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Key announcements this week include the FDA approval of an eye disease drug as well as a diabetes treatment and label expansions for existing products. Regulatory and pipeline updates were also provided by companies like AstraZeneca (AZN - Free Report) and Johnson & Johnson (JNJ - Free Report) .
Recap of the Week’s Most Important Stories
Aerie’s Rhopressa Gains FDA Approval: Aerie Pharmaceuticals got a boost with the earlier-than-expected FDA approval of Rhopressa for the lowering of elevated intraocular pressure (“IOP”) in patients with open-angle glaucoma or ocular hypertension. While approval was expected considering a favorable advisory panel vote in October, approval came about a couple of months ahead of the Feb 28, 2018 PDUFA (Prescription Drug User Fee Act) goal date. Rhopressa is the first product in Aerie’s portfolio and the company expects to launch the product by mid-second quarter of 2018 (Read more: Aerie Gets Early FDA Approval for Lead Drug Rhopressa).
Merck/Pfizer’s Diabetes Drug Gets FDA Nod: SGLT2 inhibitor, Steglatro (ertugliflozin), which has been developed by Merck (MRK - Free Report) and Pfizer (PFE - Free Report) , gained FDA approval for the treatment of type II diabetes. Steglatro will be entering the highly crowded diabetes market which already has other SGLT2 inhibitors in the form of Invokana, Farxiga and Jardiance. Steglatro has also been approved for use in combination with metformin under the brand name Segluromet and with Januvia under the brand name Steglujan.
Priority Review for AstraZeneca’s Tagrisso Label Expansion: AstraZeneca’s supplemental New Drug Application (sNDA) for the use of Tagrisso (osimertinib), for the first-line treatment of patients with metastatic non-small cell lung cancer (“NSCLC”) whose tumors have EGFR mutations has been granted priority review by the FDA. Approval for this indication would expand the patient population significantly (Read more: AstraZeneca's Tagrisso Label Expansion Filing Accepted by FDA).
J&J’s Janssen in CAR-T Deal, Priority Review for Apalutamide: J&J’s Janssen Biotech has inked a worldwide collaboration and license agreement with Legend Biotech USA Inc. and Legend Biotech Ireland Limited, subsidiaries of Genscript Biotech Corporation, for the development, manufacture and commercialization of a chimeric antigen receptor (“CAR”) T-cell drug candidate, LCAR-B38M. LCAR-B38M, which specifically targets the B-cell maturation antigen (“BCMA”), is currently under regulatory review in China for multiple myeloma (“MM”).
Meanwhile, clinical studies are being planned for the United States. Under the terms of the deal, global net trade sales, excluding the Greater China area, will be recorded by Janssen. The companies will split costs and profits equally except in Greater China, where Janssen and Legend will have a 30/70% cost-sharing/profit-split arrangement. The deal terms also include a $350 million upfront payment from Janssen and additional payments on the achievement of development, regulatory and sales milestones.
This is the latest agreement in the field of CAR-T, which has been attracting a lot of interest in recent quarters.
Janssen also announced that it got priority review status from the FDA for its New Drug Application (“NDA”) for apalutamide, the company’s investigational, next-generation oral androgen receptor (“AR”) inhibitor for the treatment of men with non-metastatic castration-resistant prostate cancer (“CRPC”). With the FDA granting priority review, a response should be out in April 2018. Given that there are no FDA-approved treatments currently available for this patient population, timely approval would be a boost for the company’s cancer portfolio.
J&J has gained 22.4% year to date, compared to the 16.1% rally of the industry it belongs to.
Allergan Provides Updates on Vraylar & Seysara: Allergan provided a couple of updates on the pipeline front. The company and its partner Gedeon Richter said that Vraylar (cariprazine) met the primary endpoint in a late-stage in adults with major depressive episodes associated with bipolar I disorder (bipolar I depression). The companies plan to seek label expansion into this indication in the second half of 2018 (Read more: Allergan's Vraylar Positive for Bipolar Disease in Phase III).
Allergan also announced that the NDA for Seysara has been accepted for review. Allergan and partner Paratek Pharmaceuticals are looking to get the antibiotic approved for the treatment of moderate to severe acne vulgaris in patients 9 years of age and older. Approval could come in the second half of 2018.
FDA Expands Label of Pfizer’s Bosulif, Grants BTD to Bavencio: The FDA has given its nod for the label expansion of Pfizer’s Bosulif for its use in newly-diagnosed chronic phase Ph+ chronic myelogenous leukemia (Ph+ CML) patients. Bosulif‘s initial approval was for use in patients with chronic, accelerated or blast phase Ph+ CML with resistance or intolerance to prior therapy.
The expanded indication will increase the addressable patient population significantly. According to the American Cancer Society, about 9,000 new CML cases were diagnosed in the United States in 2017.
