This study aims to evaluate if a 6-month course of pancrelipase (CREON) treatment improves symptoms of exocrine pancreatic insufficiency (EPI) after an attack of acute pancreatitis. Diagnosis of EPI is measured by a fecal elastase value of <200, and patients must have a qualifying symptom burden based on the EPI symptom tracker survey. Blood and stool will be analyzed as part of this study, and other surveys of health status will be used to track improvement of symptoms.

Start Date01 Feb 2024

Sponsor / Collaborator

The Ohio State University

[+5]

NCT01682421 / WithdrawnNot ApplicableIIT

Investigation of Treatment With Topical Corticosteroid After Posterior Lamellar Corneal Transplantation

After corneal transplantation, topical corticosteroids are used to reduce the risk of rejection.
However, the optimal postoperative treatment regimen is unknown. In most cases, a topical steroid is administered for at least 6 months after surgery, but it remains to be determined whether potent steroids offer better protection than weak steroids. Also, the length of the treatment is debated.
Since the use of steroids is not without potential serious ocular side effects, it is of considerable importance to investigate these problems.
The study aims to examine the frequency of rejection episodes after posterior lamellar keratoplasty; specifically comparing a short course of potent steroids versus a long course of weak steroids.

Start Date01 Sep 2012

Sponsor / Collaborator

Århus Universitetshospital

NCT01652157 / TerminatedNot Applicable

A Long-Term Prospective Observational Safety Study of the Incidence of and Risk Factors for Fibrosing Colonopathy in US Patients With Cystic Fibrosis Treated With Pancreatic Enzyme Replacement Therapy: A Harmonized Protocol Across Sponsors(The CF-FC Study)

This is a long-term study in cystic fibrosis patients who are participating in the Cystic Fibrosis Patient Registry to assess the occurrence and risk factors for a rare bowel disorder called fibrosing colonopathy (narrowing of the large intestine). Patients will be followed at their regular clinical care visits over a 10-year period and approached if they develop symptoms of fibrosing colonopathy for collection and use of further detailed information.

Start Date31 Jul 2012

Sponsor / Collaborator

AbbVie, Inc.

[+4]

100 Clinical Results associated with Pancrelipase(Eurand)

100 Translational Medicine associated with Pancrelipase(Eurand)

100 Patents (Medical) associated with Pancrelipase(Eurand)

115

Literatures (Medical) associated with Pancrelipase(Eurand)

01 Apr 2023·Journal of pharmacy practice

Efficacy of a Viokace Pancreatic Enzyme Protocol for Clearing Occluded Enteral Feeding Tubes: A Quality Assurance Evaluation

Article

Author: Kurish, Heena P. ; Stumpf, Janice L. ; Bruck, Cheryl L. ; Gabriel, Jacenta M.

Background: A previous retrospective study documented restored patency to 48.2% of occluded enteral feeding tubes using alkalinized Creon pancreatic enzyme capsules. In light of the low efficacy rate, the institutional enteral feeding tube clearance protocol was subsequently revised to incorporate a newly marketed non–enteric-coated Viokace pancreatic enzyme tablet, despite the lack of published data for this indication. Objective: This study aims to evaluate the effectiveness of a Viokace-based alkalinized pancreatic enzyme protocol to clear occluded enteral feeding tubes in a university health system. Methods: This retrospective, cohort quality assurance study included adult and pediatric patients receiving a Viokace-based pancreatic enzyme protocol for enteral feeding tube occlusions in a university health system during a 12-month period. The primary outcome was effectiveness in enteral tube clearance as documented in the electronic medical record. Efficacy of the new protocol was also compared with a Creon-based alkalinized solution using historical data. Results: The Viokace protocol successfully cleared 176 of the 277 (63.5%) occluded enteral feeding tubes occurring in 205 patients included in the analysis. The revised protocol was significantly more effective at clearing occluded enteral feeding tubes ( P = 0.0056) than a protocol using Creon pancreatic enzyme capsules. Conclusion: According to this retrospective evaluation, an alkalinized Viokace pancreatic enzyme protocol was effective in clearing 63.5% of occluded enteral feeding tubes. This significantly higher success rate than previously documented with a Creon-based protocol supports the change in pancreatic enzyme formulations in the institutional protocol.

01 Dec 2021·Addictive behaviors reports

Associations amongst form of cocaine used (powder vs crack vs both) and HIV-related outcomes

Article

Author: Cook, Robert L ; Liu, Yiyang ; Gebru, Nioud Mulugeta ; Spencer, Emma C ; Richards, Veronica L

INTRODUCTION:

Cocaine (including powder and crack) use is common among people with HIV (PWH). We identified socio-demographic and behavioral factors associated with cocaine use (overall and various forms) among PWH; we also examined differences in HIV treatment outcomes across cocaine exposure groups.

METHODS:

The study sample (N = 1166) was derived from two cohorts of PWH in Florida between 2014 and 2020. Baseline data were linked to the Enhanced HIV/AIDS Reporting System (eHARS) which tracks HIV viral load. Socio-demographics and polysubstance use were compared by cocaine use and the three cocaine use groups (powder only n = 101, crack only n = 91, or both n = 65). The association between the three cocaine use groups, ART adherence, and HIV viral suppression (<200 copies/mL) in the following year was assessed by multivariate logistic regression.

RESULTS:

People who used cocaine had lower HIV treatment adherence and viral suppression than those who did not use. People who used powder cocaine only were more likely to be younger, Hispanic/Latinx, and employed than those who used crack only or both. Compared to people who used both powder and crack cocaine, those who used one form of cocaine had 3 + odds of having durable viral suppression in the following year.

CONCLUSION:

The dual use of both powder and crack cocaine was associated with significantly worse HIV outcomes compared to use of only one form of cocaine. Screening for powder and crack cocaine use and timely intervention are needed to improve HIV treatment outcomes among this high-risk population.

01 Oct 2021·Journal of orthopaedic traumaQ3 · MEDICINE

Incidence of Surgical Site Infections and Acute Kidney Injuries After Topical Antibiotic Powder Application in Orthopaedic Trauma Surgery

Q3 · MEDICINE

Article

Author: Chu, Xiangquan ; Chambers, Lori ; Parry, Joshua A ; Mauffrey, Cyril ; Balabanova, Alla

OBJECTIVES:

To compare the incidence of deep surgical site infections (SSI) and acute kidney injuries (AKI) in patients who did and did not receive topical antibiotics during the open treatment of fractures.

DESIGN:

Retrospective comparative cohort.

SETTING:

Level 1 trauma center.

PATIENTS/PARTICIPANTS:

Three hundred ninety-six patients undergoing open fixation of fractures.

INTERVENTION:

The topical antibiotic group included 78 (20%) patients. Vancomycin only was used in 28 (7%) patients with the median dose (interquartile range) of 1 g (1-2 g) and vancomycin/tobramycin was used in 48 (12%) patients with a median dose (interquartile range) of 2 g (1-2 g)/1.2 g (1.2-1.2 g).

MAIN OUTCOME MEASUREMENTS:

Deep SSI requiring debridement and AKI (>50% increase in creatinine compared with preoperative level).

RESULTS:

There was no detectable difference in SSI between the topical antibiotic and control groups (13% vs. 10%, odds ratio (OR) 1.3, 95% confidence interval (CI) 0.6 to 2.9). Variables associated with SSI on multivariate analysis included open fracture (OR 3.2, CI 1.5 to 6.5) and an American Society of Anesthesiologists classification of >2 (OR 2.7, CI 1.3 to 5.3). There was no detectable difference in AKI between the topical antibiotic and control groups (1 (2%) vs. 7 (5%); OR 0.3, CI 0.04 to 3).

CONCLUSION:

There was no detectable difference, with wide confidence intervals, in SSI and AKI between the topical antibiotic and control groups. Further studies need to be conducted to evaluate the relationship between topical antibiotics and clinical outcomes in orthopaedic trauma surgery.

