A decades-old glau­co­ma drug tossed aside by Pfiz­er gets a new life at a small biotech

Months ago, Pfiz­er made a grim an­nounce­ment that it would stop man­u­fac­tur­ing phos­pho­line io­dide, its decades-old “mir­a­cle drug” for a rare form of glau­co­ma. The phar­ma said its in­ven­to­ry would run dry by May 2021, leav­ing some pa­tients with few op­tions short of surgery.

But af­ter snag­ging the rights and the rest of Pfiz­er’s sup­ply, a small New York biotech is look­ing to give phos­pho­line io­dide new life.

Pfiz­er is hand­ing over the drug’s NDA and trade­mark to Fera Phar­ma­ceu­ti­cals, a Lo­cust Val­ley, New York-based com­pa­ny run by for­mer San­doz US CEO Frank Del­laFera, the phar­ma said in a state­ment on Mon­day.

While Fera de­clined a re­quest for com­ment, Del­laFera shared this gen­er­al state­ment re­gard­ing the com­pa­ny’s vi­sion on its web­site: “Our goal is sim­ple — to keep more qual­i­ty health­care choic­es alive for the peo­ple who need them.”

Phos­pho­line io­dide was ap­proved back in 1960, and un­til re­cent­ly was man­u­fac­tured by Pfiz­er to treat apha­kic glau­co­ma, a rare con­di­tion that can oc­cur af­ter cataract surgery. The dis­ease is as­so­ci­at­ed with poor con­trol of in­traoc­u­lar pres­sure, and fail­ure to low­er that pres­sure can re­sult in blind­ness. With­out med­ica­tion to do so, some pa­tients must re­sort to surgery.

“For the few pa­tients I have on it, noth­ing but surgery could re­place it,” one cataract and glau­co­ma sur­geon post­ed on Twit­ter back in May.

Pfiz­er cit­ed sup­ply chain is­sues and a de­cline in pa­tient use as the rea­son why it de­cid­ed to stop mak­ing phos­pho­line io­dide. The com­plex sup­ply chain has be­come in­creas­ing­ly un­sta­ble over the years, the com­pa­ny said, adding that about 100 pa­tients use the drug cur­rent­ly in the US.

Last month, the FDA agreed to ex­tend the drug’s ap­proved shelf life from 24 to 36 months, adding an ad­di­tion­al year to the la­bel to ad­dress short-term short­ages. And ac­cord­ing to Pfiz­er, Fera has “the ca­pa­bil­i­ties, ex­pe­ri­ence, and mo­ti­va­tion to bring P.I. to pa­tients on a sus­tain­able and ex­pe­dit­ed ba­sis.”

Both Pfiz­er and Fera de­clined to com­ment on the fi­nan­cial terms of the deal. Some wor­ry the new own­er­ship could lead to price hikes for the drug, which cur­rent­ly costs around $100 per 5ml, ac­cord­ing to drugs.com.

Pfiz­er says it will pro­vide con­sul­ta­tion ser­vices to Fera, though it’s un­clear what the com­pa­ny’s plans are go­ing forth — or if it will be able to avoid the same man­u­fac­tur­ing is­sues that haunt­ed Pfiz­er.

So­cial cred­it: AP Im­ages

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.

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.

Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

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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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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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Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

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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.