In­di­an drug­mak­er seeks to toss 'bloat­ed' bil­lion-dol­lar law­suit over Covid vac­cine can­di­date

A drug man­u­fac­tur­er is look­ing to end a suit brought on by a Seat­tle-based biotech.

Em­cure Phar­ma­ceu­ti­cals, a Pune, In­dia-based man­u­fac­tur­er of gener­ic drugs, is press­ing a court in Wash­ing­ton to toss out a suit brought on by HDT Bio over a vac­cine to pre­vent Covid-19.

The cur­rent mo­tion filed by Em­cure on Fri­day seeks to dis­miss the case on sev­er­al grounds, par­tial­ly be­cause the court has no au­thor­i­ty over an In­di­an com­pa­ny, Em­cure says, and be­cause there is no way that Em­cure could dam­age HDT.

“HDT Bio Corp. hauled Em­cure Phar­ma­ceu­ti­cals Ltd. an In­di­an gener­ic drug man­u­fac­tur­er and dis­trib­u­tor with no Wash­ing­ton con­tacts, in­to this Court so it could dis­par­age Em­cure, dam­age its rep­u­ta­tion, and, at the same time, cre­ate pub­lic­i­ty for it­self,” the mo­tion said. “The Com­plaint’s bloat­ed bil­lion-dol­lar dam­ages de­mand shows this case for what it is: a made-for-head­lines hit piece.”

The mo­tion claims that the al­le­ga­tions from HDT arise from agree­ments be­tween HDT and Em­cure’s sub­sidiary Gen­no­va Bio­phar­ma­ceu­ti­cals. HDT ini­tial­ly part­nered with Gen­no­va in Ju­ly 2020 to help with the po­ten­tial vac­cine’s de­vel­op­ment in In­dia, where the coun­try’s reg­u­la­tor re­cent­ly signed off on Phase II and III tri­als. How­ev­er, HDT has al­ready sued Gen­no­va in the Lon­don Court of In­ter­na­tion­al Ar­bi­tra­tion. Em­cure al­so al­leges that does not have any con­trol over Gen­no­va.

The mo­tion al­so states that HDT did not iden­ti­fy its trade se­crets, al­leg­ing that HDT’s de­scrip­tion of the trade se­crets in ques­tion is too vague and, by its very own al­le­ga­tions, are pub­licly dis­closed in patents which can­not form a prop­er le­gal ba­sis to as­sert a claim for trade se­cret mis­ap­pro­pri­a­tion.

No ac­tion has been tak­en yet by the court.

The ini­tial suit filed by HDT in March stat­ed that Em­cure sought to cut ties with HDT, file patents on HDT tech and go pub­lic on the strength of the vac­cine. HDT al­leged in its suit that Em­cure and Gen­no­va took over, planned for a pub­lic stock of­fer­ing, and then nev­er looked back, even re­fus­ing to share clin­i­cal da­ta with HDT.

“Gen­no­va’s ul­ti­mate re­fusal to pro­vide ei­ther Phase II or Phase III clin­i­cal da­ta killed a po­ten­tial $100,000,000 deal with an ex­ist­ing HDT part­ner,” HDT al­leged in its orig­i­nal suit.

HDT was backed with an $8.2 mil­lion NIH grant and was look­ing to de­vel­op its self-am­pli­fy­ing RNA vac­cine, or saR­NA vac­cine, which al­so us­es the firm’s pro­pri­etary lipid nanopar­ti­cle tech. The com­plaint is filled with claims that HDT’s vac­cine will out­per­form the cur­rent­ly au­tho­rized mR­NA vac­cines, claim­ing that it is “safer, cheap­er, more portable, and like­ly more ef­fec­tive than the mR­NA vac­cines on the mar­ket.” How­ev­er, to date, no saR­NA vac­cine has ever been ap­proved by the FDA.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

Dif­fu­sion to hand Nas­daq spot to EIP Phar­ma for PhI­Ib de­men­tia study of ex-Ver­tex drug

One of the more than a dozen bidders for Diffusion Pharmaceuticals’ spot on Nasdaq has prevailed.

Boston biotech EIP Pharma will merge with Diffusion in an all-stock deal, with plans to start a Phase IIb clinical trial in the coming months in a common form of dementia with no approved treatments. The combined company will be renamed CervoMed.

The nine-year-old privately-held EIP is working on a former Vertex drug that it will test in a 160-person Phase IIb in patients with dementia with Lewy bodies, or DLB. The National Institute on Aging is expected to fund that trial with a $21 million grant. With the reverse merger, slated for closing in the middle of this year, EIP will be funded through that readout in the second half of 2024. EIP’s equity and debt holders will own about 77.25% of the combined company.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

FDA ap­proves Nar­can opi­oid over­dose re­ver­sal spray for over-the-counter sale

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

J&J bows out of RSV vac­cine race, end­ing PhI­II study and ced­ing to Pfiz­er, GSK

Johnson & Johnson announced Wednesday morning it is ending development of its adult RSV vaccine that was in the middle of a 27,200-patient trial, giving up a big slice of what’s expected to be the next multibillion-dollar pharma market.

The decision came down to the shifting RSV “competitive landscape,” a company spokesperson tells Endpoints News, adding the “breadth of options” was much different than when J&J first started its pivotal study. The spokesperson declined to comment on the Phase III data, saying only the shot is undergoing an “ongoing assessment.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.