No­var­tis wins an­oth­er biosim­i­lar round with an OK for its Rit­ux­an copy­cat

Car­ol Lynch, San­doz Glob­al Head of Biosim­i­lars

No­var­tis just racked up its fourth new biosim­i­lar ap­proval in Eu­rope, this time gain­ing a thumbs up for its knock­off of Roche megablock­buster Rit­ux­an.

The EC gave the phar­ma gi­ant’s gener­ics unit San­doz a green light to sell Rixathon as a cheap­er al­ter­na­tive to its brand­ed ri­val at Roche. And it marks Roche’s sec­ond biosim­i­lar com­peti­tor, fol­low­ing Cell­tri­on’s win for Trux­i­ma, flagged through ear­li­er this year.

No­var­tis now has the au­thor­i­ty to sell its copy­cat for all in­di­ca­tions ap­proved for Rit­ux­an, which earned a whop­ping $7.5 bil­lion for Roche.

The news marks grow­ing com­pe­ti­tion for Roche as it racks up some hits and miss­es on the de­vel­op­ment front. Just days ago it was forced to de­fend the close­ly watched re­sults for a late-stage study com­bin­ing Per­je­ta and Her­ceptin, which just bare­ly man­aged to beat Her­ceptin alone in pre­vent­ing a re­cur­rence of breast can­cer. And it’s been deal­ing with the stun­ning fail­ure of its PD-L1 check­point Tecen­triq in a piv­otal tri­al, af­ter it was ap­proved for use. Roche needs to ex­pand its new­er fran­chise drugs to make way for the ex­pect­ed drop in rev­enue from flag­ship drugs like Rit­ux­an as biosim­i­lars start to eat in­to its mar­ket share.

“To­day’s ap­proval of Rixathon rep­re­sents a big win for pa­tients in Eu­rope with blood can­cers or im­muno­log­i­cal dis­eases be­cause it en­ables in­creased ac­cess to bi­o­log­ics. It al­so al­lows health­care sys­tems to re­de­ploy re­sources to oth­er ar­eas of high need, par­tic­u­lar­ly in­no­v­a­tive ther­a­pies” said Car­ol Lynch, the glob­al head of bio­phar­ma­ceu­ti­cals for San­doz.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

David Meline (file photo)

Mod­er­na’s new CFO took a cut in salary to jump to the mR­NA rev­o­lu­tion­ary. But then there’s the rest of the com­pen­sa­tion pack­age

David Meline took a little off the top of his salary when he jumped from the CFO post at giant Amgen to become the numbers czar at the upstart vaccines revolutionary Moderna. But the SEC filing that goes with a major hire also illustrates how it puts him in line for a fortune — provided the biotech player makes good as a promising game changer.

To be sure, there’s nothing wrong with the base salary: $600,000. Or the up-to 50% annual cash bonus — an industry standard — that comes with it. True, the 62-year-old earned $999,000 at Amgen in 2019, but it’s the stock options that really count in the current market bliss for all things biopharma. And there Meline did well.

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Por­tion of Neil Wood­ford’s re­main­ing in­vest­ments, in­clud­ing Nanopore, sold off for $284 mil­lion

It’s been precisely one year and one day since Neil Woodford froze his once-vaunted fund, and while a global pandemic has recently shielded him from the torrent of headlines, the fallout continues.

Today, the California-based patent licensing firm Acacia Research acquired the fund’s shares for 19 healthcare and biotech companies for $284 million.  Those companies include shares for public and private companies and count some of Woodford’s most prominent bio-bets, such as Theravance Biopharma, Oxford Nanopore and Mereo Biopharma, according to Sky News, which first reported the sale. It won’t include shares for BenevelontAI, the machine learning biotech once valued at $2 billion.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

David Chang steps up to CEO spot at WuX­i's cell and gene ther­a­py CD­MO; David Meline is the new CFO at Mod­er­na

David Meline didn’t stay retired for long. As reported yesterday, the former Amgen exec will replace Lorence Kim as CFO of Moderna as the Big Pharma has sprinted to the front of the Covid-19 vaccine pack, getting selected as one of the finalists for Operation Warp Speed. Meline, who gets started on Monday, announced his retirement as Amgen’s CFO in October 2019, remaining in the role until the end of the year. But he’s back in the saddle at a crucial time as Moderna prepares for Phase III studies of their SARS-CoV-2 vaccine. Meline previously held leadership positions at 3M and General Motors.