Design Therapeutics Inc. has set terms for its initial public offering, in which the California-based biopharmaceutical company focused on gene targeted chimeras (GeneTAC) expects to raise up to $240 million, and be valued at up to $1.08 billion. The company is offering 12 million share in the IPO, which is expected to price between $18 and $20 a share. The company expects to have about 53.8 million shares outstanding after the IPO. The stock is expected to list on the Nasdaq under the ticker symbol “DSGN.” Goldman Sachs, SVB Leerink and Piper Sandler are the lead underwriters. The company recorded a net loss of $8.3 million on grant revenue of $226,000 in 2020 after a loss of $2.0 million on grant revenue of $834,000 in 2019.
Monday, March 22, 2021
Roche, Genentech: Tecentriq Meets Primary Endpoint in Interim Lung Cancer Trial
Swiss drug major Roche Group (RHHBY) and its U.S. unit Genentech announced Monday positive results from Phase III IMpower010 study evaluating Tecentriq (atezolizumab) in people with early lung cancer.
According to the companies, Tecentriq in the trial met its primary endpoint of disease-free survival or DFS at the interim analysis in people with resectable early stage lung cancer compared to best supportive care or BSC.
Tecentriq showed a statistically significant improvement in DFS as adjuvant therapy following surgery and chemotherapy in all randomised Stage II-IIIA populations with non-small cell lung cancer or NSCLC.
It is the first Phase III study that shows a cancer immunotherapy helped people with early lung cancer live longer without their disease returning.
Evotec, Takeda in RNA Targeting Drug Discovery and Development Alliance
Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) today announced that the Company has entered into a multi-RNA target alliance with Takeda Pharmaceutical Company Limited ("Takeda") with the goal to discover and develop RNA targeting small molecule therapeutics for highly attractive targets that are difficult to address via more conventional approaches.
Evotec and Takeda will jointly identify and develop small molecules targeting a range of RNA targets aligned with Takeda's research and development areas. The collaboration will leverage Evotec's extensive RNA targeting platform to optimally identify promising RNA sequences to target with small molecule ligands that can be developed into potentially first-in-class therapeutics.
Under the terms of the agreement, Evotec will receive significant research funding and will be eligible to receive discovery, pre-clinical, clinical, commercial and sales milestone payments of up to US$ 160 m per programme. Additionally, Evotec is entitled to tiered royalties on net sales of any products resulting from the collaboration.
ENDO 2021: Rhythm Pharma Phase 2 Data on Continued Weight Loss on Setmelanotide
-- Responders with HET obesity achieved mean weight loss of greater than 12 percent at nine months on setmelanotide therapy --
-- Additional poster presentations include Phase 3 data in Bardet-Biedl and Alström syndromes and analyses of adverse events in Phase 2 and Phase 3 studies in POMC, PCSK1, or LEPR deficiency showing consistent safety results for setmelanotide --
Sunday, March 21, 2021
COVID vax was available to anyone 18 and up at Orlando jazz event: commissioner
While people were seen enjoying live music at Bill Fredrick Park at Lake Thorton on Saturday, many people got to get vaccinated for COVID-19, but some were outside of the state and county eligibility requirements.
The jazz festival was a much-needed mental break from the COVID pandemic, according to Orlando City Commissioner Bakari Burns.
“This is a mental health time, as well. We’ve all been isolated in the house, so we are looking at this as an opportunity to get out and get some fresh air,” Burns said.
Burns was seen on a Facebook Live post as a host of the music festival, sharing people could not only enjoy music, but get vaccinated for COVID as well. Tickets for the event at Bill Frederick Park sold out earlier this week, according to the Facebook page of Burns.
In his Facebook Live post near the 5:30 mark, Burns can be heard saying, “We all need to consider getting the vaccine if you haven’t. The good thing about the event today is if you are 18 and up, you can get vaccinated.” He made this post around 1:13 p.m. on Saturday. Around three hours later Burns clarified his statement and said anyone 18 and older with comorbidities.
