Monthly Archives: March 2022

The National Health Security Office (NHSO) and the Rajavithi hospital are speeding up the mailing out of anti-viral Favipiravir medicine to more than 3,500 COVID-19 patients in Bangkok and surrounding areas who are unable to access the home isolation program.

NHSO Secretary-General Dr. Jadet Thammathat-Aree explained yesterday (Thursday) that the main reason that this group of patients have been unable to get help from the NHSO so far is because its 1330 hotline system has been so overwhelmed with calls from patients that they cannot get through, and existing isolation facilities are full, causing another problem, which is a backlog of waiting patients who have already registered for isolation facilities.

After being made to wait for help for several days, he said that many registered patients have tried to contact the NHSO again via the hotlines and other channels, further overwhelming the system.

Dr. Jadet said that the NHSO has already increased the hotline lines and more people have been recruited to answer calls from the patients. They have also sought help from private call centres to ease the workload at the NHSOs call centre, but still the hotline system is overwhelmed.

For the 3,500 plus patients who are waiting for help, he said that it would take about five days for the NHSO and Rajavithi Hospital to mail them the Favipiravir medicine, if their condition is not serious.

After having received and taken the medication, he recommends that patients stay home in isolation for about ten days.

Besides Favipiravir, the NHSO, in cooperation with the Department of Thai Traditional and Alternative Medicine and the Army Region 1, have distributed more than 40,000 sets of Fah Talai Jone herbal tablets to more than 900 communities in Bangkok, for distribution to registered patients who are yet to get a response from the NHSO.

These patients, he said, can approach their community leaders or public health volunteers to receive the herbal medicine.

The Ministry of Public Health has distributed Favipiravir anti-rival medicine, Fah Talai Jone herbal medicine and other drugs to more than 8,000 COVID-19 patients in the four days since the launch on March 4th of the out-patient medical service program, known as found, distribute, done.

Besides state and medical college hospitals, which have been providing out-patient medical services to between 200-300 patients each per day, he said that hospitals in provinces around Bangkok have also been instructed to provide similar services, via their acute respiratory infection (ARI) clinics, to accommodate as many as 18,000 patients who are yet to get access to help via the NHSOs hotline system.

Dr. Kiattibhoom said the out-patient service program has reduced the calls to the 1330 hotline system of the NHSO from about 70,000 to about 50,000.

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Thailand to expedite mailing of Favipiravir to COVID-19 patients - Thai PBS World

COVID-19 Vaccine Janssen: small vessel vasculitis added as a side effect

EMAs medicines safety committee (PRAC) has recommended that small vessel vasculitis with cutaneous manifestations (inflammation of blood vessels in the skin which may result in a rash, pointed or flat, red spots under the skins surface and bruising) should be added to the product information of COVID-19 Vaccine Janssen as a possible side effect of unknown frequency.

Small vessel vasculitis can be caused by viral or bacterial infections as well as by medicines and vaccines. Generally, manifestations of the disease spontaneously resolve over time with appropriate supportive care.

PRAC has reviewed a total of 21 cases reported globally in the context of the latest summary safety report, including 10 cases consistent with the established definition of single organ cutaneous vasculitis (vasculitis affecting a single organ). For most of these 10 cases no other obvious explanation was identified; eight of these cases occurred soon after the administration of the vaccine.

As of 31 December 2021, approximately 42.5 million doses of the vaccine had been administered worldwide.

The PRAC will continue to monitor for cases of vasculitis and will communicate further if new information becomes available.

The PRAC has recommended that a warning for flare-ups of capillary leak syndrome (CLS) should be added to the product information for the COVID-19 vaccine Spikevax.

CLS is an extremely rare, serious condition that causes fluid leakage from small blood vessels (capillaries), resulting in rapid swelling of the arms and legs, sudden weight gain, feeling faint, thickening of the blood, low blood levels of albumin (an important blood protein) and low blood pressure. CLS is frequently related to viral infections, some blood cancers, inflammatory diseases and some treatments.

The PRAC assessed all the available data as well as all the cases of CLS reported in the Eudravigilance database after the administration of the mRNA vaccines Spikevax and Comirnaty.

