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ON101 Cream (1.25%),15g ointment per tube. Twice daily for up to 16 weeks.

Drug: ON101 Cream

AquacelR HydrofiberR dressing

AquacelR HydrofiberR dressings will be changed daily, on alternate days or three times a week according to need, but not longer than 7 days.

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Susquehanna International Group, LLP 22,765 Mar 30, 2020 0.30% 23,220

Morgan Stanley 12,879 Mar 30, 2020 0.17% 13,136

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Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers (ON101 (WH-1))

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT01898923

Recruitment Status ƒÊ :Recruiting

First Posted ƒÊ : July 15, 2013

Last Update Posted ƒÊ : January 22, 2020

See Contacts and Locations

Sponsor:

Oneness Biotech Co., Ltd.

Information provided by (Responsible Party):

Oneness Biotech Co., Ltd.

Study Details

Tabular View

No Results Posted

Disclaimer

How to Read a Study Record

Study Description

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Brief Summary:

The primary objective of this study is to evaluate the efficacy of the new treatment of WH-1 ointment compared to Aquacel® Hydrofiber® dressing, applied to chronic diabetic foot ulcers for up to 16 weeks.An additional objective of this study is to collect safety information including adverse events and clinical laboratory abnormalities.

Condition or disease ƒÊ

Intervention/treatment ƒÊ

Phase ƒÊ

Diabetic Foot

Drug: ON101 Cream

Other: Aquacel® Hydrofiber® dressing

Phase 3

Detailed Description:

This trial is designed as a randomized, evaluator blinded, active-controlled, multi-center study comparing the efficacy and safety of WH-1 ointment and Aquacel® Hydrofiber® dressing in the treatment of diabetic foot ulcers. Independent evaluators who blinded to subjects¡¦ treatment will evaluate whether the wound has healed. Eligible subjects will be randomized to receive either WH-1 ointment or Aquacel® Hydrofiber® dressing in a 1:1 allocation. The study treatment will be applied to the selected ulcer for a maximum period of 16 weeks, until the wound/ulcer closure (wound size of 0) for two consecutive visits at least 2 weeks apart, or until the subject exited the study as treatment failure. After that, all subjects regardless of wound healing at the end of comparison period will be followed for 12 weeks to investigate durability. During the follow-up period, Aquacel® Hydrofiber® dressing will be applied for subjects who have unhealed or with recurrent wound. Each target ulcer with wound photographs for blind assessment will be monitored at each scheduled visit.

One interim analysis is planned at around 50% of study information; the final analysis will be conducted at the end of the study.

Study Design

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Study Type ƒÊ : Interventional (Clinical Trial)

Estimated Enrollment ƒÊ : 236 participants

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: Single (Outcomes Assessor)

Primary Purpose: Treatment

Official Title: Randomized Controlled Study to Evaluate the Efficacy and Safety of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers

Study Start Date ƒÊ : September 2012

Estimated Primary Completion Date ƒÊ : June 2020

Estimated Study Completion Date ƒÊ : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetic Foot Foot Health

U.S. FDA Resources

Arms and Interventions

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Arm ƒÊ

Intervention/treatment ƒÊ

Experimental: ON101 Cream

ON101 Cream (1.25%),15g ointment per tube. Twice daily for up to 16 weeks.

Drug: ON101 Cream

Aquacel® Hydrofiber® dressing

Aquacel® Hydrofiber® dressings will be changed daily, on alternate days or three times a week according to need, but not longer than 7 days.

Other: Aquacel® Hydrofiber® dressing

Outcome Measures

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Primary Outcome Measures ƒÊ : 1.The incidence of complete ulcer closure [ Time Frame: 16 weeks ]

The primary variable is the number of target ulcers healed in each group within 16 weeks. The primary efficacy outcome is the comparison of the incidence of complete healing of the target ulcer between the two treatment groups at the end of treatment.

For the purpose of this study a complete healing will be defined as complete epithelialization which is maintained with no drainage for at least 2 weeks and is confirmed by a blinded assessor.

Secondary Outcome Measures ƒÊ : 1.The time of healing rate [ Time Frame: 16 weeks ]

Time to complete ulcer healing, The time of the original healing will be taken as the time to healing.

2.change in ulcer area [ Time Frame: 16 weeks ]

Percentage change in ulcer surface area from baseline

3.50% reduction in ulcer area [ Time Frame: 16 weeks ]

Percentage of subjects with a 50% reduction of ulcer surface area

4.Incidence of infection of the target ulcer [ Time Frame: 16 weeks ]

Incidence of infection of the target ulcer

Eligibility Criteria

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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study: 20 Years to 80 Years (Adult, Older Adult)

Sexes Eligible for Study: All

Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria

1.Has signed a written informed consent prior to the first study evaluation;

2.Male or female is at least 20 and < 80 years of age;

3.Diabetes mellitus (type 1 or 2) with an HbA1c < 12.0% measured during screening or within three months prior to randomization;

4.An ankle brachial index on the target limb at least 0.8 measured during screening or within three months prior to randomization;

5.The target ulcer must have the following characteristics:

◦Grade 1 or 2 per Wagner Ulcer Classification System;

◦No higher than the ankle;

◦No active infected;

◦A cross-sectional area of between 1 and 25 cm2 post-debridement;

◦Present for at least 4 weeks before randomization;

6.If female and of childbearing potential has a negative pregnancy test and is not breastfeeding at screening visit;

7.Able and willing to attend the scheduled visits and comply with study procedures.

Exclusion Criteria:

1.Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement;

2.Acute Charcot¡¦s neuroarthropathy as determined by clinical and/or radiographic examination;

3.Has undergone revascularization procedure aimed at increasing blood flow in the treatment target limb < 4 weeks prior to randomization;

4.Poor nutritional status defined as an albumin < 2.5 g/dL;

5.Aspartate Aminotransferase(AST, GOT) and/or Alanine Aminotransferase(ALT, GPT) >3 x the normal upper limit;

6.Serum Creatinine >2 x the normal upper limit;

7.Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 4 weeks before randomization;

8.Use of any investigational drug or therapy within the 4 weeks prior to randomization;

9.A psychiatric condition (e.g., suicidal ideation), current or chronic alcohol or drug abuse problem, determined from the subject¡¦s medical history, which, in the opinion of the Investigator, may pose a threat to subject compliance;

10.Judged by the investigator not to be suitable for the study for any other reason.