The words “18 and up” were heard by hundreds who rushed to the pop-up vaccination site to get a shot of getting the Johnson and Johnson vaccine.
“I got a text from my ex-wife, and she told me that they were vaccinating people that are 18 and up, which I was really surprised by,” Derrick Potts, 46, said.
Only around 250 shots were available.
News 6 spoke with Burns after the Facebook Live post aired and asked to clarify on how the pop-up clinic was able to disregard the state and county guidelines, and said he was only in charge of the jazz festival and not the clinic, which Burns said was controlled by the state’s Department of Emergency Management and went on to say he stands by the current eligibility requirements.
“The state guidelines are 60 and up, regardless, but we go down to 50, I believe, Monday, and then the county guidelines are 40 and up,” Burns said. “Now, for 18 and up, if you’re medically vulnerable, you are eligible to receive the vaccine.”
While present, News 6 did observe many people who did not meet proper guidelines receive the COVID vaccine shot, but people News 6 spoke with said as long as people are being vaccinated, it’s a good thing.
“I mean, I understand seniors first, that’s a great approach that DeSantis had, but I love the fact that we are lowering that number now as we get more and more vaccinations available,” Potts said.
Burns, who is a known advocate of distributing the COVID shot especially to the elderly and minority communities, said either way, people need to consider getting the vaccine if they already haven’t done so.
“We talk about vaccine hesitancy, but I like to say vaccine confidence, because that’s what we need to do is increase the confidence, because it’s going to take all of us to end this pandemic,” Burns said.
News 6 contacted the Florida Department of Emergency Management to clarify who is eligible to get the vaccine and which pop-up events like this one will allow a broader range in age for people to get vaccinated. Unfortunately, at this time News 6 has not heard back.
More Philly pharmacies carrying COVID-19 vaccine
Three calls to the city Public Health Department didn’t get her an appointment to receive a COVID-19 vaccine dose. Nor did visits to her local Rite Aid.
Then, two weeks ago, René Marie Gamble’s quest ended when she least expected.
While running errands in her North Philadelphia neighborhood, she saw a sign outside Patriot Pharmacy on 22nd Street that it was offering vaccinations. Gamble, 60, has arthritis, high blood pressure, COPD, and asthma, not to mention allergies, and she had filled prescriptions at Patriot for more than a year. She just walked in, and a staffer helped her register for a vaccine appointment — a real blessing for a woman who’s not a big internet user.
On Wednesday, the first day the pharmacy could give shots, she got her first dose.
“As far as I know I’m the first one of all my friends that’s getting the shot so far,” Gamble said.
Independent pharmacies have been arguing for months that they can help make the vaccine rollout more equitable to those in at-risk communities who might not have internet access or the ability to travel to far-flung clinics, and are more comfortable getting the new vaccine from someone they know and trust.
“People need to know that it’s available, and my clientele, they come to me,” said Ben Nachum, Patriot’s owner, whose pharmacy is in a zip code with a 92% Black population. “They should get that benefit of me reaching out to them.”
Philadelphia now has 19 independent pharmacies approved to supply vaccine doses, up from just two in early February. About 10 of those were added in the last few days, the city health department reported. An additional 47 are still waiting for approval.
“They made it very cumbersome for everybody to do anything,” said Mel Brodsky, executive director of the Philadelphia Association of Retail Druggists, “down to asking what kind of model number you have on your freezer.”
`I’d rather come here’
Many independent pharmacies don’t have the space or the facilities to handle a lot of vaccine. Nachum, for one, ordered 300 doses for the week, he said. Health experts who encourage a more diffuse vaccine distribution model say the city needs lots of pharmacies dealing in small quantities.
“You need hundreds of pharmacies doing that,” said Esther Chernak, a physician and director of Drexel University’s Center for Public Health Readiness and Communication, “and you get to some significant numbers.”
City officials have acknowledged the value of independent pharmacies because of their deep connections with their communities, and a spokesperson said the Public Health Department is “eagerly anticipating approving more to be vaccine providers.”
But the arduous approval process “is how we can be sure that vaccines are safe and effective when administered,” said James Garrow, the department spokesperson.
