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.”

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

CEO Markus Warmuth (Monte Rosa)

Monte Rosa rakes in $96M Se­ries B as it pre­pares 'mol­e­c­u­lar glue' plat­form for IND-en­abling stud­ies

About four months after completing an extension to its Series A, Monte Rosa Therapeutics is putting its next foot forward with another heap of cash.

The Boston-based biotech is back with $96 million in Series B financing with a goal to get its lead program ready for IND-enabling studies by the end of the year. Though Monte Rosa is keeping its specific target a secret for now, the company has been researching how to utilize its protein degradation technology in breast cancer and non-small cell lung cancer, among other areas.

Vas Narasimhan (AP Images)

UP­DAT­ED: Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

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David Berry (Flagship)

Flag­ship's next big tech­no­log­i­cal bet? The cloud

Earlier this month, Flagship announced their big bet on the software half the industry is talking about, launching the AI and machine learning startup. Now, they and a couple other investors are gambling $100 million on a software that much of the public generally thinks of as a cool, IT afterthought: cloud computing.

The idea, says founder and Flagship partner David Berry, is one of scale: The sheer magnitude of biological data that you can store on cloud technology is unprecedented. And that size, when leveraged properly, can allow you to ask questions and form insights that are similarly unprecedented.

Jim Roberts and Brian Finrow (Lumen Bioscience)

With a $4M fed­er­al grant, Lu­men jumps in­to the Covid-19 treat­ment race

It’s been less than a month since Lumen Bioscience announced a $16 million Series B to engineer spirulina — a nutrient-packed super food — for diseases like traveler’s diarrhea, norovirus and C. difficile colitis. And now, the biotech has pulled in another $4 million to do the same for Covid-19.

The approach is quite similar to other gastrointestinal targets the company is pursuing, co-founders and Brian Finrow and Jim Roberts said. The Seattle-based company is working on a camelid antibody cocktail to combat GI infection common among Covid-19 patients. In a study published in the American Journal of Gastroenterology, a majority of Covid-19 patients showed GI and respiratory symptoms, and 25% had only GI symptoms.

FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials, and could help shore up public trust in the agency and any eventual vaccine.

PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

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Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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Covid-19 roundup: J&J be­gins piv­otal Phase III tri­al for vac­cine; Con­tro­ver­sial hu­man chal­lenge tri­als to be­gin in Lon­don — re­port

Johnson & Johnson announced it’s beginning a pivotal Phase III trial for its Covid-19 candidate, JNJ-78436735 — the first single-dose vaccine in this stage.

The Phase III trial, dubbed ENSEMBLE, will enroll 60,000 patients worldwide, making it the largest Phase III study of a Covid-19 vaccine to date. J&J said the candidate achieved positive interim results in a Phase I/IIa study, which will be published “imminently.” There’s a possibility that the first batches will be ready for potential emergency use in early 2021, according to the company.

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