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Mallinckrodt files lawsuit against US health agencies
Mallinckrodt has filed a lawsuit against the US Health and Human Services (HHS) and Centers for Medicare and Medicaid Services (CMS) over a decision to change Medicaid rebates for its Acthar Gel.
CMS recently asked Mallinckrodt to change the drug’s base date average manufacturer price (AMP), which is used to calculate the rebates. This move reverses CMS’ written authorisations of the base date AMP provided in 2012, which has been in use since 2013.
Mallinckrodt claims that the agency’s decision will eliminate Acthar Gel’s 10% Medicaid net sales and lead to non-recurring charges of up to $600m.
The decision could also hinder its investment in research and development (R&D) for a pipeline focused on therapeutic areas with fewer treatment options.
Mallinckrodt general counsel Mark Casey said: “With our repeated attempts to engage both HHS and CMS in productive discussions ultimately rebuffed, we find ourselves with no other choice than to vigorously defend our position, through the courts, that Medicaid patients should have access to this important therapy.”
Acthar Gel is indicated for spasms in babies and children aged less than two years and to treat multiple sclerosis (MS) in adults. The medicine was approved by the US Food and Drug Administration (FDA) in 2010 and received reaffirmations for approval of 18 Acthar Gel indications, based on supportive clinical data submission.
Mallinckrodt noted that upon the basis of the 2010 approval, CMS expressly authorised a base date AMP for the drug in writing in 2012. The company argues that the latest CMS decision that the medicine with the infantile spasms indication is not eligible for its own base date AMP violates regulations.
In its lawsuit, Mallinckrodt is asking the court to overturn the CMS’s decision.
Schrödinger raises $110m to develop drug discovery platform
Schrödinger has raised $110m during a funding round to develop its computational platform, which combines physics-based molecular simulations and machine learning for the exploration of chemical space.
The platform was used to discover Agios’ ivosidenib and enasidenib, which are marketed by Agios and Celgene. The drugs are approved by the US Food and Drug Administration (FDA) to treat cancer.
The technology has also led to multiple clinical-stage assets, as well as more than 12 programmes that are currently in the discovery and development stages.
With the latest funding round, Schrödinger expects the platform to enable discovery of compounds for therapeutic indications and materials design.
Previous investors for the technology joined the financing round, including Bill and Melinda Gates Foundation Trust, WuXi AppTec’s Corporate Venture Fund, Deerfield Management, Baron, Qiming Venture Partners and GV, formerly Google Ventures.
New investors also joined, including Invus, Pavilion Capital, Oculus co-founder Michael Antonov through his investment fund Tubus Management, and Laurion Capital Management.
With the new financing, Schrödinger intends to support its drug discovery pipeline and expand its partnerships with biopharma companies. The funds will be invested in ongoing research and development (R&D) efforts to expand the use of its platform.
Schrödinger CEO Ramy Farid said: “Our platform has been validated again and again across hundreds of targets in real-world drug discovery projects.
“We are committed to leveraging the platform to speed the discovery of new medicines, and we’re delighted to receive such broad support from investors to further our mission.”
Established in 1990, Schrödinger operates in the US, Europe, Japan and India with approximately 400 employees. The company also has business partners in China and Korea.
Charity LifeArc sells rights to Keytruda for more than $1bn
UK-based medical research charity LifeArc has sold its royalty interest in Merck’s Keytruda (pembrolizumab) for $1.297bn to the European subsidiary of Canada Pension Plan Investment Board (CPPIB).
LifeArc was created from Medical Research Council (MRC)’s technology branch in 2017. MRC Technology collaborated in the humanising of the antibody anti-Programmed cell death-protein 1 (PD-1) therapy, which is now marketed by Merck.
This transaction is expected to transform LifeArc into one of the UK’s largest medical research charities in terms of size of investment assets.
The charity’s CEO Dr Melanie Lee said: “This agreement with CPPIB allows us to increase our support for new approaches and collaborations and bolster access to our expertise and resources.
“Ultimately, we can support life sciences research and accelerate the development of new therapies, diagnostics and devices for those people in greatest need.”
Chairman of the board Dr John Stageman said: “The agreement with CPPIB is a once in a generation opportunity, providing LifeArc with additional resources to accelerate our work.
“We are continuing to evolve our strategy and approach to maximise the impact on innovation, sustainability and patient benefit.”
CCPIB global head of credit investments and senior managing director John Graham said: “This investment in Keytruda provides us the opportunity to continue expanding CPPIB’s global intellectual property program.
“The acquisition of royalty interests from LifeArc for this market-leading cancer therapy provides stable, long-term cash flows.”
This sale follows on from a move by MRC Technology in 2016 to monetise a portion of its rights to Keytruda to a private equity fund managed by DRI Capital for $150m. As a result, MRC Technology was able to create two funds worth £30m: the LifeArc Philanthropic Fund providing grants for translational research into rare diseases and the LifeArc Seed Fund focused on early stage spin-out companies.
