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, /PRNewswire/ --  (NYSE: MNK), a global biopharmaceutical company, today announced that the of the (FDA) voted to recommend approval for its investigational agent terlipressin to treat adults with hepatorenal syndrome type 1 (HRS-1) (8 yes; 7 no). HRS-1 is an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis.1 Terlipressin is an investigational agent being evaluated for the treatment of HRS-1 in the , and its safety and effectiveness have not yet been established by the FDA.

"Mallinckrodt is pleased with the advisory committee's positive vote in favor of approval for terlipressin, supporting the potential clinical value terlipressin can bring to patients with HRS-1 in need of an approved therapy in the ," said , M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. "We acknowledge the clinical challenges associated with treating this complex disease in such a critically ill patient population. We are committed to working closely with the FDA as it continues to review our application."

HRS-1 requires a diagnosis of exclusion, and is often a challenge to diagnose in a timely manner.2 If left untreated, HRS-1 has a median survival time of approximately two weeks and greater than 80 percent mortality within three months.2,3 At present, there are no approved drug therapies for HRS-1 in the ,4 and it is estimated to affect between 30,000 and 40,000 Americans annually.5,6

"Terlipressin plus albumin is the recommended standard-of-care therapy for HRS-1 in many other countries, where terlipressin is approved," said , M.D., on behalf of the . "HRS-1 is one of the most severe complications of end stage liver disease and the favorable vote from the advisory committee is encouraging to patients in need of treatment."

While recommendations of the advisory committee are not binding, the FDA will consider the advice provided by the committee as part of the New Drug Application (NDA) review. The FDA assigned terlipressin a Prescription Drug User Fee Act (PDUFA) target date of September 12, 2020. The company announced the FDA accepted for review its NDA for terlipressin in , which was based, in part, on results from the Phase 3 CONFIRM trial. The CONFIRM trial was the largest-ever prospective study (n=300) conducted to assess the safety and efficacy of terlipressin in patients with HRS-1, for potential use in the and . Initial results were presented at The Liver Meeting® 2019, the annual meeting of the (AASLD).

About Terlipressin

Terlipressin is a potent vasopressin analogue selective for V1 receptors being investigated for the treatment of HRS-1 in the and Canada. It is an investigational product in these countries as the safety and efficacy have not been established with, nor has approval been granted by, regulatory authorities in either country. Terlipressin is approved for use outside the and Canada.

ABOUT MALLINCKRODT 

Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.

Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.

CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements with regard to terlipressin, including the regulatory review process and related timing, as well as its potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.

CONTACT

For Media Inquiries


201-396-8551
[email protected]

Investor Relations
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Vice President, Finance and Investor Relations Officer
314-654-3638
[email protected]

Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. © 2020 Mallinckrodt. US-2001138 07/20

References

1 National Organization for Rare Disorders. Hepatorenal Syndrome. Available at: https://rarediseases.org/rare-diseases/hepatorenal-syndrome/. Accessed .
2 Gines P, Sola E, Angeli P, et al. Hepatorenal syndrome. Nature Reviews. (2018) 4:23. 
Colle I and Laterre PF. Hepatorenal syndrome: the clinical impact of vasoactive therapy, Expert Review of Gastroenterology & Hepatology. (2018) 12:2, 173-188, DOI: 10.1080/17474124.2018.1417034. 
Boyer TD, Medicis JJ, Pappas SC, et al. A randomized, placebo-controlled, double-blind study to confirm the reversal of hepatorenal syndrome type 1 with terlipressin: the REVERSE trial design.  2012:4. https://www.dovepress.com/a-randomized-placebo-controlled-double-blind-study-to-confirm-the-reve-peer-reviewed-article-OAJCT. 
C Pant, B S Jani, M Desai, A Deshpande, , , R Gilroy, M Olyaee. Hepatorenal syndrome in hospitalized patients with chronic liver disease: results from the Nationwide Inpatient Sample 2002–2012. 2016; 64:33–38.
: Quick Facts. Available at: https://www.census.gov/quickfacts/fact/table/US/PST045218. Accessed .

