Lipocine shares tum­ble (again) af­ter the FDA shows an­oth­er testos­terone ther­a­py the door

An­oth­er testos­terone ther­a­py is get­ting the heave ho at the FDA.

Ma­hesh Pa­tel

Lipocine $LPCN re­port­ed this morn­ing that the agency has is­sued a com­plete re­sponse let­ter re­ject­ing Tlando as a new ther­a­py for hy­pog­o­nadism. The biotech spelled out what the FDA says is lack­ing in the ap­pli­ca­tion, and plans to fol­low up with a sit-down to de­fine a path back to a new pitch.

Shares of the biotech tum­bled 15%.

The FDA has sig­nif­i­cant­ly raised the bar on testos­terone re­place­ment treat­ments, un­hap­py with the way they’ve been wide­ly used by a gray­ing gen­er­a­tion of men — de­spite some health risks.

Lipocine was ham­mered back in Jan­u­ary when an ex­pert pan­el turned thumbs down on their ap­pli­ca­tion, look­ing to prof­it on a ther­a­py that was de­signed to re­place the gels now in use. That vote came a day af­ter Clarus was stiff armed on its sec­ond try on Jaten­zo. And a whole line­up of com­pa­nies have been stymied on this front in re­cent years.

Dou­glas Bauer

“I vot­ed ‘no’ be­cause … the in­di­ca­tion is the same as the ex­ist­ing prepa­ra­tions and we know there is huge off-la­bel use,” not­ed com­mit­tee mem­ber Dou­glas Bauer of the Uni­ver­si­ty of Cal­i­for­nia San Fran­cis­co, in a re­port from Med­Page To­day. “I think that’s un­ac­cept­able, and I don’t think that the spon­sor’s pro­pos­als to try to change that, frankly, are like­ly to be very suc­cess­ful.”

Lipocine, nev­er­the­less, will sol­dier on. The com­pa­ny iden­ti­fied a va­ri­ety of ar­eas they would need to work on, in­clud­ing of­fer­ing more in­sights in­to the ther­a­py’s ef­fect on blood pres­sure and track­ing pa­tients to de­ter­mine when they should stop us­ing the drug.

“While we are dis­ap­point­ed by the FDA’s de­ci­sion, the de­fi­cien­cies iden­ti­fied in the CRL are with­in our ex­pec­ta­tions fol­low­ing the meet­ing we had on Jan­u­ary 10, 2018 with the Bone, Re­pro­duc­tive and Uro­log­ic Drugs Ad­vi­so­ry Com­mit­tee of the FDA. We are as­sess­ing the con­tent of the CRL, in­clud­ing the in­for­ma­tion that may be need­ed to re­solve the de­fi­cien­cies. We re­main com­mit­ted to work with the FDA to bring Tlando to pa­tients,” said CEO Ma­hesh Pa­tel.

Fangliang Zhang, AP Images

UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Mer­ck wins a third FDA nod for an­tibi­ot­ic; Mereo tack­les TIG­IT with $70M raise in hand

Merck — one of the last big pharma bastions in the beleaguered field of antibiotic drug development — on Friday said the FDA had signed off on using its combination drug, Recarbrio, with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The drug could come handy for use in hospitalized patients who are afflicted with Covid-19, who carry a higher risk of contracting secondary bacterial infections. Once SARS-CoV-2, the virus behind Covid-19, infects the airways, it engages the immune system, giving other pathogens free rein to pillage and plunder as they please — the issue is particularly pertinent in patients on ventilators, which in any case are breeding grounds for infectious bacteria.