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Wednesday, June 2, 2021

Bahrain, Facing Covid Surge, Starts Giving Pfizer Boosters to Recipients of Chinese Vaccine

 The Persian Gulf island nation of Bahrain, battling a sharp resurgence of Covid-19 despite high levels of inoculation with a Chinese-made vaccine, has started giving booster shots to vulnerable citizens using a different vaccine made by Pfizer Inc. and BioNTech SE, a senior official said.

Waleed Khalifa al Manea, Bahrain's undersecretary of health, said the vaccine manufactured by state-owned Chinese drugmaker Sinopharm, which has accounted for more than 60% of Bahrain's inoculations so far, was providing a high degree of protection. More than 90% of people hospitalized in the current Covid-19 wave, the worst the country has faced, hadn't been vaccinated, he said.

Still, Dr. al Manea added, Bahrain residents who are over 50, are obese or have chronic illnesses now are being urged to get another shot six months after their full Sinopharm vaccination -- with the Pfizer-BioNTech vaccine. The government started offering the boosters at the end of May, he said.

Bahrain, which has made the Pfizer-BioNTech vaccine available to unvaccinated residents for months, will continue to offer the choice of Sinopharm to those who prefer the Chinese vaccine, Dr. al Manea said. The government's BeAware app allows users to book a Sinopharm booster shot, but says that Pfizer-BioNTech is recommended for more-vulnerable population groups.

Sinopharm and other Chinese vaccines have become key tools of Beijing's international diplomacy, especially in developing nations unable to secure sufficient doses of U.S. and European-made shots. Sinopharm and another shot, manufactured by Sinovac Biotech Ltd., have already received emergency approval from the World Health Organization.

The two vaccines are manufactured with inactivated virus, a long-used technique for making vaccines. The Pfizer-BioNTech shot relies on a new technology employing messenger RNA.

Published clinical data on Sinopharm's efficiency among the population groups most vulnerable to severe disease is scant. The vaccine's main clinical trial involved 40,382 participants in the Middle East, most of them in the United Arab Emirates.

The study's peer-reviewed results, published on May 26 by the Journal of the American Medical Association, found 78% efficacy against symptomatic disease for one of two versions of the Sinopharm vaccine. However, the cohort was made up mostly of healthy young men -- the participants' mean age was 36 -- and the study reported only two cases of severe disease, a statistically insufficient amount, in the placebo group.

"Conclusions about prevention of severe cases cannot be made," the study said, adding that it "could not address the question of whether the inactivated vaccines prevent against asymptomatic infection." With no participants older than 60 developing an infection, the study also had no data on whether Sinopharm's vaccine works in that age group.

In a separate, unpublished, real-world study of Sinopharm in Serbia, 29% of 150 participants were found to have zero antibodies against the virus three months after they received the first of two shots of the vaccine. The average age of the people who participated in the Serbian study was higher than 65.

"The Sinopharm vaccine is not immunogenic enough, and it appears that its impact is especially low on elderly recipients," said Olgica Djurkovic-Djakovic, the doctor who headed the study at the University of Belgrade and shared the findings with The Wall Street Journal. Ten people out of the 150 who received Sinopharm and participated in the study contracted Covid-19, she said.

Sinopharm, which hasn't responded to requests for comment for this article, said in March that it was studying whether to recommend a third booster shot, without sharing details. The company hasn't publicly addressed questions about its vaccine's efficacy since then. Chinese Foreign Ministry spokesperson Hua Chunying, asked at a May 12 press briefing about a Journal article on a virus spike in the Seychelles, another nation heavily dependent on Sinopharm, said such reporting "exposes their unhealthy mind-set of denigrating China at every turn."

In Bahrain, daily Covid-19 deaths have leapt to 12 per million people in recent weeks -- an outbreak nearly five times more lethal than India's -- prompting the island nation's government to shut down shopping malls and restaurants in an effort to limit the spread. Dr. al Manea attributed this upsurge to holiday celebrations during and at the end of the Muslim holy month of Ramadan. "The infections came mainly from family gatherings -- we had Ramadan, which is a very social event in Bahrain."

