Bris­tol My­ers li­cens­es for Evotec mol­e­cule for $20M; FDA ap­proves Im­pel's mi­graine nasal spray Trud­he­sa

Bris­tol My­ers Squibb has ex­er­cised its op­tion with Evotec for EVT8683, a small mol­e­cule cre­at­ed by the Ger­man biotech to tar­get a spe­cif­ic “cel­lu­lar stress re­sponse.”

The com­pa­nies have ob­tained clear­ance to start hu­man tri­als, close to 4.5 years af­ter ini­ti­at­ing a part­ner­ship.

Ac­cord­ing to an Evotec state­ment, “the pro­gramme tar­gets a key cel­lu­lar stress re­sponse mech­a­nism which has the po­ten­tial to de­liv­er dis­ease-mod­i­fy­ing treat­ments for sev­er­al dev­as­tat­ing neu­rode­gen­er­a­tive dis­eases.”

Evotec CSO Cord Dohrmann com­ment­ed in a state­ment: “We are very ex­cit­ed to bring a first drug can­di­date which orig­i­nat­ed from Evotec’s iP­SC dis­cov­ery plat­form in­to the clin­ic.”

Through this opt-in, Bris­tol My­ers will pay Evotec $20 mil­lion and lead fur­ther de­vel­op­ment and com­mer­cial­iza­tion.

Im­pel an­nounces FDA ap­proval of Trud­he­sa in nasal spray form for mi­graines

Seat­tle, WA-based biotech Im­pel Neu­roPhar­ma said to­day that the FDA ap­proved Trud­he­sa nasal spray for the treat­ment of mi­graines, with or with­out au­ra in adults. Trud­he­sa was pre­vi­ous­ly known as INP104. The com­mer­cial launch of the drug is planned for ear­ly next month.

Adri­an Adams, chair­man and CEO of Im­pel, said in a state­ment: “The ap­proval of Trud­he­sa marks the cul­mi­na­tion of more than a decade of re­search and ad­vanced en­gi­neer­ing. We are grate­ful for all the pa­tients and in­ves­ti­ga­tors who par­tic­i­pat­ed in our clin­i­cal tri­als.”

This ap­proval comes on­ly a few months af­ter Im­pel launched its IPO in April, rais­ing $80 mil­lion and pric­ing its shares at $15 apiece.

The NDA for the spray in­clud­ed the re­sults of a Phase III, open-la­bel, piv­otal safe­ty study known as STOP 301. More than 5,650 mi­graine at­tacks were treat­ed over 24 or 52 weeks dur­ing the study.

Im­pel will host a con­fer­ence call re­gard­ing Trud­he­sa’s FDA ap­proval on Sep­tem­ber 7th.

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.

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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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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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.

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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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.

FDA ad­comm to de­cide on mol­nupi­ravir EUA; Can­cer at­las un­veils new po­ten­tial drug tar­get

The FDA has another adcomm coming down the pipeline — this time on Covid-19 oral antiviral molnupiravir.

The federal agency’s advisory committee will meet on November 30th to go over Merck and Ridgeback’s EUA request for their investigational antiviral drug, and discuss the available data supporting its use in Covid-19 patients.

This comes two weeks after Merck claimed that their antiviral pill reduced the chance that newly diagnosed Covid-19 patients would be hospitalized or die by 50%. The pharma made the announcement after interim data on 775 patients in their clinical trial showed the antiviral’s potential.

FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

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.