In a blow to Eli Lil­ly, No­vo Nordisk lands FDA OK for their next big en­try in the di­a­betes mar­ket: Ozem­pic

An en­er­gized FDA has come through with an ap­proval of No­vo Nordisk’s once-week­ly GLP-1 di­a­betes drug semaglu­tide, open­ing the door to a mar­ket many an­a­lysts are con­vinced is worth more than $2 bil­lion a year in peak sales. And it could spell big trou­ble for ri­val Eli Lil­ly.

Mads Krogs­gaard Thom­sen

Type 2 di­a­betes is a mas­sive and fast-grow­ing dis­ease, with a glob­al mar­ket that has re­ward­ed a hand­ful of key play­ers like No­vo Nordisk a multi­bil­lion-dol­lar mar­ket. And No­vo ran a typ­i­cal­ly thor­ough Phase III pro­gram.

In do­ing so, No­vo al­so came up with su­pe­ri­or da­ta to Eli Lil­ly’s Trulic­i­ty, set­ting up a head-to-head show­down that could cost Lil­ly dear­ly.

Re­searchers al­so came up with some trou­bling in­stances of di­a­bet­ic retinopa­thy, which can lead to blind­ness. But a near unan­i­mous vote by a group of out­side ex­perts at the FDA felt that was an is­sue that could be mon­i­tored, in light of the ben­e­fits in glycemic con­trol the drug of­fered.

No­vo al­so isn’t done with the de­vel­op­ment of this drug, now Ozem­pic, for the big US mar­ket. Re­searchers are busi­ly putting it through an­oth­er big test as an obe­si­ty ther­a­py af­ter trig­ger­ing some im­pres­sive weight loss among obese pa­tients. And they would be squar­ing off against some unim­pres­sive ri­vals now on the mar­ket.

In an R&D up­date dur­ing its Cap­i­tal Mar­kets Day at its HQ near Copen­hagen just days ago, in­ves­ti­ga­tors for the com­pa­ny said they will re­cruit 4,500 pa­tients for a Phase II­Ia obe­si­ty tri­al for semaglu­tide. And they plan to launch the 68-week study next year, along­side a “land­mark” car­dio­vas­cu­lar out­comes study with 12,500 peo­ple en­rolled.

“We are very ex­cit­ed about the first ap­proval of Ozem­pic and look for­ward to mak­ing this im­por­tant in­no­va­tion avail­able to peo­ple in the US with type 2 di­a­betes in the be­gin­ning of 2018,” said Mads Krogs­gaard Thom­sen, ex­ec­u­tive vice pres­i­dent and chief sci­ence of­fi­cer, in a state­ment. “Type 2 di­a­betes is a com­plex dis­ease, but with the unique clin­i­cal pro­file of Ozem­pic, we be­lieve it has the po­ten­tial to set a new stan­dard for the treat­ment of the dis­ease.”

The FDA is now just a few ap­provals from break­ing the 45 NDAs of­fered in 2015.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Mathai Mammen (Rob Tannenbaum, Endpoints News at BIO 2018)

Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck five years ago, where the soft-spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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Illustration: Kim Ryu for Endpoints News

Why non-opi­oid pain drugs keep fail­ing — and what's next for the field

In 1938, Rita Levi-Montalcini was forced to move her lab into her bedroom in Turin, as Mussolini’s facist government expelled Jewish people from studying or working in schools in Italy. Levi-Montalcini, then just a few years out of medical school and using sewing needles as scalpels in her makeshift lab, would soon discover nerve growth factor, or NGF, in chicken embryos.

Her discoveries formed the basis of our understanding of the peripheral nervous system and how cells talk to each other, and Levi-Montalcini went on to win the Nobel Prize in 1986. Much later, NGF was hailed as a promising target for new pain therapies, with some analysts quoting an $11 billion market. However, the latest anti-NGF candidate, Pfizer and Eli Lilly’s tanezumab, was rejected by the FDA last year because of a side effect that dissolved bone in some of its patients.

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Samantha Du, Zai Lab CEO

Any­one still look­ing for a CD47? Zai Lab shelves PhI pro­gram af­ter re­view­ing 'com­pet­i­tive land­scape'

Over the past few years, the promise of blocking CD47 — a “don’t eat me” signal co-opted by cancer cells — has sent drugmakers big and small into a frenzy. But one biotech is now bowing out.

Zai Lab is deprioritizing ZL-1201, its CD47 inhibitor, scrapping plans for a Phase II trial. It will now “pursue out-licensing opportunities,” the company said in its Q2 update. The decision was based on a review of the competitive landscape, it added, without going into further details.

Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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HHS Secretary Xavier Becerra (Patrick Semansky/AP Images)

US weighs new route of ad­min­is­tra­tion for mon­key­pox vac­cine as cas­es climb — re­port

Less than a week after HHS Secretary Xavier Becerra declared monkeypox a national health emergency, reports have emerged that the US plans to extend its vaccine supply by opting for a different route of administration.

Officials are expected to call for intradermal injection of Bavarian Nordic’s Jynneos vaccine — the only shot approved specifically for monkeypox in the US — as opposed to subcutaneous injection, unnamed sources told both the New York Times and Washington Post on Tuesday.

'Messy at best': Is the US re­peat­ing the same Covid mis­steps with mon­key­pox mes­sag­ing?

When Kyle Planck first suspected he might have monkeypox in late June, he went to the CDC website and found six photos of different types of lesions. And that was about it for general public information.

Planck, who is a sixth-year PhD pharmacology researcher at Weill Cornell, kept looking though and found a separate part of the CDC website meant for healthcare professionals. There he found a medical slide deck with more pictures, professional journal articles and more details about symptoms and diagnosis.

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US to stop sup­ply­ing Lil­ly's mAb for Covid-19 this month as com­mer­cial mar­ket awaits

Federal officials said yesterday that shipments of Eli Lilly’s bebtelovimab — one of the final two remaining mAb treatments for Covid-19 — would halt later this month, setting up a commercial market where the government no longer pays for the doses and hospitals and other clinics will have to purchase supplies.

According to ASPR, the arm of HHS that ships Covid-19 drugs, states have ordered 627,536 bebtelovimab courses, and 383,515 courses have been administered as of July 31. The US has paid Lilly a total of about $1.27 billion for all of the courses so far, amounting to about $2,100 per course to start and then receiving a discounted $1,833 ASP for the later part of the deal. According to the Wall Street Journal, Lilly’s list price for bebtelovimab is $2,100 per dose.

Stanley Erck, Novavax CEO (Photographer: Kevin Dietsch/UPI/Bloomberg via Getty Images)

No­vavax shares shred­ded as Covid vac­cine sales fall more than 90% in Q2

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room: