AstraZeneca's Imfinzi drug fails in head and neck cancer trial

 AstraZeneca said on Friday its Imfinzi drug did not prolong survival in a trial testing it as an initial treatment of head and neck cancer, a setback in its push to widen use of the immunotherapy beyond lung cancer.

Revenues from Imfinzi, mainly used against certain types of lung cancer, gained 42% to $1.48 billion in the first nine months of 2020, its fastest growing product.

“We will continue to build on the established benefits of Imfinzi in early lung cancer and small cell lung cancer, to bring immunotherapy treatment options to all patients who may benefit,” said Astra’s head of oncology, Dave Fredrickson.

The drug is also being tested against tumours affecting the bladder and cervix, among other cancer types.

https://www.reuters.com/article/astrazeneca-cancer/update-1-astrazenecas-imfinzi-drug-fails-in-head-and-neck-cancer-trial-idUSL4N2KB29E

Sanofi eyes mores savings, higher profitability after earnings rise

 Sanofi said on Friday it aimed to grow earnings per share this year after it posted stronger-than-expected results in the fourth quarter, and the drugmaker committed to boosting cost savings and profitability further through to 2025.

The French firm, which stunned investors last year with the delay of a COVID-19 vaccine candidate, confirmed an operating income margin target of 30% for 2022 and set itself a goal to improve it to more than 32% three years later.

The company is hosting a virtual investor day later on Friday that will largely focus upcoming drugs.

https://www.reuters.com/article/sanofi-results/sanofi-eyes-mores-savings-higher-profitability-after-earnings-rise-idUSL8N2KA6SU

Pfizer Confirms U.S. Patent Term Extension for IBRANCE tol March 2027

 Pfizer Inc. (NYSE: PFE) today announced that the U.S. Patent and Trademark Office (USPTO) recently issued a U.S. Patent Term Extension (PTE) certificate for IBRANCE® (palbociclib). The certificate extends the term of U.S. Patent No. RE47,739 (‘739) by more than four years until March 5, 2027. The PTE certificate was granted under the patent restoration provisions of the Drug Price Competition and Patent Term Restoration Act of 1984.

https://www.businesswire.com/news/home/20210205005079/en/Pfizer-Confirms-U.S.-Patent-Term-Extension-for-IBRANCE%C2%AE-palbociclib-Until-March-2027

Spero Therapeutics: FDA Hold on SPR720 Phase 2a Trial

 Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multi-drug resistant bacterial infections and rare diseases, today announced that the United States Food and Drug Administration (FDA) informed Spero that a clinical hold has been placed on its Phase 2a clinical trial of SPR720, Spero’s investigational oral antimicrobial agent being evaluated in patients with nontuberculous mycobacterial pulmonary disease (NTM-PD).

Spero received verbal notification of the clinical hold for the SPR720 Phase 2a trial but has not yet received written notice from the FDA. The clinical hold follows the notification by Spero to the FDA of its decision to pause dosing in its ongoing Phase 2a clinical trial of SPR720 as a precautionary measure following events in its ongoing animal toxicology study of SPR720. The decision to implement the pause was made based on a recommendation from Spero’s Safety Review Board (SRB), following review of data from an ongoing toxicology study of SPR720 in adult non-human primates in which mortalities with inconclusive causality to treatment were observed. The animal study is being conducted to assess the potential toxicity of SPR720 over a 4-month duration. A concurrent 4-month study of SPR720 in rats is proceeding uneventfully. These studies are meant to support longer-term treatment with SPR720 beyond the 28 days currently supported by IND-enabling toxicology studies. Spero is in discussion with FDA to evaluate the findings and determine the further development pathway for the SPR720 clinical program. No serious adverse events have been observed in any human study participants.

https://www.globenewswire.com/news-release/2021/02/05/2170670/0/en/Spero-Therapeutics-Provides-Update-on-SPR720-Phase-2a-Clinical-Trial.html

Pfizer withdraws application for emergency use of its COVID-19 vaccine in India

 Pfizer Inc has withdrawn an application for emergency-use authorization of its COVID-19 vaccine in India that it has developed with Germany’s BioNTech, the company told Reuters on Friday.

The U.S. company, which was the first drugmaker to apply for emergency use authorization of its COVID-19 vaccine in India, had a meeting with the country’s drugs regulator on Wednesday and the decision was made after that, the company said.

“Based on the deliberations at the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its application at this time,” it said in a statement to Reuters.

“Pfizer will continue to engage with the authority and re-submit its approval request with additional information as it becomes available in the near future.”

