Photocure fundamentale forhold (PHO)

[TekBot]

08/04-2019 11:15:06: (PHO) Photocure: New Data on Cysview® to be presented at the upcoming AUA 2019 Annual Meeting

On the booth urologists will have the opportunity to experience BLC with Cysview, using both the rigid and flexible equipment.

BLC with Cysview will also be presented during plenary and poster sessions at the AUA annual meeting including:
…

Vis børsmeldingen

May 3, 2019 (FRIDAY)

·  10:25 AM to 11:40 AM: Blue Light Cystoscopy for the diagnosis of Bladder Cancer by Dr. Badrinth Konety from University of Minnesota (Minneapolis, MN), MCP S105
·  4:45PM - 5:45 PM: Surgical Techniques: Tips & Tricks: Oncology Dr. Lotan, UTSW, (Dallas Tx) will present BLC with Cysview Flexible during the session W375e

May 4, 2019 (SATURDAY)

·  3:30 PM - 5:30 PM: Poster presentation: Flexible Blue Light Cystoscopy with Hexaminolevulinate provides opportunity to finalize Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer in the Outpatient Clinic. Results from a Nordic Registry Study, W181ab

About Bladder Cancer
Bladder cancer is the sixth most commonly diagnosed cancer in the US and is the fourth most common cancer found in men in the US.(1, 2) It is estimated that there will be 80,470 new cases of bladder cancer and 17,670 deaths due to bladder cancer in 2019.(3) Risk factors for bladder cancer include advancing age, cigarette smoking, occupational exposure to dyes, tar, rubber and solvent, and chronic bladder irritation and infections.(4) Bladder cancer is one of the most expensive cancers to manage. It is estimated that upwards of $5.71 billion will be spent on bladder cancer in the US in the year 2020.(5)

Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall.(4) NMIBC is in the inner layer of cells.(3) These cancers are the most common (75%) of all bladder cancer cases and include the subtypes carcinoma in situ (CIS), Ta and T1 lesions.(5) MIBC is when the cancer has grown into deeper layers of the bladder wall.(2) These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat.(6) 

About Hexvix®/Cysview® (hexaminolevulinate HCl)
Hexvix®/Cysview® is a drug that is selectively taken up by tumor cells in the bladder making them glow bright pink during Blue Light Cystoscopy (BLCTM). BLC™ with Hexvix® /Cysview® improves the detection of tumors and leads to more complete resection, fewer residual tumors and better management decisions.

Cysview® is the tradename in the US and Canada, Hexvix® is the tradename in all other markets. Photocure is commercializing Cysview® /Hexvix® directly in the US and the Nordic region and has strategic partnerships for the commercialization of Hexvix®/Cysview® in Europe, Canada, Australia and New Zealand. Please refer to https://bit.ly/2wzqSQQ for further information on our commercial partners.

All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA.

For more information, please contact:

Dan Schneider
President and CEO
Photocure ASA
Tel: + 1-609 759-6515
Email: ds@photocure.com

Erik Dahl
CFO
Photocure ASA
Tel: +4745055000
Email: ed@photocure.com

About Photocure ASA
Photocure: The Bladder Cancer Company delivers transformative solutions to improve the lives of bladder cancer patients. Our unique technology, which makes cancer cells glow bright pink, has led to better health outcomes for patients worldwide. Photocure is headquartered in Oslo, Norway, and listed on the Oslo Stock Exchange (OSE: PHO). For more information, please visit us at www.photocure.com, www.hexvix.com or www.cysview.com 

---

1 National Cancer Institute. SEER Stat Facts: Bladder Cancer 2017. https://seer.cancer.gov/statfacts/html/urinb.html. Accessed on January 25, 2019.

 (http://#_ftnref2)2 American Cancer Society’s (ACS) publication. Cancer Facts and Figures 2017: Special Section - Rare Cancers in Adults, and the ACS website. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2017/cancer-facts-and-figures-2017.pdf.  Accessed on March 25, 2019.

3 American Cancer Society. Key Statistics for Bladder Cancer 2019. https://www.cancer.org/cancer/bladder-cancer/about/key-statistics.html. Accessed on March 25, 2019.

 (http://#_ftnref4)4 American Cancer Society. Bladder Cancer. http://www.cancer.org/cancer/bladdercancer/detailedguide/bladder-cancer-additional. Accessed on March 25, 2019.

 (http://#_ftnref5)5 Mariotto AB, Yabroff KR, Shao Y, Feuer EJ, Brown ML. Projections of the cost of cancer care in the United States: 2010-2020. J Natl Cancer Inst. 2011;103(2):117-28.

