Life Science News

  • The XEN 63 Gel Implant is intended to reduce intraocular pressure (IOP) in patients with primary open angle glaucoma 1
  • XEN 63 is a minimally invasive, micro-incisional glaucoma surgery designed to lower IOP 2
  • XEN 63 Gel Implant provides innovative treatment option for Canadians impacted by glaucoma

 ABBVie (NYSE: ABBV) announced today the availability of the XEN ® 63 Gel Implant, a surgical implant designed to lower high eye pressure in open angle glaucoma sufferers, where previous medical treatment options have failed. 1 The XEN 63 Gel Implant is an additional option for surgeons, clinically proven to reduce intraocular pressure (IOP) in patients with primary open angle glaucoma. 3

AbbVie Logo (CNW Group/AbbVie Canada)

"I see the impact of glaucoma on patients' quality of life every day in my practice. Glaucoma typically damages the peripheral vision first, so it often goes unnoticed by patients as the disease worsens. That's why glaucoma is known as the silent thief of sight," said Dr. David Yan , Ophthalmologist-in-Chief, Mount Sinai Hospital, University of Toronto and Glaucoma Service Director, Kensington Eye Institute. "XEN 63 Gel Implant offers patients a new surgical option to reduce intraocular pressure when medical therapy cannot adequately control the disease and renewed hope to prevent optic nerve damage."

XEN 63 is a gel implant consisting of a small 6mm long tube, delivered via a micro-incisional glaucoma surgery. 1 , 2 It creates a new fluid outflow channel using a similar principle to conventional trabeculectomy, but allows fluid to bypass the impaired trabecular meshwork, the drainage system that becomes impaired in glaucoma. 2 ,4

"Glaucoma affects more than 728,000 Canadians. It is one of the leading causes of preventable blindness. Anyone can develop glaucoma but there are several different factors that can increase your risk of developing the disease," said Doug Earle , President and CEO of Fighting Blindness Canada. "It's both exciting and important to see new, innovative treatment options being approved that could have a positive impact on Canadians living with primary open angle glaucoma."

"As a leader in Eye Care in Canada , we are committed to help preserve and protect people's vision through innovating and addressing the greatest unmet needs in glaucoma," says Tracey Ramsay , Vice President and General Manager, AbbVie Canada. "Today, we're pleased to launch the XEN 63 Gel Implant and offer a minimally invasive solution for uncontrolled primary open angle glaucoma."

The glaucoma treatment spectrum extends from pharmacotherapy involving topical medications (eye drops) as the first-line therapy to traditional, invasive filtration surgeries, such as trabeculectomy and aqueous shunt implantation. 5,6,7 Common challenges associated with pharmacotherapy include ineffective use (e.g., incorrect dose timing or administration), 8 ,9 local or systemic side effects (e.g., irritation) or toxicity, 10,11 and considerable lifetime costs. 12 Filtration surgical options are typically used in advanced glaucoma cases or when targeting a very low intraocular pressure as a treatment outcome. 13 These invasive surgeries may be considered for medically refractory cases, or when there are such issues as intolerable side effects or from ineffective use of medications. 14

About Glaucoma

Glaucoma affects more than 728,000 Canadians and takes the form of several related disease types, the most common being open angle glaucoma. 15 Glaucoma is characterized by a build-up of aqueous humour fluid and increased intraocular pressure (IOP) that damages the optic nerve. 15 There is no cure for glaucoma, but early detection and treatment can help prevent damage to the optic nerve, and as a result, save vision. 15

About XEN 63

XEN is a gel implant consisting of a small 6mm long tube, delivered via a micro-incisional glaucoma surgery, which is intended to reduce intraocular pressure in patients with primary open angle glaucoma where previous medical treatments have failed. 1 The XEN filtration procedure creates a new fluid outflow channel using a similar principle to trabeculectomy, but allows fluid to bypass the impaired trabecular meshwork. 2,3 XEN is inserted via an ab-interno approach 1 (from within the anterior chamber) and allows aqueous humor to flow out from the anterior chamber into the subconjunctival space, minimizing tissue disruption seen with trabeculectomy or traditional glaucoma drainage implants. 1,3, 16 XEN 63 consists of a small tube that is 6mm long. 1 The inner diameter of XEN63 is 63µm and the external diameter is 170µm. 1 XEN63 has an outflow resistance of 2-3mmHg. 6 XEN63 was developed to increase the aqueous humor flow rate with the intention of potentially providing lower IOPs.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.ca . Follow @abbviecanada on Twitter and Instagram , or find us on LinkedIn.

