Bio­gen lays out a plan to “stream­line” ops, add $400M to fund neu­ro­sciences R&D, new deals

Bio­gen saw its share price $BI­IB pop up more than 5% Tues­day morn­ing as the com­pa­ny re­port­ed sharply high­er rev­enue for Spin­raza, in­di­cat­ing that they have a ma­jor com­mer­cial hit on their hands. And CEO Michel Vounatsos is seiz­ing the mo­ment, out­lin­ing plans to in­vest hun­dreds of mil­lions more each year in its neu­ro­sciences R&D work as he plans to ful­fill a vow to make Bio­gen the lead­ing com­pa­ny in the field. Those plans in­clude late-stage ac­qui­si­tions and “deals of all sizes.”

Michel Vounatsos, Bio­gen

To do that, Bio­gen said that it plans to “stream­line” op­er­a­tions — usu­al­ly code for lay­offs, which is a tac­tic that Bio­gen em­ploys reg­u­lar­ly — with a plan to boost “pri­or­i­tized R&D and com­mer­cial val­ue cre­ation op­por­tu­ni­ties” by $400 mil­lion a year by 2019.

This strat­e­gy will re­ly on see­ing the busi­ness de­vel­op­ment team get busy on deals, some­thing an­a­lysts have been wait­ing for now for more than a year.

Here’s the pledge:

Bio­gen’s new pri­or­i­ty for cap­i­tal de­ploy­ment is to in­vest in build­ing its pipeline through in­creased busi­ness de­vel­op­ment ac­tiv­i­ty. The Com­pa­ny con­tin­ues to fo­cus on max­i­miz­ing long-term share­hold­er val­ue cre­ation, and aims to de­ploy cap­i­tal to gen­er­ate re­turns mean­ing­ful­ly above its cost of cap­i­tal. Bio­gen views in­vest­ment in growth as its top pri­or­i­ty, but al­so rec­og­nizes the val­ue of op­por­tunis­ti­cal­ly re­turn­ing ex­cess cap­i­tal to share­hold­ers through share re­pur­chas­es.

“We will ex­plore deals of all sizes and will re­main dis­ci­plined about our ap­proach,” Vounatsos told an­a­lysts in the morn­ing call. And the ex­ec­u­tive team un­der­scored that the com­pa­ny plans to add late-stage as­sets to the pipeline, un­der­scor­ing their will­ing­ness to spend big.

Bio­gen has done deals over the past year, but a num­ber of an­a­lysts have com­plained that they haven’t seen the com­pa­ny get down to busi­ness in earnest. Vounatsos took over as CEO in that en­vi­ron­ment at the be­gin­ning of the year, af­ter a long stretch with George Scan­gos at the helm. Case in point, Ge­of­frey Porges not­ed at JP Mor­gan in Jan­u­ary that:

Bio­gen has one of the clean­est bal­ance sheets in large cap biotech­nol­o­gy and could af­ford to take on lever­age for mean­ing­ful neu­ro­science M&A deals.

Bio­gen has a big fo­cus on new Alzheimer’s drugs, pur­su­ing a piv­otal pro­gram for ad­u­canum­ab as well as bag­ging an an­ti-tau an­ti­body from Bris­tol-My­ers Squibb last month in a $360 mil­lion deal.

The ques­tion now is whether Bio­gen plans a string of new deals or a ma­jor, trans­for­ma­tion­al buy­out, the kind of M&A that the in­vest­ment com­mu­ni­ty has been lust­ing to see.

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.

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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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.

#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.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists. HHS con­tin­ues to claim Azar “will de­fer com­plete­ly to the FDA"

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

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.

#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.