Contacts and Locations

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01898923

Contacts

Contact: Liu +886-2-2703-1098 ext 594

Locations

Show Hide Hide 21 study locations

United States, California

Limb Preservation Platform, Inc. Active, not recruiting

Fresno, California, United States

China, Guangdong

Sun Yat-sen Memorial Hospital, Sun Yat-sen University Recruiting

Guangzhou, Guangdong, China

Nanfang Hospital of Southern Medical University Recruiting

Guanzhou, Guangdong, China

The First Affiliated Hospital, Sun Yat-sen University Recruiting

Guanzhou, Guangdong, China

China, Henan

The First Affiliated Hospital of Henan Science & Technology University Recruiting

Luoyang, Henan, China

China, Jiangsu

The First Affiliated Hospital of Soochow University Recruiting

Suzhou, Jiangsu, China

Affiliated Hospital of Jiangsu University Recruiting

Zhenjiang, Jiangsu, China

China, Shandong

Shandong Provincial Hospital Recruiting

Jinan, Shandong, China

China, Shanghai

Ruijin Hospital, Shanghai Jiaotong University School of Medicine Recruiting

Shanghai, Shanghai, China

Shanghai TCM-Interated Hospital Recruiting

Shanghai, Shanghai, China

Taiwan

Chang Gung Medical Hospital_Kaohsiung Active, not recruiting

Kaohsiung, Taiwan

Buddhist Tzu Chi Medical Hospital Active, not recruiting

New Taipei City, Taiwan

MacKay Memorial Hospital-Tamsui Branch Active, not recruiting

New Taipei City, Taiwan

China Medical University Hospital Active, not recruiting

Taichung City, Taiwan

Chi Mei Medical Center-Yongkang Active, not recruiting

Tainan City, Taiwan

MacKay Memorial Hospital-Taipei Branch Active, not recruiting

Taipei City, Taiwan

National Taiwan University Hospital Active, not recruiting

Taipei City, Taiwan

Taipei Veterans General Hospital Active, not recruiting

Taipei City, Taiwan

Tri-Service General Hospital Active, not recruiting

Taipei City, Taiwan

Chang Gung Medical Hospital_Linkou Active, not recruiting

Taoyuan City, Taiwan

China Medical University Hospital-Beigang Branch Active, not recruiting

Yunlin, Taiwan

Sponsors and Collaborators

Oneness Biotech Co., Ltd.

More Information

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Responsible Party: Oneness Biotech Co., Ltd.

ClinicalTrials.gov Identifier: NCT01898923 History of Changes

Other Study ID Numbers: ON101CLCT02

First Posted: July 15, 2013 Key Record Dates

Last Update Posted: January 22, 2020

Last Verified: January 2020

Keywords provided by Oneness Biotech Co., Ltd.:

WH-1,Diabetic Foot,Ulcer

Additional relevant MeSH terms:

Diabetic Foot

Foot Ulcer

Diabetic Angiopathies

Vascular Diseases

Cardiovascular Diseases

Leg Ulcer

Skin Ulcer

Skin Diseases

Diabetes Complications

Diabetes Mellitus

Endocrine System Diseases

Diabetic Neuropathies

Foot Diseases

Carboxymethylcellulose Sodium

Laxatives

Gastrointestinal Agents

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Lebrikizumab Phase 2b Study

The randomized, double-blind, placebo-controlled, parallel-group Phase 2b study was designed to evaluate the safety and efficacy of lebrikizumab as monotherapy compared with placebo and establish a dosing regimen for the Phase 3 program in patients with moderate-to-severe atopic dermatitis.

The study enrolled 280 patients ages 18 years and older with moderate-to-severe atopic dermatitis at 57 sites in the United States.

Three different lebrikizumab treatment dosing arms were evaluated, compared to a placebo arm, with patients randomized in a 3:3:3:2 fashion as follows:

• Group 1: A loading dose of 250 mg of lebrikizumab at baseline (day 0), followed by 125 mg of lebrikizumab every four weeks.

• Group 2: A loading dose of 500 mg of lebrikizumab at baseline (day 0), followed by 250 mg of lebrikizumab every four weeks.

• Group 3: A loading dose of 500 mg of lebrikizumab at baseline (day 0) and week 2, followed by 250 mg of lebrikizumab every two weeks.

• Group 4: Placebo at baseline (day 0) and every two weeks thereafter.

www.businesswire.com/news/home/20191017005896/en/Dermira-Presents-Data-Phase-2b-Study-Lebrikizumab

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1.Lebrikizumab 2b ¤¤-­««×AD Á{§Éªº«ü¼Ð(2019/3¤ë¤½¥¬)

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EASI-50 77.0%**

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EASI-50 45.8%

EASI-75 24.3%

EASI-90 11.4%

IGA0/1 15.3%

*p<0.05, **p<0.01, and ***p<0.001 versus placebo

www.businesswire.com/news/home/20191017005896/en/Dermira-Presents-Data-Phase-2b-Study-Lebrikizumab

------------

2.1Dupliumab 3´Á ¤¤-­««×AD, 2­ÓSOLO1/SOLO2 Á{§Éªº«ü¼Ð(2016¦~¤½¥¬)

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EASI-90 36%/30%

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(¤T)¹ï·Ó²ÕPlacebo

EASI-50 25%/22%

EASI-75 15%/12%

EASI-90 8%/7%

IGA0/1 10%/8%

www.nejm.org/doi/full/10.1056/NEJMoa1610020?cookieSet=1

2.2 Dupliumab 2b Á{§Éªº«ü¼Ð(2014¦~/7¤ë¤½¥¬)/16¶gªvÀø/n=380 ,6²Õ,

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www.drugs.com/clinical_trials/regeneron-sanofi-announce-positive-results-phase-2b-study-dupilumab-atopic-dermatitis-16580.html

----------------

3.---2019/12 ,³q¹L¤T´ÁÁ{§Éªºtralokinumab,---

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Published: May 26, 2020 at 8:44 a.m. ET

By Jaimy Lee

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Published: May 26, 2020 at 8:44 a.m. ET

By Jaimy Lee

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Shares of Regeneron Pharmaceuticals Inc. REGN, -4.33%were up 0.4% in premarket trading on Tuesday, the day after the company said it will spend $5 billion to buy back some of its own shares after Sanofi SNY, -0.06%announced it is selling most of its stake in Regeneron. Sanofi¡¦s stock had also gained 0.4% in premarket trading on Tuesday. While Sanofi¡¦s exit is occurring earlier than expected (agreement lock-up expires on Dec. 20, 2020, and liquidation was expected to take multiple years), we don¡¦t believe it will cause material disruption to REGN¡¦s stock, SVB Leerink¡¦s Geoffrey Porges wrote in a note to investors on Tuesday. Sanofi owns 23.2 million shares of Regeneron, a roughly 20% stake, and plans to sell 12.8 million shares. Regeneron will fund the buyback with $3.5 billion in cash and $1.5 billion in bridge financing. The French drugmaker had first made an investment in Regeneron in 2004; the two companies have also collaborated since 2003 on a number of Food and Drug Administration-approved therapies, including rheumatoid arthritis treatment Kevzara, PCSK9 inhibitor Praluent, and eczema drug Dupixent. Kevzara is currently in clinical trials testing the drug as a treatment for COVID-19 patients. The registered offering and share repurchase will have no impact on the ongoing collaboration between Regeneron and Sanofi, Regeneron said in a statement. Selling about 23 million shares in Regeneron may generate $13 billion in cash for Sanofi, setting the company up to make a mid-cap biotechnology deal, RBC Capital Markets analysts wrote on Monday. Since the start of the year, Sanofi¡¦s stock is down 5.4% and shares of Regeneron have gained 54.7%. The S&P 500 SPX, +1.22%is down 8.5%.

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Jefferies Virtual Healthcare Conference

June 2-4, 2020

Jefferies remains vigilantly focused on the health, safety and well-being of our clients and employees. As such, our annual Healthcare Conference will take place virtually on June 2-4, 2020.

The new format will include video & audio company presentations, interactive panels, and 1x1 meetings conducted via organized conference calls. This virtual gathering of over 400 public & private healthcare companies and 2,500 leading executives, institutional investors, private equity investors & VCs will address near- and long-term investment opportunities and discuss the current mechanisms driving healthcare in the U.S. and internationally.

Registration is now open for Jefferies clients. Please contact your Jefferies representative to register.

To add this conference to your Microsoft Outlook calendar, click here.

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www.jefferies.com/IdeasAndPerspectives/Conferences/325/060220

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20 May 2020

ASLAN CEO Dr Carl Firth and Chief Business Officer Stephen Doyle to participate at Jefferies Healthcare Conference 2020, 2-4 June, New York

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Company presentation

May 2020

NASDAQ: ASLNTPEx: 6497

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Prevalence of Childhood & Adult Atopic Dermatitis (AD)

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The prevalence of childhood AD has steadily increased from 8% to ~12% since 1997. 4

An estimated 16.5 million U.S. adults (7.3%) have AD that initially began at >2 years of age, with nearly 40% affected by moderate or severe disease. 9

Atopic dermatitis is not solely a disease of childhood onset; 1 in 4 adults report adult-onset of initial symptoms. 10, 11

Atopic dermatitis affects a similar number of male and female children, however, studies have shown it is more common in adult females than males. 2, 5, 6, 8, 9, 12, 13

In the U.S., AD affects more African-American/black children and European-American children compared to Hispanic children. 5, 7, 12

Although study percentages vary, adults that are multiracial or white tend to have the highest prevalence of atopic dermatitis. 2, 9, 14

African-American/black and Hispanic children tend to have more severe AD compared to white children. 8, 14

Children born outside the U.S. have a 50% lower risk of developing AD that increases after living in the U.S. for 10 years. 15

80% of individuals affected with AD experience disease onset prior to 6 years of age, and current data suggests at least 80% will ¡§outgrow¡¨ their AD by adolescence or adulthood. 16, 17

Children with more severe, persistent AD have a higher risk for prolonged disease, although AD may persist regardless of severity. 17, 18

nationaleczema.org/research/eczema-facts/

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H.C. Wainwright Keeps a Buy Rating on Aslan Pharmaceuticals (ASLN)

Ryan Adist-May 12, 2020, 10:24 AM EDT

In a report released today, Yi Chen from H.C. Wainwright reiterated a Buy rating on Aslan Pharmaceuticals (ASLN), with a price target of $5.00. The company¡¦s shares closed last Tuesday at $1.95.

According to TipRanks.com, Chen is a 5-star analyst with an average return of 21.8% and a 46.9% success rate. Chen covers the Healthcare sector, focusing on stocks such as Interpace Diagnostics Group, HTG Molecular Diagnostics, and EyePoint Pharmaceuticals.

Currently, the analyst consensus on Aslan Pharmaceuticals is a Moderate Buy with an average price target of $5.00.

www.berich.com.tw/dp/TalkTalk/Talk_detail.asp?II=204490#reply_a

May 12, 2020

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A pooled analysis of two phase 2 clinical trials

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.journals.lww.com/jaanp/Fulltext/2018/09000/Efficacy_and_safety_of_dupilumab_for_the_treatment.10.aspx

Efficacy and safety of dupilumab for the treatment of moderate-to-severe atopic dermatitis in adults

A pooled analysis of two phase 2 clinical trials

---------------------------------------

journals.lww.com/jaanp/Fulltext/2018/09000/Efficacy_and_safety_of_dupilumab_for_the_treatment.10.aspx

Efficacy and safety of dupilumab for the treatment of moderate-to-severe atopic dermatitis in adults

A pooled analysis of two phase 2 clinical trials

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Efficacy and safety of dupilumab for the treatment of moderate-to-severe atopic dermatitis in adults

A pooled analysis of two phase 2 clinical trials

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Sales of Eylea were $1.2 billion for the quarter, 9% higher than a year earlier.

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nonperele.com/regeneron-stock-is-climbing-after-earnings-beat-expectations/

Shares of Regeneron Pharmaceuticals jumped Tuesday morning as the company reported earnings that beat consensus estimates.

Regeneron (ticker: REGN) reported earnings of $6.60 per share for the first quarter of 2020, beating the S&P Capital IQ Consensus of $6.09. The company reported revenue of $1.8 billion for the quarter, 33% better than a year earlier.

The stock was up 4.5% in premarket trading. S&P 500 futures were up 1.2%.

The company reiterated that it plans to begin human trials of its experimental antibody cocktail to both prevent and treat Covid-19 in June, and said it would have ¡§large-scale quantities available by late summer.¡¨

¡§Over 30 years, the Regeneron team has built a science and technology engine uniquely suited to address the Covid-19 pandemic and we are applying our signature passion, innovation, and drive to advance solutions,¡¨ CEO Leonard Schleifer said in a statement.

The company said there was limited impact from Covid-19 on sales of Eylea, a treatment for wet, age-related macular degeneration, in the first quarter, though sales were down in April. It said its supply of commercialized products was adequate, and that fully-enrolled trials would continue, though it had paused enrollment in some studies.

Sales of Eylea were $1.2 billion for the quarter, 9% higher than a year earlier.

¡§Clean [first-quarter] beat,¡¨ Cowen analyst Yaron Werber wrote Tuesday morning in a note. ¡§Overall good [quarter] in this environment.¡¨

In his own note, RBC Capital Markets analyst Kennen MacKay said the company hadn¡¦t provided revenue guidance, and raised concerns about Eylea sales.

