Market Place
WHO announces new naming system for COVID variants; FDA seeks US$ 6.5 billion from Biden’s first budget
This week, we have lots of updates from the US Food and Drug Administration (FDA). The agency is seeking US$ 6.5 billion in funding under President Joe Biden’s US$ 6 trillion FY2022 budget proposal announced last week. It will use this for investments in critical public health infrastructure and vital public health programs. The FDA approved Amgen’s Lumakras — the first treatment for non-small cell lung cancer. The agency also approved Alkermes’treatment, Lybalvi, for schizophrenia and bipolar I disorder and BridgeBio’s targeted cancer treatment — Truseltiq. Moreover, the agency expanded the product labels of Bristol Myers’ Zeposia (for treatment of ulcerative colitis) and Biohaven’s Nurtec ODT (for both prevention and treatment of migraines).
In Covid news, the WHO has decided to use Greek letters to refer to variants of SARS-CoV-2. The EMA has allowed the use of Pfizer’s vaccine in children aged 12 to 15. However, the European Centre for Disease prevention and Control (ECDC) has said the EU should take account of global shortages of Covid-19 vaccines before rolling out shots for adolescents.
In M&A news, German biotech MorphoSys announced it will buy cancer drugmaker Constellation Pharmaceuticals in a US$ 1.7 billion deal. MorphoSys also announced a long-term funding partnership with Royalty Pharma worth US$ 1.425 billion upfront.
Russia’s Supreme Court has rejected a lawsuit filed by Gilead Sciences, wherein the American company had challenged a decision of the Russian government to allow a Russian firm to develop and market remdesivir. And German Chancellor Angela Merkel has defended patent protection, while China has changed its IP laws to benefit drug manufacturers.
Variants go Greek: WHO uses alpha, beta, delta to refer to UK, South African, Indian strains
Last month, the Indian government had objected to the B.1.617.2 variant of SARS-CoV-2 (the virus that causes Covid-19) being referred to as the ‘Indian variant’. Though the World Health Organization (WHO) had never named it the Indian variant, the agency has now announced a new naming system for variants of Covid-19. The WHO will use Greek letters to refer to variants first detected in countries like the UK, South Africa, and India.
The UK variant for instance is labelled as ‘alpha’, the South African as ‘beta’, and the Indian as ‘delta’. The WHO said this is to simplify discussions, and to help remove stigma around the names.
“No country should be stigmatized for detecting and reporting variants,” the WHO's Covid-19 technical lead, Maria Van Kerkhove, said. She also called for “robust surveillance” of variants, and for the sharing of scientific data to help stop the spread.
The Greek letters will refer to both variants of concern, and variants of interest. A full list of names has been published on the WHO website. These letters will not replace existing scientific names.
French study on Pfizer jab’s efficacy on delta variant: A study undertaken by France’s Pasteur Institute has found that the Pfizer-BioNTech vaccine is slightly less effective on the delta variant, but still protects against this more transmissible strain.
“Despite slightly diminished efficacy, the Pfizer vaccine probably protects” against the Indian variant, according to laboratory test results, said Olivier Schwartz, the institute’s director and co-author of the study.
The study sampled 28 healthcare workers in Orleans — 16 of them had received two doses of the Pfizer vaccine, while 12 had received one dose of the AstraZeneca vaccine. People who had received two doses of Pfizer saw a threefold reduction in their antibodies against the delta variant, but were still protected, the study said.
“The situation was different with the AstraZeneca vaccine, which induced particularly low levels of antibodies neutralizing” the Indian variant, it added.
Russian Supreme Court rejects Gilead’s remdesivir lawsuit
Last week, Russia’s Supreme Court rejected a lawsuit filed by Gilead Sciences, wherein the American drugmaker had challenged a decision of the Russian government to allow Pharmasyntez, a Russian firm, to develop and market remdesivir, an antiviral drug being used for the treatment of Covid-19, without its consent.Late last year, the Russian government had granted Pharmasyntez a compulsory license for one year to manufacture remdesivir under a different name without Gilead’s permission.
