Sesen believes it remains on track for FDA decision on Vicineum by August 18

 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced the expansion of its executive leadership team in support of the Company’s continued transformation into a commercial-stage company with the hiring of John Knighton as Vice President and Chief Compliance Officer, effective August 16, 2021. The Company’s Biologics License Application (BLA) for Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), the Company’s lead program, is currently under Priority Review with the US Food and Drug Administration (FDA) with a target Prescription Drug User Fee Act (PDUFA) date of August 18, 2021.

https://finance.yahoo.com/news/sesen-bio-strengthens-executive-leadership-120000224.html

US telemedicine company owner charged with $784m fraud

 A jury in the US has charged a Florida man who owns multiple telemedicine companies in connection with a massive healthcare scam that involved a massive $784 million in fraudulent claims being submitted to Medicare.

Creaghan Harry (53) is accused of conspiracy to commit health care fraud and wire fraud, and four counts of income tax evasion, activity which allowed him to live  a “lavish lifestyle,” according to the Department of Justice, which said it is “one of the largest Medicare fraud schemes ever charged.”

Harry was previously charged with co-conspirators Lester Stockett and Elliot Loewenstern with conspiracy to defraud the US and paying and receiving kickbacks, and money laundering offences.

If convicted, he could serve up to 60 years in prison. The maximum penalty for healthcare fraud and conspiracy to commit money laundering is 20 years each, and he also faces 10 years for each count of receipt of kickbacks, and five-year terms for tax evasion and conspiracy to defraud the US.

The three defendants are associated with telemedicine companies Video Doctor Network, AffordADoc and Telemed Health Group. In 2019, Stockett pleaded guilty to committing $424 million in Medicare fraud, and agreed to pay $200 million in restitution, as well as forfeit assets and property traceable to proceeds of the conspiracy.

At the time, Assistant Attorney Brian Benczkowski said that Stockett and his conspirators “lined their own pockets with hundreds of millions of dollars by exploiting telemedicine technology meant to help elderly and disabled patients in need of healthcare.”

The fraud involved Harry and his accomplices solicited illegal kickbacks and bribes from durable medical equipment (DME) suppliers and marketers in exchange for orders for braces and medications, said the DoJ.

The telemedicine companies are the accused of paying physicians to write medically unnecessary orders for the products. The orders were forwarded to the DME suppliers, which then fraudulently billed Medicare. It is estimated that at least $247 million was paid out in reimbursement to the network.

Harry attempted to conceal the fraud by setting up shell companies in the US and overseas – including the Dominican Republic – that received payments from the DME suppliers, according to the DoJ. The money was then transferred to the telemedicine companies, which paid the physicians.

He is also accused of committing income tax evasion on a large scale in the calendar years between 2015 and 2018, a period in which he did not file an income tax return or pay taxes on this income.

Last year, prosecutors moved to deny Harry bail on the grounds that he was considered a flight risk. Criminal charges remain pending against Loewenstern.

https://pharmaphorum.com/news/us-telemedicine-company-owner-charged-with-784m-fraud/

Genmab gets another Darzalex boost

 Just a few years ago it looked uncertain whether Genmab/Johnson & Johnson’s Darzalex would hit 2024 forecasts of $6bn. Now sales of the multiple myeloma drug are set to come close to this figure already this year. During second-quarter results yesterday Genmab upped its 2021 Darzalex revenue guidance to $5.6-5.9bn, from $5.2-5.6bn previously. And the anti-CD38 MAb is now expected to breach the $10bn barrier by 2026, according to sellside consensus compiled by Evaluate Pharma. Jefferies analysts go further, estimating peak multiple myeloma sales of $10bn, plus $2bn from other indications. However, Genmab might not end up seeing as big a reward as it would like: the group is disputing how much J&J should be paying in royalties, with a resolution not expected for months. A look at the biggest drugs in 2026 shows Darzalex at number six, behind behemoths like Keytruda and Opdivo. One product on this list whose sales prospects look in doubt is Abbvie’s Jak inhibitor Rinvoq, which has had an approval decision delayed in atopic dermatitis, an important new indication. But Abbvie remains bullish, recently reaffirming a previous prediction that the drug can bring in $8bn by 2025.

