Biotech M&A is back. Ipsen set to fork out up to $1.3B for rare dis­ease spe­cial­ist Clemen­tia

Merg­er Mon­day is back in full swing. Along with Roche buy­ing Spark Ther­a­peu­tics $ONCE, Parisian biotech Ipsen (Eu­ronext: $IPN) is beef­ing up its rare dis­ease ar­se­nal by ac­quir­ing Cana­da’s Clemen­tia Phar­ma­ceu­ti­cals, less than two years af­ter the Mon­tre­al-based drug de­vel­op­er’s $120 mil­lion IPO.

Un­der the terms of the deal, Ipsen will pay $25 per Clemen­tia share — a rough­ly 68% pre­mi­um to its Fri­day close — for a to­tal of $1.04 bil­lion, in ad­di­tion to an­oth­er $6/share if Clemen­tia’s lead ex­per­i­men­tal drug, palo­varotene, can be used to treat a rare bone dis­ease called mul­ti­ple os­teo­chon­dro­mas (MO), which could trans­late to an­oth­er $263 mil­lion.

Clemen­tia’s shares $CM­TA sky­rock­et­ed 73.5% in pre­mar­ket trad­ing.

Palo­varotene has been re­pur­posed by Clemen­tia for a pair of rare dis­eases, af­ter Roche failed to show the retinoic acid re­cep­tor gam­ma (RARγ) se­lec­tive ag­o­nist could work against em­phy­se­ma, a form of chron­ic ob­struc­tive pul­monary dis­ease (COPD).

The Swiss drug­mak­er had plans to shelve the drug, but re­searchers un­der­scored the po­ten­tial of the class of drugs in pre­vent­ing bone for­ma­tion and fi­bro­sis (retinoic acid sig­nal­ing is be­lieved to play a role in mus­cle cell gen­er­a­tion). Clemen­tia took the drug off Roche’s shelf, for two bone dis­or­ders: fi­brodys­pla­sia os­si­f­i­cans pro­gres­si­va (FOP) and MO.

A mar­ket­ing ap­pli­ca­tion for the drug to treat episod­ic flare-ups as­so­ci­at­ed with FOP is ex­pect­ed to be sub­mit­ted to the FDA in the sec­ond half of this year — and if ap­proved the drug is set for launch mid-2020. For the FOP in­di­ca­tion, the FDA has laid out a red car­pet for the drug, with or­phan drug des­ig­na­tion, break­through ther­a­py sta­tus, fast track sta­tus and rare pe­di­atric dis­ease des­ig­na­tion, so the odds are in its fa­vor for an ac­cel­er­at­ed re­view, if the NDA is ac­cept­ed.

In an ini­ti­a­tion note pub­lished last month Baird an­a­lysts cheered the po­ten­tial of the drug: “(With) strik­ing ef­fi­ca­cy and a po­ten­tial ac­cel­er­at­ed NDA fil­ing in an ul­tra-rare con­di­tion, we have con­vic­tion that pa­lo can dom­i­nate the FOP ther­a­peu­tic land­scape.”

A Phase III study test­ing the treat­ment as a chron­ic dos­ing reg­i­men for FOP, a Phase II tri­al for MO, and a Phase I tri­al for dry eye dis­ease are al­so on­go­ing.

In a note on Mon­day, Leerink’s Joseph Schwartz said the on­go­ing phase III study test­ing palo­varotene in FOP pa­tients could fur­ther demon­strate and sup­ple­ment its ef­fi­ca­cy in the pa­tient pop­u­la­tion, es­ti­mat­ing peak sales of more than $400 mil­lion for the in­di­ca­tion by 2030.

Schwartz ex­pects in­ter­im da­ta from on­go­ing MO study in pe­di­atric pa­tients by the end of next year, and topline da­ta by 2021. On the ba­sis of a “sig­nif­i­cant­ly high­er pro­ject­ed preva­lence of MO”, he fore­cast peak sales of over $1 bil­lion by 2030.

The deal is ex­pect­ed to be con­sum­mat­ed in the sec­ond quar­ter, and will have a lim­it­ed di­lu­tive im­pact on Ipsen’s core op­er­at­ing mar­gin for 2019 and 2020, the com­pa­ny said on Mon­day.

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,100+ biopharma pros reading Endpoints daily — and it's free.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,100+ biopharma pros reading Endpoints daily — and it's free.

Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Covid-19 roundup: Mer­ck­'s $356M sup­ply deal on hold as FDA asks for more da­ta; UK stud­ies of­fer more in­for­ma­tion on ef­fi­ca­cy of Pfiz­er/BioN­Tech vac­cine af­ter one dose

Merck is pushing back plans to supply the US government with a Covid-19 drug after the FDA asked for more data to support an emergency use authorization.

The antibody, MK-7110, had looked promising in a Phase III study conducted by OncoImmune before Merck came along and bought the biotech for $425 million. At the interim analysis, investigators looked at data from 203 patients and concluded that a single dose of the drug cut the risk of death or respiratory failure by more than 50% among severe patients. And those taking the drug had a 60% higher chance of improvement in clinical status compared to placebo.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,100+ biopharma pros reading Endpoints daily — and it's free.

CEO Fred Aslan (Artiva)

NK cell ther­a­py play­er Arti­va makes some more noise, pulling in $120M Se­ries B less than a month af­ter Mer­ck deal

Not even one month after Big Pharma took notice of Artiva when Merck signed a collaboration worth nearly $2 billion in milestones, the off-the-shelf NK cell biotech already has its next big fundraise.

Artiva returns from the venture well Friday with a $120 million Series B round, money they will use to get their first program into the clinic and to file INDs for another two candidates. The raise marks the latest development in a rapidly expanding footprint for Artiva, which, in addition to the Merck deal last month, has now raised almost $200 million since its Series A last June.

Fatty liver conceptual image, 3D illustration showing fatty liver silhouette made from micrograph of liver steatosis (Shutterstock)

The path to NASH: un­der­stand­ing the role of se­vere obe­si­ty in a com­plex, mul­ti-sys­tem dis­ease

Biotech Voices is a collection of exclusive opinion editorials from some of the leading voices in biopharma on the biggest industry questions today. Think you have a voice that should be heard? Reach out to senior editors Kyle Blankenship and Amber Tong.

We often think a person’s transition from a healthy to a diseased state is binary. But that’s often not the case. In reality, the onset of a disease is not something that occurs overnight, and the majority lie on a continuum that is impacted by a multitude of factors. Some of these factors are in a patient’s control. Others are not.

This is the case in nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), two of the most complex diseases that “live” on this proverbial continuum. The clinical onset of NAFLD — and ultimately NASH — is a complex process that is closely related to obesity, insulin resistance and impaired adipose tissue metabolism.

With dust set­tled on ac­tivist at­tack, Lau­rence Coop­er leaves Zio­pharm to a new board

Laurence Cooper has done his part.

In the five years since he left a tenured position at Houston’s MD Anderson Cancer Center to become CEO of Boston-based Ziopharm, he’s steered the small-cap immunotherapy player through patient deaths in trials, clinical holds, short attacks and, most recently, an activist attack on the board.

So when the company has “fantastic news” like an IND clearance for a TCR T cell therapy program, he’s ready to pass on the baton.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,100+ biopharma pros reading Endpoints daily — and it's free.