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Mallinck­rodt be­comes the lat­est vic­tim of the FDA's pan­dem­ic-re­lat­ed de­lays as it push­es off ap­pli­ca­tion for skin graft

Kyle Blankenship

Managing Editor

With Covid-19 lock­ing down trav­el across the world, not even drug safe­ty reg­u­la­tors have been spared from cost­ly de­lays. For the FDA, whose in­spec­tion sched­ule keeps the trains on time for new mar­ket­ing ap­provals, those de­lays are con­tin­u­ing to prove cost­ly.

The FDA has pushed re­view of Mallinck­rodt’s al­lo­gene­ic skin graft for burns, dubbed Strat­a­Graft, af­ter the agency ad­mit­ted it wasn’t able to con­duct a plant in­spec­tion in the need­ed time­frame for a de­ci­sion, the drug­mak­er said last week.

Mallinck­rodt tied the de­lay to “Covid-19 trav­el re­stric­tions” and said it had no hang-ups about its graft’s chances at an ap­proval.

“We are con­fi­dent in the ef­fi­ca­cy and safe­ty of Strat­a­Graft for the treat­ment of deep par­tial-thick­ness burns based on our piv­otal Phase 3 clin­i­cal tri­al re­sults,” CSO Steven Ro­mano said in a re­lease. “We plan to work close­ly with the FDA to com­plete the re­view and sched­ule its site in­spec­tion.”

With the pan­dem­ic con­tin­u­ing to rage, the FDA has been forced to pri­or­i­tize planned in­spec­tions for new drug ap­pli­ca­tions. Of­ten, that sys­tem has fa­vored drug­mak­ers with new mol­e­cules with a high clin­i­cal need and shoved to the side low­er-im­por­tance prod­ucts, par­tic­u­lar­ly in aes­thet­ics.

In late No­vem­ber, the FDA de­layed its re­view of Re­vance’s frown-line in­jec­tion dax­i­bot­u­linum­tox­i­nA, say­ing it didn’t have enough time to look over its Newark, Cal­i­for­nia, man­u­fac­tur­ing fa­cil­i­ty on time. In Oc­to­ber, the agency pushed back Spec­trum’s neu­trope­nia can­di­date Rolon­tis af­ter of­fi­cials twice de­layed a plant in­spec­tion of South Ko­rea’s Han­mi, which holds the drug’s li­cense.

Mean­while, in­spec­tion de­lays have al­so nixed time­ly ap­provals for big­ger-name prod­ucts as well. The FDA re­peat­ed­ly de­layed a site in­spec­tion for Bris­tol My­ers Squibb’s liso-cel, even­tu­al­ly con­duct­ing a site vis­it at Lon­za Hous­ton’s con­tract site in De­cem­ber that re­sult­ed in a Form 483. That de­lay pushed liso-cel’s ap­proval past the Dec. 31 cut­off point tied to a $9 CVR in­vestors held from Bris­tol’s ac­qui­si­tion of Cel­gene.

Lon­za af­ter the fact said the FDA’s de­lays didn’t give ei­ther com­pa­ny enough time to ad­dress any par­tic­u­lar man­u­fac­tur­ing is­sues, which are quite com­mon for CAR-Ts on the whole. Liso-cel was even­tu­al­ly ap­proved ear­li­er this month and will be mar­ket­ed as Breyanzi.

