Con­sti­pa­tion drug mak­er Syn­er­gy looks to rene­go­ti­ate bloat­ed loan agree­ment — shares tum­ble

Grap­pling with the slow up­take of its con­sti­pa­tion drug Tru­lance, Syn­er­gy Phar­ma­ceu­ti­cals $SGYP has prac­ti­cal­ly thrown in the tow­el say­ing that it does not an­tic­i­pate re­ceiv­ing any takeover of­fers that sit well with its cur­rent mar­ket val­ue and is thus hop­ing to rene­go­ti­ate its hefty loan agree­ment.

Two years pri­or to the ap­proval and launch of Tru­lance in 2017, Syn­er­gy said, it was eval­u­at­ing strate­gic op­tions, in­clud­ing part­ner­ships and a sale. Hav­ing re­ceived no of­fers that met its ex­pec­ta­tions, the New York-based drug­mak­er elect­ed to go it alone. This May, how­ev­er, Syn­er­gy said it was un­der­go­ing a strate­gic re­view and in par­al­lel try­ing to rene­go­ti­ate its term loan agree­ment with CRG, which was an­nounced in Sep­tem­ber 2017 as $300 mil­lion in debt fi­nanc­ing struc­tured as se­nior se­cured loans.

So far, Syn­er­gy has failed to amend its agree­ment with CRG. The loan deal con­tains “a min­i­mum liq­uid­i­ty covenant that ab­sent re­lief from CRG may not be sat­is­fied. Syn­er­gy is con­tin­u­ing dis­cus­sions with CRG for covenant re­lief and in par­al­lel the com­pa­ny is cur­rent­ly pur­su­ing fi­nanc­ing al­ter­na­tives…but there is no as­sur­ance that the com­pa­ny can se­cure CRG’s con­sent or oth­er­wise ob­tain any such fi­nanc­ing…in which case the com­pa­ny could de­fault un­der the term loan agree­ment and may have to pur­sue or oth­er­wise ac­cel­er­ate strate­gic al­ter­na­tives, in­clud­ing the pos­si­bil­i­ty of seek­ing bank­rupt­cy pro­tec­tion,” Syn­er­gy said in a state­ment on Fri­day.

Shares plunged 67% af­ter Syn­er­gy put out the re­lease at mar­ket close Thurs­day.

Tru­lance se­cured FDA ap­proval in Jan­u­ary 2017 for chron­ic id­io­path­ic con­sti­pa­tion (CIC), and brought in a pal­try $16.8 mil­lion over the course of the year, in which Syn­er­gy al­so launched Poop Troop — a se­ries of an­i­mat­ed emo­jis de­signed to en­cour­age con­ver­sa­tion about the im­pact of CIC.

Af­ter win­ning ap­proval for the drug in ir­ri­ta­ble bow­el syn­drome with con­sti­pa­tion (IBS-C) this Jan­u­ary, sales were ex­pect­ed to perk up. But Iron­wood Phar­ma’s $IR­WD 2012-ap­proved Liz­ness has re­mained in its pole po­si­tion, and Tru­lance failed to per­form in line with Syn­er­gy’s ex­pec­ta­tions.

Now, Syn­er­gy is pro­ject­ing Tru­lance net sales for 2018 in the range of $42 mil­lion to $47 mil­lion, well be­low the min­i­mum rev­enue covenant of $61 mil­lion in its term loan agree­ment with CRG. In fact, things could get worse for Syn­er­gy come 2019, as com­peti­tor Arde­lyx’s $ARDX drug tena­panor, which is cur­rent­ly un­der FDA re­view, is ex­pect­ed to hit the mar­ket.

Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Mer­ck makes a triple play on Covid-19: buy­ing out a vac­cine biotech, part­ner­ing on an­oth­er pro­gram and adding an an­tivi­ral to the mix

Merck is making a triple play in a sudden leap into the R&D campaign against Covid-19.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

The deal with IAVI covers recombinant vesicular stomatitis virus (rVSV) technology that is the basis for Merck’s successful Ebola Zaire virus vaccine. That’s going into the clinic later this year.

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The Advance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

Piv­otal myas­the­nia gravis da­ta from ar­genx au­gur well for FcRn in­hibitors in de­vel­op­ment

Leading the pack of biotechs vying for a piece of the generalized myasthenia gravis (gMG) market with an FcRn inhibitor, argenx on Tuesday unveiled keenly anticipated positive late-stage data on its lead asset, bringing it one step closer to regulatory approval.

