AUSTRALIA - Juno Pharmaceuticals Acquires Noradrenaline 2 mg/2 mL & 4 mg/4 mL from Mayne Pharma

MELBOURNE, AUSTRALIA – Juno Pharmaceuticals is pleased to announce the acquisition of noradrenaline 2 mg/2 mL and 4 mg/4 mL concentrated injection from Mayne Pharma; an important addition to Juno’s growing range of vasopressors and critical care medicines.

As part of the acquisition, Juno will receive the intellectual property and regulatory approvals for NORADRENALINE MYX 2 mg/2 mL concentrated solution for injection ampoule and NORADRENALINE MYX 4 mg/4 mL concentrated solution for injection ampoule, along with associated contracts and agreements.

This acquisition is Juno’s second for 2019 and is another milestone in Juno’s continued growth and vision to be the leader in supply of off-patent products in hospitals across Australia and New Zealand.

Our focus on hospital injectable medicines and hospital customers makes us ideally placed to supply this product in the Australian market, noted Juno CEO & Managing Director, Mark Crotty. It is exciting to see our range of hospital products growing rapidly, customers see us as their trusted partner in this area.

The agreement comes into effect on July 16th, 2019 and Juno’s Key Account Managers will work closely with customers and wholesalers to ensure a smooth transition and continuity of supply. As with all Juno products, continuous, reliable supply is a top priority.

From July 16th, 2019, all commercial enquiries regarding noradrenaline should be directed to your local Juno representative. Any adverse event reporting, product complaints and medical enquiries should directed to Juno Medical Information on 1800 620 076 ormedical-enquiries@www.junopharm.com.au

AUSTRALIA - Juno Acquires Local Portfolio of Essential Injectable Medicines from AstraZeneca

MELBOURNE, AUSTRALIA – Juno Pharmaceuticals Pty Ltd is pleased to announce the acquisition of a local portfolio of essential injectable medicines from AstraZeneca Pty Ltd.  This acquisition will see Juno’s product range grow to over 60 molecules, focussed mainly in the hospital segment.

As part of the acquisition, Juno will receive the intellectual property and regulatory approvals for ten products (eight unique molecules), along with associated contracts and agreements.

This acquisition is the second Juno has made since commencing sales in 2015 and is another milestone in Juno’s continued growth and vision to be the leader in supply of off-patent products in hospitals across Australia and New Zealand.

These critical medicines play a vital role in patient care in Australian and New Zealand hospitals. Our focus at Juno is to build a compelling portfolio that meets the local and unique needs of Australian and New Zealand hospitals, noted Juno CEO & Managing Director, Mark Crotty.

The agreement comes into effect on April 1st, 2019 and Juno’s key account managers will work closely with customers and wholesalers to ensure a smooth transition.

From April 1st, 2019, all commercial enquiries regarding the products below should be directed to your local Juno representative.  Any adverse event reporting, product complaints and medical enquiries should directed to Juno Medical Information on 1800 620 076 or medical-enquiries@www.junopharm.com.au

About Juno

Juno Pharmaceuticals is a rapidly growing, local Australian and New Zealand business and are experts in off-patent prescription pharmaceuticals. Juno’s portfolio includes medicines across a diverse range of therapeutic areas, with hospital products the core focus of the business. The acquisition of this portfolio is in line with Juno’s mission to improve the health of society, through delivering high quality products to patients, and value to hospitals, the government and tax payers.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular, Renal & Metabolism and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

For more information, please visit www.astrazeneca.com and www.astrazeneca.com.au.

EUROPE - Speciality European Pharma Limited to rebrand as Contura in order to consolidate its corporate structure and drive growth

Speciality European Pharma Limited (“SEP”), the parent of a European healthcare group, is pleased to announce the rebranding of itself and each of its subsidiaries as Contura (“the Group”). The rebrand will consolidate the Group under a single corporate identity and positions it for future growth.

“I am pleased to see Contura moving into the next stage of its development, consolidating its position as a leading manufacturer and distributor of speciality medical device and pharmaceutical products. Contura has grown rapidly over recent years and I look forward to our journey as we continue to build on our existing products whilst expanding into new therapy areas with our hydrogel platform. With the recent filing of our premarket approval application for Bulkamid in the United States we also anticipate significant geographic expansion for our products in the years ahead.”

Patrick Banks, Chief Executive Officer.

About SEP and Contura

The Group specialises in the distribution and sale of healthcare products, both pharmaceuticals and medical devices, focused primarily in the fields of urology and urogynaecology. Its lead products are:

Bulkamid®

Aquamid®

Mitem®

Regurin® XL

Cystistat®

The Group was founded in 2000 and has built an experienced and accomplished management team. It came together as a result of SEP’s acquisition of Contura A/S, a Danish company based in Copenhagen, in 2013. Contura A/S had two marketed products at the time of its acquisition, Bulkamid® and Aquamid® . It also had a number of development programmes focused on additional uses of its hydrogel technology.

