William Schultz and Margaret Dotzel (Zuckerman Spaeder)

Pair of ex-HHS coun­sels crit­i­cize bill to 'u­pend' 180-day ex­clu­siv­i­ty for first gener­ic drugs

Three years ago, a pair of bi­par­ti­san con­gress­men in­tro­duced leg­is­la­tion called the “Bring­ing Low-cost Op­tions and Com­pe­ti­tion while Keep­ing In­cen­tives for New Gener­ics,” or BLOCK­ING Act — claim­ing to try and keep drug prices down by in­creas­ing com­pe­ti­tion among gener­ic drug mak­ers.

Kurt Schrad­er

And while trade or­ga­ni­za­tions like the gener­ic-fo­cused As­so­ci­a­tion for Ac­ces­si­ble Med­i­cines sent a let­ter to then-Pres­i­dent Trump ex­press­ing their op­po­si­tion to that act, two high-rank­ing ex-gov­ern­ment of­fi­cials are speak­ing out against it — and ex­plain­ing why it might not help.

Mar­garet Dotzel and William Schultz co-au­thored a re­port ear­li­er this month about the pro­posed BLOCK­ING Act, say­ing in short that in­stead of, as bill co-spon­sor Con­gress­man Kurt Schrad­er (D-OR) said it would stop gener­ic drug “park­ing” and mir­ror a pro­pos­al to “speed de­vel­op­ment of more af­ford­able gener­ics to spur com­pe­ti­tion,” it would in­stead do the op­po­site.

The bill was orig­i­nal­ly writ­ten to pro­vide a workaround to gener­ic drug “park­ing,” the prac­tice where com­pa­nies who are the first to get to the FDA with a gener­ic can­di­date, pause at the ten­ta­tive ap­proval stage. In short, the bill would al­low the FDA to ap­prove gener­ic drugs from ri­val com­peti­tors who were not the first be­fore the agency if cer­tain con­di­tions were met. These would in­clude:

  • A sub­se­quent Para­graph IV AN­DA is ready for fi­nal ap­proval but for a first ap­pli­cant’s el­i­gi­bil­i­ty for 180- day ex­clu­siv­i­ty;
  • At least 30 months have passed since the first ap­pli­cant sub­mit­ted its AN­DA to FDA;
  • The 30-month patent lit­i­ga­tion stay of AN­DA ap­proval in­voked when patent in­fringe­ment lit­i­ga­tion is time­ly ini­ti­at­ed does not pre­clude ap­proval of a first ap­pli­cant’s AN­DA; and
  • FDA has not ap­proved a first ap­pli­cant’s AN­DA as of the date the first three re­quire­ments above are met.

Dotzel and Schultz are at­tor­neys with the na­tion­al­ly-rec­og­nized law firm Zuck­er­man Spaed­er, but Schultz pre­vi­ous­ly served as gen­er­al coun­sel at HHS and as the deputy com­mis­sion­er for pol­i­cy at the FDA. Dotzel was the act­ing gen­er­al coun­sel and deputy gen­er­al coun­sel at HHS and the as­so­ciate com­mis­sion­er for pol­i­cy while at the FDA.

In the 11-page re­port ti­tled “An Ev­i­dence-based As­sess­ment of the BLOCK­ING Act,” the pair dove in­to case stud­ies of drugs that un­der the BLOCK­ING Act would not have ac­cel­er­at­ed gener­ic en­try and pa­tient ac­cess due to a va­ri­ety of fac­tors. The drugs that the at­tor­neys dove in­to in­clud­ed Xi­fax­an, Revlim­id, Cialis, Ry­tary and Bel­bu­ca buc­cal film — and in all but one of those cas­es (Bel­bu­ca), the at­tor­neys ar­gued that the gener­ic en­try and pa­tient ac­cess would not have ac­cel­er­at­ed un­der BLOCK­ING be­cause “the sub­se­quent ap­pli­cant will not launch up­on ap­proval due to a patent set­tle­ment.”

Fur­ther, they went af­ter a se­ries of as­sump­tions that they ar­gue were piv­otal to how the leg­is­la­tion was writ­ten. The pri­ma­ry ones were that, from their view:

  • “There is an as­sump­tion that, for its part, FDA or­di­nar­i­ly ap­proves a first ap­pli­cant’s AN­DA with­in 30 months of sub­mis­sion”
  • “There is an as­sump­tion that a sub­se­quent ap­pli­cant will legal­ly be able to be­gin mar­ket­ing its drug prod­uct once FDA ap­proval is se­cured.”

Ac­cord­ing to the at­tor­neys, those are in­cor­rect, point­ing to da­ta that showed that the mean and me­di­an FDA re­view times for Para­graph IV AN­DAs were over 4 years — 51 months at the me­di­an and 57 months on av­er­age.

Dotzel and Schultz al­so added, “Sub­se­quent ap­pli­cants fre­quent­ly sign on to the same base­line patent set­tle­ment with ei­ther the same or a lat­er launch date as the first ap­pli­cant. That means that sub­se­quent ap­pli­cants will be legal­ly pre­clud­ed from launch­ing, notwith­stand­ing an AN­DA ap­proval grant­ed by BLOCK­ING.”

In sum­ma­ry, the Act, ac­cord­ing to Dotzel and Schultz:

will not ac­cel­er­ate gener­ic drug en­try. In­stead, it will up­end the crit­i­cal 180- day ex­clu­siv­i­ty in­cen­tive by mak­ing it far less pre­dictable and there­fore far less valu­able. As a re­sult, few­er gener­ic drug man­u­fac­tur­ers are like­ly to make the sig­nif­i­cant in­vest­ment need­ed to chal­lenge patent es­tates on ex­pen­sive brand-name drugs, even when those chal­lenges could have been suc­cess­ful or re­sult­ed in fa­vor­able set­tle­ments. The net ef­fect will be that brand-name prices will re­main high­er for longer, and there will be few­er gener­ic drugs avail­able to pa­tients.

How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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Scoop: Roche scraps one of two schiz­o­phre­nia PhII tri­als due to missed pri­ma­ry end­point

Roche has terminated one of two Phase II trials testing its drug ralmitaront in patients with schizophrenia, the Big Pharma confirmed to Endpoints News.

The study was terminated last month, according to a June 22 update to the registry on clinicaltrials.gov. Begun in September 2020, the trial was looking at ralmitaront in patients with acute schizophrenia. The trial enrolled 286 patients out of an originally planned 308.

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Years af­ter link­ing arms with Bris­tol My­ers and both Mer­cks, Sutro finds its lat­est part­ner in Tokyo

Astellas and Sutro Biopharma are linking arms on a new field of antibody-drug conjugates that they hope will improve upon existing cancer immunotherapies.

The Tokyo pharma will dole out $90 million in cash for the collaboration, the companies said Monday afternoon. That upfront payment will extend the South San Francisco biotech’s runway from late 2023 into the first half of 2024, Cowen analysts noted.

Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

Roivant chops sick­le cell gene ther­a­py, der­ma­tol­ogy drugs to fo­cus on 'high­er val­ue pro­ject­s'

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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