FDA of­fers sur­prise OK for My­lan’s Co­pax­one knock­offs, slam­ming Te­va

Heather Bresch, CEO of My­lan

My­lan won its years-long quest to gain an FDA OK for its copy­cat of Te­va’s 40 mg and 20 mg dos­es of the mul­ti­ple scle­ro­sis drug Co­pax­one, trig­ger­ing a se­ries of stock moves as in­vestors re­act­ed quick­ly to the un­ex­pect­ed ad­vance.

My­lan had been de­layed by in­for­ma­tion re­quests from the FDA, which prompt­ed some an­a­lysts ear­li­er to write off any pos­si­bil­i­ty of an OK this year. But FDA com­mis­sion­er Scott Got­tlieb has made swifter gener­ic ap­provals — with the im­plic­it promise of low­er drug prices — a top pri­or­i­ty at the agency.

Now Te­va is fac­ing a se­ri­ous show­down for its fran­chise brand­ed drug at a time it’s been hin­dered by price ero­sion in its own gener­ic port­fo­lio. The Is­raeli com­pa­ny has been forced to re­struc­ture this year, with a weak pipeline and a key clin­i­cal fail­ure for its MS drug suc­ces­sor this year.

Te­va’s shares $TE­VA dropped 13% this morn­ing.

Ever­cor­eISI’s Umer Raf­fat read­i­ly con­ced­ed this morn­ing that he had been wrong about the tim­ing on this. He added that My­lan ap­pears to be putting a lot of mus­cle in­to its roll­out.

My­lan is in­sti­tut­ing a pa­tient sup­port pro­gram to en­sure that pa­tients don’t have a “hard land­ing” with no sup­port ser­vices when they tran­si­tion off of Te­va’s “Shared So­lu­tions”. My­lan al­so in­tends to have co­pay as­sis­tance as well as nurs­ing sup­port. There is clear­ly some SG&A spend be­ing al­lo­cat­ed to this launch on My­lan’s part – not a tra­di­tion­al AB rat­ed gener­ic launch.

Mo­men­ta, which has strug­gled as well in get­ting its ri­val in­to the mar­ket­place, al­so took a hit — shares $MN­TA dropped 25% in ear­ly trad­ing.

The big win­ner was My­lan, which saw its stock $MYL spike 16%.

Said My­lan CEO Heather Bresch:

My­lan has in­vest­ed tens of mil­lions of dol­lars over many years to bring this im­por­tant med­i­cine to mar­ket.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Christian Itin, Autolus CEO (UKBIO19)

Au­to­lus tips its hand, bags $220M as CAR-T show­down with Gilead looms

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

Endpoints Premium

Premium subscription required

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

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

David Light, Valisure CEO

Val­isure in the hot seat: New Form 483 over a 2021 in­spec­tion as CEO fires back

The notorious drug testing company Valisure, which has made a name for itself by forcing FDA’s hand with some of its safety-related uncoverings, received a letter this week after the FDA uncovered violations at its Connecticut-based testing lab in 2021.

The letter, which was sent on Dec. 5, stated that the FDA is “concerned” that Valisure was not aware of  drug supply chain security requirements.

Mark Cuban (Jed Jacobsohn/AP Images)

Mov­ing to the em­ploy­er side of health­care, Mark Cuban's Cost Plus Drugs part­ners with a PBM

From “Shark Tank” to direct-to-consumer generic drugs, Mark Cuban has made another inroad in the ongoing battle over prescription drug prices. His cost-plus-15% generic drug company, frequently undercutting many competitors, now has its sights set on the employer healthcare market.

Cost Plus Drugs, which originally pledged to cut out PBMs, has now partnered with the PBM EmsanaRx, majority owned by the Purchaser Business Group on Health, to launch a supplemental drug discount program designed specifically for self-funded employers, the company announced Thursday.

WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,300+ biopharma pros reading Endpoints daily — and it's free.

Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Publicis Groupe CEO Arthur Sadoun (L) is joined by actor Michael Douglas in a holiday message encouraging HPV vaccination (Publicis Groupe/YouTube)

Pub­li­cis for­goes light­heart­ed hol­i­day mes­sage for more se­ri­ous HPV warn­ing with celebri­ty guest

When is an annual holiday greeting more like a disease awareness ad? That’s the case in this year’s video from French-based advertising holding company Publicis Groupe featuring chairman and CEO Arthur Sadoun and his predecessor Maurice Lévy.

The typically jovial interaction between the two quickly takes a serious turn to HPV cancers and vaccines — along with a guest star appearance by actor Michael Douglas.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,300+ biopharma pros reading Endpoints daily — and it's free.