 (http://#_ftnref6)6 Pulver D, Schoenberg M, Pulver F. Bladder Cancer: A Patient-Friendly Guide to Understanding Your Diagnosis and Treatment Options. Patient-Friendly Publishing; 2017.

http://www.netfonds.no/quotes/release.php?id=20190408.Cision.20190408:BIT:1493:0

[Savepig]

@Rodjer fikk gehør hos photocure ir ser vi, det er flott!

About Bladder Cancer
Bladder cancer is the sixth most commonly diagnosed cancer in the US and is the fourth most common cancer found in men in the US.(1, 2) It is estimated that there will be 80,470 new cases of bladder cancer and 17,670 deaths due to bladder cancer in 2019.(3) Risk factors for bladder cancer include advancing age, cigarette smoking, occupational exposure to dyes, tar, rubber and solvent, and chronic bladder irritation and infections.(4) Bladder cancer is one of the most expensive cancers to manage. It is estimated that upwards of $5.71 billion will be spent on bladder cancer in the US in the year 2020.(5)

[Rodjer]

Savepig,
Ja vi fikk gehør og Schneider gjorde som han lovet og dette lover bra for fortsettelsen.

[tekdude]

det var ikke småtteri av et beløp heller, 5.71 milliarder dollar…

[Gheno]

Shorten er redusert fra 259.768 (1,19%) til 236.096 (1,08%)

[TekBot]

09/04-2019 16:45:00: (PHO) Update on BLC™ with Hexvix® from The Australian Government Department of Health

“The new listings from the Australian Government Department of Health is an important recognition and a promising first step in our efforts to achieve full reimbursement, making Hexvix accessible to more patients in Australia. Photocure sees great opportunities in Australia and our partner Juno will be applying for reimbursement of the drug in the near future,” says Dan Schneider, President and CEO of Photocure.

Blue Light Cystoscopy with hexaminolevulinate for improved diagnosis, treatment and management of non-muscle invasive bladder cancer will from May 1,2019 be listed under new medical benefit schedule (MBS) items giving additional fees for the use of Hexvix with rigid cystoscopes compared to white light rigid cystoscopy alone.
…

Vis børsmeldingen

Four new MBS items have been established specifically for Hexvix rigid cystoscopy: Two covering Hexvix rigid cystoscopy with biopsy and ureteroscopy, and two covering rigid cystoscopy with resection.

“When Blue Light Cystoscopy with Hexvix is used with a rigid cystoscope the providers will bill and get reimbursement for the instillation procedure. This is an additional reimbursement compared to using white light cystoscopy alone, and an instillation specific fee for the BLC procedure. We look forward to continuing to work with Juno and the Australian authorities towards our goal of full reimbursement”, Schneider concludes.

Link to announcement (https://www.legislation.gov.au/Details/F2019L00502)

About Hexvix®/Cysview® (hexaminolevulinate HCl)
Hexvix®/Cysview® is a drug that is selectively taken up by tumor cells in the bladder making them glow bright pink during Blue Light Cystoscopy (BLCTM). BLC™ with Hexvix® /Cysview® improves the detection of tumors and leads to more complete resection, fewer residual tumors and better management decisions.

Cysview® is the tradename in the US and Canada, Hexvix® is the tradename in all other markets. Photocure is commercializing Cysview® /Hexvix® directly in the US and the Nordic region and has strategic partnerships for the commercialization of Hexvix®/Cysview® in Europe, Canada, Australia and New Zealand. Please refer to https://bit.ly/2wzqSQQ for further information on our commercial partners.

All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA. 

For more information, please contact:
Dan Schneider
President and CEO
Photocure ASA
Tel: + 1-609 759-6515
Email: ds@photocure.com

Erik Dahl
CFO
Photocure ASA
Tel: +4745055000
Email: ed@photocure.com

About Photocure ASA
Photocure: The Bladder Cancer Company delivers transformative solutions to improve the lives of bladder cancer patients. Our unique technology, which makes cancer cells glow bright pink, has led to better health outcomes for patients worldwide. Photocure is headquartered in Oslo, Norway, and listed on the Oslo Stock Exchange (OSE: PHO). For more information, please visit us at www.photocure.com, www.hexvix.com or www.cysview.com 

http://www.netfonds.no/quotes/release.php?id=20190409.Cision.20190409:BIT:3185:0

[TekBot]

09/04-2019 16:45:06: (PHO) Update on BLCT with Hexvix® from The Australian Government Department of Health

Oslo, Norway, April 9, 2019:

Photocure ASA (PHO:OSE) today announces that Blue Light Cystoscopy (BLCT)
…

Vis børsmeldingen

procedures with Hexvix® will be reimbursed in Australia from May 1, 2019,
following new listings from the Australian Government Department of Health.
“The new listings from the Australian Government Department of Health is an
important recognition and a promising first step in our efforts to achieve full
reimbursement, making Hexvix accessible to more patients in Australia. Photocure
sees great opportunities in Australia and our partner Juno will be applying for
reimbursement of the drug in the near future,” says Dan Schneider, President and
CEO of Photocure.

