Over­wrought mar­ket­ing? Ads, not re­search, cre­ate some phar­ma best-sell­ers

An over­head light draw­ing at­ten­tion to his face, ac­tor Dan­ny Glover starts to cry, drop­ping his head in­to one hand — then, he abrupt­ly switch­es over to deep bel­ly laughs, be­fore re­sum­ing a straight face. “When I act, if I do this it’s to­tal­ly in my con­trol,” he says, get­ting to the point: “But for some­one with pseudob­ul­bar af­fect, choos­ing to cry or laugh may not be your de­ci­sion.”

The 60-sec­ond TV ad­ver­tise­ment, which ran wide­ly late last year, con­cerns a neu­ro­log­i­cal con­di­tion known by the acronym PBA, char­ac­ter­ized by in­ap­pro­pri­ate, un­con­trolled out­bursts of laugh­ing or cry­ing. Though no drug is men­tioned, the ad­ver­tise­ment is spon­sored by Avanir Phar­ma­ceu­ti­cals, an Al­iso Viejo, Calif., firm that launched Nuedex­ta, a pricey, brand-name med­i­cine that tar­gets the dis­or­der. The ad ends by re­fer­ring peo­ple to a web­site and toll-free num­ber for more in­for­ma­tion.

PBA is re­al, most­ly af­fect­ing peo­ple with neu­ro­log­i­cal con­di­tions such as mul­ti­ple scle­ro­sis, a re­cent stroke or Lou Gehrig’s dis­ease. It runs the spec­trum from mild to se­vere im­pair­ment. Be­cause the de­f­i­n­i­tion of the con­di­tion is am­bigu­ous, es­ti­mates of its preva­lence vary wide­ly. Some clin­i­cians say PBA is rel­a­tive­ly un­com­mon among their pa­tients, while Avanir sets the num­ber at near­ly 2 mil­lion.

But the ad cam­paign has helped fu­el the con­tro­ver­sy over how di­rect-to-con­sumer (DTC) ad­ver­tis­ing — typ­i­fied by ads that call on you to “ask your doc­tor” about a pos­si­ble treat­ment — takes niche med­i­cine and pro­motes its use for a broad range of pa­tients and fos­ters the use of pricey pre­scrip­tion prod­ucts when cheap­er ones might suf­fice.

“I sus­pect this dis­ease is be­ing re­de­fined to in­clude over­ly emo­tion­al peo­ple” through ad­ver­tis­ing, said Adri­ane Fugh-Berman, a doc­tor who teach­es at George­town Uni­ver­si­ty Med­ical Cen­ter and has in­ves­ti­gat­ed phar­ma­ceu­ti­cal mar­ket­ing prac­tices. The Unit­ed States is one of two coun­tries that al­lows ad­ver­tis­ing of pre­scrip­tion drugs.

Not so, says the com­pa­ny in a writ­ten state­ment out­lin­ing that its ef­forts are “fo­cused on rais­ing aware­ness about PBA to help peo­ple bet­ter un­der­stand the symp­toms of a con­di­tion that is of­ten over­looked, mis­un­der­stood and mis­di­ag­nosed.”

The case of Nuedex­ta is no­table be­cause of its price, more than $700 a month for a sup­ply of the twice-a-day pills. The drug is a com­bi­na­tion of two low-cost in­gre­di­ents — an over-the-counter cough med­i­cine and a gener­ic heart drug — that, pur­chased sep­a­rate­ly, would run rough­ly $20 a month based on on­line cost es­ti­ma­tors. To be sure, the com­par­i­son is ap­ples to or­anges be­cause the dosage of the heart drug is so much low­er in Nuedex­ta than is gen­er­al­ly avail­able on its own by pre­scrip­tion. Ex­perts say a do-it-your­self treat­ment would be dif­fi­cult and po­ten­tial­ly dan­ger­ous for a con­sumer to try to con­coct. “You’d have to get the ex­act dos­es right, and that would be tricky,” said Dr. Aiesha Ahmed, a neu­rol­o­gist at Penn State Her­shey Med­ical Cen­ter who has re­searched the preva­lence of PBA and its treat­ment op­tions.

