Days after buyout news, Vifor outlines plan to offload ‘non-core’ finished drug manufacturing wing

Aus­tralian firm CSL paid a steep price ear­li­er this week for Vi­for Phar­ma and its pipeline of iron and kid­ney drugs. Look­ing to en­sure it starts its next phase as bat­tle-ready as pos­si­ble, Vi­for will now dump its ‘non-core’ man­u­fac­tur­ing busi­ness as it slims down be­fore the merge.

Vi­for Phar­ma will of­fload its fin­ished drug man­u­fac­tur­ing wing to Swiss CD­MO Cor­den­Phar­ma in a deal de­signed to stream­line the biotech’s busi­ness as it awaits reg­u­la­to­ry ap­proval for a $11.7 bil­lion buy­out by CSL an­nounced ear­li­er this week.

The di­ves­ture will see Cor­den­Phar­ma as­sume con­trol of Vi­for man­u­fac­tur­ing op­er­a­tions in Fri­bourg and Et­tin­gen, Switzer­land, and Lis­bon, Por­tu­gal, and con­tin­ue man­u­fac­tur­ing drugs cur­rent­ly pro­duced on site. Mean­while, Vi­for will hold on to its pro­duc­tion fa­cil­i­ty in St. Gallen, Switzer­land, where it will fo­cus on pro­duc­ing the API nec­es­sary to make its iron ther­a­pies, the com­pa­ny said.

Vi­for will hold on to the com­mer­cial teams as­so­ci­at­ed with those three sites, the com­pa­ny said.

‘In sup­port of our am­bi­tious growth strat­e­gy, op­ti­miz­ing our man­u­fac­tur­ing foot­print will en­able us to build an even stronger, more ef­fi­cient or­ga­ni­za­tion fo­cus­ing on core ca­pa­bil­i­ties in nephrol­o­gy, and to max­i­mize and lever­age our mar­ket-lead­ing ex­per­tise and in­tel­lec­tu­al prop­er­ty in iron de­fi­cien­cy,’ Vi­for CEO Ab­bas Hus­sain said in a state­ment.

Ear­li­er this week, CSL un­veiled plans to ac­quire Vi­for for $11.7 bil­lion — a steep pre­mi­um for an emerg­ing drug­mak­er with a re­cent his­to­ry of set­backs but one the Aus­tralian firm saw as a mean­ing­ful ad­di­tion to its broad­en­ing port­fo­lio. On top of its iron ther­a­pies, Vi­for has a li­cense-heavy pipeline of drugs in the works, in­clud­ing part­nered kid­ney drug ANG-3777, which has failed mul­ti­ple mid-stage tests.

Talks be­tween CSL and Vi­for re­port­ed­ly be­gan in March, but ru­mors ger­mi­nat­ed ear­li­er this month when Aus­tralian out­lets such as The Aus­tralian and the Aus­tralian Fi­nan­cial Re­view re­port­ed CSL and Vi­for were in ne­go­ti­a­tions for a po­ten­tial deal.

Sensor-based technology for clinical trial data collection represents the latest medical paradigm shift. There are more than 700 clinical studies involving wearable devices currently underway in the United States. A study from Intel IT projects their inclusion in clinical trials will surge to 70% by 2025.

Apps, biosensors and patient-centered technologies increase visibility of comprehensive patient data. Pharma leaders anticipate the benefits of wearables to include better data (58%), faster results (33%) and lower trial costs (10%).

Richard Pazdur (via AACR)

There’s no denying that Merck’s Keytruda set a high bar for checkpoint inhibitors in development everywhere. But when it comes to the often redundant development of PD(L)-1 antibodies worldwide, FDA’s top cancer doctors Rick Pazdur and Julia Beaver are calling for more industry coordination.

‘Efforts to corral this enthusiasm should focus on increased international partnerships between sponsors of approved checkpoint inhibitors and those developing novel agents to be used with anti–PD-1 and anti–PD-L1 antibodies rather than developing ‘me too’ drugs,’ Beaver and Pazdur wrote Wednesday in the New England Journal of Medicine.

