Pfizer buys Biohaven for US$ 11.6 billion; FDA issues Form 483 to Sun Pharma’s India unit

By PharmaCompass

2022-05-12

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The week began with this year’s largest acquisition in the pharma world thus far, as cash-rich Pfizer acquired Biohaven Pharmaceuticals for US$ 11.6 billion. With this deal, Pfizer gets rights to the leading oral migraine drug in the US – Nurtec ODT.

Moderna’s new CFO Jorge Gomez assumed charge on Monday this week, but had to quit on Tuesday as his previous employer Dentsply Sirona disclosed an internal probe related to financial reporting.

In regulatory news, the US Food and Drug Administration (FDA) issued a Form 483 with 10 observations to Sun Pharmaceutical’s Halol manufacturing plant in Gujarat, India. The agency also restricted the use of Johnson & Johnson’s Covid-19 vaccine due to 60 cases of thrombosis with thrombocytopenia syndrome, including nine deaths.

A report by the US House of Representatives’ panel on coronavirus said around 400 million doses of Covid-19 shots had been destroyed last year at Emergent BioSolutions’ facility in Baltimore due to cross-contamination issues, as opposed to the US government’s estimate of 85 million doses. The facility used to manufacture AstraZeneca and J&J’s vaccines.

In drug approval news, AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate (ADC) Enhertu has clinched another approval from the FDA. It is now approved as a second-line therapy for breast cancer patients who reported a return of the disease within six months of receiving another HER2-targeting drug.

In manufacturing news, Novartis temporarily suspended the production of two of its cancer drugs – Lutathera and Pluvicto – after potential quality issues were found in the manufacturing process at its facilities in Ivrea (Italy) and Millburn, New Jersey. And GE’s healthcare unit increased the production of medical dyes at its Ireland plant to combat shortages caused by the closure of its Shanghai factory.

Pfizer buys Biohaven for US$ 11.6 billion in 2022’s largest pharma deal

Pfizer is putting its cash pile accumulated from the sales of its Covid-19 products – vaccine Comirnaty and pill Paxlovid – to good use. Announcing the largest pharma deal of this year, cash-rich Pfizer on Tuesday said it will acquire New Haven-based drugmaker Biohaven Pharmaceuticals for US$ 11.6 billion.

As part of the deal, Pfizer will pay US$ 148.50 per share in cash, an increase of about 79 percent over Monday’s closing price.

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The deal will hand Pfizer the rights to the leading oral migraine drug in the US – Nurtec ODT – a potential blockbuster that analysts say could add billions of dollars in yearly sales to Pfizer’s account. Nurtec belongs to a class of migraine treatments called calcitonin gene-related peptide (CGRP) inhibitors.

The Biohaven deal is Pfizer’s largest since its US$ 14 billion purchase of cancer drugmaker Medivation in 2016. The New York-based drugmaker had bagged a 2.6 percent stake in the biotech along with the ex-US rights to Nurtec ODT for US$ 500 million in November last year. The drug brought in sales worth US$ 462.5 million in 2021.

Biohaven has six other CGRP migraine drugs in development and Pfizer expects Biohaven’s migraine drugs to top US$ 6 billion in annual sales. Pfizer plans to spin off Biohaven’s non-migraine drugs into a new publicly traded company called New Biohaven.

Moderna’s new CFO quits in a day as former employer discloses accounting probe

Moderna Inc had announced the appointment of Jorge Gomez in April as its chief financial officer (CFO). Gomez was replacing David Meline, who had recently retired. Ironically, Gomez, who assumed charge on Monday, had to quit on Tuesday after his previous employer Dentsply Sirona Inc disclosed an internal probe related to financial reporting.

Last month, Dentsply Sirona had fired its then-CEO Don Casey without disclosing a reason. The company is a dental equipment manufacturer and dental consumables producer.

With Gomez’s departure, Moderna brought Meline back into the fold on Wednesday. The company has reopened its search for a new CFO.

