After a relatively slower M&A activity this year so far, two companies, J&J JNJ and Sanofi SNY proposed acquisitions of biotechs, Momenta Pharmaceuticals and Principia Biopharma, respectively. In other news, the FDA approved Roche’s RHHBY new nervous system disorder drug, Enspryng (satralizumabs) and Novartis’ NVS relapsing multiple sclerosis drug, Kesimpta (ofatumumab).
Recap of the Week’s Most Important Stories
J&J to Buy Momenta for $6.5B: J&J has offered $6.5 billion to buy Momenta Pharmaceuticals, which focuses on making novel drugs to treat rare, immune-mediated disorders. With the deal, J&J will get full global rights to Momenta’s pipeline candidate nipocalimab, which is being developed for autoantibody-driven autoimmune diseases like generalized myasthenia gravis (phase II). The acquisition, if successfully closed, will strengthen J&J’s pipeline position in autoimmune disease.
The FDA granted approval to J&J’s blockbuster cancer medicine, Darzalex in combination with Amgen’s Kyprolis and dexamethasone in patients with relapsed/refractory multiple myeloma as second to fourth-line treatment option. The FDA approval is based on data from the phase III CANDOR study and phase Ib EQUULEUS study. The approval represents the eighth approved indication for Darzalex and the drug’s first approval in the relapsed/refractory setting.
Sanofi to Buy Principia Biopharma: Sanofi has offered $100 per share in cash for an aggregate equity value of approximately $3.68 billion to buy San Francisco-based late-stage biotech Principia Biopharma. Principia has two late-stage Bruton tyrosine kinase (BTK) inhibitors for immune-mediated diseases, SAR442168 and rilzabrutinib, in its pipeline. The deal is likely to strengthen Sanofi’s core R&D areas of autoimmune and allergic diseases.
FDA Approves Roche’s New Nervous System Disorder Drug: The FDA granted approval to Roche’s Enspryng (satralizumabs) as a subcutaneous treatment option for anti-aquaporin-4 antibody positive neuromyelitis optica spectrum disorder(NMOSD), a rare autoimmune disorder of the central nervous system. Enspryng, using novel recycling antibody technology, targets and inhibits interleukin-6 receptor activity, which plays a key role in NMOSD related inflammation. Enspryng is the first and only FDA approved therapy to treat NMOSD.
FDA Approves Novartis Ofatumumab: The FDA also granted approval to Novartis’ ofatumumab, a novel B-cell therapy to treat patients with relapsing multiple sclerosis (RMS). Ofatumumab will be marketed by the brand name of Kesimpta. Approved as a subcutaneous injection, Kesimpta becomes the first FDA approved B-cell therapy that can be self-administered at home using an autoinjector pen. Ofatumumab is marketed by Novartis for oncology indications as an intravenous infusion under the brand name, Arzerra.
Merck’s Keytruda Esophageal Cancer Study Meets Goals: Merck’s MRK pivotal phase III KEYNOTE-590 study, evaluating blockbuster PD-L1 inhibitor Keytruda in combination with chemotherapyas first-line treatment for patients with esophageal cancer regardless of histology, met its primary endpoint of overall survival and progression-free survival. In the study Keytruda+chemotherapy significantly improved OS and PFS compared with chemotherapy in the intention-to-treat (ITT) population. Keytruda+chemotherapy also significantly improved objective response rate (ORR), thereby meeting the study’s secondary endpoint.
Glaxo Begins Dosing in 5-in-1 Meningitis Vaccine Phase III Study: Glaxo GSK began patient dosing in a phase III study on its 5-in-1 meningitis (MenABCWY) vaccine candidate. The study will compare the safety, tolerability and immunogenicity of Glaxo’s candidate to its own marketed meningococcal vaccines, Bexsero and Menveo. The study investigators will enroll 3,650 participants (aged 10-25 years) in the United States, Europe, Turkey and Australia. The 5-in-1 meningitis vaccine candidate has the potential to reduce the number of injections required compared to current FDA-approved meningitis vaccines as it has been designed to protect against all 5 vaccine-preventable serogroups with one combined product.
Lilly Expands Tyvyt Deal with China Partner: Lilly LLY announced a global expansion of its deal with Innovent Biologics for their immuno-oncology medicine, Tyvyt, which they developed in China. Lilly and Innovent currently co-market Tyvyt in China for relapsed or refractory classic Hodgkin's lymphoma after at least two lines of systemic chemotherapy. Per the expanded deal, Lilly will obtain exclusive rights to Tyvyt for geographies outside of China from Innovent for an upfront payment of $200 million and up to $825 million in potential milestone payments. Lilly plans to seek approval of Tyvyt in the United States and other markets.
FDA Gives Priority Review to 4-Week Dosing Regimen of AstraZeneca’s Imfinzi: The FDA granted priority review to a supplemental biologics license application (sBLA) seeking approval of a new four-week, fixed-dose regimen of its drug Imfinzi in the approved indications. Imfinzi is presently approved to treat stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy and previously treated advanced bladder cancer and can be administered as a weight-based dosing of 10mg/kg every two weeks. If approved, the four-week, fixed-dose regimen (1500 mg) would reduce the patients’ medical visits by half. The FDA’s decision is expected during the fourth quarter of 2020.
The NYSE ARCA Pharmaceutical Index rose 0.8% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here is how the eight major stocks performed in the last five trading sessions.
Last week, all the stocks were in the green with Roche recording the highest increase (3%).
In the past six months, AstraZeneca (AZN) has risen the most (18.8%) while Novartis has declined the most (3.2%).
(See the last pharma stock roundup here: FDA Approval for Roche’s SMA Drug & Other Updates)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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