¡§Lack of [fiscal-year] Eylea guidance may add to some concern around recent script trends suggesting a significant decline in the final weeks of [the first quarter] and beyond due to the impact of Covid-19,¡¨ MacKay wrote.

Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com

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Amgen and Adaptive Biotechnologies

Type: Antibody treatment

Stage: Preclinical

Background: The very early-stage collaboration between Amgen Inc. US:AMGNand Adaptive Biotechnologies Corp. US:ADPTseeks to discover antibodies that can be used to prevent or treat COVID-19. Financial terms of the exclusive collaboration will be completed ¡§in the coming weeks,¡¨ the companies said April 2. ¡§There may well be more than one generation of antibody therapeutics entering the clinic,¡¨ Amgen R&D EVP David Reese told investors on an earnings call.

Also in the works: Amgen will test Otezla as a COVID-19 therapy treating respiratory distress in late-stage patients, with the company saying April 30 that it plans to put the oral psoriasis drug into trials ¡§in the coming weeks.¡¨

Year-to-date stock performance: Amgen¡¦s stock is down 1.9%; Adaptive¡¦s is up 10.3%.

Altimmune

Type: Vaccine

Stage: Preclinical

Name: AdCOVID

Background: Altimmune Inc. US:ALTsaid March 30 it is partnering with University of Alabama at Birmingham to develop a single-dose, intranasal COVID-19 vaccine. They said they plan to put the vaccine candidate into Phase 1 trials in the third quarter. The preclinical company is also developing vaccines for anthrax and the flu.

Year-to-date stock performance: Shares of Altimmune have gone up 60.8%.

BioNTech and Pfizer

Type: mRNA vaccine

Stage: Phase 1/2

Name: BNT162 program

Background: Pfizer Inc. US:PFE announced March 17 it would help develop and distribute BioNTech SE¡¦s US:BNTXCOVID-19 vaccine candidate, though the deal excludes China. The 360 patients in the U.S. trial had started to receive the first doses of the four vaccine candidates included in the study as of May 5. Dosing in 200 participants in the German trial began April 23. As part of the deal, Pfizer will pay $185 million upfront, with additional possible future milestone payments of up to $563 million. Mikael Dolsten, Pfizer¡¦s chief scientific officer, said during an April 28 earnings call that the companies expect the first round of trial data in May or June, with the vaccine candidate moving into ¡§expanded trials that could allow emergency use or accelerated approval coming in the fall, possibly October.¡¨

BioNTech is also testing the vaccine in collaboration with Shanghai Fosun Pharmaceutical Group Co. Ltd. in China.

Pfizer and BioNTech for several years have said they are working on mRNA-based influenza vaccines.

Year-to-date stock performances: Shares of BioNTech have soared 47.6%; Pfizer¡¦s stock is down 1.7%.

CytoDyn

Type: Treatment

Stage: Phase 2 and Phase 2b/3 clinical trials

Name: leronlimab

Background: CytoDyn Inc. US:CYDY,a preclinical biotechnology company based in Vancouver, is testing its experimental drug leronlimab in two types of COVID-19 patients. The investigational therapy hasn¡¦t been approved for any indications; for COVID-19, it is being proposed as a treatment for mild-to-moderate respiratory complications that occur in patients with the disease as well as severely and critically ill patients.

The randomized, double-blind, placebo-controlled study will test the efficacy and safety of leronlimab in 75 patients. CytoDyn had been studying the experimental therapy as a treatment for people with HIV and a form of metastatic breast cancer.

Year-to-date stock performance: CytoDyn¡¦s stock has soared 213.0%.

Gilead Sciences

Type: Treatment

Stage: Emergency use authorization

Name: remdesivir

Background: Gilead Sciences Inc. US:GILDis a longtime drugmaker best known for developing the first major cure for hepatitis-C in Sovaldi, a therapy that changed the standard of care for that disease but also kicked off the national debate about drug pricing. The company has experience developing and marketing HIV drugs, including Truvada for pre-exposure prophylaxis (PrEP), its preventive HIV medicine.

It received an emergency use authorization from the Food and Drug Administration in the U.S. on May 1 based on preliminary results from two clinical trials: one conducted by the NIAID, and one by Gilead. In the NIAID trial, COVID-19 patients taking the drug had a median recovery time of 11 days, compared with 15 days for those patients taking placebo. NIAID director Dr. Anthony Fauci has said the drug is now considered the standard of care; however, other experts have had mixed responses to the data. Dr. Eric Topol, director of the Scripps Research Translational Institute, said he thinks the drug is effective based on the preliminary data that has been made public. ¡§It¡¦s just not that potent,¡¨ he said via email.

The drug was also used in two randomized, controlled clinical trials in China. Results from one trial, which was stopped early, found the drug didn¡¦t produce ¡§statistically significant clinical benefits,¡¨ according to findings published in The Lancet.

Gilead in late March had to halt individual compassionate use requests for remdesivir as outbreaks worsened in the U.S., having provided the investigational therapy to 1,000 patients. ¡§The system cannot support and process the overwhelming number of applications we have seen with COVID-19,¡¨ Gilead CEO Daniel O¡¦Day said March 28.

The company told investors on May 1 it may spend up to $1 billion this year to develop and manufacture remdesivir, and it aims to have 500,000 treatment courses by October and 1 million by the end of 2020.

Gilead¡¦s notable clinical trials:

1. The National Institute of Allergy and Infectious Diseases trial has enrolled patients in a randomized, double-blind, placebo-controlled Phase 3 trial evaluating 1,063 hospitalized patients with COVID-19 at 68 sites worldwide, including at three sites in Singapore and South Korea, according to the NIAID. However, the majority of the study locations are in the U.S. The study began Feb. 21 and is expected to conclude April 1, 2023. Preliminary results from this trial were used to inform the EUA.

2. A Gilead-sponsored randomized, open-label Phase 3 trial is testing remdesivir in 1,600 patients with moderate COVID-19. It previously said it would enroll 600 participants. The trial started enrolling patients in March, with results to come in May. The clinical trial listing states the study is taking place in 13 countries, including Hong Kong, Singapore, South Korea and the U.S.

3. A Gilead-sponsored randomized, open-label Phase 3 trial is evaluating remdesivir in 6,000 patients with severe COVID-19. The drugmaker previously said it planned to include 400 participants in the trial. The trial started enrolling patients in March, and early results based on 397 patients included in the initial phase of the study were used to inform the EUA. The clinical trial listing states the study is taking place in Hong Kong, Singapore, South Korea and the U.S.

