News brief­ing: Gilead part­ner Gala­pa­gos sells off CRO for $37M; Polyphor bags $3.3M from CF Foun­da­tion

Close Gilead al­ly Gala­pa­gos is sell­ing off one of its con­tract re­search or­ga­ni­za­tions to a Pol­ish phar­ma com­pa­ny.

Gala­pa­gos has agreed to sell 100% of the out­stand­ing shares in the CRO Fi­delta to Selvi­ta, in a deal worth rough­ly $37 mil­lion ex­pect­ed to close in the first week of Jan­u­ary. The ac­qui­si­tion is ex­pect­ed to near­ly dou­ble Selvi­ta’s rev­enues, the com­pa­ny says, as well as ex­pand its drug dis­cov­ery ef­forts.

“This is a per­fect fit for us: an ex­ten­sive­ly ex­pe­ri­enced or­ga­ni­za­tion, with a full range of in-house drug dis­cov­ery ca­pa­bil­i­ties and an es­tab­lished track record of clin­i­cal can­di­date de­liv­ery,” Selvi­ta CEO Bo­gus­law Sieczkows­ki said.

Fi­delta’s main ar­eas of fo­cus are in­flam­ma­tion, fi­bro­sis, and an­ti-in­fec­tives, and its R&D fa­cil­i­ty is lo­cat­ed in Croa­t­ia. With the ac­qui­si­tion, Selvi­ta hopes to boost its ca­pac­i­ties in drug me­tab­o­lism and phar­ma­co­ki­net­ics, in vi­vo phar­ma­col­o­gy and tox­i­col­o­gy.

For Gala­pa­gos, the move comes on the heels of bad news af­ter bad news fol­low­ing the news that one of their top de­vel­op­ment pro­grams fell flat in a mid-stage study for os­teoarthri­tis last month. The pro­gram missed the pri­ma­ry and all key sec­ondary end­points, and came af­ter Gilead had in­vest­ed $5 bil­lion to col­lab­o­rate with the com­pa­ny. — Max Gel­man

Polyphor nets $3.3M from CF Foun­da­tion

The CF Foun­da­tion is best known for fi­nanc­ing de­vel­op­ment of the Ver­tex CFTR in­hibitors that have changed the lives of mil­lions of peo­ple with cys­tic fi­bro­sis. But the non-prof­it ven­ture al­so doles out cash for projects that could ame­lio­rate the var­i­ous com­pli­ca­tions that come with CF, be­yond the di­rect dis­ease bi­ol­o­gy.

On Tues­day, the foun­da­tion gave Polyphor $3.3 mil­lion to fund a Phase Ib/IIa tri­al on their in­haled an­tibi­ot­ic for chron­ic Pseudomonas aerug­i­nosa in­fec­tions in cys­tic fi­bro­sis. The bac­te­ria can in­fect peo­ple with­out CF, but it is a par­tic­u­lar threat for peo­ple with the lung dis­or­der, even those who are on CFTR in­hibitors.

Like many an­tibi­ot­ic com­pa­nies, Polyphor has strug­gled over the last two years as the bit­ter eco­nom­ics of the mar­ket be­came in­creas­ing­ly clear. Mak­ing mat­ters worse, the com­pa­ny had to scrap a Phase III on their lead drug in May of 2019, af­ter kid­ney com­pli­ca­tions cropped up.

Af­ter rais­ing $165 mil­lion in 2018 off the strength of that lead drug, the com­pa­ny has more re­cent­ly turned to grants, win­ning up to $18.44 mil­lion this year from CARB-X. – Ja­son Mast

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

Michelle McMurry-Heath, BIO CEO (BIO via YouTube)

BIO looks to re­struc­ture, lay­ing off staff amid chal­lenge to the trade org's nor­mal face-to-face style

The biopharma industry, on the whole, had a red-letter year in 2020 amid Covid-19, with fundraising at an all-time high and major players speeding vaccines ahead to approval. But for BIO, the industry’s leading trade organization, the pandemic has prompted a reconsideration of the game plan.

BIO will pivot to digital as the Covid-19 pandemic continues to rage, making “some staff reductions” as it looks to bring its roughly 37,000 in-person meetings each year to the web, the organization said Thursday.

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Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Covid-19 roundup: Italy won­ders aloud if it can sue Pfiz­er for vac­cine short­falls; US recom­mits to WHO un­der Biden ad­min­is­tra­tion

As reports crop up that deliveries of Pfizer and BioNTech’s Covid-19 vaccine are being unexpectedly cut, Italy wonders if it can take the vaccine developers to court, according to the Wall Street Journal. 

After its shipment for this week was cut by 29%, the Italian government consulted its attorney general about taking legal action, the WSJ reported. Pfizer and BioNTech had warned the EU and Canada last week that their allocations would be reduced as Pfizer upgrades its Belgium factory. What Italy says it doesn’t appreciate, though, is the short notice.

Mike Grey, Plexium chairman (Horizon Therapeutics)

Plex­i­um adds in­dus­try vet Mike Grey to the brain trust with new in­vestor cash fund­ing its pro­tein degra­da­tion play

About 15 months since closing a $28 million Series A, a San Diego protein-degradation upstart returned to the venture well Thursday with an extension of that round and some new hires, including one of the city’s best-connected biotech execs.

Plexium has bagged an additional $35 million in financing, the biotech said, money that will push undisclosed oncology and immuno-oncology programs into the clinic. In addition, longtime industry vet Mike Grey is jumping on as chairman of the board, and two others from Thursday’s leads — Adam Goulburn from Lux Capital and Rob Hopfner from Pivotal BioVentures — joined the board too.