It was a busy week for the FDA’s Oncologic Drugs Advisory Committee (ODAC) which reviewed several experimental treatments this week including Novartis’ NVS CAR-T cell drug. Meanwhile, French pharma giant Sanofi SNY announced it will be acquiring a vaccines company.
Recap of the Week’s Most Important Stories
FDA Panel Supports Novartis Car-T Drug: Novartis got a huge boost with an FDA advisory panel voting unanimously in favor of the company’s experimental CAR-T cell therapy CTL019. Novartis is looking to get the treatment approved for pediatric, young adult relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (ALL). The positive vote is a major milestone for the company which could become the first to launch a CAR-T cell therapy if the FDA follows the advisory panel’s advice. CTL019 is currently under priority review in the U.S. -- with the advisory panel issuing a positive recommendation, we believe chances of gaining approval are high (Read more: Novartis CAR-T Therapy Drug Recommended by FDA Panel).
So far in 2017, Novartis has outperformed the Zacks categorized Large Cap Pharmaceuticals industry with shares gaining 13.3% while the industry is up 11.3%.
FDA Nod for J&J Psoriasis Treatment: J&J’s JNJ Tremfya gained FDA approval for the treatment of moderate to severe plaque psoriasis. This makes the drug the first and only biologic approved that selectively blocks only IL-23, a cytokine that plays a key role in plaque psoriasis. Although the psoriasis market is pretty crowded, Tremfya demonstrated superior results in skin clearance compared with Humira in head-to-head analyses at weeks 16, 24 and 48.
Tremfya is currently in a late-stage study for the treatment of active psoriatic arthritis and a phase III program evaluating its efficacy compared with Cosentyx in the treatment of moderate to severe plaque psoriasis.
Mar 2018 PDUFA Date for Pfizer’s Xeljanz Label Expansion: Pfizer’s PFE sNDA for Xeljanz has been accepted for review by the FDA with a response expected in Mar 2018. Timely approval would make Xeljanz the first oral Janus kinase (JAK) inhibitor to be available for people living with moderately to severely active ulcerative colitis (UC).
Pfizer also got a favorable vote from the FDA’s advisory panel for its acute myeloid leukemia (AML) drug, Mylotarg, for newly-diagnosed patients. A final decision from the FDA should be out by Sep 2017. Mylotarg was initially approved in 2000 but was subsequently withdrawn from the market after a late-stage study failed to show a clinical benefit. Moreover, a higher rate of fatalities resulting from treatment-related toxicity was observed in the Mylotarg arm.
Priority Review for Lilly’s Advanced Breast Cancer Drug: Lilly LLY got priority review from the FDA for its CDK 4 & 6 inhibitor abemaciclib. The company is looking to get abemaciclib approved as monotherapy and combination therapy (with fulvestrant) for patients with advanced breast cancer. Given the priority review status, Lilly should get a response from the FDA in the first quarter of 2018. Currently approved CDK 4/6 inhibitors include Pfizer’s Ibrance and Novartis’ Kisqali (Read more: Lilly's Breast Cancer Drug Gets Priority Review Status by FDA).
Lilly also entered into a settlement agreement with generic players to settle patent infringement lawsuits related to the Cialis (tadalafil) unit dose patent. With the settlement agreement, the patent, which was previously set to expire on Apr 26, 2020, will now end on Sep 27, 2018. Cialis is approved for the treatment of erectile dysfunction (ED) and the frustrating urinary symptoms of benign prostatic hyperplasia (BPH). Cialis sales were $2.5 billion in 2016.
Lilly said that the Adcirca (tadalafil) patent will remain protected until Nov 21, 2017, or May 21, 2018, if pediatric exclusivity is granted. Adcirca is approved for pulmonary arterial hypertension (Read more: Lilly Settles Patent Litigation on Cialis with Generic Firms).
Sanofi to Buy Vaccines Company for Up To $750M: Sanofi, which failed in its efforts to acquire Medivation and Actelion, announced that it will be acquiring Protein Sciences, a U.S.-based privately held vaccines biotech company, for up to $750 million. This includes an upfront payment of $650 million and up to $100 million on the achievement of certain milestones.
With this acquisition, Sanofi is looking to expand its flu portfolio with the addition of a non-egg based vaccine. Protein Sciences’ Flublok Quadrivalent Influenza Vaccine (QIV), which was approved by the FDA in Oct 2016, is the only recombinant protein-based flu vaccine approved by the agency. The acquisition is scheduled to close in the third quarter of 2017.
Sanofi is a Zacks Rank #2 (Buy) stock -- you can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Mylan’s Herceptin Biosimilar Gets Favorable Panel Vote: Mylan MYL got a boost with its biosimilar version of Herceptin (trastuzumab) getting a favorable recommendation from an FDA advisory panel. The panel voted 16-0 in support of eligible indications of the reference product which include HER2+ breast cancer in the metastatic and adjuvant settings. The biosimilar version has been developed under a collaboration with Biocon.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
The NYSE ARCA Pharmaceutical Index gained 0.4% over the last five trading sessions. Among major stocks, AstraZeneca AZN was down 3.7% while Lilly gained almost 3%. Over the last six months, AstraZeneca was up 17.1% while Bristol-Myers was down 1.4% (See the last pharma stock roundup here: MRK's Keytruda MM Combo Studies on Clinical Hold, Bayer to Revise Outlook).
What's Next in the Pharma World?
Watch out for J&J’s second quarter earnings results -- the company will be reporting on Jul 18.
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