Stocks Tumble As White House Backs WTO Plan To Waive IP Protection For COVID Vaccines

 In a major rebuke to the west's biggest vaccine makers (including Pfizer, Moderna and J&J), President Joe Biden has decided to break with the Bill Gates-backed status quo and support a WTO initiative to make COVID-19 vaccine intellectual property open to all.

Biden's top trade representative Katherine Tai, the administration's point person on the waiver issue, told Bloomberg in an interview Wednesday that the White House has decided to back the waiver. As a result, the Biden White House will now actively seek to convince other WTO members to back the proposal, an issue that will take time and "not be easy."

"We are for the waiver at the WTO, we are for what the proponents of the waiver are trying to accomplish, which is better access, more manufacturing capability, more shots in arms," Tai said in an interview on Wednesday.

[...]

"In terms of how soon the WTO can deliver -- that literally depends on the WTO members, collectively, being able to deliver, and so I am the first one to admit that what we are leaning into is a process that is not going to be easy,” Tai said. She added that she sees energy from WTO Director-General Ngozi Okonjo-Iweala “to take this opportunity and see what is the WTO capable of."

US stocks pulled back on the news, with the tech-heavy Nasdaq leading the selloff, as support for the WTO waiver proposal sponsored by India and South Africa would likely help accelerate the pace of vaccinations across the developing world.

Shares of Pfizer...

...and Moderna...

...were hit particularly hard since the success of the waiver would likely severely devalue their COVID vaccine business, which Pfizer said just yesterday will likely be a "durable revenue stream" as COVID vaccines likely become an annual dose like the flu vaccine.

Before announcing his divorce, Bill Gates recently doubled down on his opposition to the IP waiver proposal, insisting (seemingly without evidence) that poorer countries would be better off waiting to buy jabs from Pfizer, Moderna, J&J and others instead of rushing to make their own under an "open vaccine"-style paradigm.

It's just the latest blow against Gates, the world's de facto COVID vaccine czar, in what is shaping up to be a rough week for the billionaire. Fortunately for him, a host of other developed nations - including the UK, EU, Japan, Switzerland, Brazil and Norway - still oppose the waiver. But US support could possibly change their views.

https://www.zerohedge.com/markets/stocks-tumble-white-house-backs-wto-plan-waive-ip-protections-covid-vaccines 

Cuomo Unveils Vaccine-Segregated Access To Yankees/Mets Games

 New York and its neighbors New Jersey and Connecticut announced Monday that they would lift most of their pandemic restrictions, allowing some sort of normalcy to return after more than a year of restrictions that limited capacity at restaurants and bars, sports and entertainment venues, and cultural and religious gatherings. Now in a bid to get everyone vaccinated, New York State Governor Andrew Cuomo is offering free vaccines at baseball games. 

Cuomo, who announced Wednesday at a press conference that his administration is teaming up with two Major League Baseball teams, including New York Yankees and New York Mets, to vaccinate fans at games. In return, the fans will receive a "free ticket." 

Then the governor also noted a new segregation policy: 

Starting May 19, full capacity seating at Yankee Stadium & Citi Field will be available for fully vaccinated people.

For unvaccinated, the capacity will be 33% to comply with CDC social distancing rules. Masks will be required for all fans.

“For baseball reopening May 19, two different categories, not Yankees, Mets [but] vaccinated, not vaccinated. Vaccinated people, normal capacity, normal seating for people who are vaccinated. We ask them to wear masks. For unvaccinated people, the six foot distancing applies with masks,” said Cuomo in his press conference.

Cuomo's decision raised a few questions for fans...

Cuomo has been trying to win back the hearts of the people after allegations of harassment, a toxic work environment, the loss of credibility around COVID-19 nursing home data. 

As a big distraction, the governor legalized recreational marijuana in late March. Now he's giving away free baseball tickets at MLB stadiums for those who get vaccinated. 

https://www.zerohedge.com/covid-19/cuomo-offers-free-ticket-yankee-and-mets-fans-who-get-vaxxed-stadium

Replimune updates on trial of melanoma combo

 Replimune Group, Inc. (Nasdaq: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic® platform, today announced a clinical development update for CERPASS, its registration-directed global randomized Phase 2 clinical trial of RP1 in combination with Libtayo® (cemiplimab) versus Libtayo for the treatment of cutaneous squamous cell carcinoma (CSCC), and for IGNYTE, its registration-directed single arm clinical trial in combination with Opdivo® (nivolumab) for the treatment of anti-PD1 failed melanoma.

