Pharma Stock Roundup: JNJ's Opioid Settlement, FDA Updates for AZN, GSK, MRK, RHHBY

This week, J&J JNJ settled with two counties of Ohio for $10 million related to the upcoming multidistrict litigation for opioid-based drug abuse. The FDA issued a complete response letter to AstraZeneca’s AZN triple-combo inhaler, PT010 while granting approval to Roche’s RHHBY Rituxan to treat pediatric patients two years and older with two rare blood vessel disorders. Meanwhile, almost all pharma bigwigs presented data from cancer studies at the European Society of Medical Oncology (ESMO) congress in Barcelona, Spain.

Recap of the Week’s Most Important Stories

JNJ Settles With Ohio Counties in Multidistrict Opioid Trial: J&J announced that it has entered into a settlement with two Ohio counties,  Summit and Cuyahoga, in connection with the upcoming October 2019 trial under the federal multidistrict litigation related to abuse of its opioid-based drugs— Duragesic, Nucynta and Nucynta ER. These lawsuits claim that J&J is one of the several companies whose opioid-based drugs were responsible for fueling the state’s opioid epidemic.

J&J has agreed to pay $10 million to resolve all claims pertaining to the scheduled trial. In addition, J&J has agreed to reimburse the counties’ legal costs of $5 million. J&J stated that it has acted responsibly with its opioid products and the settlement is not an admission of liability. In August 2019, J&J was ordered by a district court in Oklahoma to pay $572 million to the state of Oklahoma in connection with a lawsuit filed by the latter.

FDA Rejects AstraZeneca’s Triple-Combo COPD Inhaler: The FDA issued a CRL to AstraZeneca’s triple-combo inhaler, PT010, for chronic obstructive pulmonary disease (COPD). The NDA was based on data from the KRONOS study. AstraZeneca said that it will meet with the FDA to discuss the step forward including submitting data from another study — ETHOS — on PT010 for review. The ETHOS data was not included in the NDA as the study was incomplete at that time. PT010 was approved in Japan in June by the trade name of Breztri Aerosphere, to relieve symptoms of COPD. The candidate is also under review in the EU and China.

AstraZeneca also announced that it is divesting the global commercial rights, excluding China, Japan, the United States and Mexico, of its acid reflux medicine, Losec (omeprazole) and other medicines containing omeprazole to Germany’s pharma company, Cheplapharm. Earlier, AstraZeneca had divested the commercial rights to Losec and other omeprazole medicines in the United States, Japan and Mexico.

The FDA approved a self-administration option for AstraZeneca’s respiratory biologic, Fasenra and a new delivery method — a pre-filled, single-use auto-injector (the Fasenra pen)

FDA Approval to Roche’s Rituxan for Rare Blood Vessel Disorders: The FDA granted approval to Roche’s Rituxan, in combination with glucocorticoids, to treat pediatric patients two years and older with two rare blood vessel disorders, granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). This is Rituxan’s first FDA approval for a pediatric indication. Rituxan is currently approved for the treatment of four autoimmune indications

Meanwhile, Roche announced yet another extension of tender offer period for shares of Spark Therapeutics. This time, the offer period has been extended till Oct 30 as the U.S. Federal Trade Commission and UK’s Competition and Markets Authority continues to review Roche’s pending acquisition of Spark.

J&J & Glaxo Submit sNDA to FDA: J&J submitted a supplemental new drug application (sNDA) to the FDA seeking label expansion of its antidepressant Spravato (esketamine) nasal spray in severely ill patient population. The sNDA was based on data from two phase III studies, ASPIRE I & II, which demonstrated a rapid reduction of depressive symptoms in adult patients with major depressive disorder who have active suicidal ideation with intent.

Glaxo GSK also submitted a sNDA to the FDA, seeking label expansion of its triple combination inhaler Trelegy Ellipta for a new indication — uncontrolled asthma. At present, Trelegy Ellipta is approved to treat COPD.

FDA Grants Priority Review to Merck’s NDAs for Antibacterial Medicine: The FDA accepted Merck’s MRK two regulatory applications, looking for approval of Dificid for the treatment of pediatric patients aged 6 months or older with Clostridium difficile infections (CDI). The first application is an NDA looking for approval of an oral suspension formulation of Dificid, which is presently available in tablet form. The second application is a sNDA looking for approval of Dificid tablets as well as the oral suspension for the pediatric patients. With the FDA granting priority review to both the applications, a decision is expected on Jan 24, 2020.

Meanwhile, Merck’s Keytruda was granted approval in China, as a monotherapy, for first-line treatment of certain patients with advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1. Keytruda is already approved in China in combination with chemotherapy in first-line setting for NSCLC.

