EU enters final talks for BioNTech-Pfizer vaccine

The European Commission said on Wednesday it had entered final stage talks with BioNTech-Pfizer to purchase up to 300 million doses of a potential vaccine against COVID-19.

This is the sixth potential vaccine for which the European Union executive has struck or plans to strike an advance purchase agreement.

The envisaged contract with Germany’s BioNTech and U.S.-based Pfizer would lead to an initial purchase of 200 million doses, with an option to buy a further 100 million, the Commission said after the conclusion of exploratory talks.

All EU members would have the possibility to buy the vaccine and could donate to poorer nations or redirect to other European countries.

EU supply would be produced by BioNTech’s sites in Germany and Pfizer’s manufacturing site in Belgium, with deliveries starting by the end of the year, the companies said in a statement.

They added they were on track to seek regulatory review of their potential vaccine in October and, subject to approval, plan to supply up to 100 million doses worldwide by the end of 2020 and about 1.3 billion doses by the end of 2021.

The proposed agreement with the European Commission would be the largest initial order of doses for Pfizer and BioNTech to date, they said.

The companies are developing a new variety of vaccine based on messenger RNA (mRNA), which makes the human body create viral proteins, prompting the immune system to produce a defensive response.

The Commission reached a first agreement last month with AstraZeneca for at least 300 million doses of its potential vaccine, mirroring moves by the United States and other wealthy states to secure stock of effective COVID-19 vaccines.

It has also concluded exploratory talks with Sanofi-GSK, Johnson & Johnson, CureVac and Moderna to buy upfront their potential COVID-19 vaccines and is in discussions with other manufacturers.

https://www.reuters.com/article/us-health-coronavirus-eu-vaccine/eu-enters-final-talks-for-biontech-pfizer-vaccine-idUSKBN2601S0

China’s CanSino defends coronavirus vaccine candidate

China’s CanSino Biologics Inc said on Wednesday that expert opinion on its high-profile coronavirus vaccine candidate should not be followed “blindly” without sufficient clinical trial data.

Scientists outside the company have expressed concern that the effectiveness of CanSino’s candidate Ad5-nCoV, which is based on a common cold virus to which many people have been exposed, could be limited. They said existing antibodies against the common cold virus might undermine Ad5-nCoV.

“Vaccine development is a practice-based science, and we should not blindly follow experts,” Zhu Tao, chief scientific officer, said during an investor conference.

He said there were instances in which vaccines created using methods doubted by experts had obtained regulatory approvals after clinical trials proved they worked.

No evidence showed that existing antibodies against the common cold could have a major adverse impact on Ad5-nCoV’s ability to trigger antibodies against the novel coronavirus, Zhu said, citing results from 128 participants tested with a lower dose of the vaccine candidate in a mid-stage trial.

Ad5-nCoV, still in final-stage trials, has been approved for use in the Chinese military.

Vaccine companies normally have to collect data in large-scale, late-stage trials to obtain regulatory approval for mass use.

It is unscientific to compare the antibody levels generated by different vaccine candidates so far, because varied testing methods could distort results, Zhu said.

AstraZeneca Plc on Tuesday said it paused a late-stage trial of one of its leading experimental viral vector-based vaccine, which uses a technology similar to CanSino’s, after an unexplained illness in a study participant.

The hiccup does not mean all viral-vector based experimental vaccines are risky, Zhu said, adding that it was not rare for clinical trials to be paused.

https://www.reuters.com/article/us-health-coronavirus-cansino/chinas-cansino-defends-coronavirus-vaccine-candidate-after-experts-cast-doubt-idUSKBN2600O9

Telehealth firm Amwell looks to raise about $560 million in U.S. IPO

Telehealth provider AmWell said on Tuesday it expects to raise about $560 million in its initial public offering in the United States, as the coronavirus pandemic boosts demand for virtual healthcare offerings.

The company set a price target of between $14 and $16 per share for its sale of 35 million shares.

Amwell said it has applied to list its shares on the New York Stock Exchange under the ticker symbol “AMWL.”

Shelter-in-place restrictions to control the pandemic have prompted people to turn to virtual consultation and treatment offerings, benefiting companies like Teladoc Health Inc (TDOC.N), which last month struck an $18.5 billion deal for chronic care provider Livongo Health Inc (LVGO.O).

Morgan Stanley, Goldman Sachs & Co and Piper Sandler are among underwriters for the proposed offering.

https://www.reuters.com/article/us-amwell-ipo/telehealth-firm-amwell-looks-to-raise-about-560-million-in-u-s-ipo-idUSKBN25Z3CB

Merck’s gefapixant successful in late-stage chronic cough studies

Following up on its initial announcement in March, Merck (NYSE:MRK) announces positive detailed results from two Phase 3 clinical trials, COUGH-1 and COUGH-2, evaluating gafapixant in adult patients with refractory or unexplained chronic cough.

