John Maraganore and Dou­glas Fam­brough used to be at each oth­er’s throats as Al­ny­lam pur­sued claims that its RNAi ri­vals at Dicer­na had im­prop­er­ly pur­loined the IP it had picked up from Mer­ck in a bar­gain base­ment fire sale.

Dou­glas Fam­brough

But that was all set­tled up close to 2 years ago with a set­tle­ment from Dicer­na’s Fam­brough. And now the two are mov­ing ahead in a close R&D part­ner­ship that makes them col­lab­o­ra­tors on a cou­ple of key dis­ease tar­gets.

In the pact an­nounced this morn­ing, the 2 new al­lies will pool their re­spec­tive RNAi drugs for al­pha-1 liv­er dis­ease, let­ting Dicer­na move ahead on the de­vel­op­ment front to see whether 1, or both, should be ad­vanced through a piv­otal pro­gram. Dicer­na will foot the bill on that ef­fort while Al­ny­lam gains ex-US com­mer­cial rights to what­ev­er comes out the reg­u­la­to­ry side with a win.

Both of these drugs — ALN-AAT02 and DCR-A1AT — are in Phase I/II at the mo­ment.

That puts them be­hind Ar­row­head, which is in a Phase II/III piv­otal with their ri­val and start­ed dos­ing pa­tients in a small mid-stage study late last year fo­cused on pa­tient re­spons­es.

John Maraganore

Then Al­ny­lam and Dicer­na are cross-li­cens­ing drugs for pri­ma­ry hy­per­ox­aluria. That cov­ers Al­ny­lam’s lumasir­an tar­get­ing gly­co­late ox­i­dase for the treat­ment of PH type 1 and Dicer­na’s ne­dosir­an tar­get­ing lac­tate de­hy­dro­ge­nase A for the treat­ment of PH types 1, 2, and 3.

They each are of­fer­ing the oth­er a roy­al­ty stream on glob­al sales.

The al­liance shoves the old dis­pute in­to the his­to­ry books, rel­e­gat­ed now to a chap­ter on IP law­suits. Al­ny­lam had been up­set af­ter watch­ing Mer­ck staffers al­leged­ly make off with the IP they were buy­ing from the phar­ma gi­ant, on­ly to wind up at their ri­val. Dicer­na’s counter-claims spot­light­ed some com­pelling anec­dotes about how eas­i­ly re­search leaked out of Mer­ck af­ter the com­pa­ny de­cid­ed to punt their R&D flop.

Dicer­na claimed that Mer­ck ex­ec­u­tives prac­ti­cal­ly did every­thing but help car­ry suit­cas­es loaded with re­search out the door as they helped line up new jobs for the de­part­ing staffers. And their case de­tailed nu­mer­ous in­stances of just how help­ful they could be.

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Drugmakers looking to design a new registry or use an existing one to support a regulatory decision on a drug’s effectiveness or safety will need to consult with a new draft guidance released Monday by the FDA.

The agency’s reliance on registry data for regulatory decisions dates back more than two decades, at least, as in 1998 Bayer won approval for its anticoagulant Refludan (withdrawn from the market in 2013 for commercial reasons) based in part on a historical control group pulled from a registry.