18 December 2018

Novo Nordisk signs dyslipidaemia drug deal with Staten Biotechnology

Novo Nordisk has signed a collaboration and exclusive option agreement with Dutch drug maker Staten Biotechnology for the development of new therapies to treat hypertriglyceridaemia.

The move is in line with Novo Nordisk’s strategy to expand into the cardiovascular diseases area.

Under the terms of the deal, Novo Nordisk will offer research and development (R&D) funding and support to Staten for developing its STT-5058 product candidate for dyslipidaemia.

Hypertriglyceridemia is characterised by high fat levels in blood and considered as a serious risk factor for cardiovascular disease, particularly in patients with diabetes and obesity.

Developed by Staten in alliance with argenx, STT-5058 is a human antibody designed to target apoC3 epitopes that reduce triglycerides and increase atherogenic remnant lipoproteins clearance.

Novo Nordisk Global Drug Discovery senior vice-president Marcus Schindler said: “Staten Biotechnology has developed STT-5058, a new promising concept validated by human genetics, for the treatment of hypertriglyceridemia.

“Combining Staten’s know-how on STT-5058, the scientific excellence of the company’s executive team and founders, with Novo Nordisk experience in drug development and commercialisation, the project holds potential to make a real difference for people suffering from cardiovascular disease.”

As part of the agreement, Novo Nordisk will potentially pay up to €430m ($487m) in signing and exercise fees, R&D funding and milestone payments to Staten Biotechnology.

Furthermore, Novo Nordisk holds the right to acquire Staten Biotechnology and in turn obtain worldwide rights to STT-5058.

Staten Biotechnology CEO Hilde Steineger said: “Novo Nordisk is joining forces with Staten Biotechnology at an exciting time for us, with the company’s lead compound moving towards its first clinical trial, aiming to address the residual cardiovascular risk in patients with hypertriglyceridaemia.

“This partnership provides the company not only with a knowledgeable development partner but also with a funding structure that allows founders, management and the founding investors to accelerate the development of the company.”

14 December 2018

Nicox and Ocumension partner to develop and commercialise glaucoma drug

French ophthalmology firm Nicox has partnered with China-based Ocumension Therapeutics to develop and commercialise its NCX 470 for the treatment of patients with glaucoma or ocular hypertension.

NCX 470 is designed to deliver bimatoprost and nitric oxide to reduce intraocular pressure (IOP) in patients with open-angle glaucoma and ocular hypertension.

The partners signed a licence agreement providing Ocumension with exclusive rights to NCX 470 in a territory that comprises mainland China, Hong Kong, Macau and Taiwan.

In turn, the Chinese firm will pay €3m upfront to Nicox, which will receive an additional €2.5m upon initiating a Phase III clinical trial of NCX 470 outside the agreed territory.

Under the terms of the deal, Nicox is also eligible to receive up to €14.5m in milestones linked to Ocumension’s progress with NCX 470, as well as €16.25m over three separate sales milestones associated with potential sales in the territory of up to €200m, and tiered royalties.

Nicox executive vice-president and chief business officer Gavin Spencer said: “This collaboration offers Nicox the opportunity to access the fast-growing Chinese ophthalmology market in partnership with an emerging player.

“Ocumension, which is financed by leading investors, has a strong team, both for development and commercialisation, with significant ophthalmology experience and we look forward to developing NCX 470 in the Chinese market with them.”

Ocumension is responsible for performing additional clinical studies for the regulatory approval of NCX 470 in the Chinese market.

The company will incur all the costs associated with the development and marketing of the candidate in the territory.

Ocumension Therapeutics CEO Ye Liu said: “Ocumension is focused on bringing novel ophthalmic therapeutics to the Chinese market, and so we welcome the opportunity to partner with Nicox, one of the leading R&D companies in the glaucoma space, to develop NCX 470.

“We believe the novel nitric oxide-donating mechanism of action of NCX 470 offers significant innovation and potential benefits for patients in our region.”

Ocumension Therapeutics is an ophthalmology company formed by the merger between Wuxi Healthcare Ventures and Frontline BioVentures.

14 December 2018

Bausch Health makes $200m bid for bankrupt Synergy Pharmaceuticals

Canada-based Bausch Health Companies (previously Valeant Pharmaceuticals) has entered a definitive agreement to acquire select assets of Synergy Pharmaceuticals for around $200m and certain assumed liabilities.

The deal will include intellectual property, customer and vendor contracts, accounts receivable and goodwill.

Synergy Pharmaceuticals is a US-based firm focused on gastrointestinal medicine. The company voluntarily filed for bankruptcy under Chapter 11 of the US Code.

Bausch Health said that it will serve as the ‘stalking horse’ bidder in a court-supervised auction and sale process.

Bausch Health chairman and CEO Joseph Papa said: “As part of our transformation strategy, we will continue to seek strategic bolt-on opportunities that we believe will help drive long-term growth in our core businesses and for the company.”

The Canadian pharmaceutical company expects the acquisition to expand its gastroenterology portfolio. Synergy’s Trulance (plecanatide) will complement Bausch Health’s Xifaxan (rifaximin).

