In a first for deuter­at­ed drugs, FDA (fi­nal­ly) OKs Te­va’s would-be Hunt­ing­ton’s block­buster Auste­do

Ten months af­ter the FDA put Te­va’s would-be block­buster deutetra­benazine on hold af­ter rais­ing some sus­pi­cions re­gard­ing cer­tain metabo­lites found in pa­tients, the FDA has giv­en the drug an OK for Hunt­ing­ton’s chorea.

Michael Hay­den, Te­va

This is a first FDA ap­proval in the world of deuter­at­ed drugs, which tweaks ther­a­pies so that they break down more slow­ly in pa­tients. That way you can use a low­er dose to greater ef­fect. In this case the drug is a small mol­e­cule in­hibitor of vesic­u­lar monoamine 2 trans­porter, or VMAT2, which is de­signed to reg­u­late the lev­els of dopamine in the brain.

The drug will be sold as Auste­do. Te­va shares $TE­VA surged 2.2% Mon­day evening.

A star-crossed Te­va paid $3.5 bil­lion to ac­quire Aus­pex for this drug two years ago, sup­pos­ed­ly set­ting up a slap shot at the first reg­u­la­to­ry OK. That ap­proval was very slow com­ing, but the pay­off has fi­nal­ly ar­rived.

The big draw­back in the ap­proval is that it came with a black box warn­ing on de­pres­sion and sui­ci­dal­i­ty. But­Te­va al­so wast­ed no time in tack­ling the mar­ket with an ag­gres­sive price point. Ja­son Ger­ber­ry at Leerink not­ed:

While physi­cians will titrate Auste­do, the av­er­age dosage is ex­pect­ed to be 24mg per day which TE­VA priced at $60,000 for a year of ther­a­py and is be­low the list price of (Valeant’s) brand Xe­nazine ($152K) and gener­ic tetra­benazine ($96K). We view tonight’s up­date as a pos­i­tive, elim­i­nat­ing any lin­ger­ing con­cerns around deep­er is­sues with the CRL (com­plete re­sponse let­ter) that de­layed Auste­do ap­proval. We cur­rent­ly fore­cast $850m in 2023E Auste­do sales.

Sev­er­al new drugs have now been re­leased with dis­count pric­ing, un­der­scor­ing a new, harsh­er en­vi­ron­ment on high drug prices.

Te­va has al­so been push­ing this drug along for tar­dive dysk­i­ne­sia, though its mixed batch of late-stage da­ta spurred some an­a­lysts to sing the prais­es of a com­pet­ing drug from Neu­ro­crine. Eval­u­atePhar­ma has tagged this drug as a po­ten­tial block­buster, with a shot at earn­ing slight­ly more than a bil­lion dol­lars a year — though that kind of cash won’t come eas­i­ly.

Still, the FDA ap­proval marks a big win for Te­va, which has been un­der the gun for years now. Cur­rent­ly be­ing re­struc­tured, the CEO de­part­ed re­cent­ly as Te­va’s gener­ic busi­ness is as­sault­ed by low­er prices and its brand­ed di­vi­sion en­dured a lengthy drought in R&D.

The ap­proval al­so marks a big plus for Con­cert Phar­ma­ceu­ti­cals $CNCE, which has been la­bor­ing at deuter­at­ing drugs with the heavy hy­dro­gen for years now.

Hunt­ing­ton’s, a lethal neu­rode­gen­er­a­tive dis­ease, is char­ac­ter­ized by harsh, repet­i­tive twist­ing and writhing as­so­ci­at­ed with chorea.

“Chorea is a ma­jor symp­tom for many liv­ing with Hunt­ing­ton dis­ease. It im­pacts pa­tients’ func­tion­al­i­ty and ac­tiv­i­ties of dai­ly liv­ing, and there have been lim­it­ed treat­ment op­tions for these pa­tients,” said Michael Hay­den, the CSO at Te­va. “Based on the re­sults demon­strat­ed in the clin­i­cal de­vel­op­ment pro­gram which sup­port­ed the ap­proval of AUSTE­DO and our on­go­ing com­mit­ment to pa­tients, we feel unique­ly po­si­tioned to bring this treat­ment op­tion for­ward.”

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Roger Perlmutter, Eikon Therapeutics CEO

Roger Perl­mut­ter builds Eikon's pipeline with deal-mak­ing flur­ry, rais­ing $106M more

Eikon Therapeutics announced three business development deals on Thursday, effectively dropping in a pipeline of cancer drugs alongside more than $100 million in fresh funding.

The Hayward, CA-based company has become one of biotech’s richest startups since its 2019 founding, having raised nearly $775 million. It’s developing a massive, automated research approach built around Nobel Prize-winning microscope science to peer inside cells and watch proteins in action. After its Series B last year, PitchBook reported a $3.02 billion valuation. And while CEO Roger Perlmutter declined to comment on that figure, he said its first tranche of nearly $106 million in Series C funding is a “meaningful step-up to our Series B valuation.”