The Committee concluded that there was insufficient evidence to establish a causal association between the two vaccines and the onset of new cases of CLS. However, the PRAC recommended the inclusion of a warning in the product information for Spikevax to raise awareness of the potential risk of flare-ups among healthcare professionals and patients. The Committee recommended this warning as some cases of flare-ups of CLS pointed towards an association with Spikevax, while the cases reported after vaccination with Comirnaty did not support such association.

Healthcare professionals should be aware of the signs and symptoms of CLS and of a possible risk of flare-ups in people with a history of CLS. Vaccinated individuals with a history of CLS should consult their treating physician when planning their vaccination.

In total 55 reported cases of CLS were reviewed, 11 with Spikevax and 44 with Comirnaty. Global exposure at the time of the assessment was estimated at approximately 559 million doses for Spikevax and 2 billion doses for Comirnaty.

As part of its advice on safety-related aspects to other EMA committees, thePRACdiscussed a direct healthcare professional communication (DHPC) containing important safety information for dexmedetomidine.

Dexmedetomidine: Increased risk of mortality in intensive care unit patients aged 65 years and less

This DHPC aims to inform healthcare professionals of the increased risk of mortality when administering dexmedetomidine in intensive care unit (ICU) patients aged 65 years and less, compared with alternative sedatives.

Dexmedetomidine is a medicine authorised for light sedation (a state of calm or feeling sleepy) of adult patients in ICUs, allowing the patient to stay awake and respond to verbal stimulation for diagnostic or surgical procedures.

SPICE III study was a randomised clinical trial comparing the effect of sedation with dexmedetomidine on all-cause mortality (deaths from any cause) with the effect of usual standard of care in 3,904 critically ill adult ICU patients in need of mechanical ventilation. The study showed no difference in the overall 90-day mortality between dexmedetomidine and alternative sedatives (propofol, midazolam). However, dexmedetomidine was associated with an increased risk of mortality in patients aged 65 years and less, compared with alternative sedatives.

The product information for dexmedetomidine is being updated with a warning describing the evidence and risk factors. Healthcare professionals are being advised to weigh these findings against the expected clinical benefit of dexmedetomidine compared to alternative sedatives in this age group.

The DHPC for dexmedetomidine will be forwarded to EMAs human medicines committee, theCHMP. Following theCHMPdecision, the DHPC will be disseminated to healthcare professionals by themarketing authorisation holder, according to an agreed communication plan, and published on theDirect healthcare professional communicationspage and innational registersin EU Member States.

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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 March 2022 | European Medicines Agency - European Medicines Agency...

Thirty-nine-year-old Avneet Bhatia is a true believer in natural healing. Hailing from an army family, fitness and sports were deep-rooted in the SOM, IIT Bombay alumnus.

At a certain stage in her life, Avneet adopted yoga and Ayurveda and found herself recovered from her ailments and completely transformed.She wanted to bring these benefits of natural therapies to more people, and eventually, she pursued a course for a year.

This initiative is like giving back to society. It can heal everybody, and more people find it accessible to find a brand they can trust to heal them naturally, Avneet tells YourStory.

Avneet Bhatia, Founder, NatureFit

Mumbai-headquartered NatureFit is an app-based digital platform that guides users towards natural therapies. One can opt from 15 therapies available, including Ayurveda, Homeopathy, Yoga, Dieticians, Physiotherapy, and Psychology, among others. Avneet says, these therapies come with no flyers or other binders suggesting no side effects.

The platform also has free health tools such as BMI Calculator, stress level, and Prakruti analysis, which tracks users sleep cycle, water intake, meals, exercise, and help them better know their health conditions.

Through its community platform Fitbook, NatureFit connects users with other nature cure lovers and health-conscious people in a fun and engaging way.

Users can create groups, share their views, take up challenges, and track their progress through the apps self-motivating health and progress tracking features, Avneet says.

Besides, NatureFit also provides 100 percent natural and herbal products in healthcare, food, grocery, beauty, and baby care segments.

Screenshot of the platform

The preventive healthcare startup available on Android and website has 3,000 doctors, 7,000 app installsand over 75 brands on its platform.

NatureFit will soon launch the iOS version of the app. As part of this launch, NatureFit is offering its users one-time free consultation with doctors and practitioners till April 1.

From April onwards, the startup will also charge a subscription fee to its doctors to use the platform. At present, it is free for all doctors.

The startup also providesB2B corporate wellness plans and has onboarded two clients with two to three more in the pipeline.

