Neil Woodford (file photo)

As in­vestors soured on his bets, records show Wood­ford paid him­self hand­some div­i­dends

Ahead of the im­plo­sion of his flag­ship fund and his rep­u­ta­tion as one of the UK’s most savvi­est stock pick­ers, Neil Wood­ford paid him­self and his busi­ness part­ner £13.8 mil­lion in div­i­dends in the year lead­ing up to the im­passe.

For the pe­ri­od be­tween April 1, 2018, to March 31, 2019 — Wood­ford In­vest­ment Man­age­ment made a post-tax prof­it of about £16.3 mil­lion, records post­ed on Com­pa­nies House on Mon­day show. The com­pa­ny paid Wood­ford Cap­i­tal, an un­lim­it­ed com­pa­ny owned by Wood­ford (with a 65% stake) and his busi­ness part­ner Craig New­man (with the re­main­ing 35% stake) £13.8 mil­lion in div­i­dends (£9 mil­lion and £4.8 mil­lion, re­spec­tive­ly).

But trou­ble for Wood­ford was al­ready brew­ing be­fore March. Ear­li­er in the month, the em­bat­tled vet­er­an was chid­ing his crit­ics for steer­ing in­vestors away and sul­ly­ing his rep­u­ta­tion, in an at­tempt to sti­fle the blood­let­ting in his flag­ship Wood­ford Eq­ui­ty In­come Fund. In an in­ter­view with the Fi­nan­cial Times, Wood­ford said the rate of with­drawals from the fund put him at risk of be­ing “out of busi­ness in about two-and-a-half years.” In the year end­ing March 31, 2018, Wood­ford In­vest­ment Man­age­ment made an af­ter-tax prof­it of £33.7 mil­lion.

Af­ter 26 years at In­vesco, Wood­ford launched his cor­ner­stone eq­ui­ty in­come fund in 2014, rais­ing bil­lions to in­vest in the life sci­ences. But some of his bets — such as Prothena, Cir­cas­sia and North­west Bio, turned sour, and those wrin­kles cul­mi­nat­ed in a long pe­ri­od of weak re­turns. Wood­ford orig­i­nal­ly an­chored his rep­u­ta­tion as a blue-chip in­vestor in com­pa­nies like GSK, but rat­tled by Gilead’s HIV prowess, he elect­ed to part ways with the British drug­mak­er in 2017 in a lengthy blog post en­ti­tled “Glax­it.”

As the trust in Wood­ford’s bets waned (the size of the fund shrank from £10.2 bil­lion to £3.7 bil­lion in two years), he at­tempt­ed to shack­le his in­vestors by sus­pend­ing their abil­i­ty to re­deem any liq­uid­i­ty from the fund. Adding fu­el to the fire, Wood­ford re­fused to waive his £100,000-a-day in­vest­ment man­age­ment fee for the cor­ner­stone fund, ig­nor­ing out­rage from the UK’s Fi­nan­cial Con­duct Au­thor­i­ty, and the chair of the Trea­sury se­lect com­mit­tee.

The saga lin­gered on when in Ju­ly Link Fund So­lu­tions (the of­fi­cial hold­er of the Wood­ford Eq­ui­ty In­come Fund) said in­vestors would be thwart­ed from re­demp­tions, sales or oth­er trans­ac­tions for an ad­di­tion­al 28 days. In the first days of sus­pen­sion, Wood­ford’s team sold at least £300 mil­lion in as­sets in at­tempt to shift away from pri­vate com­pa­nies to­ward more liq­uid stocks.

Mean­while, Wood­ford’s oth­er funds al­so suf­fered. Har­g­reaves Lans­down, which has in the past sold and pro­mot­ed the Wood­ford funds via its re­tail in­vest­ment plat­form, with­drew £45 mil­lion — its en­tire po­si­tion — from the in­vest­ment man­ag­er’s In­come Fo­cus Fund. The per­for­mance of the Wood­ford Pa­tient Cap­i­tal Trust al­so took a hit. Brex­it un­cer­tain­ty at the time did not help, with ner­vous in­vestors with­draw­ing an eye-pop­ping £15.3 bil­lion out of UK Eq­ui­ty In­come funds in gen­er­al in the 16 months lead­ing up to April 2019, ac­cord­ing to da­ta com­piled by Morn­ingstar.

By Oc­to­ber, the dis­graced Wood­ford was fired and his flag­ship Eq­ui­ty In­come Fund was dis­man­tled. “This was Link’s de­ci­sion and one I can­not ac­cept, nor be­lieve is in the long-term in­ter­ests [of in­vestors],” he told Reuters.

