Biogen to acquire Reata for US$ 7.3 billion; GSK sues Pfizer for violation of its RSV jab patents

By PharmaCompass

2023-08-03

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In this week’s Phispers, we bring you news on Biogen’s US$ 7.3 billion acquisition of Texas-based biotech Reata Pharmaceuticals to strengthen its rare disease portfolio. AstraZeneca’s rare diseases unit Alexion has bought Pfizer’s gene therapy portfolio for up to US$ 1 billion.

In approvals, the US Food and Drug Administration (FDA) has granted approval to GSK's Jemperli in combination with chemotherapy as first-line treatment for endometrial cancer.

GSK has sued Pfizer over violation of four of its respiratory syncytial virus (RSV) vaccine patents. Pfizer and Roche have reported decline in second quarter (Q2) revenues due to a sharp drop in sales of their Covid products.

In news from clinical trials, Merck has announced positive results from late-stage trial of Keytruda in combination with chemotherapy for the treatment of high-risk, early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer. Lilly’s experimental obesity drug, Mounjaro, has helped patients lose 26 percent of weight on average in two late-stage studies.

In regulatory news, the US Food and Drug Administration (FDA) has issued a warning letter to Intas Pharmaceuticals’ Gujarat facility in India for violations of current good manufacturing practices (cGMPs). And India has found violations of both manufacturing and laboratory practices at Riemann Labs, the company that made Naturcold cough syrup. A batch of Riemann’s cough syrup was linked to the death of at least six children in Cameroon.

Biogen to acquire Reata for US$ 7.3 billion to boost rare disease portfolio

Biogen has agreed to acquire rare disease drugmaker Reata Pharmaceuticals for approximately US$ 7.3 billion. The acquisition will give Biogen access to Reata’s FDA-approved drug Skyclarys, the first and only treatment approved for Friedreich’s ataxia, a rare genetic disorder that damages the nervous system in adults and adolescents aged 16 years and older. Skyclarys was approved in the US in February this year. Analysts expect the drug to touch US$ 1.3 billion in sales by 2029.

Astra’s rare disease unit to buy Pfizer’s gene therapies: AstraZeneca’s rare disease subsidiary, Alexion Pharmaceuticals, has reached an agreement to buy Pfizer’s portfolio of preclinical gene therapy programs and enabling technologies for up to US$ 1 billion. The deal will give Alexion access to Pfizer’s novel adeno-associated virus (AAV) capsids, known for their effectiveness in delivering therapeutic gene cargos for gene therapy and gene editing.

GSK sues Pfizer over violation of four of its RSV shot patents

GSK has taken Pfizer to court in the US alleging that the New York-headquartered drugmaker’s RSV vaccine Abrysvo violates GSK’s patent rights in its rival RSV shot Arexvy. The British pharma giant states that Abrysvo infringed on four patents the company has for Arexvy. The lawsuit alleges that Pfizer knowingly used a number of vaccine ingredients developed by GSK and protected under GSK’s patents “without permission.” GSK also noted that its vaccine was in development seven years prior to Pfizer’s. Both Pfizer and GSK’s vaccines were approved by the FDA for patients 60 years or older in May this year.

Pfizer, Roche report drop in Q2 revenues due to fall in sales of Covid products

Pfizer reported a significant decline in the second quarter (Q2) sales with revenue of US$ 12.7 billion, a decline of 54 percent compared to Q2 2022. Sales of its Covid-19 vaccine Comirnaty fell 83 percent to US$ 1.49 billion, and its antiviral treatment Paxlovid fell 98 percent to US$ 143 million. Pfizer has said it is prepared to cut costs if Covid-related revenue continues to disappoint this year.

Meanwhile, Roche’s Q2 group sales also fell by two percent due to a falling demand for Covid-19 products. However, excluding Covid-19 products, there is an eight percent rise in group sales.

GSK’s Jemperli bags FDA nod as first-line treatment for endometrial cancer

GSK has received FDA approval for its oncology drug Jemperli (dostarlimab) combined with chemotherapy (carboplatin and paclitaxel) as the first frontline treatment option for adult patients with primary advanced or recurrent endometrial cancer. A marketing authorization application is also under review by the European Medicines Agency (EMA). This approval positions Jemperli ahead of Merck’s Keytruda as the potential first-line treatment for endometrial cancer.

Merck’s Keytruda shows gains in ER+/HER2- breast cancer trial: Merck announced positive late-stage study results of its blockbuster drug Keytruda (pembrolizumab) along with chemotherapy in the treatment of high-risk, early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer. The study showed that the combination of Keytruda and chemotherapy was able to help clear all signs of tumor in patients compared to neo-adjuvant placebo plus chemotherapy.

Meanwhile, Merck’s investigational 21-valent pneumococcal conjugate vaccine – V116 – has achieved positive outcomes in two late-stage trials. If approved, V116 will be the first pneumococcal conjugate vaccine specifically designed for adults.

Lilly’s Mounjaro leads to 26% weight loss: Eli Lilly has reported positive results from two late-stage trials of its experimental obesity drug, Mounjaro (tirzepatide), being tested in overweight and obese patients without type 2 diabetes. Patients experienced an average weight reduction of 26.6 percent after intensive lifestyle changes or with continued treatment before stopping the drug. Mounjaro had bagged FDA approval to treat adults with type 2 diabetes in May 2022.

FDA issues warning letter to Intas’ India facility for cGMP violations

FDA has issued a warning letter to Intas Pharmaceuticals’ drug manufacturing facility in Sanand (Gujarat, India) for multiple violations of cGMPs. The letter highlights several issues related to data, quality, and the failure to establish and follow necessary laboratory control procedures.

Prior to this warning letter, FDA had issued a Form 483 with 11 observations to the same facility in December 2022, alleging that its employees had destroyed manufacturing-related documents.

India finds violations at Riemann Labs in Cameroon cough syrup case

India has found violations of both manufacturing and laboratory practices at Riemann Labs, the company that made Naturcold cough syrup. A batch of Riemann’s cough syrup was linked to the death of at least six children in Cameroon.

Regulators inspected the company’s production unit in the state of Madhya Pradesh in India and issued a notice after finding lapses, the state’s drug controller said. The Indian government has directed Riemann Labs to stop all manufacturing activities. Riemann Labs is the fourth Indian cough syrup maker to stop production after regulators found lapses.

Meanwhile, India has found multiple deficiencies among drugmakers following wide-ranging inspections across the country’s pharmaceutical industry, including a lack of raw materials testing.

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