NatureFits B2C ecommerce platform has completed around 100 orders, clocking revenue of Rs 50,000. In the last two months, the startup has generated a revenue of Rs 15 lakh.

In the last few years, the Ayurveda, Yoga, Naturopathy, Unani, Siddha, and Homoeopathy (AYUSH) ministry has been seeing good growth. At present, over 7.7 lakh registered AYUSH doctors practice in India.

According to the Research and Information System for Developing Countries (RIS), its market size has grown 17 percent in 2014-20. Despite the slump in economic activity due to the pandemic in 2020, the industry is projected to reach $20.6 billion in 2021 and $23.3 billion in 2022.

Avneet says,The interest in these products was fueled by the recommendations from the Ministry of AYUSH to fight COVID-19. AYUSH signifies the combination of an alternative system of medicine, which was earlier known as the Indian System of Medicine.

Bootstrapped with nearly Rs 90 lakh, the healthcare startup aims to reach 30,000 doctors in the next two years. NatureFit is targeting one lakh app installs and plans to onboard 300 brands by the end of 2022.

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This Mumbai-based healthcare startup provides natural therapies to products all in one app - YourStory

I believe that taking periodic breaks from the news can promote mental calm and help renew your spirits. In this way, the anxiety and overstimulation catalyzed by the media may be minimized, and your body will function better. Dr. Andrew Weil, the bushy-bearded, alternative-medicine doc, proposing news fasts in his 1995 book Spontaneous Healing.

REGULAR PERSON: Whats unfolding in Ukraine is unbelievable. It happened so fast, its shocking and awful, and I cant stop watching the news and reading about it all day long. Im exhausted.

PERSON ON A NEWS FAST: What?

REGULAR PERSON: Its just horrible. The humanitarian crisis is heartbreaking, sometimes I just burst into tears. What if the war spreads across Europe? Or worse? Putin has nuclear weapons!

PERSON ON A NEWS FAST: What?

REGULAR PERSON: And I hope theres not another coronavirus variant anytime soon. Just as COVID starts to wane for now a terrifying war breaks out. Cant we get a break? Im not sure I can take any more. My neck is so stiff, I can barely turn my head.

PERSON ON A NEWS FAST (playing Sudoku): What?

REGULAR PERSON: And dont get me started on threats to our democracy. Can you believe these new voting laws in Texas, Georgia, and elsewhere? Creating confusion and designed to keep people from voting? All fueled by Trumps metastatic Big Lie about the 2020 election? Oh my god, look at my arm. Those hives werent there a minute ago.

PERSON ON A NEWS FAST (smiling at a beam of sunlight warming a kitten asleep on some laundry): What?

REGULAR PERSON: And now theyre banning books about sexuality, gender, and racism! And passing laws that could send teachers and librarians to jail. My mouth tastes like metal.

PERSON ON A NEWS FAST: What?

REGULAR PERSON: What?

PERSON ON A NEWS FAST: What?

REGULAR PERSON: And what if Trump is reelected in 2024? He just suggested bombing Russia with planes made to look like Chinese aircraft to start a war between Russia and China. This is a serious, dangerous time thats filled with unserious, dangerous people. I cant breathe.

PERSON ON A NEWS FAST (gazing at a vase of fresh-cut flowers): What?

REGULAR PERSON: And just this morning I read about the massive mental-health crisis in America, made much worse during COVID. Stress, anxiety, grief, loneliness, isolation, uncertainty, sleeping problems, and more. Our kids are suffering, were suffering, everyones suffering. I wake up from nightmares every night at 3 a.m. And why are my feet always cold?

PERSON ON A NEWS FAST: What?

REGULAR PERSON: And now a war thats broadcast 24/7, scenes of real-life violence played on infinite loop, delivered by the networks almost like entertainment, interspersed with commercials for Downy and personal-finance apps and restaurants serving all-you-can-eat chicken tenders. Its jarring to see war, entertainment, and commercials intermingled that way. Its like no one read Neil Postmans Amusing Ourselves to Death.

PERSON ON A NEWS FAST: What? Who?

REGULAR PERSON: In his 1985 book, Postman compared George Orwells 1984 to Aldous Huxleys Brave New World and, among other insights, concluded that weve become exactly what Huxley predicted: Orwell feared that the truth would be concealed from us. Huxley feared the truth would be drowned in a sea of irrelevance.