SPONSORED

October 11, 2021 06:00 AM EDT

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

Brian Abrahams

Co-Head of Biotechnology Research

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

October 17, 2021 05:42 PM EDTUpdated 1 hour ago

R&D

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

John Carroll

Editor & Founder

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

Endpoints News

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October 16, 2021 06:00 AM EDT

Weekly

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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October 15, 2021 10:21 AM EDTUpdated 11:05 AM

R&D

No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

John Carroll

Editor & Founder

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

October 14, 2021 11:07 AM EDTUpdated 11:32 AM

Startups

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

October 14, 2021 10:55 AM EDTUpdated October 15, 03:10 PM

R&D

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

John Carroll

Editor & Founder

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

Kyle Blankenship

Managing Editor

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

FDA's vac­cine ad­comm unan­i­mous­ly sup­ports Mod­er­na's boost­er in same pop­u­la­tions as Pfiz­er's boost­er

Zachary Brennan

Senior Editor

The FDA’s vaccine advisory committee on Thursday voted 19-0 in support of expanding Moderna’s Covid-19 vaccine EUA for booster doses for certain high-risk individuals. FDA is expected to authorize the Moderna booster shortly.

Similarly to the Pfizer booster shot, Moderna’s will likely be authorized for those older than 65, adults at high risk of severe Covid-19, and adults whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of Covid-19. But unlike the Pfizer adcomm, where FDA had to scramble to get the committee to vote in favor of a booster, this committee was unanimous with the Moderna shot.

Rob Califf (AP Photo/Pablo Martinez Monsivais, File)

October 14, 2021 01:10 PM EDTUpdated October 15, 05:44 AM

People

FDA+

Biden like­ly to nom­i­nate Ver­i­ly's Rob Califf to lead the FDA again

Zachary Brennan

Senior Editor

Capping a controversially long period for the FDA to go without a permanent leader, President Joe Biden is likely to select Verily’s Rob Califf, a former FDA commissioner under President Obama, as the next FDA commissioner nominee.

A former Duke cardiologist and member of the prestigious National Academy of Medicine, Califf will be a welcome face for an agency grappling with high-profile retirements in CBER and CDER. He’ll also return to a role that he was comfortable in for a short stint at the end of Obama’s presidency. The Washington Post first reported the news.

Sours: https://endpts.com/mallinckrodt-becomes-the-latest-victim-of-the-fdas-pandemic-related-delays-as-it-pushes-off-application-for-skin-graft/
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News Release

, /PRNewswire/ --  (OTCMKTS: MNKKQ), a global biopharmaceutical company, today announced that the (FDA) has approved StrataGraft® (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen – dsat) for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns). Please see Important Safety Information for StrataGraft below.

Experience the interactive Multichannel News Release here:
https://www.multivu.com/players/English/8801751-mallinckrodt-stratagraft

This project was funded in part with from the (BARDA), part of the Secretary for Preparedness and Response at the (HHS), under contract HHSO100201500027 for , a Mallinckrodt company, to develop StrataGraft.

The FDA approval is supported by data from the pivotal Phase 3 STRATA2016 clinical trial of a single application of StrataGraft in patients with acute thermal burns containing intact dermal elements (deep partial-thickness burns) involving 3%-37% total body surface area, which was conducted at burn centers. Results, which were recently published in Burns, showed a significantly smaller area of burn wounds treated with StrataGraft required autografting by 3 months compared to the area of burn wounds treated exclusively with autograft (p<0.0001).

"While autografting is effective in providing closure of the original wound in patients with deep partial-thickness burns, it can lead to donor site complications, including pain, itching, increased risk of infection and scarring," said , M.D., burn surgeon and burn unit medical director at the Regional Burn Center at Baton Rouge General. "The approval of StrataGraft represents an important advancement in the treatment of patients with deep partial-thickness burns. Burn surgeons will now have a new biologic treatment to eliminate or reduce the need for autografting."

Each year, approximately 40,000 patients in require hospitalization for the treatment of severe burns.1 Autograft is the current standard of care for deep partial-thickness burns – complex skin injuries in which the damage extends through the entire epidermis (outermost layer of skin) and into the lower part of the dermis (innermost layer of skin). Autograft involves the surgical harvesting of healthy skin from an uninjured site on the patient and transplanting the skin graft to the injury, creating a donor site wound and leaving the patient with more wounded areas requiring care.

