Pharma Stock Roundup: Merck, Eli Lilly, AbbVie And More

This week was ruled by cancer data presentations at the annual meeting of the American Society of Clinical Oncology ("ASCO") in Chicago by pharma bigwigs like Bristol-Myers Squibb BMY, Merck MRK and Roche RHHBY, among others. JAK inhibitors were in the news this week with Eli Lilly LLY finally gaining FDA approval for its rheumatoid arthritis ("RA") candidate Olumiant (baricitinib) in the United States while AbbVie ABBV presented positive top-line data from its fifth late-stage study on upadacitinib in RA.

The Week's Most Important Stories

Lilly Gets FDA Nod For Lower Dose Of Olumiant: Eli Lilly and partner Incyte gained FDA approval for the lower dose of (2 mg) of the companies' JAK inhibitor, Olumiant. The FDA did not approve the higher dose (4 mg) and the drug's label was approved with a boxed warning stating risk of serious infections, malignancies and thrombosis. Olumiant is already marketed in Europe and Japan and generated sales of $32.2 million in the first quarter of 2018. In the United States, Lilly faced significant trouble in getting FDA nod for Olumiant. In April last year, the FDA had issued a complete response letter for the new drug application seeking approval of Olumiant, requesting additional information to determine the most appropriate doses. This year in April, an FDA advisory committee had recommended approval of the lower dose of the drug while not recommending the higher dose of 4 mg on inadequate safety profile to support an approval relative to its benefits.

AbbVie's 5th Late-Stage Upadacitinib Study Succeeds: AbbVie's oral JAK-1 selective inhibitor, upadacitinib, met all primary as well as secondary endpoints in the fifth phase III study from its SELECT program. Top-line data from the study showed thata significantly higher proportion of patients treated with upadacitinib in both 15 and 30 mg doses achieved superior responses compared to chemotherapy agent methotrexate. AbbVie plans to submit regulatory applications for upadacitinib in rheumatoid arthritis in the second half of the year.

Allergan Under Activist Pressure To Split CEO-Chairman Roles: Allergan AGN was under pressure this week after two hedge-fund firms, Senator Investment Group and Appaloosa, disclosed a letter urging the company to engage in a management and board overhaul. The firms asked the pharmaceutical company to split its chairman and chief executive roles, both presently held by Brent Saunders, among other management changes. Appaloosa run by David Tepper and Senator Investment Group run by Douglas Silverman, suggested an outsider should be hired for either of the roles. The letter comes on the heels of Allergan's strategic plan announced last week to divest its women's health and infectious disease units. Allergan responded by saying that the board has been refreshed with the addition of three members in the last 16 months.

GlaxoSmithKline Completes Buyout of Novartis' Stake in Consumer Healthcare JV: GSK GSK announced that it has completed its previously announced deal to buy out Novartis' NVS 36.5% stake in the Consumer HealthCare joint venture for $13 billion (£9.2 billion),

With the acquisition of Novartis' stake, Glaxo now has 100% ownership of its Consumer Healthcare unit, which includes products such as Sensodyne and Flonase. Glaxo and Novartis created the JV in 2015 as part of a three-part transaction between the two companies by combining their consumer divisions.

Pfizer to Invest More in Venture Capital Arm: Pfizer PFE plans to invest $600 million in its venture capital arm, Pfizer Ventures which will be invested in small biotechs and other emerging growth companies. About 150 million will be earmarked for companies involved in promising early-stage neuroscience research.

Meanwhile, Pfizer's regulatory applications for orally-available PARP inhibitor, talazoparib, for metastatic breast cancer patients with an inherited BRCA mutation, were accepted for review by the FDA and the European Medicines Agency. In the United States, the new drug application (NDA) was granted priority review by the FDA with a decision accepted in December this year.

Top-line results from talazoparib's registrational study, EMBRACA, in germline-BRCA mutated breast cancer, presented in December 2017 demonstrated superiority of talazoparib over chemotherapy in improving progression free survival.

Roche's Haemophilia A Candidate Gets Priority Review: Roche's sBLA looking for label expansion of its drug, Hemlibra for people with haemophilia A without factor VIII inhibitors was granted priority review by the FDA. Hemlibra is presently marketed for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in haemophilia A patients with factor VIII inhibitors. With the FDA granting priority review, a decision is expected on Oct 14.

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