Puma in­vestors fret, as Ner­l­ynx Q1 sales fall un­com­fort­ably short of Wall Street es­ti­mates

“We are not pleased with our first-quar­ter Ner­l­ynx rev­enues,” Puma Biotech­nol­o­gy chief Alan Auer­bach said in a post-earn­ings con­fer­ence call on Thurs­day, cit­ing a spate of dis­con­cert­ing fac­tors, in­clud­ing pa­tient dis­con­tin­u­a­tions. In­vestors con­curred with his as­sess­ment, as the stock $PBYI cratered. The dis­dain con­tin­ued ear­ly Fri­day, as shares fell near­ly 37% to $18.96 be­fore the bell.

Alan Auer­bach

The drug, which was in-li­censed by Puma from Pfiz­er $PFE, was ap­proved by the FDA in Ju­ly 2017, to pre­vent breast can­cer re­lapse, fol­low­ing ther­a­py in pa­tients with HER2-pos­i­tive can­cer. The treat­ment is known to have a poor tol­er­a­bil­i­ty pro­file, pre­dom­i­nant­ly re­lat­ing to di­ar­rhea. The Los An­ge­les-based com­pa­ny post­ed Q1 Ner­l­ynx sales of $45.6 mil­lion — a 25% de­cline quar­ter-over-quar­ter — and well be­low Street con­sen­sus ex­pec­ta­tions of about $67 mil­lion.

“The dis­con­tin­u­a­tions oc­cur more fre­quent­ly in the first month. While most physi­cians pre­scribe an an­ti-di­ar­rheal med­ica­tion with Ner­l­ynx, our re­search shows that some pa­tients may not fill the an­ti-di­ar­rheal pre­scrip­tion. There were al­so some physi­cians not pre­scrib­ing any an­ti-di­ar­rheal pro­phy­lax­is med­ica­tions at all, which we be­lieve was due to the lack of aware­ness of the da­ta from our con­trol tri­al us­ing pro­phy­lac­tic an­ti-di­ar­rheal drugs,” Puma CCO Steven Lo said on the call.

Steven Lo

Oth­er rea­sons for the sales miss were at­trib­uted to: pa­tient dis­con­tin­u­a­tions ow­ing to the pro­gres­sion of the dis­ease, or loss of in­sur­ance; an ab­nor­mal­ly high va­can­cy rate in the sales force, with 18 of 80 sales ter­ri­to­ries en­dur­ing turnover dur­ing the quar­ter; and pa­tients com­plet­ing one year of treat­ment on Ner­l­ynx as in­di­cat­ed on the la­bel.

“The neg­a­tive im­pact from treat­ment dis­con­tin­u­a­tions di­rect­ly re­lat­ed to Ner­l­ynx’s chal­leng­ing tol­er­a­bil­i­ty pro­file, which has seem­ing­ly had a re­laps­ing/re­mit­ting im­pact on quar­ter­ly com­mer­cial re­sults, was ex­plic­it­ly de­scribed as worse than ex­pect­ed – in­creas­ing­ly se­quen­tial­ly…Def­i­nite­ly more dis­con­cert­ing, how­ev­er, was the rev­e­la­tion that at cer­tain pe­ri­ods dur­ing the quar­ter, the com­pa­ny’s “high­er than av­er­age va­can­cy rate in (their) sales force” with 18 of 80, or 22% of sales ter­ri­to­ries ‘not hav­ing a sales rep at some point in the quar­ter.’ While seats have ap­par­ent­ly been most­ly re-filled…this sce­nario rais­es con­cerns re­gard­ing the sus­tain­abil­i­ty of the ap­par­ent re­bound seen in April (2Q to date). How­ev­er, the sub­dued tone with which com­men­tary was de­liv­ered, makes it chal­leng­ing to muster con­fi­dence that com­mer­cial dy­nam­ics can achieve even low­ered full-year 2019 Ner­l­ynx sales guid­ance,” Cowen an­a­lysts wrote in a note.

SVB Leerink an­a­lysts low­ered their 2019 US rev­enue es­ti­mates to $221 mil­lion from $265 mil­lion and tem­pered their peak US sales ex­pec­ta­tions to about $369 mil­lion from $400 mil­lion.

Af­ter suc­cess­ful­ly lob­by­ing Eu­ro­pean reg­u­la­tors to have a change of heart and ap­prove Ner­l­ynx last year, Puma palmed off the treat­ment to Pierre Fab­re — its sixth mar­ket­ing part­ner —with the Unit­ed States and Japan as the on­ly re­main­ing un­en­cum­bered ma­jor mar­kets.

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Take­da swoops in to buy lit­tle biotech part­ner and its celi­ac drug poised to 'change stan­dard of care'

Having spent three years carefully grooming PvP Biologics and its drug for celiac disease, Takeda is happy enough with the proof-of-concept data to buy it all.

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Bio­gen touts new ev­i­dence from the gene ther­a­py com­pa­ny it wa­gered $800M on

A year ago, Biogen made a big bet on a small gene therapy company. Now they have new evidence one of their therapies could work.

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Mi­cro­bio­me Q&A: New study maps the vagi­na's 'op­ti­mal mi­cro­bio­ta' — and its im­pli­ca­tions for bio­phar­ma

The widely-held notion that the “optimal” vaginal microbiota is dominated by one strain of lactic-acid producing bacteria has now been challenged in a new paper, published in Nature Communications on Wednesday, which used advanced gene sequencing methods to map out the most comprehensive gene catalog of the human vaginal microbiome.

Things have changed in the more than 50 years since the concept of vaginal microbiota transplants was proposed and subsequently tainted by a Texas-based gynecologist who transplanted the vaginal fluid of women who had bacterial vaginosis into healthy females, suspecting he had isolated the bacteria responsible for the condition.

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In at least one life-sci hub, gen­der and di­ver­si­ty ini­tia­tives haven’t made a dent

Gender and racial diversity at the top of UK life science companies has hardly budged over the last seven years despite repeated advocacy efforts, according to a new report.

The report, from the recruiting firm Liftstream, found that 14.8% of directors on life sciences boards were women and 21.1% of top executives were women. That’s a modest bump from the 9.8% of directors and 18.1% of executives Liftstream identified in their last report from 2014. The percentage of women CEOs moved from 8% to 9.8%.

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Will a 'risk-of­f' mind­set has­ten cell ther­a­py M&A? Io­vance surges on buy­out chat­ter

Is it time for some cell therapy M&A?

Investors of Iovance Biotherapeutics certainly thought so, sending its stock $IOVA up as much as 40% after Bloomberg reported that the cancer-focused biotech is talking to potential buyers.

While 2019 saw a number of high-profile gene therapy company takeovers — led by Roche’s $4.3 billion bid of Spark as Astellas went for Audentes, Biogen snapped up Nightstar and Vertex absorbed Exonics — large players appeared to prefer partnering on the cell therapy front, particularly when it comes to cancer. Hal Barron put his weight behind Rick Klausner’s startup as he rebuilt GlaxoSmithKline’s cancer pipeline. Takeda turned to MD Anderson to license their natural killer cell therapy.

One less ri­val for Im­muno­vant, as Alex­ion aban­dons FcRn in­hibitor

Less than one year after Alexion parted with $25 million upfront to secure access to a second anti-FcRn asset, it is abandoning the experimental drug. The discontinuation, disclosed at the SVB Leerink Global Healthcare Conference in New York during a fireside chat, bodes well for rival Immunovant.

The drug (ABY-039), partnered for development with Sweden’s Affibody, was forsaken on the basis of early-stage data that was not viewed favorably, Baird and SVB Leerink analysts noted.

Clin­i­cal tri­al spon­sors have to dis­close decade’s worth of un­re­leased da­ta, fed­er­al judge rules

A decade’s worth of unreleased trial data may soon see the light of day.

A New York federal judge ruled this week that the FDA and the NIH have for years misinterpreted a law that would require companies, universities and other clinical trial sponsors to release trial data from studies completed between 2007 and 2017. The ruling covers drugs and medical devices that were experimental when the study was completed but have since been approved, potentially putting hundreds of sponsors out of compliance if they don’t put their results on clinicaltrials.gov.

Laurie Glimcher and Ansbert Gadicke (Justin Knight, Dana-Farber Cancer Institute)

Ty­ing ba­sic sci­ence to spin­outs, Dana-Far­ber de­buts sis­ter funds to­tal­ing $126M with MPM Cap­i­tal

As one of the most prestigious cancer institutes in the US, Dana-Farber has enjoyed considerable support for its entrepreneurial pursuits, spinning out about 30 companies in the past 12 years.

“Now where we’ve always struggled — where every cancer center struggled — is support of basic science,” Barrett Rollins, chief scientific officer emeritus, told Endpoints News.

And then two of its trustees had an idea. What if they tied philanthropy to investment in Dana-Farber startups, requiring a donation to basic science as a condition for accessing its brightest biotech venture ideas?