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.

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

Bristol Myers Squibb (Alamy)

CVS re­sumes cov­er­age of block­buster blood thin­ner af­ter price drop fol­lows Jan­u­ary ex­clu­sion

Following some backlash from the American College of Cardiology and patients, Bristol Myers Squibb and Pfizer lowered the price of their blockbuster blood thinner Eliquis, thus ensuring that CVS Caremark would cover the drug after 6 months of it being off the major PBM’s formulary.

“Because we secured lower net costs for patients from negotiations with the drug manufacturer, Eliquis will be added back to our template formularies for the commercial segment effective July 1, 2022, and patient choices will be expanded,” CVS Health said in an emailed statement. “Anti-coagulant therapies are among the non-specialty products where we are seeing the fastest cost increases from drug manufacturers and we will continue to push back on unwarranted price increases.”

#Can­nes­Lions2022: Con­sumer health ex­ecs call on agen­cies to in­volve pa­tients in cre­ative process

CANNES — When Tamara Rogers joined GSK back in 2018, “science was king and R&D were the gods.” Now the global chief marketing officer of consumer healthcare wants to make room for another supreme being: the consumer.

As health and wellness becomes more relevant to consumers amid the pandemic, four health-focused executives called on marketers to involve patients in their creative process in a panel discussion at the Cannes Lions advertising creativity festival.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.