1

AbbVie Canada. Add XEN 63 Gel Implant Health Canada directions for use.

2

European Glaucoma Society Terminology and Guidelines for Glaucoma, 5th Edition. (2021). British Journal of Ophthalmology , 105(Suppl 1), pp.1–169. doi:10.1136/bjophthalmol-2021-egsguidelines

3

Lavin-Dapena C, Cordero-Ros R, D'Anna O, Mogollón I. XEN 63 gel stent device in glaucoma surgery: A 5-years follow-up prospective study. Eur J Ophthalmol. 2021 Jul;31(4):1829-1835. doi: 10.1177/1120672120952033. Epub 2020 Aug 18. PMID: 32811168. https://pubmed.ncbi.nlm.nih.gov/32811168/

4

De Gregorio A, et al. Clin Ophthalmol. 2018;12:773-782. doi:10.2147/OPTH.S146919.

5

Samuelson TW, Katz LJ, Wells JM, Duh YJ, Giamporcaro JE, US iStent Study Group. Randomized evaluation of the trabecular micro-bypass stent with phacoemulsification in patients with glaucoma and cataract. Ophthalmology. 2011 Mar;118(3):459-67.

6

Malvankar-Mehta MS, Iordanous Y, Chen YN, Wang WW, Patel SS, Costella J, et al. iStent with phacoemulsification versus phacoemulsification alone for patients with glaucoma and cataract: A meta-analysis. PLoS One [Internet]. 2015 [cited 2018 Jan 2];10(7):e0131770. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4492499/

7

Saheb H, Ahmed II. Micro-invasive glaucoma surgery: current perspectives and future directions. Curr Opin Ophthalmol. 2012 Mar;23(2):96-104.

8

Okeke CO, Quigley HA, Jampel HD, Ying GS, Plyler RJ, Jiang Y, et al. Adherence with topical glaucoma medication monitored electronically the Travatan Dosing Aid study. Ophthalmology. 2009 Feb;116(2):191-9.

9

Terminology and guidelines for glaucoma [Internet]. 4th ed. Savona (ITA): European Glaucoma Society; 2014 Jun. [cited 2017 Aug 8]. Available: http://www.icoph.org/dynamic/attachments/resources/egs_guidelines_4_english.pdf

10

Everitt DE, Avorn J. Systemic effects of medications used to treat glaucoma. Ann Intern Med. 1990 Jan 15;112(2):120-5.

11

Sambhara D, Aref AA. Glaucoma management: relative value and place in therapy of available drug treatments. Ther Adv Chronic Dis [Internet]. 2014 Jan [cited 2017 Dec 22];5(1):30-43. Available: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3871276

12

Iordanous Y, Kent JS, Hutnik CM, Malvankar-Mehta MS. Projected cost comparison of Trabectome, iStent, and endoscopic cyclophotocoagulation versus glaucoma medication in the Ontario Health Insurance Plan. J Glaucoma. 2014 Feb;23(2):e112-e118.

13

Perez-Torregrosa VT, Olate-Perez A, Cerda-Ibanez M, Gargallo-Benedicto A, Osorio-Alayo V, Barreiro-Rego A, et al. Combined phacoemulsification and XEN45 surgery from a temporal approach and 2 incisions. Arch Soc Esp Oftalmol. 2016 Sep;91(9):415-21.

14

Michael Raj, Charlotte Wells, Caitlyn Ford. Minimally Invasive Glaucoma Surgery: Implementation Considerations. Ottawa: CADTH; 2018. (Environmental scan; no. 76). https://www.cadth.ca/minimally-invasive-glaucoma-surgery-implementation-considerations-0

15

Fighting Blindness. Glaucoma. Available at: https://www.fightingblindness.ca/eyehealth/eye-diseases/glaucoma/

16

Lewis RA. J Cataract Refract Surg. 2014;40(8):1301–6. doi: 10.1016/j.jcrs.2014.01.032.

