We­govy woes con­tin­ue as man­u­fac­tur­ing is­sues will lead to fur­ther short­age of Novo's obe­si­ty drug

As the new year rapid­ly ap­proach­es, and gyms and health food stores across Amer­i­ca pre­pare for a wave of peo­ple seek­ing weight loss, No­vo Nordisk has an­nounced that it does not ex­pect to meet de­mand for We­govy, its pre­scrip­tion in­jectable weight-loss med­ica­tion for obe­si­ty, un­til the sec­ond half of 2022 in the US.

The short­age comes due to man­u­fac­tur­ing is­sues at a con­tract man­u­fac­tur­er that was tasked with fill­ing sy­ringes for the pens. The news comes just days af­ter No­vo an­nounced that it would in­vest rough­ly $2.58 bil­lion to ex­pand its man­u­fac­tur­ing hub in Kalund­borg, Den­mark with three new fa­cil­i­ties and the ex­pan­sion of a fourth to keep up with the suc­cess of its di­a­betes and obe­si­ty med semaglu­tide, We­govy and Ry­bel­sus.

“We were mak­ing progress and had pro­ject­ed to sta­bi­lize sup­ply in ear­ly 2022,” the com­pa­ny said in a state­ment. “How­ev­er, we have been in­formed that our con­tract man­u­fac­tur­er re­spon­si­ble for fill­ing the We­govy pens for the US mar­ket has tem­porar­i­ly stopped de­liv­er­ies and man­u­fac­tur­ing fol­low­ing is­sues re­lat­ed to good man­u­fac­tur­ing prac­tices.”

This is not No­vo’s first time deal­ing with a short­age of the drug in its young life. Sup­ply sold out in June, soon af­ter the FDA is­sued an ap­proval for the drug and it launched. There’s al­ready a one-month de­lay that led to No­vo apol­o­giz­ing to cus­tomers for its in­abil­i­ty to meet with an “un­prece­dent­ed de­mand.”

No­vo al­so spon­sored a mar­ket­ing cam­paign fea­tur­ing ac­tress Queen Lat­i­fah at the helm to change the nar­ra­tive around obe­si­ty, look­ing to frame the di­ag­no­sis as a man­age­able health con­di­tion in­stead of a char­ac­ter flaw.

Over 40% of Amer­i­ca’s adult pop­u­la­tion, around 100 mil­lion peo­ple, are clas­si­fied as obese. Less than 10% of that pop­u­la­tion takes an an­ti-obe­si­ty med­ica­tion. We­govy is the same med­ica­tion as No­vo’s type 2 di­a­betes drug Ozem­pic, but at a high­er dose.

“We are do­ing our ut­most to over­come sup­ply con­straints, but un­for­tu­nate­ly this will take time to re­solve,” the com­pa­ny said.

The chal­lenges fac­ing sup­ply are not go­ing to im­pact the 2021 fi­nan­cial out­look that has al­ready been re­port­ed, No­vo said in a state­ment.

Obe­si­ty drugs have his­tor­i­cal­ly strug­gled fol­low­ing FDA ap­proval. No­vo’s Sax­en­da, launched in 2015, re­quires dai­ly in­jec­tions, and on­ly 100,000 pa­tients were pre­scribed the drug. Cur­rax’s Con­trave failed to gain trac­tion, though it is still in play long-term, and Vivus filed for bank­rupt­cy less than 10 years af­ter its weight loss drug Qsymia failed to gen­er­ate even $9 mil­lion in sales in Q1 2020.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

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.

Who are the women blaz­ing trails in bio­phar­ma R&D? Nom­i­nate them for End­points' 2022 spe­cial re­port

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

Up­dat­ed: Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The subbleases are “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” Biogen spokesperson Ashleigh Koss wrote in a statement to Endpoints News, adding that the company has had subleases across several buildings for years.

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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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Alessandro Maselli, Catalent CEO

Catal­ent ac­quires North Car­oli­na CD­MO for $475M, boost­ing oral solids work

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

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Pfiz­er launch­es re­bate pro­gram for rare dis­ease pa­tients who have to stop tak­ing Panzy­ga

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.

Horizon's back-to-school campaign for children with cystinosis includes an all about me poster as part of a care package box.

Hori­zon read­ies kids and fam­i­lies for back to school with week­long ac­tiv­i­ties around rare dis­ease cysti­nosis

Going back to school is usually a bumpy readjustment from summer freedom for all kids, but especially for kids with chronic health conditions. Horizon Therapeutics is hoping to help smooth the way for some who have the rare disease cystinosis. Cystinosis is a genetic disease that causes the amino acid cystine to build up in different tissues and organs.

The “Gear Up” for school campaign is running all week with different online and at-home events and activities for families and children with cystinosis. Each family who signed up receives a care package mailed to their home including an activity coloring book “Michael’s Show-and-Tell.” The book tells Michael’s story about living with cystinosis while offering kids matching, coloring and finding object games along with information.

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EMA is­sues warn­ing of IVF drug short­age due to man­u­fac­tur­ing is­sues

The European Medicines Agency recently noted the shortage of a drug that is used frequently in IVF procedures where women have ovarian stimulation (i.e. fertility treatment where the ovaries are stimulated to produce more eggs).

The drug, known as cetrotide, is now facing a shortage in Europe due to a potential manufacturing issue.

The EMA’s warning on Wednesday states that a technical issue at the main manufacturing site for cetrotide resulted in the closure of the site between December 2021 and March of this year. This led to reductions and delays in the supply of cetrotide.

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Phar­mas spend mil­lions on di­a­betes ad­ver­tis­ing, but few pa­tients can re­call brand names — sur­vey

While many Big Pharma diabetes brands spend millions of dollars on TV ads every year, most people with type 2 diabetes don’t recognize specific drug brand names, according to a new study.

No brand garnered more than 30% recognition in Phreesia Life Science’s latest in-office patient survey of more than 4,000 adults with type 2 diabetes. Eli Lilly’s Trulicity topped the list as the most recognized brand with 29% of those surveyed recalling it, followed by Boehringer Ingelheim and Lilly’s Jardiance at 27% and Merck’s Januvia and Novo Nordisk tying for the third spot with 24%. Meanwhile, 76% of the patients surveyed were familiar with the generic treatment metformin.

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