The pill doesn’t cure PBA but must be tak­en for the rest of a pa­tient’s life to help re­duce the laugh­ing or cry­ing episodes. While it’s the on­ly Food and Drug Ad­min­is­tra­tion-ap­proved drug specif­i­cal­ly for PBA, doc­tors have suc­cess­ful­ly treat­ed the con­di­tion with sev­er­al al­ter­na­tives cost­ing far less — all an­ti­de­pres­sants.

“The cost for mix­ing two old drugs to­geth­er is un­con­scionable,” said Jer­ry Avorn, pro­fes­sor of med­i­cine at Har­vard Med­ical School and chief of the Di­vi­sion of Phar­ma­coepi­demi­ol­o­gy and Phar­ma­coeco­nom­ics at Brigham and Women’s Hos­pi­tal.

The strate­gic mar­ket­ing of Nuedex­ta is part of a broad­er trend in which even small phar­ma­ceu­ti­cal firms turn to high-cost air­waves to en­cour­age use of their prod­ucts. Phar­ma­ceu­ti­cal in­dus­try spend­ing on DTC tele­vi­sion ads has been on the rise — up 62 per­cent since 2012 to an es­ti­mat­ed $6.4 bil­lion in 2016 — even as TV ad­ver­tis­ing for oth­er prod­uct types stayed flat, ac­cord­ing to Kan­tar Me­dia, a con­sult­ing firm that tracks mul­ti­me­dia ad­ver­tis­ing. By last year, drug ads were the sixth-most-com­mon cat­e­go­ry of tele­vi­sion ad­ver­tise­ment — be­hind such things as cars and restau­rants — up from 12th just five years ago.

A num­ber of the ads, like Nuedex­ta’s, pro­mote med­ica­tion for rel­a­tive­ly un­usu­al con­di­tions, such as a sleep dis­or­der that af­fects on­ly peo­ple who are blind; or more com­mon con­di­tions, such as opi­oid-in­duced con­sti­pa­tion.

Drug­mak­ers de­fend the slew of ad­ver­tise­ments as ed­u­cat­ing pa­tients who may not un­der­stand they have a dis­ease or that their symp­toms can be treat­ed. The un­con­trolled laugh­ing or cry­ing of PBA “is quite de­bil­i­tat­ing,” and Nuedex­ta pro­vides sub­stan­tial re­lief for many, said Avanir’s chief med­ical of­fi­cer, Rick Mala­mut, a neu­rol­o­gist who re­cent­ly joined the com­pa­ny.

Avanir de­clined to say how much it is spend­ing to mar­ket Nuedex­ta. In jus­ti­fy­ing the price, Mala­mut said the com­pa­ny had in­vest­ed hun­dreds of mil­lions of dol­lars over 10 years on re­search be­fore win­ning FDA ap­proval in late 2010. More is now be­ing spent to re­search whether it — or oth­er Avanir prod­ucts — could help with oth­er neu­ro­log­i­cal con­di­tions.

“We un­der­stand the cost of med­ica­tion is bur­den­some for peo­ple with­out [in­sur­ance] cov­er­age,” he said, not­ing the com­pa­ny of­fers fi­nan­cial as­sis­tance to help such pa­tients.

Some ex­perts say the cost isn’t worth it: “If it were your loved one, there would prob­a­bly be a val­ue to pre­vent these episodes,” said Mark Pauly, a health econ­o­mist at the Whar­ton School of the Uni­ver­si­ty of Penn­syl­va­nia, of the bouts of laugh­ter and cry­ing. But, he added: “As a hard­heart­ed econ­o­mist, I have to ask if it’s worth $700 a month.”