Blue Light Cystoscopy with hexaminolevulinate for improved diagnosis, treatment
and management of non-muscle invasive bladder cancer will from May 1,2019 be
listed under new medical benefit schedule (MBS) items giving additional fees for
the use of Hexvix with rigid cystoscopes compared to white light rigid
cystoscopy alone.

Four new MBS items have been established specifically for Hexvix rigid
cystoscopy: Two covering Hexvix rigid cystoscopy with biopsy and ureteroscopy,
and two covering rigid cystoscopy with resection.

“When Blue Light Cystoscopy with Hexvix is used with a rigid cystoscope the
providers will bill and get reimbursement for the instillation procedure. This
is an additional reimbursement compared to using white light cystoscopy alone,
and an instillation specific fee for the BLC procedure. We look forward to
continuing to work with Juno and the Australian authorities towards our goal of
full reimbursement”, Schneider concludes.

Link to announcement (https://www.legislation.gov.au/Details/F2019L00502)

About Hexvix®/Cysview® (hexaminolevulinate HCl)
Hexvix®/Cysview® is a drug that is selectively taken up by tumor cells in the
bladder making them glow bright pink during Blue Light Cystoscopy (BLCTM). BLCT
with Hexvix® /Cysview® improves the detection of tumors and leads to more
complete resection, fewer residual tumors and better management decisions.

Cysview® is the tradename in the US and Canada, Hexvix® is the tradename in all
other markets. Photocure is commercializing Cysview® /Hexvix® directly in the US
and the Nordic region and has strategic partnerships for the commercialization
of Hexvix®/Cysview® in Europe, Canada, Australia and New Zealand. Please refer
to https://bit.ly/2wzqSQQ for further information on our commercial partners.

All trademarks mentioned in this release are protected by law and are registered
trademarks of Photocure ASA.

For more information, please contact:
Dan Schneider
President and CEO
Photocure ASA
Tel: + 1-609 759-6515
Email: ds@photocure.com

Erik Dahl
CFO
Photocure ASA
Tel: +4745055000
Email: ed@photocure.com

About Photocure ASA
Photocure: The Bladder Cancer Company delivers transformative solutions to
improve the lives of bladder cancer patients. Our unique technology, which makes
cancer cells glow bright pink, has led to better health outcomes for patients
worldwide. Photocure is headquartered in Oslo, Norway, and listed on the Oslo
Stock Exchange (OSE: PHO). For more information, please visit us at
www.photocure.com, www.hexvix.com or www.cysview.com

http://www.netfonds.no/quotes/release.php?id=20190409.OBI.20190409S85

[Sponplate]

Ikke første gang det har vært et opphold i nye registreringer på cysview.com. Får håpe det kommer en god bolk igjen snart.

[TekBot]

17/04-2019 08:00:26: (PHO) Photocure ASA - Notice of the annual general meeting 9 May 2019

Oslo, 17 April 2019: Photocure ASA (OSE: PHO), calls for the annual general
meeting of PHO to be held at Hoffsveien 4, 1st floor, 0275 Oslo, Norway on 9 May
2019 at 17:00 hours (CET).
…

Vis børsmeldingen

The notice convening the general meeting, including the agenda and the board’s
proposals to the matters to be dealt with, is enclosed with this notification
and will be sent to all shareholders with known addresses.

Relevant documents referred to in the notice are made available on
www.photocure.com.

For further information, please contact:

Photocure

CFO Erik Dahl
Tel: +47 450 55 000, Email: ed@photocure.com

About Photocure ASA

Photocure: The Bladder Cancer Company delivers transformative solutions to
improve the lives of bladder cancer patients. Our unique technology, which makes
cancer cells glow bright pink, has led to better health outcomes for patients
worldwide. Photocure is headquartered in Oslo, Norway, and listed on the Oslo
Stock Exchange (OSE: PHO). For more information, please visit us at
www.photocure.com, www.hexvix.com or www.cysview.com

This information is subject to the disclosure requirements pursuant to section 5
-12 of the Norwegian Securities Trading Act.