LEVEL OF EVIDENCE:

Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

News (Medical) associated with Pancrelipase(Eurand)

08 Jul 2022

·www.biospace.com

Report: Merck in Advanced Talks to Acquire Seagen for $40B

Merck is in late-stage discussions to acquire Seagen for about $40 billion, sources told The Wall Street Journal. Seagen is an appealing oncology target for Merck at a time when the latter is looking to bolster its cancer portfolio as mega-blockbuster Keytruda (pembrolizumab) teeters on the patent cliff. The WSJ report suggests Merck is offering more than $200 per share and hopes to close the deal on or before its quarterly earnings report on July 28. On Wednesday, Seagen’s stock closed at $175.13 per share. Rumors about the talks have been ongoing for several weeks. Seagen’s market cap is above $32 billion. In September 2020, the two companies inked a co-development pact to advance ladiratuzumab vedotin, a potential cancer therapy. Merck threw $600 million into the deal up front and acquired 5 million shares of Seagen stock for $1 billion. They also have a licensing deal for Tukysa in countries outside the U.S., Canada and Europe, for which Merck paid $125 million at the outset. Merck’s Keytruda, an anti-PD-1 checkpoint inhibitor, brought in $7.2 billion last year alone. In Q1 this year, the drug raked in $4.7 billion, up 23% from last year over the same period. Keytruda will lose exclusivity in 2028. Last year it made up 35.2% of Merck’s total revenue. Seagen’s focus is on antibody-drug conjugates (ADCs). These therapies link cancer-specific antibodies to cancer toxins. Its best-known drug is Adcetris. Merck is one of the top oncology companies in the world but doesn’t have much of a focus on ADCs. Its market cap is $233 billion. In a note to investors in June, Wells Fargo analyst Mohit Bansal wrote, “The real value to MRK (Merck) is qualitative as SEGEN (Seagen) adds durability and diversity to the company beyond Keytruda,” according to Seeking Alpha. If Merck and Seagen do close on a deal, they can expect regulators to take a close look. The U.S. Securities and Exchange Commission has increased its scrutiny of larger mergers and is taking a hard look at competing products, sometimes forcing companies to divest drugs before the deal is approved. As an example, in 2020, when AbbVie acquired Allergan, the SEC and other regulators required the companies to divest brazikumab and Zenpep (pancrelipase). If they do manage to pull the deal together, it will be the largest life science M&A activity for the year to date. So far, the largest deal has been Pfizer’s acquisition of Biohaven for $11.6 billion. It’s been a relatively quiet year, with M&A activity in the sector down 58% compared to the first half of 2021, with a valuation of $61.7 billion. In the first half of this year, there have been 137 deals, down 33% from the same period in 2021. Other deals include Bristol Myers Squibb’s acquisition of Turning Point Therapeutics for $4.1 billion, GSK's takeover of Affinavax for $3.3 billion and Biocon Biologics’ acquisition of Viatris’ biosimilar portfolio and related commercial and operational capabilities for $3.3 billion. There are numerous factors behind the slow M&A market, including ongoing supply chain problems, inflation, political uncertainty globally with the Russia-Ukraine war, and higher input costs, especially around packaging, due to inflationary pressures. Still, many biopharma companies have plenty of cash, especially if they have had any COVID-19-related products approved over the last two years. A recent PwC report noted that “pharma is in a good position to combat this issue as most companies have plenty of cash on hand and can take more risks by purchasing early-stage assets. With capital becoming harder to come by for most biotechs, pharma is in a good position to acquire many of these companies at a discount from their highs of just a couple of years ago.”

