This week was a relatively busy one for the pharma sector, marked by earnings of bigwigs like Merck MRK, Pfizer PFE and Lilly LLY. Meanwhile, the European Commission granted approval to AbbVie’s ABBV new plaque psoriasis drug Skyrizi (risankizumab) and Sanofi SNY/Lexicon Pharmaceuticals’ dual SGLT1 and SGLT2 inhibitor, Zynquista (sotagliflozin). The Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (EMA) recommended marketing approval for several drugs.
Recap of the Week’s Most Important Stories
Q1 Earnings Update: Pfizer, Glaxo and Merck beat estimates for first-quarter earnings and sales. Pfizer raised the mid-point of its earnings expectations for 2019 by a penny and confirmed its previous outlook for full-year sales. Merck raised its expectations for both earnings and sales for the year while Glaxo GSK maintained its previous earnings guidance for 2019.
Lilly beat estimates for earnings in Q1. Though the company raised its earnings guidance for 2019, it lowered its full-year revenue forecast.
EU Approval to Sanofi & AbbVie Drugs: The European Commission granted approval to AbbVie’s Skyrizi (risankizumab) for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy. Skyrizi was approved in the United States in late April and is expected to be launched this month. It was approved in Japan in March.
Lexicon Pharmaceuticals and partner Sanofi announced that the European Commission granted approval to their dual SGLT1 and SGLT2 inhibitor, Zynquista (sotagliflozin), in combination with insulin, for the treatment of type I diabetes in adult patients. In March, the FDA had issued a complete response letter (“CRL”) to the new drug application (“NDA”) seeking approval for Zynquista.
CHMP Gives Positive Opinion to Several Drugs: AstraZeneca/Merck’s PARP inhibitor Lynparza gained a positive CHMP opinion, recommending expanded approval for first-line maintenance treatment of BRCA-mutated advanced ovarian cancer. It is already approved in the United States for the indication. The CHMP also gave nod to Novo Nordisk’s Esperoct (turoctocog alfa pegol, N8-GP) for the treatment of haemophilia A. The drug was approved by the FDA in February this year. Glaxo also gained positive CHMP opinion for its once-daily, single-tablet two-drug regimen (2DR), Dovato for the treatment of newly-diagnosed adults with HIV-1 infection. Dovato is a fixed-dose combination of Tivicay (dolutegravir - 50 mg) in combination with lamivudine (300 mg) and was approved by the FDA last month. Pfizer’s new PARP inhibitor, Talzenna also gained a positive opinion from the CHMP for inherited (germline) BRCA-mutated advanced breast cancer.
The final decision by the European Union on these products is expected in the coming months.
J&J Files sNDA to Expand Label of Erleada: J&J JNJ filed a supplemental new drug application (sNDA) with the FDA seeking approval of its new prostate cancer drug Erleada in an expanded patient population. The sNDA is looking to get Erleada approved to treat patients with metastatic castration-sensitive prostate cancer (mCSPC) while the drug is already marketed in the United States for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC). The sNDA filing is supported by data from the phase III TITAN study.
Glaxo/J&J File NDA for Long-Acting Two-Drug HIV Regimen: Glaxo’s HIV subsidiary, ViiV Healthcare and partner J&J filed a NDA looking for approval of long-acting, two-drug regimen of ViiV Healthcare’s cabotegravir and Janssen’s Edurant (rilpivirine). The companies are seeking approval for the two-drug monthly regimen for the treatment of HIV-1-infected adults who had maintained viral suppression and who are not resistant to cabotegravir or rilpivirine. The approval was based on data from the phase III ATLAS study, which showed that the two-drug regimen, injected once a month, had similar efficacy to a standard of care, daily, oral three-drug regimen at week 48.
Glaxo and its partner Innoviva’s phase III study (CAPTAIN) evaluating their triple combination once-daily single inhaler Trelegy Ellipta versus Relvar/Breo Ellipta for a new indication -uncontrolled asthma - met the primary endpoint. Data from the study showed that treatment with Trelegy Ellipta led to statistically significant improvement in lung function in such patients, thereby meeting the study’s primary endpoint. At present, Trelegy Ellipta is approved to treat chronic obstructive pulmonary disease.
Bayer Gets FDA’s Priority Review for Prostate Cancer Candidate: Bayer’s new drug application looking for approval of its prostate cancer candidate, darolutamide was accepted and granted priority review by the FDA. In February 2019, Bayer completed the rolling submission of the NDA for darolutamide to the FDA. The submission is based on data from the phase III ARAMIS study in men with non-metastatic castration-resistant prostate cancer (nmCRPC). Regulatory applications are also under review in Europe and Japan.
Here is how the seven major stocks performed in the last five trading sessions:
It was a mixed performance last week with Pfizer gaining the most (3.6%) and AstraZeneca declining the most (1.5%)
In the past six months too, Merck has been the biggest gainer (8.8%) while Bristol-Myers declined the most (9.9%).
(See the last pharma stock roundup here: Pharma Stock Roundup: AZN, MRK, GSK Get Regulatory Approvals, Sandoz Inks New Deal)
What's Next in the Pharma World?
Watch out for the earnings of Allergan and regular pipeline and regulatory updates next week.
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