Paragon Bioservices

Jan 5, 2023

Tyler Patchen News Reporter Sarep­ta spent much of last year march­ing for­ward with its can­di­date SRP-9001, a gene ther­a­py treat­ment for the rare but fa­tal Duchenne mus­cu­lar dy­s­tro­phy, even­tu­al­ly fil­ing a BLA for an ac­cel­er­at­ed ap­proval, with a May 29 PDU­FA date and a like­ly ad­comm on the way too. The Cam­bridge, MA-based biotech on Thurs­day signed a com­mer­cial sup­ply agree­ment with the New Jer­sey-based CD­MO Catal­ent to man­u­fac­ture SRP-9001 and to sup­port oth­er gene ther­a­py can­di­dates in Sarep­ta’s pipeline for an­oth­er rare, ge­net­ic dis­ease re­lat­ed to mus­cle de­te­ri­o­ra­tion, known as limb-gir­dle mus­cu­lar dy­s­tro­phy (LGMD). Fi­nan­cial de­tails of the deal were not dis­closed and End­points News did not hear back from Catal­ent by press time. “Our part­ner­ship with the Sarep­ta team spans near­ly a decade across mul­ti­ple pro­grams and modal­i­ties, and we look for­ward to work­ing to­geth­er to man­u­fac­ture these po­ten­tial­ly life-chang­ing and life-sav­ing prod­ucts for pa­tients di­ag­nosed with DMD and LGMD,” said Alessan­dro Masel­li, Catal­ent’s CEO in a state­ment . Catal­ent main­tains sev­er­al gene ther­a­py man­u­fac­tur­ing sites, in­clud­ing two in Mary­land, out­side of Bal­ti­more, and one in Bel­gium. Sarep­ta orig­i­nal­ly set­tled on a long-term man­u­fac­tur­ing agree­ment with Paragon Bioser­vices in 2018, but a year lat­er, Catal­ent ac­quired Paragon for $1.2 Bil­lion. Alessan­dro Masel­li In 2019, Sarep­ta inked a $1.15 bil­lion deal with Roche for the rights to the ther­a­py out­side the Unit­ed States, while Sarep­ta held on to the US rights. In ear­ly 2021, SRP-9001 failed in an ini­tial Phase II study, which Sarep­ta at­trib­uted to dif­fer­ences in base­line mea­sures be­tween the old­er chil­dren of the place­bo and treat­ment groups. That fail cut the biotech’s stock in half. How­ev­er, in the sec­ond part of that Phase II study, 20 pa­tients who had re­ceived the place­bo treat­ment crossed over to get Sarep­ta’s gene ther­a­py, the pa­tients showed sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ments in the mo­tor abil­i­ties test that was al­so used in Part 1. John Carroll Editor & Founder Moderna CEO Stéphane Bancel made it clear early on in their M&A mapping phase that the biotech would be hunting the world for just the right mRNA-related deals to build the company into a global powerhouse. And nothing illustrates that strategy better than the $85 million tuck-in that the biotech is unveiling this morning. Bancel has struck a deal to buy Tokyo-based OriCiro Genomics and its work on cell-free synthesis and amplification of plasmid DNA, building up their set of tech for manufacturing aimed at scaling up production faster and carving weeks out of the process. Keep reading Endpoints with a free subscription Unlock this story instantly and join 154,900+ biopharma pros reading Endpoints daily — and it's free. SIGN UP News Reporter A month after the FDA rejected its neuroblastoma drug, the biotech Y-mabs said it will cut 35% of its workforce to save cash and focus on commercializing its lone approved product, Danyelza. The FDA rejected its drug omburtamab on Dec. 2, based on questions about the company’s clinical trial and after an advisory committee voted 16-0 against recommending the drug. The cuts will reduce operating expenses by 28%, and give Y-mabs enough cash to get through the first quarter of 2026. Keep reading Endpoints with a free subscription Unlock this story instantly and join 154,900+ biopharma pros reading Endpoints daily — and it's free. SIGN UP Paul Schloesser Associate Editor Amgen started off the new year with a bang, joining forces with ADC player Synaffix and agreeing to dole out as high as $2 billion in Synaffix’s largest ADC licensing deal to date. The Dutch biotech — running in the same circles as ADC Therapeutics, Seagen, MacroGenics and Emergence Therapeutics — said Thursday that it secured a licensing deal with Amgen to develop new ADCs. As part of the deal, the Big Pharma gets access to Synaffix’s ADC platforms and technology, starting out with one ADC program. Amgen retains an option to exclusively license four more programs at a later date, but what those programs could be remains under wraps. Read More Beth Snyder Bulik Senior Editor McKinsey Consulting’s Brian Fox is joining Klick Group to boost its commercialization practice. The 18-year McKinsey veteran headed up the commercial life sciences practice there before joining Klick this week in a bid to drive its go-to-market capabilities with clients. Fox’s expertise spans product launches, sales force management, medical and corporate affairs, market access and clinical development. Klick already offers many of those services to biotech and pharma customers, but is looking to Fox to “turbocharge” those efforts, Klick co-founder and chairman Leerom Segal said. Keep reading Endpoints with a free subscription Unlock this story instantly and join 154,900+ biopharma pros reading Endpoints daily — and it's free. SIGN UP Kyle LaHucik Associate Editor GSK is tapping into WuXi Biologics’ T cell-engaging antibodies in a deal worth as much as $1.5 billion , as the UK drugmaker looks to follow suit of others in the T cell-engager field, which includes Amgen’s marketed cancer drug Blincyto. Only $40 million of the GSK deal will initially go to the Shanghai-based contract research and manufacturing giant, but with a biobuck bet above $1 billion, the Big Pharma sees lots of potential. The pact is a boon to WuXi, which suffered a loss of billions in market value after being placed on the US Department of Commerce’s unverified list last February. WuXi was removed from the list last month. Read More Zachary Brennan Senior Editor Pharma’s annual price increases on drugs — the vast majority of which usually occur in January of every year — didn’t noticeably spike this year (so far) when compared to recent years, and experts say it doesn’t seem like pharma is desperate yet to make up for what may be major losses in sales thanks to government negotiations for some high-earning drugs come 2026. Analysts at 46Brooklyn published their latest 450+ available increases on list prices (not to be confused with the prices people pay out of pocket), as of Jan. 1, finding that as with previous years, most of the increases remained at or below the industry bar of 10%, and a median price increase of 5% so far in 2023. Read More