In­dia’s Lupin bags Sym­bio­mix and its new­ly ap­proved an­tibi­ot­ic for $150M-plus

Just a few weeks af­ter the FDA ap­proved Sym­bio­mix Ther­a­peu­tics’ sin­gle-dose an­tibi­ot­ic Solosec (sec­nida­zole) for a com­mon form of gy­ne­co­log­i­cal in­fec­tions, the Amer­i­can arm of In­dia’s Lupin has stepped in to buy the com­pa­ny for $150 mil­lion in cash plus sales mile­stones.

Work­ing on the in­stall­ment plan, Lupin is pay­ing $50 mil­lion up­front for Sym­bio­mix, with the rest spread over an un­spec­i­fied pe­ri­od of time.

Their new an­tibi­ot­ic was giv­en the FDA’s Qual­i­fied In­fec­tious Dis­ease Prod­uct sta­tus, which comes with 10 years of mar­ket ex­clu­siv­i­ty.

Vini­ta Gup­ta

Ear­li­er in Sep­tem­ber Newark, NJ-based Sym­bio­mix out­lined its Phase III da­ta for sec­nida­zole, which in a mod­i­fied in­tent-to-treat pop­u­la­tion of 189 women with bac­te­r­i­al vagi­nosis demon­strat­ed clin­i­cal out­come re­spon­der rates of 53.3% for 2 g sec­nida­zole com­pared with 19.3% for place­bo (p<0.001). The cure rate was 64% for 2 g sec­nida­zole com­pared with 26.4% for place­bo.

Sybio­mix worked with Catal­ent on their man­u­fac­tur­ing op­er­a­tions for the an­tibi­ot­ic, work­ing out of the biotech’s 260,000-square-foot op­er­a­tions in Som­er­set, NJ.

New an­tibi­otics have been com­ing along at a steady pace this year, usu­al­ly from small out­fits like this. The Big Phar­ma crowd still has shown lit­tle in­ter­est in de­vel­op­ing new an­tibi­otics, de­spite a ris­ing tide of drug re­sis­tance. The mar­ket is still dom­i­nat­ed by cheap gener­ics, though a slate of biotechs be­lieve that de­mand will soon catch up to the sup­ply they have in the clin­ic.

“We are de­light­ed to com­plete the ac­qui­si­tion of Sym­bio­mix and its Solose brand, which im­me­di­ate­ly ex­pands Lupin’s US women’s health spe­cial­ty busi­ness in­to the high­ly-com­ple­men­tary gy­ne­co­log­i­cal in­fec­tion sec­tor,” said Vini­ta Gup­ta, CEO of Lupin, in a state­ment. “This trans­ac­tion is an im­por­tant mile­stone in the evo­lu­tion of our Spe­cial­ty busi­ness and gives Lupin a new ther­a­peu­tic to bring to ob­ste­tri­cians and gy­ne­col­o­gists to treat a se­ri­ous health con­di­tion they see fre­quent­ly in their prac­tices.”

Dr. Gabriel Kremmidiotis, Chief Scientific Officer (center) heads up the biotech ClinicReady team of scientific and medical affairs specialists with a 20-year track record. Dr. Jorgen Mould Avance Clinical Scientific Affairs Specialist (left) and Yvonne Lungershausen, Avance Clinical’s CEO.

How Clini­cReady by Aus­tralian CRO Avance Clin­i­cal de­liv­ers pre­clin­i­cal project man­age­ment and sci­en­tif­ic and reg­u­la­to­ry ad­vice to get biotechs in­to clin­ic faster.

Avance Clinical has formed a dedicated scientific and regulatory affairs service, ClinicReady by Avance Clinical, in response to increased demand from biotechs for preclinical study management and scientific and regulatory advice to take their products to first-in-human trials.

The highly regarded Avance Clinical scientific and regulatory team, which has been advising biotech clients on their drug development for more than 20 years, is now a dedicated ClinicReady service under the Avance Clinical banner.

FDA chief Stephen Hahn on Capitol Hill earlier this week (Getty Images)

As FDA’s work­load buck­les un­der the strain, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

Hans Schambye

Galec­to reaps $64M to bring lead drug across IPF fin­ish line, while mak­ing moves in NASH and be­yond

Back in 2018, Hans Schambye raised $90 million to kick off a late-stage trial that could put Galecto Biotech’s lead drug on the final stretch toward approval for idiopathic pulmonary fibrosis. Two years later, he’s collected another $64 million to complete it.

The Copenhagen-based company has managed to continue recruitment for the 450-patient trial in spite of the pandemic, the CEO told Endpoints News, with data expected by the middle of 2022.

Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Play-by-play of Gilead­'s $21B Im­munomedics buy­out de­tails a fren­zied push — and mints a new biotech bil­lion­aire

Immunomedics had not really been looking for a buyout when the year began. Excited by its BLA for Trodelvy, submitted to the FDA in late 2019, executive chairman Behzad Aghazadeh started off looking for potential licensing deals and zeroed in on four potential partners, including Gilead, following January’s JP Morgan Healthcare Conference in San Francisco. Such talks advanced throughout the year, with discussions advancing to the second round in mid-August.

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The win­dow is wide open as four more biotechs join the go-go IPO class of 2020

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.

J&J of­fers PhI/IIa da­ta show­ing its sin­gle-dose vac­cine can stir up suf­fi­cient im­mune re­sponse

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

President Donald Trump reacts after signing an executive order following his remarks on his healthcare policies yesterday in Charlotte, North Carolina (Getty Images)

Op-ed: Will phar­ma re­al­ly pay for Trump’s lat­est law­less promise to 33 mil­lion Medicare ben­e­fi­cia­ries? Not like­ly

Sitting atop the executive branch, President Donald Trump is the ultimate authority at the FDA. He can fast track any vaccine to approval himself. If it came to that, of course.

What he can’t do is unilaterally order the legislative branch to loosen the Treasury’s coffers for $6.6 billion. Nor can he command pharmaceutical companies to pay for $200 vouchers sent to 33 million Medicare beneficiaries for prescription drugs before the election.

New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust in the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.