Still, the mar­ket has proved lu­cra­tive. Nuedex­ta’s sales have risen from about $37 mil­lion in 2012 to $218 mil­lion last year, ac­cord­ing to Eval­u­atePhar­ma, which tracks phar­ma­ceu­ti­cal in­dus­try pric­ing and mar­kets.

Strate­gi­cal­ly Rais­ing A Drug’s Pro­file

The sto­ry of Nuedex­ta be­gan with Richard Smith, a neu­rol­o­gist whose Cen­ter for Neu­ro­log­ic Study was look­ing to de­vel­op a new treat­ment for Lou Gehrig’s dis­ease, al­so known as ALS. In the ear­ly 2000s, Smith com­bined dex­tromethor­phan — the main in­gre­di­ent in cough syrups such as Ro­bi­tussin — with quini­dine, a drug used to treat ir­reg­u­lar heart rhythms. The heart drug helps boost and main­tain lev­els of the dex­tromethor­phan in the blood­stream.

What his re­search team ob­served in pre­lim­i­nary stud­ies was that pa­tients “al­most im­me­di­ate­ly start­ed re­port­ing an ef­fect on PBA,” said Smith, in a tele­phone in­ter­view. The drug was even­tu­al­ly sold to Avanir. In Oc­to­ber 2006, the FDA re­spond­ed that the drug looked ap­prov­able, but in­ves­ti­ga­tors had “fun­da­men­tal ques­tions about both the ef­fec­tive­ness and safe­ty of the prod­uct.”

The com­pa­ny then low­ered the dose of the heart drug and per­formed an­oth­er clin­i­cal tri­al, which found the drug cut in half the num­ber of episodes of un­con­trolled laugh­ing or cry­ing by pa­tients who took it rather than a place­bo. It was not com­pared with oth­er treat­ments al­ready in use and the pa­tients in the study had ei­ther MS or ALS. It gained the FDA’s OK in late 2010.

Ear­ly on, Avanir ex­ec­u­tives were clear that they had big am­bi­tions for the new prod­uct. In 2013, then-CEO Kei­th Katkin tout­ed the drug as a “pipeline in a pill” to in­vestors, pre­dict­ing it could even­tu­al­ly be used in a host of con­di­tions, from pain re­lat­ed to MS to ag­i­ta­tion in pa­tients with de­men­tia.

Dur­ing and af­ter ap­proval of the drug, Avanir pro­vid­ed ed­u­ca­tion­al talks for doc­tors aimed at rais­ing the pro­file of the lit­tle-known con­di­tion and ex­pand­ing the use of their drug.

It made a pitch to con­sumers with a 2013 ad cam­paign on­line and on tele­vi­sion that di­rect­ed view­ers to a web­site. The cam­paign pro­duced “an over­whelm­ing” re­sponse, with “350,000 new unique vis­i­tors to the web­site or calls to the hot­line,” Kei­th A. Katkin, the chief ex­ec­u­tive at the time, told in­vestors that year.

That po­ten­tial — along with oth­er drugs in Avanir’s re­search labs — helped prompt Japan-based Ot­su­ka Hold­ings to pur­chase Avanir in 2014 for $3.5 bil­lion.

But af­ter mar­ket­ing sur­veys found that, still, on­ly about one-third of po­ten­tial pa­tients and pri­ma­ry care doc­tors who treat such pa­tients knew about PBA, Avanir de­cid­ed to en­list Glover’s celebri­ty fire­pow­er, said Lau­ren D’An­ge­lo, se­nior di­rec­tor of mar­ket­ing for Avanir.

The ad fea­tur­ing Glover, who doesn’t him­self have PBA or any per­son­al link to it, was on ca­ble and na­tion­al news pro­grams spo­rad­i­cal­ly in 2015 and through the end of De­cem­ber the fol­low­ing year. Glover’s pub­li­cist didn’t of­fer any ad­di­tion­al com­ment for this sto­ry.