"Today's FDA approval of StrataGraft marks a significant milestone for the burn care community and underscores our unwavering commitment and ability to bring paradigm-changing treatment options to patients with severe and critical conditions," said , M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. "We are deeply appreciative of the patients who participated in the StrataGraft clinical trials, the physicians and study investigators involved in the clinical development program, and our employees, who have worked tirelessly over the last 20 years to help us bring StrataGraft to burn surgeons and the patients they treat."

In the pivotal Phase 3 clinical trial, 96% (68 of 71) of the StrataGraft-treated burn sites across all participants did not require autografting. The difference in the percent area of StrataGraft and control autograft treatment sites that required autografting by 3 months was 98% (p<0.0001). The proportion of patients achieving durable closure of the StrataGraft treatment site at 3 months without autograft placement was 83% (95% CI: 74, 92). The proportion of patients achieving durable closure of the autograft control treatment site at 3 months without additional autograft placement was 86% (95% CI: 78, 94).

"Multiple health security threats can result in severe burn wounds, and, to save lives in a public health emergency, healthcare providers need products that are effective and easy to use," said BARDA Director , Ph.D. "Having new products available on the commercial market to improve routine care for burn patients gives healthcare providers a level of familiarity and comfort in using the products. This improves our healthcare response during a national emergency and reduces the long-term cost of national preparedness."

Clinical trials demonstrated that the safety profile of StrataGraft with regard to wound-related events, including erythema, swelling, local warmth and wound site infections, was comparable to that of autografting in clinical studies. The most common (>2%) adverse reactions were pruritus (itching), blisters, hypertrophic scar and impaired healing. There were no reports of rejection to StrataGraft in the clinical studies, and no patients discontinued study participation due to adverse reactions.

About StrataGraft
StrataGraft is a viable, bioengineered, allogeneic, cellularized scaffold product derived from keratinocytes grown on gelled collagen containing dermal fibroblasts. StrataGraft is designed to deliver viable cells to support the body's own ability to heal. StrataGraft contains metabolically active cells that produce and secrete a variety of growth factors and cytokines. Growth factors and cytokines are known to be involved in wound repair and regeneration. The product is designed with both dermal and epidermal layers composed of well-characterized human cells. StrataGraft is intended to be applied in appropriate aseptic conditions, such as the operating room, and can be sutured, stapled or secured with a tissue adhesive.

The FDA granted StrataGraft orphan drug designation, and it was among the first products designated by the Agency as a Regenerative Medicine Advanced Therapy (RMAT) under the provisions of the 21st Century Cures Act. At the time of approval, the FDA awarded , a Mallinckrodt company, a Priority Review Voucher (PRV).

Mallinckrodt is currently conducting a StrataGraft continued access clinical trial (StrataCAT, NCT04123548) under an Expanded Access Program (EAP). The trial sites involved in the pivotal Phase 3 trial (STRATA2016, NCT03005106) have the opportunity to participate in this multicenter, open-label study. The company is planning to evaluate StrataGraft for the treatment of adults with full-thickness burns (also referred to as third-degree burns).

Additionally, Mallinckrodt plans to conduct a study evaluating StrataGraft in the treatment of pediatric populations. The safety and effectiveness of StrataGraft in pediatric patients (<18 years) have not been established.

BARDA expressed interest in StrataGraft as a medical countermeasure in response to large-scale burn incidents, and provided funding and technical support for the continued development of StrataGraft. These efforts are part of BARDA's strategy to build emergency preparedness in response to mass casualty events involving trauma and thermal burns by developing novel medical countermeasures for adult and at-risk populations. In the case of a mass casualty thermal burn event, the Government Accountability Office estimates that more than 10,000 patients might require thermal burn care.The limited number of specialized burn centers and related medical infrastructure in creates a public health need for therapies that could be deployed quickly for use in these and other care sites.

IMPORTANT SAFETY INFORMATION

INDICATION
StrataGraft® is an allogeneic cellularized scaffold product indicated for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns).

IMPORTANT SAFETY INFORMATION
Contraindications

  • Do not use in patients with known allergies to murine collagen or products containing ingredients of bovine or porcine origin.

Warnings and Precautions

  • StrataGraft contains glycerin. Avoid glycerin in patients with known sensitivity (irritant reaction) to glycerin.
  • Severe hypersensitivity reactions may occur. Monitor for both early and late symptoms and signs of hypersensitivity reaction following StrataGraft application, and treat according to standard medical practice.
  • StrataGraft contains cells from human donors and may transmit infectious diseases or infectious agents, eg, viruses, bacteria, or other pathogens, including the agent that causes transmissible spongiform encephalopathy (TSE, also known as Creutzfeldt-Jakob disease [CJD or variant CJD]).

    StrataGraft is a xenotransplantation product because of an historic exposure of the keratinocyte cells to well-characterized murine cells. The cell banks have been tested and found to be free of detectable adventitious agents, and mouse cells are not used in the manufacture of StrataGraft; however, these measures do not entirely eliminate the risk of transmitting infectious diseases and disease agents.

    Transmission of infectious diseases or agents by StrataGraft has not been reported.
  • Because StrataGraft is a xenotransplantation product, StrataGraft recipients should not donate whole blood, blood components, plasma, leukocytes, tissues, breast milk, ova, sperm, or other body parts for use in humans.

Adverse Reactions

  • The most common adverse reactions (incidence ≥2%) were itching (pruritus), blisters, hypertrophic scar, and impaired healing. Other adverse events reported are included in the full Prescribing Information.

Pediatric Use

  • The safety and effectiveness of StrataGraft in pediatric patients (<18 years) have not been established.

Please see full Prescribing Information.

About Mallinckrodt
Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.

Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.

Cautionary Statements Related to Forward-Looking Statements
This release includes forward-looking statements concerning StrataGraft, including anticipated launch timing, its potential impact on patients and anticipated benefits associated with its use, and future clinical trial plans. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the , all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.

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Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners.

©2021 Mallinckrodt. US-2001740 06/21

________________________
1. Burn Incidence Fact Sheet. http://ameriburn.org/who-we-are/media/burn-incidence-fact-sheet/. Accessed .
2 United States Government Accountability Office. National Preparedness: Countermeasures for Thermal Burns. https://www.gao.gov/assets/590/588738.pdf. Accessed .

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Mallinckrodt Pharmaceuticals - THERAKOS ECP Immunomodulation™

September 14, 2020 10:42 AM EDTUpdated 11:02 AM

FDA+

FDA shoots down Mallinck­rodt's re­demp­tion at­tempt, spurns rare kid­ney dis­ease drug for a sec­ond time

What­ev­er hope Mallinck­rodt had fol­low­ing a nar­row rec­om­men­da­tion by the FDA ad­vi­so­ry com­mit­tee to ap­prove ter­li­pressin has been dashed by a firm re­jec­tion.

The com­plete re­sponse let­ter stabbed right through the UK drug­mak­er’s case for the drug, as reg­u­la­tors are ask­ing for “more in­for­ma­tion to sup­port a pos­i­tive risk-ben­e­fit pro­file for ter­li­pressin” as a treat­ment of the rare kid­ney dis­ease known as he­pa­tore­nal syn­drome type 1, or HRS-1.

This is the sec­ond time reg­u­la­tors are spurn­ing the drug, which got a fast track des­ig­na­tion in 2005 on­ly to be re­ject­ed in 2009. Soon af­ter­wards its orig­i­nal de­vel­op­er, Or­phan Ther­a­peu­tics, out-li­censed North Amer­i­can rights to Ikaria Ther­a­peu­tics, which Mallinck­rodt ac­quired in 2015.

Dis­ap­point­ed, Mallinck­rodt CSO Steven Ro­mano said his team stands by the da­ta from the Phase III CON­FIRM study, “the largest clin­i­cal tri­al ever con­duct­ed in this rare con­di­tion” in­volv­ing 300 pa­tients.

