Attorney General Merrick Garland (Nicholas Kamm, Pool via AP)

Ex­clu­sive: Bi­par­ti­san let­ter to Mer­rick Gar­land warns of opi­oid over­dose drug short­ages

De­mo­c­rat Mar­cy Kap­tur of Ohio joined with Re­pub­li­can Andy Har­ris of Mary­land in pen­ning a new let­ter to At­tor­ney Gen­er­al Mer­rick Gar­land rais­ing fresh con­cerns about the most re­cent opi­oid set­tle­ments that re­quire Te­va Phar­ma­ceu­ti­cals to pro­vide more than $200 mil­lion worth of nalox­one sup­plies to just three states over 10 years, and which might cre­ate short­ages else­where.

Mar­cy Kap­tur

The let­ter, first ob­tained by End­points News, ques­tions what Gar­land’s plans are mov­ing for­ward, es­pe­cial­ly con­sid­er­ing Con­gress pre­vi­ous­ly raised warn­ings in Au­gust 2020 that man­u­fac­tur­ers sup­ply­ing MAT drugs to states at no cost in lieu of pay­ing out their set­tle­ments could cre­ate bot­tle­necks in sup­plies.

“At that time, con­cerns cen­tered on the im­pact of glob­al opi­oid set­tle­ment and FDA re­spond­ed that this would be bet­ter posed to the De­part­ment of Jus­tice (DOJ). These same con­cerns have es­ca­lat­ed in light of re­cent an­nounce­ments that mul­ti­ple states — Flori­da, Rhode Is­land and Texas — are al­low­ing the drug man­u­fac­tur­er to not on­ly pro­vide MAT treat­ment drugs but al­so opi­oid re­ver­sal agents, like nalox­one,” Kap­tur and Har­ris wrote.

Most re­cent­ly, Te­va agreed to pay part of its set­tle­ment with the state of Flori­da by pro­vid­ing gener­ic Nar­can (nalox­one hy­drochlo­ride nasal spray) val­ued at $84 mil­lion (whole­sale ac­qui­si­tion cost) over 10 years. Rhode Is­land’s AG sim­i­lar­ly agreed to a deal where Te­va will sup­ply 50,000 kits of Nalox­one (100,000 nasal sprays) per year for 10 years, val­ued at $62.5 mil­lion, as well as opi­oid treat­ment Sub­ox­one val­ued at $16 mil­lion over 10 years.  And in Texas, the state will get $75 mil­lion worth of Nar­can from Te­va over 10 years.

Andy Har­ris

“The un­in­tend­ed con­se­quences that could re­sult from these mis­guid­ed set­tle­ments are even more con­cern­ing,” the rep­re­sen­ta­tives wrote. “Al­low­ing one com­pa­ny to pro­vide free drugs to en­tire pa­tient pop­u­la­tions is tak­ing a vi­tal­ly im­por­tant choice away from physi­cians and pa­tients. These set­tle­ments span 10 or 15 years, de­pend­ing on the agree­ment, fun­da­men­tal­ly al­ter­ing the mar­ket and sti­fling in­no­va­tion in that space.”

And Kap­tur and Har­ris are ask­ing whether the DOJ has the au­thor­i­ty it needs to as­sess the im­pact that these set­tle­ments will have on the MAT and nalox­one mar­kets.

Mean­while, the FDA may need more con­gres­sion­al au­thor­i­ty to en­sure that opi­oids com­ing to mar­ket are bet­ter than what’s cur­rent­ly avail­able, com­mis­sion­er Rob Califf said at a hear­ing last week.

Sen. Mike Braun (R-IN) agreed that the FDA could use this ad­di­tion­al au­thor­i­ty to rein in opi­oid ap­provals as the cri­sis led to more than 100,000 over­dose deaths in 2021, ac­cord­ing to the CDC.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Yuling Li, Innoforce CEO

In­no­force opens new man­u­fac­tur­ing site in Chi­na

Innoforce is off to the races at its new site in the city of Hangzhou, China.

The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ.

The company said it’s investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces.

FDA grants or­phan drug des­ig­na­tion to Al­ger­non's ifen­prodil, while ex­clu­siv­i­ty re­mains un­clear

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.

‘Catchy’ de­sign tops big ad buys on­line for grab­bing on­col­o­gists’ at­ten­tion — sur­vey

The cancer drug ads that get oncologists’ attention online are informative and use clear, eye-catching designs. That’s ZoomRx’s assessment in its most recent tracking survey, and while not necessarily surprising, the details in the research do break a few common misconceptions.

One of those is frequency, also known as the number of impressions an ad gets. No matter how many times oncologists saw a particular cancer drug ad, effectiveness prevailed in the survey across five drug brands. ZoomRx measured effectiveness as a combination of most attention-getting, relevant information and improved perception as reported by the doctors.

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Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Tim Walbert, Horizon Therapeutics CEO (via YouTube)

And then there were two: Janssen bows out of Hori­zon takeover ne­go­ti­a­tions

Horizon Therapeutics announced last week that it was in talks with three pharmaceutical giants that could take over the company. You can now remove one of them from the equation.

J&J’s Janssen, after Horizon reported its initial involvement in early discussions to acquire the rare disease biotech, issued a statement Saturday that said Janssen “does not intend to make an offer for Horizon,” and that Janssen is bound by restrictions set in Rule 2.8 of the Irish Takeover Rules. These rules are in place for any company interested in taking over Irish companies, with Horizon Therapeutics currently based in Dublin.

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Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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