Durec­t's non-opi­oid painkiller brush­es aside check­ered past, gain­ing FDA ap­proval in shoul­der surg­eries

Af­ter a long and of­ten bumpy ride, Durect’s non-opi­oid painkiller has re­ceived the FDA’s en­dorse­ment.

US reg­u­la­tors ap­proved the sus­tained-re­lease bupi­va­caine so­lu­tion for use up to 72 hours af­ter cer­tain shoul­der surg­eries, Durect an­nounced Tues­day morn­ing. The drug is called Posimir, and its ap­proval breathes life in­to a com­pa­ny that once teetered on pen­ny stock ter­ri­to­ry af­ter the pro­gram racked up two tri­al fail­ures and a CRL.

Durect’s $DR­RX shares shot up about 24% in ear­ly Tues­day trad­ing. The com­pa­ny will be re­quired to con­duct two post­mar­ket­ing, non-clin­i­cal stud­ies.

Doc­tors will be able to use the drug in what’s called sub­acro­mi­al de­com­pres­sion surg­eries that treat shoul­der im­pinge­ments. The in­juries stem from too much repet­i­tive use and cause pain when in­di­vid­u­als raise their arms over their heads.

Nor­mal­ly, such surg­eries are per­formed arthro­scop­i­cal­ly in an out­pa­tient set­ting, in­sert­ing sur­gi­cal in­stru­ments in­to small in­ci­sions made in the shoul­der with the aid of a small cam­era. The idea be­hind the drug is to de­liv­er it di­rect­ly in­to the shoul­der space be­tween the col­lar­bone and ball-and-sock­et joint once the surgery it­self is com­plet­ed.

Posimir then func­tions as a lo­cal anal­gesic and an al­ter­na­tive to oral opi­oid painkillers typ­i­cal­ly ad­min­is­tered in re­cov­ery. The first three days af­ter the surgery are usu­al­ly the most painful, Durect says, and Posimir con­tin­u­ous­ly re­leas­es bupi­va­caine in the shoul­der for 72 hours or more to com­bat that pain.

The com­pa­ny added that the 660 mg of bupi­va­caine con­tained in the drug is more than any oth­er ap­proved sin­gle-dose, sus­tained-re­lease bupi­va­caine prod­uct. Durect is aim­ing at a mar­ket that sees about 600,000 such shoul­der surg­eries per year where full re­cov­ery time can last from weeks to months.

For now, Posimir will be lim­it­ed to this type of pro­ce­dure, as the drug is not in­di­cat­ed for soft tis­sue sur­gi­cal pro­ce­dures or oth­er or­tho­pe­dic pro­ce­dures, such as ad­min­is­tra­tion in­to a joint or bone.

Posimir’s rocky his­to­ry be­gan sev­er­al years ago. Durect re­port­ed a tri­al fail­ure back in 2012, and in 2014 the FDA re­ject­ed its pitch over safe­ty con­cerns. Af­ter reg­u­la­tors re­quest­ed a change to the tri­al in 2016, Durect con­duct­ed an­oth­er study di­vid­ed in­to two parts: a place­bo arm and com­para­tor arm.

That study al­so flopped in 2017, demon­strat­ing no sta­tis­ti­cal dif­fer­ence in pa­tient re­sponse be­tween the arms in pain re­duc­tion for the first 48 hours af­ter surgery. The news sent Durect shares crash­ing in­to pen­ny stock ter­ri­to­ry at the time and al­so dinged its part­ner No­var­tis, where the San­doz unit had paid $20 mil­lion up­front in a $293 mil­lion deal.

Posimir re­turned to the FDA in an ad­comm in Jan­u­ary 2020, and the pan­el could not de­cide whether to rec­om­mend ap­proval. It split down the mid­dle with a 6-6 vote, not­ing neu­ro­log­i­cal safe­ty con­cerns and sug­gest­ing the ther­a­py’s du­ra­tion of ac­tion was lim­it­ed to 12 to 24 hours. Those in fa­vor of ap­proval not­ed pa­tients could see ben­e­fits sim­ply be­cause the drug is not an opi­oid.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

Credit: Shutterstock

How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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(Photo courtesy Pfizer)

FDA's vac­cine ad­comm votes al­most unan­i­mous­ly in fa­vor of Pfiz­er's Covid-19 vac­cine for younger chil­dren

The FDA’s Vaccines and Related Biological Products Advisory Committee on Tuesday voted 17-0, with one panelist abstaining, that the benefits of the Pfizer-BioNTech Covid-19 vaccine outweigh the risks for children between the ages of five and 12.

The vote will likely trigger a process that could allow the shots to begin rolling out as early as next week.

The vaccine, which is one-third of the adult Pfizer dose, proved to be about 90% effective in a placebo-controlled trial in which about 1,500 kids in this age range received the vaccine, and only about 12% of those receiving the vaccine had any adverse event. All serious adverse events in the trial were unrelated to the vaccine.

Peter Nell, Mammoth Biosciences CBO

UP­DAT­ED: Jen­nifer Doud­na spin­out inks a Mam­moth CRISPR deal with Ver­tex worth near­ly $700M

When a company gets its start in gene editing pioneer Jennifer Doudna’s lab, it’s bound to make headlines. But three years in, the fanfare still hasn’t died down for Mammoth Biosciences. Now, the Brisbane, CA-based company is cheering on its first major R&D pact.

Mammoth unveiled a nearly $700 million deal with Vertex on Tuesday morning, good for the development of in vivo gene therapies for two mystery diseases. The stars of the show are Mammoth’s ultra-small CRISPR systems, including two Cas enzymes licensed from Doudna’s lab over the past couple years, Cas14 and Casɸ.

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FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

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Robert Califf (Pablo Martinez Monsivais, AP Images, File)

UP­DAT­ED: As buzz on Califf FDA nom heats up, in­dus­try and agency in­sid­ers of­fer a strong nod for the ‘per­fect’ choice

For once in this long, dramatic road to finding a new FDA commissioner, there’s been some continuity. Both CNN and Politico reported this weekend that Rob Califf met with President Biden to discuss the permanent commish role, following earlier news broken by the Washington Post that all signs point to Califf.

Although there may be a few Democrats who continue to grandstand about the dangers of COI (Califf has worked for Verily, sits on the board of Centessa Pharmaceuticals, and has other ties to industry research), with the pandemic ongoing and the need for some kind of continuity at FDA mounting, Califf is likely to meet the same fate as when he first won Senate confirmation in 2016, by a vote of 89-4 — Bernie Sanders and 6 others didn’t vote.

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Sean Ianchulev, Eyenovia CEO and CMO

Re­cent court de­ci­sion push­es FDA to re­ject and re­clas­si­fy drug-de­vice com­bo, crush­ing shares

Back in April, the FDA lost a crucial court case in which its broad discretion of regulating medical products that might satisfy the legal definitions of either “drug” and/or “medical device” was sharply curtailed.

In addition to the appeals court ruling that Genus Medical Technologies’ contrast agent barium sulfate (aka Vanilla SilQ) should not be considered a drug, as the FDA had initially ruled, but as a medical device, the agency also was forced to spell out which drugs would transition to devices as a result of the ruling.

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UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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