Cere­cor’s $1M Lil­ly deal put it in the right place at the right time to­day

Call it col­lat­er­al — though per­haps tem­po­rary — good for­tune.

When Alk­er­mes $ALKS whis­tled up an in­stant spike for their share price on pos­i­tive Phase III da­ta for their de­pres­sion drug ALK-5461, shares of mi­cro­cap Cere­cor $CERC al­so ig­nit­ed. The stock had bounced up 56% in pre­mar­ket trad­ing be­cause it has a mid-stage drug, CERC-501, that has the same mech­a­nism as the Alk­er­mes can­di­date.

Just like ‘5461, CERC-501 is a kap­pa opi­oid re­cep­tor an­tag­o­nist. And while no two drugs are nec­es­sar­i­ly ex­act­ly alike, the re­sem­blance was good enough for in­vestors look­ing for oth­er bene­fac­tors of this da­ta.

Cere­cor’s bounce is good for a mul­ti­mil­lion-dol­lar boost in its mar­ket cap, if it sticks (watch that num­ber, the boost was fad­ing fast in ear­ly trad­ing this morn­ing). That’s many times the $1 mil­lion the Bal­ti­more-based biotech paid Eli Lil­ly up front to land rights to this drug back in Feb­ru­ary of 2015.

“We were hap­py with the deal terms,” CEO Uli Hack­sell tells me this morn­ing. (And who could doubt that to­day?) Lil­ly was will­ing to prac­ti­cal­ly give this one away (my words) be­cause of the phar­ma gi­ant’s in­ten­tion to pur­sue an­oth­er enor­mous Phase III pro­gram for its Alzheimer’s drug solanezum­ab (his words). CERC-501 was ei­ther go­ing to be out-li­censed or shelved.

Iron­i­cal­ly, Cere­cor is not cur­rent­ly test­ing their drug for de­pres­sion. But it is en­gaged in a mid-stage pro­gram that ranges from smok­ing with­draw­al to anx­i­ety, co­caine ad­dic­tion and PTSD.

“Our in­ten­tion is to start a Phase II study next year in de­pres­sion for 501 as well,” adds the CEO. Hack­sell, the for­mer CEO of Aca­dia, which fi­nal­ly capped a lengthy quest for an ap­proval of the an­tipsy­chot­ic Nu­plazid ear­li­er this year.

Now Hack­sell says he’s bull­ish that his ri­val to ‘5461 can help re­place the an­tipsy­chotics that come in­to play when pa­tients with de­pres­sion fail the first rounds of sug­gest­ed treat­ments.

Time will tell. In the mean­time, Cere­cor is await­ing the full da­ta set from Alk­er­mes’ third Phase III with plans to soak up as many lessons as pos­si­ble for its own de­vel­op­ment cam­paign.

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.

No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'


Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Rahul Singhvi, Resilience CEO

A Bob Nelsen start­up turns to Har­vard to help sharp­en its tech, in­spir­ing first spin­out

One of Bob Nelsen’s latest projects is headed to Harvard.

Resilience, a company started with the goal of establishing itself as a “one-stop-shop” for companies looking to scale manufacturing, including for hard-to-develop cell and gene therapies, is less than a year old. Friday, it announced a five-year R&D deal with Harvard University that includes $30 million to develop biologics, including vaccines, nucleic acids and cell and gene therapies.

Susan Galbraith speaking at Endpoints News' virtual EUBIO21 summit

Imfinzi/treme­li­mum­ab com­bo scores As­traZeneca an­oth­er OS win — this time in liv­er can­cer

Is the tide turning on AstraZeneca’s battered PD-L1/CTLA4 combo?

A single priming dose of the experimental tremelimumab, followed by Imfinzi every four weeks, beat Nexavar (sorafenib) in helping a group of liver cancer patients live longer in a Phase III study, the company reported, meeting the primary endpoint.

Specifically, the two drugs extended overall survival for patients with unresectable hepatocellular carcinoma who had not received prior systemic therapy and were not eligible for localized treatment.

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FDA+ roundup: Marks on Wood­cock­'s tenure as act­ing com­mis­sion­er; FDA lead­ers of­fer per­spec­tive on bar­ri­ers to di­ver­si­ty in re­search

CBER director Peter Marks praised Janet Woodcock’s work as acting FDA commissioner, and while noting that Biden needs to nominate someone to fill the role permanently by Nov. 16, he said he has “no idea” when that actually might occur.

“Dr. Woodcock has been at the agency for over three decades and she, during that time, has proven herself to be a remarkably capable manager,” Marks said at the Alliance for Regenerative Medicine’s meeting Tuesday. “And she’s been managing as if she’s commissioner, unlike some previous acting [commissioners] who are afraid to actually do things. She doesn’t appear to be afraid to do things. I have not felt any different now from when we had a commissioner in place,” he added.

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