24 October 2018

AstraZeneca and Innate Pharma extend oncology alliance

AstraZeneca’s MedImmune division and French biotechnology company Innate Pharma have entered into a new agreement to bolster their respective oncology portfolios.

Under the terms of the agreement, AstraZeneca will gain complete rights to monalizumab, a humanised anti-NKG2A antibody being developed under a prior partnership signed with Innate Pharma in 2015.

AstraZeneca additionally obtains option rights for co-development and co-commercialisation of a CD39-targeting antibody called IPH5201, along with four of Innate Pharma’s preclinical molecules.

Besides, the pharmaceutical giant is licensing commercial rights for Lumoxiti drug in the US and European Union (EU) to Innate Pharma.

Lumoxiti, which is being developed to treat hairy cell leukaemia (HCL), has the US Food and Drug Administration (FDA) approval, but is yet to be reviewed in Europe.

The multi-term agreement will also see the acquisition of a 9.8% equity stake in Innate Pharma by AstraZeneca through share issuance.

AstraZeneca CEO Pascal Soriot said: “Our expanded collaboration with Innate Pharma enables us to further strengthen our leadership in immuno-oncology, and to explore the potential of next-generation immuno-oncology pathways, together with the world-class scientific team of Innate.”

As part of the expanded monalizumab alliance, AstraZeneca will pay $100m to Innate in the first quarter of next year. This payment is in addition to the financial terms agreed by the partners in 2015.

AstraZeneca will also pay $50m upfront for the development collaboration associated with Innate’s IPH5201. The company will also provide option exercise fee, milestones and royalties.

For the option to exclusively licence four preclinical molecules from Innate’s portfolio, AstraZeneca will offer $20m upfront.

AstraZeneca can exercise these options before the molecules advance into clinical development. If exercised, the company will have to pay option exercise fee, along with milestones and royalties.

Innate will hold the potential for co-promotion and profit sharing related to IPH5201 and the four preclinical molecules in the EU.

For Lumoxiti licence, Innate will make $50m upfront payment to AstraZeneca, which is also eligible for future commercial and regulatory milestone-based payments.

23 October 2018

Oncotype DX test reduces chemotherapy recommendations 

At the European Society for Medical Oncology (ESMO) Conference 2018 in Munich, Genomic Health announced data showing its Oncotype DX genomic test causes changes to treatment recommendations and substantially reduces the number of chemotherapy referrals for early stage, hormone receptor-positive, HER-2-negative breast cancer patients.

Genomic Health’s ESMO 2018 presentation was based on two studies carried out in Ireland, Italy and France.

The study in Ireland assessed the impact of the genomic test on treatment decisions during routine clinical practice for node positive (N+) breast cancer. Results of the test significantly impacted the treatment advice that healthcare professionals gave to patients in 64% of cases and caused a 27% reduction in chemotherapy recommendations.

The second study in France and Italy involved both N+ and node negative (N0) patients. The results from the Oncotype Dx changed treatment advice for 35% of patients and there was net reduction in chemotherapy recommendations of 43%.

Oncotype Dx produces a breast recurrence score based on patient’s genomic code helping clinicians to determine the best treatment option for patients.

Head of the breast cancer unit of Bethesda Hospital, Germany, Professor Ulrike Nitz said: “These new results show the unique value of adding genomic information provided by the Oncotype DX test to better target chemotherapy.

“Oncotype DX identifies patients who can safely be spared chemotherapy toxicity and side effects. Furthermore, we have to be concerned about a relevant proportion of patients who seem to be undertreated if the risk of recurrence is evaluated using only traditional clinical parameters.

“The use of the Oncotype DX test allows us to tailor treatment plans more accurately to suit the needs of individuals, and to use resources more effectively.”

These results support previous data from the TAILORx trial, which showed the utility of the genomic test to determine the benefit of chemotherapy treatment on specific patients

Genomic Health UK managing director Steve Ogram said: “There is a wealth of evidence from around the world to demonstrate that the Oncotype DX test is a crucial tool in guiding decisions on clinical care for breast cancer patients.

“Over the summer, the world’s biggest adjuvant breast cancer treatment trial – TAILORx – drew on 10,000 cases to definitively confirm that Oncotype DX is the only test that reduces both under-treatment and overtreatment with chemotherapy.”

22 October 2018

Pfizer’s palbociclib increases survival in breast cancer patients

A new international clinical trial (PALOMA-3) has yielded positive data for the treatment of breast cancer using Pfizer’s Ibrance (palbociclib) in combination with hormone therapy, fulvestrant.

Led by London-based Institute of Cancer Research (ICR) and The Royal Marsden NHS Foundation Trust, the trial involved 521 advanced, hormone-sensitive, HER2- breast cancer patients at 144 research centres across 17 countries.

Data showed numerical improvement of nearly seven months in overall survival with palbociclib plus fulvestran, compared to placebo in combination with fulvestrant.

ICR said that the investigational drug’s benefit was better in women who had previously responded well to hormone therapy. These patients lived ten months longer with the combination treatment.