Pfizer also announced that the FDA has granted Breakthrough Therapy Designation (“BTD”) for Bavencio (avelumab) for use in combination with Inlyta in treatment-naïve patients with advanced renal cell carcinoma (“RCC”). Avelumab is partnered with Merck KGaA. Breakthrough Therapy Designation helps fasten the development and review of drugs which are being evaluated for the treatment of serious conditions and where preliminary clinical evidence indicates that the drug may be substantially better than existing treatments on clinically significant endpoint(s).
This is the second time that Bavencio has received BTD for a hard-to-treat cancer, the first time being for the treatment of patients with metastatic Merkel cell carcinoma (mMCC) whose disease has progressed after at least one previous chemotherapy regimen.
Label Expansion and Clinical Trial Collaboration for BMY’s Opdivo: Bristol-Myers Squibb’s (BMY - Free Report) PD-1 immune checkpoint inhibitor, Opdivo, gained FDA approval for yet another indication. The regulatory agency granted approval to Opdivo for intravenous use for the adjuvant treatment of patients with completely resected melanoma with lymph node involvement or metastatic disease. Opdivo is already approved for a wide range of indications alone as well as in combination with other agents and is currently in several studies as well.
In fact, the company also announced a clinical trial collaboration with TARIS Biomedical for the evaluation of the safety, tolerability, and preliminary efficacy of TARIS’ TAR-200 (GemRIS) in combination with Opdivo. A phase Ib study will evaluate the combination in patients with muscle invasive bladder cancer (“MIBC”) who are scheduled for radical cystectomy. Opdivo is one of the prioritized brands in Bristol-Myers’s portfolio with the product bringing in sales of $3.6 billion in the first nine months of 2017.
The NYSE ARCA Pharmaceutical Index was up slightly (0.4%) over the last five trading sessions. Among major stocks, Merck was up 1.1% while Lilly and Bristol-Myers declined 1%. Over the last six months, Bristol-Myers was up 11.1% while Glaxo declined 16.3% (See the last pharma stock roundup here: Teva Announces Major Job Cuts, Lilly Provides 2018 Outlook).
What's Next in the Pharma World?
Watch out for regulatory and pipeline news from pharma stocks.
Looking for Stocks with Skyrocketing Upside?
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
Image: Bigstock
Pharma Stock Roundup: Aerie's Rhopressa Approved, Label Expansion for BMY, Pfizer Drugs
Key announcements this week include the FDA approval of an eye disease drug as well as a diabetes treatment and label expansions for existing products. Regulatory and pipeline updates were also provided by companies like AstraZeneca (AZN - Free Report) and Johnson & Johnson (JNJ - Free Report) .
Recap of the Week’s Most Important Stories
Aerie’s Rhopressa Gains FDA Approval: Aerie Pharmaceuticals got a boost with the earlier-than-expected FDA approval of Rhopressa for the lowering of elevated intraocular pressure (“IOP”) in patients with open-angle glaucoma or ocular hypertension. While approval was expected considering a favorable advisory panel vote in October, approval came about a couple of months ahead of the Feb 28, 2018 PDUFA (Prescription Drug User Fee Act) goal date. Rhopressa is the first product in Aerie’s portfolio and the company expects to launch the product by mid-second quarter of 2018 (Read more: Aerie Gets Early FDA Approval for Lead Drug Rhopressa).
Merck/Pfizer’s Diabetes Drug Gets FDA Nod: SGLT2 inhibitor, Steglatro (ertugliflozin), which has been developed by Merck (MRK - Free Report) and Pfizer (PFE - Free Report) , gained FDA approval for the treatment of type II diabetes. Steglatro will be entering the highly crowded diabetes market which already has other SGLT2 inhibitors in the form of Invokana, Farxiga and Jardiance. Steglatro has also been approved for use in combination with metformin under the brand name Segluromet and with Januvia under the brand name Steglujan.
Priority Review for AstraZeneca’s Tagrisso Label Expansion: AstraZeneca’s supplemental New Drug Application (sNDA) for the use of Tagrisso (osimertinib), for the first-line treatment of patients with metastatic non-small cell lung cancer (“NSCLC”) whose tumors have EGFR mutations has been granted priority review by the FDA. Approval for this indication would expand the patient population significantly (Read more: AstraZeneca's Tagrisso Label Expansion Filing Accepted by FDA).
J&J’s Janssen in CAR-T Deal, Priority Review for Apalutamide: J&J’s Janssen Biotech has inked a worldwide collaboration and license agreement with Legend Biotech USA Inc. and Legend Biotech Ireland Limited, subsidiaries of Genscript Biotech Corporation, for the development, manufacture and commercialization of a chimeric antigen receptor (“CAR”) T-cell drug candidate, LCAR-B38M. LCAR-B38M, which specifically targets the B-cell maturation antigen (“BCMA”), is currently under regulatory review in China for multiple myeloma (“MM”).
