Indacaterol Acetate/Glycopyrronium Bromide/ Mometasone Furoate

Harold Cunningham/Getty Images Novartis announced that after conducting an interim analysis from its CIRRUS-1 trial of CFZ533 (iscalimab), it is discontinuing the trial in kidney transplant patients. The drug is dosed with tacrolimus and other immunosuppressive therapies to prevent organ rejection. The company indicated the drug would continue to be developed to treat hidradenitis suppurativa and Sjögen’s syndrome and other autoimmune diseases. It is currently being evaluated in the Phase II CONTRAIL trial in liver transplant patients and other studies in type 1 diabetes and lupus nephritis. The study data apparently indicated that iscalimab was not as effective as tacrolimus at preventing organ rejection in kidney transplant patients when both were added to standard immunosuppressive therapies. Those therapies included drugs such as mycophenolate mofetil and corticosteroids. Earlier studies suggested iscalimab might be more effective than tacrolimus. In those studies, patients had kidney biopsies as healthy as normal kidneys about one year after transplant. Studies show that less than 50% of donated kidneys last 10 years. Any therapy that can extend the life of donated kidneys would have a significant impact on patients and donor organ availability. Worldwide, there are approximately 3.2 million people with end-stage renal disease. The CIRRUS-1 trial evaluated 418 transplant patients and studied three different doses of iscalimab. The drug is a fully human antibody that targets the CD40 antigen. It is engineered to inhibit immune reactions to foreign transplanted tissue. The study was expected to run to at least 2023. Novartis also announced that it is presenting abstracts at the upcoming European Respiratory Society (ERS) International Congress 2021 from September 5 to 8 on its 12 Enerzair Breezhaler and Atectura Breezhaler. The data continues to support the efficacy of Enerzair Breezher, and there will also be an interim analysis of patient engagement and adherence levels of the Enerzair Breezhaler’s optional digital companion. “Our presence at ERS this year reiterates our commitment to patients through the further development of first-in-class therapies like Enerzair Breezhaler, as well as by exploring the potential of digital health companions and the carbon footprint of our solutions,” said Dominic Brittain, Respiratory Global Program Head, Novartis Pharmaceuticals. “As a global leader in respiratory and allergy, we remain committed to reimagining medicine for patients living with chronic respiratory diseases like asthma.” And on September 1, Novartis inked a commercial agreement with the National Health Service (NHS) in England as part of a collaboration to develop a population health management approach for high cholesterol levels in patients with atherosclerotic cardiovascular disease (ASCVD). This deal comes after a positive final recommendation from the National Institute for Health and Care Excellence (NICE) for using inclisiran in primary care for adults for its licensed indication. It is licensed in Europe for adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, in addition to diet modification. “High cholesterol is a major cause of cardiovascular disease—disease of the heart and blood vessels,” said Jules Payne, chief executive at HEART UK, the cholesterol charity. “It is very common and can affect anyone including those who are young, slim, fit and active. HEART UK looks forward to continuing our leading role in helping people effectively manage their cholesterol and we warmly welcome the collaboration between Novartis and the NHS to enable more people to access this innovative medicine.”

Valeo insiders participation of $2.6 million MONTRÉAL, April 27, 2021 /PRNewswire/ - Valeo Pharma Inc. (CSE: VPH) (OTCQB: VPHIF) (FSE: VP2) ("Valeo" or the "Company"), a Canadian pharmaceutical company, announced today that it has upsized and closed a $6.645 million non-brokered private placement of unsecured non-convertible debenture units (the "Private Placement"). The Company issued 6,645 unsecured non-convertible debentures units (the "Debenture Units") at a purchase price of $1,000 per Debenture Unit for gross proceeds of $6,645,000. Each Debenture Unit consist of one (1) unsecured non-convertible debenture of the Company in the principal amount of $1,000 (each, a "Debenture") and 200 Class "A" share purchase warrants (each, a "Warrant"). Each Warrant entitles the holder thereof to purchase one Class "A" Share of the Company (each, a "Share") at an exercise price of $1.60 at any time up to 24 months following the closing date of the Offering (the "Closing Date"). The Debentures will mature at the latest 9 months after the closing and bear interest at a rate of 8% per annum from the date of issue, payable in cash, semi-annually in arrears. "The closing of this upsized placement is testament to the confidence and support our insiders and those close to the Company have in management and Valeo's business model", said Steve Saviuk, CEO. "I cannot over emphasize what a pivotal year 2021 is becoming with the recent launch of Redesca® and the imminent launches of Enerzair® Breezhaler® and Atectura® Breezhaler®". The securities issued under the Private Placement are subject to a four-month hold period in accordance with applicable securities legislation. The Company has paid $38,500 as finder's fees to arm's-length parties in connection with the Private Placement and issued a total of 7,700 broker warrants in compliance with applicable securities laws. Insiders, Senior Executives, staff members and 3 Directors of the Company all participated in the Private Placement for an aggregate amount of $2.6 million. The net proceeds of the Offering will be used for working capital and general corporate purposes. Participation of insiders of the Company in the Private Placement constitutes a "related party transaction" as defined under Regulation 61-101 respecting Protection of Minority Security Holders in Special Transactions ("Regulation 61-101"). The Company intends to rely on exemptions from the formal valuation and minority shareholder approval requirements provided under sections 5.5(a) and 5.7(a) of Regulation 61-101 on the basis that participation in the Private Placement by insiders will not exceed 25% of the fair market value of the Company's market capitalization and also because the Company's Common Shares trade only on the Canadian Securities Exchange (CSE). A material change report was not filed in connection with the participation of the insiders in at least 21 days in advance of the closing of the Private Placement, which the Company deemed reasonable in the circumstances, in order to close the transaction as soon as practicable to enable it to use the funds. About Valeo Pharma Valeo Pharma is a Canadian pharmaceutical company dedicated to the commercialization of innovative prescription products in Canada with a focus on Respiratory Diseases, Neurology, Oncology and Hospital Specialty Products. Headquartered in Kirkland, Quebec Valeo Pharma has all the required capabilities and the full infrastructure to register and properly manage its growing product portfolio through all stages of commercialization. For more information, please visit and follow us on LinkedIn and Twitter. Forward Looking Statements This press release contains forward-looking statements about Valeo's objectives, strategies and businesses that involve risks and uncertainties. These statements are "forward-looking" because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE. Company Codes: OTC-QB:VPHIF, CNSX:VPH, Frankfurt:VP2, OTC-PINK:VPHIF