Meanwhile, a pivotal phase III study evaluating Merck’s new combination antibacterial injection, Recarbrio, for another indication — hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) — met the primary endpoint. Recarbrio is a fixed combination of relebactam with imipenem/cilastatin. Recarbrio was approved for the treatment of adults with complicated urinary tract infections and complicated intra-abdominal bacterial infections caused by certain susceptible gram-negative bacteria in July

Pfizer’s Abrocitinib Meets Endpoints in 2nd Phase III Study: Pfizer’s PFE investigational JAK1 inhibitor abrocitinib (PF-04965842) met all co-primary and secondary endpoints in a second late-stage study, evaluating it for the treatment of atopic dermatitis (AD), also called eczema. Positive top-line data from thefirst late-stage study on abrocitinib were announced in May this year.

In the phase III study, which tested two doses of the drug, abrocitinib achieved statistically significantly higher improvement in clearing the skin of patients by week 12 compared to placebo. Importantly, a statistically significant number of patients experienced a reduction in pruritus or itching severity by week two.

Novartis’ Studies on Inhaled Asthma Combination Treatments Meet Endpoints: Novartis’ NVS two studies under its phase III PLATINUM clinical development program, which evaluated inhaled once-daily fixed-dose combination treatments, QVM149 and QMF149 in patients with uncontrolled asthma, met the primary endpoint. While the IRIDIUM study evaluated an inhaled combination QVM149 ((indacaterol acetate, glycopyrronium bromide and mometasone furoate), the PALLADIUM study evaluated an inhaled combination QMF149 (indacaterol acetate and mometasone furoate). Data from the PALLADIUM study showed that once-daily QMF149 led to superior improvement in lung function versus mometasone furoate. In the IRIDIUM study, once-daily QVM149 demonstrated statistically significant improvement in lung function versus QMF149.

Update from ESMO: At Europe’s biggest oncology conference, AstraZeneca and Glaxo presented detailed data from late-stage studies evaluating their PARP inhibitors, Lynparza and Zejula, respectively, for a broader advanced ovarian cancer patient population

AstraZeneca and Merck’s Lynpazra added to bevacizumab as a first-line maintenance treatment reduced the risk of disease progression or death by 41% in women suffering from advanced ovarian cancer regardless of their biomarker status or surgical outcome. Glaxo’s Zejula (niraparib), as monotherapy for maintenance therapy of women with first-line ovarian cancer, cut the same risk by 38%, irrespective of the biomarker status.

AstraZeneca also presented detailed data from the phase III PROfound study which evaluated Lynparza in men with metastatic castration-resistant prostate cancer (mCRPC) who have a mutation in their homologous recombination repair (HRRm) genes.  In the study, Lynparza doubled the time without radiographic disease progression in this advanced prostate cancer patient population.

Novartis’ CDK4/6 inhibitor Kisqali in combination with fulvestrant achieved statistically significant improvement in overall survival (OS) with a 28% reduction in risk of death, per data presented from the phase III MONALEESA-3 study. This is the second study in which Kisqali has demonstrated positive OS in postmenopausal women with HR+/HER2- advanced or metastatic breast cancer.

Lilly presented OS data from the phase III MONARCH 2 study, which evaluated Verzenio plus fulvestrant in HR+, HER2- advanced breast cancer patients who experienced disease progression following endocrine therapy. The data showed that OS rate in Verzenio plus fulvestrant arm was 46.7 months while in the placebo plus fulvestrant arm, the same was 37.3 months.  Verzenio plus fulvestrant is already approved for the above patient population on the basis of progression-free survival data from the same study. Lilly will now look to get approval for OS data from the study to be included on the drug’s label.

AstraZeneca presented new data from the phase III FLAURA study, which demonstrated the superior OS benefit of Tagrisso to standard-of-care medicines in patients with EGFR mutated non-small cell lung cancer (NSCLC). Meanwhile, Merck and Bristol-Myers presented data from label expansion studies on their respective PD-L1 inhibitors, Keytruda and Opdivo, respectively. While Merck presented Keytruda data in triple-negative breast cancer, Bristol Myers presented OS data from CheckMate -227 study, evaluating Opdivo plus low-dose Yervoy in advanced non-small cell lung cancer and five-year survival data on Opdivo plus Yervoy in advanced melanoma.

Pfizer presented detailed data from a phase III study evaluating a combination of Braftovi, Mektovi and cetuximab for the treatment of BRAFV600E-mutant metastatic colorectal cancer. Braftovi plus Mektovi, which Pfizer acquired from its recent acquisition of Array BioPharma, was launched as a treatment for BRAF-mutant melanoma, last year.

The NYSE ARCA Pharmaceutical Index declined 1.4% in the last five trading sessions.

Large Cap Pharmaceuticals Industry 5YR % Return

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, only J&J was in the green, rising 1.8%. AstraZeneca declined the most (5%).

In the past six months, Bristol-Myers has been the biggest gainer (6.2%) while Pfizer lost the most (17.6%).

(See the last pharma stock roundup here: FDA Approves Expanded Use of MRK/J&J’s Drugs & Other Updates)

What's Next in the Pharma World?

Watch out for regular pipeline and regulatory updates next week.

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