PHO AGM 2019 NOTICE -
ENG (https://mb.cision.com/Public/17498/2790676/9fc633b12d623d37.pdf) PHO AGM
2019 NOTICE -
NOR (https://mb.cision.com/Public/17498/2790676/a27c501224b23cd6.pdf)

http://www.netfonds.no/quotes/release.php?id=20190417.OBI.20190417S10

[TekBot]

17/04-2019 08:00:30: (PHO) Photocure ASA - Annual accounts 2018

Oslo, 17 April 2019: Photocure ASA (OSE: PHO), has published the annual accounts
and annual report for the financial year 2018.
The Company’s annual accounts for the financial year 2018, including the
…

Vis børsmeldingen

financial statements and annual report for the financial year 2018, are together
with the auditor’s report attached to this notice.

The documents are also available at the Company’s website, www.photocure.com.

For further information, please contact:
Photocure

CFO Erik Dahl
Tel: +47 450 55 000, Email: ed@photocure.com

About Photocure ASA

Photocure: The Bladder Cancer Company delivers transformative solutions to
improve the lives of bladder cancer patients. Our unique technology, which makes
cancer cells glow bright pink, has led to better health outcomes for patients
worldwide. Photocure is headquartered in Oslo, Norway, and listed on the Oslo
Stock Exchange (OSE: PHO). For more information, please visit us at
www.photocure.com, www.hexvix.com or www.cysview.com

This information is subject to the disclosure requirements pursuant to section 5
-12 of the Norwegian Securities Trading Act.

PHO ANNUAL REPORT
2019 (https://mb.cision.com/Public/17498/2790692/aa27af5321a10822.pdf)

http://www.netfonds.no/quotes/release.php?id=20190417.OBI.20190417S11

[Rodjer]

https://www.auajournals.org/doi/abs/10.1097/01.JU.0000556229.36701.e5?fbclid=IwAR2y_1-SyX0h5alil7x6Nkb8VSyYBjEUHlgE1BnkMPR367rk1HGJhsHwfMk&

[Savepig]

Hovedkonkurrenten:

Olympus Urology Europe (OlympusUrology)

[Bingo123]

Tøff konkurrent ?

[Rodjer]

Det er en konkurrent, men BLC er WL og NBI overlegen.
Utfra Schneider sine uttalelser er det nok ikke usannsynlig at PHO på et tidspunkt inngår samarbeid med Olympus også.
Om dette har blitt uttalt for å presse KS eller om det er reelt vites ikke, men mener bestemt at det er dialog.

[Bingo123]

Hvis produktene til Photocure er helt overlegne, hva er da grunnen til at Olympus i det hele tatt holder på? Er det soleklart for alle at blålys fra photocure er vinneren?

[Rodjer]

Det finnes lassevis av artikler om dette og jeg har ikke anledning å finne dem fram nå, men denne hadde jeg liggende så du kan starte med den.

NBI (Narrow Band Imaging) er en annen teknologi innen enhanced cystocopy
FDA gir BLC grade B, mens NBI bare får Grade C.

https://www.urologytimes.com/genitourinary-cancers/point-stand-alone-white-light-cystoscopy-thing-past

Blc er dyrere i bruk, men når det gjelder å overleve og å beholde blæren er det ikke tvil om at Blc gir pasientene størst sjanse.

[Snoeffelen]

NBI hadde ikke god nok klinisk dokumentasjon til å få refusjon, BLC har overbevisende klinisk dokumentasjon og får refusjon.

[Londonmannen]

Slik er fet med den saken.

Vi går nå inn i slutten av april og like inn i mai kommer Q1. Noe overskudd blir det ikke, men spennende å høre siste nytt om problemene KS hadde høsten 2018 og utpå vinteren 2019, samt antall nye scope utplassert. Men tviler på at det er nok sprengstoff til at det skjer noe revolusjonerende med kursen. Må nok vente til uti 2H før det drar seg til.

[TekBot]

25/04-2019 09:43:57: (PHO) Photocure - Urology Experts publish guidelines for best use of BLC with Cysview® in the surveillance of bladder cancer

An expert panel published their consensus opinion regarding when and how to use Cysview, to detect bladder cancer using a flexible cystoscope. Link: Nature Reviews Consensus (https://go.nature.com/2GxBrWB)

The expert panel of Urologists discussed key factors that must be considered to use BLC with Cysview in everyday practice after an extensive review of literature, their key conclusions were:
…

Vis børsmeldingen

A strong recommendation for:

· the first follow-up cystoscopy at 3 months after TURBT for intermediate and high-risk patients
· at the 3 and 6 months surveillance cystoscopy, and then every 6 months for high risk patients in the first two years

Most recommended:

· prior to intravesical therapy if there is concern for residual disease after TURBT
· use at time of office fulguration and/or biopsy for low grade tumors

In addition, it was concluded that BLC with Cysview may have a role in evaluating patients with a positive cytology or equivocal lesions on WLC.

