Boehringer In­gel­heim joins the crowd and goes all-in on on­colyt­ic virus­es, buy­ing Vi­raTher­a­peu­tics in $244M deal

Boehringer In­gel­heim de­cid­ed 3 years ago it that would take an ac­tive role in fos­ter­ing the on­colyt­ics virus biotech Vi­raTher­a­peu­tics. 

The Ger­man com­pa­ny’s ven­ture arm in­vest­ed in the fledg­ling’s biotech’s tiny $4 mil­lion A round in the sum­mer of 2015. BI ex­ecs came back with a $230 mil­lion dis­cov­ery deal — build­ing in a buy­out op­tion — and then added a sec­ond pro­gram. And this morn­ing they’re go­ing all in, buy­ing the com­pa­ny in a deal val­ued at $244 mil­lion.

BI is keep­ing the com­pa­ny — a spin­out of Aus­tria’s Med­ical Uni­ver­si­ty of Inns­bruck — right where it is, adding the group and the re­gion­al con­nec­tions they have on cam­pus as a sub­sidiary as they look to jump in­to the clin­ic with a lead pro­gram.

Heinz Schw­er

Boehringer first tied up with Vi­raTher­a­peu­tics just months ahead of Am­gen’s land­mark ap­proval of T-Vec, the world’s first mar­ket­ed on­colyt­ic virus. And since then the field has ex­plod­ed with new re­search projects as dozens of new play­ers brewed up to beat the pi­o­neer.

Ear­li­er this year J&J ex­e­cut­ed one of its clas­sic bil­lion-dol­lar deals to buy BeneVir. Mer­ck’s R&D chief Roger Perl­mut­ter — who steered the T-Vec deal at Am­gen — bagged Vi­r­a­lyt­ics for $394 mil­lion. A re­cent study from the Can­cer Re­search In­sti­tute found 69 OVs in clin­i­cal de­vel­op­ment and an­oth­er 95 in a pre­clin­i­cal pro­gram.

What’s the big deal?

On­colyt­ic virus­es are the Tro­jan horse of im­muno-on­col­o­gy. The virus­es are de­signed to in­fect can­cer cells, in­vad­ing the dis­ease, and then ex­plod­ing them, which sub­se­quent­ly sig­nals the im­mune sys­tem to mount an at­tack on the sur­vivors. There’s a clear clin­i­cal track record show­ing how they work. And now a host of ri­vals like PsiOxus and many, many oth­ers be­lieve that sys­temic ad­min­is­tra­tion will do a bet­ter job. 

Vi­raTher­a­peu­tics ex­ecs — led by Mor­phoSys vet Heinz Schw­er — have al­so been busy en­gi­neer­ing an OV ther­a­py that they be­lieve can do a bet­ter job of ini­tial­ly evad­ing de­tec­tion by the im­mune sys­tem, avoid­ing trig­ger­ing any an­ti­bod­ies and the­o­ret­i­cal­ly mak­ing it pos­si­ble to do re­peat ad­min­is­tra­tions.

Not sur­pris­ing­ly, BI al­so plans to whip up a pipeline of com­bi­na­tion ap­proach­es, arm­ing their OV with can­cer drugs that can both amp up the im­mune sys­tem at­tack and charge di­rect­ly at can­cer cells.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

FDA au­tho­rizes Pfiz­er's vac­cine boost­er for se­niors, those at high risk for se­vere Covid-19

The Biden administration’s goal of kicking off its booster shot drive for the entire US population this week is not quite going as planned.

First, Pfizer applied for approval of a supplemental application for the booster shots, but since last Friday’s adcomm reviewing them, the plan has devolved into an EUA, which the FDA issued late Thursday evening.

The population that is now eligible for the booster, six months after receiving the first pair of Pfizer-BioNTech vaccines, also narrowed from what Pfizer applied for (everyone who’s eligible for the initial Pfizer shots) to just those who are 65 or older, or at high-risk of a Covid infection, including health care workers and others with occupational hazards.

Stéphane Bancel, AP Images

Fi­nal analy­sis of US-fund­ed Mod­er­na Covid vac­cine tri­al shows 98% ef­fi­ca­cy against se­vere dis­ease

A final look at the results of the placebo-controlled Moderna trial in the New England Journal of Medicine, published Thursday afternoon, shows how the vaccine continues to prevent Covid-19 and severe cases after more than five months following the second shot.

Of the more than 30,000 enrolled in the trial that ultimately led to the vaccine’s EUA, only two people in the vaccine group got a severe form of the disease, compared to 106 in the placebo group — leading to an efficacy of 98%.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

The fire un­der Glax­o­SmithK­line's Em­ma Walm­s­ley grows as an­oth­er well-known ac­tivist in­vestor grabs its pitch­fork — re­port

Bluebell Capital Partners, a proxy brawler fresh off a campaign to oust global food giant Danone’s CEO and most of its board of directors, has bought a stake in UK drugmaker GlaxoSmithKline with its eyes trained directly on Emma Walmsley, the Financial Times reported Wednesday.

The London-based hedge fund joins another notorious activist firm in Paul Singer’s Elliott Management, which earlier this year called for a shakeup in leadership at GSK to handle what the company described as a wealth of riches across the drug giant’s portfolio hindered by limited vision from top staff.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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Paul Hudson, Sanofi CEO (Raphael Lafargue/Abaca/Sipa USA; Sipa via AP Images)

In­side look: How a po­ten­tial part­ner­ship turned in­to a $1.9B buy­out for Sanofi

A couple of months before the FDA was set to make a decision on Kadmon’s so-called “knock-your-socks-off kind of results” for its chronic graft-versus-host disease drug, Sanofi put out feelers for a potential collaboration. But an early approval triggered an offer to buy the company outright — and Sanofi didn’t win without a fight, according to an inside look.

Sanofi’s head of business development and licensing Matthieu Merlin reached out to Kadmon on June 26 with a simple request: He wanted to introduce himself and explore potential partnerships, according to an SEC filing. It had been several months since Kadmon’s belumosudil arrived on the FDA’s doorstep, and after delaying their decision once, regulators said they’d have an answer by Aug. 30. But Sanofi wasn’t the only company interested in getting to know the execs over at Kadmon.

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