers.