J&J woos Mer­ck­'s Math­ai Mam­men to helm of phar­ma R&D, Hait takes over on ex­ter­nal in­no­va­tion

J&J is ex­e­cut­ing a change­up in the lead­er­ship of its multi­bil­lion-dol­lar R&D group.

Math­ai Mam­men

The phar­ma gi­ant, which re­cent­ly sig­naled plans to ex­pand its drug pipeline — which costs about $7 bil­lion a year to op­er­ate (the to­tal R&D bud­get was $9.1 bil­lion last year)— re­cruit­ed Mer­ck SVP Math­ai Mam­men to take Bill Hait’s role as phar­ma R&D chief, ac­cord­ing to a state­ment out Wednes­day night.

Bill Hait

Hait, mean­while, is switch­ing to a new job as glob­al head of ex­ter­nal in­no­va­tion, a role that en­com­pass­es a net­work of part­ner­ing teams that span the plan­et, ab­sorb­ing dozens of new part­ner­ships each year in one of the in­dus­try’s most am­bi­tious out­reach ef­forts.

J&J, with one of the world’s top 5 R&D ops, is plan­ning to do this trans­fer in stages. Mam­men, who joined Mer­ck from Ther­a­vance in ear­ly 2016, is join­ing J&J lat­er this month and then mov­ing up to phar­ma R&D chief at the be­gin­ning of 2018.

Paul Stof­fels

Mam­men’s new role will have him re­port­ing di­rect­ly to J&J chief sci­en­tif­ic of­fi­cer Paul Stof­fels.

Mam­men will now be in charge of keep­ing an am­bi­tious new promise by Joaquin Du­a­to, J&J’s world­wide chair­man for phar­ma­ceu­ti­cals, to see J&J’s brand­ed drug mar­ket main­tain a clip of 5% an­nu­al growth through 2020 — even as pub­lic and pri­vate pay­ers in the US press new chal­lenges to what new and old drugs cost.

Un­der Hait, J&J’s R&D group put a ma­jor fo­cus on on­col­o­gy, with a slate of new drugs like Darza­lex, apa­lu­tamide (ARN-509), Ze­ju­la (ni­ra­parib) and ta­la­co­tuzum­ab for AML. Some of these were picked up in a se­ries of bil­lion-dol­lar deals backed by a qui­et but per­sis­tent group of drug de­vel­op­ers not­ed for some ma­jor wins in re­cent years.

Days ago Hait told re­porters that the com­pa­ny ex­pects 14 new meds to ar­rive on the mar­ket in next five years, with 50 line ex­ten­sions on al­ready ap­proved ther­a­pies. And he in­clud­ed a full slate of po­ten­tial block­busters.

Stof­fels, mean­while, has been field­ing teams of deal­mak­ers in glob­al of­fices in­side Lon­don, Shang­hai, Boston/Cam­bridge and the Bay Area, all in­ter­con­nect­ed with gi­ant screen con­nec­tions for in­ter­con­ti­nen­tal meet­ings. He’s cre­at­ed a 24/7 op­er­a­tion that not on­ly scouts for ma­jor new pro­grams it can li­cense, but a host of part­ner­ships where the plan is to wait pa­tient­ly, play a sup­port role and see what these up-and-com­ers can ac­com­plish. Hait will now play a ma­jor role in over­see­ing that group as J&J con­tin­ues to reach out­side to find new ideas.

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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Saurabh Saha, Centessa CEO (BIO19)

One of 2021's star biotech play­ers flags an­oth­er big set­back for the pipeline

Two months after scuttling their lead drug, Centessa’s executive team is back with the latest in a series of setbacks that have tanked its stock and blown holes in its strategic lineup of biotech subs.

The company reported in its Q2 post today that it has decided to scrap ZF874 after a patient demonstrated elevated liver enzymes — a classic red safety flag — in a Phase I study for alpha-1-antitrypsin (A1AT).

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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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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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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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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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