A key announcement this week was Novartis’ (NVS - Free Report) plan to sell parts of its Sandoz unit to India’s Aurobindo Pharma for approximately $1 billion. Meanwhile, regulatory and pipeline updates were provided by companies like AstraZeneca (AZN - Free Report) , Merck (MRK - Free Report) , Pfizer (PFE - Free Report) , Roche (RHHBY - Free Report) and Johnson & Johnson (JNJ - Free Report)
Recap of the Week’s Most Important Stories
Novartis to Sell Parts of Sandoz for $1 Billion: Novartis said it will sell selected portions of the Sandoz US portfolio, comprising approximately 300 products, to Aurobindo Pharma USA Inc., a subsidiary of India’s Aurobindo Pharma Ltd.
Novartis is selling its Sandoz U.S. generic and branded dermatology business and generic U.S. oral solids portfolio to Aurobindo Pharma for $900 million in cash and an additional $100 million of potential earn-outs. The divesture will allow Sandoz to focus on biosimilars, value-added medicines and complex generics such as injectables, respiratory and ophthalmics. The transaction is expected to close next year. (Read more: Novartis to Sell Sandoz's Dermatology Business to Aurobindo)
AstraZeneca’s SLE Study Fails: AstraZeneca’s late-stage study, TULIP 1, evaluating its pipeline candidate, anifrolumab for the debilitating autoimmune disease, systemic lupus erythematosus, failed to meet the primary endpoint. Top-line data from the study failed to show a reduction of disease activity as measured by the SLE Responder Index in patients treated with anifrolumab. (Read more: AstraZeneca's Lupus Drug Misses Primary Endpoint in Study).
Sanofi’s Cablivi Gets EU Nod: The European Commission granted marketing authorization to Sanofi’s (SNY - Free Report) Cablivi (caplacizumab) for the treatment of a rare blood disorder called acquired thrombotic thrombocytopenic purpura. The decision was expected as the Committee for Medicinal Products for Human Use (“CHMP”) had recommended the drug’s approval in July. Cablivi was added to Sanofi’s portfolio with the acquisition of Ablynx this year. In the United States, Sanofi’s regulatory application for Cablivi was granted priority review by the FDA with a decision expected on Feb 6, 2019. (Read more: Sanofi's Blood Disorder Drug Cablivi Gets Approval in Europe)
Merck’s Gets Priority Review Status for Keytruda sBLA: Merck’s supplemental Biologics License Application (sBLA) looking to expand the label of Keytruda for recurrent locally advanced or metastatic Merkel cell carcinoma (MCC)— a rare form of skin cancer — was granted priority review by the FDA. A decision is expected on Dec 28.
Merck and Japanese partner Eisai’s tyrosine kinase inhibitor, Lenvima was approved by the by Chinese regulatory authorities for the first-line treatment of unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer. Lenvima was approved for this indication in the United States and EU last month and in Japan in March.
J&J Files for Esketamine in the U.S.: J&J filed a new drug application (NDA) to the FDA for esketamine nasal spray, which has been developed for treatment-resistant depression in adults. J&J expects to file a regulatory application in the EU later this month. (Read more: J&J Submits NDA to the FDA for Depression Drug in Adults)
Breakthrough Therapy Status for Pfizer’s and AstraZeneca’s Products: The FDA granted Breakthrough Therapy designation to Pfizer’s pipeline candidate, PF-06651600, which is being developed for alopecia areata, a chronic autoimmune skin disease that causes hair loss on the scalp, face, or body.
The same status was also given to AstraZeneca’s respiratory candidate, tezepelumab for severe uncontrolled asthma. The designation was based on data from the phase IIb PATHWAY study, which showed that tezepelumab reduced annual asthma exacerbation rate, a measure of deterioration of asthma.
FDA Delays Decision on Roche’s sBLA Filing: The FDA delayed the review period for Roche’s sBLA for its blockbuster drug, Tecentriq, in combination with its another cancer drug, Avastin plus carboplatin and paclitaxel for the first-line treatment of metastatic NSCLC, by three months. The FDA’s decision is now expected on Dec 5. The FDA delayed the decision as it needs time to review the additional information submitted by Roche, which it considers a major amendment to the sBLA. The original sBLA was filed based on progression free survival and overall survival data from the IMpower 150 study.
The NYSE ARCA Pharmaceutical Index rose 1.1% in the last four trading sessions.
Here is how the seven major stocks performed in the last four trading sessions:
It was a mixed performance this week. While AstraZeneca declined the most (4.8%), J&J recorded the highest gain of 1.4% in the last four trading sessions.
In the past six months, Lilly remains the biggest gainer (33.6%) while Bristol-Myers declined the most (8.7%).
(See the last pharma stock roundup here: Approval of NVS & ABBV Cancer Drugs, MRK’s HIV Drug in Focus)
What's Next in the Pharma World?
Watch out for several pipeline and regulatory updates next week
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