Meanwhile, clinical studies are being planned for the United States. Under the terms of the deal, global net trade sales, excluding the Greater China area, will be recorded by Janssen. The companies will split costs and profits equally except in Greater China, where Janssen and Legend will have a 30/70% cost-sharing/profit-split arrangement. The deal terms also include a $350 million upfront payment from Janssen and additional payments on the achievement of development, regulatory and sales milestones.
This is the latest agreement in the field of CAR-T, which has been attracting a lot of interest in recent quarters.
Janssen also announced that it got priority review status from the FDA for its New Drug Application (“NDA”) for apalutamide, the company’s investigational, next-generation oral androgen receptor (“AR”) inhibitor for the treatment of men with non-metastatic castration-resistant prostate cancer (“CRPC”). With the FDA granting priority review, a response should be out in April 2018. Given that there are no FDA-approved treatments currently available for this patient population, timely approval would be a boost for the company’s cancer portfolio.
J&J has gained 22.4% year to date, compared to the 16.1% rally of the industry it belongs to.
Allergan Provides Updates on Vraylar & Seysara: Allergan provided a couple of updates on the pipeline front. The company and its partner Gedeon Richter said that Vraylar (cariprazine) met the primary endpoint in a late-stage in adults with major depressive episodes associated with bipolar I disorder (bipolar I depression). The companies plan to seek label expansion into this indication in the second half of 2018 (Read more: Allergan's Vraylar Positive for Bipolar Disease in Phase III).
Allergan also announced that the NDA for Seysara has been accepted for review. Allergan and partner Paratek Pharmaceuticals are looking to get the antibiotic approved for the treatment of moderate to severe acne vulgaris in patients 9 years of age and older. Approval could come in the second half of 2018.
FDA Expands Label of Pfizer’s Bosulif, Grants BTD to Bavencio: The FDA has given its nod for the label expansion of Pfizer’s Bosulif for its use in newly-diagnosed chronic phase Ph+ chronic myelogenous leukemia (Ph+ CML) patients. Bosulif‘s initial approval was for use in patients with chronic, accelerated or blast phase Ph+ CML with resistance or intolerance to prior therapy.
The expanded indication will increase the addressable patient population significantly. According to the American Cancer Society, about 9,000 new CML cases were diagnosed in the United States in 2017.
Pfizer also announced that the FDA has granted Breakthrough Therapy Designation (“BTD”) for Bavencio (avelumab) for use in combination with Inlyta in treatment-naïve patients with advanced renal cell carcinoma (“RCC”). Avelumab is partnered with Merck KGaA. Breakthrough Therapy Designation helps fasten the development and review of drugs which are being evaluated for the treatment of serious conditions and where preliminary clinical evidence indicates that the drug may be substantially better than existing treatments on clinically significant endpoint(s).
This is the second time that Bavencio has received BTD for a hard-to-treat cancer, the first time being for the treatment of patients with metastatic Merkel cell carcinoma (mMCC) whose disease has progressed after at least one previous chemotherapy regimen.
Label Expansion and Clinical Trial Collaboration for BMY’s Opdivo: Bristol-Myers Squibb’s (BMY - Free Report) PD-1 immune checkpoint inhibitor, Opdivo, gained FDA approval for yet another indication. The regulatory agency granted approval to Opdivo for intravenous use for the adjuvant treatment of patients with completely resected melanoma with lymph node involvement or metastatic disease. Opdivo is already approved for a wide range of indications alone as well as in combination with other agents and is currently in several studies as well.
In fact, the company also announced a clinical trial collaboration with TARIS Biomedical for the evaluation of the safety, tolerability, and preliminary efficacy of TARIS’ TAR-200 (GemRIS) in combination with Opdivo. A phase Ib study will evaluate the combination in patients with muscle invasive bladder cancer (“MIBC”) who are scheduled for radical cystectomy. Opdivo is one of the prioritized brands in Bristol-Myers’s portfolio with the product bringing in sales of $3.6 billion in the first nine months of 2017.
Bristol-Myers is a Zacks Rank #3 (Hold) stock - you can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Performance
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
The NYSE ARCA Pharmaceutical Index was up slightly (0.4%) over the last five trading sessions. Among major stocks, Merck was up 1.1% while Lilly and Bristol-Myers declined 1%. Over the last six months, Bristol-Myers was up 11.1% while Glaxo declined 16.3% (See the last pharma stock roundup here: Teva Announces Major Job Cuts, Lilly Provides 2018 Outlook).
What's Next in the Pharma World?
Watch out for regulatory and pipeline news from pharma stocks.
Looking for Stocks with Skyrocketing Upside?
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
See the pot trades we're targeting>>