The ad is “non-brand­ed” — mean­ing the drug is not men­tioned — and there­fore isn’t re­quired by the FDA to list side ef­fects and risks. In­stead, it sim­ply sug­gests pa­tients ask their doc­tor about treat­ment or go a web­site to find out more about PBA. Aware­ness among pri­ma­ry care doc­tors rose to 72 per­cent and 52 per­cent among pa­tients.

“It was an ex­treme­ly suc­cess­ful cam­paign,” D’An­ge­lo said. “We drove a lot of pa­tients in­to doc­tors’ of­fices. The chal­lenge was they did not ask for Nuedex­ta by name.” For sales, that was a prob­lem. In­stead of get­ting Nuedex­ta, some pa­tients were in­cor­rect­ly di­ag­nosed or pre­scribed an an­ti­de­pres­sant, she said.

So, in 2017, the drug­mak­er un­veiled a new ad­ver­tis­ing cam­paign.

This one, which is cur­rent­ly run­ning on prime-time TV, fea­tures a man in­ex­plic­a­bly burst­ing in­to tears at a child’s birth­day par­ty. It in­tends to move po­ten­tial cus­tomers be­yond “could you have PBA?” to “ask your doc­tor for Nuedex­ta.”

“We are mim­ic­k­ing what we want them to do, to ask about PBA and ask about Nuedex­ta,” said D’An­ge­lo.

And there’s good rea­son for this kind of mes­sag­ing. A 2016 poll, for in­stance, con­duct­ed by Med­scape, an on­line physi­cian ed­u­ca­tion web­site, found that 62 per­cent of physi­cians said they would or might pre­scribe an in­nocu­ous, even place­bo treat­ment to a pa­tient who didn’t need it but de­mand­ed it.

Some neu­rol­o­gists are fans of the drug. Ken­neth Heil­man, a pro­fes­sor of neu­rol­o­gy at the Uni­ver­si­ty of Flori­da School of Med­i­cine and a fel­low of the Amer­i­can Acad­e­my of Neu­rol­o­gy says Nuedex­ta “seems to con­trol [PBA symp­toms] very well.” He al­so doesn’t ob­ject to the ad­ver­tis­ing cam­paign, since it might be use­ful in alert­ing fam­i­ly physi­cians who don’t know about the dis­or­der. (Dr. Heil­man does not get any mon­ey from Avanir.)

Who Needs Nuedex­ta? Do You?

But PBA can be dif­fi­cult to di­ag­nose, be­cause symp­toms — cry­ing and emo­tion­al volatil­i­ty — can be at­trib­uted to oth­er con­di­tions, such as de­pres­sion. In­ap­pro­pri­ate laugh­ter or tears are rel­a­tive­ly com­mon in de­men­tia, re­ferred to mere­ly as “emo­tion­al la­bil­i­ty” in many oth­er coun­tries, but may not con­sti­tute a prob­lem that needs treat­ment. Many ex­perts wor­ry that “pa­tient aware­ness” and press­ing doc­tors to write pre­scrip­tions will lead to overuse.

On the PBA in­for­ma­tion­al web­site, cre­at­ed by Avanir, the com­pa­ny pro­vides a sev­en-ques­tion self-as­sess­ment.

The ques­tion­naire al­lows a range of an­swers about the fre­quen­cy of symp­toms, with test tak­ers able to re­spond nev­er, rarely, oc­ca­sion­al­ly, fre­quent­ly or most of the time. Ques­tions in­clude: “There are times when I feel fine one minute, and then I’ll be­come tear­ful the next over some­thing small or for no rea­son at all.” “I find my­self cry­ing very eas­i­ly.” “There are times when I won’t be think­ing of any­thing hap­py or fun­ny at all, but will sud­den­ly be over­come by fun­ny or hap­py thoughts.”