At the time, the government had said the move is in the interests of Russia's own security. According to the decree, Russia had to pay a compensation to Gilead, the drug’s patent-holder. The amount was not specified.
Pharmasyntez had asked the Kremlin to allow it to produce a generic version of remdesivir before the government decree was issued. In July last year, the company had reportedly also written to Gilead to obtain their consent in the form of a voluntary license but didn’t hear back.
Pharmasyntez produces remdesivir under the name Remdeform. A shipment of the drug was sent by Russia to India on Tuesday as part of humanitarian aid, since the country has been facing a huge spike in Covid-19 cases in the second wave of the pandemic.
Gilead said it was disappointed by the Supreme Court's ruling, terming the issuance of a compulsory license as “unnecessary and counterproductive”.
Merkel defends patent protection; China rolls out revisions to its IP laws
German Chancellor Angela Merkel has urged G20 countries to fund the COVAX initiative to provide Covid-19 vaccines to the world’s poorer countries. However, she stressed that patent protection was vital to the development of drugs.
Merkel said the world needs to apply the lessons of the coronavirus crisis in preparing for future pandemics. “This includes not weakening the incentives for research and development but developing them further if necessary,” she said. “Patent protection plays an important role here.”
Meanwhile, starting this month, China is changing its patent protection laws and drug manufacturers reportedly stand to benefit the most.
The country is aiming to give makers of brand name drugs more tools to protect their IP, allowing such companies to sue before a similar generic product is launched in China.
China will establish a patent linkage system similar to the Hatch-Waxman Act of 1984, which created the modern regulatory framework in the US. It will provide a process for branded companies to challenge generic drugs early and could reshape patent litigation in China.
ECDC says consider global shortages even as EMA approves Pfizer jab for adolescents
The European Medicine Agency’s human medicines committee (CHMP) has recommended granting an extension of indication for Pfizer’s Covid-19 vaccine to include use in 12 to 15 year old children. The vaccine is already approved for people aged 16 and above.
Meanwhile, the European Centre for Disease prevention and Control (ECDC) has said European Union countries should take account of global shortages of Covid-19 vaccines before rolling out vaccines for adolescents.
Moderna applies for full FDA nod: This week, Moderna became the latest drug company to apply to the US Food and Drug Administration (FDA) for full approval of its Covid-19 vaccine for use in people 18 and older. The FDA nod will allow the company to market the shot directly to consumers. Last month, Pfizer had applied to the FDA for a full approval. So far, these vaccines have the FDA’s emergency use authorization.
FDA approves Amgen’s Lumakras — first treatment for non-small cell lung cancer
Last week, the US Food and Drug Administration (FDA) approved Lumakras (sotorasib) as the first treatment for adult patients with non-small cell lung cancer (NSCLC) whose tumors have a specific type of genetic mutation called KRAS G12C and who have received at least one prior systemic therapy.
The agency approved Lumakras three months ahead of schedule. This is the first approved targeted therapy for tumors with any KRAS mutation, which accounts for approximately 25 percent of mutations in NSCLC. The accelerated approval is based on response rates in a study of 124 NSCLC patients with KRAS G12C mutations.
“KRAS mutations have long been considered resistant to drug therapy, representing a true unmet need for patients with certain types of cancer,” said Richard Pazdur, director of FDA's Oncology Center of Excellence. “Today’s approval represents a significant step towards a future where more patients will have a personalized treatment approach.”
Alkermes’ drug for schizophrenia bags nod: The FDA has also approved Alkermes’ treatment — Lybalvi — for schizophrenia and bipolar I disorder. The company said it expects to commercially launch the drug in the fourth quarter of 2021. In November, the FDA had declined to approve the drug, citing concerns related to a tablet coating process at its manufacturing site. Lybalvi is a once-daily, oral antipsychotic drug composed of olanzapine, an established antipsychotic agent, and samidorphan, a new chemical entity.
