Alex­ion takes its first step re­build­ing the pipeline, adding a rare dis­ease drug in $855M cash buy­out

Biotech buy­outs are all the rage these days. To­day, it’s Alex­ion’s $ALXN turn to score with a deal that adds a Phase III drug for a rare dis­ease to its pipeline — mark­ing the new ex­ec­u­tive crew’s “first step” in re­or­ga­niz­ing the pipeline.

Alex­ion struck a deal to buy Stock­holm-based Wil­son Ther­a­peu­tics for $855 mil­lion in cash, of­fer­ing its back­ers a rich pay­day af­ter gath­er­ing a set of mid-stage da­ta demon­strat­ing their drug can flush ex­cess cop­per from the blood of pa­tients with Wil­son dis­ease.

Jonas Hans­son, Wil­son CEO

Wil­son’s last pub­lic ven­ture raise came 4 years ago, when Abing­worth and MVM Life Sci­ence Part­ners stepped up with a $40 mil­lion B round with found­ing in­vestor Health­Cap. And the num­bers in­di­cate that they made out hand­some­ly with the buy­out deal to­day.

Their drug, WTX101, binds to cop­per and al­bu­min, al­low­ing it to be cleared. And Alex­ion had time to con­sid­er proof-of-con­cept num­bers on its safe­ty and ef­fi­ca­cy — with a dis­play planned at EASL this week — as they swooped in to nab the Phase III pro­gram.

The ac­qui­si­tion deal puts Alex­ion on track to play a role in a high-pro­file de­bate over the cost of drugs in the US. Wil­son dis­ease is treat­ed with a drug called Syprine, which was ac­quired by Valeant — and which then spiked the price in a clas­sic price-goug­ing move that Amer­i­can gov­ern­ment of­fi­cials are help­less to pre­vent. Te­va re­cent­ly came along with a gener­ic, but caused out­rage when they set the price at $18,375 for a bot­tle of 100 pills, which the New York Times re­port­ed is 21 times what the orig­i­nal brand­ed drug cost in 2010.

Ac­cord­ing to a state­ment from Wil­son Ther­a­peu­tics’ board, Alex­ion wasn’t the on­ly bid­der, with Lazard gath­er­ing bids in a com­pet­i­tive process launched ear­ly this year.

But it was the most ea­ger.

The deal comes on the heels of a re­or­ga­ni­za­tion at Alex­ion af­ter Lud­wig Hantson stepped in to lead the com­pa­ny last year, bring­ing in a new crew and mak­ing plans to re­lo­cate to Boston. Hantson made it crys­tal clear that aside from the big fran­chise drug Soliris and a next-gen fol­lowup, he didn’t find much to get ex­cit­ed about. That fol­lowup drug, though, wasn’t good enough to prove su­pe­ri­or to Soliris, which could leave the com­pa­ny vul­ner­a­ble as ri­vals gath­er with late-stage tests of their own.

The buy­out al­so spot­lights the M&A spree now un­der­way in biotech, com­ing fast af­ter No­var­tis’ $8.7 bil­lion ac­qui­si­tion of AveX­is on Mon­day. A busy start to Q2 fol­lows a big M&A fren­zy in Q1, with Sanofi buy­ing Biover­a­tiv and Abl­ynx and Cel­gene bag­ging Juno. And more deals are like­ly to fol­low as top play­ers snap up fresh as­sets af­ter a drought of deals last year.

“Wil­son dis­ease is a rare dis­or­der that can lead to se­vere liv­er dis­ease, in­clud­ing cir­rho­sis and acute liv­er fail­ure, as well as de­bil­i­tat­ing neu­ro­log­i­cal mor­bidi­ties such as im­paired move­ment, gait, speech, swal­low­ing, and psy­chi­atric dis­or­ders. WTX101 is an in­no­v­a­tive prod­uct that ad­dress­es the un­der­ly­ing cause of the dis­ease and has the po­ten­tial to de­fine a new stan­dard of care in treat­ing Wil­son dis­ease, an area that has not had a new treat­ment in over two decades,” said Hantson in a state­ment. “The ac­qui­si­tion of Wil­son Ther­a­peu­tics is a strong strate­gic fit for Alex­ion giv­en the over­lap with our cur­rent clin­i­cal and com­mer­cial fo­cus on meta­bol­ic and neu­ro­log­ic dis­or­ders, and is an im­por­tant first step in re­build­ing our clin­i­cal pipeline.”