SOURCE AbbVie Canada

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ABBV
Sirona Biochem Announces Exclusive Global Licensing Agreement with Allergan Aesthetics

Sirona Biochem Announces Exclusive Global Licensing Agreement with Allergan Aesthetics

Sirona Biochem Corp . (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona ") is pleased to announce it has entered into a global exclusive licensing agreement with Allergan Aesthetics, an AbbVie company (NYSE: ABBV), pursuant to which Allergan Aesthetics will develop and commercialize topical skin care treatments based on active ingredients derived from certain of Sirona's patents for TFC-1067 and related family of compounds.

"We are very pleased to have finalized terms with a global leader in medical aesthetics and the innovator behind SkinMedica™, a leader in the science of skin rejuvenation," said Dr. Howard Verrico, CEO of Sirona Biochem. "Our most recent clinical trial of TFC-1067 was a collaborative effort with Allergan Aesthetics to demonstrate the clinical potential in topical skin care treatments. This further validates our platform technology as viable for additional commercial products which we are actively pursuing. We would like to thank Dr. Linda Pullan of Pullan Consulting who assisted with our current success."

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Biogen and AbbVie Receive Positive Opinion from the CHMP on ZINBRYTA™ (Daclizumab) for Treatment of Multiple Sclerosis

CAMBRIDGE, Mass. & NORTH CHICAGO, Ill.–(BUSINESS WIRE)–The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has adopted a positive opinion
recommending the granting of a marketing authorization for ZINBRYTA™
(daclizumab) intended for the treatment of relapsing forms of multiple
sclerosis (RMS), Biogen
(NASDAQ: BIIB) and AbbVie (NYSE:
ABBV) announced today. ZINBRYTA is a once-monthly, self-administered,
subcutaneous investigational treatment for RMS. ZINBRYTA is also
currently under regulatory review in the United States, Switzerland,
Canada and Australia.
For people with relapsing forms of MS (RMS) and active disease,
ZINBRYTA has the potential to offer robust efficacy, a manageable safety
profile through patient monitoring, and once-monthly subcutaneous
dosing,” said Alfred Sandrock, M.D., Ph.D., executive vice president and
chief medical officer at Biogen. “ZINBRYTA may offer another option for
people with multiple sclerosis (MS) with its targeted mechanism of
action (MOA) which did not cause broad and prolonged immune cell
depletion.”
The CHMP positive opinion is now referred to the European Commission
(EC), which grants marketing authorizations for centrally authorized
medicines in the European Union. A decision from the EC is expected
within the coming months.
Together with Biogen, AbbVie is committed to meeting the needs of
patients with MS, and the positive opinion issued by the CHMP is a
critical step that moves us closer to bringing ZINBRYTA to patients in
Europe,” said Michael Severino, M.D., executive vice president, research
and development and chief scientific officer, AbbVie.
According to the CHMP opinion, the benefits of ZINBRYTA are its ability
to reduce the annualized relapse rate (ARR), as well as the risk of
24-week confirmed disability progression. The opinion is based on
results from two clinical trials, DECIDE and SELECT, in which ZINBRYTA
150 mg, administered subcutaneously every four weeks improved results on
key measures of MS disease activity in patients with RMS compared to
AVONEX 30 mcg intramuscular injection administered weekly and placebo,
respectively.
In the DECIDE study, the overall incidence of adverse events was similar
in the ZINBRYTA and AVONEX groups. In patients treated with ZINBRYTA
compared to AVONEX, there was an increased incidence of serious
infections (4% versus 2%), serious cutaneous reactions (2% versus <1%),
elevations of liver transaminases greater than five times the upper
limit of normal (6% versus 3%), gastrointestinal disorders (31% versus
24%), and depression (8% versus 6%).
About ZINBRYTA™ (daclizumab)
ZINBRYTA (daclizumab) is an investigational compound being developed for
the treatment of relapsing forms of MS. ZINBRYTA is a new form of a
humanized monoclonal antibody that selectively binds to the
