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Last week, big names like Merck (MRK - Free Report) and Pfizer (PFE - Free Report) reported earnings results. Johnson & Johnson (JNJ - Free Report) was also in the news related to a jury verdict for its talc powder lawsuit.
Recap of the Week’s Most Important Stories
A Look at Earnings Results: Two major pharma players, Merck and Pfizer, reported first quarter results last week. While Merck surpassed estimates (Read more: Merck Beats on Q1 Earnings & Sales, Ups Annual View), Pfizer topped earnings estimates but missed on revenues (Read more: Pfizer Q1 Earnings Beat, Sales Lag, 2017 View Intact). Pfizer’s revenues were impacted by fewer selling days as well as the divestiture of Hospira Infusion Systems. The company will be losing exclusivity on Viagra in the U.S. later this year.
J&J Ordered to Pay More than $110M by St. Louis Jury: J&J took a hit with a St. Louis jury ordering the company to pay more than $110 million to a woman related to claims that using the company’s talcum products led to ovarian cancer. J&J intends to appeal the verdict. J&J’s talc supplier has also been ordered to pay damages.
EU Label Expansion for Merck’s Keytruda: Merck’s anti-PD-1 therapy Keytruda gained EU approval for use in patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) and Adcetris (brentuximab vedotin), or who are transplant-ineligible and have failed Adcetris. This marks the first hematologic malignancy approval for Keytruda in the EU. Keytruda is one of the most important new product launches at Merck and the company is working on expanding the label and boost sales.
The FDA is expected to respond on the approvability of Keytruda for use in combination with pemetrexed and carboplatin for the treatment of patients with metastatic or advanced non-small cell lung cancer (NSCLC) regardless of PD-L1 expression by May 10, 2017. Keytruda is also under Priority Review in the U.S. for the first-line treatment of patients with locally advanced or metastatic urothelial cancer, a type of bladder cancer, who are ineligible for cisplatin-containing therapy. An application for second-line use is also under Priority Review with a response for both applications expected by Jun 14, 2017. Moreover, a response from the FDA regarding Keytruda’s approvability for the treatment of previously treated patients with advanced microsatellite instability-high cancer is expected by Jun 9, 2017.
Updates on Pfizer’s Xeljanz: A 5mg twice daily as well as an extended release 11 mg once daily formulation of Pfizer’s Xeljanz (tofacitinib citrate) has been accepted for review by the FDA for the treatment of adult patients with active psoriatic arthritis (PsA). A response from the agency is expected in Dec 2017.
Pfizer also announced the publication of detailed results from phase III oral studies on Xeljanz in ulcerative colitis (UC) in The New England Journal of Medicine. All three pivotal studies -- OCTAVE Induction 1, OCTAVE Induction 2 and OCTAVE Sustain -- met their primary endpoints, showing that Xeljanz was more effective than placebo in inducing and maintaining remission in patients with moderate to severe UC.
Teva’s Laquinimod Misses Primary Endpoint in Late-Stage Study: Teva (TEVA - Free Report) and Active Biotech announced that their experimental multiple sclerosis (MS) treatment, laquinimod, failed to meet the primary endpoint in the CONCERTO study that was conducted in patients with relapsing-remitting multiple sclerosis (RRMS). The companies, however, said that there were some positive data on a number of secondary and exploratory endpoints. Teva and its partner do not have any plans currently to pursue laquinimod further in RRMS, though the companies are continuing to evaluate it in two other studies -- one for primary progressive MS (PPMS) and the other for Huntington disease (HD).
This is not the first time that Teva has faced a setback with laquinimod. Way back in 2012, the company was seeking EU approval for the drug -- however, in 2014, the EMA said that laquinimod’s risk-benefit profile is not favorable. The CONCERTO study was intended to further address the risk-benefit profile of laquinimod.
Then last year in January, Teva discontinued the highest dose of laquinimod in all studies following the occurrence of non-fatal cardiovascular events in eight patients receiving the highest doses in the CONCERTO study and in the other ongoing study for PPMS. The studies continued with the lower- and mid-dosages.
AstraZeneca Gets First Approval for Imfinzi: AstraZeneca (AZN - Free Report) got a boost with the FDA granting accelerated approval to the company’s bladder cancer drug, Imfinzi (durvalumab). Imfinzi is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) whose disease has progressed during or following platinum-containing chemotherapy, or within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery.
We note that Bristol-Myers’ Opdivo gained approval for this indication earlier this year in February. Roche’s Tecentriq is also approved for this patient population though it is also approved for patients unable to tolerate cisplatin-containing chemo.
AstraZeneca is evaluating Imfinzi as a 1st- line treatment in urothelial carcinoma as monotherapy as well as in combination with tremelimumab. Meanwhile, results from a phase III study on Imfinzi lies in the 1st line NSCLC patient population are expected in mid-2017.