Results: The EUA followed two weeks of clinical trial data leaks that sent the company¡¦s stock soaring or tumbling depending on the news. Stat News reported April 16 that University of Chicago Medicine researchers saw ¡§rapid recoveries¡¨ in 125 COVID-19 patients remdesivir, though that data isn¡¦t part of the full clinical trial data set. A week later, Stat and the Financial Times reported that a draft of the clinical trial results for remdesivir showed that the drug didn¡¦t speed up improvement in patients in China or prevent them from dying. The summary was reportedly published by accident on the World Health Organization¡¦s (WHO) website and then taken down.

What¡¦s next: The drugmaker plans to donate 1.5 million vials, about 140,000 10-day courses of treatment, of the drug through June. It also said May 5 that it plans to contract with pharmaceutical manufacturers abroad to ensure access to remdesivir outside of the U.S. The Institute for Clinical and Economic Review, a group that assesses the cost-effectiveness of medicines, said Gilead would need to charge $10 for a course of treatment to recoup its costs, but could be priced as high as $4,500 per course of treatment to be considered effective.

Year-to-date stock performance: Shares of Gilead are up 21.2%.

GlaxoSmithKline

Type: Vaccine, treatment

Name: AS03 adjuvant system for vaccines

Background: GlaxoSmithKline US:GSKis another leading vaccine maker, having brought to market vaccines for human papillomavirus (HPV) and the seasonal flu, among others. It has announced a string of wide-reaching collaborations during the pandemic, most notably a deal with Sanofi to jointly develop a vaccine candidate. (Sanofi is also working with BARDA on a separate vaccine program.) As part of this agreement, Sanofi¡¦s S-protein COVID-19 antigen will be paired with GlaxoSmithKline¡¦s adjuvant technology; the companies expect to launch clinical trials in the second half of the year. Terms of the agreement are expected to be completed this month.

Also in the works: GSK said Feb. 3 that the CEPI-funded University of Queensland will have access to its vaccine adjuvant platform technology, which is believed to both strengthen the response of a vaccine and limit the amount of vaccine needed per dose. A separate deal with Clover Biopharmaceuticals Inc., a Chinese biotechnology company, which was announced in February, is also using its adjuvant technology in combination with its vaccine candidate, COVID-19 S-Trimer, in preclinical studies. Dr. Thomas Breuer, chief medical officer for GSK Vaccines, is leading work on vaccines and the adjuvant platform.

Separately, GSK and Vir Biotechnology Inc. announced a deal in early April, in which GSK made a $250 million equity investment in Vir as the two companies work together to develop two of Vir¡¦s experimental therapies, VIR-7831 and VIR-7832, expected to go to Phase 2 clinical trials sometime in 2020.

Year-to-date stock performance: Shares of GSK have tumbled 11.3%.

Heat Biologics

Type: Vaccine

Stage: Preclinical

Background: Heat Biologics Inc. US:HTBXhas previously announced that it is developing a vaccine for the novel coronavirus with the University of Miami Miller School of Medicine. It disclosed March 17 in a financial filing that its COVID-19 vaccine candidate had been added to the World Health Organization¡¦s ¡§draft landscape¡¨ of 41 candidate vaccines. ¡§We are finalizing completion of the vaccine and plan to commence preclinical testing this quarter,¡¨ Heat CEO Jeff Wolf said in an April 29 statement.

The company also recently joined the Alliance for Biosecurity, which may help it ¡§secure government funding to support its rapid development, production, and distribution¡¨ of its COVID-19 vaccine, according to Maxim Group analysts.

Year-to-date stock performance: Heat¡¦s stock has gained 14.8%.

Inovio Pharmaceuticals

Type: DNA-based vaccine

Timeline: Phase 1 clinical trial

Name: INO-4800

Background: Another CEPI grantee (with roughly $17 million in total awards), Inovio Pharmaceuticals Inc. US:INOis testing its vaccine candidate in a Phase 1 clinical trial at two sites in the U.S.: the Perelman School of Medicine at the University of Pennsylvania and the Center for Pharmaceutical Research in Kansas City, Mo.

Inovio develops immunotherapies and vaccines but hasn¡¦t yet had a product approved for treatment. For INO-4800, preclinical testing was performed between Jan. 23 and Feb. 29. The company began clinical trials in the U.S. with up to 40 participants in April, dosing the first patient on April 6. Inovio said it expects to have the first results from the trial in the fall and to have 1 million doses of the vaccine ready for additional clinical trials or emergency use by the end of the year.

Inovio on March 12 announced a $5 million grant from the Bill & Melinda Gates Foundation to test a delivery device for its vaccine candidate. In late March, Inovio said that Ology Bioservices Inc., a contract development and manufacturing organization, had received a $11.9 million contract from the Department of Defense to support future potential manufacturing of Inovio¡¦s vaccine candidate for military personnel.

Year-to-date stock performance: Shares of Inovio have soared 209.5%.

Johnson & Johnson

Type: Vaccine

Stage: Preclinical

Background: Johnson & Johnson US:JNJannounced Feb. 11 that it was working with BARDA to test its vaccine candidate, with each party providing $1 billion for research and development and the public-health organization funding the Phase 1 trials.

¡§We are also in discussions with other partners, that if we have a vaccine candidate with potential, we aim to make it accessible to China and other parts of the world,¡¨ Dr. Paul Stoffels, J&J¡¦s chief scientific officer, said in a statement.

On March 13, J&J said it started preclinical testing on multiple candidates in collaboration with Beth Israel Deaconess Medical Center in Boston, and by March 30 it had identified a lead vaccine candidate. The company said it is scaling up its vaccine manufacturing capabilities in the U.S. and abroad as part of its commitment to bring ¡§an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use.¡¨

The company aims to put its lead vaccine candidate in a Phase 1 clinical trial in September, the company said March 30, and it may have investigational doses of the vaccine available by early 2021 for emergency use.

Also in the works: J&J said in February that it had partnered with BARDA on a project that aims to screen existing antiviral medications, including experimental or approved therapies, that may be effective against COVID-19. Similar to GSK, J&J¡¦s AdVac and PER. C6 technologies are used to improve the development process for a vaccine and were also used to develop J&J¡¦s experimental Ebola vaccine.

Year-to-date stock performance: Shares of J&J are up 2.6%.

Moderna

Type: RNA-based vaccine

Stage: Phase 1

Name: mRNA-1273

Background: Moderna Inc. US:MRNAreceived funding from CEPI in January to develop an mRNA vaccine against COVID-19. On Feb. 24, it said it had shipped the first batch of mRNA-1273 to the NIAID for a Phase 1 clinical trial in the U.S.