PERSON ON A NEWS FAST: Sorry, did you say something? I was watching people dance in sync on TikTok. Look at them go!

REGULAR PERSON: Uh, Mr. Van Winkle? Do you know that your long, white beard looks just like Dr. Andrew Weils long white beard? And that Ive never seen you together?

PERSON ON A NEWS FAST: Sorry, dont know anyone named Weil. Wait! Is he Dutch? Because the last thing I remember is drinking some liquor from a Dutchmans keg, playing a few rounds of nine pins, and then falling asleep under this enormous old tree.

REGULAR PERSON: Thats a lovely tree. Its an ash. I hope it isnt killed by the invasive emerald ash borer thats devastating trees across the Berkshires. Why cant I shake this dull headache?

PERSON ON A NEWS FAST (yawning): What?

Bill Shein doesnt have a bushy white beard, but over the last few weeks his hair has grayed at twice the usual rate.

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REASON GONE MAD: Reality overwhelms - theberkshireedge.com

Andrii Yalanskyi/iStock via Getty Images

The PTAB's ruling against UC Berkley turned the CRISPR space upside down. Sleepy biotechs such as Editas Medicine (NASDAQ:EDIT) became popular overnight (at least for a few days), while favorites like Intellia Therapeutics (NASDAQ:NTLA) and CRISPR (NASDAQ:CRSP) saw their shares drop. Pundits believe that NTLA and CRSP, who license CRISPR/Cas9 tech from UC Berkely, will need to negotiate a new license from the Broad Institute of Harvard and MIT. In a recent press release published last Friday, NTLA alluded to this prospect. However, NTLA will likely wait before seeking a new license until UC Berkley's appeal result comes out. It doesn't make sense to sign a license with the Broad Institute only for an appeal to reverse the verdict back in UC Berkley's favor. Second, there is uncertainty over the willingness of the Broad to license CRISPR/Cas9 tech, at least in certain areas, given its contract provisions with EDIT. For example, NTLA and EDIT have hemoglobinopathies programs targeting Sickle Cell Disease "SCD" and Beta-Thalassemia Major "TDT." The Broad Institute/EDIT license contains provisions that limit the Broad institute's ability to license CRISPR/Cas9 for products under development by EDIT.

I expect NTLA's management to talk down the long-term impact of the ruling, similar to UC Berkely, which stated that it still maintains 40 foundational patents, aside from the thirteen covered by the verdict. However, I believe that our previous investment thesis is no longer valid, and while I continue holding NTLA shares, my speculative trade has become more uncertain.

NTLA projected leadership in the CRISPR space, with an aggressive pipeline that seemed to mirror an entrepreneurial spirit, manifested in its flagship ATTR investigational drug, the first in-vivo therapy targeting liver cells. Promising clinical data from the ATTR program solidified this image, outpacing competitors such as CRSP, whose in-vivo liver programs are still in the pre-clinical stage. EDIT chose a more trodden path, focusing on well-studied areas, namely hemoglobinopathies and ocular diseases, two popular choices in the industry due to ease of delivery and established literature, increasing chances of clinical trial success.

However, the recent ruling unveiled weaknesses around its technological prowess. For example, NTLA's strategy for treating genetic diseases mirrors limitations of CRISPR/Cas9, contrary to what Dr Jennifer Doudna and Dr Emmanuell Charpentier led us to believe, depicting CRISPR as an ultimate tool for gene editing. Many scientists now think that gene treatments will take multiple forms and technologies.

NTLA-2002, NTLA's latest program to enter the clinical stage, is one example. Hereditary Angioedema "HAE" is caused by a mutation in the SERPING1 gene, leading to deficiency in the C1 inhibitor protein and a subsequent buildup of bradykinin. Instead of fixing the SERPING1 gene, NTLA-2002 aims to knock out the kallikrein B1 gene, the DNA responsible for producing bradykinin to achieve a biological balance. Another example is NTLA's NTLA-2001 program. Instead of fixing the mutated TTR gene, the investigational drug completely knocks it out, solving the problem of ATTR accumulation but causing problems around vitamin A deficiency, reducing the number of times its edge over alternative therapies. Gene knockout is also the industry's strategy to treat SCD and B-Thal. Instead of fixing the root of the problem, the companies created a gene treatment to knockout a different gene to increase the production of fetal hemoglobin, which also reflects the nascent stage of the in-vivo programs.

