The biggest news this week was Pfizer’s (PFE - Free Report) announcement of its plans to re-organize its business into three new segments, effective next year. J&J (JNJ - Free Report) was ordered by a St Louis jury to pay approximately $4.7 billion to nearly two dozen women in a lawsuit related to its talc-based products. Merck (MRK - Free Report) , AbbVie (ABBV - Free Report) and Bristol-Myers (BMY - Free Report) provided updates on their cancer drugs.
Pfizer to Re-Organize Business Units: Pfizer is re-organizing its business into three business segments, separating its consumer healthcare business into a standalone unit. Beginning 2019, Pfizer will report under three new business units — Innovative Medicines, Established Medicines and Consumer Healthcare. Presently, Pfizer has two reporting segments namely Innovative Health and Essential Health.
The present Innovative Health unit will be called the Innovative Medicines unit and will now include biosimilars and a new hospital business unit for anti-infectives and sterile injectables — both of which are presently reported under Essential Health. The Essential Health unit will now be renamed to Established Medicines. This unit will include Pfizer’s legacy brands that have lost or will lose market exclusivity. (Read more: Pfizer to Reorganize Business Into Three New Units)
J&J to Pay $4.7 Billion in Talc Lawsuit: J&J was ordered by a jury in a St. Louis court to pay $4.69 billion in damages to 22 women who alleged that its talc-based products, including its baby powders, contained asbestos, which caused them to develop ovarian cancer. The damages comprised $550 million in compensatory damages and $4.14 billion in punitive damages. J&J, in an official statement, said the verdict was unfair and it would appeal against it. It also said its talc products neither contained asbestos nor caused cancer. J&J faces more than 9,000 cases for its talc products.
Trump Slams Pfizer for Price Hikes; Pfizer Defers Increases: In a tweet, President Donald Trump slammed Pfizer for raising prices of several of its prescription drugs, effective from Jul 1. Trump said Pfizer and other U.S. drugmakers should be “ashamed” that they had raised drug prices for “no reason.” The tweet also said that by raising drug prices in the United States, these drug companies were offering “bargain basement prices” overseas. He warned that the administration will respond. A day after this tweet was published, Pfizer issued a statement saying it will defer the price increases until the President’s drug pricing blueprint goes into effect or until the end of the year, whichever is earlier.
AbbVie’s Imbruvica Lymphoma Study Fails: AbbVie announced that a late-stage study evaluating its cancer drug Imbruvica for the first-line treatment of diffuse large B-cell lymphoma (DLBCL) failed to meet the primary endpoint.
The study evaluated the addition of Imbruvica to R-CHOP (combination of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone), which is the existing standard of care for DLBCL, an aggressive form of non-Hodgkin lymphoma (NHL) versus R-CHOP plus placebo. However, the study data showed that adding Imbruvica to R-CHOP did not improve event-free survival (EFS) in the targeted patient population. Imbruvica is presently FDA approved for eight indications including five B-cell blood cancers, as well as in chronic graft-versus-host-disease. The drug, which AbbVie markets in partnership with J&J, recorded sales of $762 million in the first quarter of 2018. This included U.S. sales of $624 million, up 36.7%, and $138 million (up 47.2%) of international profit sharing with J&J.
AbbVie also filed a supplemental new drug application (sNDA) to the FDA for a label expansion of Venclexta (venetoclax) for the first-line treatment of acute myeloid leukemia (AML). AbbVie is looking to get Venclexta approved in combination with a hypomethylating agent (“HMA”) or with low-dose cytarabine (“LDAC”) in AML patients who are ineligible for intensive chemotherapy. (Read more: AbbVie's Imbruvica Fails in Phase III Blood Cancer Study)
Merck’s Keytruda sBLA Gets Priority Review: Merck’s supplemental biologics license application (sBLA) looking to expand the label of Keytruda for previously treated patients with advanced hepatocellular carcinoma (HCC), the most common type of liver cancer, was granted priority review by the FDA. The FDA’s decision is expected on Nov 9. The sBLA filing was based on data from the phase II KEYNOTE-224 study. (Read More: Merck's Keytruda Gets FDA's Priority Review for Liver Cancer)
Bristol-Myers Opdivo+Yervoy Combo Gets FDA Nod for Colorectal Cancer: Bristol-Myers announced accelerated approval for a combination of its immuno-oncology drugs, Opdivo and Yervoy for a type of colorectal cancer. The combination is now approved for previously treated patients with DNA mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer. The Opdivo + Yervoy combination is also approved in two other tumor types — first-line treatment of intermediate or poor-risk advanced renal cell carcinoma and unresectable or metastatic melanoma. (Read more: Bristol-Myers' Combo Drugs Get FDA Nod for Colorectal Cancer)
CTI BioPharma Slumps on Study Failure: Shares of CTI BioPharma (CTIC - Free Report) slumped on Monday as a pivotal study evaluating a combination regimen of its cancer drug, Pixuvri, in non-Hodgkin lymphoma failed to improve progression free survival. Pixuvri has conditional approval in Europe, as monotherapy for the treatment of multiply relapsed or refractory aggressive B-cell NHL. However, it is yet to receive approval in the United States. (Read more: CTI BioPharma Falls After Failure of Pivotal Lymphoma Study)
The NYSE ARCA Pharmaceutical Index rose 2.1% in the last five trading sessions.
Here is how the seven major stocks performed in the last five trading sessions:
All the stocks recorded an increase last week with AstraZeneca (AZN - Free Report) gaining the most (5.8%).
In the past six months, Glaxo has been the biggest gainer (11.3%) while J&J (JNJ - Free Report) declined the most (12.4%).
(See the last pharma stock roundup here: Pharma Stock Roundup: NVS to Divest Eye Care Unit, CHMP Gives Nod to Several Drugs)
What's Next in the Pharma World?
Watch out for the earnings of some of the bigwigs of the pharma world later this month beginning with J&J on Jul 17.
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