Merdad Parsey, Gilead CMO

Four months af­ter CRL due to con­t­a­m­i­nant wor­ries, Gilead re­turns to FDA for next-gen HIV drug

Just shy of four months ago, Gilead’s next-gen HIV drug can­di­date lenaca­pavir got hit with a CRL over CMC is­sues in­volv­ing the type of vials planned for use. Now, the phar­ma is head­ed back to the FDA for round two.

Gilead an­nounced Mon­day af­ter­noon that it had re­filed its NDA sub­mis­sion filled with new CMC da­ta af­ter the FDA es­sen­tial­ly balked at borosil­i­cate glass vials, orig­i­nal­ly used for the non-oral form of lenaca­pavir. The drug can­di­date, which re­cent­ly won a pos­i­tive opin­ion from Eu­rope’s CHMP, is be­ing de­vel­oped for HIV-1 in­fec­tion “in heav­i­ly treat­ment-ex­pe­ri­enced (HTE) peo­ple with mul­ti-drug re­sis­tant (MDR) HIV-1 in­fec­tion.”

Many com­pa­nies have run in­to par­tic­u­late con­t­a­m­i­na­tion is­sues, and this is not the first time Gilead has such a prob­lem on its hands. Just last De­cem­ber, Gilead had to re­call two lots of Vek­lury due to glass con­t­a­m­i­na­tion is­sues.

Reg­u­la­tors pre­vi­ous­ly slapped a clin­i­cal hold on 10 tri­als — al­so last De­cem­ber — while study­ing in­jectable ver­sions of the ex­per­i­men­tal HIV-1 cap­sid in­hibitor, due to con­cerns that vials made of borosil­i­cate glass could lead to the for­ma­tion of tiny glass par­ti­cles seep­ing in­to the so­lu­tion. Gilead CMO Mer­dad Parsey said at the time that “We are com­mit­ted to work­ing dili­gent­ly with FDA to re­solve this glass vial com­pat­i­bil­i­ty qual­i­ty is­sue and re­sume in­jectable lenaca­pavir dos­ing in the af­fect­ed stud­ies in a time­ly fash­ion.”

That hold was lift­ed in May, two months af­ter the drug was ini­tial­ly re­ject­ed and af­ter Gilead found a new so­lu­tion with which the reg­u­la­to­ry agency was con­tent.

Jared Baeten

Gilead’s VP of HIV clin­i­cal de­vel­op­ment Jared Baeten said in a state­ment that “There are peo­ple with HIV who have se­vere­ly lim­it­ed treat­ment op­tions due to re­sis­tance to mul­ti­ple an­ti­retro­vi­ral ther­a­py class­es,” adding that the Cal­i­for­nia com­pa­ny is com­mit­ted to un­met needs.

Baeten tells End­points News that Gilead cur­rent­ly has no plans at look­ing at lenaca­pavir out­side of HIV treat­ment and pre­ven­tion. And with the new progress, Gilead has start­ed re-dos­ing pa­tients in mul­ti­ple clin­i­cal tri­als for HIV treat­ment — the ba­sis of Gilead’s NDA, ac­cord­ing to Baeten. On top of that, the restart­ed clin­i­cal tri­als in­clude lenaca­pavir in par­tic­i­pants as a pre-ex­po­sure pro­phy­lax­is, test­ing the drug as a method of HIV pre­ven­tion.

As for what makes the re­sub­mit­ted NDA dif­fer­ent from the first, Gilead said in a state­ment that “the NDA re­sub­mis­sion con­tains com­pre­hen­sive CMC da­ta to sup­port the com­pat­i­bil­i­ty of lenaca­pavir with an al­ter­na­tive vial type made from alu­mi­nosil­i­cate glass,” plus pre-clin­i­cal and clin­i­cal da­ta.

And now, the com­pa­ny is play­ing the wait­ing game to hear what FDA thinks, and whether the changes made are enough for the ap­pli­ca­tion to be ac­cept­ed, an­a­lyzed and run through a new, yet-undis­closed PDU­FA date. If it gets ap­proved, lenaca­pavir will be the first HIV-1 cap­sid in­hibitor on the mar­ket.

Lenaca­pavir has been billed as Gilead’s next big thing in its HIV ar­se­nal, giv­en the drug’s po­ten­tial to not on­ly al­low dos­ing just once every six months but block HIV-1 at mul­ti­ple stages of the virus’s life­cy­cle and work to both treat and pre­vent in­fec­tion. GSK’s Vi­iV Health­care is al­so in the long-act­ing HIV treat­ment game, with its pre-pro­phy­lax­is in­jectable cabote­gravir be­ing the first HIV treat­ment to pro­vide an al­ter­na­tive to a once-com­mon­place dai­ly pill reg­i­men.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,700+ biopharma pros reading Endpoints daily — and it's free.

Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance Chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

Pharma brands are trying to figure out new ways to better reach patients and doctors, but also measure results. (Credit: Shutterstock)

Do phar­ma TV and so­cial ads work? Phar­ma mar­ket­ing agen­cies adopt­ing new tech so­lu­tions to find out

It’s a timeworn advertising question — is my ad campaign working? In pharma, that can be an especially difficult question to answer in part because of privacy regulations, but also because the brands spend a lot of money on TV commercials where viewers can’t directly click on an ad.

Healthcare marketing services companies like Lasso and CMI Media Group are trying to change that with new measurement methods and partnerships that aim to get closer to patients’ and physicians’ actions.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,700+ biopharma pros reading Endpoints daily — and it's free.

Corey McCann, Pear Therapeutics CEO

Pear Ther­a­peu­tics touts Q2 growth while scal­ing back full-year goals and chop­ping 9% of staff

Pear Therapeutics set some ambitious goals back in March, predicting a five-fold boost in revenue and a surge in new prescriptions for its digital therapeutics. Now the company is scaling back those estimates and chopping 9% of its workforce — an all-too-common occurrence in biotech lately.

CEO Corey McCann unveiled Pear’s Q2 numbers on Thursday, touting a 20% quarter-over-quarter revenue growth totaling $3.3 million. That’s more than double what the company made in Q2 2021, and McCann thinks the team could see a nearly four-fold jump in revenue this year, falling in the range of $14 million to $16 million.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,700+ biopharma pros reading Endpoints daily — and it's free.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,700+ biopharma pros reading Endpoints daily — and it's free.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,700+ biopharma pros reading Endpoints daily — and it's free.

Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,700+ biopharma pros reading Endpoints daily — and it's free.