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Berlin, January 10, 2023 – On the event of the 41st J.P. Morgan Healthcare convention in San Francisco, Bayer AG introduced it’s elevating its mixed peak gross sales forecast for key development drivers in its pharma portfolio to over twelve billion euros. This improved outlook comes amid the corporate’s potential blockbuster medication monitoring forward of schedule and focused investments in Analysis and Growth (R&D) replenishing its pharmaceutical growth pipeline.
Nubeqa™ (darolutamide), which has the potential to develop into the usual of look after prostate most cancers sufferers from the early- to the late-stage of this illness, has projected peak gross sales potential of greater than three billion euros. Its market share within the US has already expanded to over 30 % in non-metastatic castration-resistant prostate most cancers (nmCRPC) and it has gained US label extension to deal with sufferers within the metastatic hormone-sensitive prostate most cancers (mHSPC) setting primarily based on the sturdy information of the
ARASENS examine. Going ahead, development will likely be pushed by additional approvals for the remedy of mHSPC within the EU, Japan, China and different main areas in addition to continued features in market share. In parallel, the continuing Section III scientific growth packages (ARANOTE and ARASEC) with darolutamide purpose to broaden its use even additional by providing remedy choices within the metastatic hormone-sensitive setting with out concomitant chemotherapies. Darolutamide’s use within the biochemical relapse and adjuvant settings can also be being investigated.
Kerendia™ (finerenone), a first- in-class non-steroidal mineralocorticoid receptor antagonist, representing a precious remedy possibility for sufferers with cardio-renal illness, might generate gross sales of greater than three billion euros. This therapeutic possibility has proven one of many strongest launch dynamics within the US market, outperforming benchmark launches within the cardiovascular area. This sturdy launch momentum is predicted to proceed, pushed by its strong place on prime of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers, its broad utility and relevance throughout normal practitioners, endocrinologists, nephrologists and cardiologists in addition to rising affected person numbers and longer remedy durations within the US. Further help for development will come from upcoming reimbursements approvals in non-US territories and additional guideline inclusions.
A step-change in development is predicted from oral issue XIa (FXIa) inhibitor asundexian. With the potential to behave as distinct possibility for the prevention of thrombosis and ischemic strokes, asundexian has projected peak gross sales of greater than 5 billion euros. It’s estimated that round 40 % of eligible sufferers are both not handled with direct oral anticoagulants or undertreated as these sufferers assess the bleeding threat to be increased than their want for thrombosis prevention. Asundexian is a first-in-class, as soon as day by day oral FXIa inhibitor, offering the potential to suppress clot formation to stop thrombosis whereas leaving the physique’s capability to answer bleeding occasions intact. Bayer’s complete Section II examine program PACIFIC confirmed that asundexian might scale back the danger of thrombotic occasions with out considerably impacting the danger of bleeding. Based mostly on these promising scientific outcomes, the landmark Section III growth program OCEANIC in atrial fibrillation and non-cardioembolic stroke has been began. Almost 30,000 sufferers worldwide are concerned on this program.
Blockbuster potential can also be attributed to elinzanetant, an revolutionary, non-hormonal small molecule being developed for the remedy of vasomotor signs throughout menopause. Vasomotor signs or scorching flashes are reported by as much as 80 % of ladies in some unspecified time in the future through the menopausal transition. They will negatively affect sleep, temper and high quality of life and are the main trigger for looking for medical consideration throughout this specific part of a lady’s life. Multiple third of ladies report extreme signs, which may final ten years or extra after the final menstrual interval. Whereas round 16 million ladies every in america and Europe endure from vasomotor signs, there are nonetheless restricted remedy choices accessible. Hormone remedy, the present commonplace of care, isn’t an possibility for a lot of ladies because of contraindications or private desire. Elinzanetant, in distinction, is an oral first-in-class, non-hormonal drug candidate, inhibiting each the neurokinin-1 and three receptors and thereby doubtlessly lowering hyperactivity of the kisspeptin, neurokinin B and dynorphin neuronal circuit concerned in thermoregulation. This drug candidate demonstrated vital and fast enchancment in vasomotor signs in Section II research and was well-tolerated. First outcomes from the Section III OASIS examine program are anticipated within the second half of 2023.
“The sturdy launches of Nubeqa™ and Kerendia™ and our compelling late-stage growth portfolio mirror our dedication to bringing revolutionary medicines to sufferers, with the long run gross sales development potential rising considerably within the subsequent couple of years,” stated Stefan Oelrich, Member of the Board of Administration, Bayer AG and President of Bayer’s Prescription drugs Division. “As well as, constructive examine outcomes from our cell & gene remedy platforms provide a possible upside that’s arduous to quantify precisely at this time however can attain multi-billion Euro vary.”
Renewing the portfolio and an ongoing shift of assets, together with the event of a stronger presence within the US, are two components of Bayer’s technique to attain sustainable long-term development. A 3rd key strategic component to boost gross sales development are the acquired platform firms BlueRock Therapeutics (BlueRock), Asklepios Biopharmaceutical (AskBio) and Vividion Therapeutics (Vividion), with their industry-leading scientific innovation which have already efficiently diversified and strengthened Bayer’s pipeline.
BlueRock, a pioneer in stem cell engineered cell remedy, is advancing a rising pipeline of revolutionary therapies for treating sufferers with neurological, immunological, cardiovascular and ophthalmic illnesses. Its most superior program BRT-DA01 is being developed for the remedy of Parkinson’s illness, a progressive neurodegenerative dysfunction attributable to nerve cell injury within the mind. It includes of pluripotent stem cell-derived dopaminergic neurons which are implanted into the mind, thus taking goal on the root explanation for the illness. In accordance with the Parkinson’s Basis, greater than 10 million individuals worldwide endure from Parkinson’s illness. BRT-DA01 has accomplished enrollment of the Section I scientific examine, anticipating information readout within the second half of 2023.