The scale au­to­mat­i­cal­ly awards sev­en points to those who take it — even when “nev­er” is the an­swer to all ques­tions. A score of 13 is need­ed to in­di­cate the po­ten­tial for PBA. A con­sumer an­swer­ing “nev­er” to one of the ques­tions, “rarely” to five and “oc­ca­sion­al­ly” to just one scores 14.

Ear­ly on, FDA re­view­ers raised ques­tions about this test and some ex­perts con­tin­ue to ex­press sim­i­lar con­cerns.

Di­ag­nos­ing who ac­tu­al­ly has a PBA con­di­tion re­quires ask­ing how it af­fects a per­son’s life, said Dr. Lau­ra Boy­lan, a neu­rol­o­gist and ad­junct pro­fes­sor at New York Uni­ver­si­ty School of Med­i­cine who treats pa­tients with psy­chi­atric con­cerns re­lat­ed to neu­ro­log­i­cal dis­eases.

While she ac­knowl­edged that PBA — which she says is more ac­cu­rate­ly called “patho­log­ic af­fect” — is un­der-rec­og­nized by the med­ical pro­fes­sion, she wor­ries about over­pre­scrib­ing: “I’m the kind of per­son who gets all teary at AT&T ads,” said Boy­lan. “I’m just like that and would not want to take a med­i­cine to stop that. What if we start giv­ing Nuedex­ta to peo­ple who are just emo­tion­al peo­ple?”

Kaiser Health News, a non­prof­it health news­room whose sto­ries ap­pear in news out­lets na­tion­wide, is an ed­i­to­ri­al­ly in­de­pen­dent part of the Kaiser Fam­i­ly Foun­da­tion.

Eli Lil­ly’s first PhI­II show­down for their $1.6B can­cer drug just flopped — what now?

When Eli Lilly plunked down $1.6 billion in cash to acquire Armo Biosciences a little more than a year ago, the stars seemed aligned in its favor. The jewel in the crown they were buying was pegilodecakin, which had cleared the proof-of-concept stage and was already in a Phase III trial for pancreatic cancer.

And that study just failed.

Lilly reported this morning that their cancer drug flopped on overall survival when added to FOLFOX (folinic acid, 5-FU, oxaliplatin), compared to FOLFOX alone among patients suffering from advanced pancreatic cancer.

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Mi­rati preps its first look at their KRAS G12C con­tender, and they have to clear a high bar for suc­cess

If you’re a big KRAS G12C fan, mark your calendars for October 28 at 4:20 pm EDT.

That’s when Mirati $MRTX will unveil its first peek at the early clinical data available on MRTX849 in presentations at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

Mirati has been experiencing the full effect of a rival’s initial success at targeting the G12C pocket found on KRAS, offering the biotech some support on the concept they’re after — and biotech fans a race to the top. Amgen made a big splash with its first positive snapshot on lung cancer, but deflated sky-high expectations as it proved harder to find similar benefits in other types of cancers.

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The FDA will hus­tle up an ex­pe­dit­ed re­view for As­traZeneca’s next shot at a block­buster can­cer drug fran­chise

AstraZeneca paid a hefty price to partner with Daiichi Sankyo on their experimental antibody drug conjugate for HER2 positive breast cancer. And they’ve been rewarded with a fast ride through the FDA, with a straight shot at creating another blockbuster oncology franchise.

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Sean Parker, AP

Sean Park­er helps cre­ate a CRISPRed cell ther­a­py 2.0 play — and he’s got a high-pro­file set of lead­ers on the team

You can rack up one more high-profile debut effort in the wave of activity forming around cell therapy 2.0. It’s another appealing Bay Area group that’s attracted some of the top hands in the business to a multi-year effort to create a breakthrough. And they have $85 million in hand to make that first big step to the clinic.

