The FDA granted approval to Bristol-Myers BMY & Roche’s RHHBY (OTC:RHHBY) PD-L1 inhibitors, Opdivo and Tecentriq for expanded lung cancer indications and AstraZeneca (NYSE:AZN) AZN/Merck’s MRK Lynparza for prostate cancer. Meanwhile, Johnson & Johnson (NYSE:JNJ) JNJ announced plans to permanently discontinue sale of its talc-based Johnson’s Baby Powder in the United States and Canada.
Recap of the Week’s Most Important Stories:
J&J Discontinues Talc-Based Baby Powder Sales in U.S./Canada: J&J said that it is permanently discontinuing sale of its talc-based Johnson’s Baby Powder in the United States and Canada. The company said that the demand for the product has been declining, blaming it on “misinformation around the safety of the product” amid a barrage of legal challenges. J&J faces thousands of lawsuits, which claim that its talc-based products, primarily its baby powders, cause cancer. There have been verdicts against J&J in its talc lawsuits. J&J has consistently denied allegations and insisted that talc-based products are safe and do not cause cancer.
FDA Approves Bristol-Myers& Roche’s Drugs for Expanded Lung Cancer Indications: The FDA granted approval to Bristol-Myers’ dual immunotherapy —Opdivo plus Yervoy—as first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1≥1%. The approval was based on data from part 1a of the phase III CheckMate -227 study. In the study Opdivo + Yervoy showed superior and durable long-term overall survival versus chemotherapy. This is the fifth indication for which FDA has granted approval to Opdivo + Yervoy combination.
The FDA also approved Roche’s Tecentriq a first-line treatment for metastatic NSCLC in patients whose tumors have high PD-L1 expression. The approval was based on data from the phase III IMpower110 study. This is Tecentriq’s fourth approval for a metastatic NSCLC indication.
The FDA also approved Bristol-Myers’ multiple myeloma treatment Pomalyst (pomalidomide) for patients with AIDS-related Kaposi sarcoma, a rare form of cancer.
FDA Approves AstraZeneca/Merck’s Lynparza for 4th Cancer Type: The FDA approved AstraZeneca and Merck’s Lynparza for HRR gene-mutated metastatic castration-resistant prostate cancer. The approval was based on data from the phase III PROfound study. Lynparza, was until now approved in three tumor types— ovarian, breast and pancreatic and pancreatic cancer is the fourth tumor type for which Lynparza is now approved.
AstraZeneca Gets $1B Funding from BARDA for Coronavirus Vaccine: AstraZeneca announced that it has received more than $1billion in funding from BARDA to help produce the vaccine which it is developing with Oxford University. Last month, AstraZeneca entered into an agreement with Oxford University for the global development and distribution of the University’s potential recombinant adenovirus vaccine, now known as AZD1222, to prevent COVID-19. AstraZeneca secured the first agreements to supply at least 400 million doses and plans to begin the first deliveries of the vaccine from September 2020. AstraZeneca has also agreed to provide the United States with up to 300 million doses. Meanwhile, AstraZeneca also said that it has the capacity to produce one billion doses if the vaccine is approved and continues to increase capacity further. AZD1222 is currently being evaluated in a phase I/II study, which began last month. Data from the study is expected to be released shortly. If the data is successful, late-stage studies with 30,000 participants are expected to begin in a number of countries.
The FDA granted Breakthrough Therapy Designation (BTD) to AstraZeneca’s Enhertu for HER2-mutant metastatic NSCLC. The BTD was based on data from the ongoing phase II ESTINY-Lung01 study. This is the third BTD for Enhertu, with the first BTD granted in 2017 for HER2-positive metastatic breast cancer. Last week, the FDA granted BTD to Enhertu for HER2-positive metastatic gastric cancer. Enhertu was approved for HER2-positive metastatic breast cancer in December 2019.
Meanwhile, AstraZeneca’s Bevespi Aerosphere was approved in China, as a maintenance treatment to relieve symptoms in patients with chronic obstructive pulmonary disease (COPD). Bevespi Aerosphere is a fixed-dose, long-acting dual bronchodilator in a pressurized metered-dose inhaler device, which is already approved in the United States, EU and several other countries.
Glaxo’s Long Acting HIV Injection Betters Daily Pills in Large Study: Interim data from Glaxo’s GSK HPTN 083 study showed that its investigational, long-acting injectable cabotegravir (CAB LA) administered every two months is 69% more effective than daily pills in preventing HIV acquisition in the study population. The interim analysis was conducted by the independent Data and Safety Monitoring Board (DSMB), which recommended thatthe study be stopped early. The participants who were receiving the current standard of care, Truvada daily pills (emtricitabine/tenofovir disoproxil fumarate 200 mg and 300 mg (FTC/TDF)) will be offered CAB LA.
Glaxo also announced a long-term partnership with South Korea’s Samsung (KS:005930) Biologics under which the latter will provide Glaxo with additional capacity for large scale manufacturing of biopharmaceutical products. The deal is worth more than $231 million over the next eight years. The flexible manufacturing capacity will be initially used for commercial production of lupus drug Benlysta and the first commercial supply is expected in 2022.
Pfizer’s New Data on DMD Gene Therapy Candidate: Pfizer PFE presented new phase Ib data on its investigational gene therapy, PF-06939926 in ambulatory boys with Duchene muscular dystrophy (DMD) at a medical conference. Preliminary safety data on nine ambulatory boys (aged 6 to 12) with DMD showed that treatment with PF-06939926 led to durable and statistically significant improvements across multiple efficacy-related endpoints measured at 12 months post-infusion. This included sustained levels of mini-dystrophin expression and improvements in muscle function measured by the North Star Ambulatory Assessment (NSAA) rating scale. Pfizer believesthe data supports the advancement of the candidate into a pivotal phase III study.
Novartis’s SMA Treatment Zolgensma Gets Approval in Europe: The European Commission granted approval to Novartis’ gene therapy, Zolgensma to treat babies and young children with spinal muscular atrophy (SMA). Zolgensma was added to Novartis’ portfolio with the 2018 acquisition of AveXis. Zolgensma was approved by the FDA last year for the treatment of pediatric patients less than two years of age with SMA.
The NYSE ARCA Pharmaceutical Index declined 0.37% in the last five trading sessions.
Here is how the nine major stocks performed in the last five trading sessions.
Last week, AbbVie (NYSE:ABBV) rose the most (3.4%) while Merck declined the most (4.4%).
In the past six months, Lilly has risen the most (29.6%) while Merck declined the most (10.7%).
(See the last pharma stock roundup here: FDA Updates for LLY, AZN, MRK, BMY and SNY)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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