The Dentsply probe, launched in March, is focused on the "use of incentives to sell products to distributors in the third and fourth quarters of 2021, and whether those were properly accounted for. The company has appointed independent outside counsel and a forensic accounting firm to assist with the investigation.

Former CFO of Immunomedics indicted for insider trading: Usama Malik, the former CFO of Immunomedics (a New Jersey-based biotechnology company), has been indicted for insider trading after allegedly giving his girlfriend non-public information about clinical trial results for a new breast cancer drug.

Malik was indicted on three counts of insider trading, securities fraud and securities fraud conspiracy, the US Department of Justice said. He had spent nearly four years at Immunomedics, leading the company to a US$ 21 billion acquisition by Gilead back in 2020.

FDA issues Form 483 with 10 observations to Sun Pharma’s Halol unit in India

The US Food and Drug Administration (FDA) has issued a Form 483 with 10 observations to Sun Pharmaceutical’s Halol manufacturing plant in Gujarat, India. The FDA had conducted a good manufacturing practices (GMP) inspection of the site between April 26 and May 9.

In March 2020, the FDA had classified the Halol facility as Official Action Indicated (OAI). The re-inspection got delayed due to pandemic-related travel restrictions. According to a Mumbai-based analyst, the OAI status of the facility still remains in force.

The Indian generic company has not disclosed the details of the observations. The pharma said it will work closely with the FDA to address the observations and respond to them within 15 business days. The Halol facility has been under FDA’s radar for the last few years. The agency has carried out 11 inspections and has handed over three OAIs (in 2020, 2017 and 2014) and one warning letter (in 2015). In December 2019, the facility also received a Form 483 with eight observations.

Novartis halts production of two cancer drugs over quality concerns at two sites

Last week, Novartis temporarily suspended the production of two of its cancer drugs – Lutathera and Pluvicto – after potential quality issues were found in the manufacturing process at its facilities in Ivrea (Italy) and Millburn, New Jersey.

Novartis did not disclose the quality issues it has identified, but said it will halt the supply of the two drugs until the issues are fixed. The Swiss pharma said it has not found any indication of risk to patients previously treated with the drugs made at the sites. It has, however, asked treatment centers to closely monitor patients for any side effects.

The FDA had approved Pluvicto in March to treat patients with a type of advanced prostate cancer. Novartis had acquired the therapy in 2018 as part of its US$ 2.1 billion purchase of Endocyte.

GE boosts dye production at Ireland: General Electric’s healthcare unit has increased production of dyes used for medical scans and tests at its factory in Cork, Ireland, to combat shortages caused by the closure of its Shanghai factory due to local Covid policies. It has also shipped products by air from Cork and Shanghai to the US to speed up deliveries.

FDA restricts use of J&J’s Covid shot after 60 blood clot cases, including nine deaths

The FDA has limited the use of Johnson & Johnson’s Covid-19 vaccine to those adults who cannot access other vaccines or who choose to take it because they would otherwise not receive a coronavirus vaccine at all.

The agency said it took the decision after 60 cases of thrombosis with thrombocytopenia syndrome (TTS), including nine deaths, were reported to its Vaccine Adverse Event Reporting System. TTS is a rare but serious condition characterized by an unusual combination of blood clots and low platelet counts.

J&J appoints CEO of consumer health spin-off: J&J has appointed company veteran Thibaut Mongon as the chief executive officer of the consumer health division that it plans to spin off by the end of 2023. In November 2021, the pharma giant had said it will split off the consumer health division that sells branded products like Tylenol and Listerine.

Mongon, who joined the company in 2000, currently serves as the executive vice-president and worldwide chairman of J&J’s consumer health division. J&J has also appointed the CFO of the consumer health division Paul Ruh as the CFO of the new entity. The leadership transition will occur after the separation is complete, J&J said.

