Gilead vet Alessan­dro Ri­va steers Glen­mark's biotech spin­off on in­de­pen­dent course

Alessan­dro Ri­va turned heads when he left his on­col­o­gy post at Gilead to front a new Glen­mark ven­ture. What was one of the in­dus­try’s top can­cer ex­ecs do­ing at a gener­ic drugs com­pa­ny?

Alessan­dro Ri­va

“No­body knew — or few peo­ple knew — that Glen­mark had and has 400 peo­ple ded­i­cat­ed to in­no­va­tion,” Ri­va told End­points News. 

The in­no­va­tion arm is now try­ing to make its name known as it spins off from Glen­mark and launch­es to­day as Ich­nos Sci­ences. With a base in Para­mus, New Jer­sey, a bi­o­log­ics wing in Switzer­land and a new chem­i­cal en­ti­ty re­search branch in In­dia, Ich­nos will clin­i­cal­ly de­vel­op five mol­e­cules aimed at first in class treat­ments for can­cer, au­to-im­mune dis­or­ders and pain.

Glen­mark ap­proved the spin­off in Feb­ru­ary. Ri­va said the new com­pa­ny was formed so Glen­mark could give suf­fi­cient at­ten­tion to the re­search, from busi­ness strat­e­gy to de­vel­op­ment.

“I joined in the be­gin­ning of April and this was one of my first ques­tions if not my on­ly one,” Ri­va said, adding he saw the an­swer first hand in the months lead­ing to the launch. “Glen­mark has re­al­ized that do­ing in­no­va­tion in au­to-im­mune, in on­col­o­gy and in pain is a dif­fer­ent busi­ness than do­ing gener­ic drugs and it re­quires a dif­fer­ent ap­proach.”

Glen­mark, though, may have had broad­er and less rosy rea­sons for the change. Be­fore the of­fi­cial launch, Fier­cePhar­ma saw the move as part of a se­ries of ef­forts by a debt-laden com­pa­ny to get lean­er. The In­di­an gi­ant al­so spun off its API busi­ness.

“We are di­vest­ing a num­ber of non­core as­sets,” Glen­mark chief ex­ec­u­tive Glenn Sal­dan­ha told Fier­cePhar­ma last month.

Glenn Sal­dan­ha Glen­mark

Glen­mark is the on­ly in­vestor in Ich­nos so far, al­though Ri­va said they were plan­ning to move an IPO when the da­ta lets them. He em­pha­sized they were a ful­ly in­de­pen­dent com­pa­ny.

At Gilead, Ri­va over­saw a can­cer di­vi­sion pumped with cash in the wake of the Kite buy­out, al­though one that strug­gled to es­tab­lish its CAR-T ther­a­py in the mar­ket­place.

Two of Glen­mark’s 5 com­pounds are on­co­log­i­cal. They’re CD3-tar­get­ed treat­ments for mul­ti­ple myelo­ma and re­frac­to­ry breast can­cer, both in Phase IA/B. Roche, Am­gen and J&J, among oth­ers, have ex­plored or in­vest­ed in CD3 ther­a­pies.

Two oth­ers are painkillers, both in Phase IIB. One is part of the wide-rang­ing search for a non-opi­oid painkiller and is an mPGES-1 in­hibitor. The oth­er is a TR­PA1 an­tag­o­nist that aims at neu­ro­path­ic pain, a no­to­ri­ous­ly dif­fi­cult tar­get.

“To the best of my knowl­edge there are no com­pa­nies that are as ad­vanced as we are,” Ri­va said of de­vel­op­ing a neu­ro­path­ic painkiller. “This is kind of dif­fi­cult.”

Al­so in Phase IIB is their OX40 an­tag­o­nist for au­to-im­mune dis­or­ders, cur­rent­ly be­ing test­ed on atopic der­mati­tis. OX40’s cen­tral role on T cells has made them a pop­u­lar tar­get for both can­cer and au­toim­mune treat­ments.

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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The lat­est Cin­derel­la sto­ry in on­col­o­gy ends with a sud­den rout as up­dat­ed da­ta dis­play spooks in­vestors

NextCure’s turn as the Cinderella of cancer-focused biotechs was short-lived.
Just a few days after its shares $NXTC zoomed up more than 250% on some very early stage results in a SITC abstract, a more complete analysis over the weekend spiked the hype and left investors in high dudgeon as the stock price collapsed back towards earth Monday.
The focus at NextCure is centered on NC318, an antibody that is intended to shut down the immunosuppressive Siglec-15 — or S-15 — target. After adding a small group of patients to the readout, investigators circled 2 clinical responses, a complete and partial response, along with 4 stable disease cases in non-small cell lung cancer.

