No­var­tis builds can­cer pipeline with a new plat­form/drug buy­out, bag­ging Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions for $3.9B

No­var­tis has just bought it­self a new can­cer ther­a­py as well as a new tech plat­form for $3.9 bil­lion in cash, bag­ging the French biotech Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions $AAAP.

The phar­ma gi­ant is pay­ing a mod­est 44% pre­mi­um over the biotech’s mar­ket val­u­a­tion from Sep­tem­ber 28, when Bloomberg re­port­ed that No­var­tis was kick­ing the tires and run­ning the num­bers on the biotech’s drug Lu­tathera (177Lu-DOTATATE).

The drug is a ra­dio­phar­ma­ceu­ti­cal — us­ing ra­dioiso­topes to tar­get neu­roen­docrine tu­mors — a fo­cus where No­var­tis has con­sid­er­able ex­pe­ri­ence. The phar­ma play­er tout­ed the piv­otal da­ta for the drug from the NET­TER-1 study, which demon­strat­ed a 79% re­duc­tion in the risk of dis­ease pro­gres­sion, with an in­ter­im me­di­an pro­gres­sion-free sur­vival rate of 8.4 months that had yet to max out.

No­var­tis al­so gets a pipeline of drugs off the new plat­form with some near-term po­ten­tial it likes. That line­up on AAA’s ex­per­i­men­tal meds in­cludes 177Lu-PS­MA-R2, which is now en­ter­ing a Phase I/II study.

Ap­proved in Eu­rope, the FDA forced the biotech in­to the wait­ing line late last year af­ter shak­ing its head at the way the com­pa­ny had pre­sent­ed some of the da­ta in its ap­pli­ca­tion, forc­ing a re­jec­tion at the time. An ap­proval would build on No­var­tis $NVS OK for Afin­i­tor in ear­ly 2016 as a treat­ment for neu­roen­docrine tu­mors, as well as its mar­ket­ing of San­do­statin.

Bruno St­rig­i­ni

Now the biotech is wait­ing for an­oth­er dead­line to loom on the de­layed ap­pli­ca­tion, and No­var­tis clear­ly be­lieves that this time reg­u­la­tors should clear it for mar­ket­ing.

The deal falls right in­to No­var­tis’ sweet spot. Out­go­ing CEO Joe Jimenez — soon to be re­placed by R&D chief Vas Narasimhan — has said sev­er­al times that the com­pa­ny is pri­mar­i­ly in­ter­est­ed in adding bolt-ons in the $2 bil­lion to $5 bil­lion range. This deal beefs up its can­cer pipeline and port­fo­lio af­ter a ma­jor swap with Glax­o­SmithK­line land­ed the UK phar­ma gi­ant’s ad­vanced on­col­o­gy drugs.

Pe­ter Welford at Jef­feries likes this deal, start­ing the peak sales fore­cast at $650 mil­lion a year for Lu­tathera, with a chance to add on about $285 mil­lion through added ap­provals.

Im­pres­sive Phase III NET­TER-1 da­ta, clin­i­cian feed­back, and a pro­pri­etary US physi­cian sur­vey all un­der­pin our con­fi­dence in Lu­tathera. The prod­uct is based on a well known con­cept of so­mato­statin ana­logues for NETs, has al­ready treat­ed >3,000 pa­tients, and ad­dress­es an un­met med­ical need. We fore­cast $650m peak sales treat­ing midgut GEP-NETs for $30/ADS NPV at 100% prob­a­bil­i­ty, as­sum­ing AAA com­mer­cialis­es it­self in US/EU tar­get­ing the spe­cial­ist cen­tres. Adop­tion to treat oth­er types of NETs could of­fer sig­nif­i­cant po­ten­tial up­side, with on­ly $7/ADS NPV cur­rent­ly as­signed as­sum­ing 60% prob­a­bil­i­ty and $285m in­cre­men­tal peak sales.

“No­var­tis has a strong lega­cy in the de­vel­op­ment and com­mer­cial­iza­tion of med­i­cines for neu­roen­docrine tu­mors where sig­nif­i­cant un­met need re­mains for pa­tients,” said Bruno St­rig­i­ni, the head of No­var­tis On­col­o­gy. “With Lu­tathera we can build on this lega­cy by ex­pand­ing the glob­al reach of this nov­el, dif­fer­en­ti­at­ed treat­ment ap­proach and work to max­i­mize Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions broad­er RLT pipeline and an ex­cit­ing tech­nol­o­gy plat­form.”

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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Sar­to­rius to ac­quire French man­u­fac­tur­er for $2.6B+ in cell and gene ther­a­py play

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

Paul Stoffels, Galapagos CEO (Andrew Harnik/AP Images)

Gala­pa­gos sends some em­ploy­ees — and a re­search unit — off to drug dis­cov­ery CRO as part of re­org

Paul Stoffels has made it clear that he views cutting jobs at Galapagos as difficult but necessary — but he’s getting creative about it.

Galapagos, headquartered in Mechelen, Belgium, has struck an arrangement with French contract research organization NovAliX to transfer its drug discovery and research activities. While NovAliX is based in Strasbourg, it will take over running the site that Galapagos ran in Romainville, France.

TScan Therapeutics' departing CEO David Southwell and CSO/COO Gavin MacBeath

TCR up­start an­nounces CEO ex­it, with CSO now act­ing re­place­ment

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.