Mark Timney Purdue from Youtube

Ex-Pur­due CEO stands to earn a huge wind­fall in No­var­tis' buy­out of the Med­i­cines Co

Mark Tim­ney, the ex-Pur­due Phar­ma CEO named in dozens of law­suits against the Oxy­Con­tin mak­er, stands to earn over $85 mil­lion in No­var­tis’s $9.7 bil­lion buy­out of the Med­i­cines Com­pa­ny.

Tim­ney joined the Med­i­cines Com­pa­ny as CEO in De­cem­ber, af­ter four years helm­ing the com­pa­ny broad­ly con­sid­ered to be at the heart of the opi­oid abuse cri­sis. SEC fil­ings from the time of his hire show he agreed to pur­chase $500,000 worth of stock at the time and was al­so grant­ed one mil­lion per­for­mance and time-vest­ed stock op­tions.

Every em­ploy­ee stock op­tion will vest per the agree­ment and No­var­tis is of­fer­ing $85 per share. With 30,000 shares he owned as of a Sep­tem­ber fil­ing and pur­chased for $21.60 a share, Tim­ney could take home a lit­tle over $87 mil­lion.

A spokesper­son for the Med­i­cines Com­pa­ny de­clined to com­ment on ex­ec­u­tive com­pen­sa­tion.

Tim­ney re­mains a named de­fen­dant in over 30 on­go­ing law­suits against Pur­due Phar­ma, the drug gi­ant ac­cused of mis­lead­ing doc­tors on the ad­dic­tive­ness of its best-sell­ing drug. Tim­ney, the Con­necti­cut At­tor­ney Gen­er­al’s com­plaint al­leges, di­rect­ed his sales­force to tout the sup­posed abuse-de­ter­rent tech­nol­o­gy in Oxy­Con­tin even as he gave in­ter­nal pre­sen­ta­tions ac­knowl­edg­ing that the tech­nol­o­gy was un­like­ly to work and pa­tients would con­tin­ue to be­come ad­dict­ed.

Tim­ney and his pre­de­ces­sor John Stew­art “par­tic­i­pat­ed di­rect­ly in Pur­due’s un­fair and de­cep­tive acts and prac­tices al­leged in this com­plaint,” the com­plaint al­leges. “They had the au­thor­i­ty to con­trol Pur­due’s busi­ness prac­tices, in­clud­ing com­plete over­sight and con­trol over Pur­due’s cor­po­rate poli­cies and ac­tiv­i­ties. They were ac­tive­ly in­volved in Pur­due’s busi­ness af­fairs and ac­tive­ly par­tic­i­pat­ed in the mak­ing of com­pa­ny pol­i­cy. They knew of the un­fair and de­cep­tive acts and prac­tices al­leged here­in, and their ac­tions and in­ac­tions re­sult­ed in the mis­con­duct.”

The Mass­a­chu­sets com­plaint al­leges “John Stew­art, Mark Tim­ney, and Craig Lan­dau each di­rect­ed Pur­due’s de­cep­tion as CEO of Pur­due Phar­ma.”

Med­i­cines Com­pa­ny spokesman Michael Blash de­fend­ed Tim­ney’s re­sume and work for the biotech in an email to End­points News: “Mark is an ac­com­plished and com­mit­ted health­care leader whose lead­er­ship has served the com­pa­ny well dur­ing this im­por­tant strate­gic phase.”

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

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Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Matt Gline, Roivant Sciences CEO (Photo by John Sciulli/Getty Images for GLG)

Pfiz­er and Roivant team up again for an­oth­er 'Van­t', set­ting up an­ti-in­flam­ma­to­ry show­down with Prometheus

Pfizer and Roivant are teaming up to launch a new ‘Vant’ aimed at bringing a mid-stage anti-inflammatory drug to market, the pair announced Thursday.

There’s no name for the startup yet, nor are there any employees. Thus far, the new company and Roivant can be considered “one and the same,” Roivant CEO Matt Gline tells Endpoints News. But Pfizer is so enthusiastic about the target that it elected to keep 25% of equity in the drug rather than take upfront cash from Roivant, Gline said.

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US month­ly costs for biosim­i­lars 'sub­stan­tial­ly high­er' than Ger­many or Switzer­land, JA­MA re­search finds

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

Kirk Myers is shown in a still image from a new film series showcasing the efforts of HIV advocates funded by Gilead.

Gilead spot­lights HIV projects and the com­mu­ni­ty lead­ers dri­ving them in new mi­ni-doc­u­men­tary films

Gilead is going behind the scenes of some of the HIV initiatives it funds through grants in a new film series narrated by the people helming the projects.

The first four films and leaders come from across the US — Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Their HIV-focused efforts range from addressing unmet needs of the transgender community to delivering social services and high-quality health care in underserved communities.

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EMA pulls an opi­oid from the 1950s used to treat dry cough

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).