‘Up to 400 million Covid shots were ruined at Emergent’s Baltimore unit’: House report

Last year, J&J had to throw away millions of doses of its Covid-19 vaccine produced at contract manufacturer Emergent BioSolutions’ facility in Baltimore due to cross-contamination issues. The factory was also manufacturing AstraZeneca’s Covid vaccine at the time. The US government and company officials had put the figure at 85 million doses.

Now, a new congressional probe has pegged the number of vaccines destroyed at around 400 million doses. The report by House of Representatives’ Select Sub-committee on the Coronavirus Crisis says Emergent had been repeatedly warned that manufacturing deficiencies, such as persistent problems with mold, poor disinfection of plant equipment and inadequate employee training, could lead to contamination at the facility. But the contract manufacturer failed to take steps to remedy the issues.

Emergent disputed many of the report’s findings, saying it had been open with federal regulators. It also disputed the 400 million figure saying doses are difficult to estimate from vaccine ingredient batches.

BioNTech’s vaccine sales triple in Q1: BioNTech’s sales and earnings in the first quarter (Q1) of this year more than tripled due to the demand for its Covid-19 vaccine that it has developed along with Pfizer. The German biotech reported €6.37 billion (US$ 6.73 billion) in revenues and €3.70 billion (US$ 3.9 billion) in net income in Q1. Despite performing better than expected in Q1, BioNTech has forecasted a full-year decline in vaccine sales. It has predicted €13 billion (US$ 13.75 billion) to €17 billion (US$ 17.98 billion) in revenues from its vaccine this year, down from €19 billion (US$ 20.10 billion) last year.

FDA may accept lower efficacy for Covid-19 vaccines for kids below five: FDA’s biologics center director Peter Marks told a Congress committee on the coronavirus crisis that vaccines for the youngest children will not have to meet the 50 percent threshold for efficacy against Covid-19 infections, especially if the jabs mirror the efficacy for adult vaccines. There is no vaccine available for this age group as of now. The agency is currently reviewing data from Moderna’s two-shot vaccine for this group. It is also awaiting further data from Pfizer on its potential three-dose shot.

Lilly’s Olumiant gets full approval to treat hospitalized Covid patients: The FDA has approved the use of Eli Lilly and Incyte’s Olumiant (baricitinib) as a standalone med to treat hospitalized Covid patients who are 18 years and above and require oxygen, ventilation or extracorporeal membrane oxygenation. The oral drug is administered once daily for up to 14 days.

Astra’s Enhertu wins another breast cancer approval, to challenge Roche’s Kadcyla

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has clinched another approval from the FDA – this time as a second-line therapy for breast cancer patients who reported a return of the disease within six months of receiving another HER2-targeting drug. ADCs are a class of drugs that are designed as a targeted therapy for treating cancer.

The latest FDA approval is based on data from a study that pitted the drug against Roche’s Kadcyla – the standard second-line treatment for HER2-positive patients. Enhertu reduced the risk of disease progression or death by 72 percent as compared to Kadcyla. It registered a three-fold increase over Kadcyla in investigator-assessed survival and a higher percentage of patients taking the drug were still alive after one year. Analysts estimate Enhertu will replace Kadcyla to treat HER2-positive breast cancer following the approval.

Astra’s rare disease drug, heart pill score wins in trials: AstraZeneca’s long-acting C5 inhibitor drug Ultomiris (ravulizumab-cwvz) has hit the primary endpoint in a late-stage clinical trial of a rare autoimmune disease affecting the central nervous system. Ultomiris was first approved in 2018 to treat paroxysmal nocturnal hemoglobinuria (a life-threatening disease of the blood) in patients at least one-month-old.

Another Astra drug, Farxiga (dapagliflozin), has delivered positive results in a phase 3 trial studying it as a treatment for heart failure. Farxiga is already approved for indications related to type 2 diabetes, heart failure with reduced ejection fraction and chronic kidney disease.

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