AcquisitionAntibodyBiosimilarADC

24 Jun 2022

·www.biospace.com

Merck, Seagen Talks Heat Up Under Cloud of Regulatory Scrutiny

Kena Betancur/Getty Images Talks between Merck and Seagen are heating up as the former looks to buy the latter, according to a report from The Wall Street Journal. If the merger-and-acquisition deal did go through, it would likely be a sizable one, since Seagen has a market cap above $32 billion. This follows last week’s report published by WSJ that stated Merck was exploring purchasing the biotech company. In September 2020, Merck and Seagen entered into an agreement to co-develop ladiratuzumab vedotincancer, a cancer treatment, with Merck pitching in $600 million upfront and acquiring 5 million shares of Seagen stock for $1 billion. They also have a licensing deal for Tukysa in countries outside the U.S., Canada and Europe, and Merck dropped $125 million upfront for that cancer drug. Both companies are strong players in the oncology space. Merck’s lead product is its blockbuster anti-PD-1 checkpoint inhibitor Keytruda (pembrolizumab). The drug brought in $17.2 billion in 2021 alone. In the first quarter of this year, Keytruda brought in $4.7 billion, an increase of 23% from the previous year. Seagen focuses on antibody-drug conjugates (ADCs). These drugs have onco-toxins attached to an antibody that delivers the drugs directly to the tumors. Its best-known drug is Adcetris. On June 6, Seagen and Genmab announced interim data from the innovaTV 205 trial of Tivdak (tisotumab vedotin) in combination with Keytruda in patients with recurrent or metastatic cervical cancer who have not received previous systemic therapy. The interim data demonstrated a confirmed objective response rate (ORR) of 41% and median durability of response that was not achieved within almost 19 months of median follow-up. Tivdak is an ADC made up of Genmab’s human monoclonal antibody directed to tissue factor (TF) and Seagen’s ADC technology. “With Genmab, we will continue to investigate tisotumab vedotin in combination with other therapies because there is still an unmet need for more effective first-line treatment for advanced cervical cancer patients,” Marjorie Green, M.D., senior vice president and head of late-stage development at Seagen, said in a statement. “We’re also researching innovative new tools to help increase awareness of the disparities and unmet needs that cervical cancer patients experience in order to better support this community in the future.” Although Merck is a powerhouse in the oncology space, it doesn’t really focus on ADCs. It has a significantly larger market cap than Seagen, at about $233 billion. According to Seeking Alpha, Seagen's shares have risen considerably since the WSJ report, and Wells Fargo analyst Mohit Bansal wrote in a note that the value of a deal would be within the $200-$220/share range. "The real value to MRK (Merck) is qualitative as SGEN (Seagen) adds durability and diversity to the company beyond Keytruda," Bansal said in the note obtained by Seeking Alpha. Although picking up Seagen would certainly beef up its already strong oncology portfolio, Merck is reportedly concerned that regulators might block the deal. The Securities and Exchange Commission has taken a close look at competing products with merging companies, sometimes forcing companies to divest drugs for the deals to go through. For example, in 2020, when AbbVie acquired Allergan, regulators required the companies to divest brazikumab and Zenpep (pancrelipase). A recent report on the industry by PwC notes that one of the reasons M&A activity has been so slow this year is concern over increased regulatory scrutiny. On the other hand, a driving factor for M&A interest is an increasing number of patent expirations. Although Keytruda is still growing, its patents start to expire in 2028. Keytruda has been approved for a long list of cancer indications, both as a monotherapy and in combination with numerous other cancer drugs. Amidst all of this, Seagen is undergoing some changes. In May, the company’s president, CEO and board member, Clay Siegall, resigned after domestic violence allegations, which had resulted in a leave of absence earlier in the month. The board is currently conducting a search for a replacement. Meanwhile, Roger Dansey, M.D., the company’s chief medical officer, is acting as interim CEO.

