Vivek Ra­maswamy strikes again, this time launch­ing a Bei­jing-based biotech play­er with a pipeline

An­oth­er day, an­oth­er start­up at Vivek Ra­maswamy’s Roivant. And this time he’s un­der­scor­ing the glob­al na­ture of the in­dus­try and his busi­ness strat­e­gy, as Chi­na’s biotech scene ex­plodes with fresh cash and some fa­mil­iar drugs.

Vivek Ra­maswamy

This morn­ing Roivant un­veiled Sino­vant along with CITICPE, a Chi­nese pri­vate eq­ui­ty group. This com­pa­ny is based in Bei­jing and Shang­hai, and it’s been as­sem­bling an ex­ec­u­tive crew and pipeline for to­day’s an­nounce­ment.

Sino­vant has been tak­ing some of Roivant’s cash re­serves to build up a pipeline of 11 drugs, fol­low­ing an in-li­cens­ing strat­e­gy that is all the rage these days. And it comes with a spe­cial Ra­maswamy twist, as the com­pa­ny looks to get start­ed in Phase III on a slate of ther­a­pies that can be po­si­tioned for a rel­a­tive­ly quick Asian launch.

The biotech has three top drugs:

  • De­r­azan­ti­nib, a fi­brob­last growth fac­tor re­cep­tor (FGFR) in­hibitor in glob­al Phase III de­vel­op­ment for the treat­ment of a liv­er can­cer — a big mar­ket in Chi­na — called in­tra­hep­at­ic cholan­gio­car­ci­no­ma.
  • Lefa­mulin, a late-stage an­tibi­ot­ic that has been stud­ied for com­mu­ni­ty-ac­quired bac­te­r­i­al pneu­mo­nia.
  • And RVT-802, brought in from sis­ter com­pa­ny En­zy­vant af­ter that Roivant sub­sidiary filed for an FDA ap­proval for a rare dis­ease called Di­Ge­orge Anom­aly.
Can­wen Jiang

Sino­vant al­so just gained the rights to de­vel­op naron­apride, a drug in­tend­ed to treat ir­ri­ta­ble bow­el syn­drome with con­sti­pa­tion.

In an­oth­er clas­sic Roivant move, Ra­maswamy has re­cruit­ed top tal­ent for this lat­est biotech ven­ture. No­var­tis vet Can­wen Jiang — who ran glob­al R&D groups for the phar­ma gi­ant — will run the op­er­a­tion af­ter years in the bio­phar­ma trench­es, work­ing on a slate of piv­otal tri­als.

The com­pa­nies aren’t talk­ing num­bers to­day, but Roivant doesn’t starve its com­pa­nies of cash. Ra­maswamy’s first big drug at Ax­o­vant — the orig­i­nal vant in what is now a grow­ing group with 13 com­pa­nies — was a no­to­ri­ous flop, but he has the best con­nec­tions in the world­wide in­dus­try and a keen un­der­stand­ing for lin­ing up bil­lions in cash re­serves.

The busi­ness plan here, says a Roivant spokesper­son, is to find clin­i­cal-stage drugs at small­er biotechs and in-li­cens­ing them for de­vel­op­ment for the Chi­nese drug mar­ket. And there are more deals to come.

The co-founder is Xi­nan Chen, who’s been work­ing on build­ing new star­tups at Roivant.


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By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

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As the world becomes increasingly dependant on Asia for the ingredients of its medicines, Sanofi sees business to be done in Europe.

The French drugmaker said it’s creating the world’s second largest active pharmaceutical ingredients (API) manufacturer by spinning out its six current sites into a standalone company: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France). They have mapped out €1 billion in expected sales by 2022 and 3,100 employees for the new operations headquartered in France.

UP­DAT­ED: NGM Bio takes leap for­ward in crowd­ed NASH field

South San Francisco-based NGM Bio may have underwhelmed with its interim analysis of a key cohort from a mid-stage NASH study last fall — but stellar topline data unveiled on Monday showed the compound induced significant signs of antifibrotic activity, NASH resolution and liver fat reduction, sending the company’s stock soaring.

