$354M ex­it pack­age in hand, Medi­va­tion CEO David Hung com­pletes a mas­ter class in biotech auc­tions

David Hung, Medi­va­tion CEO

Now that Medi­va­tion CEO David Hung has com­plet­ed the deal of a life­time with a stratos­pher­ic buy­out, he’s grab­bing a $35 mil­lion gold­en para­chute that is sched­uled to burst open in about a month and car­ry him back down to earth in style. And that’s part of a $354 mil­lion pack­age of stock and op­tions he can now cash out of.

The de­tails on the gold­en para­chute — along with a blow-by-blow ac­count of the bid­ding process that led up to Pfiz­er’s $14 bil­lion win­ner — were all in­clud­ed in an SEC fil­ing on Tues­day. And it makes for re­quired read­ing for any biotech ex­ec look­ing to make the big score some sun­ny day.

Oliv­er Brandi­court, Sanofi CEO

The game got start­ed in late March, when new Sanofi CEO Olivi­er Brandi­court con­tact­ed Hung and asked for a call. Days lat­er, the sto­ry was leaked to the busi­ness press, and Medi­va­tion was in play.

The re­view of what fol­lowed over the next few months in­cludes some in­ter­est­ing de­tails on Medi­va­tion’s re­sponse to Sanofi’s ini­tial low­ball of­fer. Nev­er hap­py with the open­ing bid, Medi­va­tion had an ace in the hole: Pfiz­er ex­ecs al­most im­me­di­ate­ly be­gan to ea­ger­ly vol­un­teer their in­ter­est to get in­to the auc­tion. And de­ter­mined to get top dol­lar, Medi­va­tion in­vit­ed more com­pa­nies to join Pfiz­er and Sanofi at the bar­gain­ing ta­ble.

To keep them en­gaged as the num­bers raced high­er, Medi­va­tion drew up a set of long range fi­nan­cial fore­casts for three dif­fer­ent sce­nar­ios in­volv­ing Xtan­di, its ap­proved can­cer drug, as well as its PARP in­hibitor ta­la­zoparib and an­oth­er mys­tery drug in the pipeline called pidilizum­ab, a can­cer treat­ment that Medi­va­tion ini­tial­ly thought was a check­point ther­a­py un­til it was forced to con­clude it wasn’t sure ex­act­ly what the mech­a­nism of ac­tion was. By the time the of­fers be­gan to fly, though, it bare­ly war­rant­ed a men­tion.

Un­der Medi­va­tion’s three sce­nar­ios, the com­pa­ny pro­ject­ed that its ex­pect­ed 2016 rev­enue of $922 mil­lion could peak at be­tween $5.7 bil­lion and $8.5 bil­lion in 2027, a lit­tle more than a decade away. And mean­while, he and the Medi­va­tion team con­duct­ed a pub­lic cam­paign to per­suade the in­dus­try that ta­la­zoparib was a cer­tain block­buster-to-be, ca­pa­ble of gen­er­at­ing more rev­enue than Xtan­di it­self.

It was all wild­ly over the top, but Hung was pulling out all the stops.

Near­ing the close of the auc­tion, Medi­va­tion set an Au­gust 20 dead­line for all fi­nal of­fers, net­ting Pfiz­er’s win­ning $81.50 bid along with two oth­ers for $80.25 and $80. For the mas­ter deal­mak­er, known for bag­ging ma­jor league col­lab­o­ra­tions that didn’t al­ways pan out, it was an un­mis­tak­able win.

For Pfiz­er, there are still years of ex­plain­ing ahead as it at­tempts to jus­ti­fy pay­ing a price many an­a­lysts thought was way too high.

UP­DAT­ED: In a stun­ning turn­around, Bio­gen says that ad­u­canum­ab does work for Alzheimer's — but da­ta min­ing in­cites con­tro­ver­sy and ques­tions

Biogen has confounded the biotech world one more time.

In a stunning about-face, the company says that a new analysis of an old dataset on aducanumab has restored its faith in the drug as a game-changer for Alzheimer’s and, after talking it over the FDA, they’ll now be filing for an approval of a drug that had been given up for dead.

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Bris­tol-My­ers makes Op­di­vo pitch for front­line lung can­cer with open la­bel PhI­II study

Despite a head start, when Bristol-Myers Squibb and its pioneering checkpoint inhibitor Opdivo suffered a key lung cancer setback in 2016, they found themselves relegated to the backseat as Merck’s Keytruda seized the wheel on the road to immunotherapy stardom. Bristol-Myers has since suffered blow after blow in its quest to take a big slice of the lucrative market, peppered with some small successes. On Tuesday, the New Jersey drugmaker touted positive data from a Phase III open-label study in a bid to carve itself a piece of the frontline lung cancer market.

Vas Narasimhan. Getty Images

Failed PhI­II fe­vip­iprant tri­als pour more cold wa­ter on No­var­tis' block­buster R&D en­gine — and spread the chill to a high-pro­file biotech

Back in July, during an investor call where Novartis execs ran through an upbeat assessment of their Q2 performance, CEO Vas Narasimhan and development chief John Tsai were pressed to predict which of the two looming Phase III readouts — involving cardio drug Entresto and asthma therapy fevipiprant, respectively — had a higher likelihood of success. Tsai gave the PARAGON-HF study with Entresto minimally better odds, but Narasimhan emphasized that their strategy of giving fevipiprant to more severe patients gave them confidence.

