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Pharma Stock Roundup: MRK to Buy XLRN, ABBV Gets FDA Nod for Migraine Drug & More
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In a rather active week for large-drug companies, Merck (MRK - Free Report) announced that it plans to buy Acceleron Pharma for about $11.5 billion. The FDA approved AbbVie’s (ABBV - Free Report) new migraine drug, Qulipta. AstraZeneca (AZN - Free Report) exercised its option to buy the full stake in Caelum Biosciences to sharpen its focus on rare-disease drugs. Sanofi (SNY - Free Report) ended the development of its mRNA-based COVID vaccine.
Recap of the Week’s Most Important Stories
Merck to Buy Acceleron For $11.5B: Merck announced a definitive agreement to acquire Acceleron Pharma for $180 per share in cash or an approximate total equity value of $11.5 billion. The deal, if successful, will add Acceleron’s promising phase III pipeline candidate, sotatercept, which is being evaluated for the treatment of pulmonary arterial hypertension. This apart, Acceleron earns royalties on sales of Reblozyl, which has been developed as part of its global collaboration with Bristol Myers. Reblozyl is approved for the treatment of anemia in certain blood disorders. The transaction is expected to be closed in the fourth quarter of 2021.
Merck’s phase III KEYNOTE-394 study on Keytruda in patients with advanced hepatocellular carcinoma previously treated with Bayer’s Nexavar (sorafenib) met its primary endpoint of overall survival (OS). The data showed that Keytruda plus best supportive care led to a statistically significant improvement in OS versus placebo plus best supportive care. The study also showed statistically significant improvements for Keytruda for the secondary endpoints of progression-free survival (PFS) and objective response rate (ORR) compared to placebo.
FDA Approves AbbVie’s New Migraine Drug: The FDA approved AbbVie’s atogepant for preventive treatment of episodic migraine in adults. The drug will be marketed as Qulipta. The regulatory application for Qulipta was based on data from a robust clinical program, which included data from the phase III ADVANCE study, a pivotal phase IIb/III study and the phase III long-term safety study. Qulipta will be available in the United States from early next month.
Pfizer Begins New Studies for COVID Prevention, mRNA Flu Vaccine: A phase II/III study (EPIC-PEP) was initiated by Pfizer to evaluate its investigational, novel oral antiviral, PF-07321332 in combination with a low dose of ritonavir for the prevention of COVID-19 infection. PF-07321332 is already being evaluated in separate phase II/III studies, one in SARS-CoV-2 infected patients who are at high risk of severe illness (including hospitalization or death) and another in infected patients who are at standard risk.
Pfizer also announced that the first participants have been dosed in a phase I study to evaluate a single dose quadrivalent mRNA influenza vaccine in healthy adults. Pfizer plans to explore the mRNA technology in respiratory viruses other than influenza and also eventually aims to expand to develop the mRNA technology in oncology and genetic diseases.
The FDA delayed its decision on Pfizer and OPKO Health’s biologics license application (“BLA”) for growth hormone deficiency (“GHD”) candidate somatrogon by three months. The FDA’s decision is now expected in January 2022.
Pfizer submitted the initial data from a pivotal phase II/III study on its COVID-19 vaccine in children 5 to less than 12 years of age. Top-line data from the study were announced earlier this month. A formal filing seeking Emergency Use Authorization (EUA) for use in children of this age group is expected to be filed soon.
Sanofi Dumps mRNA COVID Vaccine Candidate: Sanofi said it is dropping plans of development of its mRNA-based COVID vaccine (which it acquired as a part of its recent acquisition of Translate Bio) after the success of Pfizer/BioNTech and Moderna in this field. The decision to drop mRNA COVID vaccine development came despite positive phase I/II study interim results. Interim data from Sanofi’s phase I/II study of its mRNA-based vaccine candidate showed neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second dose was given across the three dosages tested. The positive data has encouraged the company to develop a modified quadrivalent mRNA-based flu vaccine, for which it targets to initiate clinical studies in 2022.
However, Sanofi continues to develop its adjuvanted recombinant protein candidate vaccine, in partnership with Glaxo, which is in phase III studies.
AstraZeneca to Fully Acquire Caelum Biosciences: AstraZeneca’s newly acquired subsidiary, Alexion has exercised its option to acquire all remaining shares of Caelum Biosciences in which it holds a minority equity interest. With the full acquisition of Caelum, AstraZeneca will add the latter’s phase III candidate, CAEL-101, a potentially first-in-class fibril-reactive monoclonal antibody for the treatment of light chain amyloidosis.