Keytruda’s global success across a range of oncology indications has exceeded expectations since its approval in 2015. According to the Financial Times, sales are predicted to exceed $8bn this year and perhaps reach $16bn by the mid-2020s.
In its most recent financial results for the first quarter of 2019, Merck noted Keytruda as one of its oncology highlights, alongside Lynparza and Lenvima.
GSK and Novartis misled consumers, says Federal Court of Australia
The Federal Court of Australia has said that subsidiaries of UK-based GlaxoSmithKline (GSK) and Swiss drugmaker Novartis misled customers by falsely promoting identical pain relief products.
According to the court, the companies marketed Voltaren Osteo Gel as a more effective treatment for osteoarthritis-related pain and inflammation, even when its ingredients were very similar to Voltaren Emulgel.
An investigation by the Australian Competition and Consumer Commission (ACCC) showed that Osteo Gel was sold at a higher price than Emulgel. The false marketing was carried out from January 2012 to March 2017.
The claims in question were printed on product packaging, as well as featured on the Voltaren and My Joint Health websites.
ACCC commissioner Sarah Court said: “Novartis and GSK misled osteoarthritis sufferers into buying the more expensive Osteo Gel thinking that it was more effective than Emulgel for treating their symptoms when this is not the case.”
The consumer watchdog added that GSK amended the Osteo Gel packaging in March 2017 to include the wording: ‘Same effective formula as Voltaren Emulgel’. The court said that these changes rectified the misleading representations.
GSK has been carrying out marketing and sales activities for Voltaren products since the portfolio was acquired from Novartis in March 2016. The UK company stopped supplying Osteo Gel products to retailers in May last year.
The court will hold a hearing in the future to determine relevant penalties. Reuters noted that the maximum sanction is three times any benefits earned from the misleading conduct or a tenth of annual turnover.
Takeda and Frazier team up to launch biopharmaceutical firm
Takeda Pharmaceutical has collaborated with US-based Frazier Healthcare Partners to launch a biopharmaceutical company named Phathom Pharmaceuticals.
The firm will develop and commercialise therapies for the treatment of gastrointestinal (GI) diseases and disorders.
Phathom Pharmaceuticals has obtained a licence from Takeda featuring exclusive commercialisation rights to vonoprazan in the US, Europe and Canada.
In turn, Takeda will receive upfront cash and equity payments, along with future milestone payments and royalties on net sales. Phathom has already made a $90m crossover financing and $50m debt facility in connection with the licence.
The $90m financing was led by Frazier Healthcare Partners with investments from Medicxi, RA Capital Management and Abingworth.
The round was also joined by accounts managed by Janus Henderson Investors, BVF Partners LP, Greenspring Associates, Richard King Mellon Foundation, Sahsen Ventures and other undisclosed institutional investors.
Phathom Pharmaceuticals interim CEO David Socks said: “We welcome their support in our efforts to advance vonoprazan, a next-generation therapeutic with the potential to make a profound impact on the lives of patients with acid-related gastrointestinal disorders.”
Discovered and developed by Takeda, vonoprazan is an oral potassium-competitive acid blocker (P-CAB) that competitively limits the potassium-binding site of gastric hydrogen potassium ATPase enzymes, which are known to be involved in acidification of the stomach.
In Asian and Latin American countries, vonoprazan is indicated to treat gastroesophageal reflux disease (GERD), the gastric and duodenal ulcers that occur following Helicobacter pylori infection, and low-dose aspirin-associated ulcers.
In the US, Europe and Canada, the drug is undergoing Phase III clinical development programmes for GERD and Helicobacter pylori infection.
Takeda gastroenterology therapeutic area unit head Asit Parikh said: “Phathom’s skilled leadership, with deep expertise in acid-related disorders, positions them well to expand access to vonoprazan in North America and Europe while Takeda continues to leverage its presence in Japan and several Asian markets.”
Takeda will promote vonoprazan in Japan in partnership with Otsuka.
Furthermore, Takeda will continue marketing the drug in multiple Asian markets, including Malaysia, Philippines, Singapore, South Korea, Taiwan and Thailand.
New UK programme to address cancer resistance to treatments
The Institute of Cancer Research London (ICR) is set to support a drug discovery programme to address treatment resistance.
The organisation will provide £75m to build a Centre for Cancer Drug Discovery, which will host the programme.
Under the scheme, researchers from various disciplines will work together to develop therapies for cancer variants that are considered lethal due to their adaptability. This approach is expected to enable long-term control.
Under the programme, artificial intelligence (AI) and advanced mathematics will be used to alter cancerous cells, manipulating them susceptible to specific treatments. The researchers will develop these therapeutics to slow down the disease’s ability to change and delay its resistance to treatment.
