Advanz Pharma Switzerland SARL

Here’s a look at what’s on the U.S. Food and Drug Administration’s schedule for the next two weeks. Despite the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) is still working on approving drugs as best it can, although it did recently announce the possibility of non-COVID-19 work being delayed. However, here’s a look at what’s on the schedule for the next two weeks. Sanofi’s Isatuximab for Multiple Myeloma and MenQuadfi, A Meningitis Vaccine Paris-based Sanofi has two separate target action dates in the next two weeks. The first target action date is for the Biologics License Application (BLA) for MenQuadfi Meningococcal Polysaccharide Tetanus Toxoid Conjugate Vaccine candidate to prevent meningococcal meningitis. The target action date is April 25, 2020. The BLA was based on positive data from Phase II and Phase III clinical trials held in the U.S. in people two years of age and older. If approved, it will be available in a fully liquid form. The trials were performed in the U.S., Europe, Asia and Latin America. The company is also running Phase III trial in those regions and Africa. The ongoing program includes different ages ranging from infants six weeks of age through older adults. The second is for its BLA for isatuximab for patients with relapsed/refractory multiple myeloma (RRMM). The target action date was April 30, 2020. The agency approved the drug on March 2, 2020, which will be marketed as Sarclisa. It is approved for use in combination with pomalidomide and dexamethasone (pom-dex) in adults with r/r multiple myeloma who have had at least two previous therapies including lenalidomide and a proteasome inhibitor. Sarclisa is a monoclonal antibody that binds to the CD38 receptor on multiple myeloma cells. Neurocrine Biosciences’ Opicapone for Parkinson’s Disease Neurocrine Biosciences has a target action date of April 26 for its New Drug Application (NDA) for opicapone for Parkinson’s disease patients experience OFF episodes. The drug is a novel, once-daily, oral, selective catechol-O-methyltransferase (COMT) inhibitor. It is indicated as an adjunctive treatment to levodopa/carbidopa. In Parkinson’s disease, the ON time is when the motor symptoms are better controlled, while the OFF time is when the effects of levodopa have worn off and the symptoms get worse. The NDA for opicapone is supported by data from 38 clinical trials, including two Phase III studies (BIPARK-1 and BIPARK-2) with more than 1,000 Parkinson’s patients treated. Correvio and United Therapeutics’ Trevyent for Pulmonary Arterial Hypertension Correvio Pharma and United Therapeutics have a target action date of April 27 for the NDA for Trevyent (treprostinil) for the treatment of pulmonary arterial hypertension (PAH). Correvio holds commercial rights to the drug for Europe and the Middle East. PAH is a form of high blood pressure that happens in the right side of the heart and in the arteries that supply blood to the lungs. It worsens over time and is life-threatening. There is no cure, but there are several drugs for it, including United’s Remodulin (treprostinil) Injection. Trevyent combines a preservative-free, parenteral formulation of treprostinil, a vasodilatory prostacyclin analogue, with United Therapeutics’ proprietary PatchPump. It is a pre-filled, pre-programmed, single use disposable infusion system for continuous subcutaneous infusion of the drug for PAH. On March 16, 2020, ADVANZ Pharma announced a deal to acquire all shares of Correvio for a total price of about $76 million. In United Therapeutics’ fourth-quarter and year-end financial report on February 26, the company said that, “recent interactions with the FDA have included a mid-cycle information request from the FDA noting several deficiencies in the Trevyent NDA. We have provided written responses to the FDA addressing these deficiencies in hopes of preserving the current PDUFA date; however, based on recent discussions with the FDA, we believe the PDUFA date could be extended beyond April 2020, and/or the FDA may issue a complete response letter if the FDA is not satisfied with our responses to the agency’s comments.”

Advanz Pharma a global pharmaceutical company focused on serving the needs of patients and healthcare providers around the world with enhanced access to high quality, niche-established medicines, today announced that through its wholly-owned subsidiary, the Company has entered into an arrangement agreement dated March 15, 2020, (the "Arrangement Agreement") to acquire all of the issued and outstanding shares of specialty pharmaceutical company Correvio Pharma Corp. The acquisition is expected to have a total purchase price of approximately $76 million 1 , which includes the repayment of certain Correvio indebtedness, pursuant to a plan of arrangement ("Plan of Arrangement") under the Canada Business Corporations Act. Correvio is a Vancouver, Canada-based specialty pharmaceutical company focused on providing innovative, high-quality brands that meet the needs of acute care physicians and patients. Correvio's commercial presence is focused on major European markets with a broader distribution network covering more than 60 countries worldwide. For the nine months ending September 30, 2019, Correvio generated revenue of approximately $21 million. "The acquisition of Correvio is an important step for ADVANZ PHARMA and is directly aligned with our P.L.A.N growth strategy," said Graeme Duncan, Chief Executive Officer of ADVANZ PHARMA. "Correvio's highly experienced European commercial team provides us with a direct commercial presence in France, Germany, Spain, Italy and the Benelux region, while further strengthening our existing presence in the Nordics and the United Kingdom." Mr. Duncan continued, "Correvio's niche portfolio, consisting of an established brand, and two growing, patent-protected brands, plus a pipeline of potential product launches, are highly complementary to our current priorities and future focus. This is a transformative transaction that we are very excited about, creating what we believe is a leading global platform with advanced commercial capabilities in Western Europe. This transaction should also enable us to access additional portfolio opportunities going forward, and optimise the launches of our pipeline products." Mark H.N. Corrigan, MD, Chief Executive Officer of Correvio, commented: "Since announcing our intent to explore strategic alternatives in December 2019, we have diligently evaluated a number of opportunities and concluded that a partnership with ADVANZ PHARMA represents the best outcome for our stakeholders and employees. We believe that bringing the highly skilled and talented employees from the two organizations together will deliver increased scale, depth of commercial capability, breadth of geographical reach and complementary business models to bring important medicines to patients across the globe." ADVANZ PHARMA believes Correvio's business will be profitable on a pro-forma basis in 2020 through a combination of top line growth and the realisation of synergies. The Company intends to pay for the acquisition of Correvio with its cash on hand. As of September 30, 2019, ADVANZ PHARMA's cash position was approximately $243 million.