Despite steroids, immunosuppressants, acetylcholinesterase inhibitors, and Alexion’s Soliris, patients with the rare, chronic neuromuscular disorder (more than 100,000 in the United States and Europe) don’t necessarily benefit from these existing options, leaving room for the crop of FcRn inhibitors in development.

Af­ter de­cou­pling from Re­gen­eron, Sanofi says it’s time to sell the $13B stake picked up in the mar­riage

With Regeneron shares going for a peak price — after doubling from last fall — Sanofi is putting a $13 billion stake in their longtime partner on the auction block. And Regeneron is taking $5 billion of that action for themselves.

Sanofi — which has been decoupling from Regeneron for more than a year now — bought in big in early 2013, back when Regeneron’s stock was going for around $165 a share. Small investors flocked to the deal, buzzing about an imminent takeover. The buyout chatter wound down long ago.

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Andrew Hopkins, Exscientia founder and CEO (Exscientia)

Af­ter years of part­ner­ships, AI biotech Ex­sci­en­tia lands first ma­jor fi­nanc­ing round at $60M

After years racking up partnerships with biotechs and Big Pharma, the AI drug developer Exscientia has landed its first large financing round.

The UK-based company raised $60 million in a Series C round led by Novo Holdings — more than double the $26 million it garnered in a Series B 18 months ago. The round will help further the company’s expansion into the US and further what it calls, borrowing a term from the software world, its “full-stack capabilities,” i.e. its ability to develop drugs from the earliest stage to the market.

Covid-19 roundup: Janet Wood­cock steps aside — for now — as FDA drug czar; WHO hits the brakes on hy­droxy study af­ter lat­est safe­ty alarm

The biopharma industry will soon get a look at what the FDA will look like once CDER’s powerful chief Janet Woodcock retires from her post.

Long considered one of the most influential regulators in the agency, if not its single most powerful official when it counts, Woodcock is being detached to devote herself full-time to the White House’s special project to fast-forward new drugs and vaccines for the pandemic. The move comes a week after some quick reshuffling as Woodcock and CBER chief Peter Marks joined Operation Warp Speed. Initially they opted to recuse themselves from any FDA decisions on pandemic treatments and vaccines, after consumer advocates criticized the move as a clear conflict of interest in how the agency exercises oversight on new approvals.

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Janet Woodcock, director of the Center for Drug Evaluation and Research (AP Images)

Covid-19 roundup: Hit with new con­flict ac­cu­sa­tions, Janet Wood­cock steps out of the agen­cy's Covid-19 chain of com­mand

Two weeks ago, FDA drug chieftain Janet Woodcock was assuring a top Wall Street analyst that any vaccine approved for combating Covid-19 would have to meet high agency standards on safety and efficacy before it’s approved. But over the weekend, after she and Peter Marks took top positions with the public-private operation meant to speed a new vaccine to lightning-fast approvals — they both recused themselves from the review process after an advocacy group argued their roles close to the White House could pose a conflict of interest.

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An­oth­er NASH de­lay for In­ter­cept frus­trates in­vestors, shares wilt

A previous FDA advisory committee delay for Intercept’s NASH drug may have dampened spirits, but investors perked up after French rival Genfit recently failed to best a placebo with its offering in a keenly anticipated pivotal study. In yet another twist on Friday, the New York drugmaker said the FDA is postponing its adcom again to accommodate the review of additional data it has asked the company to furnish.

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FDA ap­proves the first gener­ic for Amar­in's Vas­cepa — but is a fish oil price war im­mi­nent?

Late last year, enthusiasm for Amarin’s fish-oil pill Vascepa burgeoned when the FDA signed off on expanding the cholesterol fighter’s label to include the drug’s beneficial impact on cardiovascular risk, but months later the exuberance for the blockbuster-to-be took a big hit when a judge invalidated key patents protecting Vascepa.

Despite Amarin’s $AMRN pledge to appeal — a process that could take months — the ruling opened the door for generic competition. Hikma Pharmaceuticals, one of three challengers in the Nevada suit, on Friday said that its generic copy of pure EPA, the omega-3 fatty acid that constitutes Vascepa, has been approved by the FDA.