The drugs will be designed to target the (apolipoprotein B mRNA-editing catalytic polypeptide-like) APOBEC family of proteins to minimise the rate of mutation in cancer cells.
APOBEC inhibitors are expected to be given in combination with a targeted cancer therapy for long-term control. Recent ICR research suggested that these inhibitors could improve the effectiveness of therapies that use viruses as immunotherapy against tumours.
Multi-drug combinations will be developed for simultaneous blocking of a variety of cancer genes.
ICR chief executive Paul Workman said: “We will create exciting new ways of meeting the challenge of cancer evolution head-on, by blocking the entire process of evolutionary diversity, using AI and maths to herd cancer into more treatable forms, and tackling cancer with multi-drug combinations as used successfully against HIV and tuberculosis.
“We firmly believe that, with further research, we can find ways to make cancer a manageable disease in the long-term and one that is more often curable, so patients can live longer and with a better quality of life. But that research will need support and our new centre will dramatically accelerate the progress we’re already making.”
The organisation plans to raise additional £15m from philanthropic donations to complete the new building and install advanced instruments and computational technologies.
Celgene’s Pomalyst secures breakthrough designation
The US Food and Drug Administration (FDA) has awarded breakthrough therapy designation to Celgene’s Pomalyst (pomalidomide) in HIV-positive and HIV-negative Kaposi sarcoma.
Pomalyst is an oral, small molecule thalidomide analogue that acts via multiple mechanisms of action. It is one of the company’s immunomodulatory imide drug (IMiD) agents that are being developed as treatments for blood cancer.
Pomalyst is indicated for multiple myeloma patients that received at least two prior therapies and saw disease progression within 60 days.
Kaposi sarcoma is a multicentric tumour caused by Kaposi sarcoma-associated herpesvirus or human herpesvirus-8. It is characterised by multiple lesions on the skin and oral mucosa. In some cases, other organs such as the lungs or gastrointestinal mucosa are affected.
The tumour is commonly found in people infected with HIV. Celgene noted that there is a significant need for new treatments due to a lack of approved therapies for HIV-positive patients that are refractory to (or intolerant of) systemic chemotherapy.
Celgene chief medical officer Jay Backstrom said: “The encouraging news of the FDA breakthrough therapy designation for Pomalyst in Kaposi sarcoma reflects the urgency in accelerating the development of therapies to address diseases of this type.
“We will continue to work closely with the agency to move this programme forward for patients with this rare and serious cancer.”
The FDA’s decision was based on findings from a clinical study led by a team in the HIV and AIDS malignancy branch at the Center for Cancer Research of the National Cancer Institute (NCI).
Celgene intends to conduct two additional clinical studies in HIV-positive and HIV-negative Kaposi sarcoma patients. One of these trials will be conducted in alliance with the AIDS Malignancy Consortium (AMC) to validate and extend data obtained in the NCI study.
AMC will sponsor the second study, which will be performed in Africa.
Celgene is planning to file a supplemental new drug application for Pomalyst in this indication by the end of this year.
AbbVie and Boehringer settle Humira biosimilar patent dispute in US
AbbVie and Boehringer Ingelheim have settled a patent dispute in the US over Cyltezo (adalimumab-adbm), a biosimilar of Humira (adalimumab).
As per the settlement agreement, AbbVie will provide Boehringer with a non-exclusive licence to its intellectual property related to Humira in the US.
The licence for Boehringer’s Cyltezo will begin on 1 July 2023. The German pharmaceutical company will make royalty payments to AbbVie for licensing the Humira patents.
Boehringer Ingelheim senior vice-president and US general counsel of legal and government affairs Sheila Denton said: “This resolution provides clarity regarding the availability of Cyltezo and allows us to focus on serving patients who need to manage their chronic disease.”
AbbVie external affairs vice-chairman and chief legal officer Laura Schumacher noted: “This is an important settlement as it resolves all Humira-related patent litigation in the US and provides access for another biosimilar manufacturer seeking to enter the US.”
Humira is an anti-tumour necrosis factor (TNF) monoclonal antibody (mAb) indicated for the treatment of Crohn’s disease, rheumatoid arthritis, ulcerative colitis, hidradenitis suppurativa and psoriasis, as well as psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis and uveitis.
It is claimed to be one of the world’s best-selling drugs, recording sales revenues of $4.9bn globally in Q4 2018.
The patent dispute between AbbVie and Boehringer has been long-standing. In February this year, the US magistrate judge asked AbbVie to produce evidence that the company was obtaining patents that could shield Humira from biosimilar competition.
This settlement expands the number of drugmakers that have agreed to wait until 2023 to launch their biosimilar versions of Humira in the US, including Mylan, Novartis unit Sandoz and Pfizer.
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