Novotech beefs up Asia-Pa­cif­ic CRO of­fer­ing with new buy­out as re­gion’s bio­phar­ma busi­ness booms

→ Asia-Pa­cif­ic CRO Novotech is ex­pand­ing, buy­ing out CRO Clin­i­cal Net­work Ser­vices as it builds up its ear­ly- to late-stage tri­al net­work in the re­gion.

CNS’ 140 staffers in Aus­tralia, New Zealand and the US will con­tin­ue to op­er­ate as an in­de­pen­dent unit, work­ing with the 400 staffers at Novotech in the Asia-Pa­cif­ic re­gion. No terms were pro­vid­ed.

CNS spe­cial­izes in ear­ly phase non-on­col­o­gy clin­i­cal tri­als across Aus­tralia and New Zealand, with Novotech spe­cial­iz­ing in “re­gion­al Asia-Pa­cif­ic and glob­al project de­liv­ery across all phas­es.”

“Ear­ly phase re­search in Aus­trala­sia has seen in­cred­i­ble growth over the last 6-7 years,” not­ed CNS man­ag­ing di­rec­tor Russ Neal. The deal “means that we are able to of­fer our clients ac­cess to Novotech’s Asia-Pa­cif­ic ex­pe­ri­ence and ex­per­tise in lat­er phase re­gion­al or glob­al tri­als. On the oth­er hand, Novotech clients can ac­cess our high­ly re­gard­ed glob­al prod­uct de­vel­op­ment and reg­u­la­to­ry af­fairs con­sul­tan­cy team, BioDesk, based out of Wash­ing­ton DC, Lon­don and Aus­tralia.”

Ab­b­Vie may have set up some im­pos­ing bar­ri­ers to any­one look­ing to en­croach on its mega-block­buster US mar­ket for Hu­mi­ra, but the walls are tum­bling down fast in Eu­rope. To­day Bio­gen and Sam­sung Bioepis re­port­ed the launch of Im­ral­di, a Hu­mi­ra knock­off, in the Eu­ro­pean mar­ket. Those copies are ex­pect­ed to chew up the fran­chise in the EU, but Ab­b­Vie knows that it’s the US where it makes the big mon­ey.

Gami­da Cell CEO Ju­lian Adams is tak­ing the next big step to­ward an IPO, with plans to sell 3.5 mil­lion shares at $13 to $15 each. That would raise about $50 mil­lion. The com­pa­ny plans to list as $GM­DA.

Os­mot­i­ca Phar­ma­ceu­ti­cals is not find­ing a warm wel­come on Wall Street. The biotech is tak­ing quite a hair­cut on its IPO, sell­ing 8.3 mil­lion shares at $7, less than half of the low end of its pro­ject­ed range. The com­pa­ny plans to list as $OSMT.

→ A stern Chi­nese gov­ern­ment has im­posed a $1.32 bil­lion (9.1 bil­lion RMB) fine on Changchun Chang­sheng, the vac­cine mak­er ac­cused of fal­si­fy­ing records and sell­ing sub­stan­dard vac­cines — amount­ing to eight vi­o­la­tions of the law, ac­cord­ing to an in­ves­ti­ga­tion by the Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion.

Deborah Dunsire. Lundbeck

UP­DAT­ED: Deb­o­rah Dun­sire is pay­ing $2B for a chance to leap di­rect­ly in­to a block­buster show­down with a few of the world's biggest phar­ma gi­ants

A year after taking the reins as CEO of Lundbeck, Deborah Dunsire is making a bold bid to beef up the Danish biotech’s portfolio of drugs in what will likely be a direct leap into an intense rivalry with a group of giants now carving up a growing market for new migraine drugs.

Bright and early European time Monday morning the company announced that it will pay up to about $2 billion to buy Alder, a little biotech that is far along the path in developing a quarterly IV formulation of a CGRP drug aimed at cutting back the number of crippling migraines patients experience each month. In a followup call, Dunsire also noted that the company will likely need 200 to 250 reps for this marketing task on both sides of the Atlantic. And analysts were quick to note that the dealmaking at Lundbeck isn’t done, with another $2 billion to $3 billion available for more deals to beef up the pipeline.

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Scott Gottlieb, AP Images

Scott Got­tlieb has a new board po­si­tion to add to the re­sume — and this one is fo­cused on a fa­vorite sub­ject

Scott Gottlieb has another position to add to his lengthy roster of boards and advisory roles in the wake of his departure from the helm of the FDA.