“BLC with Cysview has been included in the AUA/SUO guidelines since 2016, and has strong data supporting its use to improve detection of cancer over white light cystoscopy. The 2019 Nature publication provides a road map for when to use BLC with Cysview during office cystoscopy as well as how to integrate it into clinical practice.  The University of Texas Southwestern (UTSW) was the first hospital in the United States to integrate Cysview into the clinic setting for surveillance cystoscopy as well as for TURBT in the operating room.  By using BLC with Cysview for patients in surveillance patient outcomes should improve and provide benefits to patients and those managing Non-Muscle Invasive Bladder Cancer (NMIBC),” says Dr. Yair Lotan M.D., Professor of Urology Helen J. and Robert S, Strauss Professorship in Urology, UTSW and the lead author on the Consensus paper.

“The expanded US label for BLC with Cysview being supported by practical recommendations for use means that more patients will have access to better management of their disease. This is an important step towards our vision of driving change in bladder cancer management,” commented Dan Schneider, President and Chief Executive Officer of Photocure ASA.

About Bladder Cancer
Bladder cancer is the fifth most commonly diagnosed cancer in the US and is the fourth most common cancer found in men in the US1, 2, 3. In 2018, it is estimated that there will be 81,190 new cases of bladder cancer will occur along with 17,240 deaths due to bladder cancer. Risk factors for bladder cancer include advancing age, cigarette smoking, occupational exposure to dyes, tar, rubber and solvent, chronic bladder irritation and infections, and prior diagnosis of bladder cancer. Bladder cancer is one of the most expensive cancers to manage, accounting for approximately $3.7 billion in direct costs each year4,5

Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall.2 NMIBC is still in the inner layer of cells. These cancers are the most common (75%) of all BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. MIBC is when the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat.2 

About Hexvix®/Cysview®
Hexvix ®/Cysview® is a drug that is selectively taken up by cancer cells in the bladder making them glow bright pink during Blue Light Cystoscopy (BLC™). BLC™ with Hexvix® /Cysview® improves the detection of tumors and leads to more complete resection, less residual tumors and better management decisions.

Cysview® is the tradename in the US and Canada, Hexvix® is the tradename in all other markets. Photocure is commercializing Cysview® /Hexvix® directly in the US and the Nordic region and has strategic partnerships for the commercialization of Hexvix® /Cysview® in Europe, Canada, Australia and New Zealand. Please refer to http://bit.ly/PHOPartners for further information on our commercial partners.

All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA. 

About Photocure ASA
Photocure, The Bladder Cancer Company, delivers transformative solutions to improve the lives of bladder cancer patients. Our unique technology, which makes cancer cells glow bright pink, has led to better health outcomes for patients worldwide. Photocure is headquartered in Oslo, Norway, and listed on the Oslo Stock Exchange (OSE: PHO). The US headquarters for Photocure Inc., are in Princeton, New Jersey. For more information, please visit us at www.photocure.com, www.hexvix.com or www.cysview.com 

For further information, please contact:         

President and CEO, Daniel Schneider
Tel: +1 5084108044
E-mail: ds@photocure.com

CFO Erik Dahl
Tel: +47 450 55 000
E-mail: ed@photocure.com

1. SEER Cancer Statistics Factsheets: Bladder Cancer. National Cancer Institute. Bethesda, MD. https://seer.cancer.gov/statfacts/html/urinb.html. Accessed April 2018.

2. Bladder Cancer. American Cancer Society. http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf. Accessed April 2018.

3. Hall M, Chang S, Dalbagni G et al. Guideline for the Management of Nonmuscle Invasive Bladder Cancer (Stages Ta, T1, and Tis): 2007 Update. J Urol. 2007;178 (6):2314-2330.

4. Avritscher EB et al., Clinical model of lifetime cost of treating bladder cancer and associated complications. Urology. 2006; 68:549-553.

5. Botteman et al. Clinical model of lifetime costs of treating bladder cancer: a comprehensive review of the published literature. Pharmacoeconomics. 2003; 21:315-1330.

http://www.netfonds.no/quotes/release.php?id=20190425.Cision.20190425:BIT:4746:0

[Savepig]

Er ganske mange som ikke har fått med seg hvor lenge PHO nå har trendet oppover, dog med en god del volatilitet. Her er chart tilbake til August 2017.

Dette blir veldig interessant når en ser den opp i mot alle de positive fundamentale nyhetene vi har fått det siste året.

Jeg synes NOK 48 er et veldig interessant punkt i Photocure.