CERPASS

“Based on the depth and durability of responses and the manageable safety profile we have seen in patients with non-melanoma skin cancers treated with RP1 in combination with Opdivo to date, we are amending the clinical trial protocol for our Phase 2 CERPASS clinical trial to include complete response (CR) rate as a primary endpoint in addition to overall response rate (ORR), and to reduce target enrollment to 180 patients,” said Robert Coffin, Ph.D., President and Chief Research and Development Officer of Replimune. “Incorporating CR as an independent additional primary endpoint should ensure a robust assessment of the clinical meaningfulness of adding RP1 to Libtayo in the primary data analysis upon which a BLA submission and FDA’s assessment for approval will be based.”

Under the modified clinical trial protocol for CERPASS, Replimune plans to add CR rate as an additional independent primary endpoint, in addition to ORR, and to reduce target enrollment from 240 patients to 180 patients. Secondary endpoints will continue to include duration of response, progression-free survival (PFS), and overall survival (OS). Replimune is maintaining its guidance to expect initial data in 2022.

Replimune plans to submit the amended CERPASS clinical trial protocol to the U.S. Food and Drug Administration (FDA) in the first half of the year.

https://finance.yahoo.com/news/replimune-provides-regulatory-registration-directed-110000054.html

Moderna booster increases antibodies against COVID-19 variants in early data

 Moderna Inc said on Wednesday early human trial data shows that a third dose of either its current COVID-19 shot or an experimental new vaccine candidate increases immunity against variants of COVID-19 first found in Brazil and South Africa.

The booster shots, given to volunteers previously inoculated with Moderna's two-dose vaccine regimen, also boosted antibodies against the original version of COVID-19, Moderna said.

The early data comes from a 40-person trial testing both Moderna's existing shot and a version developed to protect against the South African variant of COVID-19 called mRNA-1273.351. Moderna is also studying a shot that combines both the new and existing vaccine.

The results show that while booster shots of either version of the vaccine increased antibodies against all of the variants of COVID-19 tested in the trial, the new booster had a bigger response against the South African variant than the original vaccine.

"We are encouraged by these new data, which reinforce our confidence that our booster strategy should be protective" against the newer variants of COVID-19, Stephane Bancel, Moderna's chief executive officer, said in a statement.

Both booster shots were well tolerated, with side effects similar to what volunteers in previous studies experienced from the second dose of its vaccine, Moderna said.

The new variants of COVID-19 first discovered in South Africa and Brazil are thought to be more resistant to existing vaccines. Both variants have been detected in the United States but comprise only a small fraction of U.S. cases so far, according to federal data last updated in April.

Moderna's study is looking at levels of antibodies in participants' blood that combat COVID-19, an early indication that they will be protected against the virus. It first announced it was studying ways to protect against the variants of COVID-19 in February.

Moderna expects to share additional data soon on another potential booster shot that mixes its existing COVID-19 vaccine with the newly developed shot.

The U.S. government scientists at the National Institute of Allergy and Infectious Diseases (NIAID) is conducting a separate early stage study of mRNA-1273.351, Moderna said.

https://finance.yahoo.com/news/1-moderna-booster-increases-antibodies-202837833.html

Tandem Diabetes Q1 results, guidance

 

• Worldwide pump shipments increased 46 percent to 25,352 pumps from 17,378 pumps

• Sales increased 44 percent to $141.0 million from $97.9 million

• Gross margin improved to 52 percent of sales from 51 percent

• Operating margin improved to negative 2 percent of sales from negative 14 percent of sales

For the year ending December 31, 2021, the Company is updating its financial guidance as follows:

• Sales are estimated to be in the range of $625 million to $640 million, which represents an annual sales growth of 25 percent to 28 percent compared to 2020. The Company’s prior sales guidance for 2021 was estimated to be in the range of $600 million to $615 million.

  • Includes international sales of approximately $125 million to $130 million, which represents an annual sales growth of 50 percent to 56 percent compared to 2020. The Company’s prior international sales guidance for 2021 was estimated to be in the range of $105 million to $110 million.