The 10 biggest drugs in 2026
Product	Company	Description	2026e sales ($bn)
Keytruda	Merck & Co	Anti-PD1 antibody	27.0
Opdivo	Bristol Myers Squibb	Anti-PD1 antibody	13.3
Eliquis	Bristol Myers Squibb	Coagulation factor Xa inhibitor	12.5
Dupixent	Sanofi/Regeneron	Anti-IL-13 & IL-4 antibody	12.2
Biktarvy	Gilead Sciences	HIV-1 integrase inhibitor & HIV-1 nucleoside reverse transcriptase inhibitor	11.2
Darzalex	Johnson & Johnson/Genmab	Anti-CD38 antibody	10.3
Tagrisso	Astrazeneca	EGFR inhibitor	9.6
Trikafta	Vertex Pharmaceuticals	CFTR potentiator & CFTR corrector	9.3
Rinvoq	Abbvie	Jak 1 inhibitor	8.9
Skyrizi	Abbvie	Anti-IL-23 antibody	8.4
Source: Evaluate Pharma. https://www.evaluate.com/vantage/articles/news/snippets/genmab-gets-another-darzalex-boost

Why is Moderna still so pricey?

 New safety concerns in Europe over Moderna’s Covid-19 vaccine Spikevax and a respected pharma analyst calling the group’s valuation ridiculous might have knocked $29bn off the biotech’s market cap, but Moderna is still worth a staggering $155.5bn. Yesterday’s 16% pullback still leaves the company with a more than fivefold share price rise since the beginning of the year, something that the Bank of America analyst Jeff Meacham, with his $115 price target, believes is unjustifiable. A look at Moderna’s pipeline appears to confirm this; the combined NPV of its products is only $27.1bn, according to Evaluate Pharma. This is a far cry from Moderna’s valuation, which is higher than Amgen's or Bristol Myers Squibb’s, whose product NPVs are respectively $109.8bn and $187.5bn. While the true potential of mRNA might not have been tapped, most of Moderna’s pipeline remains early stage, and is in competitive areas like flu and RSV, or in tropical diseases. Additionally, current Covid-19 vaccine sales, the main driver of Moderna’s recent performance, are forecast to fall to just $2bn in 2026. The company is also unlikely to deliver a 100% pipeline success rate, leaving the question of why Moderna shares have not corrected further.

Moderna products by NPV
Product	Treatment area	Today's NPV ($m)	NPV as % of share price
Marketed
Spikevax	Covid-19 vaccine	20,199	13%
Phase 2
mRNA-1647	Cytomegalovirus vaccine	2,484	2%
AZD8601	Myocardial ischaemia therapy	282	0%
mRNA-4157	Personalised cancer vaccine	97	0%
Phase 1
mRNA-1345	RSV vaccine	2,002	1%
mRNA-2752	OX40L/IL-23/IL-36y for solid tumours/lymphoma	775	0%
mRNA-1653	hMPV/PIV3 vaccine	529	0%
mRNA-3927	Propionic acidaemia therapy	276	0%
mRNA-1893	Zika vaccine	252	0%
mRNA-1944	Chikungunya anti-viral	5	0%
mRNA-5671	Kras vaccine	1	0%
Preclinical
mRNA-3283	Phenylketonuria therapy	208	0%
Total		27,110	18%
Source: Evaluate Pharma.