AntibodyADCAcquisitionPatent Expiration

24 Aug 2021

·www.pharmaceutical-technology.com

Current and future players in the cystic fibrosis market

The currently available marketed drugs for cystic fibrosis (CF) target multiple aspects of the disease. Inhaled antibiotics are used for the treatment of chronic lung infections, mucolytic agents are used for reducing the viscosity of the mucus in the lungs, pancreatic enzyme replacement therapies (PERTs) are used for the treatment of CF-related exocrine pancreatic insufficiency (EPI), and CF transmembrane conductance regulator (CFTR) modulators enhance CFTR function, targeting the underlying cause of disease. The disease-modifying nature of CFTR modulators has transformed the treatment paradigm for CF over the last decade, setting a trend that is likely to persist to 2030. More than a dozen pharmaceutical companies make up the current players in the CF market (Figure). Vertex is the clear market leader, dominating the CF space with four marketed CFTR modulators available throughout the seven major markets (7MM) (US, France, Germany, Italy, Spain, UK and Canada), including Kalydeco (ivacaftor), Orkambi (lumacaftor/ivacaftor), Symdeko/Symkevi (tezacaftor/ivacaftor and ivacaftor), and Trikafta/Kaftrio (elexacaftor, tezacaftor, ivacaftor). Since the global approval of Kalydeco in 2012, Vertex has greatly expanded the number of CF-related mutations that are eligible for CFTR modulator treatment across all age groups. Currently, Vertex’s Trikafta/Kaftrio is the world’s first triple-combination therapy for which approximately 90% of the CF population will likely be eligible. While Vertex is currently the only company with products in the CFTR modulator drug class, other players stand out with marketed products in other drug classes. Chiesi possesses two inhaled antibiotic products, Bramitob/Bethkis (tobramycin) in the US and five major European markets (5EU) (France, Germany, Italy, Spain and the UK) and Quinsair (levofloxacin) in the 5EU, as well as the mucolytic Bronchitol (mannitol) in the US and the PERT product Pertzye (pancrelipase) in the US. Two other key companies include Viatris (formerly Mylan), which owns the most widely-used inhaled antibiotic therapies, TOBI (tobramycin) and TOBI Podhaler (tobramycin inhalation powder), and Nestlé HealthScience, which owns two PERT products, Zenpep (pancrelipase) and Viokace (pancrelipase). The rest of the pharmaceutical companies with marketed drugs used for the treatment of CF include Gilead, Teva, Genentech, AbbVie, Vivus, Horizon Therapeutics and Pharmaxis. Vertex and AbbVie are the only two companies with clear stakes in both the current and future CF market. Vertex is currently pursuing label expansion for Kalydeco to CF patients ages 0 months to less than 12 months in Canada, and Trikafta/Kaftrio to pediatric CF patients ages 2-5 years in the US and 2-11 years in the 5EU and Canada. Additionally, two new products from this company are expected to launch within the next five years: VX-561 and VX-121 + tezacaftor + VX-561. Currently, AbbVie markets Creon, the most widely used PERT by CF patients. The company has two pipeline agents, ABBV-3067, a CFTR potentiator that is being studied in late-stage Phase II trials alone and in combination with galicaftor (ABBV-2222), a CFTR corrector. If successful, AbbVie will be Vertex’s first competitor in the CFTR modulator market. Laurent Pharmaceuticals is expected to be the only new player in the CF space by 2030. It is currently developing an anti-inflammatory agent, LAU-7b (fenretinide), for reducing the levels of inflammation and the severity of pulmonary infections with Pseudomonas aeruginosa. While this pipeline agent has an innovative mechanism of action and is a first-in-class drug, the company is a novice within the CF field and has not yet brought a drug to market. Due to the limited number of pipeline agents in late-stage development, GlobalData anticipates that the current players in the CF market will likely maintain their competitive positions by 2030. Related Report Cystic Fibrosis – Global Drug Forecast and Market Analysis to 2030 Get the Report Latest report from Browse over 50,000 other reports on our store. Visit GlobalData Store

First in Class

100 Deals associated with Pancrelipase(Eurand)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	A09AA02	DB00085

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Exocrine Pancreatic Insufficiency	US	Eurand Pharmaceuticals, Inc.	27 Aug 2009

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Pancreatitis, Chronic	Phase 3	US	Forest Laboratories LLC	01 Nov 2007
Pancreatitis, Chronic	Phase 3	CA	Forest Laboratories LLC	01 Nov 2007
Pancreatitis, Chronic	Phase 3	PL	Forest Laboratories LLC	01 Nov 2007
Pancreatitis, Chronic	Phase 3	SK	Forest Laboratories LLC	01 Nov 2007
Steatorrhea	Phase 3	US	Forest Laboratories LLC	01 Nov 2006
Cystic Fibrosis	Phase 3	US	Forest Laboratories LLC	01 May 2006