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Take­da tees up $420M deal for celi­ac an­ti­dote, con­tin­u­ing R&D re­fo­cus

Sometime in the 1st century AD, a patient presented to Arataeus looking like a varicose ghost. He was “emaciated and atrophied, pale, feeble and incapable of performing any of his accustomed works,” the Greek physician wrote, with hollow temples and huge veins running all over his body.

A dysfunctional digestive system, Arataeus concluded – an imbalance he attributed to a “heat” deficiency in a system he and other Greeks regarded as functioning similarly to an oven – and coined a term: coeliac disease, after the Greek word for abdomen.

UP­DAT­ED: The FDA sets a reg­u­la­to­ry speed record, pro­vid­ing a snap OK for Ver­tex's break­through triplet for cys­tic fi­bro­sis

The FDA has approved Vertex’s new triplet for cystic fibrosis at a record-setting speed.

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IM­brave150: Roche’s reg­u­la­to­ry crew plans a glob­al roll­out of Tecen­triq com­bo for liv­er can­cer as PhI­II scores a hit

Just weeks after Bristol-Myers Squibb defended its failed pivotal study pitting Opdivo against Nexavar in liver cancer, Roche says it’s beat the frontline challenge with a combination of their PD-L1 Tecentriq with Avastin. And now they’re rolling their regulatory teams in the US, Europe and China in search of a new approval — badly needed to boost a trailing franchise effort.
Given their breakthrough and Big Pharma status as well as the use of two approved drugs, FDA approval may well prove to be something of a formality. And the Chinese have been clear that they want new drugs for liver cancer, where lethal disease rates are particularly high.
Researchers at their big biotech sub, Genentech, say that the combo beat Bayer’s Nexavar on both progression-free survival as well as overall survival — the first advance in this field in more than a decade. We won’t get the breakdown in months of life gained, but it’s a big win for Roche, which has lagged far, far behind Keytruda and Opdivo, the dominant PD-1s that have captured the bulk of the checkpoint market so far.
Researchers recruited hepatocellular carcinoma — the most common form of liver cancer — patients for the IMbrave150 study who weren’t eligible for surgery ahead of any systemic treatment of the disease.
Roche has a fairly low bar to beat, with modest survival benefit for Nexavar, approved for this indication 12 years ago. But they also plan to offer a combo therapy that could have significantly less toxicity, offering patients a much easier treatment regimen.
Cowen’s Steven Scala recently sized up the importance of IMbrave150, noting:

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UP­DAT­ED: Clay Sie­gall’s $614M wa­ger on tu­ca­tinib pays off with solid­ly pos­i­tive piv­otal da­ta and a date with the FDA

Back at the beginning of 2018, Clay Siegall snagged a cancer drug called tucatinib with a $614 million cash deal to buy Cascadian. It paid off today with a solid set of mid-stage data for HER2 positive breast cancer that will in turn serve as the pivotal win Siegall needs to seek an accelerated approval in the push for a new triplet therapy.

And if all the cards keep falling in its favor, they’ll move from 1 drug on the market to 3 in 2020, which is shaping up as a landmark year as Seattle Genetics prepares for its 23rd anniversary on July 15.

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That $335M JV Bay­er set up on CRISPR/Cas9? They’re let­ting the biotech part­ner car­ry on

Bayer committed $300 million to set up a joint venture on CRISPR/Cas9 tech with CRISPR Therapeutics $CRSP. But they’re handing off control now to the smaller biotech while retaining a couple of opt-ins for programs nearing an IND.

Bayer $BAY made much of the fact that they were going all-in on gene editing when they did their deal 3 years ago with CRISPR Therapeutics, which pitched $35 million in on their end. This was the cornerstone of their plan to set up new JVs that could make some serious leap forwards in hot new R&D spaces. Now CRISPR will have full management control of Casebia as they pursue programs in hemophilia, ophthalmology and autoimmune diseases.
Samarth Kulkarni, the CEO at CRISPR, made it sound like a natural progression.

J&J's block­buster Ste­lara wins US ap­proval for ul­cer­a­tive col­i­tis

J&J’s Stelara, which is set to be in the top ten list of blockbusters come 2025, is now cleared by the FDA for use in ulcerative colitis (UC), an inflammatory disease of the large intestine.

The biologic targets interleukin (IL)-12 and IL-23 cytokines, which are known to play a key role in inflammatory and immune responses. Stelara, which generated about $4.7 billion in the first nine months of 2019, is a key player in the crowded marketplace of drugs to treat autoimmune disorders such as psoriasis, rheumatoid arthritis and Crohn’s disease. AbbVie’s star therapy, Humira, continues to dominate, despite its looming patent cliff in the United States, while others including J&J’s $JNJ own anti-IL23 Tremfya, Lilly’s $LLY anti-IL-17 Taltz and AbbVie’s $ABBV recently approved anti-IL-23 antibody Skyrizi carve out a slice of market share.