There was no set commitment to approving a certain number of pharmacies per week, Garrow said. Meanwhile, though, other vaccination efforts are leaving out people who should be first in line.
While Philadelphia’s FEMA-run mass clinic reported on Friday it had given 100,000 doses in less than three weeks of operation, those getting shots there have overwhelmingly been white and under the age of 64, despite restrictions designed to prioritize seniors and people of color, who have borne a disproportionate burden from the virus. The reasons for the disparity include an online sign-up system that allowed ineligible people to register, as well as the fact that until recently, no walk-ins were accepted.
This week, the city began reserving half of the site’s doses for walk-up vaccinations of residents from 22 under-vaccinated zip codes, an effort that appears to have significantly shifted the demographics of recipients in the first two days the policy was in effect. Still, non-Hispanic Black recipients in particular remained underrepresented, making up 19.5% of vaccine recipients in a city where they are 40.1% of the population.
Standing outside in a long line at the FEMA site, or some of the other large vaccination clinics, was a nonstarter for Gamble, who has had knee replacement surgery. And she knows Nachum and Patriot Pharmacy.
“I’d rather come here because I know him,” she said. “It makes me feel more comfortable getting it.”
Betty Mack, 76, is not a regular Patriot customer but lives just two blocks from the pharmacy. She wasn’t even looking for a vaccination when she walked by Patriot two weeks ago. But it was too convenient to pass up.
“I walked by, I saw the sign,” she said after getting her shot Wednesday. “I come in, filled out the form, and here I am.”
During the pandemic, Mack has seen only her daughters, granddaughters, and close friends indoors, and then only if they wore masks. After getting fully immunized, she said, she plans to visit family and enjoy someone else’s food.
“I’m tired of cooking,” she said.
Unique flexibility
Pharmacies can prioritize their own customers by calling them to see if they want to be vaccinated. They can give shots on-site, or off-site. Joe Ralston, owner of Academy Pharmacy in Northeast Philadelphia, began giving people shots March 10.
“I had a list of my customers who qualified and were most vulnerable and we started there by making in-store appointments,” said Ralston, who does about 20 vaccinations a day in his small pharmacy, and more in a larger space in the same building. Social distancing, plus the need for patients to wait after injection to be checked for rare allergic reactions, makes giving the COVID-19 vaccines a space-consuming task.
He’s also taken vaccine to the homes of regular customers whose disabilities make it hard for them to go out.
Pharmacies’ flexibility is an advantage for groups like the Southeast Asian Mutual Assistance Associations Coalition (SEAMAAC) that are trying to organize clinics for people with mobility issues, language barriers, or can’t use the internet. If the organization can get doses, it can register people for appointments through door-to-door visits and phone calls. On Friday, the group and Philadelphia FIGHT partnered with Sunray Drugs to host a small vaccination clinic in the former Edward Bok Technical School.
Nguyen is furious the city has yet to approve his group’s application to carry vaccine doses at a wellness center in the same building, but he said being able to arrange a clinic through Sunray is a small relief.
“Without the help of pharmacies like Sunray,” he said, “we would be getting nothing.”
City data showed Sunray administered 435 vaccine doses in the first week of March, the latest data available. Of the recipients, 42.8% were Black, 16.6% were Hispanic, 15.2% were Asian, and 24.1% were white.
Still, equity is also a concern in the pharmacy program. The city has little ability to require pharmacies to ensure communities at all income levels are being served.
“We stress that they should be working to distribute with a mind to equity,” said Garrow, “but are only requiring them to follow the Philadelphia phase 1a and 1b eligibility criteria.”
Ralston said he knows which of his customers should be vaccinated but has less control at large clinics, where appointments are made online.
“We know some of these people aren’t being honest, but at that point it’s either waste a dose or vaccinate them,” he said, referring to the fact that the vaccines are highly perishable.
Pharmacies approved to carry vaccine are inundated with requests.
“We’re receiving hundreds of phone calls, emails, texts every single day,” he said. “It’s just really difficult to run our normal business.” Every dose administered must be reported to the federal government within 24 hours, he said, another burdensome task.