FDA’s Priority Tag for Glaxo Cabotegravir Long-Acting for PrEP: The FDA granted priority review to Glaxo’s (GSK - Free Report) new drug application seeking approval for its long-acting cabotegravir for prevention of HIV also called pre-exposure prophylaxis or PrEP. The FDA’s decision is expected on Jan 24, 2022. The NDA filing was based on data from two phase IIb/III studies, HPTN 083 and HPTN 084. Regulatory applications in other countries will be filed by the end of 2021. The long-acting injectable regimen of cabotegravir is approved in combination with J&J’s Edurant (rilpivirine), as Cabenuva, for the treatment of HIV-1 infection in virologically suppressed adults
Glaxo’s HIV subsidiary, ViiV Healthcare, announced that it is in-licensing rights to a third integrase inhibitor, S-365598 from Shionogi for an upfront payment of £20 million. S-365598, a pre-clinical candidate, has shown potential for use in ultra-long-acting HIV regimens (regimens that can be taken with infrequent dosing of every three months or longer.). Clinical studies on S-365598 are expected to begin by 2023.
FDA Grants Expanded Use of Lilly’s Erbitux: The FDA approved Lilly’s (LLY - Free Report) drug Erbitux in combination with Pfizer’s Braftovi (encorafenib) for metastatic colorectal cancer with a BRAF V600E mutation. Pfizer’s Braftovi had received approval from the FDA for the same indication in April 2020 in combination with Erbiux. The FDA approval for Erbitux+ Braftovi for the above indication was based on data from Pfizer’s phase III BEACON CRC study.
Lilly also said that it will lower the list price of its non-branded insulin, the Insulin Lispro injection, from Jan 1, 2022, by an additional 40% in the United States. The new list price will be 70% less than the counterparts of Lispro’s injection Humalog U-100.
J&J’s Xarelto Betters Aspirin in Pediatric Fontan Procedure Study: J&J (JNJ - Free Report) announced data from a phase III study, which showed that an oral suspension formulation of its medicine, Xarelto led to numerically fewer blood clots and clinical events associated with blood clots compared to aspirin in pediatric patients with congenital heart disease who have undergone the Fontan procedure.
J&J also initiated a phase III study (EVERGREEN) on its investigational RSV vaccine candidate in adults ages 60 years or older. The study, which was initiated based on positive data from the phase IIb CYPRESS study, is expected to enroll approximately 23,000 participants 60 years and older.
The NYSE ARCA Pharmaceutical Index declined 1.9% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: MRK to Buy XLRN, ABBV Gets FDA Nod for Migraine Drug & More
In a rather active week for large-drug companies, Merck (MRK - Free Report) announced that it plans to buy Acceleron Pharma for about $11.5 billion. The FDA approved AbbVie’s (ABBV - Free Report) new migraine drug, Qulipta. AstraZeneca (AZN - Free Report) exercised its option to buy the full stake in Caelum Biosciences to sharpen its focus on rare-disease drugs. Sanofi (SNY - Free Report) ended the development of its mRNA-based COVID vaccine.
Recap of the Week’s Most Important Stories
Merck to Buy Acceleron For $11.5B: Merck announced a definitive agreement to acquire Acceleron Pharma for $180 per share in cash or an approximate total equity value of $11.5 billion. The deal, if successful, will add Acceleron’s promising phase III pipeline candidate, sotatercept, which is being evaluated for the treatment of pulmonary arterial hypertension. This apart, Acceleron earns royalties on sales of Reblozyl, which has been developed as part of its global collaboration with Bristol Myers. Reblozyl is approved for the treatment of anemia in certain blood disorders. The transaction is expected to be closed in the fourth quarter of 2021.
Merck’s phase III KEYNOTE-394 study on Keytruda in patients with advanced hepatocellular carcinoma previously treated with Bayer’s Nexavar (sorafenib) met its primary endpoint of overall survival (OS). The data showed that Keytruda plus best supportive care led to a statistically significant improvement in OS versus placebo plus best supportive care. The study also showed statistically significant improvements for Keytruda for the secondary endpoints of progression-free survival (PFS) and objective response rate (ORR) compared to placebo.
FDA Approves AbbVie’s New Migraine Drug: The FDA approved AbbVie’s atogepant for preventive treatment of episodic migraine in adults. The drug will be marketed as Qulipta. The regulatory application for Qulipta was based on data from a robust clinical program, which included data from the phase III ADVANCE study, a pivotal phase IIb/III study and the phase III long-term safety study. Qulipta will be available in the United States from early next month.
Pfizer Begins New Studies for COVID Prevention, mRNA Flu Vaccine: A phase II/III study (EPIC-PEP) was initiated by Pfizer to evaluate its investigational, novel oral antiviral, PF-07321332 in combination with a low dose of ritonavir for the prevention of COVID-19 infection. PF-07321332 is already being evaluated in separate phase II/III studies, one in SARS-CoV-2 infected patients who are at high risk of severe illness (including hospitalization or death) and another in infected patients who are at standard risk.
