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Pharma Stock Roundup: LLY Offers Cheap Zepbound, EU Okays Some Drugs
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This week, the European Commission (“EC”) granted approval to Merck’s (MRK - Free Report) Winrevair for pulmonary arterial hypertension (PAH), J&J’s (JNJ - Free Report) Balversa for a type of bladder cancer and Roche’s (RHHBY - Free Report) PiaSky for paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder. Eli Lilly (LLY - Free Report) launched a discounted single-dose vial version of its popular obesity drug, Zepbound (tirzepatide). Pfizer (PFE - Free Report) launched a digital healthcare platform to improve access to its migraine drugs and some vaccines.
Recap of the Week’s Most Important Stories
Lilly Launches Zepbound Vials at 50% Discount: Lilly launched 2.5 mg and 5 mg single-dose vials of Zepbound (tirzepatide), priced at least 50% lower than the list price of competing GLP-1 medicines for obesity. A four-week supply of the 2.5 mg vials has been priced at $399 while the same for the 5 mg dose will cost $549. Zepbound is presently available in a single-dose pen (autoinjector). The vials should be easier to manufacture than these pens, which can help improve supply to meet the huge demand. These cheaper versions of Zepbound will be available through Lilly’s direct-to-consumer website called LillyDirect for self-pay for patients with a valid on-label prescription. The availability of these Zepbound single-dose vials is expected to broaden access for obesity patients especially those without insurance. The launch of single-dose vials also lowers the need for people to use compounded versions of tirzepatide.
EU Approves Merck’s PAH Drug Winrevair: The EC granted approval to Merck’s novel activin signaling inhibitor, Winrevair (sotatercept), for treating adult patients with PAH. Winrevair can now be prescribed to treat PAH in adult patients with World Health Organization (WHO) Functional Class (FC) II to III in the EU in combination with other PAH therapies. The approval was based on data from the STELLAR study. Winrevair was approved by the FDA to treat PAH, WHO Group 1, in March this year and recorded sales of $70 million in the second quarter.
Merck is discontinuing two phase III studies, KEYNOTE-867 and KEYNOTE-630, evaluating blockbuster PD-L1 inhibitor Keytruda for a type of lung cancer and skin cancer, respectively. The studies were stopped on the recommendation of an independent Data Monitoring Committee as their risk/benefit profile did not support continuing them. KEYNOTE-867 evaluated Keytruda in combination with stereotactic body radiotherapy for the treatment of patients with stage I or II (stage IIB N0, M0) non-small cell lung cancer (NSCLC). The study was discontinued as it failed to meet its primary endpoint of an improvement in event-free survival as well as a key secondary endpoint, overall survival.
The second study, called KEYNOTE-630, evaluated Keytruda for the adjuvant treatment of patients with high-risk locally advanced cutaneous squamous cell carcinoma following surgery and radiation. In the study, Keytruda failed to show statistical significance in recurrence-free survival, the study’s primary endpoint.
A second pivotal phase III study was initiated on bomedemstat, an LSD1 inhibitor, for the treatment of patients with essential thrombocythemia (ET) in patients who have previously not received cytoreductive therapy. Patients are now being enrolled in the study called Shorespan-007. The study will enroll approximately 300 patients globally. The primary endpoint of the study is a durable clinicohematologic response rate. The first study on bomedemstat, called Shorespan-006, is being conducted in ET patients who have an inadequate response to or are intolerant of hydroxyurea.
J&J’s Balversa Gets EU Approval for Urothelial Carcinoma: The European Commission (“EC”) granted approval to J&J’s Balversa (erdafitinib), a kinase inhibitor, for treating unresectable or metastatic urothelial carcinoma, harboring susceptible FGFR3 genetic alterations. Urothelial carcinoma (UC) is the most common type of bladder cancer. The approval was based on data from cohort 1 of the phase III THOR study. In the United States, Balversa was approved by the FDA under the accelerated pathway in 2019 for FGFR-altered locally advanced or metastatic UC. The accelerated approval was later converted to a full approval by the FDA in January this year.
The EC also approved the expanded use of Rybrevant (amivantamab) for NSCLC based on data from the MARIPOSA-2 study. The approval is for Rybrevant in combination with chemotherapy (carboplatin and pemetrexed) for the treatment of adult patients with advanced NSCLCwith EGFR exon 19 deletions after failure of prior therapy. At present, Rybrevant is approved as a monotherapy in the EU for advanced NSCLC with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. It is also approved for use in combination with carboplatin and pemetrexed, for the first-line treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations.