In prospect, the opportunities for new products include:

• approval of Bulkamid® in the United States (stress urinary incontinence)

• approval of Arthrosamid® in the EU (synovial implant for osteoarthritis)

• approval of Bulkamid® VUR in the EU and other territories (vesicoureteral reflux)

The Group has an established sales and marketing infrastructure in the leading European markets, either through its own sales force or through distribution partners. It has offices in the UK, Denmark, Germany, France and Italy and employs some 45 staff Europe wide.

Contact Patrick Banks, CEO

1Phone number: +44 (0)20 7421 7400

Please visit our rebranded web page for further information:

www.contura.com

AUSTRALIA - Juno Acquires Amneal Hospital Product Portfolio

Juno Pharmaceuticals announced today that it has acquired Amneal Pharmaceuticals’ injectables, ophthalmic, and oncology product portfolios in Australia.

“Juno is excited to add the Amneal Australia hospital injectable, ophthalmic, and oncology range to its growing portfolio. This Amneal portfolio complements many of Juno’s existing assets nicely and Juno is particularly excited to be managing products such as Bicnu (carmustine),” said CEO and Managing Director of Juno Australia, Mark Crotty.

Juno is a rapidly-growing local Australian business that recorded its first full year of commercial sales in 2016. Juno’s business model is based on partnering across all stages of the commercial cycle and has a core focus on local Australian hospital customer needs. The acquisition of Amneal’s portfolio is Juno Australia’s first since its formation in 2013 and when added to its existing product portfolio and strong pipeline, the acquisition is expected to position Juno as one of the largest generic injectable product hospital suppliers in the Australian market.

The acquisition takes effect from August 31st, 2017. Juno will work with Amneal to ensure a smooth transition of the business with suppliers and customers.

For all queries please contact:

Mark Crotty, +61 424 152 881

EUROPE - Specialty European Pharma Acquired by Juno

Juno Pharmaceuticals and Aspire Pharma are pleased to announce the acquisition of Specialty European Pharma (SEP), a pan-European specialty pharmaceutical and medical devices group. The acquisition came into effect June 22, 2016 and positions SEP to achieve long term growth through investment in their proprietary development portfolio, with short term goals including the launch of urethral bulking agent Bulkamid in the United States and EU approval of the synovial implant Athrosamid.

Ian Jacobson, Chief Executive Officer at Juno, said: “We are very excited about our acquisition of SEP and partnership with its management team. SEP’s niche product portfolio and strategic focus aligns perfectly with Juno’s corporate mission and we look forward to building on SEP’s impressive track record of growth. We view SEP as a company that has only begun to realize its considerable potential and we are confident that in partnership with its existing management team, we can build it into one of Europe’s leading pharmaceutical and medical device companies.”

SOUTH AFRICA - Juno Pharmaceuticals Acquires Stake in Trinity Pharma

Juno Pharmaceuticals South Africa is pleased to announce that it has acquired a minority stake in Trinity Pharma in partnership with India-based Strides Pharma, which purchased a majority stake in the rapidly-growing South African retail pharmaceutical company effective December 2017.

The Juno team is excited to partner with both Trinity’s existing management team – which is staying on as a minority partner following the transaction – and the Strides group as they collectively work to build on Trinity’s already robust sales base and product pipeline. With our collective efforts and investment, Trinity stands poised to establish itself as a leader in the South African pharmaceutical space over the next decade and beyond.

EUROPE - Aspire Wins Bimatoprost Case at UK Patents Court

Aspire Pharmaceuticals, with the help of Accord Healthcare, won its first case at the UK Patents Court, officially declaring Allergan’s patent protecting the main formulation of their commercial enhanced Bimatroprost ophthalmic solution, known as Lumigan 0.01%, invalid.

Aspire and Accord both sought to market their own generic versions of Lumigan 0.1mg/mL, obtaining marketing authorizations which they did not dispute would infringe on Allergan’s European patent EP1753434, instead arguing successfully in front of the court that the patent was invalid on the grounds of obviousness.

Aspire’s successful argument was based on a paper by R. A .Laibovitz et al1, which the courts established as evidence of the composition being part of the common general knowledge (GGK) relating to developing ophthalmic eye drops containing Bimatoprost.

1 “Comparison of the Ocular Hypotensive Lipid AGN 192024 with Timolol”, Arch. Opthalmol., 119(7), 994-100 (2001)

CANADA - Judy Dabey Appointed as General Manager of Juno Pharmaceuticals Canada (formerly MDA)

The Juno Group is pleased to announce the appointment of Judy Dabey the new General Manager of Juno Pharmaceuticals Canada (JPC).

Initially brought in to support JPC as its Chief Operating Officer, Judy has been integral to both the construction of JPC’s expanded operations team and its rapidly growing sales base throughout the past 18 months.

A longtime friend and trusted partner of the Juno group, Judy brings with her over 30 years of diverse pharmaceutical industry experience, having held a diverse range of local and global senior positions throughout her career across the likes of Actavis, Cobalt, Merck Generics, Genpharm and Upjohn.