“HRS-1 is a com­plex dis­ease that af­fects a crit­i­cal­ly ill pa­tient pop­u­la­tion with no ap­proved treat­ment in the U.S. at present,” he added in a state­ment. “We are sur­prised by and dis­agree with the FDA’s de­ci­sion and re­main com­mit­ted to pur­su­ing all avail­able op­tions as we con­tin­ue work­ing with the FDA to­ward ap­proval of ter­li­pressin in or­der to help ad­dress this dif­fi­cult and life-threat­en­ing syn­drome.”

Just a year ago, Cowen an­a­lysts hailed the pos­i­tive da­ta as a “key suc­cess” for em­bat­tled Mallinck­rodt, which was fac­ing a litany of fail­ures for its ac­quired pipeline while un­der a cloud of opi­oid lit­i­ga­tion and law­suits tar­get­ing “ill-got­ten gains” from Ac­thar, its cash cow.

To­day the CRL counts as “yet an­oth­er set­back” in SVB Leerink an­a­lyst Ami Fa­dia’s eyes.

“We note that de­spite the over­all pos­i­tive vote, in our view the tone of the Ad­Com dis­cus­sion was de­cid­ed­ly cau­tious, strug­gling to bal­ance the high-un­met need with no cur­rent­ly avail­able treat­ment op­tions with con­cerns about lack of clin­i­cal ben­e­fit and an un­cer­tain risk mit­i­ga­tion plan,” she wrote.

On the ef­fi­ca­cy front, the FDA’s (and some of the out­side ex­perts’) chief con­cern was that the pri­ma­ry end­point — which ter­li­pressin met — was a sur­ro­gate end­point that mea­sures cre­a­ti­nine lev­els in blood. But it was un­clear whether that led to clin­i­cal im­prove­ments for HRS-1 pa­tients, who were char­ac­ter­ized by cir­rho­sis and could de­vel­op life-threat­en­ing kid­ney fail­ure with­in days.

More im­por­tant­ly, more pa­tients died in the drug arm than in the place­bo arm. And the FDA wasn’t sat­is­fied with the risk mit­i­ga­tion strat­e­gy that Mallinck­rodt of­fered. There was, how­ev­er, “no clear out­line on what would be con­sid­ered suf­fi­cient for ap­proval,” Fa­dia point­ed out.

Af­ter much de­lib­er­a­tion in Ju­ly, the Car­dio­vas­cu­lar and Re­nal Drugs Ad­vi­so­ry Com­mit­tee vot­ed 8-7 for ap­proval. Paul Rid­ker, a car­di­ol­o­gist at Brigham and Women’s Hos­pi­tal and one of the pan­elists, said he vot­ed yes but al­so wrote in “but bare­ly.”

Ap­proved in Eu­rope un­der the brand name Gly­pressin, ter­li­pressin now faces an un­cer­tain fu­ture in the US.

Mallinck­rodt, which has hint­ed at a po­ten­tial bank­rupt­cy fil­ing, didn’t spec­i­fy what the next steps will be. In­vestors sent the stock $MNK down 11.62%, edg­ing close to pen­ny-stock ter­ri­to­ry at $1.06.

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October 11, 2021 06:00 AM EDT

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

Brian Abrahams

Co-Head of Biotechnology Research

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

October 17, 2021 05:42 PM EDTUpdated 1 hour ago

R&D

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

John Carroll

Editor & Founder

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

Endpoints News

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October 16, 2021 06:00 AM EDT

Weekly

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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October 15, 2021 10:21 AM EDTUpdated 11:05 AM

R&D

No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

John Carroll

Editor & Founder

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

October 14, 2021 11:07 AM EDTUpdated 11:32 AM

Startups

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

October 14, 2021 10:55 AM EDTUpdated October 15, 03:10 PM

R&D

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

John Carroll

Editor & Founder

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

Kyle Blankenship

Managing Editor

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

FDA's vac­cine ad­comm unan­i­mous­ly sup­ports Mod­er­na's boost­er in same pop­u­la­tions as Pfiz­er's boost­er

Zachary Brennan

Senior Editor

The FDA’s vaccine advisory committee on Thursday voted 19-0 in support of expanding Moderna’s Covid-19 vaccine EUA for booster doses for certain high-risk individuals. FDA is expected to authorize the Moderna booster shortly.