Ibrance is an oral inhibitor of CDKs 4 and 6 that are known to be key regulators of the cell cycle triggering cellular progression. PALOMA-3 assessed the use of adding the drug to the hormone therapy.

It was observed that three years after enrolment, 49.6% of patients treated with the palbociclib combination were still alive, compared with 40.8% of women who were given only fulvestrant.

The palbociclib arm is also reported to have experienced a longer delay of 17.6 months until the start of chemotherapy, compared to 8.8 months with fulvestrant alone.

ICR molecular oncology professor Nicholas Turner said: “Delaying the need for chemotherapy is a central goal of treatment for women with this disease. This new data from PALOMA-3 shows that adding IBRANCE to fulvestrant led to a substantial improvement in this important area.

“The difference in overall survival and prolonged time to chemotherapy demonstrated in PALOMA-3 further support the role of Ibrance in combination with endocrine therapy as a standard of care in HR+, HER2- metastatic breast cancer.”

The most common adverse reactions observed during the PALOMA-3 trial included neutropenia, leukopenia, infections, fatigue and nausea. Longer follow-up did not reveal any new safety signals.

UK National Institute for Health and Care Excellence (NICE) recommended Pfizer’s palbociclib for the treatment of breast cancer in November last year.

In December, the drug obtained the US Food and Drug Administration (FDA) priority review for its supplemental new drug application seeking approval for metastatic breast cancer.

17 October 2018

Samsung BioLogics may face legal action for alleged accounting breach

South Korea-based biopharmaceutical company Samsung BioLogics is likely to face disciplinary measures due to an alleged accounting breach.

The country’s financial watchdog is close to completing its reinvestigation into the alleged accounting violations of Samsung BioLogics. This probe is believed to have drawn the same conclusion as the first round of examination, according to Pulsenews.

In July, the Securities and Futures Commission (SFC), which is the auditing unit of Financial Services Commission (FSC), withheld verdict on irregularities in accounting practice claimed by the Financial Supervisory Service (FSS). It ordered the FSS to revisit the issue.

The FSS, however, has reportedly drawn the same conclusion and is likely to refer the issue to prosecutors for further probe and this may lead to fines of up to KRW6bn ($5.32m).

SFC may ease penalty during the final review, reported the website.

Following the report, the company’s shares dropped by 7.8%, which is its lowest since August, as reported by Financial Times.

The watchdog claimed that the firm had violated accounting practices in 2015 to boost the value of Samsung Bioepis before going public. Samsung Bioepis is a joint venture with US-based biotech firm Biogen.

Accounting breaches have been found dating back to 2012.

This month, the FSS is likely to serve a preliminary notice to the firm as well as its auditors on measures regarding the alleged breach. Following this, the disciplinary measures are likely to be discussed by the SFC and then finalised by the FSC at the end of the year.

Samsung BioLogics has reportedly committed to take legal measures against the government offices and also submitted self-remedial proposals to opt for a settlement out of court.

Samsung Group is already facing pressure to address labour problems besides reducing the complexity of its ownership structure.

16 October 2018

AstraZeneca to continue UK investment freeze due to Brexit uncertainty

Anglo-Swedish biopharma company AstraZeneca’s non-executive chairman Leif Johansson has unveiled to French newspaper La Monde that the company will continue its freeze on manufacturing investments in Britain if uncertainty over Brexit continues.

Johansson told La Monde: “If a transition deal does not make clear what will happen in the future, we will maintain our decision not to invest.

“A Brexit agreement will need to ensure that Britain does not become an isolated island in the middle of the Atlantic Ocean.”

A spokesperson for AstraZeneca said: “The chairman was talking about a decision announced over a year ago to freeze future investment in manufacturing. There has been no change to our investment plans in the UK.”

The company’s announcement coincided with another stall in Brexit negoatiations, which has led experts to conclude that a final deal may be delayed to December.

This follows AstraZeneca’s announcement in July that it had started stockpiling drugs in preparation for Brexit in both the UK and central European countries. The company has spent £40m so far on planning for Brexit.

The stockpiling of drugs by pharma companies has been encouraged by the UK Government. In August, Secretary of Health and Social Care Matt Hancock wrote a letter to the pharma industry, which included the government’s guidelines regarding stockpiling medicines.

Hancock also separately informed GPs, pharmacists and other healthcare professionals that they should not start stockpiling medicines in case of a no-deal Brexit and instead rely on pharmaceutical companies.

Anti-Brexit campaign group Best for Britain has warned that stockpiling six weeks’ worth of medicines could cost up to £2bn based on data from healthcare think tank King’s Fund.

AstraZeneca is not the only company moving its investment away from the UK over Brexit uncertainty.

Earlier in October, Recardio announced it was halting its UK activities, primarily stopping recruiting of participants for a clinical trial for its drug dutogliptin, due to concerns about how Brexit would affect the approval of medicines.

16 October 2018

Allele Biotechnology gets NIH grant to develop sepsis therapies

Allele Biotechnology and Pharmaceuticals has secured a grant from the US National Institutes of Health (NIH) unit National Institute of General Medical Sciences to develop nanoantibody (nAb) therapies for sepsis.

