April 1, 2020 10:53 AM EDTUpdated 01:01 PM
News Briefing

Flex­ion se­cures Chi­na deal for os­teoarthri­tis drug; Strug­gling to find a buy­er, Ako­rn throws in the tow­el

Amber Tong

Senior Editor

→ Flex­ion may be hit­ting the brakes on clin­i­cal tri­als, in­clud­ing one for its os­teoarthri­tis drug Zil­ret­ta, but that’s not stop­ping the biotech from plot­ting reg­u­la­to­ry ac­tion in Chi­na. Hong Kong Tain­uo has com­mit­ted $10 mil­lion up­front to seize the de­vel­op­ment and com­mer­cial­iza­tion rights to Zil­ret­ta, with plans to ap­ply for a clin­i­cal tri­al in Chi­na by the end of the year. Flex­ion, which said it has 10 months of fin­ished goods in the US and 12 months of ac­tive phar­ma­ceu­ti­cal in­gre­di­ent avail­able, will sup­ply all prod­ucts to the Chi­nese part­ner.

→ Strug­gling spe­cial­ty gener­ic mak­er Ako­rn has giv­en up on find­ing a buy­er, end­ing a sale process that it said was neg­a­tive­ly im­pact­ed by the broad­er mar­ket un­cer­tain­ties un­der the Covid-19 cri­sis. There are no bids on the ta­ble that would suf­fi­cient­ly pay off all its loans, the com­pa­ny said.

AUTHOR

Amber Tong

Senior Editor

amber@endpointsnews.com @AmberTongPW
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December 5, 2022 06:00 AM EST

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

Allucent

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.

December 1, 2022 03:46 PM ESTUpdated 04:58 PM
FDA+

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

Zachary Brennan

Senior Editor

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.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)
December 5, 2022 03:04 PM EST
Pharma
Manufacturing

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

Tyler Patchen

News Reporter

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)
December 5, 2022 01:46 PM ESTUpdated 02:21 PM
Pharma
FDA+

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

Nicole DeFeudis

Editor

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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Rick Modi, Affinia Therapeutics CEO
December 5, 2022 08:26 AM ESTUpdated 08:58 AM
Financing
Startups
Cell/Gene Tx

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Kyle LaHucik

Associate Editor

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.

Endpoints News

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December 5, 2022 07:35 AM ESTUpdated 07:47 AM
Deals

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

Amber Tong

Senior Editor

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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December 3, 2022 06:00 AM ESTUpdated 15 hours ago
Weekly

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

Amber Tong

Senior Editor

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.

You may start to notice more stories exclusively available to Premium subscribers. This week alone, paid subscribers can read our in-depth reporting on Alzheimer’s data, digital therapeutics and Allogene’s cell therapy for solid tumors, as well as scoops on Twitter ads and Catalent. With your support, we can keep growing our team and spend more time on quality work. We have both individual and company plans available — check them out to unlock the full Endpoints experience.

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Yuling Li, Innoforce CEO
December 5, 2022 03:38 PM EST
Pharma
Manufacturing

In­no­force opens new man­u­fac­tur­ing site in Chi­na

Tyler Patchen

News Reporter

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.

December 5, 2022 03:08 PM EST
Pharma
FDA+

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

Nicole DeFeudis

Editor

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.

Flex­ion se­cures Chi­na deal for os­teoarthri­tis drug; Strug­gling to find a buy­er, Ako­rn throws in the tow­el

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

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

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

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

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

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

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

In­no­force opens new man­u­fac­tur­ing site in Chi­na

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