Market Place
Pfizer CEO expects Covid vaccine approval by October; Favipiravir shows inconclusive results against Covid-19
This week, Phispers brings you updates on vaccines for the novel coronavirus.
While the FDA gave fast track designation to two experimental Covid vaccines being developed by BioNTech and Pfizer, Moderna said it plans to start phase 3 trials on its vaccine by the end of the month.
The FDA said it is looking to restart inspections in the US.
In M&A news, Roche shelled out US$ 775 million for Blueprint Medicine’s RET inhibitor, pralsetinib; Blackstone launched a fund for life sciences; and Zymeworks expanded its collaboration with Merck to develop up to three additional multi-specific antibody candidates.
Sanofi entered into a multi-program strategic collaboration with biotech firm Kymera Therapeutics to develop and commercialize first-in-class protein degrader therapies.
Japanese researchers said Fujifilm Holdings Corp’s Avigan (favipiravir) yielded inconclusive results as a treatment of Covid-19. And, there was yet another explosion at a chemical plant in Visakhapatnam, situated in south India.
Vaccine update: FDA fast tracks Pfizer’s shot; Moderna to start phase 3 trials on July 27
The US Food and Drug Administration (FDA) has given the ‘fast track’ designation to two experimental coronavirus vaccines being jointly developed by German biotech firm BioNTech and US pharma giant Pfizer.
Pfizer and BioNTech have four investigational vaccine candidates from their BNT162 mRNA-based vaccine program being assessed in ongoing trials in the US and Germany. Out of these, two candidates — BNT162b1 and BNT162b2 — are the most advanced.
The fast track status granted to BNT162b1 and BNT162b2 will speed up the review process. The companies said they expect to begin a large trial with up to 30,000 participants later this month.
Earlier this month, the companies said BNT162b1 showed potential against the virus and was found to be well tolerated in early stage human trials. The data is expected to be released in July.
If the ongoing studies are successful, and the vaccine candidate receives regulatory approval, the companies said they expect to make up to 100 million doses by 2020-end and potentially more than 1.2 billion doses by 2021-end.
In an interview with TIME, Pfizer CEO Albert Bourla said he believes the FDA approval could come by October. BioNTech CEO Ugur Sahin also said the mRNA vaccine candidate could be ready for regulatory submission by the fall or winter, pending success in a massive pivotal study.
After Bourla made that statement, Merck CEO Kenneth Frazier said raising Covid-19 vaccine hopes is “a grave disservice”. In a Harvard Business Review report, Frazier said Covid-19 vaccines under development are not guaranteed to work and people who say they expect a vaccine before year-end are doing a “grave disservice to the public.”
“If you’re going to use a vaccine on billions of people, you better know what that vaccine does,” he added.
Moderna to begin phase 3 trials by month-end: The first published data from an early-stage trial of Moderna’s experimental Covid-19 vaccine showed it led patients to produce antibodies that can neutralize the novel coronavirus, though it caused minor side effects in many patients.
The results were published in the New England Journal of Medicine. Moderna had previously released some results in a press release, but many experts said they were not sufficient to draw many conclusions.
Moderna posted a listing on clinicaltrials.gov, a government registry, that says it will start a Phase 3 study in 30,000 patients on July 27.
FDA looking to restart domestic inspections; unlikely to send teams to China for now
The US Food and Drug Administration (FDA) has said it plans to resume onsite domestic inspections beginning July 20, 2020, after a four-month moratorium on most on-site walkthroughs due to the ongoing pandemic. The inspections will be "prioritized", FDA Commissioner Stephen Hahn said.
The agency will weigh local virus activity when deciding which sites to inspect. FDA said it will prioritize which inspections it conducts in the coming months using a new risk assessment system to determine the state- and county-level risk posed by the virus. FDA said the risk level will determine what types of regulatory activities the agency and its partners carry out.
Hahn said the agency will rely on both White House and Centers for Disease Control and Prevention (CDC) guidelines to steer its inspections operations and protect its staff from being exposed to the virus.
As a safety measure, FDA will pre-announce all inspections. The announcement comes nearly two months after the agency said it will implement a phased approach to restarting surveillance inspections.
Risk of arbitrary detention in China: FDA inspections in China are not likely to get started anytime soon since the US warned its citizens of “heightened risk of arbitrary detention” in China as tensions between the two countries have been on the rise. According to the websites of US Embassy & Consulates in China, American citizens may be detained without access to US consular services or information about their alleged crimes.
