Laurence Cooper and Scott Tarriff

Mi­nor­i­ty in­vestor Wa­ter­Mill suc­ceeds in ac­tivist at­tack of Zio­pharm, win­ning two board seats and re­moval of chair­man

The ac­tivist at­tack launched at Zio­pharm On­col­o­gy $ZIOP that turned in­to an ug­ly and bit­ter pub­lic feud has come to a con­clu­sion.

Two of the three board nom­i­nees put forth by 3.3% mi­nor­i­ty in­vestor Wa­ter­Mill As­set Man­age­ment Corp. will be join­ing Zio­pharm’s board af­ter re­ceiv­ing the nec­es­sary 50%+ votes from share­hold­ers, Wa­ter­Mill said Thurs­day morn­ing. Ad­di­tion­al­ly, a ma­jor­i­ty of Zio­pharm share­hold­ers vot­ed to re­call chair­man Scott Tar­riff, the firm said.

No­tably, Wa­ter­Mill founder Robert Post­ma, who first ini­ti­at­ed the at­tack in ear­ly No­vem­ber, is not join­ing the board de­spite al­so gain­ing enough sup­port from in­vestors, Wa­ter­Mill said. Zio­pharm’s board is capped at eight mem­bers and had pre­vi­ous­ly stood at sev­en pri­or to the vot­ing dead­line, al­low­ing for on­ly the two who re­ceived high­er vote shares to join with Tar­riff’s re­moval.

In ear­ly No­vem­ber, Wa­ter­Mill be­gan its at­tack seek­ing to re­place three board mem­bers and Tar­riff with three in­di­vid­u­als: Post­ma, Jaime Vieser and Hol­ger Weis. Two mem­bers of the board tar­get­ed by Wa­ter­Mill re­signed in the fol­low­ing weeks and one still re­mains.

“We wel­come Messrs. Vieser and Weis as the newest mem­bers of Zio­pharm’s Board of Di­rec­tors,” Zio­pharm said in a state­ment. “We al­so wish to thank Scott Tar­riff, a mem­ber of the Board since 2015 and Chair­man since 2018, for the nu­mer­ous pos­i­tive con­tri­bu­tions and tire­less com­mit­ment to the pa­tients we hope to serve.”

Full re­sults of the vote will not be avail­able un­til Zio­pharm files an up­date with the SEC, and the tim­ing of the 8-K re­mains un­clear, a com­pa­ny spokesman told End­points News. Zio­pharm de­clined to com­ment on the vote and the sta­tus of Post­ma’s po­si­tion be­yond its press re­lease.

In a state­ment, Post­ma said that Vieser and Weis “are ful­ly com­mit­ted to putting this con­test be­hind them and im­me­di­ate­ly help­ing the Board chart the right path for­ward.” He lat­er added:

While we an­tic­i­pate that many sup­port­ive share­hold­ers will be dis­ap­point­ed that our full slate is not join­ing the Board at this time, Wa­ter­Mill is con­struc­tive­ly en­gag­ing with Zio­pharm to try to en­sure that the mes­sage sent by a crit­i­cal mass of in­vestors is re­spect­ed. Wa­ter­Mill re­mains com­mit­ted to al­ways do­ing what is best for Zio­pharm.

It’s not yet clear if Wa­ter­Mill will con­tin­ue push­ing for the last in­di­vid­ual to step down and be re­placed with Post­ma, or if that ac­tion falls un­der what Post­ma says is “best” for the com­pa­ny.

Though the mi­nor­i­ty in­vestor of­fi­cial­ly be­gan its at­tack in ear­ly No­vem­ber, the Zio­pharm brouha­ha had stemmed from months of sim­mer­ing feel­ings over the com­pa­ny’s di­rec­tion. Wa­ter­Mill and oth­er in­vestors had raised ob­jec­tions over a for­mer board mem­ber at Zio­pharm’s an­nu­al meet­ing over the sum­mer, and that in­di­vid­ual was re­placed in Sep­tem­ber.

Then the board re­place­ment bid be­gan, with Wa­ter­Mill seek­ing the as­cen­sion of all three of Post­ma, Vieser and Weis in or­der to tru­ly right the ship. At the time the at­tack be­gan, Zio­pharm shares were down rough­ly 50% since the start of 2020, with Wa­ter­Mill claim­ing the board as then con­sti­tut­ed re­spond­ed to com­plaints with “clear dis­dain” and in­stalled the oust­ed board mem­ber’s boss, de­spite say­ing they’d hire an out­side firm to con­duct a search.

Things on­ly got ugli­er from there, with Zio­pharm at­tempt­ing to paint one of Wa­ter­Mill’s nom­i­nees — Weis — as unique­ly un­qual­i­fied to serve on the board. The com­pa­ny cit­ed pub­lic bank­rupt­cy fil­ings from the biotech De­meRx in 2018, which Zio­pharm said showed Weis’ his­to­ry of cor­po­rate mal­prac­tice.

Wa­ter­Mill coun­tered by say­ing Zio­pharm was en­gag­ing in a “des­per­ate, low-road smear cam­paign,” cit­ing state­ments from two for­mer De­meRx ex­ec­u­tives who vouched for Weis. Though Zio­pharm’s board saw heavy churn over the last six months, Tar­riff and CEO Lau­rence Coop­er had not re­placed any of the de­part­ing mem­bers with Wa­ter­Mill nom­i­nees.

Zio­pharm’s share prices have not ful­ly re­cov­ered since a pa­tient died in a gene ther­a­py study back in 2016 af­ter de­vel­op­ing an in­tracra­nial he­m­or­rhage 15 days af­ter start­ing treat­ment. The death was deemed to be un­re­lat­ed to the treat­ment.

Then in 2018, Zio­pharm was forced to hit the brakes on a CAR-T ther­a­py when the FDA placed a clin­i­cal hold on its Phase I study of a treat­ment that could be built in 2 days to ex­press CD-19, IL-15 and a safe­ty switch for CD-19/pos­i­tive leukemias and lym­phomas. Ear­li­er this year, though, Zio­pharm saw some ear­ly, pos­i­tive over­all sur­vival da­ta for their con­trolled IL-12 treat­ment in glioblas­toma. The com­pa­ny is al­so look­ing at com­bin­ing that ex­per­i­men­tal drug with Re­gen­eron’s Lib­tayo.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

Growth hor­mone from No­vo Nordisk is in short­age over man­u­fac­tur­ing de­lays

Novo Nordisk’s growth hormone Norditropin is in shortage because of manufacturing delays, according to an FDA site that tracks drug shortages as well as the American Society of Health-System Pharmacists’ shortages list.

The FDA has shortages of the drug listed for its 5, 10, 15 and 30 mg doses, while the pharmacists’ group, also known as ASHP, reported shortages of the same doses, except for the 15 mg version.

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PhRMA calls for more di­verse in­fra­struc­ture up­grades to US emer­gency tri­als frame­work

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.

Mar­ket­ingRx roundup: What could a US Tik­Tok ban mean for phar­ma? Pfiz­er, Lil­ly lead phar­ma March Mad­ness ad­ver­tis­ers

Just as pharma marketers finally make moves into TikTok, the threat of a US ban on the social media channel is now looming. Already banned on federal employee phones by an initial Congressional act, more bills and maybe bans are on the way. With rare bipartisan agreement, lawmakers have introduced legislation that would give the US president the power to ban TikTok (although not mentioned by name) and other foreign-owned technology platforms that represent a security threat to the US.

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Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.