This week Lilly (LLY - Free Report) and AstraZeneca (AZN - Free Report) released their third-quarter 2018 results. Pfizer (PFE - Free Report) gained FDA approval for a new cancer medicine, its third cancer drug approval in less than two months while Bristol-Myers (BMY - Free Report) got a nod from the same regulatory body for a triplet cancer combination for multiple myeloma.
Recap of the Week’s Most Important Stories
Earnings: Lilly’s third-quarter results were mixed as it beat estimates for earnings but missed the same for sales. Lilly, however, raised its previously issued outlook for adjusted earnings while increasing the lower end of the total revenue guidance. Going forward, new products like Trulicity, Taltz, Basaglar, Cyramza, Jardiance, Lartruvo, Verzenio and Olumiant are expected to drive revenues.
AstraZeneca beat estimates for both earnings and sales in the third quarter and maintained its previously issued outlook for 2018. AstraZeneca’s product sales rose 9% at CER in the quarter to $5.27 billion. Higher sales of newer medicines, particularly cancer drugs, and strong performance in emerging markets, mainly China, offset lower sales of many other legacy medicines to drive product sales. With its product sales returning to growth after a long time, Pascal Soriot, AstraZeneca’s chief executive officer, said this marks “the start of a period of sustained growth” for several years.
Pfizer Gets FDA Nod for Another Cancer Medicine: Pfizer gained FDA’s accelerated approval for a cancer medicine, lorlatinib, to be marketed by the trade name of Lorbrena. Lorbrena can be prescribed for the treatment of patients with ALK-positive metastatic non-small cell lung cancer (“NSCLC”) who have received prior treatment with one or more ALK TKIs.
This is the third cancer medicine approval for Pfizer in less than two months. In late September, it gained FDA approval for Vizimpro (dacomitinib) for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in patients with EGFR activating mutations. In October, the FDA approved Talzenna (talazoparib), an orally-available PARP inhibitor for advanced breast cancer.
Bristol-Myers Cancer Combination Drugs in Focus: Bristol-Myers gained FDA approval for a new immunotherapy combination – a triplet combination of Empliciti (elotuzumab), pomalidomide and dexamethasone for certain previously treated patients with multiple myeloma.
Bristol-Myers signed a collaboration deal with Infinity Pharmaceuticals to evaluate a combination of its PD-1 inhibitor, Opdivo and Infinity’s investigational immunotherapy, IPI-549 for the treatment of advanced urothelial cancer. The companies plan to initiate MARIO-275, a randomized, global phase II study to evaluate the combination drugs in the first half of 2019. The combination drugs are already being evaluated in a phase I/Ib study in patients with advanced solid tumors.
Sanofi’s Dupixent Gets FDA Nod for Adolescent Patients: Sanofi (SNY - Free Report) and partner Regeneron gained priority review for a supplemental Biologics License Application (sBLA) looking for approval of their atopic dermatitis drug, Dupixent for adolescent patients (12 years to 17 years of age). The FDA’s decision is expected by Mar 11, 2019. Dupixent is already approved in the United States and Europe for treating adult patients for the same disease. Last month, Dupixent was approved by the FDA as an add-on maintenance treatment in adults and adolescents (12 years of age or older) with moderate-to-severe asthma.
Lilly’s Diabetes Drug Succeeds in Reducing Cardiovascular Risk: Lilly announced data from an outcomes study (REWIND) on Trulicity, which showed that the GLP-1 receptor agonist led to superior reduction in cardiovascular events like death, non-fatal myocardial infarction (heart attack) or non-fatal stroke in a broad range of type II diabetes patients. Importantly, only 31% of the participants in the REWIND study had established CV disease compared to other CV outcomes studies, which have a much greater percentage of type II diabetes patients already with a heart disease. The statistically significant heart risk reduction shown by Trulicity in the study demonstrates that the drug may be able to cater to a much broader patient population if the data is approved to be included on the label.
Meanwhile, initial data from a real-world study, EMPRISE, showed that Jardiance was associated with reduced risk for hospitalization for heart failure compared with DPP-4 inhibitors in type II diabetes patients with and without cardiovascular disease.
Lilly signed a multi-year collaboration deal with small cancer biotech, NextCure, Inc. to develop novel cancer targets utilizing the latter’s proprietary discovery platform - FIND-IO. For the deal, Lilly will make an upfront payment of $25 million to NextCure and the latter will also be entitled to receive milestones and royalty payments if Lilly can successfully develop new cancer medicines under the collaboration.
AstraZeneca Sells Rights to Older Asthma & Rhinitis Drugs: AstraZeneca announced an agreement to divest rights to three older respirator products to a Swiss pharmaceutical group, Covis Pharma. Covis Pharma gained ex-U.S. marketing rights as well rights to U.S. royalties for AstraZeneca’s three medicines - Alvesco indicated for persistent asthma and Omnaris and Zetonna indicated for nasal symptoms associated with rhinitis. Covis Pharma already has the U.S. rights for Alvesco, Omnaris and Zetonna, which it acquired from AstraZeneca in 2017. Covis Pharma will pay AstraZeneca $350 million for rights to the three drugs plus conditional sales-related payments of up to $21 million over four years from 2019.
AbbVie Settles With Momenta on Humira Biosimilar: AbbVie (ABBV - Free Report) signed a non-exclusive licensing deal with Momenta regarding the latter’s proposed biosimilar version of Humira. Per the deal, Momenta will have a non-exclusive license to launch its biosimilar Humira in the United States on Nov 20, 2023. In Europe, Momenta can launch Humira biosimilar when it gets approval from the European Medicines Agency.
AbbVie has similar licensing deals with Amgen, Mylan, Sandoz and Biogen/Samsung Bioepis. Amgen, Mylan, Sandoz and Samsung Bioepis/Biogen’s Humira biosimilars are expected to be launched in the United States in 2023 while in the EU, Amgen, Sandoz and Biogen’s biosimilars were launched in October this year.
While Amgen, Sandoz and Samsung Bioepis’ biosimilar versions are already approved by the FDA, Mylan is yet to gain FDA approval.
The NYSE ARCA Pharmaceutical Index rose 2.6% in the last five trading sessions.
Here is how the seven major stocks performed in the last five trading sessions:
All stocks were in the green this week except Bristol-Myers and Pfizer. While Bristol-Myers recorded a massive decline of 15%, Merck (MRK - Free Report) rose the most (5.5%) in the last five trading sessions.
In the past six months, Lilly has been the biggest gainer (36.2%) while Bristol-Myers recorded the lowest gain (3.3%).
(See the last pharma stock roundup here: PFE, AGN Q3 Earnings, LLY, NVS Collaboration Deals in Focus)
What's Next in the Pharma World?
Watch out for pipeline and regulatory updates next week.
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