EUROPE - Contura Launches Bulkamid in the US

On January 28, 2020, Contura received FDA approval for its proprietary urethral bulking agent (UBA), Bulkamid. This injectable hydrogel, consisting of 2.5% polyacrylamide and 97.5% water, is currently marketed in over 25 countries worldwide and is approved for the treatment of stress urinary incontinence (SUI).

Bulkamid works as a permanently implanted bulking agent, that helps facilitate improved control of the urethra closing mechanism, in addition to supporting additional local cell growth to help provide long lasting relief of SUI symptoms.

The safety and efficacy of Bulkamid was attested to by a clinical study supporting Contura’s PMA, which found that 75% of women who used Bulkamid experienced a material improvement in their symptoms associated with SUI. This minimally invasive device is already the preferred SUI treatment method for women across the UK, and the Contura team is excited to bring this safe and effective product to the millions of American women suffering from SUI.

CANADA - MDA Pharmaceuticals Rebrands as Juno

Effective March 2020, MDA Pharmaceuticals shall officially be known as Juno Pharmaceuticals Canada (“JPC”). This rebranding serves to better align the company’s brand with that of its international parent, particularly as the company begins to rapidly expand its local market presence.

No changes to MDA/JPC personnel are anticipated in conjunction with the aforementioned rebranding.

CANADA - Michael Ash Appointed as President of Juno OTC

The Juno Group is pleased to announce the appointment of Michael Ash as the new President of Juno OTC.

Michael brings with him an impressive network of retail relationships, cultivated throughout decades of both local and international industry experience. Michael’s expertise in product and brand development, sales and distribution, and product packaging have matured throughout various high profile and progressive sales positions at companies including Apotex Inc, NutraLab Canada Ltd, and more recently FV Pharma.

EUROPE - Contura Announces Acquisition of Proprietary Product Bulkamid by Axonics

Contura Ltd is pleased to announce the acquisition of Bulkamid by Axonics Modulation Technologies, Inc. (NASDAQ: AXNX) for a total consideration of $200 million USD in cash and stock, plus a potential $35 million USD milestone payment, contingent upon the achievement of $50 million USD of Bulkamid sales in any consecutive 12-month period prior to December 31, 2024.

Headquartered in Irvine, CA, Axonics is a global leader in Sacral Neuromodulation, providing customer-centric solutions to treat urinary and bowel dysfunction and improve quality of life for both patients and their families.

“This acquisition is highly synergistic, leverages our expansive commercial footprint and gives us the opportunity to expand our SNM business around the world,” Axonics CEO Raymond W. Cohen said in regards to the acquisition. “Axonics will provide urogynecologists and urologists with a complete suite of clinically differentiated incontinence solutions for their patients, thereby enhancing Axonics’ value proposition to new and existing customers. Interestingly, in many cases, the patient seeking treatment presents with mixed incontinence, meaning with both SUI and urge urinary incontinence symptoms. “Similar to SNM, we see the highly underpenetrated SUI market as poised for significant and durable growth in the years ahead, driven by outstanding clinical results and increased patient awareness.”

Bulkamid, a urethral bulking agent (UBA) consisting of 2.5% polyacrylamide and 97.5% water, is an injectable hydrogel indicated for the treatment of stress urinary incontinence (SUI), a condition which effects millions of women across the globe annually. The product garnered international sales of approximately $12 million in 2019 and was subsequently approved by the US FDA in Q1 2020.

EUROPE - Aspire Ranked as One of the Fasted Growing Pharmaceutical Firms in the UK

Aspire is pleased to announce that it has once again been recognized by PharmaTimes Magazine as one of the fastest growing pharma firms in the UK, the fourth consecutive year that Aspire has been identified as a top performer. Having been awarded an official ranking of 20 in Alantra’s annual ranking of The Pharma Fast 50, the recognition is particularly impressive in the context of the global pandemic and is a true testament to the dedication and enthusiasm of the entire team at Aspire.

The piece is published in the March 2021 edition of the PharmaTimes Magazine, and can be accessed using the following link https://lnkd.in/gSmZkSK

CANADA - Health Canada Approves Juno's Enoxaparin Biosimilar

On October 14, 2020, Juno Pharmaceuticals Corp. (JPC) received a Notice of Compliance from Health Canada for Noromby and Noromby HP, biosimilar drugs referencing Lovenox® and Lovenox HP®. The approval is a significant milestone not only in JPC’s corporate development, marking the rapidly growing pharmaceutical company’s first entry into the local biosimilars market, but is of broader significance for Canadian healthcare as the first enoxaparin sodium biosimilar to be approved in Canada.

The anticoagulant/antithrombotic agent has been approved for both intravenous administration and subcutaneous injection, and in multiple strengths, including 20 mg/0.2mL, 30 mg/0.3mL, 40 mg/0.4mL, 60 mg/0.6mL, 80 mg/0.8mL, 100 mg/mL, 120 mg/0.8mL and 150 mg/mL.

Enoxaparin sodium is commonly used in the treatment/prevention of both pulmonary embolism and deep vein thrombosis and has also previously been used to treat patients suffering from acute coronary syndrome.