 

Top 10 biopharma companies by market cap
Rank	Company	Market cap ($bn)*
1	Johnson & Johnson	$457.5bn
2	Roche	$345.6bn
3	Pfizer	$259.2bn
4	Lilly	$252.6bn
5	Novo Nordisk	$230.9bn
6	Novartis	$206.9bn
7	Merck & Co	$190.4bn
8	Astrazeneca	$175.4bn
9	Moderna	$155.5bn
10	Bristol Myers Squibb	$148.6bn
Source: Yahoo Finance *as at August 11. https://www.evaluate.com/vantage/articles/news/snippets/why-moderna-still-so-pricey

Endo generic's here to help fill Chantix shortage

 Pfizer’s reign over the smoking treatment space with its cessation med Chantix is coming to a close.

Trying to fill a recent shortage for Pfizer’s smoking med caused by safety concerns, the FDA has approved Par Pharmaceuticals’ copycat version, also known as varenicline, “well ahead” of its expected review date, the agency said a statement on Wednesday.

Though Pfizer’s generic rival Par Pharmaceuticals received the FDA’s special expedited treatment, impending copycat competition wasn’t unexpected given Chantix lost its main patent in November last year.

Chantix, first approved in 2006, drew in $1.1 billion in global sales back in 2019. The number fell 17% last year as the pandemic shuttered doctors offices. Most of Pfizer’s blockbuster sales can be attributed to its numerous price hikes over the years, according to GoodRx. In a 2018 report, the group found that Chantix’s price had more than doubled over 5 years. 

But Chantix’s glory days are set to wind down with Par’s generic. It’s unclear when Endo, which owns Par, will start rolling out its copycat, although it’s likely imminent given the FDA’s hurry. A spokesperson wasn’t available for comment. 

For months, people trying to wean off smoking have faced short Chantix supplies after Pfizer halted worldwide distribution in late June. That came after the drugmaker detected unacceptable levels of potential carcinogens, known as nitrosamines, in a number of Chantix lots. Weeks later, the company recalled certain batches in the U.S.

Nitrosamines, which are common in everyday life, are found in water and certain foods. High levels can increase the risk of cancer over time, Pfizer said. 

Responding to the shortage, the FDA in July allowed certain manufacturers to temporarily distribute their tablets with N-nitroso-varenicline levels below an interim limit of 185 ng a day "until the impurity can be eliminated or reduced to acceptable levels." The agency also said patients should also continue using recalled Chantix lots since the dangers of smoking outweigh the cancer risk.

On top of that, the FDA temporarily allowed Apotex to distribute its generic Apo-Varenicline tablets, already used in Canada, in the U.S. prior to Par’s first generic approval on Wednesday.

https://www.fiercepharma.com/pharma/endo-s-smoking-cessation-generic-rushed-over-fda-s-finish-line-effort-to-fill-chantix

Oncocyte Sees $2M in Q2 Revenues, Beating Wall Street Estimate

 Oncocyte said after the close of the market on Tuesday that its revenues for the three months ended June 30 were $2 million, compared to $143,000 in the same period of 2020 and beating analysts' average estimate of $1.57 million.

The Irvine, California-based firm said the majority of revenues were attributable to tech transfer under a licensing deal announced last December with Chinese firm Burning Rock Biotech for Oncocyte's DetermaRx lung cancer test. Revenues from DetermaRx also increased compared to the prior year's quarter.

During a call discussing the company's earnings, Oncocyte CEO Ron Andrews said that the company is anticipating continued momentum for DetermaRx.

"We have continued our expansion into new hospitals with a total of 176 onboarded hospitals at the end of Q2 … an approximate 43 percent growth over what we reported for Q1. At the end of Q2 we also had a total of 317 onboarded physicians, which is a 45 percent increase over what we reported in the first quarter," he said.

"Continuing to grow our population of accounts and physicians … gives us continued confidence that as the effects of the pandemic begins to wane, we'll see early-stage surgeries for lung cancer get back to pre-pandemic levels, and our volumes grow at an even faster pace," Andrews added.

Pharma Services revenues were slow in contrast, reflecting variability in the timing of customer projects.

According to Andrews, Oncocyte expects to gain further traction in this area as well, with new, near-term opportunities on the horizon for collaboration with pharma and molecular diagnostic developers.