Clinical trials: The first patient in the Phase 1 trial received a dose of the vaccine candidate on March 16. The study is expected to enroll 45 healthy adult patients, between the ages of 18 and 55 years old, in an open-label Phase I clinical trial to test mRNA-1273 as a vaccine for COVID-19. Participants will be followed for one year. The trial, which is expected to conclude June 1, 2021, will be conducted at Kaiser Permanente Washington Health Research Institute in Seattle. CEPI funded the manufacturing of the investigational vaccine for the first phase of the trial, which is evaluating different doses for safety and immune response. A Phase 2 trial is expected to begin in the second quarter.

In mid-April, Moderna said it will receive up to $483 million in BARDA funding to support its vaccine development program. ¡§We believe that we would be able to supply millions of doses a month in 2020 and with further investments, tens of millions a month in 2021, if the vaccine candidate is successful in the clinic,¡¨ Moderna CEO Stéphane Bancel said at the time.

Year-to-date stock performance: Moderna¡¦s shares have gained 146.8%.

Novavax

Type: Vaccine

Stage: Phase 1 clinical trial

Name: NVX-CoV2373

Background: Novavax Inc. US:NVAX,a preclinical biotechnology company, announced Feb. 26 that it had several vaccine candidates in preclinical animal studies. By April 8, the company said it had identified a COVID-19 vaccine candidate, and it plans to initiate a Phase I clinical study in mid-May. The first phase of the placebo-controlled study will enroll 130 healthy adults; the first round of data from that study is expected in July.

In March the company said it had received $4 million from CEPI to develop a COVID-19 vaccine and that Emergent BioSolutions Inc. would support contract development and manufacturing for the experimental vaccine.

Year-to-date stock performance: Its stock has gained 334.4%.

Regeneron Pharmaceuticals

Type: Prevention and treatment

Stage: Preclinical

Name: REGN-COV2

Background: On Feb. 4, Regeneron Pharmaceuticals Inc. US:REGNannounced it is working on developing monoclonal antibodies as treatments for COVID-19, and during a May 5 earnings call it disclosed the name of the treatment, REGN-COV2. The company¡¦s VelocImmune platform uses genetically engineered mice with humanized immune systems in preclinical testing. ¡§We are aiming to have hundreds of thousands of prophylactic doses ready for human testing by end of August,¡¨ a spokesperson said. Christos Kyratsous, vice president of infectious disease R&D and viral vector technology, is running the project.

Clinical trials are expected to begin in June.

Year-to-date stock performance: Regeneron¡¦s shares are up 37.0%.

Regeneron Pharmaceuticals and Sanofi

Type: Treatment

Stage: Phase 2/3 clinical trial

Name: Kevzara

Background: The FDA approved Kevzara, a treatment developed by Regeneron and Sanofi US:SNY,as a therapy for rheumatoid arthritis in 2017 as part of a recently concluded longstanding R&D partnership between the two companies.

Clinical trials: Regeneron and Sanofi said March 16 they had started a Phase 2/3 trial testing Kevzara as a treatment for patients who have been hospitalized with severe COVID-19 infections. This randomized, double-blind, placebo-controlled trial is expected to enroll up to 400 patients and will take place at 16 sites in the U.S. New York¡¦s Mount Sinai Hospital, the first site, has started enrolling patients, according to a company spokesperson.

The aim is to evaluate if the drug lessens patient fevers and their need for supplemental oxygen. The Phase 3 trial will evaluate if Kevzara prevents deaths and reduces need for mechanical ventilation, supplemental oxygen, or hospitalization. Early results from a small 21-person trial in China that haven¡¦t been peer-reviewed found that some patients who were taking a similar drug, Roche Holdings¡¦ Actemra, reported reductions in fever, and 7% of them had a reduced need for supplemental oxygen within days of starting treatment.

Results: On March 30, the companies said the first patient in their global trial had been treated. However, in late April, the companies said they would limit the Phase 3 trial to only include patients defined as critical, which includes those requiring mechanical ventilation, high-flow oxygenation, or being cared for in an intensive care unit, given that sicker patients seemed to show some improvement while taking the drug. The next phase of the study will also only include a higher dose of the drug (400 milligrams) and the placebo, and not the lower dose of 200 milligrams used in the mid-stage trial.

Roche

Type: Treatment

Stage: Phase 3 clinical trial

Name: Actemra

Background: Roche Holdings AG¡¦s CH:ROGActemra was first approved in 2010 as a rheumatoid arthritis drug. The Swiss drugmaker has initiated a Phase 3 clinical trial evaluating Actemra as a treatment for patients with COVID-19 who have been hospitalized with severe pneumonia. Roche began enrolling around 330 patients in early April, at 55 sites in the U.S. and elsewhere in the world. The company plans to examine patient mortality and need for mechanical ventilation or an intensive care unit stay among other primary and secondary endpoints. On April 3, the first patients in the trial, which is in partnership with BARDA, were treated, a Roche spokesperson said by email. Results are expected in early summer, the company said April 22.

Also in the works: Roche has developed a diagnostic and an antibody test for COVID-19. Both have received EUAs from the FDA.

Year-to-date stock performance: Roche¡¦s stock is down 1.3%.

­

Sanofi

Type: Vaccines

Stage: Preclinical

Name: No name yet

Background: Starting Feb. 18, Sanofi is working with BARDA to test a preclinical vaccine candidate for severe acute respiratory syndrome (SARS) for COVID-19 using its recombinant DNA platform. A spokesperson said Sanofi aims to put a vaccine into a Phase 1 clinical trial between March 2021 and August 2021. It announced a separate program with Translate Bio Inc. US:TBIOon March 27 to develop a mRNA vaccine.

The French drugmaker has a long history of producing vaccines in its Sanofi Pasteur business and acquired this candidate through its 2017 acquisition of Protein Sciences for $750 million. It previously worked with the organization on flu vaccines. Scientists in Meriden, Ct., are working on the vaccine; David Loew, Sanofi Pasteur¡¦s EVP, is leading the project.

Year-to-date stock performance: Shares of Sanofi are down 0.7%.

Takeda Pharmaceutical

Type: Treatment

Stage: Preclinical

Name: TAK-888

Background: Japanese drugmaker Takeda Pharmaceutical Co. Ltd. US:TAK JP:4502 said March 4 that it plans to test hyperimmune globulins for people who are at high risk for infection.

As part of its research, which will be performed in Georgia, Takeda said it would need access to plasma from people who have recovered from COVID-19 or those who have received a vaccine if one is developed. Dr. Rajeev Venkayya, president of Takeda¡¦s vaccine business, is the co-lead of the company¡¦s COVID-19 response team. In April, Takeda and CSL Behring US:CSLLYsaid they formed an alliance to develop a plasma-derived treatment for COVID19. Biotest AG and Octapharma also joined the alliance.

Also in the works: Like J&J, Takeda plans to examine whether other therapies, both experimental or with regulatory approval, may have treatment potential.