high-affinity interleukin-2 (IL-2) receptor subunit (CD25) that is
expressed at high levels on T-cells that become activated in people with
MS. ZINBRYTA modulates IL-2 signaling without general immune cell
depletion.
Biogen and AbbVie are jointly developing ZINBRYTA.
About Biogen
Through cutting-edge science and medicine, Biogen discovers, develops
and delivers worldwide innovative therapies for people living with
serious neurological, autoimmune and rare diseases. Founded in 1978,
Biogen is one of the world’s oldest independent biotechnology companies
and patients worldwide benefit from its leading multiple sclerosis and
innovative hemophilia therapies. For more information, please visit www.biogen.com.
Follow us on Twitter.
Biogen Safe Harbor
This press release contains forward-looking statements, including
statements about the anticipated timing of the EC’s decision on the
marketing authorization for ZINBRYTA, and potential impact of ZINBRYTA,
if approved. These statements may be identified by words such as
“believe,” “expect,” “may,” “potential,” “will” and similar expressions,
and are based on our current beliefs and expectations. You should not
place undue reliance on these statements. Drug development and
commercialization involve a high degree of risk. Factors which could
cause actual results to differ materially from our current expectations
include the risk that the EC may fail to approve or may delay approval
of ZINBRYTA or may not follow the recommendation of the CHMP,
uncertainty of success in commercialization of ZINBRYTA For more
detailed information on the risks and uncertainties associated with our
drug development and commercialization activities and risks relating to
our collaborations with third parties, please review the Risk Factors
section of our most recent annual or quarterly report filed with the
Securities and Exchange Commission. Any forward-looking statements speak
only as of the date of this press release and we assume no obligation to
update any forward-looking statements, whether as a result of new
information, future events or otherwise.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in
2013 following separation from Abbott Laboratories. The company’s
mission is to use its expertise, dedicated people and unique approach to
innovation to develop and market advanced therapies that address some of
the world’s most complex and serious diseases. Together with its
wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000
people worldwide and markets medicines in more than 170 countries. For
further information on the company and its people, portfolio and
commitments, please visit www.abbvie.com.
Follow @abbvie on
Twitter or view careers on our Facebook or LinkedIn
page.
Forward-Looking Statements
Some statements in this news release may be forward-looking statements
for purposes of the Private Securities Litigation Reform Act of 1995.
The words “believe,” “expect,” “anticipate,” “project” and similar
expressions, among others, generally identify forward-looking
statements. AbbVie cautions that these forward-looking statements are
subject to risks and uncertainties that may cause actual results to
differ materially from those indicated in the forward-looking
statements. Such risks and uncertainties include, but are not limited
to, challenges to intellectual property, competition from other
products, difficulties inherent in the research and development process,
adverse litigation or government action, and changes to laws and
regulations applicable to our industry.
Additional information about the economic, competitive, governmental,
technological and other factors that may affect AbbVie’s operations is
set forth in Item 1A, “Risk Factors,” in AbbVie’s 2014 Annual Report on
Form 10-K, which has been filed with the Securities and Exchange
Commission. AbbVie undertakes no obligation to release publicly any
revisions to forward-looking statements as a result of subsequent events
or developments, except as required by law.

Enbrel Biosimilar Marks Victory for Merck and Samsung

The biosimilar alliance between Merck (NYSE:MRK) and Samsung Bioepis appears to have paid off, as the companies have won South Korean approval for their copy of Amgen’s (NASDAQ:AMGN) blockbuster drug Enbrel.
According to Fierce Biotech:

Korea’s Ministry of Food and Drug Safety signed off on the injection, to be marketed as Brenzys, to treat rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and psoriasis in adults. The biosimilar, developed as SB4, proved itself equivalent to Amgen’s cash cow in a 596-patient study disclosed this year, reducing symptoms of rheumatoid arthritis on pace with its reference product, according to Merck and Samsung.
Brenzys’ approval marks the first marketing victory for the two companies, a milestone Merck hopes will be a harbinger of future success in biosimilars.
The approval could also have major implications for Samsung Bioepis, long rumored to be considering a U.S. IPO. Details of the company’s Wall Street plans have been tricking out for months, and The Wall Street Journal reported in August that Samsung is planning a $1 billion debut offering for its biologics division, valuing the company at about $7 billion.
Samsung Bioepis, a joint venture with Biogen ($BIIB) that is 85% owned by the South Korean company, joined forces with Merck in 2013 in a wide-ranging deal designed to crack the growing market for off-patent biological treatments. Beyond Enbrel, the pair are working on copies of the similar Humira from AbbVie ($ABBV) and Remicade from Johnson & Johnson ($JNJ). The companies are also developing biosimilars of Sanofi’s ($SNY) blockbuster insulin Lantus and Roche’s ($RHHBY) cancer treatment Herceptin.

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Gilead Sciences: U.S. Military Veteran Battles Lymphoma With Car T-Cell Therapy: Marcus' Story

Marcus arrived home to Mississippi from his military assignment overseas, excited to see his 20-month-old son, when he realized something was wrong

"I started noticing that I had a little growth right here on my neck. About two weeks later, I had a growth in my left groin area, the size of a softball," recalls Marcus. "I was like, this isn't right. I'm 36 years old, and I had never been sick in my life."

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Sirona Biochem Announces Start of Clinical Trial for Anti-Aging Compound TFC-1326

Sirona Biochem Announces Start of Clinical Trial for Anti-Aging Compound TFC-1326

Sirona Biochem Corp . (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona ") is pleased to announce that the clinical trial, for novel anti-aging compound TFC-1326, started on December 5 th 2022.

The trial, which will take place in Paris, is designed to assess the compound's efficacy in reversing aging facial skin, including restoring lost volume (plumping) and reducing fine wrinkles. The formulation is a cream base with TFC-1326 at a concentration of 1% and no other active ingredients.

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Kite and Daiichi Sankyo Announce Changes to YESCARTA® CAR T-Cell Therapy Licensing Agreement in Japan

Daiichi Sankyo to Transfer Yescarta Marketing Authorization in Japan to Gilead Sciences K.K. –

Kite Cell Therapy Business Unit at Gilead Sciences K.K. Will Manage the Sales and Promotion Activities in Japan After the Marketing Authorization Transfer –

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Aptose to Hold Clinical Update and Data Review of AML Drug Tuspetinib on Sunday, December 11th

Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral kinase inhibitors to treat hematologic malignancies, today announced that the company's management team will provide a corporate update on Sunday, December 11, 2022, at 10:00 AM EST 9:00 CST, in conjunction with poster presentations at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition, being held in New Orleans, LA. The webcast event will include a comprehensive review of current clinical data for Aptose's lead compound tuspetinib, formerly HM43239, a myeloid kinase inhibitor, as well as an update on luxeptinib, Aptose's oral, dual lymphoid and myeloid kinase inhibitor.

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The Gummy Project Enters State of Texas with Purchase Order from 5-star Luxury Hotel Located in Austin, Texas

The Gummy Project Enters State of Texas with Purchase Order from 5-star Luxury Hotel Located in Austin, Texas

  • Purchase Order from 5-star luxury hotel in Austin, Texas marks the achievement of another milestone in The Gummy Project's ongoing highly strategic multi-channel sales strategy
  • The Peachy Bees and Watermelon Sharks are expected to be for sale in each of the hotel's guest room private bars

The Gummy Project (CSE: GUMY) (FSE: 0OS) (OTCQB: GUMYF) ("GUMY" or the "Company") is pleased to announce that it has received a purchase order for its Peachy Bees and Watermelon Sharks from a 5-star luxury hotel located in Austin, Texas (the "Luxury Hotel").

"Entering an additional US state and having our gummies for sale at this Luxury Hotel is another significant achievement for the Company as we continue to expand in both Canada and the US," said Charlie Lamb, President and CEO of GUMY.

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New Data for Trodelvy Demonstrate Clinical Efficacy Across Trop-2 Expression Levels in HR+/HER2- Metastatic Breast Cancer

Late-Breaking TROPiCS-02 Analysis Shows that Trodelvy Demonstrates Consistent Efficacy Across Trop-2 Expression Levels –

Trop-2 is Highly Expressed in 90% of Breast Cancers

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