The scan­dal has made life dif­fi­cult for the com­pa­nies Wood­ford once en­dorsed, which have since borne the brunt of his fall from grace. Sev­er­al drug­mak­ers, such as Ar­ix Bio­sciences, Au­to­lus, and Prothena have ei­ther be­come a prime tar­get for short at­tacks or seen ex­ag­ger­at­ed re­ac­tions to set­backs.

2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

How to cap­i­talise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

UP­DAT­ED: FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

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UP­DAT­ED: Eli Lil­ly’s $1.6B can­cer drug failed to spark even the slight­est pos­i­tive gain for pa­tients in its 1st PhI­II

Eli Lilly had high hopes for its pegylated IL-10 drug pegilodecakin when it bought Armo last year for $1.6 billion in cash. But after reporting a few months ago that it had failed a Phase III in pancreatic cancer, without the data, its likely value has plunged. And now we’re getting some exact data that underscore just how little positive effect it had.

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Stephen Hahn, AP

The FDA has de­val­ued the gold stan­dard on R&D. And that threat­ens every­one in drug de­vel­op­ment

Bioregnum Opinion Column by John Carroll

A few weeks ago, when Stephen Hahn was being lightly queried by Senators in his confirmation hearing as the new commissioner of the FDA, he made the usual vow to maintain the gold standard in drug development.

Neatly summarized, that standard requires the agency to sign off on clinical data — usually from two, well-controlled human studies — that prove a drug’s benefit outweighs any risks.

Over the last few years, biopharma has enjoyed an unprecedented loosening over just what it takes to clear that bar. Regulators are more willing to drop the second trial requirement ahead of an accelerated approval — particularly if they have an unmet medical need where patients are clamoring for a therapy.

That confirmatory trial the FDA demands can wait a few years. And most everyone in biopharma would tell you that’s the right thing for patients. They know its a tonic for everyone in the industry faced with pushing a drug through clinical development. And it’s helped inspire a global biotech boom.

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UP­DAT­ED: New play­ers are jump­ing in­to the scram­ble to de­vel­op a vac­cine as pan­dem­ic pan­ic spreads fast

When the CNN news crew in Wuhan caught wind of the Chinese government’s plan to quarantine the city of 11 million people, they made a run for one of the last trains out — their Atlanta colleagues urging them on. On the way to the train station, they were forced to skirt the local seafood market, where the coronavirus at the heart of a brewing outbreak may have taken root.

And they breathlessly reported every moment of the early morning dash.

In shuttering the city, triggering an exodus of masked residents who caught wind of the quarantine ahead of time, China signaled that they were prepared to take extreme actions to stop the spread of a virus that has claimed 17 lives, sickened many more and panicked people around the globe.

CNN helped illustrate how hard all that can be.

The early reaction in the biotech industry has been classic, with small-cap companies scrambling to headline efforts to step in fast. But there are also new players in the field with new tech that has been introduced since the last of a series of pandemic panics that could change the usual storylines. And they’re volunteering for a crash course in speeding up vaccine development — a field where overnight solutions have been impossible to prove.

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Wuhan virus out­break trig­gers in­evitable small-biotech ral­ly

Every few years, a public health crisis (think Ebola, Zika) spurred by a rogue pathogen triggers a small-biotech rally, as drugmakers emerge from the woodwork with ambitious plans to treat the mounting outbreak. In most cases, that enthusiasm never quite delivers.

Things are no different, as the coronavirus outbreak in Wuhan, China takes hold. There have been close to 300 confirmed human infections in China, and at least four deaths. Coronaviruses are a large family of viruses, which include MERS and SARS. On Tuesday, the CDC reported the virus was detected in a US traveler returning from Wuhan.

Mer­ck KGaA spin­out gets first fund­ing to bring dual-act­ing can­cer mol­e­cules in­to the clin­ic

Two and a half years after launch, Merck KGaA spinout iOnctura is getting its first major round of funding.

The oncology startup raised €15 million ($16.6 million) to put its lead drug into the clinic and get its second drug past IND-enabling tests. INKEF Capital and VI Partners co-led the round and were joined by the biotech’s longtime backer M Ventures, an arm of Merck KGaA, and Schroder Adveq.

Am­gen aug­ments Asia foothold by tak­ing over Astel­las joint ven­ture in Japan

California-based Amgen, which does the bulk of its business in the United States, made its ambition to reinvigorate its growth prospects by expanding its presence in Asia clear at the sidelines of the JP Morgan healthcare conference in San Francisco earlier this month.

The Thousand Oaks-based company on Thursday executed its plan to dissolve the joint venture with Astellas — created in 2013 — to operate the unit independently in Japan. With its rapidly aging population, the region represents an appealing market for Amgen’s osteoporosis treatments Prolia and Evenity as well as a cholesterol-lowering injection Repatha.