Af­ter los­ing its high-pro­file rheuma­toid arthri­tis part­ner­ship just two years ear­li­er, Sanofi’s Bel­gium-based biotech Abl­ynx could once again put an Ab­b­Vie pact on the chop­ping block af­ter post­ing a Phase II flop this morn­ing.

Abl­ynx re­port­ed out bad news that vo­bar­il­izum­ab dis­ap­point­ed yet again, fail­ing to meet its pri­ma­ry end­points in a Phase II lu­pus study. It’s the same drug that fiz­zled in RA, which Ab­b­Vie punt­ed back in 2016.

The drug was the sub­ject of a glob­al li­cens­ing agree­ment inked with Ab­b­Vie back in 2013, which came with an up­front pay­ment of $175 mil­lion and mile­stones up to $665 mil­lion. The deal gave Ab­b­Vie the op­tion to li­cense vo­bar­il­izum­ab in RA and in lu­pus. It’s un­clear what Ab­b­Vie will choose, but the fu­ture isn’t look­ing good for vo­bar­il­izum­ab.

Robert Zeldin

“Ab­b­Vie will re­view the com­plete da­ta set when avail­able from the Phase II Steady SLE study to de­ter­mine whether to ex­er­cise its op­tion to li­cense vo­bar­il­izum­ab,” Abl­ynx said in a state­ment. “Should Ab­b­Vie ex­er­cise the op­tion, it would trig­ger a pay­ment to Abl­ynx. If the op­tion is not ex­er­cised, Abl­ynx’s agree­ment with Ab­b­Vie would ter­mi­nate.”

Abl­ynx, which has a nanobody plat­form tech and sev­er­al drugs in its pipeline, was snatched up by Sanofi for $4.8 bil­lion in Jan­u­ary. That was af­ter shoot­ing down two pre­vi­ous bids from No­vo Nordisk. The deal got Sanofi Abl­ynx’s lead drug capla­cizum­ab, which has shown con­sid­er­able promise in treat­ing the ul­tra-rare blood clot­ting dis­or­der ac­quired throm­bot­ic throm­bo­cy­topenic pur­pu­ra (aTTP).

Still, the vo­bar­il­izum­ab fail­ure will like­ly sting. The failed Phase II study en­rolled 312 pa­tients with lu­pus across five treat­ment arms. Ad­verse events that led to study drug dis­con­tin­u­a­tion were re­port­ed in 12.4% of all vo­bar­il­izum­ab treat­ed pa­tients com­pared to 6.5% in the place­bo group. Two deaths were re­port­ed in the vo­bar­il­izum­ab group.

“We are dis­ap­point­ed that vo­bar­il­izum­ab didn’t show a dose re­sponse in the analy­sis of the study’s pri­ma­ry end­point, how­ev­er, vo­bar­il­izum­ab was well tol­er­at­ed in all test­ed dose groups, con­firm­ing its fa­vor­able safe­ty pro­file,” said Abl­ynx CMO Robert Zeldin in a state­ment. “We will con­tin­ue to an­a­lyze the full da­ta set and thank the study par­tic­i­pants and their fam­i­lies as well as the in­ves­ti­ga­tors and staff who con­tributed to this study.”

The rapid development of technology — and the resulting avalanche of data — are catalysts for significant change in the biopharmaceutical industry. This translates into urgent pressures for today’s biopharma, including a need to quickly and affordably develop products with proven therapeutic efficacy and value. This urgency is expedited by the growth of value-based contracting, where access to reimbursement and profit depends on these abilities.

On May 24, FLX Bio, a small cancer and inflammation biotech with backing from GV, changed its name to RAPT Therapeutics and filed confidentially for an IPO. On July 5th, they filed to raise up to $86 million. On July 22, they announced the IPO with a $75 million goal.  And on August 1, they abruptly and without explanation called it all off.

Now, without explanation, they’re reviving the bid, filing again for a $75 million IPO, this time with a new bookrunner and a new drug candidate in the clinic. The terms will be the same: 5 million shares at $14-$16 per share. It would give them a diluted market value of $351 million.

Ahead of its third-quarter results next week, Amgen on Tuesday disclosed the planned retirement of David Meline, who has served as the company’s chief financial officer since 2014.

Meline will be replaced by Ernst & Young vet, Peter Griffith, as CFO come January 1, 2020 — but until then Griffith will serve as executive vice president, finance.

“Over the last 5 years at Amgen, Meline instituted many major changes that led to operational efficiencies and margin expansion while successfully returning cash to shareholders. Now that Amgen is on solid footing, it was a good time to step away,” Cowen’s Yaron Werber wrote in a note. “We do not anticipate any major changes to strategy or operations immediately due to this transition as Amgen is on solid footing.”

Never underestimate the power of a good showing at a scientific conference.
In a presentation late last year, the researchers at Pliant Therapeutics launched a series of discussions about the preclinical data they were pulling together around their work on their small-molecule integrin inhibitor aimed at transforming growth factor beta, or TGF-β, a key pathway involved in fibrosis.
And they got some serious attention for the work.
“We got interest from pharma partners and at the end Novartis basically made it,” says Pliant CEO Bernard Coulie.