BridgeBio’s cancer drug approved: BridgeBio has bagged yet another nod this year, after winning an approval for its rare disease drug Nulibry. This week, the FDA approved BridgeBio’s targeted cancer treatment, Truseltiq. The drug was previously known as infigratinib. The drug has been granted accelerated approval in previously-treated, locally advanced or metastatic bile duct cancer with an FGFR2 fusion or rearrangement.
FDA seeks US$ 6.5 billion in funding under Biden’s US$ 6 trillion FY2022 budget proposal
The US Food and Drug Administration (FDA) is seeking US$ 6.5 billion in funding for FY2022 under President Joe Biden’s US$ 6 trillion budget proposal announced last week. This marks an 8 percent increase, amounting to US$ 477 million, over the agency’s FY2021 budget.
The agency has said the US$ 6.5 billion budget will be used for “investments in critical public health infrastructure, core food safety and medical product safety programs and other vital public health programs,” which includes US$ 3.6 billion in budgeting authority and US$ 2.9 billion in user fees.
Investments in critical public health infrastructure would total US$ 185 million and include data modernization (US$ 75.9 million), improvements to buildings and infrastructure (US$ 37.5 million), expanded laboratory safety (US$ 53.5 million) and more internal capacity to support over 18,000 FDA employees (US$ 17.9 million). The FDA said its data infrastructure is outdated, and the funds will go to supporting current operations as well as to “keep pace” with new regulatory responsibilities, requirements, and legislation.
FDA expands product labels of Bristol Myers’ Zeposia, Biohaven’s Nurtec ODT
When Biohaven Pharmaceuticals’ Nurtec ODT was launched last year, it joined the league of other medicines from Allergan and Eli Lilly that seek to provide immediate relief from migraines. But Nurtec ODT went a notch higher last week when the FDA expanded its product label for both prevention and treatment of migraines.
The FDA approved Biohaven’s dissolvable Nurtec ODT (rimegepant) for preventive treatment in people who experience episodic migraines, or fewer than 15 days of headaches per month.
This makes Nurtec ODT the first oral anti-CGRP drug approved for the preventive treatment of migraines and the only migraine medication approved as a dual therapy for both acute and preventive use.
The FDA based its decision on Nurtec ODT’s phase 3 trial results that showed the drug beat the placebo and led to a 4.3 day reduction in monthly migraine days after three months of treatment.
Zeposia gets FDA nod for ulcerative colitis: The other drug whose product label was expanded last week is Bristol Myers Squibb’s oral drug Zeposia. The FDA had approved Zeposia in March last year for treating multiple sclerosis. Now, the agency has approved the drug to treat adults with ulcerative colitis, a chronic inflammatory bowel disease.
Bristol Myers gained Zeposia in 2019 through its US$ 74 billion buyout of Celgene. Zeposia will compete with Takeda’s Entyvio, which was approved in 2014 by the FDA for ulcerative colitis.
MorphoSys buys Constellation for US$ 1.7 billion; inks funding deal with Royalty Pharma
On Wednesday, German biotech MorphoSys announced it will buy cancer drugmaker Constellation Pharmaceuticals in a US$ 1.7 billion deal. The deal is expected to close in the third quarter.
Constellation’s two lead assets are the BET inhibitor pelabresib and CPI-0209, an EZH2 inhibitor. Both are in mid- to late-stage clinical trials in hematological and solid tumors. The company has other preclinical compounds in the pipeline as well.
MorphoSys also announced it has entered into a long-term funding partnership with Royalty Pharma. The funding partnership with Royalty Pharma is worth US$ 1.425 billion upfront and will “anchor” the Constellation deal, MorphoSys’ CEO Jean-Paul Kress, told investors.
The PharmaCompass Newsletter – Sign Up, Stay Ahead
Feedback, help us to improve. Click here
Image Credit : Phisper Infographic by SCORR MARKETING & PharmaCompass is licensed under CC BY 2.0
“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”