Trulance is indicated for adults with chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C), while Xifaxan is approved to treat IBS with diarrhea and minimise risk of overt hepatic encephalopathy (HE) recurrence in adults.

The deal will also add Synergy’s investigational gastrointestinal candidate, dolcanatide.

Papa added: “The acquisition of the assets of Synergy will enhance our Salix Pharmaceuticals business.

“We believe Trulance is a natural complement to Xifaxan (rifaximin), and with the scale and strength of our sales footprint in GI and primary care, our Salix team will be able to offer physicians and patients multiple treatment options that span the types of irritable bowel syndrome.”

As per the sale process, Bausch Health’s bid is subject to higher or better offers, where other parties could make competing proposals.

Further, the transaction is subject to customary closing conditions and Bankruptcy Court approval.

If the bid is successful, Bausch Health expects to complete the acquisition by the first quarter of next year.

13 December 2018

NIH to support HIV care and prevention research in the US

The National Institute of Allergy and Infectious Diseases (NIAID), a National Institutes of Health (NIH) division, has announced plans to fund human immunodeficiency virus (HIV) care and prevention research in the south of the US.

The initiative will support multiple collaborations with medical research institutions to explore new approaches to implement treatment and prevention tools in regions with the highest rates of new HIV cases.

The southern part of the US was selected because it reports the highest rates of new HIV diagnoses, patients and related deaths.

Tools to be included under the initiative are daily antiretroviral therapy, pre-exposure prophylaxis (PrEP) and emergency post-exposure prophylaxis (PEP).

The new funds will be utilised to deepen ongoing research at the NIH-funded Centers for AIDS Research (CFARs) to minimise HIV burden across the world.

CFARs in the US South will build on existing alliances with local health authorities, community-based groups, the Centers for Disease Control and Prevention programmes, and the Ryan White HIV/AIDS Program.

The partners will aim to determine and assess strategies to connect people living with the infection or at risk of its acquisition with prevention services and medical care.

NIAID director Anthony Fauci said: “The Centers for AIDS Research are our research boots on the ground, working in diverse communities nationwide.

“This new initiative harnesses their local expertise to design smart, innovative ways to fill the gaps in HIV treatment and prevention care that are pervasive in the US South.”

The health research organisation intends to provide supplemental funding to the current CFAR programme early next year. The CFARs are co-funded and managed by 14 institutes and centres at the NIH.

11 December 2018

New Zealand moves towards legalising medical cannabis

New Zealand’s parliament has passed an amendment to the Misuse of Drugs Act 1975 that will allow terminally ill patients to possess and use cannabis.

Previously, marijuana could only be used in a medical capacity with the approval of the Health Minister.

The amendment will also create a regulatory body to oversee locally manufactured medical cannabis products for the national and international market and will mean cannabidiol products will no longer be classed as controlled drugs.

The related regulations, licensing rules and quality standards are expected to take a year to be established and implemented, so the amendment creates a legal defence for terminally ill patients to start smoking cannabis immediately.

The Member of Parliament responsible for the amendment Minister of Health David Clarke said: “People nearing the end of their lives should not have to worry about being arrested or imprisoned for trying to manage their pain.

“This is compassionate and caring legislation that will make a real difference to people … they can use illicit cannabis without fear of prosecution.”

However, the amendment has been criticised by the opposition. The Associated Press reported that the opposition’s health spokesman Dr Shane Reti called the law ‘lazy and dangerous’ as it did not specify the future plans and allowed the public smoking of cannabis

He said: “We support medicinal cannabis but strongly oppose the smoking of loose-leaf cannabis in public. Smoked loose-leaf is not a medicine.”

The amendment has now been sent to the Queen for Royal Assent. It comes before a national referendum on recreational marijuana, which the Labour-Green coalition government promised would occur in the next two years.

Earlier this year, the UK changed the law to allow expert doctors in the UK to legally prescribe cannabis-based medicines for patients without requiring approval from an expert panel for access.

10 December 2018

CEPI and Imperial College London collaborate on Disease X vaccines project

The Coalition for Epidemic Preparedness Innovations (CEPI) in Norway and Imperial College London have formed an alliance to develop new vaccines against known and unknown pathogens, which are commonly referred to as Disease X.

Under the $8.4m project, the partners will create a synthetic, self-amplifying RNA (saRNA) vaccine platform called RapidVac for the quick development of vaccines.

The saRNA technology will leverage the body’s own cell system to make an antigen in order to trigger an immune response, rather than directly injecting the antigen.

Development of vaccines currently takes approximately ten years, however, the new collaboration aims to cut this time to a total of 16 weeks – from identification of antigen to release of the product for clinical trials.

Imperial College London Mucosal Infection and Immunity chair Robin Shattock said: “We believe that synthetic self-amplifying RNA based vaccines offer the best opportunity for a ‘just in time’ response to infectious outbreaks, providing the needed technological shift to aggressively redefine the timelines for vaccine production.”