The small business innovative research grant will be utilised to formulate new single-domain nAb treatments targeting ‘cytokine storm’, an early inflammatory response in the sepsis pathogenesis leading to dysfunction of vascular endothelial barrier.

According to the company, monoclonal antibody drugs could not demonstrate meaningful improvements of sepsis mortality rate in clinical trials as the antibodies did not produce significant benefits within relevant time.

To address these challenges, Allele Biotechnology engineered multi-valent and multi-specific nAbs to act against cytokine storms. nAbs are small fragments of antibodies that are stable and easy to produce.

In animal models of sepsis, the structural and functional properties of the nAbs are said to have contributed to their superior therapeutic efficacy compared to traditional antibody drugs.

The company observed that nAbs have a significant capability to penetrate tissues and tumours. These antibodies can also bind certain difficult-to-access epitopes.

Sepsis and septic shock are known to be the primary causes of death in intensive care units.

The global incidence of the condition has only enhanced over the years, while the mortality rate is reported to be virtually unchanged for the past 30 years, as no cure or effective therapies are available.

Allele Biotechnology started nAb research in 2008, and currently generates the antibodies for a variety of devastating diseases such as cancers, inflammation, neurological and ophthalmological conditions.

The company plans to utilise the new NIH funding support for advancing into clinical stage to explore a therapy that reduces death from sepsis.

15 October 2018

Otsuka expands digital medicines alliance with Proteus Digital

Otsuka Pharmaceutical has expanded its global collaboration agreement with Proteus Digital Health for advancing a portfolio of digital medicines and care models to help patients with severe mental illness.

Under the renewed alliance, the partners will further develop and commercialise digital medicines over the next five years.

The new agreement includes the Abilify Mycite drug-device combination product that secured US Food and Drug Administration (FDA) approval for the treatment of multiple mental disorders.

As part of the partnership, Otsuka made $88m in related equity and additional payments to Proteus.

Otsuka North America Pharmaceutical business division president and CEO Kabir Nath said: “We are pleased to continue to focus on opportunities to further integrate digital medicines into healthcare eco-systems to provide value-added outcomes for patients suffering from unmet medical needs in the mental health field.

“Our expanding collaboration with Proteus is a cornerstone of this strategy, and further enables us to serve the mental health community by developing additional innovative technology solutions.”

Otsuka and Proteus employees will jointly work towards commercial development and market coordination for the Abilify Mycite System.

The team will also focus on software integration and standardisation, manufacturing and supply chain integration, and coordination.

Also, the partners will develop an expanded portfolio of other digital medicines, including atypical antipsychotics embedded with Proteus sensors.

They will devise next-generation product features and sensor capabilities aimed at expanding the potential of digital medicine offerings.

Proteus Digital Health president and CEO Andrew Thompson said: “This commitment to a broad, inter-operable platform is the core reason for us to expand our collaboration with Otsuka in mental health.

“This expanded collaboration is a great opportunity to bring novel digital medicine solutions to mental health patients.”

In April, Proteus announced the development of a pipeline of 31 digital medicines called DigiMeds.

The company formulated 15 DigiMeds for cardiovascular and metabolic conditions, seven for infectious diseases and additional products for cancer.

15 October 2018

Rival companies to tap $20bn global market with biosimilars for Humira

Rival companies have lined up to create biosimilars for Humira (adalimumab), which is currently marketed by US-based biopharmaceutical company AbbVie, as the European patent on the drug is expected to expire on 16 October, reports Financial Times.

Humira is used for the treatment of a wide range of conditions, including rheumatoid arthritis, psoriasis and Crohn’s disease.

With the expiry of the patent, which has kept Humira away from generic competition for the past 15 years, rival pharmaceutical companies intend to replace the drug with their biosimilars, with an aim to secure a position in the nearly $20bn global market.

The big name companies expected to enter the market with biosimilars for Humira include Fujifilm Kyowa Kirin Biologics, Amgen, Sandoz, Biogen and Samsung Bioepis.

Based in Japan, Fujifilm Kyowa Kirin Biologics has granted an exclusive licence to Mylan for the commercialisation of Humira biosimilar Hulio in Europe.

All of these companies have received regulatory approval from Europe for the launch of their respective substitutes.

In a statement, AbbVie was quoted by Financial Times as saying that it “welcomes the introduction of biosimilars that have demonstrated they are as safe and efficacious as their reference products.”

However, the company has stated that “patients who are stable on their existing biologic therapy should not be switched to another product for non-medical reasons.”

According to the UK National Health Service (NHS), the most competitively priced suppliers of Humira biosimilars will gain a larger share of the market, while all other companies will have access to “some of the market upon receipt of a compliant bid to avoid dominance.”

An NHS commissioning document seen by the newspaper stated: “Our aim is that at least 90% of new patients will be prescribed the best value biological medicine within three months of launch of a biosimilar medicine, and at least 80% of existing patients within 12 months, or sooner if possible.”

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