There are an estimated 50+ companies focused on developing drugs for non-alcoholic steatohepatitis, or NASH, a common liver disease that has long flummoxed researchers. The first wave of NASH drug developers struggled with efficacy as well as safety — and companies big and small have crashed and burned.

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Mickey Kertesz, KidsandArtOrg via YouTube

Soft­Bank's newest, $165M biotech in­vest­ment looks for in­fec­tious traces in the blood

SoftBank has found its newest biotech investment.

The Japanese bank has invested $165 million into Karius, a company that uses blood tests to diagnose infectious diseases, as part of its new Vision Fund 2. The full scope of the new fund has yet to be announced, but the first and newly-beleaguered Vision Fund poured $100 billion into technology companies, including the biotechs Vir Biotechnology and Roivant and the sequencing company 10x Genomics.

Methicillin-resistant Staph aureus (Shutterstock)

FDA grants ‘break­through’ sta­tus to an­tibi­ot­ic al­ter­na­tive as Con­tra­Fect rush­es to join fight against su­per­bug

An experimental drug that promises to be the first anti-infective agent to prove superior to vancomycin — an antibiotic approved in 1958 — has notched the FDA’s “breakthrough” status.

ContraFect said the designation was based on Phase II data in which exebacase was tested against a superbug known as methicillin-resistant Staph aureus, or MRSA. In a subgroup analysis, the clinical responder rate at day 14 was 42.8% higher than that among those treated with standard of care, the company said (p=0.010).

Zhong Nanshan, CGTN via YouTube

Har­vard joins coro­n­avirus fight with $115 mil­lion and a high-pro­file Chi­nese part­ner

For two months, as the novel coronavirus swelled from a few early cases tied to a Wuhan market to a global epidemic, most of the world’s focus and dollars have flowed toward emergency initiatives: building vaccines at a record pace, plucking experimental antivirals out of freezers to see what sticks and immunizing mice for new antibodies.

Now a new and well-funded collaboration between Harvard and a top Chinese research institute will play the long game. In a 5-year, $115 million initiative backed by China Evergrande Group, researchers from the Harvard Medical School, Harvard T.H. Chan School of Public Health and Guangzhou Institute for Respiratory Health will study the virus in an effort to develop therapies against infections by the novel coronavirus, known as SARS–CoV-2, and to prevent new ones.

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In the first step of what’s likely to be a long and uphill battle for the drugmaker, the FDA has accepted Novartis’s BLA submission for a new multiple sclerosis drug and given it priority review. The PDUFA date for the potential blockbuster drug is in June.

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Juergen Horn

An­i­mal health vet Juer­gen Horn makes new an­ti­body play for pets, rak­ing $15M in Se­ries A haul

Zoetis forked over $85 million in 2017 to acquire Nexvet Biopharma and its pipeline of monoclonal antibodies. Juergen Horn, Nexvet’s former chief product development officer, has now secured $15 million for his own biologic company for animals: Invetx.

Buoyed by emerging advances in gene therapies for humans, scientists have started looking at harnessing the technology for animals setting up companies such as Penn-partnered Scout Bio and George Church-founded Rejuvenate Bio. But akin to Nexvet, Invetx is working on leveraging the time-tested science of monoclonal antibodies to treat chronic diseases that afflict man’s best friend.

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As the coronavirus originating out of Wuhan spreads to South Korea, Italy and Iran, stoking already intense fears of a pandemic, GlaxoSmithKline has found another pair of trusted hands to place its adjuvant system. China’s Clover Biopharmaceuticals will add the adjuvant to its preclinical, protein-based vaccine candidate against SARS-CoV-2.

Clover, which is based in the inland city of Chengdu, boasts of a platform dubbed Trimer-Tag that produces covalently-trimerized fusion proteins. Its candidate, COVID-19 S-Trimer, resembles the viral spike (S)-protein found in the virus.