One of the world's vaccination leaders, Bahrain has fully vaccinated 47% of its people, more than the 41% vaccination rate in the U.S. or the 38% in the U.K.

The Seychelles, an Indian Ocean archipelago that became the world's most vaccinated nation due to donations of the Sinopharm vaccine from the U.A.E. and of an AstraZeneca PLC shot by India, with 65% of the population fully vaccinated, also saw cases and deaths surge to records in May. The WHO pointed out that most of those who had fallen sick with Covid-19 there were either unvaccinated or had only received their first dose. The Seychelles health ministry said it is considering administering a third booster shot to vulnerable residents.

The U.A.E. said in March that it already began administering a third booster shot of Sinopharm to some residents who failed to develop antibodies with the first two. In the U.A.E., where Sinopharm accounts for the majority of administered vaccines, unvaccinated residents -- like in Bahrain -- can now choose which vaccine to take.

In Dubai, the most populous of the seven members of the U.A.E., the emirate's health authorities have also quietly begun revaccinating with Pfizer-BioNTech those residents who had been fully inoculated with Sinopharm, according to dozens of recipients.

Dubai resident Brindha Satheshwaran, 42, was vaccinated with Sinopharm in January and said she felt protected until her husband, also inoculated with the Chinese vaccine, took an antibody test that turned out to be negative. She said they both decided to get two doses of Pfizer-BioNTech, and received the first of them in late May.

"Several people I know are finding out they have not developed antibodies after Sinopharm and are rushing to book to get Pfizer," Ms. Satheshwaran said.

In its initial report on Phase 3 trials of Sinopharm, the U.A.E. government said in December that the vaccine offered 86% protection against symptomatic disease and 100% protection against moderate and serious disease.

Largely on the strength of the U.A.E.-led clinical trials in the Middle East, Sinopharm has signed contracts to sell 175 million doses to countries that range from Egypt to Hungary to Argentina, while donating another 18 million, according to Beijing-based Bridge Consulting. Dubai ruler Sheikh Mohammed bin Rashid al Maktoum, Serbian President Aleksandar Vucic and Philippine President Rodrigo Duterte are among several national leaders to have publicly taken the Sinopharm shot. Several nations are building vaccine plants to manufacture Sinopharm locally.

Impressed by initial promises of 100% protection against severe Covid-19, Dubai-based Egyptian consultant Eman Shaaban, 38, said she pulled out all stops to get U.A.E. residency for her mother Rawya el-Sayyed, 67, so she would be able to get vaccinated with Sinopharm.

Ms. Sayyed, who had high blood pressure and Type 2 diabetes, received both doses, returned to Cairo in March, and contracted the disease during Ramadan, which began on April 13 in Egypt. She died on May 16.

"I did not really see this coming until she was put on a ventilator, because everyone was saying: Vaccines protect you from death," Ms. Shaaban said.

https://www.marketscreener.com/quote/stock/PFIZER-INC-23365019/news/Bahrain-Facing-a-Covid-Surge-Starts-Giving-Pfizer-Boosters-to-Recipients-of-Chinese-Vaccine-35504196/

Japan working to supply COVID-19 vaccines to Taiwan this month

 Japanese foreign minister Toshimitsu Motegi in parliament on Thursday said he is working to supply COVID-19 vaccines to Taiwan this month, Kyodo news agency reported.

Prime Minister Yoshihide Suga on Wednesday said Japan will donate about 30 million vaccine doses to other countries and regions through the COVAX programme. 

https://www.marketscreener.com/news/latest/Japan-working-to-supply-COVID-19-vaccines-to-Taiwan-this-month-Kyodo--35505030/

India signs deal with domestic vaccine maker Biological-E for 300 million doses

 

India's government said on Thursday it has inked a deal with domestic vaccine maker Biological-E for 300 million COVID-19 vaccine doses for 15 billion rupees ($205.62 million), the first such order for unapproved shots.

The vaccine, which is currently undergoing phase-3 clinical trials, is likely to be available in the next few months, the health ministry said in a statement.

