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By PharmaCompass
2022-03-17
Impressions: 1812
Biogen released longer-term data for its Alzheimer’s drug Aduhelm that shows patients experienced reductions in two key disease indicators after nearly two-and-a-half years of treatment. The founders of Taiwanese biosimilar outfit JHL Biotech were sentenced to one year and one day in prison for stealing Genentech’s trade secrets and for lying to investors.
This week’s Phispers is packed with news from the field of oncology. Sanofi struck an exclusive collaboration agreement with dominant ADC player Seagen for a better oncology pipeline. However, one of its top oral drug candidates meant to treat a common type of breast cancer that grows in response to oestrogen has failed to slow the progression of the disease.
Similarly, Astra and Merck’s cancer drug, Lynparza, bagged additional FDA approval for treatment of patients with early-stage breast cancer. However, FDA rejected Astra’s application to extend the use of its blockbuster asthma drug Fasenra for the treatment of chronic rhinosinusitis with nasal polyps.
The week also saw setbacks in the use of combo drugs for cancer. A late-stage study undertaken by Merck that evaluates a combination of two blockbuster drugs – Keytruda and Lynparza – in patients with advanced prostate tumors failed to meet its main goals. And Bristol Myers’ Opdivo and Nektar’s bempegaldesleukin failed a phase 3 study that was testing the combo as a first line of treatment in patients with previously untreated unresectable or metastatic melanoma.
In regulatory news, FDA issued three observations to Zydus Lifesciences’ manufacturing facility in Jarod (Gujarat), India. The agency also announced new rates for its over-the-counter (OTC) monograph drug user fee program (OMUFA) for the 2022 fiscal year.
Meanwhile, Novartis, AbbVie and Eli Lilly joined a growing number of drugmakers that are suspending or scaling back their operations in Russia following Moscow’s invasion of Ukraine. And the White House said the US government will not be able to provide additional Covid-19 booster shots and will run out of monoclonal antibodies by May this year unless the Congress sanctions funds to fight the pandemic.
Biogen releases longer-term data on Aduhelm to show drop in two key indicators for Alzheimer’s
Biogen Inc released longer-term data for its Alzheimer’s disease therapy — Aduhelm — on Wednesday, its controversial commercial rollout notwithstanding. According to the data, patients in a long-term trial of Aduhelm experienced reductions in two key disease indicators after nearly two-and-a-half years of treatment.
In patients who have been treated with Aduhelm for up to two-and-a-half years, the drug continued to lower the levels of amyloid beta plaques in the brain and blood levels of the p-tau181 protein, Biogen said. Amyloid-beta and tau make up the plaques and tangles in the brain that are the hallmark of Alzheimer's disease.
The company, however, did not offer additional data on whether this reduction in amyloid can slow cognitive decline.
Approved last year, Aduhelm became the first treatment to be cleared for Alzheimer’s in 20 years, despite one of its two large-scale clinical trials failing to show benefits. Experts have questioned its approval and the US government’s Medicare program has proposed that the drug’s use only be allowed by patients enrolled in a new trial.
JHL founders to face imprisonment for stealing Genentech’s trade secrets
The founders of Taiwanese biosimilar outfit JHL Biotech, Racho Jordanov and Rose Lin, who have pleaded guilty to stealing trade secrets from Genentech, will be imprisoned for a year and one day.
Jordanov (the then CEO) and Lin (COO) had hired Genentech employees to obtain confidential information required to speed up the development of biosimilars to Genentech’s blockbuster cancer drugs. They then appealed to the investors and defrauded them of US$ 101 million.
Jordanov and Lin were indicted on multiple counts, including money laundering and obstruction to justice. By pleading guilty to conspiracy to commit trade secrets theft and wire fraud, the duo got the remaining charges dismissed.
Both have been sentenced to a prison term of 12 months and one day, to be followed by 36 months of supervised release, including nine months in home confinement for Jordanov.
Sanofi strikes deal with ADC player Seagen; its breast cancer drug suffers setback in phase 2 trial
It was a mixed week for Sanofi. While the French drugmaker is doubling down on antibody drug conjugates (ADCs), a field it had forayed into some 20 years back, it also suffered a setback in a phase 2 trial for a breast cancer drug.
