Gang of 7: Boehringer joins group of com­pa­nies tar­get­ed over drug dis­count pro­gram

Boehringer In­gel­heim on Mon­day joined a grow­ing list of bio­phar­ma com­pa­nies un­der pres­sure from the Biden ad­min­is­tra­tion’s HRSA af­ter re­strict­ing their own par­tic­i­pa­tion in a hos­pi­tal dis­count drug pro­gram be­cause of what they claim is an ex­ces­sive num­ber of con­tract phar­ma­cies.

Whether these vi­o­la­tions are vi­o­la­tions as HRSA con­tends will like­ly be de­cid­ed in court. Mean­while, HRSA has made its stance clear as it pre­vi­ous­ly sent iden­ti­cal let­ters to As­traZeneca, Eli Lil­ly, No­var­tis, No­vo Nordisk, Sanofi and Unit­ed Ther­a­peu­tics, ex­plain­ing how the ad­min­is­tra­tion has de­ter­mined their poli­cies plac­ing re­stric­tions on 340B pro­gram pric­ing re­lat­ed to con­tract hos­pi­tal phar­ma­cies are in di­rect vi­o­la­tion of the statute.

Late last month, HRSA sent let­ters to the six oth­er com­pa­nies in­form­ing them their vi­o­la­tions have been re­ferred to the HHS Of­fice of the In­spec­tor Gen­er­al, which can levy $5,000 fines each.

Mau­reen Testoni

In the case of Boehringer, HRSA in­formed the com­pa­ny its Aug. 1 pol­i­cy re­strict­ing ac­cess to 340B prices for cer­tain en­ti­ties is un­law­ful. HRSA di­rect­ed Boehringer to pro­duce a plan by Oct. 18 to re­store the dis­count­ed pric­ing and said the com­pa­ny must is­sue cred­its or re­funds to af­fect­ed hos­pi­tals for all past over­charges.

Mau­reen Testoni, pres­i­dent and CEO of 340B Health, a non­prof­it hos­pi­tal group, said in a state­ment: “We com­mend HRSA for tak­ing quick en­force­ment ac­tion against Boehringer In­gel­heim as we re­quest­ed, and we call on the com­pa­ny’s ex­ec­u­tives to heed the gov­ern­ment’s di­rec­tive and re­store statu­to­ry dis­counts for safe­ty-net hos­pi­tals. BI’s pol­i­cy of with­hold­ing dis­counts for many of its out­pa­tient drugs, in­clud­ing those used to treat pa­tients with di­a­betes, is im­mense­ly harm­ful to 340B hos­pi­tals and the pa­tients they serve.”

Boehringer did not re­spond to a re­quest for com­ment.

The oth­er com­pa­nies em­broiled in le­gal and HRSA bat­tles have ar­gued that they re­main in full com­pli­ance of the law, and the 340B pro­gram has bal­looned quick­ly thanks to the use of con­tract phar­ma­cies.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.

Some can­cer pa­tients now have to find oth­er op­tions as Bris­tol My­er­s' Abrax­ane falls in­to short­age from man­u­fac­tur­ing woes

When Beth Hogan, a metastatic pancreatic cancer patient, showed up for her infusion at Yale’s Smilow Cancer Hospital in New Haven, CT on Oct. 11, she said she was informed that day that she would not be receiving Bristol Myers Squibb’s Abraxane, part of her combo treatment, because of a shortage.

“I was told we don’t know when you can have it,” she told Endpoints News via email, adding that she doesn’t expect to receive any Abraxane this coming Monday at her treatment appointment either, and she doesn’t know when things will change.

Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)

Up­dat­ed: Bio­gen sells just $300K worth of Aduhelm in Q3, as ques­tions on long-term vi­a­bil­i­ty re­main

Barely anyone is accessing Biogen’s controversial Alzheimer’s treatment, with the company reporting just $0.3 million in Aduhelm sales in the third quarter. Although investors will be looking to the longer term, when CMS may decide to cover the drug and open the floodgates for more reimbursement, use of the drug is currently stalled.

Since June, when the FDA first signed off on the drug under its accelerated pathway, Biogen said Wednesday that it’s sold a total of $2 million worth of Aduhelm. That’s a far cry from the peak Wall Street sales estimate of about $9 billion in annual sales, and even a ways away from the sell-side consensus of about $17 million in Q3 sales.

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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Eli Lil­ly or­dered to pay roy­al­ties on block­buster di­a­betes drugs, though ex­act dam­ages are un­clear

A federal court found Eli Lilly in breach of a royalty agreement with an Arizona company, likely sending the case — which deals with Lilly’s blockbuster diabetes drugs — to a trial.

The Arizona District Court ordered Lilly to pay the royalties to Tucson, AZ-based Research Corporation Technologies, per an opinion delivered Tuesday, stemming from a 1990 agreement involving materials used in manufacturing Lilly’s insulin products. Lilly had agreed to pay a 2% royalty on worldwide sales, and the exact amount of damages will be determined in a trial, Judge Scott Rash wrote.

Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.