The FDA advisory committee met and voted 11 to 2 against recommending approval of Brinavess, citing safety concerns. The FDA is not required to follow the recommendations of its adcoms, but typically does. Correvio Pharma Corp., based in Vancouver, British Columbia, indicated that it is considering a sale after a U.S. Food and Drug Administration (FDA) advisory committee voted against approving its Brinavess (vernakalant hydrochloride, IV). This is an antiarrhythmia drug for the rapid conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults. Brinavess is already approved for marketing in Europe, Canada and several other countries. It is approved in the EU for rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults for non-surgery patients who had AF less than 7 days duration, for post-cardiac surgery patients with AF less than 3 days duration. It is not yet approved in the U.S. Correvio has a target action date of December 24, 2019 for its resubmitted New Drug Application (NDA) for Brinavess. However, the FDA advisory committee met and voted 11 to 2 against recommending approval of Brinavess, citing safety concerns. The FDA is not required to follow the recommendations of its adcoms, but typically does. The NDA was built on data from SPECTRUM, a post-authorization safety study conducted in Europe of 1,778 unique patients across a total of 2,009 treatment episodes after dosing of Brinavess. The data showed that Brinavess successfully converted 70.2% of the treated AF patients into normal sinus rhythm. It also demonstrated a median time to conversion of 11 minutes from the start of the first infusion in the patients who were successfully converted. “Given yesterday’s FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting outcome for Brinavess (vernakalant IV) for the conversion of atrial fibrillation (AF), we believe it is in the best interest of our stakeholders to expand our internal corporate development efforts and formally evaluate strategic alternatives for the company,” said Mark H.N. Corrigan, Correvio’s chief executive officer. Corrigan added, “We have a strong and growing commercial portfolio of assets being sold across the globe and we will immediately begin preparations for a potential strategic transaction while we await the U.S. Food and Drug Administration (FDA)’s decision regarding Brinavess. We are also taking steps to reduce operating costs outside the core European commercial business and a transaction committee has been formed within the Board of Directors.” The adcom’s vote was an indication they did not believe the benefit-risk pro the drug was enough to support approval. The company’s commercial portfolio outside the U.S. is expected to bring in about $30 million in revenue this year. That portfolio is made up of four approved and commercialized branded products and one product candidate. They are Xydalba (dalbavancin hydrochloride) for acute bacterial skin and skin structure infections; Zevtera/Mabelio (ceftobiprole medocaril sodium), an antibiotic for community- and hospital-acquired pneumonia; Brinavess; Aggrastat (tirofiban hydrochloride) for the reduction of thrombotic cardiovascular events in patients with acute coronary syndrome; and Trevyent, a drive device combination that delivers treprostinil, a treatment for pulmonary arterial hypertension. Correvio has hired Piper Jaffray to help review its strategic options. Without indicating whether it expected job cuts, the company stated it planned to reduce its operating costs in North America. This way it would focus its resources on essential commercial and business development activities. Correvio has made attempts to get approval for Brinavess in the U.S. since 2006. The FDA has never approved it because of safety concerns. At one point the U.S. trials were placed on hold after the death of a patient. The clinical hold is still in place. In a 2014 research and review paper in Current Cardiology Reviews , John Camm, with St. George’s University of London, UK, wrote, “The terms of the [European] approval are very strictly aligned to the evidence base for vernakalant. … Regulators were able to label the drug to avoid the majority of other adverse effects of vernakalant offered an alternative to amiodarone in patients with mild or moderate heart disease. Although amiodarone achieves conversion in a high proportion of patients its action is relatively delayed. A clear unmet need could potentially be filled by this new antiarrhythmic drug.” Although the paper is five years old, Camm’s conclusion likely holds today: “The difference between regulatory opinions on both sides of the Atlantic is disturbing and perplexing. Agencies in Europe and the USA came to different conclusions when examining the same evidence-base. Thus, neither opinion can be entirely or easily accepted.”