Novartis Exercises Option in Conatus Deal: Swiss drugmaker Novartis (NVS - Free Report) has decided to exercise its option under its Dec 2016 agreement with Conatus for the global development and commercialization of emricasan. With the option being exercised, Novartis will get an exclusive license for emricasan and will boost its pipeline of treatments for chronic liver diseases, including nonalcoholic steatohepatitis (NASH).
Emricasan is currently in a phase IIb study in patients with decompensated liver cirrhosis caused by NASH.
The Conatus announcement comes shortly after Novartis entered into a clinical trial agreement with Allergan to conduct a phase IIb study on Novartis’ FXR agonist and Allergan's cenicriviroc (CVC) for the treatment of NASH (Read more: Allergan Collaborates with Novartis to Treat NASH).
NASH is an increasingly common, progressive form of fatty-liver disease which is becoming a significant and growing health issue given the rising obesity epidemic. With no treatments currently approved for this disease, the market opportunity is significant. Several companies are working on developing treatments for NASH -- the market could be worth billions of dollars and many companies are hoping to cash in on this opportunity.
Performance
The NYSE ARCA Pharmaceutical Index was up 1.1% over the last five trading sessions with most major pharma stocks recording gains. Merck was up 2.6% with shares jumping on Q1 results while Pfizer’s shares slipped 1.3%. Over the last six months, Lilly (LLY - Free Report) was up 13.8% (See the last pharma stock roundup here: Lilly, Bristol-Myers, Novartis Q1 Earnings & More).
What's Next in the Pharma World?
A response from the FDA about the approvability of Merck's Keytruda for use in combination with pemetrexed and carboplatin for the treatment of patients with metastatic or advanced NSCLC regardless of PD-L1 expression is expected this week. Label expansion into the new indication would open up the non-squamous lung market and cover patients irrespective of PD-L1 expression.
More Stock News: 8 Companies Verge on Apple-Like Run
Did you miss Apple's 9X stock explosion after they launched their iPhone in 2007? Now 2017 looks to be a pivotal year to get in on another emerging technology expected to rock the market. Demand could soar from almost nothing to $42 billion by 2025. Reports suggest it could save 10 million lives per decade which could in turn save $200 billion in U.S. healthcare costs.
A bonus Zacks Special Report names this breakthrough and the 8 best stocks to exploit it. Like Apple in 2007, these companies are already strong and coiling for potential mega-gains. Click to see them right now >>
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
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Pharma Stock Roundup: Merck, Pfizer Report Q1 Earnings, J&J Talc Powder Lawsuit
Last week, big names like Merck (MRK - Free Report) and Pfizer (PFE - Free Report) reported earnings results. Johnson & Johnson (JNJ - Free Report) was also in the news related to a jury verdict for its talc powder lawsuit.
Recap of the Week’s Most Important Stories
A Look at Earnings Results: Two major pharma players, Merck and Pfizer, reported first quarter results last week. While Merck surpassed estimates (Read more: Merck Beats on Q1 Earnings & Sales, Ups Annual View), Pfizer topped earnings estimates but missed on revenues (Read more: Pfizer Q1 Earnings Beat, Sales Lag, 2017 View Intact). Pfizer’s revenues were impacted by fewer selling days as well as the divestiture of Hospira Infusion Systems. The company will be losing exclusivity on Viagra in the U.S. later this year.
So far in 2017, Merck has outperformed the Zacks categorized Large Cap Pharmaceuticals industry with shares gaining 18.3% while Pfizer has underperformed with shares declining 1%. The industry is up 2.8% year to date. Merck and Pfizer are both Zacks Rank #3 (Hold) stocks -- you can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
J&J Ordered to Pay More than $110M by St. Louis Jury: J&J took a hit with a St. Louis jury ordering the company to pay more than $110 million to a woman related to claims that using the company’s talcum products led to ovarian cancer. J&J intends to appeal the verdict. J&J’s talc supplier has also been ordered to pay damages.
EU Label Expansion for Merck’s Keytruda: Merck’s anti-PD-1 therapy Keytruda gained EU approval for use in patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) and Adcetris (brentuximab vedotin), or who are transplant-ineligible and have failed Adcetris. This marks the first hematologic malignancy approval for Keytruda in the EU. Keytruda is one of the most important new product launches at Merck and the company is working on expanding the label and boost sales.
The FDA is expected to respond on the approvability of Keytruda for use in combination with pemetrexed and carboplatin for the treatment of patients with metastatic or advanced non-small cell lung cancer (NSCLC) regardless of PD-L1 expression by May 10, 2017. Keytruda is also under Priority Review in the U.S. for the first-line treatment of patients with locally advanced or metastatic urothelial cancer, a type of bladder cancer, who are ineligible for cisplatin-containing therapy. An application for second-line use is also under Priority Review with a response for both applications expected by Jun 14, 2017. Moreover, a response from the FDA regarding Keytruda’s approvability for the treatment of previously treated patients with advanced microsatellite instability-high cancer is expected by Jun 9, 2017.