The 45 mg dose (twice daily) met the primary efficacy endpoint in both studies, demonstrating a statistically significant reduction in 24-hour cough frequency at week 12 (COUGH-1) versus placebo (geometric mean coughs/hour = 18.24 at baseline compared to 7.05 at primary endpoint, 32.9% relative reduction; p=0.041) and statistically significant reduction in 24-hour cough frequency at week 24 (COUGH-2) (baseline = 18.55 vs. 6.83 at primary endpoint, 26.1% relative reduction; p=0.031).

The 15 mg dose failed to achieve the primary endpoint in either trial.

No new safety signals were reported. The discontinuation rates for the 45 mg dose in COUGH-1 & 2 were 15% and 20%, respectively, compared to 3% and 8%, respectively, in the 15 mg dose arm and 3% and 5%, respectively, in the control arm. Mild-to-moderate taste-related adverse events were the most common, 58.0%/68.6% for 45 mg, 10.7%/19.5% for 15 mg and 3.3%/8.3% for placebo.

Gefapixant is an orally administered selective P2X3 receptor antagonist. Excessive activation of P2X3 receptors is associated with hyper-sensitization of sensory neurons which, in the airways and lungs, triggered by injury or infection, can cause chronic cough (cough that lasts more t eight weeks).

https://seekingalpha.com/news/3612040-mercks-gefapixant-successful-in-late-stage-chronic-cough-studies

Heron Therapeutics cheers FDA Type A meeting for HTX-011

September 8, 2020

Heron Therapeutics (NASDAQ:HRTX) announces a successful Type A meeting with the FDA in which alignment was reached to resubmit the New Drug Application or NDA for HTX-011 in Q4.

It is used for management of postoperative pain and is the first and only extended–release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution

“We expect to resubmit the HTX-011 NDA in the next few months and appreciate the FDA’s commitment to an expeditious review for this Breakthrough Therapy product.” says CEO and president  Barry Quart, Pharm.D.

“HTX-011 has the potential to be the company’s best-selling product by a good margin. The company expects sales of approximately $70 million to $80 million in FY2020, almost all of it from CINVANTI.” says contributor Bret Jensen in his article ‘Heron Therapeutics: The Play Now‘ on Seeking Alpha.

Dive deeper in Corporate Presentation more details on HTX-011

https://seekingalpha.com/news/3612103-heron-therapeutics-cheers-fda-type-meeting-for-htxminus-011

PolarityTE teams up with Co-Diagnostics to expand COVID-19 testing platform

PolarityTE (NASDAQ:PTE) subsidiary, Arches Research has entered into a strategic partnership with Co-Diagnostics (NASDAQ:CODX) to expand COVID-19 testing operations.

Under the agreement, Arches will provide COVID-19 testing for customers referred by Co-Diagnostics and, to support additional demand, latter will provide testing equipment in exchange for commitment to use only Co-Diagnostics’ tests on the equipment.

Arches has previously been performing COVID-19 testing using CODX’s Logix Smart COVID-19 test kit.

https://seekingalpha.com/news/3612086-polarityte-teams-up-co-diagnostics-to-expand-covidminus-19-testing-platform

Celgene rights down on potential delay in key approval

The Contingent Value Right (CVR) (NYSE:BMY.RT) associated with Bristol Myers Squibb’s (BMY -2.2%) $74B takeover of Celgene is down ~24% today in apparent reaction to management comments at a Citigroup conference revealing that the manufacturing plant for CAR T therapies has not yet been inspected by the FDA.

The disclosure has unnerved investors considering the agency’s November 16 action date for its review of the company’s marketing application for CAR T lisocabtagene maraleucal (liso-cel) for relapsed/refractory large B-cell lymphoma patients who have received at least two prior lines of treatment.

The FDA nod is one of two qualifying milestones for a $9 payout. The other is U.S. approval of CAR T idecabtagene vicleucel (ide-cel) (bb2121) for multiple myeloma (MM) patients who have received at least three prior lines of treatment by March 31, 2021.

In May, BMY received a Refusal to File letter from the agency in response to its ide-cel marketing application citing the need for additional information in the Chemistry, Manufacturing and Control (CMC) module.

Celgene and licensor bluebird bio (BLUE +3.9%) have been collaborating on CAR T therapies since March 2013. Per a March 2018 contract, the companies agreed to co-develop and co-promote bb2121 for MM in the U.S.

https://seekingalpha.com/news/3612232-celgene-cvr-down-24-on-potential-delay-in-key-approval