M&A update: Roche buys Blueprint’s cancer drug; Blackstone launches life sciences fund
Roche is paying Blueprint Medicines US$ 775 million upfront for rights to its RET inhibitor (a drug that targets RET genetic alterations), pralsetinib. The deal prepares Roche to compete with Eli Lilly for patients with RET fusion-positive tumors affecting organs including the lungs and thyroid. Two months back, Lilly received FDA nod for Retevmo (selpercatinib) — the first therapy specifically for patients with advanced RET-driven lung and thyroid cancer.
According to Roche, pralsetinib could win FDA approval in non-small cell lung cancer (NSCLC) later this year. Blueprint has filed for approval of pralsetinib in the US and Europe this year on the strength of data linking it to a 91 percent response rate in RET fusion thyroid cancer. Pralsetinib achieved a 65 percent response rate in RET fusion-positive NSCLC and a 50 percent response rate across all RET fusion-positive solid tumors.
Blackstone’s life sciences fund: Last week, Blackstone launched a fund for life sciences, known as Blackstone Life Sciences. The fund was oversubscribed and closed at US$ 4.6 billion in total capital commitments — the largest life sciences private fund raised to date.
Blackstone Life Sciences is a private, global investment platform with capabilities to invest across the lifecycle of companies and products within the key life science sectors. Blackstone Life Sciences has three main investment strategies: strategic collaborations with established life science companies, late-stage product financings, and growth investments in emerging companies.
Zymeworks expands collaboration with Merck: After a decade of first partnering with Merck, Canadian biotech company Zymeworks has expanded its collaboration with the New Jersey-headquartered pharma giant.
Zymeworks signed a new licensing agreement with Merck, granting the American drugmaker the right to develop up to three additional multi-specific antibody candidates. In exchange, Zymeworks will receive an undisclosed upfront payment and nearly US$ 900 million in combined regulatory (US$ 411 million) and commercial (US$ 480 million) milestones.
The deal also comes with an option on three more antibodies for Merck’s animal health group with its own set of terms.
Sanofi in strategic partnership with Kymera: French drugmaker Sanofi has entered into a multi-program strategic collaboration with Cambridge, Massachusetts-based biotech firm Kymera Therapeutics.
The two drugmakers will develop and commercialize first-in-class protein degrader therapies targeting IRAK4 in patients with immune-inflammatory diseases. IRAK4 (short for interleukin-1 receptor-associated kinase 4) is a protein kinase involved in signaling innate immune responses from toll-like receptors. The companies will also partner on a second early stage program.
As per the terms of the partnership, Kymera will receive US$ 150 million in cash upfront and may receive more than US$ 2 billion in potential development, regulatory and sales milestones, as well as significant royalty payments. Kymera retains the option to participate in development and commercialization for both programs in the US.
Fujifilm’s favipiravir shows inconclusive results, say Japanese researchers
Japanese researchers had some bad news for Fujifilm Holdings Corp’s Avigan (favipiravir) — in the clinical trials, the drug yielded inconclusive results as a treatment for Covid-19.
Although patients who were given the drug early in the trial showed more improvement than those who got delayed doses, the results did not reach statistical significance, Fujita Health University researcher Yohei Doi said.
Avigan was developed by a subsidiary of Fujifilm and it was approved in Japan as an emergency influenza treatment in 2014. In March, a Chinese official said it appeared to help patients recover from Covid-19. It is now the subject of at least 25 clinical trials around the world.
In May, Japanese Prime Minister Shinzo Abe had said he hoped the drug would be approved as a Covid-19 treatment. A shortage of patients in Japan had delayed the progress of clinical trials.
The results were announced at a news conference held last week after the completion of a clinical trial conducted between March and May on 89 patients across Japan.
In May, the lead researcher on the Avigan trial had said it’s too early to make a call on whether the drug works or not, and patients are still being enrolled. Favipiravir has been approved as a Covid-19 treatment in Russia and India.
Vizag (India) witnesses second accident at pharma unit in two weeks
In India, the city of Visakhapatnam in Andhra Pradesh has witnessed a spat of gas leaks and explosions. After a gas leak at Sainor Life Sciences plant in the Vizag Pharma City on June 30, which killed two people, there was a massive explosion at a chemical plant this week.
On July 13, a huge fire broke out at the solvents’ recovery unit of Visakha Solvents Ltd, which recovers waste solvents from pharmaceutical units, located in Ramky Pharma City of Paravada on the outskirts of Visakhapatnam.
According to news website The Hans Ind, a charred body was found at the site of Visakha Solvents. The body was identified as that of K. Srinivasa Rao, a senior chemist, working in the company.
According to preliminary investigations, there were five reactors in the plant and one of them exploded. This is the third such accident in the district in the last two months. Apart from the gas leak at Sainor Life Sciences, Visakhapatnam also saw a gas leak at LG Polymers India Ltd in May this year.
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.”