Today it’s Ken Drazan and the team at South San Francisco-based ArsenalBio that are coming from behind the curtain for a public bow, backed by billionaire Sean Parker and a collection of investors that includes Beth Seidenberg’s new venture investment operation based in LA.
Drazan — a J&J Innovation vet with a long record of entrepreneurial endeavors — exited the stage in 2018 when his last mission ended as he stepped aside as president of Grail. It wasn’t long, though, before he was helping out with a business plan for ArsenalBio that revolved around the work of a large group of interconnected scientists supported by the Parker Institute for Cancer Immunology.
The biotech started by putting together an “arsenal” of technologies aimed at making cell therapies for cancer much, much better than the rather crude first-generation drugs that hit the market from Novartis and Kite.
Their drugs have become the baseline against which all others are being measured.
“The technology set we’re developing is independent of the chassis,” Drazan tells me. “It doesn’t have to be autologous (extracted from the patient) or allogeneic (off the shelf). It doesn’t have to be a T cell, it could be a B cell.” But they are starting out on the autologous side, where they have the most knowledge and insight into manufacturing techniques.
It also doesn’t have to be close to the clinic.
Drazan expects the biotech will be working its way through preclinical operations for “a few years,” with enough money from the $85 million launch round to get into humans.
By today’s superheated fundraising standards, that’s not a huge amount of cash. Lyell, another cell therapy 2.0 startup we featured last week, raised $600 million in a year, including a big chunk of cash from GlaxoSmithKline. Drazan is interested in dealmaking as well, but he also knows he has the cash necessary to support the company for a good run — a key part of what it takes to bring together a stellar team of top players.

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Hal Barron, GSK's president of R&D and CSO, speaks to Endpoints News founder and editor John Carroll in London at Endpoints' #UKBIO19 summit on October 8, 2019

[Video] Cel­e­brat­ing tri­al fail­ures, chang­ing the cul­ture and al­ly­ing with Cal­i­for­nia dream­ers: R&D chief Hal Bar­ron talks about a new era at GSK

Last week I had a chance to sit down with Hal Barron at Endpoints’ #UKBIO19 summit to discuss his views on R&D at GSK, a topic that has been central to his life since he took the top research post close to 2 years ago. During the conversation, Barron talked about changing the culture at GSK, a move that involves several new approaches — one of which involves celebrating their setbacks as they shift resources to the most promising programs in the pipeline. Barron also discussed his new alliances in the Bay Area — including his collaboration pact with Lyell, which we covered here — frankly assesses the pluses and minuses of the UK drug development scene, and talks about his plans for making GSK a much more effective drug developer.

This is one discussion you won’t want to miss. Insider and Enterprise subscribers can log-in to watch the video.

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Med­ical an­i­ma­tion: Mak­ing it eas­i­er for the site and the pa­tient to un­der­stand

Medical animation has in recent years become an increasingly important tool for conveying niche information to a varied audience, particularly to those audiences without expertise in the specialist area. Science programmes today, for example, have moved from the piece-to-camera of the university professor explaining how a complex disease mechanism works, to actually showing the viewer first-hand what it might look like to shrink ourselves down to the size of an ant’s foot, and travel inside the human body to witness these processes in action. Effectively communicating a complex disease pathophysiology, or the novel mechanism of action of a new drug, can be complex. This is especially difficult when the audience domain knowledge is limited or non-existent. Medical animation can help with this communication challenge in several ways.
Improved accessibility to visualisation
Visualisation is a core component of our ability to understand a concept. Ask 10 people to visualise an apple, and each will come up with a slightly different image, some apples smaller than others, some more round, some with bites taken. Acceptable, you say, we can move on to the next part of the story. Now ask 10 people to visualise how HIV’s capsid protein gets arranged into the hexamers and pentamers that form the viral capsid that holds HIV’s genetic material. This request may pose a challenge even to someone with some virology knowledge, and it is that inability to effectively visualise what is going on that holds us back from fully understanding the rest of the story. So how does medical animation help us to overcome this visualisation challenge?