But first, the good news. Sanofi announced an exclusive collaboration agreement with dominant ADC player Seagen for a better oncology pipeline. The two drugmakers will jointly fund and develop up to three ADC programs for the treatment of cancer. ADCs are antibodies engineered to deliver potent anti-cancer drugs to tumor cells expressing a specific protein.
The collaboration will utilize Sanofi's proprietary monoclonal antibody (mAb) technology and Seagen’s proprietary ADC technology.
In a major setback to Sanofi, one of its top oral drug candidates meant to treat a common type of breast cancer that grows in response to oestrogen has failed to slow the progression of the disease.
Sanofi said results from a phase 2 trial showed that the drug, amcenestrant, did not meet its primary endpoint of improving progression-free survival over endocrine treatment of physician's choice. A total of 367 patients with ER+/HER2- advanced or metastatic breast cancer had enrolled in the open-label study.
Novartis, AbbVie, Lilly join list of drugmakers scaling back operations in Russia
On Tuesday, Novartis, AbbVie and Eli Lilly joined a growing number of drugmakers that are suspending or scaling back their operations in Russia following Moscow’s invasion of Ukraine.
Novartis said it is suspending all investments, marketing activities and all scientific events organized by the company or any external parties in Russia. It also announced a donation of US$ 3 million to several NGOs.
AbbVie said it has suspended operations for all its aesthetics products in the country. Lilly has decided to suspend sales of all “non-essential medicines,” investments and promotions and will not start any new clinical trials. Lilly plans to send essential medicines for conditions such as cancer and diabetes. It will also donate any profit it makes from continued sales in Russia.
On Monday, Pfizer, Bayer and Abbott Laboratories had pulled back from non-essential spending in the country. Sanofi has also announced plans to immediately stop the supply of all non-essential medicines and vaccines along with all advertising and media activities in Russia. Merck said it “will no longer make investments in Russia.” Johnson & Johnson and Bristol Myers Squibb have suspended new patient recruitments and clinical trial site activations in Ukraine, Belarus and Russia.
US to run out of vaccines, drugs to treat Covid-19, unless Congress allots more funds
The US government will not be able to provide additional Covid-19 booster shots and will run out of monoclonal antibodies to treat Covid-19 by May this year unless the Congress sanctions funds to fight the pandemic, the White House said on Tuesday.
The White House had requested the Congress for US$ 22.5 billion as emergency funds to tackle the pandemic. While Republicans objected to the aid saying it was not needed, some Democrats were not sure how it will be distributed.
Astra’s asthma drug hits FDA roadblock, but breast cancer drug bags add-on nod
AstraZeneca’s blockbuster asthma medicine Fasenra (benralizumab) suffered a setback as the US Food and Drug Administration (FDA) rejected the drugmaker’s application to extend the use of the drug for the treatment of chronic rhinosinusitis with nasal polyps.
The British-Swedish drugmaker said the agency has issued a complete response letter (CRL) asking it for additional clinical trial data, and that it is working closely with the FDA on the next steps.
Chronic rhinosinusitis with nasal polyps is characterized by an inflammation of the mucus membranes of the nose and sinus cavities. It is accompanied by growths, or nasal polyps, which can block the nasal passages and cause difficulty in breathing.
Astra-Merck’s Lynparza snags add-on nod: The FDA on Friday approved Astra and Merck’s cancer drug, Lynparza, as a treatment for patients with early-stage breast cancer.
Lynparza has now been approved for patients with a form of genetically mutated high-risk early-stage breast cancer called BRCA-mutated HER2-negative, who have already been treated with chemotherapy either before or after surgery. The approval makes Lynparza the first PARP inhibitor — a class of drugs that keep cancer cells damaged by chemotherapy from repairing themselves — and the first targeted therapy for post-surgery breast cancer.
The companies said results from a late-stage study showed the drug reduced the risk of breast cancer recurrences and second cancers or death by 42 per cent compared with placebo.
Lynparza is already approved in the US to treat BRCA-mutated metastatic breast cancer already treated with chemotherapy.