Im­age: Lud­wig Hantson, Alex­ion CEO.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Eisai and METAvivor plan to debut the latest 'This is MBC' campaign at the San Antonio Breast Cancer Symposium (SABCS).

Ei­sai re-ups metasta­t­ic breast can­cer aware­ness cam­paign with strik­ing pa­tient pho­tographs

Eisai is debuting the newest ads in its long-running “This is MBC” campaign this week. In what’s become an annual tradition, Eisai and metastatic breast cancer advocacy partner METAvivor will show the striking photographs of people living with metastatic breast cancer first at the San Antonio Breast Cancer Symposium (SABCS).

The new “Imagine” campaign features 12 patients photographed around waterfalls to symbolize that same kind of sudden drop into a pool that MBC causes in a person’s life, said Beth Fairchild, co-founder of #CancerCulture who was the president of METAvivor six years ago when the campaign began. Fairchild, who is living with MBC, has helped create all of the annual “This is MBC” campaigns.

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Pfiz­er and BioN­Tech look to toss Mod­er­na patent suit, call­ing claims 'unen­force­able'

Pfizer and BioNTech took a swing at Moderna’s Covid-19 patent claims in Massachusetts federal court on Monday, calling them “invalid,” “overbroad” and “unenforceable.”

The defendants also filed counterclaims against the Cambridge, MA-based biotech, seeking a dismissal of the case, recovery of court fees and an official judgment invalidating Moderna’s claims.

Moderna sued Pfizer and BioNTech back in August, alleging that the partners’ Covid-19 vaccine Comirnaty copied parts of Moderna’s vaccine technology patented before the pandemic, when it was developing an mRNA vaccine for MERS, another respiratory illness.

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Sum­i­to­vant sub­sidiaries En­zy­vant and Al­ta­vant merge in­to com­bined com­pa­ny

Two Sumitovant Biopharma entities are merging under one name, effective immediately.

Enzyvant Therapeutics and Altavant Sciences announced they have merged to form a singular entity focused on developing therapies for patients with rare diseases. The combined company will keep the name Enzyvant and along with clinical development will eventually include in-house manufacturing.

Bill Symonds, the current CEO of both Altavant and Enzyvant, is now CEO of the merged company.

Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Bob Duggan, Summit Therapeutics co-CEO

Bounc­ing from ma­jor set­back, Sum­mit hands out $500M cash for can­cer drug — thanks to a loan from bil­lion­aire CEO

After hitting a dead end with Summit Therapeutics’ lead program, Bob Duggan has found the drug that he believes will usher into a compelling second act. So compelling, in fact, that it involves $500 million cash — and he’s taking money out of his own pocket to fund the deal.

Striking a partnership with Akeso Therapeutics out of China, Summit is bringing in a bispecific antibody that blocks both PD-1 and VEGF called ivonescimab. Akeso, which has a PD-1/CTLA-4 bispecific approved in China, has already taken ivonescimab into multiple clinical trials, including a Phase III in lung cancer.

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Glen­mark hit with warn­ing let­ter over pro­ce­dures, qual­i­ty con­trol is­sues at In­dia man­u­fac­tur­ing plant

The generics producer Glenmark Pharmaceuticals has been handed a warning letter by US regulators.

The letter, which was sent to the manufacturer on Nov. 22, noted issues from an inspection over the summer at Glenmark’s facility in the town of Colvale, India, in the state of Goa.

According to the letter, the FDA found that Glenmark’s investigation of rejected batches of drugs “failed to extend to other batches, dosage strengths, and drug products.” The warning letter also noted that the site had failed to establish “adequate written procedures” for production and process control to ensure drugs have the correct strength, quality and purity.

Klick Health is lighting the way, literally, this holiday season to encourage connection for lonely seniors in long-term care facilities.

Klick Health an­nu­al hol­i­day spot­light se­nior lone­li­ness and the pow­er of con­nec­tion

Every year Klick Health leans into a cause for the holidays, and this year it’s highlighting the sometimes lonely season for seniors. So Klicksters, as employees call themselves, decided to brighten one nursing home community in hopes of inspiring others to do the same.

Klick literally lit up the Tony Stacey Centre for Veterans Care, a long-term care home in Toronto where 75% of residents receive no visitors during the holiday season. The agency brought staff and family along with lighting crews and musicians for a “Light the Way” event, creating a video of the experience debuting on Tuesday.

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