Similarly to the Pfizer booster shot, Moderna’s will likely be authorized for those older than 65, adults at high risk of severe Covid-19, and adults whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of Covid-19. But unlike the Pfizer adcomm, where FDA had to scramble to get the committee to vote in favor of a booster, this committee was unanimous with the Moderna shot.

Rob Califf (AP Photo/Pablo Martinez Monsivais, File)

October 14, 2021 01:10 PM EDTUpdated October 15, 05:44 AM

People

FDA+

Biden like­ly to nom­i­nate Ver­i­ly's Rob Califf to lead the FDA again

Zachary Brennan

Senior Editor

Capping a controversially long period for the FDA to go without a permanent leader, President Joe Biden is likely to select Verily’s Rob Califf, a former FDA commissioner under President Obama, as the next FDA commissioner nominee.

A former Duke cardiologist and member of the prestigious National Academy of Medicine, Califf will be a welcome face for an agency grappling with high-profile retirements in CBER and CDER. He’ll also return to a role that he was comfortable in for a short stint at the end of Obama’s presidency. The Washington Post first reported the news.

Sours: https://endpts.com/fda-shoots-down-mallinckrodts-redemption-attempt-spurns-rare-kidney-disease-drug-for-a-second-time/

Fda mallinckrodt

UPDATE [10-17-2016 and 11-4-16] FDA proposes to withdraw approval of two generic versions of Concerta (methylphenidate hydrochloride)  

The FDA is proposing to withdraw approval of two generic versions of Concerta (methylphenidate hydrochloride) extended-release (ER) capsules, used to treat attention-deficit hyperactivity disorder.  Mallinckrodt Pharmaceuticals and UCB/Kremers Urban (formerly Kudco) the companies that make the generic products, have failed to demonstrate that their products provide the same therapeutic effect as (are bioequivalent to) the brand-name drug they reference. 

This action is related to steps the FDA took in November 2014.  At that time, the FDA announced that, based on an analysis of data, it had concerns that the Mallinckrodt and Kudco (now UCB/Kremers Urban) products may not produce the same therapeutic effects as Concerta.  At that time, the FDA requested that Mallinckrodt and Kudco either (1) voluntarily withdraw their products from the market and request that FDA withdraw approval of their product’s Abbreviated New Drug Applications (ANDAs) or (2) within six months, provide data to confirm that their products are bioequivalent to Concerta consistent with the revised draft guidance for industry for bioequivalence testing for these products.

At that time, the FDA changed the Orange Book therapeutic equivalence code for these two products  from AB (indicating therapeutic equivalence) to BX (data are insufficient to determine therapeutic equivalence).

Neither Mallinckrodt nor UCB/Kremers Urban has voluntarily withdrawn its product from the market, and neither has provided data confirming its product’s bioequivalence consistent with the revised recommendations.  Accordingly, the FDA is proposing to withdraw approval of the products’ ANDAs and is announcing an opportunity for the firms to request a hearing on the proposal.  As part of this process, the FDA is publishing Notices of Opportunity for Hearing (NOOHs) on its Proposals to Withdraw Marketing Approval in the Federal Register. If approval of these ANDAs is withdrawn by the FDA, the products will no longer be able to be marketed in the U.S.

Each NOOH explains that the firm may request a hearing to show why approval of their ANDA should not be withdrawn and has the opportunity to raise, for administrative determination, all issues relating to the legal status of the drug products covered by these applications. Each firm must respond in writing, within 30 days, to request a hearing. If the firm fails to do so, the opportunity for a hearing will be waived.

During the course of this process, the FDA will update the related Mallinckrodt and UCB/Kremers Urban dockets as new information becomes available.