Biological E., which also has a separate deal to produce about 600 million doses of Johnson & Johnson's COVID-19 shot annually, said on Tuesday it entered into a licensing agreement with Providence Therapeutics Holdings to manufacture the Canadian company's mRNA COVID-19 vaccine in India.

Biological-E will run a clinical trial of Providence's vaccine in India and seek emergency use approval.

India, world's second most populous country has suffered a disastrous second wave of infections that is only now abating.

Health experts India needs to carry out mass vaccination of its 1.3 billion people to reduce the impact of subsequent waves.

Prime Minister Narendra Modi's government has drawn criticism for a slow vaccine rollout even though India is one of the world's biggest manufacturers of doses.

Earlier in May, Biological-E Managing Director Mahima Datla had told Reuters that the company plans producing 75 million to 80 million doses a month from August.

https://www.marketscreener.com/news/latest/India-signs-deal-with-domestic-vaccine-maker-Biological-E-for-300-million-doses--35504905/

Why Petmed Express Soared

 Shares of Petmed Express (NASDAQ:PETS) were soaring today, riding the surge in meme stocks that was led by AMC Entertainment, whose shares nearly doubled today. Petmed Express wasn't far behind as shares of the online pet pharmacy finished up 58.4%.


The online pet pharmacy seemed to benefit from the same interest from investors on Reddit's WallStreetBets forum and other online platforms who were looking to execute a short squeeze, though PetMed Express wasn't specifically mentioned on WallStreetBets. As of May 13, 35% of the stock's float was sold short, meaning a significant number of investors were betting that the stock would fall. 

On an extremely high volume day when more than 10 million shares changed hands, compared to an average of less than 500,000, short-sellers may have rushed back in to close out their bets to avoid losing money as the stock soared over the course of the trading session.

Today's pop wasn't a total surprise as Petmed Express surged in late January alongside other meme stocks like Gamestop and AMC Entertainment, gaining 68% in just three days. However, it gave back most of those gains soon after.


As a business, Petmed Express has seen middling results in recent years with its top line steadily growing in the single digits. In fiscal 2021, which ended on March 31, revenue grew 8.8% to $309.2 million and earnings per share rose 18% to $1.52. 

Today's gain was an anomaly, and it's unclear if the stock will fade again like it did in January, but AMC's recent surge shows that the short-squeeze pops we saw earlier in the year can happen at any moment.

https://www.fool.com/investing/2021/06/02/why-petmed-express-stock-skyrocketed-today/

Chamath Palihapitiya Launches 4 New Biotech SPACs

 One of the most famous voices in the SPAC industry is launching four new SPACs and also making several changes to his existing lineup of SPACs and former SPACs.

What Happened: Chamath Palihapitiya is launching four new SPACs targeting the biotechnology sector. Each SPAC is seeking to raise $200 million and will not contain warrants.

The SPACs are Social Capital Suvretta Holdings Corp I NASDAQDNAASocial Capital Suvretta Holdings Corp II NASDAQDNAB, Social Capital Suvretta Holdings Corp III NASDAQDNAC and Social Capital Suvretta Holdings Corp IV NASDAQDNAD.

The SPACs break away from the traditionally named Social Capital Hedosophia line of SPACs from Palihapitiya’s Social Capital and Hedosophia. That line of SPACs also featured similarly-sequenced tickers, IPOA to IPOF.

Palihapitiya filed names for seven additional SPACs in the IPO line in February and had previously announced plans to launch SPACs IPOA to IPOZ.


The New SPACs: The four new SPACs are a partnership between Social Capital and Kishan Mehta, the portfolio manager of the Averill strategy at Suvretta. The new company will use “scientists, physicians, entrepreneurs and biotechnology-oriented investors around a shared vision of identifying and investing in innovative and agile biotechnology companies.”

Suvretta was founded in 2011 and has $4.5 billion in assets under management. The investment firm uses industry insights and fundamental-based stock selection according to the prospectus.

The Averill strategy is a “healthcare-oriented investment strategy that focuses on identifying companies that are disruptive to the healthcare industry.”