• Gross margin is estimated to be approximately 55 percent

• Adjusted EBITDA(1) is estimated to be 14 percent to 15 percent of sales

• Non-cash charges included in cost of goods sold and operating expenses are estimated to be approximately $80 million, which include:

• Approximately $65 million in non-cash, stock-based compensation expense

• Approximately $15 million of depreciation and amortization

• Conference Call

  The Company will hold a conference call and simultaneous webcast today at 4:30pm Eastern Time (1:30pm Pacific Time). The link to the webcast will be available by accessing the Events & Presentations tab in the Investor Center of the Tandem Diabetes Care website at http://investor.tandemdiabetes.com, and will be archived for at least 30 days. To listen to the conference call via phone, please dial 855-427-4396 (U.S./Canada) or 484-756-4261 (International) and use the participant code "8046918."

• https://finance.yahoo.com/news/tandem-diabetes-care-announces-first-200500944.html

Sarepta Q1 net sales up 24%

 Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported financial results for the first quarter of 2021.

“In the first quarter, we obtained FDA approval for and launched our third RNA therapy for Duchenne, AMONDYS 45™ (casimersen). The first AMONDYS 45 patient was treated within the first week of approval. Serving the community with EXONDYS 51, VYONDYS 53, and AMONDYS 45, we achieved net product revenue of $124.9 million, a 24% increase over the same quarter in 2020,” stated Doug Ingram, Sarepta’s president and CEO. “We also made significant strides in the advancement of our pipeline. Two days ago we announced positive results for the 30 mg/kg cohort of SRP-5051, our lead PPMO candidate. As we reported, after a median of only 12-weeks and three doses, the PPMO showed a significant dose-dependent increase in expression, exhibiting an 18 times greater level of exon skipping and nearly an order of magnitude greater level of dystrophin production as compared to EXONDYS 51, the currently approved standard of care for those with Duchenne amenable to exon 51 skipping. SRP-5051 achieved this in about half the time as EXONDYS 51 and with only about 12% of the dose exposure.”

Mr. Ingram continued, “Also in the first quarter we reported positive data from our ongoing study of SRP-9003, our investigational gene therapy for limb-girdle muscular dystrophy Type 2E at the 2021 Muscular Dystrophy Association Annual Clinical and Scientific Conference, reporting robust expression, a good safety profile, good durability to two years, and significantly better functional results than age-matched natural history. For SRP-9001, our investigational gene therapy for Duchenne, we have gained invaluable and proprietary insight from the read out of Part 1 of Study 102 which we have used to refine the protocol of our next trial, Study 301. We remain on track to report data in the second quarter from Study 103 (ENDEAVOR), our open-label study evaluating the performance of our commercially representative SRP-9001 material.”

https://www.globenewswire.com/news-release/2021/05/05/2223838/36419/en/Sarepta-Therapeutics-Announces-First-Quarter-2021-Financial-Results-and-Recent-Corporate-Developments.html

Biden says he plans to back WTO IP waiver for COVID-19 vaccines

 President Joe Biden on Wednesday threw his support behind a proposed World Trade Organization waiver of intellectual property rights for COVID-19 vaccines, bowing to mounting pressure from Democratic lawmakers and more than 100 other countries.

Biden, who had backed a waiver during the 2020 presidential campaign, voiced his support after a speech at the White House.

"Yes, I'm going to talk about that later today, yes," Biden told reporters in reply to a question about whether he intended to back the waiver.

Biden's chief trade negotiator, U.S. Trade Representative Katherine Tai, issued a statement shortly after Biden spoke, announcing the Biden administration's support for the proposed measure, which would temporarily waive certain IP rights to help countries respond to the COVID-19 pandemic.

“This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures," Tai said in a statement.

"The Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines."

Tai said the United States would participate in text-based negotiations at the WTO to ensure the waiver could happen, but cautioned those negotiations would take time.

WTO decisions require a consensus of all members.

The United States and several other countries had previously blocked negotiations at the WTO about the waiver proposal led by India and South Africa aimed at helping developing countries to produce COVID-19 vaccines using the IP of pharmaceutical companies.

https://www.reuters.com/business/healthcare-pharmaceuticals/biden-says-plans-back-wto-waiver-vaccines-2021-05-05/