Pfizer also announced that the first participants have been dosed in a phase I study to evaluate a single dose quadrivalent mRNA influenza vaccine in healthy adults. Pfizer plans to explore the mRNA technology in respiratory viruses other than influenza and also eventually aims to expand to develop the mRNA technology in oncology and genetic diseases.
The FDA delayed its decision on Pfizer and OPKO Health’s biologics license application (“BLA”) for growth hormone deficiency (“GHD”) candidate somatrogon by three months. The FDA’s decision is now expected in January 2022.
Pfizer submitted the initial data from a pivotal phase II/III study on its COVID-19 vaccine in children 5 to less than 12 years of age. Top-line data from the study were announced earlier this month. A formal filing seeking Emergency Use Authorization (EUA) for use in children of this age group is expected to be filed soon.
Sanofi Dumps mRNA COVID Vaccine Candidate: Sanofi said it is dropping plans of development of its mRNA-based COVID vaccine (which it acquired as a part of its recent acquisition of Translate Bio) after the success of Pfizer/BioNTech and Moderna in this field. The decision to drop mRNA COVID vaccine development came despite positive phase I/II study interim results. Interim data from Sanofi’s phase I/II study of its mRNA-based vaccine candidate showed neutralizing antibody seroconversion in 91% to 100% of study participants, two weeks after the second dose was given across the three dosages tested. The positive data has encouraged the company to develop a modified quadrivalent mRNA-based flu vaccine, for which it targets to initiate clinical studies in 2022.
However, Sanofi continues to develop its adjuvanted recombinant protein candidate vaccine, in partnership with Glaxo, which is in phase III studies.
AstraZeneca to Fully Acquire Caelum Biosciences: AstraZeneca’s newly acquired subsidiary, Alexion has exercised its option to acquire all remaining shares of Caelum Biosciences in which it holds a minority equity interest. With the full acquisition of Caelum, AstraZeneca will add the latter’s phase III candidate, CAEL-101, a potentially first-in-class fibril-reactive monoclonal antibody for the treatment of light chain amyloidosis.
FDA’s Priority Tag for Glaxo Cabotegravir Long-Acting for PrEP: The FDA granted priority review to Glaxo’s (GSK - Free Report) new drug application seeking approval for its long-acting cabotegravir for prevention of HIV also called pre-exposure prophylaxis or PrEP. The FDA’s decision is expected on Jan 24, 2022. The NDA filing was based on data from two phase IIb/III studies, HPTN 083 and HPTN 084. Regulatory applications in other countries will be filed by the end of 2021. The long-acting injectable regimen of cabotegravir is approved in combination with J&J’s Edurant (rilpivirine), as Cabenuva, for the treatment of HIV-1 infection in virologically suppressed adults
Glaxo’s HIV subsidiary, ViiV Healthcare, announced that it is in-licensing rights to a third integrase inhibitor, S-365598 from Shionogi for an upfront payment of £20 million. S-365598, a pre-clinical candidate, has shown potential for use in ultra-long-acting HIV regimens (regimens that can be taken with infrequent dosing of every three months or longer.). Clinical studies on S-365598 are expected to begin by 2023.
FDA Grants Expanded Use of Lilly’s Erbitux: The FDA approved Lilly’s (LLY - Free Report) drug Erbitux in combination with Pfizer’s Braftovi (encorafenib) for metastatic colorectal cancer with a BRAF V600E mutation. Pfizer’s Braftovi had received approval from the FDA for the same indication in April 2020 in combination with Erbiux. The FDA approval for Erbitux+ Braftovi for the above indication was based on data from Pfizer’s phase III BEACON CRC study.
Lilly also said that it will lower the list price of its non-branded insulin, the Insulin Lispro injection, from Jan 1, 2022, by an additional 40% in the United States. The new list price will be 70% less than the counterparts of Lispro’s injection Humalog U-100.
J&J’s Xarelto Betters Aspirin in Pediatric Fontan Procedure Study: J&J (JNJ - Free Report) announced data from a phase III study, which showed that an oral suspension formulation of its medicine, Xarelto led to numerically fewer blood clots and clinical events associated with blood clots compared to aspirin in pediatric patients with congenital heart disease who have undergone the Fontan procedure.
J&J also initiated a phase III study (EVERGREEN) on its investigational RSV vaccine candidate in adults ages 60 years or older. The study, which was initiated based on positive data from the phase IIb CYPRESS study, is expected to enroll approximately 23,000 participants 60 years and older.
The NYSE ARCA Pharmaceutical Index declined 1.9% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here’s how the eight major stocks performed in the last five trading sessions.
In the last five trading sessions, Merck gained the highest (2.1%) while Pfizer declined the most (2.7%)
In the past six months, Lilly recorded the maximum gain (24.7%) while Novartis declined the most (5%)
(See the last pharma stock roundup here: PFE Booster Jab Gets FDA Nod, JNJ’s New Data on COVID-19 Shot)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.