Palihapitiya will serve as the CEO and Chairman of all four SPACs, with Mehta serving as the President or Director of each SPAC.

Target Market: The SPACs are targeting the biotechnology sector, specifically companies that can improve quality of life. The filings cite new drugs that can treat Hepatitis C in weeks and new immunotherapies that are targeting fatal forms of cancer.

“Agile private biotechnology companies are uniquely positioned to embrace advances in drug development and rapidly innovate to develop life-changing therapies for patients.”

The filings highlight research and treatment options for the central nervous system and peripheral nervous system.

“Our management team will seek to capitalize on advances in nervous system therapeutic development by pursuing compelling investment opportunities in this space.”

Target areas could include CNS, neurodegenerative diseases, psychiatric diseases and addiction. The SPACs will target companies that have “multiple opportunities for success.”

Chamath’s SPACs: Palihapitiya has completed SPAC mergers for Virgin Galactic Holdings SPCE 7.75%Opendoor Technologies OPEN 7.35%, Clover Health Investments CLOV 13.07% and SoFi Technologies Inc SOFI 2.47%.

Palihapitiya’s Social Capital Hedosophia Holdings Corp IV IPOD 0.1% and Social Capital Hedosophia Holdings Corp VI IPOF 0.39% are both searching for targets with IPOF rumored to be bringing Equinox public.

Disclosure: Author has a long position in SPCE, IPOD and IPOF.

https://www.benzinga.com/general/biotech/21/06/21401280/chamath-palihapitiya-launches-4-new-biotech-spacs-what-investors-should-know

Lyell aims to follow Juno, Sana as Wall Street cools to biotech IPOs

 

  • Lyell Immunopharma, a well-funded cell therapy developer aligned with GlaxoSmithKline and co-founded by former National Cancer Institute director Rick Klausner, has outlined plans to go public with a group of experimental cancer treatments. 
  • The Californian biotech is one of a growing list of companies aiming to develop cell therapies for solid tumors, which have so far proven intractable targets for cell-based treatments but are among the most common cancer types. Lyell uses technologies meant to improve T cell function and durability, which the biotech claims could broaden the reach of treatment and prevent relapses. None of its programs will be in human testing until at least next year, however. 
  • Lyell could become the 10th cell or gene therapy maker to go public in 2021, which would far outpace any of the past four years, according to data compiled by BioPharma Dive. But the biotech is shooting for an IPO at a difficult time. Most members of the 2021 class trade below their offering price, and several have sat in the queue for more than a month.
Three years after Celgene paid $9 billion to buy Juno Therapeutics, two biotechs with strong ties to the pioneering cell therapy developer are testing the public markets. And as with Juno, both of them come with very high expectations.  

First came Sana Biotechnology, whose $588 million IPO in February remains the sector's largest of the year and third-biggest since 2018, according to BioPharma Dive's database. Sana raised more than $700 million while privately held, was co-founded by Juno executives Steve Harr and Hans Bishop, and its top investor was Arch Venture Partners, the VC firm that originally backed Juno. 

Lyell now aims to follow in Sana's footsteps. Two Juno co-founders, Klausner and Stan Riddell, were both involved in Lyell's formation. Riddell's research contributed to the Juno cell therapy Breyanzi, now owned by Bristol Myers Squibb. The company raised even more than Sana — nearly $1 billion, according to its prospectus — before seeking an IPO. And Arch has reprised its role as top investor again, holding roughly 17% of the company. 

Both are part of a new wave of companies trying to advance the field of cell therapy beyond the blood cancers that Breyanzi and a handful of similar products are approved to treat. Sana, for instance, wants to tweak an array of different cell types to treat a range of diseases, not just genetically modify T cells for blood cancers, as Juno did. 

Lyell, by contrast, uses two complementary genetic reprogramming technologies to boost the function of T cells and thus, at least theoretically, make any type of T cell therapy more potent and broaden its reach. One of those technologies combats the T cell "exhaustion" that occurs, its founders discovered, more often in the solid tumors that cell therapies have struggled with. Another gives T-cells durable "stemness," or ability to self-renew and multiply. 