Unlock this story instantly and join 125,800+ biopharma pros reading Endpoints daily — and it’s free.

Novo Nordisk scored a pair of double wins the last couple years with the approval of two different forms of semaglutide, the company’s newest blockbuster product line. Now, Novo is setting aside a serious pile of cash to take its manufacturing ops into the future as the company looks to level up.

Novo will invest roughly $2.58 billion (DKK 17 billion) to greatly expand its manufacturing footprint at its central hub in Kalundborg, Denmark, with three new facilities and the expansion of a fourth on the way, the company said this week.

Unlock this story instantly and join 125,800+ biopharma pros reading Endpoints daily — and it’s free.

Pfizer CEO Albert Bourla (Evan Vucci, AP Images)

The Covid-19 pandemic has been an extremely profitable time for Pfizer, and the massive drugmaker is using that leverage to advance its portfolio writ large. Now, Pfizer’s emerging gene therapy biz will have some new elbow room as it continues to grow in the coming years.

Pfizer this week opened a $68.5 million gene therapy manufacturing facility in Durham, North Carolina, as part of a multi-year, $800 million plan to outfit its next-gen therapeutics business, the company said Wednesday.

Unlock this story instantly and join 125,800+ biopharma pros reading Endpoints daily — and it’s free.

Crowd gathering at the Westin St. Francis for JPM in 2019 (Endpoints News)

Well, see you in January 2023.

In a surprise about-face, #JPM22 will now be fully virtual after organizers of the popular biotech conference decided to pull the plug on a live event in San Francisco given fears over the Omicron variant and a growing chorus of drugmakers opting out.

The move is no big surprise after reports swirled about some of the industry’s biggest players nixing plans to attend live and pressuring the bank to reconsider the annual meet at the Westin St. Francis. STAT reported Tuesday that Moderna and Amgen, among other large drugmakers, had already pulled out.

Eli Lilly, Gilead, Thermo Fisher and other industry groups and nonprofits like BIO and USP are seeking some slight changes and more clarity from the International Council of Harmonisation on its new guidance related to continuous manufacturing.

The guidance, known as Q13, focuses on continuous manufacturing and its potential to lower manufacturing costs and reduce the physical footprint of manufacturing facilities compared to traditional batch manufacturing, according to USP. Continuous manufacturing also may improve quality control, lower the variability in manufactured products, and provide enhanced flexibility in production quantity and utilization of manufacturing lines.

The FDA on Wednesday not only approved the first generic versions of the decades-old diabetes insipidus treatment vasopressin, but also simultaneously offered a particularly damning rebuke of a citizen petition attempting to block the generic, while promising to pass along the matter to the Federal Trade Commission.

The response could prove troublesome for the sponsor of the brand name version of the drug, Endo’s Par Sterile Products, which brought in more than $780 million in 2020 for its brand name version of the drug Vasostrict.

Hilleman Laboratories is opening a vaccine and biologics development hub in Singapore to aid the company’s journey to develop affordable vaccines against infectious diseases.

A 30,000-square-foot site will go up at 138 Depot Road in Biopolis at a brand new R&D center at the Biopolis industrial park. The project will cost around $58 million with a two-year buildout expected.

The manufacturing site will supply clinical trial materials for up to Phase II development, and the R&D facility will be working on candidate selection, design, the manufacturing process development, and preclinical studies. The two locations will work together to provide concept-to-Phase II services.

For the first time, Biogen released details Thursday on how it intends to prove that its by turns celebrated and maligned drug Aduhelm can actually slow the decline of patients with Alzheimer’s, as required by the FDA.

The biotech said it will launch a global 1,300-person trial next May that will randomize early-stage Alzheimer’s patients to receive either Aduhelm or placebo. It will probably take about four years for the trial to generate results, the company said, pushing a final answer to 2026.

Unlock this story instantly and join 125,800+ biopharma pros reading Endpoints daily — and it’s free.
https://endpts.com/days-after-buyout-news-vifor-outlines-plan-to-offload-non-core-finished-drug-manufacturing-wing/