FDA ap­proves first gener­ic drug to re­ceive CGT des­ig­na­tion

The FDA on Wednes­day ap­proved sev­er­al ver­sions of Apo­tex’s potas­si­um chlo­ride oral so­lu­tion as the first gener­ic drugs to re­ceive a Com­pet­i­tive Gener­ic Ther­a­py (CGT) des­ig­na­tion.

Thanks to the FDA Reau­tho­riza­tion Act of 2017 (FDARA), the CGT des­ig­na­tion al­lows gener­ic drugs to come to mar­ket faster than they oth­er­wise would have, but on­ly in cas­es where there is one ap­proved com­peti­tor gener­ic drug in the ac­tive sec­tion of the Or­ange Book.

Those re­ceiv­ing a CGT des­ig­na­tion may re­ceive re­view en­hance­ments and ex­pe­dit­ed re­view of their ab­bre­vi­at­ed new drug ap­pli­ca­tions (AN­DAs). Ap­pli­cants for drugs that re­ceive a CGT des­ig­na­tion are al­so el­i­gi­ble for a 180-day pe­ri­od of mar­ket­ing ex­clu­siv­i­ty if they are the first ap­proved ap­pli­cant for that CGT and meet oth­er con­di­tions.

And in a unique twist, un­der a spe­cial for­fei­ture rule for CGTs, the ap­pli­cant must com­mer­cial­ly mar­ket the CGT with­in 75 days af­ter the date of ap­proval of its AN­DA or it will for­feit its ex­clu­siv­i­ty.

Though the CGT is on­ly for gener­ics with one com­peti­tor, in an up­date to the agency’s Man­u­al of Poli­cies and Pro­ce­dures (MAPP) in June 2017 on the pri­or­i­ti­za­tion of the re­view of AN­DAs, FDA says: “Gener­ic prod­ucts for which there are few­er than three AN­DAs ap­proved for the ref­er­ence list­ed drug (RLD) and for which there are no block­ing patents or ex­clu­siv­i­ties on the RLD may re­ceive ex­pe­dit­ed re­view.”

The potas­si­um chlo­ride oral so­lu­tion prod­ucts ap­proved Wednes­day (potas­si­um chlo­ride oral so­lu­tion USP, 10% (20 mEq/15 mL) and 20% (40 mEq/15 mL)) are el­i­gi­ble for 180 days of CGT ex­clu­siv­i­ty and were ap­proved in the first cy­cle of re­view, FDA said.

FDA Com­mis­sion­er Scott Got­tlieb said in a state­ment: “The quick im­ple­men­ta­tion of this new path­way is part of our broad­er ef­fort to fos­ter gener­ic com­pe­ti­tion and help ad­dress the high cost of drugs.”

FDA in June 2017 al­so re­leased two lists of gener­ic drugs, each of which con­tain more than 100 ac­tive in­gre­di­ents, in­clud­ing one “for which FDA could im­me­di­ate­ly ac­cept an AN­DA with­out pri­or dis­cus­sion,” and the sec­ond for drugs “in­volv­ing po­ten­tial le­gal, reg­u­la­to­ry, or sci­en­tif­ic is­sues which should be ad­dressed with the Agency pri­or to sub­mis­sion of an AN­DA.”


First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email news@raps.org for more in­for­ma­tion. 

Fangliang Zhang, AP Images

Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Mer­ck wins a third FDA nod for an­tibi­ot­ic; Mereo tack­les TIG­IT with $70M raise in hand

Merck — one of the last big pharma bastions in the beleaguered field of antibiotic drug development — on Friday said the FDA had signed off on using its combination drug, Recarbrio, with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The drug could come handy for use in hospitalized patients who are afflicted with Covid-19, who carry a higher risk of contracting secondary bacterial infections. Once SARS-CoV-2, the virus behind Covid-19, infects the airways, it engages the immune system, giving other pathogens free rein to pillage and plunder as they please — the issue is particularly pertinent in patients on ventilators, which in any case are breeding grounds for infectious bacteria.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

RA Cap­i­tal, Hill­house join $310M rush to back Ever­est's climb to com­mer­cial heights in Chi­na

Money has never been an issue for Everest Medicines. With an essentially open tab from their founders at C-Bridge Capital, the biotech has gone two and a half years racking up drug after drug, bringing in top exec after top exec, and issuing clinical update after update.

But now other investors want in — and they’re betting big.

Everest is closing its Series C at $310 million. The first $50 million comes from the Jiashan National Economic and Technological Development Zone; the remaining C-2 tranche was led by Janchor Partners, with RA Capital Management and Hillhouse Capital as co-leaders. Decheng Capital, GT Fund, Janus Henderson Investors, Rock Springs Capital, Octagon Investments all joined.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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