Af­ter months of ne­go­ti­a­tions with states and fed­er­al plain­tiffs ac­cus­ing it of in­sti­gat­ing the opi­oid cri­sis through ag­gres­sive and de­cep­tive mar­ket­ing tac­tics, Pur­due Phar­ma is ready to pay $10 to $12 bil­lion to set­tle it all.

Dan Pol­ster Fed­er­al Bar As­so­ci­a­tion

The po­ten­tial deal would cov­er hun­dreds of law­suits be­ing waged against the com­pa­ny by states, cities, towns and tribes, which is be­ing over­seen by Unit­ed States dis­trict judge Dan Pol­ster in Cleve­land, along­side cas­es in­volv­ing oth­er pre­scrip­tion opi­oid mak­ers. As part of the deal, the Sack­ler fam­i­ly — who had been charged with build­ing a “multi­bil­lion-dol­lar drug em­pire based on ad­dic­tion” — will give up own­er­ship in Pur­due.

The ma­jor­i­ty of the set­tle­ment will come in the form of in-kind drug do­na­tions and prof­its, with the ex­cep­tion of a $3 bil­lion cash pay­ment from the Sack­ler fam­i­ly ($4.5 bil­lion if they man­age to sell Mundiphar­ma, an­oth­er drug com­pa­ny they own, for more). Pur­due has re­port­ed­ly pledged to pro­vide more than $4 bil­lion in drugs, in­clud­ing mar­ket­ed and ex­per­i­men­tal treat­ments for opi­oid ad­dic­tion and over­dose re­ver­sals, to the pub­lic for free. Un­der a new pub­lic ben­e­fit trust struc­ture, all sales of its oth­er drugs — in­clud­ing Oxy­Con­tin, the opi­oid at the cen­ter of its mis­deeds — would al­so go to the plain­tiffs.

If the set­tle­ment is reached, Pur­due will set a re­struc­tur­ing plan in­to mo­tion by first de­clar­ing Chap­ter 11 bank­rupt­cy, then tran­si­tion in­to a trust made of court-ap­point­ed trustees, who will then se­lect a board of di­rec­tors to run the day-to-day op­er­a­tions.

“While Pur­due Phar­ma is pre­pared to de­fend it­self vig­or­ous­ly in the opi­oid lit­i­ga­tion, the com­pa­ny has made clear that it sees lit­tle good com­ing from years of waste­ful lit­i­ga­tion and ap­peals,” the com­pa­ny said in a state­ment to NBC News, which first re­port­ed the deal.

Pur­due Phar­ma — which has re­port­ed­ly made more than $35 bil­lion in Oxy­Con­tin sales — and the Sack­ler fam­i­ly have pre­vi­ous­ly de­nied the le­gal al­le­ga­tions against them.

It’s un­clear whether, or how many, plain­tiffs are on board with the pro­posed terms of the deal. Pur­due is fram­ing it as a take it or leave it deal, since they plan to file for bank­rupt­cy no mat­ter the out­come and the re­sult­ing amount that could go in­to a set­tle­ment would be low­er than cur­rent­ly of­fered, ac­cord­ing to NBC.

An­drew Pol­lis Case West­ern Re­serve

“(The deal is) very sig­nif­i­cant. Nev­er be­fore have we ever seen a mem­ber of a pri­vate in­dus­try of­fer so much mon­ey to try to deal with a pub­lic health cri­sis of this mag­ni­tude,” An­drew Pol­lis, a law pro­fes­sor at Case West­ern Re­serve Uni­ver­si­ty, told NBC.

Opi­oid-re­lat­ed over­dos­es have claimed al­most 400,000 lives from 1999 to 2017, ac­cord­ing to the CDC. Gov­ern­ment at­tor­neys have brought over 2,000 law­suits against opi­oid man­u­fac­tur­ers and dis­trib­u­tors, both seek­ing dam­ages and at­tempt­ing to hold ex­ec­u­tives be­hind the de­ci­sions to boost opi­oid sales at all costs ac­count­able.

In May, ex­ec­u­tives at In­sys — which mar­kets a po­tent fen­tanyl spray — were found guilty of en­gag­ing in a bribery scheme to get doc­tors to pre­scribe their drug, Sub­sys. The com­pa­ny had pre­vi­ous­ly agreed to pay $225 mil­lion to set­tle fed­er­al lit­i­ga­tions, but are still in set­tle­ment talks with states af­ter de­clar­ing bank­rupt­cy. And on Mon­day glob­al phar­ma con­glom­er­ate J&J was found guilty and fined $572 mil­lion in an Ok­la­homa court for its role in the opi­oid epi­dem­ic there.

The par­ties have un­til Fri­day to re­port back to Pol­ster on the deal, the dis­trict judge who had en­cour­aged the set­tle­ment talks, the Wash­ing­ton Post not­ed.

Hepatitis delta, also known as hepatitis D, is a liver infection caused by the hepatitis delta virus (HDV) that results in the most severe form of human viral hepatitis for which there is no approved therapy.