Lyell is using both to go after solid tumors — non-small cell lung cancer, triple-negative breast cancer and more — with multiple different types of cell therapies. One treatment, for example, is a CAR-T therapy in the mold of Breyanzi, Novartis' Kymriah and others. Another is a similar, but notably different form of cell therapy known as tumor-infiltrating lymphocyte, or TIL, being advanced by biotechs like Iovance Biotherapeutics.

Lyell is leaning on those technologies, its high-profile founders and Juno ties, and a wide-ranging alliance with GlaxoSmithKline — one of the firm's top investors — to fuel its push to Wall Street. That type of strategy worked for Sana, but Lyell is gunning for an IPO when the market has cooled to recent biotech offerings. 

On the positive side, 34 drug developers have raised at least $50 million in an IPO this year, more than doubling the pace of such offerings in any year since 2018. And as was the case in 2020, most of them are either in preclinical or early-stage testing, according to BioPharma Dive's database. That indicates investors "may still be enthusiastic over new technologies and ‘innovation,'" Jefferies analyst Michael Yee recently wrote in a research note. 

But only two biotechs have gone public in May after at least nine in each of the prior three months. (The tally for May could potentially rise to four by the end of the week.) Six have been in the IPO queue for at least a month without setting terms for their offerings, suggesting they won't get out for at least a while longer. And a majority of the biotechs in 2021's IPO class now trade below their offering price. That includes Sana, which was given one of the largest initial biotech valuations ever but whose shares have fallen roughly 20% below their $25 debut. 

Those results are a break from prior years and suggest "investors will be more valuation sensitive this year," Yee wrote. 

https://www.biopharmadive.com/news/lyell-ipo-cell-therapy-cancer/600847/

Biogen Alzheimer's med, if approved, may face extra hurdles, slow sales ramp: analysts

 Just a handful of days are left until patients, families, investors and Biogen executives will know the next chapter for the company’s controversial Alzheimer’s disease drug candidate aducanumab. But even if the drug scores its coveted FDA nod, a quick rollout is no sure thing, analysts say.

Confusion among physicians, resistance from payers and even the need for frequent follow-ups could slow the launch, pharma watchers said.

The FDA is slated to deliver a decision on aducanumab by June 7. If the agency approves the drug, physicians might still struggle with key questions such as who should get it and for how long. Payers might balk at its price and erect extra hurdles that could significantly limit its reimbursement, analysts warn. And a potential requirement for constant patient screening and monitoring may also stress the healthcare system.


Back in November, a panel of independent FDA advisers voted overwhelmingly against aducanumab, arguing that existing conflicting clinical trial results don’t prove the drug is effective. The resounding snub reflects that some practicing doctors likely aren’t convinced of aducanumab’s efficacy and may be reluctant to prescribe it. 

If approved, aducanumab would be the first disease-modifying therapy for Alzheimer’s. The many unknowns behind that first have some physicians concerned, SVB Leerink analyst Marc Goodman said in an investor note ahead of the advisory committee meeting.

Biogen’s been positioning the anti-beta amyloid drug for early-stage symptomatic patients who test positive for beta-amyloid plaques. However, mixed results from the two phase 3 clinical trials have left many wondering whether the drug only works in a yet unidentified subgroup of patients—or at all.

An Alzheimer’s specialist Goodman interviewed at the time said that many of his colleagues are skeptical about aducanumab and would like to see more data from an additional phase 3 trial to confirm its effect.

Aside from that concern, patients in aducanumab’s clinical trials were only treated for 18 months, so questions remain as to how long patients should remain on treatment, as well as how often physicians should monitor for a side effect called amyloid-related imaging abnormalities (ARIA) that involves swelling in the brain. The Alzheimer’s expert Goodman spoke with believes it would be easy to have a symptom-based management program that tests patients when they have a headache, but he would find it more cumbersome to monitor for asymptomatic ARIA.

But reluctance from physicians may be the easiest hurdle to cross for a potential launch.

“Doctors will be under pressure from their patients and their patients’ families to use the drug because there’s really nowhere else to go,” Mizuho analyst Salim Syed said during a recent interview.


