In sud­den re­vamp, Cel­gene CEO Alles bids his COO good­bye and looks to re­gain con­fi­dence with man­age­ment shuf­fle

Stag­gered by a se­ries of late-stage set­backs capped by the FDA’s re­fusal to ac­cept its ap­pli­ca­tion on their lead­ing late-stage drug and look­ing vul­ner­a­ble on its num­bers, Cel­gene CEO and chair­man Mark Alles is re­vamp­ing the lead­er­ship struc­ture at the wob­bly biotech.

Scott Smith

Num­ber one on the to-do list: Scott Smith is out as pres­i­dent and COO, with im­me­di­ate ef­fect. He’s not re­tir­ing or off in search of new op­por­tu­ni­ties. He’s just out.

The man­age­ment re­vamp will leave Alles in charge of every­thing from clin­i­cal de­vel­op­ment to reg­u­la­to­ry, the all-im­por­tant hema­tol­ogy and on­col­o­gy fran­chise as well as in­flam­ma­tion and im­munol­o­gy.

Mark Alles

Re­port­ing di­rect­ly to him: Nadim Ahmed, pres­i­dent, glob­al hema­tol­ogy and on­col­o­gy; Ter­rie Cur­ran, pres­i­dent, glob­al in­flam­ma­tion and im­munol­o­gy; Jay Back­strom, chief med­ical of­fi­cer and head of glob­al reg­u­la­to­ry af­fairs; and Joanne Beck, ex­ec­u­tive vice pres­i­dent, glob­al phar­ma­ceu­ti­cal de­vel­op­ment and op­er­a­tions.

And the re­or­ga­ni­za­tion ap­pears to still be un­der way. Jef­feries’ Michael Yee not­ed Mon­day night: “The com­pa­ny is re­or­ga­niz­ing its ex­ec­u­tive team in the mean­time, and we could hear sev­er­al hires/pro­mo­tions over the com­ing months.”

The move comes short­ly af­ter Bob Hug­in’s de­par­ture as ex­ec­u­tive chair­man of the com­pa­ny he ran to great ac­claim for years. But the ap­plause has qui­et­ed sig­nif­i­cant­ly over the past year. Cel­gene’s $710 mil­lion cash roll of the dice on the in­flam­ma­to­ry bow­el dis­ease drug mon­gersen (GED-301) came up snake eyes in Phase III last fall. Most re­cent­ly the FDA re­ject­ed Cel­gene’s ap­pli­ca­tion for ozan­i­mod, an em­bar­rass­ment for a com­pa­ny that prid­ed it­self on its abil­i­ty to ex­e­cute ef­fec­tive­ly.

That could have been for­giv­en eas­i­ly enough, but in­vestors have been alarmed over weak fi­nan­cials un­der­scor­ing the com­pa­ny’s ex­tra­or­di­nary de­pen­dence on Revlim­id and the big, reg­u­lar price hikes it needs to keep on top of the game. Revlim­id’s patent po­si­tion is al­so un­der as­sault.

Just week’s ago Baird’s Bri­an Sko­r­ney not­ed that re­peat­ed sna­fus have cre­at­ed a sit­u­a­tion where “in­vestors are hes­i­tant to get back in­to what was once biotech’s poster child for con­tin­ued growth and sol­id ex­e­cu­tion.”

Alles wants it all back, and he now has fi­nal re­spon­si­bil­i­ty for all of it.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.

Almirall is tapping artificial intelligence on behalf of its sales force for insights and efficiencies. (via Shutterstock)

Almi­rall rolls out sales rep ar­ti­fi­cial in­tel­li­gence sys­tem, cut­ting pre-call prep and 'wind­shield time'

Dermatology specialty pharma Almirall is making its sales reps smarter. Not with extra training or educational courses, but instead with artificial intelligence tools.

It began a soft launch of a sales rep AI and machine learning platform it calls Polaris last August in one of its 7 US coverage regions. The platform from Aktana gathers information from across Almirall internal sources and external ones – such as claims and prescribing data – to generate insights for reps. Now, instead of spending hours prepping for a sales call, Polaris can generate details about a physician’s preferences, past behaviors and prescription habits for reps in minutes, said Almirall head of commercial operations Vincent Cerio.

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Te­va, Al­ler­gan reach yet an­oth­er opi­oid set­tle­ment — ef­fec­tive­ly end­ing WV tri­al

Teva and Allergan have reached settlements with multiple states over their involvement in the opioid crisis. Their latest is worth 9 figures.

West Virginia attorney general Patrick Morrisey announced the newest settlement, worth $161.5 million, at a press conference on Wednesday. The deal would resolve claims that the companies helped fuel the state’s opioid epidemic. If it goes through, it could become the largest state-negotiated settlement in West Virginia’s history, according to Reuters.

Roche un­veils three new mon­key­pox tests as cas­es rise

Health experts maintain that the current monkeypox situation is a stark contrast to Covid. Even so, a handful of biotechs have sprung to action, including Roche, who quickly developed a set of three tests to detect the virus.

Roche and subsidiary TIB Molbiol unveiled their Lightmix Modular Virus test kits on Wednesday — three unique test kits that can help track the spread of monkeypox.

The first kit detects orthopoxviruses, including all monkeypox viruses originating from the West African and Central African forms of the virus. The second kit is a specific test that detects monkeypox viruses only, while the third simultaneously tests for both orthopoxviruses and monkeypox viruses.