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Eu­ro­pean Par­lia­ment calls mem­ber states to ac­tion on an­timi­cro­bial re­sis­tance

Members of the European Parliament have called on EU countries to develop national action plans against antimicrobial resistance (AMR), calling it a top-three priority health threat.

Parliament on Thursday announced recommendations for the fight against AMR, including national action plans that must be updated at least every two years, an EU-level database tracking AMR and antimicrobial use and increased partnership between the pharma industry, patient groups and academia.

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Albert Bourla, Pfizer CEO (Michel Euler/AP Images, Pool)

FDA ap­proves Pfiz­er’s RSV shot for old­er adults, tee­ing up a com­pet­i­tive $17B vac­cine mar­ket

The FDA approved Pfizer’s RSV vaccine called Abrysvo for older adults on Wednesday, placing another Big Pharma onto the commercial stage ahead of the next RSV season.

Pfizer’s approval comes weeks after GSK won approval for its rival shot, Arexvy. Those two vaccines are both approved for use in adults 60 years and older and will be reviewed by a CDC panel in June before they’re expected to commercially launch this fall. Wall Street analysts see RSV as the next multibillion-dollar vaccine market, with Jefferies analysts recently forecasting the RSV market will grow to $17 billion over the next decade.

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Richard Pazdur, FDA's OCE director (Flatiron Health via YouTube)

FDA's can­cer chief weighs in on com­mon chemo short­ages — re­port

Richard Pazdur, director of the FDA’s Oncology Center of Excellence, attributes the current shortage of two cancer drugs to drug companies that haven’t invested in building out their production capacity.

In an interview with The Cancer Letter, a weekly cancer publication, Pazdur said that the current shortages of cisplatin and carboplatin, a pair of drugs used to treat a wide range of cancer patients, are the result of two problems: manufacturers not investing in enhancing production capacity, and drug companies being dependent on one supplier of raw ingredients. The cisplatin shortage followed an inspection that revealed quality issues at a manufacturing facility, which then led to the shutdown of production. This led to a surge in carboplatin demand, creating a secondary shortage.

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Can­cer as­so­ci­a­tion says na­tion­al bud­get deal threat­ens re­search fund­ing

As the US House of Representatives is expected to vote this evening on a deal that would raise the nation’s debt ceiling, some biopharma industry advocates worry about how proposed budget restrictions could affect drug research.

The proposed budget deal includes relatively flat funding for non-defense spending over the next fiscal year, and a 1% increase in fiscal year 2025, which the Association for Clinical Oncology said on Wednesday would “considerably restrict potential resources for the National Institutes of Health (NIH) and National Cancer Institute (NCI) at a time when scientists are on the cusp of so many promising cancer discoveries.”

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Photo: Ida Marie Odgaard/Ritzau Scanpix/Sipa USA/Sipa via AP Images

FDA warns about com­pound­ed semaglu­tide-based drugs

The FDA has warned the public that compounded versions of popular GLP-1 drugs Ozempic and Wegovy may not include the same ingredients as the prescription medications, and that has raised questions about their safety and effectiveness.

The regulator said Tuesday it has received reports of adverse events related to compounded versions of semaglutide, the active ingredient in Ozempic and Wegovy. Some products being marketed as semaglutide contain the salt formation of semaglutide, which is not considered safe or effective.

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Ky­owa Kirin re­news sup­port for foun­da­tion that ful­fills wish­es for ter­mi­nal­ly ill adults

Although not as well-known as the pediatric-focused Make-A-Wish organization, the Dream Foundation has been making wishes come true for adults diagnosed with a terminal illness for decades. Kyowa Kirin began supporting the group six years ago, and now is doubling down on its commitment and extending its pledge through next year.

The financial support of Kyowa Kirin and on-the-ground work by its employees have directly led to 100 final dreams for people across the US and Puerto Rico. The Dream Foundation overall grants 2,500 requests each year to people who have a prognosis of 12 months or less to live. The wishes fulfilled range from family trips to places such as Disneyland or beach destinations to professional sports games to meet a sports hero.

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San­doz plans to stay lo­cal af­ter No­var­tis sep­a­ra­tion, se­lect­ing new HQ in Basel

Sandoz, a generics maker that Novartis plans to spin off later this year, has picked its new headquarters — and it’s only 2.4 miles away from its current digs on the Novartis campus.

The Novartis unit said Thursday that it plans to move to an office building in Basel called Elsässertor sometime in mid-2024.

Sandoz CEO Richard Saynor said in a news release that the location in the heart of Basel “will allow us to create a working environment that meets our business needs,” citing the talent pool in the Swiss city. Sandoz added that the workspace is designed to allow for “closer collaboration and teamwork.”

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