Payers could represent a bigger problem for Biogen’s rollout.

The FDA can give its green light, but payers will likely turn to their own experts to evaluate reimbursement dynamics, RBC Capital Markets analyst Brian Abrahams noted in a report in December. “If their own experts mirror AdComm panelists, access could be limited depending on the payer,” he said. It typically takes months after approval for payer committees to review drugs, and early payer feedback suggests that aducanumab would be no different, he added.


“We will be ready to support and prepare our clients to ensure appropriate and affordable access to this therapy if the FDA approves aducanumab,” Express Scripts said in a statement shared with Fierce Pharma. “As with all newly approved medications, the Express Scripts independent Pharmacy & Therapeutics Committee would review the clinical data for aducanumab and share a coverage recommendation in the coming months.”

It’s not unprecedented for insurers to push back at controversial new medicines. After Sarepta Therapeutics’ Duchenne muscular dystrophy drug Exondys 51 won its approval in 2016, some large plans initially rejected access and said the drug hadn’t proven its clinical benefit. Coverage improved after patient advocacy groups brought the restrictions to the public spotlight, but plans continue to deny access even today, Abrahams said.

While that’s just one “anecdotal example,” the Sarepta situation illustrates that payers need “demonstrated clinical rationale” and support from influential doctors to sign off on coverage, he added.

Mizuho’s Syed suggested that payers will “thread the needle” if aducanumab gets its go-ahead.

“I don’t think payers are going to … say 'absolutely not' because at the end of the day it’s an FDA-approved product,” he said in an interview. “But they will make it difficult.”

Payers could base their decision on the total healthcare spending burden associated with aducanumab, and they might also try to identify the patients with the best chances of responding, Syed said.


On the pricing front, the analyst suggested that Biogen should pay attention to recommendations from the Institute for Clinical and Economic Review. The U.S. drug cost watchdog recently said aducanumab’s list price should fall between $2,500 to $8,300 to be considered cost-effective. In reaching the numbers in a draft report, it also pointed to “insufficient” evidence on the drug’s benefits.

In the end, Abrahams believes initial coverage for aducanumab will be “highly fragmented.” The situation may improve as real-world experience accumulates and if, more importantly, organizations such as the American Academy of Neurology include the drug in their guidelines, which he said would be hard for payers to ignore.


Aside from doctor concerns and payer restrictions, patient selection and monitoring could prove to be another stumbling block.

As Biogen’s head of neurodegeneration development, Samantha Budd Haeberlein, explained during the advisory committee discussion, aducanumab’s filing included language that amyloid testing such as a PET scan should be used before starting treatment. But as Biogen CEO Michel Vounatsos noted during an investors conference call in April, neither PET nor an alternative cerebrospinal fluid amyloid testing are currently covered by payers.


Biomarker screening is already popular in cancer treatment, so as Vounatsos put it, “there is a path forward” for reimbursement for amyloid diagnostics. The problem with aducanumab, though, is that it may require regular doctor visits and testing to ensure that patients remain mild to be eligible to stay on the treatment. That tracking of disease development, plus the ARIA monitoring, could further overwhelm the current system.

A 2017 study (PDF) by the Rand Corporation predicts that patients would have to wait an average of 18.6 months for Alzheimer’s treatment in 2020—assuming a disease-modifying therapy reaches the market that year—thanks to limited capacity of dementia specialists, access to imaging testing and to infusion centers. Biogen sponsored the study.

“We know that the availability of specialist and diagnosis capabilities are a bottleneck,” Vounatsos said during the call. About 600 care facilities will be able to treat patients with aducanumab upon a potential approval, Biogen figures.

In all, the expert Goodman interviewed projected a slow sales ramp for aducanumab given the multiple barriers ahead. The specialist thinks it “may take a while to establish the infrastructure and capability for using adu in practice,” Goodman wrote.

https://www.fiercepharma.com/marketing/biogen-s-alzheimer-s-drug-aducanumab-if-approved-may-face-extra-hurdles-slow-sales-ramp