UCB tries to win some re­spect in the crowd­ed pso­ri­a­sis mar­ket with a dual IL-17 ap­proach — and it won't be easy

For a pharma company with about $5 billion in revenue, a couple of respectably sized blockbuster drugs on the market and some high-profile partners like Amgen, Belgium’s UCB has kept an unusually low profile on the pipeline side of things over the years.
Until now.
Just days after striking a $2.1 billion deal to buy Ra Pharmaceuticals and its C5 rival to Soliris, UCB is posting positive top-line Phase III results for a dual IL-17 inhibitor that it’s steering into one of the most competitive commercial spaces in the industry. And despite plenty of obvious challenges as they struggle to roll out Evenity with Amgen and patent expirations loom on its franchise drugs, including Cimzia, the company just may be ready to tackle some of the biggest players on the planet.
In their first of 3 Phase III studies for bimekizumab, researchers touted top-line wins on statistically significant results on clearing plaque psoriasis, including a victory over J&J’s IL-23 contender Stelara on key endpoints. The drug targets both IL-17A and IL-17F, a modification on the IL-17A strategy laid out for Taltz (Eli Lilly) and Cosentyx (Novartis). And the new group also includes J&J’s Tremfya and AbbVie’s Skyrizi.
We don’t know the PASI90 and IGA scores — but UCB knows that with the kind of heavyweight competition it faces with Novartis and others, marginal gains for patients won’t stack up. So we’ll be watching for the hard numbers. And there’s another head-to-head with Cosentyx that will play a big role in pushing up analysts’ projections on peak sales, which currently fall well short of blockbuster status.
UCB hasn’t exactly been in the spotlight for the last few years, but it’s in a position now that the company has to win some respect in R&D, with blockbuster projects that can keep investors’ attention at a time the industry is experiencing booming R&D development efforts around the planet.
It hasn’t been easy. There was a setback on a lupus drug partnered with Biogen. But there have been some advances, with a deal to buy Proximagen’s NDA-ready nasal spray therapy USL261, designed as a rescue therapy for acute repetitive seizures, for $150 million in cash and another $220 million in sales and regulatory milestones. There was even a report that the company was kicking the deflated tires at Acorda, though nothing came of that.
Late last year UCB also committed to spend up to £200 million on a new R&D hub in the UK.
That may not translate into a lot of excitement right now, but they’re trying. And there’s a subtle promise that more deals may be in the works.

Swamy Vijayan. Plexium

San Diego up­start de­buts dis­cov­ery en­gine that puts a twist to pro­tein degra­da­tion

For years, the idea of protein degradation — utilizing the cell’s natural garbage disposal system to mark problematic proteins for destruction — remained an elegant but technically difficult concept. But now established as a promising clinical strategy, with major biopharma players such as Bayer, Gilead and Vertex trying to grab a foothold via partnership deals, a San Diego startup is looking to exploit it and push its limits.

CSL ac­cus­es ri­val Pharm­ing of par­tic­i­pat­ing in a scheme to rip off IP on HAE while re­cruit­ing se­nior R&D staffer

Pharming has landed in the middle of a legal donnybrook after recruiting a senior executive from a rival R&D team at CSL. The Australian pharma giant slapped Pharming with a lawsuit alleging that the Dutch biotech’s new employee, Joseph Chiao, looted a large cache of proprietary documents as he hit the exit. And they want it all back.
Federal Judge Juan Sanchez in the Eastern District Pennsylvania court issued an injunction on Tuesday prohibiting Chiao from doing any work on HAE or primary immune deficiency in his new job and demanding that he return any material from CSL that he may have in his possession. And he wants Pharming to tell its employees not to ask for any information on the forbidden topics.
For its part, Pharming fired off an indignant response this morning denying any involvement in extracting any kind of IP from CSL, adding that it’s cooperating in the internal probe that CSL has underway.

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