Year-to-date stock performance: Shares of Takeda are down 10.0%.

Vaxart

Type: Vaccine

Stage: Preclinical

Background: Vaxart Inc. US:VXRTwas one of the first companies to announce plans to develop a vaccine when it did so Jan. 31. In March, the clinical-stage company announced that Emergent BioSolutions will help develop and manufacture its oral vaccine candidate.

¡§We believe an oral vaccine administered using a room temperature-stable tablet may offer enormous logistical advantages in the rollout of a large vaccination campaign,¡¨ Vaxart CEO Wouter Latour said in a March 18 news release.

The company plans to start a Phase 1 clinical trial in the U.S. in the second half of 2020, a company executive said. As of March 31, it has five vaccine candidates for preclinical testing.

Year-to-date stock performance: Vaxart¡¦s stock is up 621.8%.

Vir Biotechnology

Type: Treatments

Stage: Preclinical

Name: VIR-2703 (also called ALN-COV), VIR-7831 and VIR-7832

Background: Vir Biotechnology Inc. US:VIRhas two preclinical treatment candidates, VIR-7831 and VIR-7832, and on May 4 said it had identified a treatment candidate as part of a partnership with Alnylam Pharmaceuticals Inc. US:ALNY.The companies said they aim to file for an investigational new drug application by the end of 2020, before the proposed inhaled treatment or prevention therapy would enter trials.

Also in the works: In many ways, Vir has been one of the most prolific partners in the biotech field during the pandemic. The preclinical company is run by George Scangos, the former CEO of Biogen Inc. US:BIIB.Starting Feb. 25, it said it was collaborating with Shanghai-based WuXi Biologics to test monoclonal antibodies as a treatment for COVID-19. If the treatment is approved, WuXi will commercialize it in China, while Vir will have marketing rights for the rest of the world. It later announced a partnership with Biogen to help develop and manufacture its monoclonal antibodies as a potential treatment for COVID-19. Biogen will handle clinical manufacturing of Vir¡¦s antibodies, the company said. Vir later announced a research agreement with Generation Bio as part of its COVID-19 antibody development program. Most recently, it announced the equity investment from GSK.

Year-to-date stock performance: Vir shares have jumped 138.2%.

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Efficacy and Safety of Lebrikizumab, a High-Affinity Interleukin 13 Inhibitor, in Adults With Moderate to Severe Atopic Dermatitis

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Singapore reports 618 new coronavirus cases, taking total to 12,693

By REUTERS APRIL 25, 2020 10:33 Email Twitter Facebook fb-messenger

April 25 - Singapore has registered 618 new coronavirus infections, its health ministry said on Saturday, taking the city-state¡¦s total number of COVID-19 cases to 12,693.

The vast majority of the new cases are migrant workers living in dormitories, the health ministry said in a statement. Seven are permanent residents.

The island of 5.7 million people now has one of the highest infection rates in Asia, according to official figures.

www.jpost.com/breaking-news/singapore-reports-618-new-coronavirus-cases-taking-total-to-12693-625844

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Dupixent/Dupilumab generated sales of £á776 million in the quarter, up 129.8%.

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·s¿A¦è¦{²ö¨½´µ¥­­ì©M¯Ã¬ù¦{¯Ã¬ù¥«¡A2018¦~1¤ë8¤é¡X Immunomedics¡AInc.¡]¯Ç´µ¹F§JªÑ²¼¥N½X¡GIMMU¡^¡]¡§ Immunomedics¡¨©Î¡§¤½¥q¡¨¡^¡ARoyalty Pharma¤µ¤Ñ«Å¥¬¡AImmunomedics¤w¦P·N¥X°â°ò©ó¾P°âªº¤À¼h²£«~±Nsacituzumab govitecan¦b¥þ²y²b¾P°âÃB¤¤¥H1.75»õ¬ü¤¸ªº¯S³\Åv¨Ï¥Î¶O¡C

Royalty PharmaÁÙ¥H¨CªÑ17.15¬ü¤¸ªº»ù®æÁʶR¤F7500¸U¬ü¤¸ªºImmunomedics´¶³qªÑ¡A¸û¸ÓªÑ²¼15¤Ñªº°l踪¥­§¡¦¬½L»ù·¸»ù15¢H¥H¤W¡C

³oµ§2.5»õ¬ü¤¸ªº¸êª÷¬°Immunomedics´£¨Ñ¤F¸ê·½¡A¥H¤ä«ù¸Ó¤½¥qªº¤U¤@¶¥¬qµo®i¡A¦]¬°¸Ó¤½¥q±Mª`©ó¶}µoÂಾ©Ê¤T³±©Ê¨Å¸¢Àù¡]TNBC¡^¡A±ß´Á§¿¸ô¤W¥ÖÀù©M¨ä¥L¦³°ª«×ÂåÀø»Ý¨Dªº¸ñ¶Hªºsacituzumab govitecan¡A¨Ã¶i¤@¨B«Ø¥ßÁ{§É¡AÂåÀø¨Æ°È¡A°Ó·~©M»s³y°ò¦³]¬I¡C¨C¦~³Ì°ª20»õ¬ü¤¸ªº²b¾P°âÃBªº¯S³\Åv¨Ï¥Î¶O²v¬°4.15¢H¡A«ö¾P°âÃB¼h¯Å³v¨B­°§C¡A¦Ó¶W¹L60»õ¬ü¤¸ªº¥þ²y²b¦~«×¾P°âÃBªº¯S³\Åv¨Ï¥Î¶O²v¬°1.75¢H¡C³o¶µ¥æ©ö±N´£¨Ñ¨¬°÷ªº²{ª÷¨Ó¬°2020¦~ªº¹BÀç´£¨Ñ¸êª÷¡C

¡§ Royalty Pharmaªº§ë¸ê¤ä«ù¤F§Ú­Ì¦bImmunomedicsªº¬J©w¾Ô²¤¡A¦¨¬°¤@®a§¹¥þ¾ã¦Xªº¥Íª«»sÃĤ½¥q¡A¨Ã¥B¬O§ÜÅé-ÃĪ«µ²¦Xª«»â°ì¤½»{ªº»â¾ÉªÌ¡A¡¨ ImmunomedicsÁ`µô­Ý­º®u°õ¦æ©xMichael Pehlµû½×¹D¡C ¡§³o¶µ¨óij¨Ï§Ú­Ìªº·~°È½d³ò¶W¥X¤F¨m苷³æÃÄgovitecan¥Î©óÂಾ©ÊTNBCªº§å­ã©Mªì¨B°Ó·~¤Æ¡A¨Ã¬°§Ú­Ì´£¨Ñ¤F¥Î©ó§¹¾ãÁ{§É©M°Ó·~°ò¦³]¬Iªº¥²­n¸ê·½¡C Royalty Pharma¦bÃѧOÀu¨q²£«~¤è­±¾Ö¦³¨}¦nªº°O¿ý¡A§Ú­Ì´Á«Ý»P¥L­Ì¦X§@¡A¦]¬°§Ú­Ì±NÄ~Äò¶}µo§Ú­Ìªºsacituzumab govitecan©M¨ä¥LÃĪ«¡A¥H§ïµ½Ãø¥HªvÀøªºÀù¯g±wªÌªºÀø®Ä¡C¡¨

