Kåre Schultz (via YouTube)

Af­ter years of busi­ness and law­suit-fu­eled de­cline, is a Te­va turn­around in sight?

For five years, Te­va’s stock tum­bled amid a po­tent cock­tail of se­ri­ous and wide­spread le­gal al­le­ga­tions, de­clin­ing com­pa­ny and in­dus­try-wide rev­enue and debt that creaked more heav­i­ly each pass­ing year. Now, their CEO and some in­vestors think they can see the light.

Te­va re­leased their quar­ter­ly earn­ings re­port yes­ter­day, and the stock took a 10% jump, to over $13. That’s still a drop in the buck­et com­pared with the years lead­ing up to 2016, when the stock briefly pushed past $70, but a no­tice­able bump af­ter a half-decade of al­most di­rect de­cline.

Those earn­ings showed Te­va’s rev­enue up to $4.5 bil­lion, a $100 mil­lion ahead of ex­pec­ta­tions, and said they ex­pect­ed strong growth in 2020 from two new drugs: Auste­do and Ajovy. In an in­ter­view with CN­BC, CEO Kåre Schultz said that the com­pa­ny had be­gun to turn a cor­ner in the shift he was brought on to lead.

“We have done the first part, which was re­struc­tur­ing,” Schultz said. That in­clud­ed clos­ing 12 man­u­fac­tur­ing sites and 40 of­fices and labs, cut­ting 13,000 em­ploy­ees and sav­ing $3 bil­lion in costs.

Bren­dan O’Grady

In ad­di­tion to the two new ap­proved drugs, one for Hunt­ing­ton’s and the oth­er for mi­graine, last year, the com­pa­ny got ap­proval for Trux­i­ma, the first US biosim­i­lar to Roche’s Rit­ux­an. Biosim­i­lar up­take in the US has tra­di­tion­al­ly been low, but Bren­dan O’Grady, the North Amer­i­can chief, told in­vestors they’ve al­ready achieved 12%-15% mar­ket share. The com­pa­ny ex­pects to bring in sev­er­al hun­dred mil­lion dol­lars a year.

Te­va’s strug­gles came from a wide range of fac­tors. In the years lead­ing up to 2016, the Is­raeli gener­ics mak­er had be­come a se­r­i­al deal­mak­er, even once at­tempt­ing to pur­chase one of their biggest com­peti­tors in My­lan Phar­ma­ceu­ti­cals. It al­so had sig­nif­i­cant rev­enue from one of its first big-brand­ed drugs: Co­pax­one, a mul­ti­ple scle­ro­sis treat­ment that was pre­scribed to a sig­nif­i­cant share of MS pa­tients and at its peak earned Te­va over $3 bil­lion in a sin­gle year.

But a few things be­gan to change around 2016. The com­pa­ny was caught up, along­side My­lan and four small­er com­pa­nies, in a ma­jor an­titrust suit in which 20 states at­tor­ney gen­er­al ac­cused them of con­spir­ing to ar­ti­fi­cial­ly in­flate prices. Mean­while, the cost of gener­ics was falling, a drop Schulz at­trib­uted to buy­ers con­sol­i­dat­ing and In­di­an and Chi­nese com­pa­nies en­ter­ing the gener­ics mar­ket.

At the same time, the com­pa­ny had grow­ing debt oblig­a­tions. Its ef­forts to come up with a re­place­ment for Co­pax­one be­fore patent ex­pi­ra­tion failed. Soon, it was al­so named in the hun­dreds of law­suits from states and lo­cal­i­ties for its role in dis­trib­ut­ing opi­oids dur­ing the opi­oid abuse epi­dem­ic and for fail­ing to ful­fill its le­gal oblig­a­tion to halt sus­pi­cious or­ders of con­trolled sub­stances.