J&J filed a biologics license application (BLA) to the FDA seeking approval of its key investigational monoclonal antibody, nipocalimab, for its first indication, generalized myasthenia gravis, an autoantibody disease. The BLA was based on data from the phase III Vivacity-MG3 study. Nipocalimab, an FcRn blocker, is in mid- and late-stage development for rare autoantibody-driven diseases. J&J believes the candidate has the potential to create a pipeline in a product
Roche’s Subcutaneous PNH Drug PiaSky Gets EU Approval: The EC also approved Roche’s C5 inhibitor, PiaSky (crovalimab), to treat PNH based on data from the COMMODORE 2 study. PNH is mostly treated with frequent intravenous infusions at doctors’ clinics. PiaSky offers the option to self-administer with proper training. It can be given at home and less frequently than intravenous infusions, which can reduce the patient’s treatment burden. PiaSky becomes the first monthly subcutaneous treatment approved for treating PNH in Europe. It combines the disease control provided by C5 inhibitors with its innovative recycling technology that enables monthly subcutaneous administration.
Pfizer Starts Website to Help Access Migraine Drugs, Vaccines: Pfizer is launching a new digital platform called PfizerForAll, marking its entry into the direct-to-consumer market, mirroring a similar move from Eli Lilly in January this year. The website will help patients get access to some vaccines as well as migraine medicines. PfizerForAll will allow patients to book an appointment with a healthcare provider the same day for in-person or telehealth consultations, find and book vaccinations for adult COVID-19, flu, RSV (respiratory syncytial virus) and pneumococcal pneumonia and receive diagnostic tests and prescription or over-the-counter medicines at home or via a preferred pharmacy. Pfizer has developed and launched the platform in partnership with healthcare organizations like UpScriptHealth, Alto Pharmacy and Instacart.
The NYSE ARCA Pharmaceutical Index rose 0.47% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: LLY Offers Cheap Zepbound, EU Okays Some Drugs
This week, the European Commission (“EC”) granted approval to Merck’s (MRK - Free Report) Winrevair for pulmonary arterial hypertension (PAH), J&J’s (JNJ - Free Report) Balversa for a type of bladder cancer and Roche’s (RHHBY - Free Report) PiaSky for paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder. Eli Lilly (LLY - Free Report) launched a discounted single-dose vial version of its popular obesity drug, Zepbound (tirzepatide). Pfizer (PFE - Free Report) launched a digital healthcare platform to improve access to its migraine drugs and some vaccines.
Recap of the Week’s Most Important Stories
Lilly Launches Zepbound Vials at 50% Discount: Lilly launched 2.5 mg and 5 mg single-dose vials of Zepbound (tirzepatide), priced at least 50% lower than the list price of competing GLP-1 medicines for obesity. A four-week supply of the 2.5 mg vials has been priced at $399 while the same for the 5 mg dose will cost $549. Zepbound is presently available in a single-dose pen (autoinjector). The vials should be easier to manufacture than these pens, which can help improve supply to meet the huge demand. These cheaper versions of Zepbound will be available through Lilly’s direct-to-consumer website called LillyDirect for self-pay for patients with a valid on-label prescription. The availability of these Zepbound single-dose vials is expected to broaden access for obesity patients especially those without insurance. The launch of single-dose vials also lowers the need for people to use compounded versions of tirzepatide.
EU Approves Merck’s PAH Drug Winrevair: The EC granted approval to Merck’s novel activin signaling inhibitor, Winrevair (sotatercept), for treating adult patients with PAH. Winrevair can now be prescribed to treat PAH in adult patients with World Health Organization (WHO) Functional Class (FC) II to III in the EU in combination with other PAH therapies. The approval was based on data from the STELLAR study. Winrevair was approved by the FDA to treat PAH, WHO Group 1, in March this year and recorded sales of $70 million in the second quarter.
Merck is discontinuing two phase III studies, KEYNOTE-867 and KEYNOTE-630, evaluating blockbuster PD-L1 inhibitor Keytruda for a type of lung cancer and skin cancer, respectively. The studies were stopped on the recommendation of an independent Data Monitoring Committee as their risk/benefit profile did not support continuing them. KEYNOTE-867 evaluated Keytruda in combination with stereotactic body radiotherapy for the treatment of patients with stage I or II (stage IIB N0, M0) non-small cell lung cancer (NSCLC). The study was discontinued as it failed to meet its primary endpoint of an improvement in event-free survival as well as a key secondary endpoint, overall survival.
