Pfizer in talks to buy Seagen; FDA panel backs Pfizer, GSK’s RSV vaccines

By PharmaCompass

2023-03-02

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Pfizer is in early-stage talks to acquire cancer-focused biotech Seagen for over US$ 30 billion. A panel of external experts to the US Food and Drug Administration (FDA) has backed both GSK and Pfizer’s respiratory syncytial virus (RSV) vaccines, setting the stage for a tight race between the two to become the first approved US shot against the disease.

After the recent enactment of the Inflation Reduction Act in the US, Eli Lilly said it will reduce the list prices of its commonly prescribed insulin products, Humalog and Humulin, by 70 percent.

The US Food and Drug Administration has approved Sanofi’s Altuviiio to prevent and treat bleeding episodes in people with hemophilia A and Reata Pharmaceuticals’ Skyclarys as a treatment to slow the progression of Friedreich’s ataxia, a rare genetic disorder. The agency has denied approval to Cytokinetics’ oral drug – omecamtiv mecarbil – for a type of heart failure. The European Medicines Agency (EMA) has advised against marketing authorization for Merck’s antiviral Covid-19 pill Lagevrio (molnupiravir) for the treatment of the disease in adults.

Meanwhile, Merck’s blockbuster cancer drug Keytruda has failed two more phase 3 trials, though it did hit primary endpoint in another phase 3 trial on non-small cell lung cancer patients when used as treatment both before and after surgery.

Generic drugmaker Akorn Pharmaceuticals has filed for bankruptcy and is shutting down its US operations. It will lay off up to 400 employees.

Pfizer in talks to buy Seagen for over US$ 30 billion to bolster oncology pipeline

Last July, there was news that Merck was in advanced talks to acquire cancer-focused biotech Seagen for around US$ 40 billion, but the talks fell through after the two sides failed to agree on the price. This week, The Wall Street Journal has reported that Pfizer is in early-stage talks to buy the Washington-based biotech. The agreement will allow Pfizer to expand its cancer treatment portfolio while offsetting a projected US$ 17 billion in sales loss due to patent expirations by 2030.

Race for first RSV jab heats up as FDA panel backs Pfizer, GSK’s vaccines

This week, both GSK and Pfizer ’s respiratory syncytial virus (RSV) vaccines secured the backing of a panel of external experts to the FDA, setting the stage for a tight race between the two rivals to become the first approved US shot against the disease.

The panel voted 7-4 in favor of Pfizer’s RSV vaccine – Abrysvo – for older adults. Similarly, the committee voted unanimously in favor of the GSK vaccine’s effectiveness in preventing lower respiratory tract disease caused by RSV in adults aged 60 and above, and voted 10-2 for its safety. The RSV vaccine market, estimated at US$ 5 billion, is poised to exceed US$ 10 billion by 2030.

Sanofi’s hemophilia A therapy, Reata’s rare genetic disorder drug bag FDA’s approval

The FDA has approved Sanofi’s Altuviiio to prevent and treat bleeding episodes in people with hemophilia A, a type of inherited bleeding disorder. The French pharma plans to launch the therapy in the US in April. It will compete against well-established treatments by rivals such as Takeda, Bayer and Novo Nordisk.

The agency has also approved Reata Pharmaceuticals’ Skyclarys (omaveloxolone) as a treatment to slow the progression of Friedreich’s ataxia, a rare genetic disorder that causes progressive damage to the nervous system. The approval is based on a mid-stage study, where patients who took the drug experienced an improvement in neurological functions.

The FDA has also approved Regeneron Pharmaceuticals and Sanofi’s Kevzara (sarilumab) for the treatment of polymyalgia rheumatica (PMR), an inflammatory rheumatic disease in adult patients who have had an inadequate response to corticosteroids.

EMA recommends Akebia’s anemia drug for CKD: Last March, FDA had declined to approve Akebia Therapeutics’ drug — Vafseo (vadadustat) — to treat anemia caused by chronic kidney disease (CKD) in both dialysis-dependent and non-dialysis patients. A year later, the drug has been recommended by the EMA for marketing authorization as a treatment for patients with anemia from CKD who are on dialysis. A final decision will be taken in about two months.

Lilly slashes prices of common insulin products by 70 percent

Eli Lilly will reduce the list prices of its commonly prescribed insulin products, Humalog and Humulin, by 70 percent. Lilly plans to implement the price cut in the fourth quarter of this year.

Lilly’s announcement comes after the recently enacted Inflation Reduction Act set a US$ 35-a-month cost-sharing limit on insulin for seniors enrolled in privately-run Medicare plans. It is expected to benefit around two million Americans, including those who are uninsured.

FDA rejects Cytokinetics’ oral drug for heart failure due to lack of efficacy data

Cytokinetics said FDA has declined to approve its oral drug — omecamtiv mecarbil — for a type of heart failure due to insufficient data on its effectiveness. In the complete response letter, the agency has asked the drugmaker to carry out an additional trial to establish the drug’s effectiveness in treating heart failure with reduced ejection fraction, a chronic condition resulting from abnormal contractions in the heart’s main pumping chamber. The decision follows a recommendation by FDA’s panel of external experts in December 2022.

Keytruda fails two late-stage cancer trials: Merck’s blockbuster cancer drug Keytruda has failed two more phase 3 trials – one in the hard-to-treat prostate cancer setting and another in a type of lung cancer. However, Merck said a phase 3 trial investigating Keytruda for patients with stage 2, 3A or 3B non-small cell lung cancer has hit its event-free survival primary endpoint. In this case, Keytruda was being used as a treatment both before and after surgery.

Form 483 to Indoco’s India facilities: The FDA has issued Form 483 with four observations to Indoco Remedies’ plant II (sterile facility) and plant III (OSD facility) in Goa (India) after conducting a GMP inspection from February 20 to 28.

Akorn shuts down US operations: Generic drugmaker Akorn Pharmaceuticals has closed its sterile manufacturing site in Decatur, Illinois, resulting in layoffs of up to 400 employees. According to a letter posted by the Herald&Review, the company has filed for bankruptcy and is shutting down its US operations. The company also has manufacturing sites in Somerset, NJ, and Amityville, NY.

Europe’s drug regulator advises against authorization of Merck’s Covid-19 pill

The EMA has advised against market authorization of Merck’s antiviral pill Lagevrio (molnupiravir) for the treatment of Covid-19 in adults. The EMA said there was not enough evidence that the pill was effective in treating Covid patients who do not need oxygen support and are at risk of their disease getting worse. Merck said it will appeal the decision.

Meanwhile, a panel of external advisers to the FDA will meet on March 16 to decide on the full approval for Pfizer’s antiviral pill Paxlovid as a treatment for mild-to-moderate Covid-19 for adults who are at high risk of progressing to a more severe form of the disease that could even lead to hospitalization or death. Paxlovid currently has an emergency-use authorization.

And, Moderna said it expects the annual sales of its Covid-19 vaccine to be around US$ 5 billion in 2023 – less than a third of the US$ 18.4 billion it had hauled in 2022.

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