HDV is a single-stranded, circular RNA virus that requires the envelope protein (HBsAg) of the hepatitis B virus (HBV) for its own assembly. As a result, hepatitis delta virus (HDV) infection occurs only as a co-infection in individuals infected with HBV. However, HDV/HBV co-infections lead to more serious liver disease than HBV infection alone. HDV is associated with faster progression to liver fibrosis (progressing to cirrhosis in about 80% of individuals in 5-10 years), increased risk of liver cancer, and early decompensated cirrhosis and liver failure.
HDV is the most severe form of viral hepatitis with no approved treatment.
Approved nucleos(t)ide treatments for HBV only suppress HBV DNA, do not appreciably impact HBsAg and have no impact on HDV. Investigational agents in development for HBV target multiple new mechanisms. Aspirations are high, but a functional cure for HBV has not been achieved nor is one anticipated in the forseeable future. Without clearance of HBsAg, anti-HBV investigational treatments are not expected to impact the deadly course of HDV infection anytime soon.

Thirteen of the top biotech venture capitalists in the country wrote a letter last week warning lawmakers that if Congress passes a drug pricing bill House Speaker Nancy Pelosi has put before lawmakers, they won’t be able to invest in biomedical research at their current rate, and patients will suffer.

“If policies such as those included within H.R. 3, the Lower Drug Costs Now Act, are passed, our ability to continue to invest in future biomedical innovation will be severely constrained, thus crushing the hopes of millions of patient waiting for the next breakthroughs to treat or cure their cancers, rare genetic diseases, Alzheimer’s, or other serious and life-threatening conditions,” they wrote in a letter addressed to the highest-ranking Democrats and Republicans in the House and Senate and acquired by Endpoints News. 

More than 3 years after Merck stepped up and paid $1 billion in cold, hard cash to gain the US commercial rights to Bayer’s high-risk heart drug vericiguat in a broad-ranging cardio alliance, the partners say their Phase III study has come through with promising data and a date with regulators.
We don’t have the data, and won’t until they put it out at an upcoming scientific session, but Merck touted the results, saying that their big Phase III VICTORIA study hit the primary endpoint  — with vericiguat combined with available therapies reducing “the risk of the composite endpoint of heart failure hospitalization or cardiovascular death in patients with worsening chronic heart failure with reduced ejection fraction (HFrEF) compared to placebo when given in combination with available heart failure therapies.”
Depending on the hard data, and how it breaks out with the combinations used, this drug could pose a threat to Novartis’ blockbuster drug Entresto, currently at $1.6 billion while analysts expect peak sales to hit $4 billion.
The drug is a soluble guanylate cyclase (sGC) stimulator, which Bayer and Merck have had high hopes for. Evidently, so did cardiologists. Cowen’s last analysis set potential sales at $400 million in 2024, but that number could go up significantly now.
Cowen’s Steve Scala noted this morning:
Vericiguat could be a lucrative product for Merck, and one with potentially under-appreciated value. At Cowen’s Therapeutics Conference in September 2019, 80% of specialists anticipated a positive result from VICTORIA whereas only 51% of investors shared this optimism.
Investigators recruited more than 5,000 patients at more than 600 centers in 42 countries for this study — one of the most expensive propositions in R&D. Millions of people in the US suffer from heart failure with reduced ejection fraction when the failing heart fails to contract properly to eject blood into the system. Bayer holds ex-US rights to the drug and also stands to earn cash from the $1.1 billion in milestones Merck agreed on for their collaboration.
Remarkably, the drug was pushed into Phase III despite failing the mid-stage trial — though investigators flagged a success at the high dose of 10 mg. In VICTORIA, researchers started patients at 2.5 mg and then titrated up to 5 and then 10 mg.

Turns out Dicerna wasn’t done with deals yet after locking in $200 million upfront from Roche for a hepatitis B cocktail two weeks ago.

Novo Nordisk has signed on as the latest partner to its GalXC RNAi platform, handing over $175 million in cash to claim any and all targets of interest in liver-related cardio-metabolic diseases that are not already reserved in previous pacts. The Danish drugmaker — which has signaled its interest to expand considerably beyond its core diabetes franchise into areas like NASH — is also purchasing $50 million worth of Dicerna’s equity at a 25% premium of $21.93 per share. More research payments and milestones extending to the billions are on the line.

→ Gene therapy maker Orchard Therapeutics has been granted an accelerated assessment for OTL-200 by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The gene therapy — in development in partnership with the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget) in Milan, Italy — being used towards the treatment of metachromatic leukodystrophy.

→ Pharmaceutical Product Development has announced that its parent company, PPD, Inc has submitted a draft to the SEC relating to the proposal of an IPO of the parent company’s common stock. Number of shares and price range have not yet been determined.

In the story lawmakers and drug pricing reform advocates have told about the drug industry, there are perhaps few greater villains than Humira and its maker AbbVie.

Between 2012 and 2018, AbbVie upped the drug’s annual after-rebates cost from $19,000 to $38,000 in the US, with sticker prices now over $60,000 per year — increases that led to accusations of price gouging, most recently from Democratic presidential frontrunner Elizabeth Warren.

The main question was not whether it would work; it was if it would be safe.

The Medicines Company is out with new data on its LDL cholesterol drug inclisiran, and they confirm the first, tentative answers: Yes. They also keep MedCo on track for an imminent  FDA submission for one of the first RNAi therapies and a drug that could flip the cholesterol market. An EU application will follow in the first quarter of 2020.