The second study, called KEYNOTE-630, evaluated Keytruda for the adjuvant treatment of patients with high-risk locally advanced cutaneous squamous cell carcinoma following surgery and radiation. In the study, Keytruda failed to show statistical significance in recurrence-free survival, the study’s primary endpoint.
A second pivotal phase III study was initiated on bomedemstat, an LSD1 inhibitor, for the treatment of patients with essential thrombocythemia (ET) in patients who have previously not received cytoreductive therapy. Patients are now being enrolled in the study called Shorespan-007. The study will enroll approximately 300 patients globally. The primary endpoint of the study is a durable clinicohematologic response rate. The first study on bomedemstat, called Shorespan-006, is being conducted in ET patients who have an inadequate response to or are intolerant of hydroxyurea.
J&J’s Balversa Gets EU Approval for Urothelial Carcinoma: The European Commission (“EC”) granted approval to J&J’s Balversa (erdafitinib), a kinase inhibitor, for treating unresectable or metastatic urothelial carcinoma, harboring susceptible FGFR3 genetic alterations. Urothelial carcinoma (UC) is the most common type of bladder cancer. The approval was based on data from cohort 1 of the phase III THOR study. In the United States, Balversa was approved by the FDA under the accelerated pathway in 2019 for FGFR-altered locally advanced or metastatic UC. The accelerated approval was later converted to a full approval by the FDA in January this year.
The EC also approved the expanded use of Rybrevant (amivantamab) for NSCLC based on data from the MARIPOSA-2 study. The approval is for Rybrevant in combination with chemotherapy (carboplatin and pemetrexed) for the treatment of adult patients with advanced NSCLCwith EGFR exon 19 deletions after failure of prior therapy. At present, Rybrevant is approved as a monotherapy in the EU for advanced NSCLC with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. It is also approved for use in combination with carboplatin and pemetrexed, for the first-line treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations.
J&J filed a biologics license application (BLA) to the FDA seeking approval of its key investigational monoclonal antibody, nipocalimab, for its first indication, generalized myasthenia gravis, an autoantibody disease. The BLA was based on data from the phase III Vivacity-MG3 study. Nipocalimab, an FcRn blocker, is in mid- and late-stage development for rare autoantibody-driven diseases. J&J believes the candidate has the potential to create a pipeline in a product
Roche’s Subcutaneous PNH Drug PiaSky Gets EU Approval: The EC also approved Roche’s C5 inhibitor, PiaSky (crovalimab), to treat PNH based on data from the COMMODORE 2 study. PNH is mostly treated with frequent intravenous infusions at doctors’ clinics. PiaSky offers the option to self-administer with proper training. It can be given at home and less frequently than intravenous infusions, which can reduce the patient’s treatment burden. PiaSky becomes the first monthly subcutaneous treatment approved for treating PNH in Europe. It combines the disease control provided by C5 inhibitors with its innovative recycling technology that enables monthly subcutaneous administration.
Pfizer Starts Website to Help Access Migraine Drugs, Vaccines: Pfizer is launching a new digital platform called PfizerForAll, marking its entry into the direct-to-consumer market, mirroring a similar move from Eli Lilly in January this year. The website will help patients get access to some vaccines as well as migraine medicines. PfizerForAll will allow patients to book an appointment with a healthcare provider the same day for in-person or telehealth consultations, find and book vaccinations for adult COVID-19, flu, RSV (respiratory syncytial virus) and pneumococcal pneumonia and receive diagnostic tests and prescription or over-the-counter medicines at home or via a preferred pharmacy. Pfizer has developed and launched the platform in partnership with healthcare organizations like UpScriptHealth, Alto Pharmacy and Instacart.
The NYSE ARCA Pharmaceutical Index rose 0.47% 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.
Image Source: Zacks Investment Research
In the last five trading sessions, Novartis rose the most (1.6%), while Lilly declined the most (1.3%).
In the past six months, while AstraZeneca rose the most (35.1%), Merck declined the most (7.5%).
(See the last pharma stock roundup here: Pharma Stock Roundup: FDA Nod to PFE, MRNA New COVID Jabs & More)
What's Next in the Pharma World?
Watch this space for regular pipeline and regulatory updates next week.
Roche and Eli Lilly have a Zacks Rank #2 (Buy) each. Pfizer and Merck have a Zacks Rank #3 (Hold) each, while J&J has a Zacks Rank of 4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.