Sen­a­tor Har­ris comes out swing­ing against Alk­er­mes and its CEO, at­tack­ing an opi­oid drug fran­chise

Alk­er­mes has earned a high-pro­file po­lit­i­cal foe on Capi­tol Hill. And the show­down sud­den­ly erupt­ed in­to a high-stakes bat­tle to­day aimed at one of the com­pa­ny’s fran­chise drugs.

Richard Pops

Cal­i­for­nia Sen­a­tor Ka­mala Har­ris to­day came out swing­ing at the Waltham, MA-based com­pa­ny — domi­ciled in Ire­land for tax pur­pos­es. In a let­ter to Alk­er­mes  $ALKS CEO Richard Pops, Har­ris seized on a string of re­ports in The New York Times and else­where claim­ing that Alk­er­mes as­signed sales reps to the courts in an at­tempt to beat the bush­es for big­ger sales of its opi­oid ad­dic­tion drug Viv­it­rol.

The De­mo­c­ra­t­ic sen­a­tor — some­times men­tioned as a pos­si­ble pres­i­den­tial can­di­date — goes on to de­mand in­for­ma­tion on the com­pa­ny’s sales and sales prac­tices, look­ing in­to why its rev­enue has grown 7 times over its 2011 lev­el of $30 mil­lion. And she adds that the cam­paign by Alk­er­mes has caused the sys­tem to over­look “cheap­er and more thor­ough­ly stud­ied treat­ments” that have been “stig­ma­tized and mar­gin­al­ized.”

Alk­er­mes shares are down 4% Mon­day af­ter­noon.

Late Mon­day, Alk­er­mes re­spond­ed to a query from me, dis­agree­ing with Har­ris and tout­ing its “dis­rup­tive ap­proach that chal­lenges the treat­ment sta­tus quo….Alk­er­mes is fo­cused on en­sur­ing that pa­tients, health­care pro­fes­sion­als and crim­i­nal jus­tice of­fi­cials are ed­u­cat­ed on Viv­it­rol and be­lieves that pa­tients should have ac­cess to all med­ica­tions. ”

Har­ris’ at­tack cen­tered on claims that Alk­er­mes has been cash­ing in on the na­tion­wide opi­oid cri­sis, which has claimed thou­sands of lives. And re­peat­ed claims the com­pa­ny en­gaged in an ex­pen­sive lob­by­ing cam­paign to help smooth its path.

Sen. Ka­mala Har­ris

The sen­a­tor wants a laun­dry list of in­for­ma­tion, in­clud­ing a list of the jails and pris­ons where Alk­er­mes has been hand­ing out sam­ples for free as well as de­tails on the speak­ers’ bu­reau used to pro­mote the ther­a­py.

Pops, a soft-spo­ken phar­ma ex­ec who’s been open­ly crit­i­cal of the way some in­dus­try lead­ers have priced their prod­ucts, would seem to be an un­like­ly sub­ject for this at­tack. But Har­ris al­so en­list­ed some ex­perts in the as­sault.

“Alk­er­mes has tak­en un­eth­i­cal drug pro­mo­tion to new depths by en­list­ing judges, law en­force­ment per­son­nel, and leg­is­la­tors to fa­vor Viv­it­rol over proven treat­ments,” said Adri­ane Fugh-Berman, pro­fes­sor, de­part­ment of phar­ma­col­o­gy and phys­i­ol­o­gy, George­town Uni­ver­si­ty Med­ical Cen­ter, in a state­ment. “Alk­er­mes’ ac­tions un­der­mine pub­lic health.”

Alk­er­mes is just the lat­est in a line­up of promi­nent bio­phar­ma com­pa­nies to draw the ire of law­mak­ers and earn the hot seat in Wash­ing­ton, DC. Al­ler­gan CEO Brent Saun­ders has most re­cent­ly held the role of poster child for in­dus­try re­form af­ter en­list­ing a Mo­hawk tribe to help pro­tect its patents on Resta­sis. And they both fol­low My­lan, Marathon and im­pris­oned biotech bad boy Mar­tin Shkre­li, which have drawn claims of price goug­ing.

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

Endpoints News

Basic subscription required

Unlock this story instantly and join 58,000+ biopharma pros reading Endpoints daily — and it's free.

We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive piv­otal for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma.

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

We don’t know what the data are yet, but DREAMM-2 falls on the heels of a promising set of data delivered 5 months ago for DREAMM-1. There investigators noted that complete responses among treatment-resistant patients rose to 15% in the extra year’s worth of data to look over, with a median progression-free survival rate of 12 months, up from 7.9 months reported earlier. The median duration of response was 14.3 months.

Endpoints News

Basic subscription required

Unlock this story instantly and join 58,000+ biopharma pros reading Endpoints daily — and it's free.

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

Endpoints News

Basic subscription required

Unlock this story instantly and join 58,000+ biopharma pros reading Endpoints daily — and it's free.

Why would Am­gen want to buy Alex­ion? An­a­lysts call hot­ly ru­mored takeover un­like­ly, but seize the mo­ment

A rumor that Amgen is closing in on buyout deal for Alexion has sparked a guessing game on just what kind of M&A strategy Amgen is pursuing and how much Alexion is worth.

Mizuho analyst Salim Syed first lent credence to the report out of the Spanish news outlet Intereconomía, which said Amgen is bidding as much as $200 per share. While the source may be questionable, “the concept of this happening doesn’t sound too crazy to me,” he wrote.

FDA asks why No­var­tis took two months to launch for­mal in­ter­nal probe, af­ter AveX­is flagged da­ta ma­nip­u­la­tion

And the plot thickens. Novartis $NVS officials are reportedly now scrambling to explain to the FDA why it took them two months to open an internal investigation into data discrepancies for their $2.1 million gene-therapy for spinal muscular dystrophy — the world’s most expensive drug.

Endpoints News

Basic subscription required

Unlock this story instantly and join 58,000+ biopharma pros reading Endpoints daily — and it's free.

Build­ing on suc­cess­ful PD-1 pact, Eli Lil­ly li­cens­es di­a­betes drug to Chi­nese part­ners at In­novent

Eli Lilly is expanding its partnership with China’s Innovent in a deal involving a diabetes drug sitting in its Phase I reserves.

The two companies had jointly developed one of China’s first homegrown PD-1 agents, scoring an approval for Tyvyt (sintilimab) late last year for relapsed/refractory classical Hodgkin’s lymphoma. This time around, Lilly is out-licensing a piece of its diabetes pipeline, a leading franchise that has historically produced the top-selling Trulicity and Humalog.

Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.

Trump ad­min­is­tra­tion re­vives bid to get drug list prices on TV ads

The Trump administration is not giving up just yet. On Wednesday, the HHS filed an appeal against a judge’s decision in July to overturn a ruling obligating drug manufacturers to disclose the list price of their therapies in television adverts — hours before it was stipulated to go into effect.

In May, the HHS published a final ruling requiring drugmakers to divulge the wholesale acquisition cost— of a 30-day supply of the drug — in tv ads in a bid to enhance price transparency in the United States. The pharmaceutical industry has vehemently opposed the rule, asserting that list prices are not what a typical patient in the United States pays for treatment — that number is typically determined by the type of (or lack thereof) insurance coverage, deductibles and out-of-pocket costs. Although there is truth to that claim, the move was considered symbolic in the Trump administration’s healthcare agenda to hold drugmakers accountable in a climate where skyrocketing drug prices have incensed Americans on both sides of the aisle.