Imperial will lead a consortium to create the RapidVac platform, which will be used to generate vaccines to protect from influenza (H1N1), rabies and Marburg viruses.

The partners expect the new vaccine platform to aid both regional and global preparedness against outbreaks of Disease X by allowing rapid production of large volumes of ‘single-shot’ and ‘cocktail’ vaccines within weeks.

CEPI CEO Richard Hatchett said: “Our partnership with Imperial represents a vital part of our plan to create vaccine platforms that can significantly reduce vaccine development times – from a matter of years to weeks.

“We cannot predict where or when Disease X will strike, but by developing these kinds of innovative vaccine technologies we can be ready for it.”

CEPI works towards development of vaccines for various diseases. In September, the organisation partnered with The Jenner Institute at the University of Oxford and Janssen Vaccines & Prevention to create a vaccine against Middle East Respiratory Syndrome Coronavirus (MERS-CoV).

In August, Emergent BioSolutions and Profectus BioSciences received a contract from CEPI to develop and manufacture a vaccine to protect from Lassa virus.

Austrian company Themis Bioscience obtained a similar contract in March for both Lassa fever and Middle East respiratory syndrome (MERS) vaccines.

7 December 2018

Mallinckrodt to spin off speciality generics business next year

After two years of planning, UK-based pharmaceutical company Mallinckrodt has announced plans to split its speciality generics and active pharmaceutical ingredients (APIs) business, in addition to the drug amitiza (lubiprostone), from its speciality pharmaceutical brands segment.

The Speciality Generics spin-off will be owned by Mallinckrodt shareholders, be headquartered in St Louis, Missouri, and will retain the Mallinckrodt name, while the separate speciality pharmaceutical brands company will be renamed.

Mallinckrodt chairman of the board Angus Russell said: “In 2016 the Board began to explore a range of strategic alternatives for the company’s Specialty Generics business, and believes there is a strong rationale and opportunity to create two new, appropriately capitalised, independent companies that have the potential to unlock and increase value over the long term.

“We expect this separation will result in greater strategic focus, allowing each business to more effectively enhance returns by commercialising new and current product offerings; drive innovation by allocating resources to the areas of highest opportunity; and pursue growth and investment strategies more directly aligned with each company’s respective goals.”

The company’s current president and CEO Mark Trudeau will remain CEO of the speciality brands segment, while current Mallinckrodt CFO, as well as president and CEO of the generics businesses, Matthew Harbaugh, is expected to lead the generics spin-off.

Trudeau said: “The spin-off of the Specialty Generics business creates an exciting new company which we believe will be well positioned to grow. Operating independently will allow this new company to more rapidly capitalise on its growth opportunities to enhance value.”

Harbaugh added: “As an independent, US-based company, I am confident that we will be well positioned to advance our R&D capabilities and continue to maintain our category leadership in controlled substances.”

The split remains subject to final board approval and US regulatory conditions and is expected to be completed in the second half of 2019.

The company’s speciality generics and API businesses, as well as amitiza, which is indicated for chronic idiopathic constipation, had net sales of $850m in the 12 months to September 2018.

The speciality brands business, which centres on H.P Acthar gel, one of the top ten most expensive drugs sold in the US, had net sales of $2.3bn over the same period.

6 December 2018

Eisai and UCL deepen drug discovery alliance

Japanese pharmaceutical company Eisai has expanded its drug discovery collaboration with University College London (UCL) in the UK for an additional five years to 2023.

The partnership, which initially commenced in 2012 for a duration of six years, is intended to advance research findings into new therapies for neurodegenerative disorders.

Under the extended alliance, the partners will carry out clinical development of a drug candidate called E2814 for Alzheimer’s disease.

E2814 is one of the projects established in the first phase of the collaboration. The candidate is an anti-tau monoclonal antibody being developed to slow the progression of neurodegenerative conditions.

Eisai and UCL have started preparations to conduct Phase I clinical studies of the therapeutic in patients suffering from Alzheimer’s in the 2018 fiscal year.

Eisai Neurology business group chief discovery officer Teiji Kimura said: “By combining the knowledge of UCL, which conducts world-class research into neurodegenerative disorders and is the operational hub of the UK Dementia Research Institute, together with the knowledge of Eisai, which possesses a rich pipeline for dementia treatments, we are doing our utmost to link the results of joint research starting with E2814 to new medicines in order to contribute to patients who are awaiting curative therapies as soon as possible.”

Alzheimer’s is a chronic, progressive, neurodegenerative disorder characterised by formation of amyloid-beta protein plaques and neurofibrillary tangles of tau protein.

E2814 is designed to target the tau protein ‘seeds’ for preventing further build-up of neurofibrillary tangles in order to potentially slow the disease progression.

Kimura added: “Significant unmet medical needs exist for neurodegenerative disorders such as Alzheimer’s disease due to a lack of effective treatments that can prevent disease progression, and Eisai’s mission is to contribute to overcoming these issues.”

According to the company, current estimates indicate an increase of dementia patients from existing 50 million to nearly 82 million in 2030.

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