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Te­va spin­out rais­es $85M in IPO; No­var­tis beefs up gener­ics unit with $440M deal

→ After Teva spinout 89bio recently announced that its IPO was being held up, the company is back in the game offering 5,304,687 shares at a price of $16 per share. The company has raised $84.9 million IPO in gross proceeds and will be listed under the ticker symbol $ETNB. BofA Securities, SVB Leerink and RBC Capital Markets are the joint book-running managers for the offering. Oppenheimer & Co is the co-manager for the offering.
→ Looking to amp up its presence in Japan’s hospitals, Novartis has struck a deal to buy out Aspen’s portfolio of generics in the world’s third largest healthcare market. The pharma giant is paying $440 million for Aspen’s Japanese subsidiary.
→ Novartis said tropifexor, a non-bile acid FXR agonist, has scored on several key biomarkers of NASH in a Phase IIb trial, including reductions in hepatic fat, alanine aminotransferase and body weight compared to a placebo at 12 weeks.

Break­through sta­tus and promise of a speedy re­view ar­rives for Op­di­vo/Yer­voy com­bi­na­tion as Bris­tol-My­ers bites at Bay­er

Its frontline and single-agent aspirations have been set back, but Bristol-Myers Squibb just took a big step forward in its efforts to apply its checkpoint inhibitor Opdivo to liver cancer. The FDA has granted breakthrough status and priority review to a combination, second-line treatment.

The designation is for Opdivo (nivolumab) in combination with Yervoy (ipilimumab),  for treating advanced hepatocellular carcinoma (HCC), the most common form of liver cancer. The PD-L1 drug was already approved as a single-agent, second-line treatment for HCC. A PDUFA date was set for March 10, 2020 — just 4 months from now.

Third time un­lucky: Lipocine's lat­est quest to mar­ket their oral testos­terone drug snubbed again by FDA

Lipocine’s latest attempt at securing approval for its oral testosterone drug has fizzled yet again.

The Utah-based drug developer on Monday said the FDA has spurned its marketing application, indicating that some efficacy data on the drug, Tlando, was not up to scratch to treat male hypogonadism, a condition characterized by low production of the hormone testosterone, which is responsible for maintaining muscle bulk, bone growth, and sexual function.

UP­DAT­ED: De­cry­ing 'ar­bi­trary and capri­cious' ac­tion, Re­genxBio sues FDA over clin­i­cal holds on gene ther­a­py

When RegenxBio disclosed that the FDA had placed a partial clinical hold on one of its lead gene therapies, execs outlined several customary next steps: continuing assessment and monitoring, delaying a related IND filing, and working with the FDA to address the matter.

As it turned out, they were planning something much less mundane. Two days after announcing the hold in its Q3 update, RegenxBio filed a lawsuit seeking to set it aside, the FDA Law Blog noted.

Roche's SMA chal­lenge to Bio­gen's Spin­raza fran­chise looms larg­er with piv­otal win

Roche has just landed a crucial advance in scoring a come-from-behind win on the spinal muscular atrophy field, giving Novartis and Biogen a run for their money.

The update was brief, but Roche said risdiplam hit the primary endpoint in the placebo-controlled pivotal SUNFISH trial, meeting the threshold for change from baseline in the Motor Function Measure 32 (MFM-32) scale after one year of treatment. The results, which is the second, confirmatory portion of a two-part study, involved 180 patients with type 2 or 3 spinal muscular atrophy between 2 and 25 years old.

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Roche steers Gazy­va in­to a new PhI­II pro­gram af­ter com­bo shows promise in lu­pus nephri­tis study

Roche is working on putting together a late-stage study for its monoclonal antibody Gazyva in patients with severe kidney disease associated with lupus after a combination approach helped patients in a mid-stage study.

The 125-patient NOBILITY trial evaluated Gazyva, combined with standard-of-care treatment mycophenolate mofetil or mycophenolic acid and corticosteroids, versus standard treatment alone. The combo met the main goal of inducing a statistically superior complete renal response (CRR) of 40% at week 76, versus 18% in patients given standard treatment, Roche said.