It was a historic week not just for Novartis NVS but also for the medical community and patients with the FDA giving its nod to the first gene therapy in the United States – Novartis’ Kymriah. This marks the beginning of a new era for the treatment of cancer and other serious and life-threatening diseases.
Recap of the Week’s Most Important Stories
Novartis Gets Head Start in CAR-T Market with Kymriah Approval: Novartis got a huge boost with the FDA approving the company’s CAR-T cell therapy, Kymriah for children and young adults with B-cell acute lymphoblastic leukemia (“ALL”) that is refractory or has relapsed at least twice. This makes Kymriah the first CAR-T cell treatment to be approved in the United States. The path-breaking immunocellular therapy is a one-time treatment that uses a patient's own T cells to fight cancer. ALL, a cancer of the bone marrow and blood, progresses quickly and is the most common childhood cancer in the United States. According to the National Cancer Institute, about 3,100 patients (20 years and younger) are diagnosed with ALL every year. Kymriah not only provides these patients with a new treatment option, it has also shown promising remission and survival rates in studies.
Novartis intends to seek label expansion for Kymriah later this year for additional indications including the treatment of adult patients with r/r diffuse large B-cell lymphoma (Also read: Novartis CAR-T Therapy Kymriah Receives FDA Approval). Shares of Novartis have gained 14.8% year to date, outperforming the industry’s 11.1% rally. Novartis is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Allergan in Settlement Agreement with Famy Care for Restasis: Allergan AGN entered into a settlement agreement with Famy Care which was looking to bring a generic version of Allergan’s eye drug, Restasis, to market. With the patent infringement lawsuit being settled, Famy Care got a license to market its generic version in the United States from Feb 27, 2024, or earlier under certain circumstances. The patents were scheduled to expire on Aug 27, 2024.
Teva’s Austedo Nabs FDA Approval for Second Indication: Teva Pharmaceutical Industries TEVA got some good news finally with the company gaining FDA approval for a second indication for Austedo. Austedo, which had gained FDA approval in Apr 2017 for the treatment of chorea associated with Huntington’s disease, is now approved for the treatment of tardive dyskinesia in adults as well. Tardive dyskinesia, a debilitating and often irreversible movement disorder, is estimated to affect about 500,000 people in the United States (Also read: Teva Austedo Gets FDA Nod for Label Expansion in Dyskinesia).
Teva is currently going through tough times with the company’s performance being impacted by generic pricing erosion. Teva has many challenges ahead – paying down debt, divesting non-core businesses to increase focus on core areas and generate cash, hiring a permanent CEO, delivering on the pipeline and getting the U.S. generics business back on track.
Lilly Provides Baricitinib Regulatory Update: Eli Lilly and Company LLY and partner Incyte provided an update regarding the resubmission of their regulatory application in the United States for their experimental rheumatoid arthritis (“RA”) treatment, baricitinib. The companies, which had previously said that they expect a delay of at least 18 months in the resubmission of the regulatory application for baricitinib, announced that they will be resubmitting the regulatory application by Jan 2018. New safety and efficacy data will be included in the resubmission (Also read: Lilly/Incyte to Re-File Baricitinib NDA Faster Than Expected).
Bayer’s Hemophilia A Drug Submitted for FDA Approval: Bayer AG BAYRY has submitted a Biologics License Application (“BLA”) in the United States for its long-acting site-specifically PEGylated recombinant human Factor VIII, BAY94-9027, for the treatment of hemophilia A. Bayer’s portfolio already includes a hemophilia A product in the form of Kogenate. If approved, BAY94-9027 would provide patients with a less frequent dosing option.
AstraZeneca Inks Deal with Takeda: AstraZeneca AZN has signed up with Takeda Pharmaceutical for the joint development and commercialization of MEDI1341, an alpha-synuclein antibody being developed for Parkinson’s disease (“PD”). The investigational treatment is scheduled to enter early-stage development later this year. While phase I development will be conducted by AstraZeneca, future clinical development activities will be handled by Takeda.
Future development and commercialization costs as well as any future revenues will be shared by the companies. Deal terms include up to $400 million for AstraZeneca including initial revenue in 2017 and development and sales milestones thereafter.
Parkinson's disease, the second most common neurodegenerative disease, is estimated to affect about seven to ten million people across the world (Also read: AstraZeneca and Takeda Ink Deal to Develop Parkinson's Drug).
Performance
Large Cap Pharmaceuticals Industry 5YR % Return
The NYSE ARCA Pharmaceutical Index was up 1.8% over the last five trading sessions. Major stocks recorded gains with Bristol-Myers Squibb rising 3.9% while Lilly was up 3.1% on the baricitinib update. Over the last six months, J&J was up 9.7% while Merck MRK declined 1.6% (See the last pharma stock roundup here: Roche Drug Gets Priority Review, EU Nod for Novartis Drug).
What's Next in the Pharma World?
Watch out for the usual pipeline and regulatory updates. Companies like AstraZeneca will be present at the European Society of Medical Oncology (ESMO) 2017 Congress with data and presentations on approved and pipeline candidates.
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