In gene remedy, AskBio is working an industry-leading adeno-associated virus (AAV)-based gene remedy platform, with demonstrated applicability in addition to glorious manufacturing amenities. AskBio has been driving Bayer’s pipeline of investigational novel gene therapies which are developed throughout a spread of neuromuscular, central nervous system, cardiovascular and metabolic illness indications. Most superior within the clinic are investigational therapies for Parkinson’s illness, Pompe illness and congestive coronary heart failure. Gene remedy packages for Huntington’s illness and a number of techniques atrophy are at the moment enrolling sufferers into first-in-human research.
The strategic collaboration with Mammoth Biosciences, Inc., with its groundbreaking gene-editing know-how as a key enabling know-how in addition to a stand-alone therapeutic modality, will considerably improve Bayer’s efforts to develop transformative therapies. Bringing collectively Mammoth’s novel CRISPR techniques with Bayer’s current gene augmentation and its induced pluripotent stem cell (iPSC) platforms will permit Bayer to unleash the total potential of its cell and gene remedy technique.
With Vividion and its industry-leading chemoproteomics platform, Bayer made a big funding to enlarge its small molecule drug discovery capabilities and pipeline of precision therapeutics. Vividion’s breakthrough know-how can unlock excessive worth, historically undruggable targets of the human illness proteome. When mixed with Bayer’s long-standing experience bringing small molecule therapeutics from discovery to growth and to market, the know-how permits unprecedented innovation for the advantage of sufferers throughout varied illness areas. The primary two packages addressing excessive profile most cancers targets are anticipated to achieve scientific Investigational New Drug Software (IND) in 2023.
“Our transformation is properly underway, as new therapeutic targets and modalities are more and more contributing to our early growth portfolio and already representing a big a part of our annual R&D assets, reflecting their significance for our renewed technique,” stated Christian Rommel, Head of Analysis and Growth and Member of the Government Committee Bayer Prescription drugs. “For 2023, we expect a number of vital growth milestones for each our early and late-stage pipeline that can permit us to additional advance medical improvements for sufferers in want.”
The numerous enchancment of Bayer’s R&D capabilities since 2018 is mirrored in a brand new and detailed presentation of its R&D pipeline accessible here.
Accelerating innovation by exterior avenues is a necessary component of Bayer’s technique. Bayer has constructed a status as a associate pushed by science and information, dedicated to openness and transparency at each step of the collaboration course of and in recent times, Bayer has efficiently utilized nice flexibility to collaborations, together with the arm’s size partnering mannequin.
“We’re targeted on a holistic method of investing in novel know-how platforms, pursuing development by exterior innovation,” stated Marianne De Backer, Head of Technique, Enterprise Growth & Licensing/Open Innovation and Member of the Government Committee Bayer Prescription drugs. “These partnerships mirror our give attention to collaborating moderately than integrating and thereby preserving the associate’s entrepreneurial tradition and expertise base. By sustaining independence by an arm’s size operational mannequin, we expertise accelerated drug growth packages outcomes.”
Bayer is consistently pursuing new approaches for participating with the biotech ecosystem and its arm’s size partnering mannequin continues to draw exterior innovators and efficiently contributes breakthrough innovation to Bayer’s enterprise.
In recent times the corporate has invested greater than seven billion USD in biotech acquisitions and managed 60 strategic and ongoing alliances. It has efficiently developed an area presence in key markets across the globe in essentially the most revolutionary scorching spots: Boston, San Francisco, Analysis Triangle Park – North Carolina, San Diego, Beijing, Berlin and Kobe, the place it’s in direct reference to native gamers, thus serving to to form revolutionary environments and drive its personal innovation technique.
Complementing in-house experience with exterior collaboration continues to be a precedence for Bayer to broaden its legacy of success in researching and creating strong therapies, with the objective to handle excessive unmet medical wants. The corporate’s arm’s size working mannequin will proceed to evolve particularly in therapeutic areas which aren’t but core to Bayer akin to neurodegenerative illnesses. Bringing personalised medication to sufferers sooner is the shared objective uniting Bayer and its companions. The distinctive nature of those therapies implies that conventional frameworks must be overhauled. Every remedy requires totally different experience, innovation and regulatory path, which no single participant will be capable of do alone.
Bayer is a world enterprise with core competencies within the life science fields of well being care and diet. Its services and products are designed to assist individuals and the planet thrive by supporting efforts to grasp the foremost challenges offered by a rising and getting older international inhabitants. Bayer is dedicated to driving sustainable growth and producing a constructive affect with its companies. On the identical time, the Group goals to extend its incomes energy and create worth by innovation and development. The Bayer model stands for belief, reliability and high quality all through the world. In fiscal 2021, the Group employed round 100,000 individuals and had gross sales of 44.1 billion euros. R&D bills earlier than particular objects amounted to five.3 billion euros. For extra info, go to www.bayer.com.
This launch might comprise forward-looking statements primarily based on present assumptions and forecasts made by Bayer administration. Varied recognized and unknown dangers, uncertainties and different components might result in materials variations between the precise future outcomes, monetary scenario, growth or efficiency of the corporate and the estimates given right here. These components embrace these mentioned in Bayer’s public reviews which can be found on the Bayer web site at www.bayer.com. The corporate assumes no legal responsibility in any respect to replace these forward-looking statements or to adapt them to future occasions or developments.