Nachum, however, has been surprised that there hasn’t been more interest from within the neighborhood. He plans to circulate fliers to spread the word. A staffer discussed changing the sign outside the business to clearly say doses are free. He’s also counting on word of mouth.
Gamble, after waiting 15 minutes to ensure she had no side effects from her first shot, left the pharmacy saying she would encourage friends to get vaccinated there, too.
“I’m going to tell them,” she said, “you better go across the street.”
Zydus Cadila Covid vax to hit markets in May-June
VACCINES HAVE BEEN a ray of hope in a world ravaged by Covid-19. While India has started mass production of two vaccines—Covishield by Serum Institute of India and Covaxin by Bharat Biotech—a third one, ZyCoV-D by Zydus Cadila, is undergoing trials. Pankaj Patel, chairman of Zydus Group, says the DNA plasmid platform vaccine is expected to hit the market by May-June. Excerpts from an interview:
When did Zydus decide to make a Covid-19 vaccine?
Somewhere in February 2020, we decided to develop a Covid vaccine. We realised that there could be a pandemic. We had experience making a vaccine for H1N1.
When is ZyCoV-D expected in the market?
Currently, we are undergoing phase III study. We have to complete the dosing and then wait for 150 symptomatic Covid patients; then we unlock and come out with efficacy data. Our guesstimate is that we should be completing the trial in May. ZyCoV-D will be in the market between May and June.
Are you not going in for emergency use approval?
In any case, approval will happen for emergency use. As a serious pharmaceutical company, we will have to complete the trial and then go for emergency use.
Will the vaccine be exported?
Yes, if the government allows. We do have a lot of requests from various countries. We would like to supply them, depending upon the government’s view at that time. Currently, it is allowing export. So, we will be exporting.
What will be the price of the vaccine?
It will not cost more than the current vaccines.
Has the company lost the advantage of being the first mover?
I do not think there is a race here. We need good science and a good product for the people of India; it should be safe and efficacious at a reasonable price.
Why are there so many concerns about the side effects of Covid vaccines?
It is a communication issue. Many people have been reading articles, news reports. There is a lot of unsubstantiated and false data floating around. It creates apprehensions. Fears can be allayed through education. We did not find any side effects in our phase II trials.
How many people were covered under phase I and phase II trials?
One thousand.
How will ZyCoV-D be different from the two vaccines approved in India?
Ours is a totally different platform compared with the current vaccines that have been approved in India and abroad. We have a DNA plasmid platform vaccine. This vaccine is given intradermally. It does not go deep inside the body. There is a specific device through which it is administered. It is needle-free, painless administering. People will not suffer side effects that are being seen in other vaccines.
Should Covid-19 vaccination be made compulsory in India?
No, I do not think it will be a great idea to make anything compulsory. It should be voluntary. Increased education will allay the fears of people.
What is the investment that has gone into the manufacturing of ZyCoV-D?
We have put up a manufacturing unit, we have done development and trials. In all, we are estimating (an outlay of) around Rs500 crore. Initially, we will produce 100 million doses and scale up to 250 million doses.
Should people be compensated for the side effects of vaccines?
Vaccines always have some side effects, minor or major. The regulator and the governments in order to simply support the vaccination have taken the responsibility for compensation through a kind of a normative method and the companies are required to support. That is a global practice. In India, we currently do not have any practice.
How did the idea of Zydus Hospital come up?
We often have to go to hospitals and I observed that many a time people face certain issues (on the management side). Being from the field of management, I wanted to minimise this. The idea was to give an acceptable level of service to patients and doctors. Hence, the hospitals.
The first one came up in Anand (my hometown), and the second one in Ahmedabad. The third one will be in collaboration with Maruti Udyog in Bechraji, near Ahmedabad. It is a joint CSR project for both companies. The fourth one will be commissioned in Vadodara in 2022.
https://www.theweek.in/theweek/specials/2021/03/18/zycov-d-will-hit-markets-in-may-june.html
Subscribe to:
Comments (Atom)