Updates on Pfizer’s Xeljanz: A 5mg twice daily as well as an extended release 11 mg once daily formulation of Pfizer’s Xeljanz (tofacitinib citrate) has been accepted for review by the FDA for the treatment of adult patients with active psoriatic arthritis (PsA). A response from the agency is expected in Dec 2017.
Pfizer also announced the publication of detailed results from phase III oral studies on Xeljanz in ulcerative colitis (UC) in The New England Journal of Medicine. All three pivotal studies -- OCTAVE Induction 1, OCTAVE Induction 2 and OCTAVE Sustain -- met their primary endpoints, showing that Xeljanz was more effective than placebo in inducing and maintaining remission in patients with moderate to severe UC.
Teva’s Laquinimod Misses Primary Endpoint in Late-Stage Study: Teva (TEVA - Free Report) and Active Biotech announced that their experimental multiple sclerosis (MS) treatment, laquinimod, failed to meet the primary endpoint in the CONCERTO study that was conducted in patients with relapsing-remitting multiple sclerosis (RRMS). The companies, however, said that there were some positive data on a number of secondary and exploratory endpoints. Teva and its partner do not have any plans currently to pursue laquinimod further in RRMS, though the companies are continuing to evaluate it in two other studies -- one for primary progressive MS (PPMS) and the other for Huntington disease (HD).
This is not the first time that Teva has faced a setback with laquinimod. Way back in 2012, the company was seeking EU approval for the drug -- however, in 2014, the EMA said that laquinimod’s risk-benefit profile is not favorable. The CONCERTO study was intended to further address the risk-benefit profile of laquinimod.
Then last year in January, Teva discontinued the highest dose of laquinimod in all studies following the occurrence of non-fatal cardiovascular events in eight patients receiving the highest doses in the CONCERTO study and in the other ongoing study for PPMS. The studies continued with the lower- and mid-dosages.
AstraZeneca Gets First Approval for Imfinzi: AstraZeneca (AZN - Free Report) got a boost with the FDA granting accelerated approval to the company’s bladder cancer drug, Imfinzi (durvalumab). Imfinzi is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) whose disease has progressed during or following platinum-containing chemotherapy, or within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery.
We note that Bristol-Myers’ Opdivo gained approval for this indication earlier this year in February. Roche’s Tecentriq is also approved for this patient population though it is also approved for patients unable to tolerate cisplatin-containing chemo.
AstraZeneca is evaluating Imfinzi as a 1st- line treatment in urothelial carcinoma as monotherapy as well as in combination with tremelimumab. Meanwhile, results from a phase III study on Imfinzi lies in the 1st line NSCLC patient population are expected in mid-2017.
Novartis Exercises Option in Conatus Deal: Swiss drugmaker Novartis (NVS - Free Report) has decided to exercise its option under its Dec 2016 agreement with Conatus for the global development and commercialization of emricasan. With the option being exercised, Novartis will get an exclusive license for emricasan and will boost its pipeline of treatments for chronic liver diseases, including nonalcoholic steatohepatitis (NASH).
Emricasan is currently in a phase IIb study in patients with decompensated liver cirrhosis caused by NASH.
The Conatus announcement comes shortly after Novartis entered into a clinical trial agreement with Allergan to conduct a phase IIb study on Novartis’ FXR agonist and Allergan's cenicriviroc (CVC) for the treatment of NASH (Read more: Allergan Collaborates with Novartis to Treat NASH).
NASH is an increasingly common, progressive form of fatty-liver disease which is becoming a significant and growing health issue given the rising obesity epidemic. With no treatments currently approved for this disease, the market opportunity is significant. Several companies are working on developing treatments for NASH -- the market could be worth billions of dollars and many companies are hoping to cash in on this opportunity.
Performance
The NYSE ARCA Pharmaceutical Index was up 1.1% over the last five trading sessions with most major pharma stocks recording gains. Merck was up 2.6% with shares jumping on Q1 results while Pfizer’s shares slipped 1.3%. Over the last six months, Lilly (LLY - Free Report) was up 13.8% (See the last pharma stock roundup here: Lilly, Bristol-Myers, Novartis Q1 Earnings & More).
What's Next in the Pharma World?
A response from the FDA about the approvability of Merck's Keytruda for use in combination with pemetrexed and carboplatin for the treatment of patients with metastatic or advanced NSCLC regardless of PD-L1 expression is expected this week. Label expansion into the new indication would open up the non-squamous lung market and cover patients irrespective of PD-L1 expression.
More Stock News: 8 Companies Verge on Apple-Like Run
Did you miss Apple's 9X stock explosion after they launched their iPhone in 2007? Now 2017 looks to be a pivotal year to get in on another emerging technology expected to rock the market. Demand could soar from almost nothing to $42 billion by 2025. Reports suggest it could save 10 million lives per decade which could in turn save $200 billion in U.S. healthcare costs.
A bonus Zacks Special Report names this breakthrough and the 8 best stocks to exploit it. Like Apple in 2007, these companies are already strong and coiling for potential mega-gains. Click to see them right now >>