Moreover, NTLA is not the first company to deliver genetic material to liver cells. Alnylam (NASDAQ:ALNY) developed Onpattro, which temporarily silences the TTR gene breaking down its mRNA. Similar did Ionis (NASDAQ:IONS) when it created Tegsedi. These two therapies also use Lipid coating to deliver the drug, similar to NTLA-2001, which licenses the Lipid Nanp Particle "LNP" tech from Novartis (NYSE:NVS). I believe these technological limitations restrict the valuation of NTLA.

From a financial perspective, the recent ruling casts uncertainty over how much NTLA will have to pay for a CRISPR license if UC Berkley loses its appeal. Beyond patent disputes, each of NTLA's programs has its unique commercial prospects, influenced by many factors, including disease prevalence, severity, availability of alternative therapies, and convenience to patients and physicians. bluebird bio's (NASDAQ:BLUE) failure to commercialize Zynteglo and ABECMA in Europe -the latter now owned and marketed by 2seventy (NASDAQ:TSVT)- gives a somber warning that clinical success and regulatory approval don't mean commercial success.

I believe that NTLA's two in-vivo programs targeting liver tissue have enough prevalence to achieve commercial success. Other alternative therapies with less efficacy and convenience generate millions to other biotechs. For example, Shire (private British biotech) generated $699.3 million from Cinryze, a C1 inhibitor for the treatment of HAE, in 2018. Unlike NTLA-2002, Cinryze is a life-long medicine costing $350,000 annually. Given that NTLA is a one-time treatment, NTLA's management will be able to negotiate a higher price if and when NTAL-2002 is approved.

NTLA-2001 also makes commercial sense, albeit not as much as NTLA-2002, ruefully for Regeneron (NASDAQ:REGN), NTLA's partner in NTLA-2001( NTLA runs NTLA-2002 independently). As mentioned above, NTLA-2001 could be very profitable. Alternative therapies such as Onpattro generated 120 million in Q3 2021, translating to $480 million annually. NTLA-2001 is also more convenient as a one-time therapy compared to Onpattro, a life-long treatment administered periodically in a clinic through an IV, a process that takes hours. However, the amount insurance companies will be willing to pay is limited, given that ATTRv is also mostly diagnosed in mature individuals (Median age at diagnosis is 62). These dynamics will factor in the pricing of NTLA-2001 if and when it is approved.

The nature of NTLA's therapies as one-time medicines could have implications on its long-run profitabilities. Although revenue might spike initially, revenue will depreciate as the patient pool starts to dry out in the long run. Eventually, NTLA-2001 revenue will be proportional to annual incidence, which is pretty low.

NTLA's other clinical-stage programs are ex-vivo therapies in Hemoglobinopathies and acute myeloid leukemia. Novartis is leading the SCD program, funded by the Bill and Melinda Gates Foundation, which procured NVS to create an affordable SCD therapy in developing countries where the disease is most prevalent. BLUE's effort to commercialize Zynteglo failed because of production cost and the concentration of B-Thal in developing nations that cannot pay for Zynteglo, which BLUE priced at $1.8 million per injection. Notably, European National Health Services also refused to pay. Hopefully, NTLA and NVS will succeed in creating a low-cost SCD therapy, which could help market the therapy given the crowdedness of the field. Almost all CRISPR biotechs have hemoglobinopathies programs, namely SCD and B-thal, and all main CRISPR biotechs use the same strategy; increasing fetal hemoglobin. Thus, price differentiation could be a critical factor for marketing.

NTLA's Acute Myeloid Leukemia "AML" program has a high commercial potential, given the limitations of current therapies, high death rates, and difficulty in treatment. In 2020, more than 20,000 new cases were diagnosed in the US. The company only recently received acceptance for its IND and began screening for trial patients. Investors should expect the first data in the first half of 2023.

NTLA stood out from the crowd with a differentiated pipeline with a market image as an entrepreneurial force in the CRISPR space. However, the current PTAB ruling revealed weaknesses in its IP portfolio, and it appears that its technological prowess is overrated.

I don't believe NTLA will outperform the market this year. Investors should expect volatility until the CRISPR/Cas9 license issue is sorted. I expect management to talk down the effect of the ruling during Barclays Global Health Conference scheduled for March 15, 2022.

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Intellia: One Patent Ruling Turns The Industry Upside Down - Seeking Alpha