This week, Lilly LLY offered to buy Dermira for $1.1 billion to add the latter’s late-stage candidate for atopic dermatitis/eczema, lebrikizumab. Meanwhile, AstraZeneca AZN announced discontinuation of a late-stage study on its fish-oil pill, Epanova in mixed dyslipidaemia on recommendation of an independent Data Monitoring Committee. While AbbVie ABBV announced data from a phase III head-to-head study on new drug Skyrizi, J&J JNJ and Bristol-Myers BMY provided some regulatory updates.
Recap of the Week’s Most Important Stories:
Lilly Offers to Buy Dermira: Lilly offered to buy Dermira for $18.75 per share in cash or approximately $1.1 billion to add the latter’s promising interleukin inhibitor for atopic dermatitis/eczema, lebrikizumab. Lebrikizumab, a monoclonal antibody that targets IL-13, is being developed in phase III studies for moderate-to-severe atopic dermatitis. The deal will also add Dermira’s marketed medicated cloth, Qbrexza for the topical treatment of primary axillary hyperhidrosis to Lilly’s immunology portfolio.
Lilly also announced plans to launch lower-priced versions of two of its insulin products,– Humalog Mix75/25 KwikPen and Humalog Junior KwikPen. The list price of these low-priced insulin injections, which will be available from mid-April, will be 50% lower than the current list price of the branded options.
AstraZeneca Abandons Heart Risk Study on Fish Oil Drug: AstraZeneca announced that it will discontinue the phase III STRENGTH outcomes study on its fish-oil pill, Epanova. The study was evaluating the cholesterol medicine Epanova to reduce the risk of cardiovascular disease in patients with mixed dyslipidaemia (MDL) or high triglyceride (TG) levels. The decision to stop the STRENGTH study was taken based on the recommendation of an independent Data Monitoring Committee as it was unlikely to demonstrate a benefit to patients
Meanwhile, AstraZeneca and partner Merck MRK announced that the FDA has granted priority review to a supplemental new drug application (sNDA) seeking approval of their PARP inhibitor Lynparza as a first-line maintenance treatment for advanced ovarian cancer regardless of patients’ biomarker status or surgical outcome. The sNDA is based on data from the PAOLA-1 study. With the FDA granting priority review, a decision from the FDA is expected in the second quarter of 2020.
AbbVie’s Skyrizi Superior to Novartis’ Cosentyx in Psoriasis Study: AbbVie announced data from a phase III head-to-head study, comparing its newly approved drug Skyrizi (risankizumab) to Novartis’ NVS Cosentyx in adults with moderate-to-severe plaque psoriasis. The data showed that Skyrizi was superior to Cosentyx across primary and all ranked secondary endpoints at 52 weeks. Treatment with Skyrizi led to significantly higher rates of skin clearance compared to Cosentyx, thereby meeting the primary endpoint of superiority. Of the total, 87% of patients treated with Skyrizi achieved the primary endpoint — at least a 90% improvement from baseline in the Psoriasis Area and Severity Index (PASI 90) at week 52 compared to 57% of Cosentyx-treated patients.
FDA Grants Priority Review to Bristol-Myers’ Opdivo sBLA: The FDA accepted Bristol-Myers’ supplemental biologics license application (sBLA), seeking approval of Opdivo plus low-dose Yervoy for first-line NSCLC in patients with no EGFR or ALK genomic tumor aberrations. The sBLA was based on data from part 1 of the phase III CheckMate-227 study. With the FDA granting priority review to the application, a decision is expected on May 15, 2020.
J&J Seeks Approval of Spravato in Expanded Patient Group in EU: J&J submitted a type II variation application to the European Medicines Agency (EMA), seeking label expansion of its Spravato (esketamine) nasal spray in patients with major depressive disorder (MDD) who have current suicidal ideation with intent in Europe. A supplemental new drug application seeking a similar label expansion was filed in the United States in October this year. The application was based on data from two phase III studies, ASPIRE I & II.
The NYSE ARCA Pharmaceutical Index was up 2.2% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here is how the seven major stocks performed in the last five trading sessions.
Last week, all the stocks were in the green. Pfizer recorded the maximum gain (4.4%).
In the past six months, Bristol-Myers has risen the most (51.6%) while Pfizer (PFE) lost the maximum (5.7%).
(See the last pharma stock roundup here: Lilly’s Upbeat 2020 Outlook, FDA Nod for PFE & MRK’s Drugs)
What's Next in the Pharma World?
Watch out for J&J’s fourth-quarter 2019 results and regular pipeline and regulatory updates next week.
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Merck & Co., Inc. (MRK) : Free Stock Analysis Report
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