Merck’s Keytruda-Lynparza cancer combo flops in phase-3 prostate cancer trial
A late-stage study undertaken by Merck that evaluates a combination of two blockbuster cancer drugs – Keytruda and Lynparza – in patients with advanced prostate tumors has failed to meet its main goals, prompting Merck to stop the trial.
The company on Tuesday said the phase 3 trial testing the combo in patients whose disease had progressed after treatment with chemotherapy and hormone therapy has failed to extend patients’ lives or slow tumor growth. The Keytruda-Lynparza combination also resulted in severe side effects. Merck said it plans to share the details of the study at an upcoming medical meeting.
Nektar’s drug fails cancer trial when used with BMS’ Opdivo; upsets US$ 3.6 billion deal
Back in 2018, Bristol Myers Squibb (BMS) had signed a potential US$ 3.6 billion licensing deal with Nektar, pinning its hope on the success of the Nektar’s drug bempegaldesleukin. But the results from a last-stage trial seems to have dashed those hopes.
Nektar on Monday said its drug bempegaldesleukin has failed a phase 3 study that was testing the drug in combination with BMS’ Opdivo as a first line of treatment in patients with previously untreated unresectable or metastatic melanoma.
Nektar and BMS have decided to stop enrollment. Nektar will, however, continue four other studies of the combo treatment in renal cell carcinoma and bladder cancer.
Court sides with BMS in Opdivo investor lawsuit: Back in 2018, several investors had filed a lawsuit against BMS alleging that the drugmaker had “misrepresented” an Opdivo study. In August 2016, BMS had revealed that Opdivo hadn’t met the primary endpoint in a phase 3 study – CheckMate-026 – that tested the drug for treatment of non-small cell lung cancer (LSCLC). This revelation was made just months after Merck had touted a win in that same setting with Keytruda.
However, the lawsuit appears to be coming to a close. Last week, the Second Circuit judges in the US sided with BMS and affirmed a federal court’s decision to dismiss the case. Opdivo won its first approval in 2014 for advanced melanoma and has since bagged add-on approvals for several cancer indications.
FDA hikes OTC monograph drug user fee by almost 20 percent
The US Food and Drug Administration (FDA) on Monday announced new rates for its over-the-counter (OTC) monograph drug user fee program (OMUFA) for the 2022 fiscal year. An OTC monograph drug is a non-prescription drug without an approved new drug application (NDA).
Certain OTC drugmakers will witness a nearly 20 percent jump in fees under OMUFA for 2022. Under the new fee schedule, the FDA hopes to rake in around US$ 24 million (after inflation and other adjustments). The agency estimates it will receive OMUFA fees from around 1,118 facilities this year, down from last year’s 1,184.
Under OMUFA, the FDA collects two types of fees. The first is the OTC Monograph Order Request (OMOR) fees, which is divided into two tiers depending on the types of drugs. The other type of fees is for monograph drug facilities (MDFs) and contract manufacturing organizations (CMOs).
This year, the Tier 1 OMOR fees (US$ 507,021) and Tier 2 OMOR fees (US$ 101,404) are going up by 1.4 percent. Meanwhile, the MDF facility fees (US$ 24,178) and CMO facility fees (US$ 16,119) are set to register a sharp increase of around 19 percent and 20 percent, respectively. The new rates will come into effect on October 1 and will be effective till September 30, 2022.
Zydus’ injectables facility in India hit with three observations
The FDA has issued three observations to Zydus Lifesciences’ manufacturing facility in Jarod, Gujarat, India. The agency carried out an inspection of the injectable facility between February 24 and March 10.
While Zydus, formerly known as Cadila Healthcare, did not clarify what the observations are, a report published in BloombergQuint listed out the three observations. According to the report, the company failed to complete testing within a predefined timeframe. There was a failure to test 250 stability sample injectables within the required days.
Second, the company has failed to follow the written procedures for quality evaluations conducted annually to review approval and rejection records of representative commercial drug batches. And finally, the buildings used for manufacturing and processing of products were not maintained well. FDA has retracted the names of the injectables that failed testing and quality tests but said the site primarily manufactured for the US market.
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