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00880100 (CTgov)	Phase 3	Steatorrhea \| Exocrine Pancreatic Insufficiency \| Cystic Fibrosis	49	Ultrase® MT12	ymgknfuefz(zspdhykgab) = hfnhofynjf ouayfqsqln (jxyogwgxzt, xgglwuabzf - xjhdslaknu) View more	-	19 Feb 2015
NCT01100606 (CTgov)	Phase 4	Cystic Fibrosis \| Exocrine Pancreatic Insufficiency	15	EUR-1008 (APT-1008) (EUR-1008 (APT-1008) in Apple Juice)	nunyieawye(oowwzsirum) = sfqyownvud bqjqhbatxm (rtlcdclcmw, orvmvtlula - lkfilewair) View more	-	10 Apr 2014
				EUR-1008 (APT-1008) (EUR-1008 (APT-1008) in Apple Sauce)	nunyieawye(oowwzsirum) = xohxhuxezr bqjqhbatxm (rtlcdclcmw, ldgfkorrqi - cvokbzjpyb) View more
NCT01327703 (CTgov)	Phase 4	Steatorrhea \| Cystic Fibrosis \| Exocrine Pancreatic Insufficiency	87	Panzytrat (Panzytrat®)	ewjootdlrs(oguplvwlyr) = gewdbhiyqm lfyyarvtif (kdujuogrnb, nkajedsbqe - iynpjgimpq) View more	-	10 Apr 2014
				Kreon (Kreon®)	ewjootdlrs(oguplvwlyr) = lqorxxlkiw lfyyarvtif (kdujuogrnb, enbtcqedtr - oiubwqvbpd) View more
NCT00981214 (CTgov)	Phase 3	Exocrine Pancreatic Insufficiency \| Cystic Fibrosis	19	EUR-1008 (APT-1008)	hvxpazjsfd(uvpfvhrtke) = jhzvwporar kkxsnixhhy (maeeihucpd, jeqngjpcke - paoviejksh) View more	-	04 Apr 2014
NCT00408317 (CTgov)	Phase 3	Steatorrhea \| Cystic Fibrosis \| Exocrine Pancreatic Insufficiency	36	Ultrase® MT20 (Ultrase® MT20)	nhugrvmwbi(zlplrlrwgg) = qaeszzpmcr bpvnlinonv (lnicgssuat, kssalskujc - lmeiivdviz) View more	-	12 Mar 2014
				Placebo (Placebo)	nhugrvmwbi(zlplrlrwgg) = wbdqoddtmp bpvnlinonv (lnicgssuat, cqwxbvobje - iyvgolfuif) View more
NCT00788593 (CTgov)	Phase 3	Pancreatitis, Chronic \| Exocrine Pancreatic Insufficiency	82	EUR-1008 (APT-1008) Low Dose (EUR-1008 (APT-1008) Low Dose)	sjkusmfrbn(ooraeizdyn) = rivunziprw wzxljcbedr (vskldqspnk, pkzkcmdfek - qpbpexddjr) View more	-	12 Mar 2014
				EUR-1008 (APT-1008) High Dose (EUR-1008 (APT-1008) High Dose)	sjkusmfrbn(ooraeizdyn) = bbaofcxzhi wzxljcbedr (vskldqspnk, cvgkdmjhgq - xlxwdhvfwh) View more
NCT00559364 (CTgov)	Phase 3	Pancreatitis, Chronic \| Steatorrhea \| Exocrine Pancreatic Insufficiency	50	Proton pump inhibitor (PPI)+Omeprazole	sjgpstvygc(kmfndnmgtk) = jevoixscng ctkdijhwkt (sydqwnsjyv, ddazxufata - ldpjkwpzlf) View more	-	12 Mar 2014
NCT01131507 (PR-018, CTgov)	Phase 4	Exocrine Pancreatic Insufficiency \| Cystic Fibrosis	15	EUR-1008 (APT-1008)	fjyfnnbjzz(gbuebqfsty) = jsxacuncit aocdstrryt (ntzlbrjegr, gzjdulzsbv - zltgussoxz) View more	-	07 Mar 2014

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