¯Á«D§´¯]³æ§Ügovitecan¬O¥Ø«e¸~½F¾Ç¤¤³Ì¿E°Ê¤H¤ßªº¹v¦VÀøªk¤§¤@¡C Royalty Pharma³Ð©l¤H­Ý­º®u°õ¦æ©xPablo Legorretaªí¥Ü¡G¡§¥¦¨ã¦³º¡¨¬Âಾ©ÊTNBC±wªÌ¥¼º¡¨¬ªºÂåÀø»Ý¨Dªº¥¨¤j¼ç¤O¡A§Ú­Ì¬Û«H¼vÅT³\¦h±wªÌªº¨ä¥L¸~½F¡¨¡C ¡§§Ú­Ì«Ü°ª¿³»PImmunomedicsÄâ¤â¶i¦æ³o¶µ¤¬´f¤¬§Qªº¥æ©ö¡A¥H¶i¤@¨B±Nsacituzumab govitecan±À¦V¦hºØ¾AÀ³¯g¡A¥Ø«eªvÀø¤èªk¦³­­¡AµLªk¹ï±wªÌ¡A§ë¸êªÌ©M§Q¯q¬ÛÃöªÌ²£¥Í¿n·¥¼vÅT¡C¡¨

§K¬Ì²Õ¾Ç©e­û·|¥D®uBehzad Aghazadeh³Õ¤h»¡¡G¡§©e­û·|¦b¹L¥hªº´X­Ó¤ë¤¤¤@ª½¦b±´¯Á²³¦h¾÷·|¡A¬°§Ú­Ì´£¨Ñ¤F¥²­nªº°]°È¸ê·½¨Ó°õ¦æ§Ú­Ìªº·~°È­«ÂI¡C¡¨ ¡§¤µ¤Ñ«Å¥¬ªº»PRoyaltyÃÄ·~¹F¦¨ªº¨óij·íµM²Å¦X¸Ó¼Ð·Ç¡A¦ý­«­nªº¬O¡AÀHµÛ§Ú­ÌÄ~Äò±´¯Á¾÷·|¡A¥H¹ê²{ªÑªF»ù­È³Ì¤j¤Æ¡A³o¤]«O«ù¤F¤½¥qªº¾Ô²¤ÆF¬¡©Ê¡C¡¨

½Ð°Ñ¾\¤µ¤Ñ­n´£¥æªº¦³Ãö8-Kªí®æªº³Ì·s³ø§i¡A¥H¶i¤@¨B¤F¸Ñ¥æ©ö¨óijªº±ø´Ú¡A¥]¬A¨ä¤¤©Ò­zªº¬Y¨Ç³q¸ÜÅv©MÂù¤èªº²×¤îÅv¡C

DLA Piper LLP¡]¬ü°ê¡^¾á¥ôImmunomedicsªºªk«ßÅU°Ý¡AGoodwin Procter LLP¾á¥ôRoyalty Pharmaªºªk«ßÅU°Ý¡C

Morris Plains, N.J. and New York, N.Y. January 8, 2018 ¡X Immunomedics, Inc., (NASDAQ: IMMU) (¡§Immunomedics¡¨ or the ¡§Company¡¨) and Royalty Pharma today announced that Immunomedics has agreed to sell tiered, sales-based royalty rights on global net sales of sacituzumab govitecan to Royalty Pharma for $175 million. Royalty Pharma has also purchased $75 million in common stock of Immunomedics, at $17.15 per share, which represents a more than 15% premium over the stock¡¦s 15-day trailing average closing price.

This $250 million funding provides Immunomedics the resources to support the Company¡¦s next phase of growth as it focuses on developing sacituzumab govitecan in metastatic triple-negative breast cancer (TNBC), advanced urothelial cancer and other indications of high medical need and on further building its clinical, medical affairs, commercial and manufacturing infrastructure. The royalty rate commences at 4.15 percent on net annual sales of up to $2 billion, declining step-wise based on sales tiers to 1.75 percent on net global annual sales exceeding $6 billion. This transaction will provide sufficient cash to fund operations into 2020.

¡§The investment by Royalty Pharma supports our stated strategy at Immunomedics of becoming a fully integrated biopharmaceutical company and a recognized leader in the field of antibody- drug conjugates,¡¨ commented Michael Pehl, President and Chief Executive Officer of Immunomedics. ¡§This agreement extends our runway beyond the approval and initial commercialization of sacituzumab govitecan for metastatic TNBC and provides us with the necessary resources for a full clinical and commercial infrastructure. Royalty Pharma has a strong track record of identifying outstanding products, and we look forward to working with them as we continue to advance sacituzumab govitecan and other drugs in our pipeline to improve the outcomes of patients with hard to treat cancers.¡¨

¡§Sacituzumab govitecan is one of the most exciting targeted therapies currently in development in oncology. It holds great potential to fulfil the unmet medical need for patients with metastatic TNBC, and we believe for other tumors affecting many patients,¡¨ remarked Pablo Legorreta, Founder & Chief Executive Officer of Royalty Pharma. ¡§We are excited to join forces with Immunomedics in this mutually beneficial transaction to further advance sacituzumab govitecan into multiple indications with currently limited treatment options to positively impact patients, investors and stakeholders.¡¨

¡§The Board over the past several months has been exploring a multitude of opportunities that provide us with the requisite financial resources to execute on our business priorities,¡¨ said Dr. Behzad Aghazadeh, Chairman of the Board of Immunomedics. ¡§The agreement with Royalty Pharma announced today certainly meets that criteria, while importantly, also maintains the strategic flexibility of the Company, as we continue to explore opportunities to maximize shareholder value.¡¨

Please refer to the current report on Form 8-K to be filed today for a further description of the terms of the transaction agreements, including certain call rights and termination rights of the parties as described therein.

DLA Piper LLP (US) served as legal advisor to Immunomedics and Goodwin Procter LLP acted as legal advisors to Royalty Pharma on the transaction.

www.immunomedics.com/our-company/news-and-events/immunomedics-royalty-pharma-announce-royalty-funding-stock-purchase-agreements-totalling-250-million/

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