The company also still plans to launch a second clinical test, DetermaIO, by the end of this year. "In terms of data, we've had a steady cadence of data that together provides compelling evidence that DetermaIO has a broad potential across a range of tumor types [and] … studies have also demonstrated the applicability of this test across all four approved immunotherapies," Andrews said.

Oncocyte incurred a net loss of $10.5 million, or $.12 per share during the quarter, compared to $9.1 million, or $.14 per share in the same period last year. Analysts on average had expected a lower loss per share of $.10.

Its Q2 R&D expenses dropped about 22 percent to $2.5 million from $3.2 million in Q2 2020. According to the company, this reflects decreases in outside services and clinical consulting for its development programs, as well as a $300,000 depreciation expense decrease.

Oncocyte's SG&A expenses doubled to $10.6 million from $5.3 million, driven by noncash stock-based compensation expenses. According to the firm, it also incurred a $2.5 million severance expense from its acquisition of Chronix Biomedical.

Oncocyte ended the quarter with $46.5 million in cash and cash equivalents and $1.1 million in marketable securities.

https://www.360dx.com/business-news/oncocyte-sees-2m-q2-revenues-beating-wall-street-estimate#.YRVal4hKjak

Fauci Confirms 'Likely, Inevitable' Everyone Will Need COVID Vaccine Booster Shot

 Within the space of a few days, the narrative has shifted from "if" booster shots are even necessary, to "only for immunocompromised", to "only for those who got vaccinations early on, due to fading efficacy", and now today, His Omniscience Anthony Fauci told 'CBS This Morning' that while it is imminent that immune compromised people will get Covid-19 vaccine booster shots, it is likely that at some point in the future everyone will need one.

“It’s likely that that will happen at some time in the future,” Fauci said, when asked if everyone will need a booster shot at some point.

That's "science" folks!

Fauci noted that this is data is being followed in real time, “literally on a weekly and monthly basis,” with cohorts of all different populations to determine if the level of protection is starting to attenuate.

“When it does get to a certain level, we will be prepared to give boosters to those people, but from what you just said a moment ago, it is imminent that we will be giving it to immune compromised,” he said.

As a reminder, the FDA is reportedly expected to announce soon that it will authorize COVID-19 vaccine booster shots for immunocompromised Americans. 

Fauci also said during an interview on NBC News' "Today" show Thursday, that:

"Inevitably, there will be a time when we'll have to give boosts to the general population."

As far as furiously moving goalposts goes, Fauci admittred earlier in the week that the Delta variant presents the additional problem that vaccinated people can also transmit the virus to someone else. That has led to the CDC revising its mask guidelines recently. But, he stressed:

“The vaccines are still doing what you originally want them to do -- to keep you out of the hospital to prevent you from getting seriously ill.”

Actually, what the CDC "originally" wanted the vaccines to do, was to prevent those who were jabbed from infecting others. Only later did we learn that too was a fabrication.

Perhaps the most 'new' science is the following...

"No vaccine, at least not within this category, is going to have an indefinite amount of protection."

Fauci comments come as debate grows over “breakthrough” infections among fully vaccinated people and whether approval should be given for booster shots. On Sunday, Israel, the first nation to roll out booster shots widely, said it had given more than 420,000 third shots to people 60 and over. At least 14 Israelis have already caught Covid-19 after having been injected with a booster shot, suggesting that the booster shot will be the first of many, and will likely last all the way through the mid-term elections because, well, mail-in ballots next November.

Which all sounds very different from the constant bombardment of "get jabbed and be free and fearless" that was punched down America's throat for most of the first half of 2021 by the Biden administration and every local health policy bureaucrat desperate to virtue signal their way to a job for life.

So the new question is... How will virtue-signaling stores/restaurants/companies with vaccine-mandated entry policies police this? Will people have be triple jabbed to be allowed to enter? Quadruple-jabbed?

https://www.zerohedge.com/covid-19/fauci-confirms-likely-inevitable-everyone-will-need-covid-vaccine-booster-shot