Author Topic: GUD.V - Knight Therapeutics  (Read 24530 times)

snowball82

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Re: GUD.V - Knight Therapeutics
« Reply #60 on: November 26, 2018, 06:15:53 PM »
New presentation. Probuphine lauched in Q4 2018. Ibsrela pending approval.   

Iluvien, Netildex, Tenapanor & 2 x TX pending submission.

http://www.gud-knight.com/wp-content/uploads/KTI_Corporate_Presentation_November_2018.pdf

Knight Therapeutics Announces Canadian Regulatory Approval for ILUVIEN®

MONTREAL, Nov. 26, 2018 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX:  GUD) ("Knight"), a leading Canadian specialty pharmaceutical company, today announced that Health Canada has approved ILUVIEN® for the treatment of diabetic macular edema (DME). ILUVIEN is a fluocinolone acetonide sustained release non-biodegradable intravitreal implant used to treat DME in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. Knight entered into an exclusive Canadian agreement for ILUVIEN with Alimera Sciences, Inc. ("Alimera") in July 2015.

"The approval of ILUVIEN is great news for Canadian DME patients, payors and healthcare providers. ILUVIEN represents a well-studied, proven effective treatment for DME patients who can benefit from CONTINUOUS MICRODOSING without the burden of frequent injections," said Jonathan Ross Goodman, CEO of Knight. "We are eager to work with all payors and stakeholders across Canada to make ILUVIEN available to Canadian patients."

"We are excited that ILUVIEN has received approval by Health Canada," said Dan Myers, CEO of Alimera. "ILUVIEN is the only treatment approved in Canada with CONTINUOUS MICRODOSING that can treat DME every day for up to three years with a single implant. We look forward to working with Knight to make ILUVIEN available to Canadian patients." 

About ILUVIEN

www.ILUVIEN.com

ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant approved in the U.S. and Canada to treat diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. Each ILUVIEN implant is designed to release submicrogram levels of fluocinolone acetonide, a corticosteroid, for 36 months to treat DME.

ILUVIEN has also received marketing authorization approvals in Austria, Belgium, the Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Spain, Sweden and the United Kingdom for the treatment of vision impairment associated with chronic diabetic macular edema (DME), considered insufficiently responsive to available therapies. ILUVIEN is available commercially in the U.S., Germany, the U.K., Austria, Ireland, Portugal, Spain, Italy, and the U.A.E.

About Diabetic Macular Edema (DME)

DME, the primary cause of vision loss associated with diabetic retinopathy, is a disease affecting the macula, the part of the retina responsible for central vision. When the blood vessel leakage associated with diabetic retinopathy results in swelling of the macula, the condition is called DME. The onset of DME is painless and may go unreported by the patient until it manifests with the blurring of central vision or acute vision loss. The severity of this blurring may range from mild to profound loss of vision. The Wisconsin Epidemiologic Study of Diabetic Retinopathy found that over a 10-year period approximately 19% of people with diabetes included in the study were diagnosed with DME. All people with type 1 or type 2 diabetes are at risk of developing DME.

About Knight Therapeutics Inc.

Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian and select international markets. Knight's shares trade on TSX under the symbol GUD. For more information about Knight, please visit the company's web site at www.gud-knight.com or www.sedar.com.

Forward-Looking Statements

This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2017. Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information or future events, except as required by law.

Contact Information

Knight Therapeutics Inc.
Samira Sakhia
President and Chief Financial Officer
514-484-4483
514-481-4116 (FAX)
info@gudknight.com
www.gudknight.com



snowball82

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Re: GUD.V - Knight Therapeutics
« Reply #61 on: January 11, 2019, 05:16:02 PM »
Knight Therapeutics Runs with Exclusive Canadian License to Puma's NERLYNX®

MONTREAL, Jan. 11, 2019 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a Canadian specialty pharmaceutical company focused on acquiring, in-licensing, selling and marketing innovative prescription and over-the-counter pharmaceutical products, today announced it has entered into an exclusive License Agreement with Puma Biotechnology, Inc. (NASDAQ: PBYI) ("Puma") granting Knight the exclusive right to commercialize NERLYNX® (neratinib) in Canada.

Puma filed a New Drug Submission for NERLYNX® with Health Canada in July 2018 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy. Under the terms of the License Agreement, Knight will be responsible for all commercial activities and future regulatory submissions for NERLYNX® in Canada. Puma will receive upfront and milestone payments up to $7.2 million USD throughout the term of this agreement, as well as double digit royalties on net sales of NERLYNX® in Canada.

"We are excited to partner with Puma to offer a new treatment option to Canadian breast cancer patients," said Jonathan Ross Goodman, Chief Executive Officer of Knight. "While adjuvant trastuzumab-based therapy has been shown to reduce the risk of recurrence in early stage HER2-positive breast cancer, up to 25% of patients treated with adjuvant trastuzumab will have a recurrence. NERLYNX® has been shown to significantly reduce the risk of recurrence in those patients who were previously treated with trastuzumab."

"Our new agreement with Knight demonstrates our commitment to bringing NERLYNX® to patients around the world while continuing to focus our commercial resources on the U.S. market," stated Alan H. Auerbach, Chief Executive Officer and President of Puma. "We are confident this new partnership will help patients in Canada access NERLYNX® at the earliest opportunity."

About NERLYNX®

NERLYNX® is potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4.  NERLYNX® was approved by the FDA in the United States in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy. In September 2018, NERLYNX® was approved by the European Commission for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy. NERLYNX® is a registered trademark of Puma Biotechnology, Inc. For more information about Puma, please visit the corporate website at www.pumabiotechnology.com.

About Knight Therapeutics Inc.

Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian and select international markets. Knight Therapeutics Inc.'s shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's web site at www.gudknight.com or www.sedar.com.

Knight Forward-Looking Statement

This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2017. Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information or future events, except as required by law.


snowball82

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Re: GUD.V - Knight Therapeutics
« Reply #62 on: January 11, 2019, 05:32:41 PM »
It seems to be a significant one for US : ..."For the year, Puma kept guidance for $175 million to $200 million in sales. This is attainable, MacKay said. Before the report, the Street had modeled $217 million for the year...."

https://www.investors.com/news/technology/puma-stock-nerlynx-sales-top/

no_free_lunch

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Re: GUD.V - Knight Therapeutics
« Reply #63 on: January 11, 2019, 07:11:11 PM »
It is good to see.   

Canada is 1/9 the size of the US, so maybe $25-30m sales potential here?  The agreement says double digit royalty payments, so after they  pay out milestones maybe 75-80% or $20-24m  gross margin once they build it out.  It will definitely help.  They are already not much over book so you would be getting those royalty payments at about 4x EBITDA and any future developments plus their in-progress products for free.
« Last Edit: January 11, 2019, 07:12:58 PM by no_free_lunch »