J&J (JNJ - Free Report) and Bristol-Myers (BMY - Free Report) set the earnings season in motion for the pharma space. Meanwhile, Lilly (LLY - Free Report) and AbbVie (ABBV - Free Report) faced pipeline setbacks with failure of their late-stage studies. Lilly’s confirmatory study to convert soft tissue sarcoma drug Lartruvo’s conditional approval to full approval and AbbVie’s Imbruvica combination study in metastatic pancreatic cancer failed to meet their respective primary endpoints.
Recap of the Week’s Most Important Headlines
Inside J&J & Bristol-Myers’ Q4 Earnings: J&J beat estimates for both earnings and sales in the fourth quarter of 2018. Sales increased 1% from the year-ago quarter to $20.4 billion while earnings per share rose 13.2% to $1.95 per share. Pharmaceutical segment sales rose 5.3% year over year. However, J&J’s sales guidance for 2019 was below expectation.
Bristol-Myers beat estimates for earnings while missing the same for sales. Revenues were up 10% year over year to $6 billion while earnings rose 38% to $94 per share. However, the company announced the voluntary withdrawal of a label expansion application for Opdivo + low-dose Yervoy combination in first-line ling cancer, which pushed its share price down. Opdivo sales were up 33% in the fourth quarter. Bristol-Myers confirmed its 2019 earnings guidance range of $4.10 to $4.20.
Lilly’s Confirmatory Study on Lartruvo Fails: Lilly’s drug Lartruvo, which had won conditional approval two years back, failed to improve survival for patients with advanced soft tissue sarcoma in a late-stage confirmatory study, ANNOUNCE.
The ANNOUNCE study evaluated Lartruvo in combination with doxorubicin, a standard of care chemotherapy compared with doxorubicin alone. The study did not meet the primary endpoints of overall survival (OS) in the full study population or in the leiomyosarcoma (LMS) sub-population. It was noticed that there was no difference in survival between the study arms for either population. The study thus did not confirm the clinical benefit of Lartruvo in combination with doxorubicin as shown earlier in a phase II study. The clinical benefit achieved earlier had led to an accelerated approval of Lartruvo+doxorubicin by the FDA and conditional marketing authorization by the European Medicines Agency in 2016.
Continued approval was contingent on verification of clinical benefit in a confirmatory study. With ANNOUNCE failing to confirm clinical benefit, Lilly said it will stop promoting Lartruvo while remaining in discussion with global regulators to determine the next steps for the drug.
AbbVie’s Imbruvica Fails in Pancreatic Cancer Study: AbbVie’s late-stage study evaluating its cancer drug, Imbruvica in combination with chemotherapy for metastatic pancreatic cancer failed to meet the primary endpoint of statistically-significant progression-free or overall survival benefit.
The RESOLVE study evaluated Imbruvica plus chemotherapy agents nab-paclitaxel and gemcitabine versus placebo in combination with these chemotherapy agents for the treatment of first-line metastatic pancreatic cancer, one of the most aggressive and deadliest forms of cancer. Imbruvica, currently approved for nine cancer indications, has multi-billion dollar potential and AbbVie is exploring the potential to expand Imbruvica’s label into solid tumors and autoimmune diseases.
FDA Accepts Merck’s sNDAs for HIV Medicines: Merck’s (MRK - Free Report) supplemental new drug applications (sNDAs) looking for label expansion of its two new HIV drugs — Pifeltro and Delstrigo — was accepted by the FDA. Pifeltro and Delstrigo were approved by the FDA in August for the treatment of adults with no prior antiretroviral treatment experience. The sNDAs are looking to get the HIV drugs approved for use in treatment-experienced adults living with HIV-1 whose virus is suppressed to switch to Pifeltro (in combination with other antiretrovirals) or Delstrigo. The FDA is expected to give its decision on Sep 20. The sNDAs were based on data from the phase III DRIVE-SHIFT study. Data from the study, presented in the past, has shown non-inferior efficacy for those who switched to Delstrigo compared to those who continued on their baseline regimen.
Sanofi’s Influenza Vaccine Gets FDA Nod for Kids: Sanofi (SNY - Free Report) announced FDA approval of 0.5 mL dose of its influenza vaccine, Fluzone Quadrivalent for use in children 6 months through 35 months of age. The 0.5 mL dose is already approved for use in patients 3 years and above. The FDA approval was based on clinical data from a phase IV safety and immunogenicity study conducted in nearly 2,000 children. Fluzone Quadrivalent’s lower 0.25 mL dose is already approved for use in this age group.
The NYSE ARCA Pharmaceutical Index declined 1.9% in the last four trading sessions.
Here is how the seven major stocks performed in the last four trading sessions:
All the seven stocks recorded a decline of more than 1% in the last four trading sessions with Pfizer (PFE - Free Report) declining the most (3.6%).
In the past six months, Lilly has been the biggest gainer (20.8%) while Bristol-Myers declined the most (15.4%).
(See the last pharma stock roundup here: Regulatory Updates in Focus at PFE, BMY, RHHBY, SNY)
What's Next in the Pharma World?
Watch out for fourth-quarter and full year 2018 earnings results by Merck, Pfizer, Allergan and others and pipeline and regulatory updates next week.
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