A For­bion-fund­ed start­up bought the rights to Am­gen's CETP in­hibitor, and is giv­ing the cho­les­terol drug an­oth­er go

Michael David­son

For­bion-fund­ed start­up NewAms­ter­dam Phar­ma has ac­quired the rights to obice­trapib: the CETP in­hibitor that CEO Michael David­son al­ways thought would be the “crown­ing” of his ca­reer.

The an­nounce­ment comes five years af­ter For­bion sold Dez­i­ma Phar­ma and obice­trapib, its sole prod­uct, to Am­gen for an up-front pay­ment of $300 mil­lion. Am­gen halt­ed de­vel­op­ment in 2017, short­ly af­ter Eli Lil­ly, Pfiz­er, Roche and Mer­ck walked away from their own CETP drugs. For­mer Pfiz­er R&D chief John LaMat­ti­na even sug­gest­ed that Am­gen might be bet­ter off cut­ting its loss­es just weeks af­ter ac­quir­ing the drug.

Af­ter reac­quir­ing obice­trapib, For­bion dropped €20 mil­lion ($23.6 mil­lion) in seed fund­ing for NewAms­ter­dam to launch in­to Phase III de­vel­op­ment.

“The in­sights from those oth­er pro­grams have been ex­treme­ly help­ful. The four fail­ures all have, you know, good rea­sons why they failed, and our drug over­comes all those is­sues,” David­son said. “We have a drug that’s more ef­fi­ca­cious in low­er­ing LDL/ApoB, it’s very safe based on IIb da­ta, and we know how to do the right tri­al to get to the end­point that’s go­ing lead to a much more ro­bust view by clin­i­cians that this is an ef­fec­tive ther­a­py to low­er LDL — es­pe­cial­ly in those that are statin-in­tol­er­ant.”

The com­pa­ny is keep­ing the fi­nan­cial terms of the deal un­der wraps for now, and the an­tic­i­pat­ed size of its Phase III tri­al. NewAms­ter­dam is in talks with the FDA, and ex­pects to en­ter Phase III in Q1 of next year, with at least two tri­als tak­ing place in the US and Eu­rope.

Obice­trapib is a CETP in­hibitor, which tar­gets ApoB and low-den­si­ty LDL cho­les­terol. It’s be­ing de­vel­oped for pa­tients who are statin-in­tol­er­ant, and David­son tout­ed that it could be the “most ef­fi­ca­cious oral ther­a­py to re­place a statin or to add to a statin to low­er LDL cho­les­terol.”

In a ran­dom­ized Phase IIb study, dubbed TULIP, the drug re­duced the num­ber of ApoB-con­tain­ing par­ti­cles that con­sti­tute LDL-c, ac­cord­ing to the com­pa­ny. NewAms­ter­dam says it’s plan­ning a “sub­stan­tial” fi­nanc­ing round be­fore the end of the year.

Sander Slootweg

Sander Slootweg, man­ag­ing part­ner at For­bion, said the drug shows po­ten­tial for a “poor­ly served” sub­set of pa­tients, who are at risk of car­dio­vas­cu­lar dis­ease and are statin-in­tol­er­ant. “With over 30 mil­lion pa­tients meet­ing these cri­te­ria, we be­lieve that obice­trapib has mega-block­buster sales po­ten­tial,” he said.

Launch­ing a com­pa­ny from the ground up isn’t new for David­son. NewAms­ter­dam is the third com­pa­ny he’s found­ed, and the CEO says he’s worked with CETP drugs for the last 30 years. He closed a deal with No­vo Nordisk to sell his Mass­a­chu­setts-based com­pa­ny Cor­vidia for more than $725 mil­lion up-front in Ju­ly, and his for­mer New Jer­sey-based com­pa­ny Omthera was sold to As­traZeneca for $443 mil­lion in 2013.

“We’re not rul­ing out the pos­si­bil­i­ty of, you know, grow­ing this in­to a sig­nif­i­cant com­pa­ny, but our fo­cus is go­ing to be pri­mar­i­ly on obice­trapib for low­er­ing LDL and re­duc­ing car­dio­vas­cu­lar events,” David­son said.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

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Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

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The pharma giant flagged plans to launch a strategic review of the business in its Q3 update, noting that “options range from retaining the business to separation.”

Analysts have been poking and prodding Novartis execs for years now as Narasimhan attempted to remodel a business that has been a drag on its performance during most of his reign in the CEO suite. The former R&D chief has made it well known that he’s devoted to the innovative meds side of the business, where they see the greatest potential for growth.

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Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

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Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

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Peter Nell, Mammoth Biosciences CBO

UP­DAT­ED: Jen­nifer Doud­na spin­out inks a Mam­moth CRISPR deal with Ver­tex worth near­ly $700M

When a company gets its start in gene editing pioneer Jennifer Doudna’s lab, it’s bound to make headlines. But three years in, the fanfare still hasn’t died down for Mammoth Biosciences. Now, the Brisbane, CA-based company is cheering on its first major R&D pact.

Mammoth unveiled a nearly $700 million deal with Vertex on Tuesday morning, good for the development of in vivo gene therapies for two mystery diseases. The stars of the show are Mammoth’s ultra-small CRISPR systems, including two Cas enzymes licensed from Doudna’s lab over the past couple years, Cas14 and Casɸ.

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Hamza Suria, AnaptysBio CEO

The biotech be­hind Glax­o­SmithK­line's PD-1 just scored a $250M cash deal for roy­al­ties

With Merck and Bristol Myers Squibb still dominating the PD-(L)1 space and the threat of lower-cost options coming from behind, is there still room for GlaxoSmithKline’s checkpoint inhibitor — the seventh to market — to make billions? For Sagard Healthcare Royalty Partners, the answer is yes.

Sagard has plumped down $250 million in cash to buy out the 8% royalty AnaptysBio owns on Jemperli sales below $1 billion.

FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

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