Part of the new in­vestor op­ti­mism stems from the fact that Te­va has reached a ten­ta­tive agree­ment to sup­ply what it calls $23 bil­lion worth of Sub­ox­one. That num­ber, though, is mis­lead­ing as to what it will ac­tu­al­ly cost Te­va, which one an­a­lyst pegged at around $2.3 bil­lion. The deal is not fi­nal­ized, though, and a sim­i­lar pro­pos­al of­fered by Pur­due Phar­ma to set­tle its claims has faced sig­nif­i­cant push­back.

FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Blueprint CEO Jeff Albers (file photo)

Blue­print plots re­turn to FDA with new Ay­vak­it da­ta in rare con­di­tion — and the an­a­lysts cheer

Over a decade after launch, Blueprint Medicines nabbed the first approval for their first drug earlier this year. Now, as they move forward with a Roche-partnered global launch, they’re touting data that could push them into more patients.

The Jeff Albers-led Cambridge biotech released their full pivotal data for Ayvakit in patients with advanced systemic mastocytosis. In one 53-person study, they showed that 76% of patients responded to the drug, 36% had complete responses and that on average their responses lasted for just over 3 years. A smaller, 32-patient study had a 75% response rate and most were still responding after 10.4 months, the last follow-up.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Can a mag­net­ic cell ther­a­py re­place corneal trans­plan­ta­tion? As eight-year jour­ney leads to the clin­ic, two broth­ers un­veil bold vi­sion

Jeff Goldberg was getting acquainted with a brand new way to do corneal transplants when an even newer, even bolder idea hit him.

It was almost 10 years ago, and Goldberg was in his first faculty position at Bascom Palmer Eye Institute at the University of Miami. Scientists had developed a new way to do cornea transplants where instead of sewing a whole donor cornea — a decades-old practice — they were just engrafting the inner layer of cells.

News brief­ing: Tiny Vac­cinex's drug flops in PhII Hunt­ing­ton's tri­al, stock craters; Siol­ta nabs $30M Se­ries B to de­vel­op mi­cro­bio­me drug

Siolta Therapeutics, a microbiome company targeting allergic diseases, raked in a $30 million Series B to develop its lead candidate, STMC-103H. The drug, which has been FDA fast-tracked, is headed for proof-of-concept trials, according to the company. Its various indications include allergic asthma, food allergies, atopic dermatitis, allergic rhinitis, and allergy prevention.

The news comes just after the California-based biotech added a prominent biopharma veteran as an advisor: 20-year Gilead CEO John Martin. The biotech also gained Richard Shames as CMO, who came by way of Protagonist Therapeutics.

Embattled CDC director Robert Redfield (AP Images)

Covid-19 roundup: CDC ad­vi­so­ry com­mit­tee de­lays pri­or­i­ty dis­tri­b­u­tion vote; EU re­port­ed­ly in­dem­ni­fy­ing vac­cine mak­ers

A federal committee that advises the CDC was expected to hold a vote Tuesday on a plan regarding the distribution for initial doses of approved Covid-19 vaccines. But that vote has been scrapped.

The Advisory Committee on Immunization Practices, or ACIP, won’t be voting until the committee members learn more about which vaccines become available first, the Wall Street Journal reported. The vote could potentially wait until a specific vaccine is authorized before recommending how to dole out the first doses.

Anthony Coyle (Repertoire)

Flag­ship's merged biotech Reper­toire nets ex-Pfiz­er CSO An­tho­ny Coyle as R&D chief

Flagship is building a big-name C-suite at its new, $220 million merged biotech.

Repertoire Immune Medicines, which already boasts former Bioverativ chief John Cox as its CEO, announced yesterday that Anthony Coyle, the former Pfizer CSO and the founding CEO of Pandion, will join as their head of R&D.

“As we progress clinical trials for our multi-clonal T cell candidates in immuno-oncology, Tony’s deep expertise in cellular immunology and novel therapeutic development will help us achieve our vision of creating a new class of transformative medicines for patients,” Cox said in a statement.