Pfizer had sought authorisation for its vaccine in India late last year, but the government in January approved two much cheaper shots - one from Oxford University/AstraZeneca and another developed at home by Bharat Biotech with the Indian Council of Medical Research. Both companies had applied for approval of their vaccines after Pfizer.

India’s Central Drugs Standard Control Organisation had declined to accept Pfizer’s request for approval without a small local trial on the vaccine’s safety and immunogenicity for Indians, Reuters has reported.

Indian health officials say they generally ask for so-called bridging trials to determine if a vaccine is safe and generates an immune response in its citizens whose genetic makeup can be different from people in Western nations. There are, however, provisions under India’s New Drugs and Clinical Trial Rules, 2019, to waive such trials in certain conditions.

Pfizer earlier told Reuters its application was supported by data from a global study that showed an overall efficacy rate of 95% with no vaccine-related, serious safety concerns.

https://www.reuters.com/article/health-coronavirus-india-pfizer/exclusive-pfizer-withdraws-application-for-emergency-use-of-its-covid-19-vaccine-in-india-idUSL4N2KB1NZ

Palihapitiya-backed Clover Health gets notice of SEC probe

 Chamath Palihapitiya-backed Clover Health Investments said Friday it received a notice of investigation from the Securities and Exchange Commission and that it intends to cooperate.

Clover, however, pushed back against a critical report from short-selling specialist Hindenburg Research, saying some claims in the report were “completely untrue.”

On Thursday, Hindenburg published a scathing report that called Clover Health a “broken business,” sending the insurance firm’s shares down more than 12%, their biggest daily percentage drop in four months. Shares of Clover rose more than 3.5% in premarket trading Friday after the company published its response. Hindenburg, which has a history of publishing short-selling research, said Thursday it does not hold a position in Clover.

Hindenburg also said Clover was under investigation from the Department of Justice and that the investigation was not disclosed to investors. In its response to the Hindenburg report, Clover said it has received inquiries from the DOJ but did not believe the inquiries were material to its investors. The company characterized the DOJ inquiries as standard practice since Clover works with the Medicare system.

Clover said it decided it did not need to disclose the DOJ inquiries after consultation with its lawyers. The company did not say what the DOJ’s inquiries were about. On the SEC side, Clover said it received the letter from the agency on Thursday following the publication of Hindenburg’s report. The company said it was unware of any investigations outside of the letter from the SEC it received Thursday.

The DOJ on Thursday declined to comment on any potential investigations or inquiries related to Clover. The SEC declined to comment on Friday.

In addition to the alleged investigations, Clover responded to Hindenburg’s critique of a separate company that shares investors and governance with Clover called Seek Insurance. Hindenburg alleged Seek Insurance, a site designed to help people find Medicare plans, doesn’t disclose its relationship to Clover even though its website characterizes itself as an unbiased platform for choosing a health plan. Clover said in its response that Seek Insurance is an affiliate of Clover, but is still independent start-up.

Clover also said Seek’s website would be updated soon with more information, and published a breakdown of the plans Seek customers choose. According to Clover, 13.5% of Seek customers chose a Clover plan, behind CVS/Aetna (17%), Humana (20%) and Cigna (20%).

Finally, Clover addressed Hindenburg’s allegations that the company’s software prompts doctors to charge the Medicare system more than necessary, a practice called “upcoding.” Hindenburg said Clover’s software encourages upcoding with “irrelevant diagnoses” to “deceive” and charge the Medicare system more. Clover denied those allegations in its response, and said doctors receive a flat payment for office visit, and that it’s up to the doctor to choose the diagnosis.

You can read all of Clover’s lengthy, point-by-point response to Hindenburg here.

https://www.cnbc.com/2021/02/05/chamath-palihapitiya-backed-clover-health-gets-notice-of-sec-investigation.html

Merck KGaA to boost lipid supply to vaccine maker BioNTech

 Germany’s Merck KGaA said on Friday it would boost its supply of lipids, a key ingredient in messenger RNA COVID-19 vaccines, to biotech firm BioNTech.

“Merck, in close collaboration with BioNTech, will significantly accelerate the supply of urgently needed lipids and increase the amount of lipid delivery towards the end of 2021,” Merck said in a statement.

Lipids, mainly in the form of lipid nanoparticles, are used to encapsulate and protect messenger RNA molecules to help them reach the designated cells in the human body.

https://www.reuters.com/article/merck-biontech-lipids/merck-kgaa-to-boost-lipid-supply-to-vaccine-maker-biontech-idUSFWN2KA1OP