Us­ing mon­ey hon­ey in­stead of threats, Sanofi wins a seat at the bar­gain­ing ta­ble for Medi­va­tion buy­out

It took a sweet­er bid and a CVR for its ex­per­i­men­tal ther­a­py ta­la­zoparib, but Sanofi $SNY can now take a seat at the bar­gain­ing ta­ble with Medi­va­tion $MD­VN in pur­suit of one of this year’s biggest biotech buy­outs.

Sanofi an­nounced this af­ter­noon that it pushed its bid to $58.00 a share – up from $52.50 – and added a $3.00 CVR for sales per­for­mance on ta­la­zoparib, Medi­va­tion’s block­buster bid for PARP in­hibitor glo­ry. That’s a po­ten­tial $11 bil­lion pay­out, up from the ini­tial $9.3 bil­lion of­fer.

Medi­va­tion care­ful­ly not­ed that it re­ject­ed the of­fer. And it’s un­like­ly to ac­cept one that isn’t sub­stan­tial­ly larg­er.

Sanofi, which has threat­ened a va­ri­ety of sanc­tions against Medi­va­tion in its push for a deal, ex­pressed con­fi­dence that it could wrap up a deal. That may be eas­i­er said than done, though, as Reuters re­port­ed this af­ter­noon that Pfiz­er and Cel­gene are al­so stand­ing in the wings now, look­ing to see what they may do to step in now. Oth­ers may fol­low.

Sanofi is the first to the ta­ble. And it clear­ly sees the ac­qui­si­tion, bag­ging Xtan­di and a promis­ing late-stage PARP in­hibitor, as a big piece in new CEO Olivi­er Brandi­court’s at­tempt to make over Sanofi.

“We view this mov­ing on past the ini­tial and painful step in the process where both par­ties have to act their very tough­est but one of them has to even­tu­al­ly flinch and move on to the next step, as a very cru­cial and sig­nif­i­cant win for MD­VN share­hold­ers; and as the first step in the process which we see cul­mi­nat­ing in the even­tu­al sale of the com­pa­ny, like­ly with­in the next six months and with a price tag that we ex­pect to be in the $70/share range, in­clud­ing the CVR,” notes RBC’s Simos Sime­oni­dis.

Medi­va­tion has kicked back hard against Sanofi, par­tic­u­lar­ly rais­ing the prospect of a first-line win­ner in ta­la­zoparib. As­traZeneca was the first to the PARP mar­ket with ola­parib, but plen­ty of com­pe­ti­tion has been in hot pur­suit of leapfrog­ging the big phar­ma’s pi­o­neer­ing ef­fort. Tesaro just post­ed promis­ing da­ta for its PARP drug as well, and J&J stepped in to bag prostate can­cer rights for its port­fo­lio.

The deal will like­ly seal Medi­va­tion CEO David Hung’s rep as a top deal­mark­er in the in­dus­try. He’s struck ma­jor col­lab­o­ra­tions and wasn’t afraid to pay Bio­Marin top mon­ey for the rights to ta­la­zoparib. And de­spite Medi­va­tion’s re­cent protests about Sanofi’s lack­lus­ter rep in on­col­o­gy R&D, this sto­ry is all about the mon­ey.

“We are pleased to have the op­por­tu­ni­ty to en­gage with Medi­va­tion,” said Olivi­er Brandi­court, Chief Ex­ec­u­tive Of­fi­cer, Sanofi. “Our will­ing­ness to in­crease our of­fer is dri­ven by our in-depth analy­sis of the ben­e­fits and val­ue cre­ation po­ten­tial of a com­bi­na­tion.  We look for­ward to dis­cus­sions with Medi­va­tion on a com­bi­na­tion which we be­lieve is the most val­ue cre­at­ing trans­ac­tion for both com­pa­nies’ share­hold­ers, and would pro­vide Medi­va­tion and its em­ploy­ees with an out­stand­ing plat­form to fur­ther grow its on­col­o­gy fran­chise.”

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Pascal Soriot, AstraZeneca CEO (via Getty images)

UP­DAT­ED: FDA slaps As­traZeneca's MCL-1 can­cer drug with a hold af­ter safe­ty is­sue — 2 years af­ter Am­gen axed a trou­bled ri­val

There are new questions being posed about a class of cancer drugs in the wake of the second FDA-enforced clinical hold in the field.

Two years after the FDA hit Amgen with a clinical hold on its MCL-1 inhibitor AMG 397 following signs of cardiac toxicity, AstraZeneca says that regulators hit them with a hold on their rival therapy of the same class.

The pharma giant noted on clinicaltrials.gov that its Phase I/II study for the MCL-1 drug AZD5991 “has been put on hold to allow further evaluation of safety related information.”

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Sur­geons suc­cess­ful­ly at­tach pig kid­ney to a hu­man for the first time, us­ing tech from Unit­ed's Re­vivi­cor

In a first, researchers reportedly successfully transplanted a pig kidney into a human without triggering an immediate immune response this week. And the technology came from the biotech United Therapeutics.

Surgeons spent three days attaching the kidney to the patient’s blood vessels, but when all was said and done, the kidney appeared to be functioning normally in early testing, Reuters and the New York Times were among those to report. The kidney came from a genetically altered pig developed through United’s Revivicor unit.

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Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.