He’ll be joining the advisory board of FasterCures, a think tank which former junk bond king Michael Milken set up to help drive more drugs to the market, looking to accelerate drug R&D. That’s a subject close to the heart of Gottlieb, who blazed a trail at the FDA focused on hustling up the process. That helped endear him to the industry, making him one of the most popular commissioners in FDA history.

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Karyopharm lines up $150 mil­lion cash in­jec­tion to back con­tro­ver­sial drug launch

Karyopharm has entered into a royalty agreement worth up to $150 million to back the launch of their multiple myeloma drug — recently approved by the FDA over the objections of a majority of the agency’s outside experts.

The deal with HealthCare Royalty Partners, worth $75 million now and $75 million once certain regulatory and commercial milestones have been reached, will fund the commercialization of Karyopharm’s oral SINE compound Xpovio (selinexor) for patients with multiple myeloma who have already had at least four prior therapies. The money will help Karyopharm as it markets its newly approved drug and pushes through clinical trials testing the drug on refractory multiple myeloma patients with one to three therapies and patients with treatment-resistant diffuse large B-cell lymphoma. It will give Karyopharm a cushion through mid-2021.

Af­ter a run of CT­LA-4 com­bo fail­ures, sci­en­tists spot­light a way to make it work — in se­lect pa­tients

CTLA-4/PD-(L)1 combinations have been one of the El Dorados of oncology, its promise forever behind that next hill but apparently unattainable after a series of pivotal clinical failures. But researchers at New York’s Memorial Sloan Kettering Cancer Center and the Technical University of Munich think they may know how to fix what’s wrong and boost the drive to next-gen cancer combos.

In a preclinical animal research program, researchers found that within a cell, checkpoints rely on a specific molecule — RNA-sensing molecule RIG-I — to work. If that sounds familiar, it’s because it has already been identified as a target for boosting immune responses and was subject to at least one Phase I/II trial. Pfizer in December allied itself with Kineta with $15 million upfront and $505 million in potential milestones to develop RIG-I immunotherapies, and three years ago Merck purchased German upstart Rigontec for $137 million upfront and over $400 million in potential milestones for the same purpose.

Pur­due Phar­ma files for bank­rupt­cy as first step in $10B opi­oid set­tle­ment

It’s settled. Purdue Pharma has filed for bankruptcy as part of a deal that would see the OxyContin maker hand over $10 billion in cash and other contributions to mitigate the opioid crisis — without acknowledging any wrongdoing in the protracted epidemic that’s resulted in hundreds of thousands of deaths.

The announcement came two weeks after news of a proposed settlement surfaced and largely confirm what’s already been reported.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Lisa M. DeAngelis, MSKCC

MSK picks brain can­cer ex­pert Lisa DeAn­ge­lis as its next CMO — fol­low­ing José Basel­ga’s con­tro­ver­sial ex­it

It’s official. Memorial Sloan Kettering has picked a brain cancer expert as its new physician-in-chief and CMO, replacing José Baselga, who left under a cloud after being singled out by The New York Times and ProPublica for failing to properly air his lucrative industry ties.

His replacement, who now will be in charge of MSK’s cutting-edge research work as well as the cancer care delivered by hundreds of practitioners, is Lisa M. DeAngelis. DeAngelis had been chair of the neurology department and co-founder of MSK’s brain tumor center and was moved in to the acting CMO role in the wake of Baselga’s departure.

Penn team adapts CAR-T tech, reengi­neer­ing mouse cells to treat car­diac fi­bro­sis

After establishing itself as one of the pioneer research centers in the world for CAR-T cancer therapies, creating new attack vehicles to eradicate cancer cells, a team at Penn Medicine has begun the tricky transition of using the basic technology for heart repair work.

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Tal Zaks. Moderna

The mR­NA uni­corn Mod­er­na has more ear­ly-stage hu­man da­ta it wants to show off — reach­ing new peaks in prov­ing the po­ten­tial

The whole messenger RNA field has attracted billions of dollars in public and private investor cash gambled on the prospect of getting in on the ground floor. And this morning Boston-based Moderna, one of the leaders in the field, wants to show off a few more of the cards it has to play to prove to you that they’re really in the game.

The whole hand, of course, has yet to be dealt. And there’s no telling who gets to walk with a share of the pot. But any cards on display at this point — especially after being accused of keeping its deck under lock and key — will attract plenty of attention from some very wary, and wired, observers.

“In terms of the complexity and unmet need,” says Tal Zaks, the chief medical officer, “this is peak for what we’ve accomplished.”

Moderna has two Phase I studies it wants to talk about now.

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