The Mallinckrodt UCB/Kremers Urban products are still approved and can be prescribed, but they are not recommended as automatically substitutable for Concerta.  Janssen manufactures an authorized generic of Concerta, which is marketed by Actavis under a licensing agreement. The Actavis product is not impacted by this announcement. In addition, on October 21, 2016, the FDA approved a generic for Concerta marketed by Mylan Pharmaceuticals.

If you or your health care professional are concerned that a methylphenidate hydrochloride ER product you are taking is not providing the desired effect, and you do not know the manufacturer, contact the pharmacy where the prescription was filled to verify the product’s manufacturer. If you, or those under your care, are taking the Mallinckrodt or Kudco products and have concerns about lack of desired effect during the dosing period, contact the prescribing health care provider to discuss whether a different drug product would be more appropriate.


[11-13-2014] FDA concerns about therapeutic equivalence with two generic versions of Concerta tablets (methylphenidate hydrochloride extended-release)

Based on an analysis of data, FDA has concerns about whether or not two approved generic versions of Concerta tablets (methylphenidate hydrochloride extended-release tablets), used to treat attention-deficit hyperactivity disorder in adults and children, are therapeutically equivalent to the brand-name drug. The two approved generic versions of Concerta are manufactured by Mallinckrodt Pharmaceuticals and Kudco Ireland Ltd. 

FDA has not identified any serious safety concerns with these two generic products.  Patients should not make changes to their treatment except in consultation with their health care professional.

If you or your health care professional are concerned the drug product is not providing the desired effect and you do not know the manufacturer, contact the pharmacy where the prescription was filled to verify the product’s manufacturer.  If you, or those under your care, are taking the Mallinckrodt or Kudco products and have concerns about lack of desired effect during the dosing period, contact the prescribing health care provider to discuss whether or not a different drug product would be more appropriate.

FDA’s Scientific Evaluation of Generic Concerta Products

An analysis of adverse event reports, an internal FDA re-examination of previously submitted data, and FDA laboratory tests of products manufactured by Mallinckrodt and Kudco have raised concerns that the products may not produce the same therapeutic benefits for some patients as the brand-name product, Concerta, manufactured by Janssen Pharmaceuticals, Inc.  Janssen also manufactures an authorized Concerta generic, which is marketed by Actavis under a licensing agreement and is identical to Janssen’s Concerta.  FDA included the authorized generic in its analysis and found it to be bioequivalent to, and substitutable for, Concerta.  Apart from the Mallinckrodt, Kudco, and Actavis products, there are no other generics for Concerta.

Methylphenidate hydrochloride extended-release products approved as generics for Concerta are intended to release the drug in the body over a period of 10 to 12 hours. This should allow for a single-dose product that is consistent with the effect of a three times per day dose of immediate-release methylphenidate hydrochloride.

In some individuals, the Mallinckrodt and Kudco products may deliver drug in the body at a slower rate during the 7- to 12-hour range. The diminished release rate may result in patients not having the desired effect.

As a result, the FDA has changed the therapeutic equivalence (TE) rating for the Mallinckrodt and Kudco products from AB to BX. This means the Mallinckrodt and Kudco products are still approved and can be prescribed, but are no longer recommended as automatically substitutable at the pharmacy (or by a pharmacist) for Concerta. 

Consequently, FDA has revised its draft guidance for industry for bioequivalence testing for methylphenidate hydrochloride extended-release tablets (Concerta). FDA has asked that within six months, Mallinckrodt and Kudco confirm the bioequivalence of their products using the revised bioequivalence standards, or voluntarily withdraw their products from the market.

FDA will continue to evaluate its testing and approval standards and bioequivalence guidances for other generic methylphenidate hydrochloride extended-release products and revise as needed.

Related Information

  • Content current as of:

Sours: https://www.fda.gov/drugs/drug-safety-and-availability/methylphenidate-hydrochloride-extended-release-tablets-generic-concerta-made-mallinckrodt-and-kudco
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