PRNewswire | July 18, 2023
Karyopharm Therapeutics Inc. a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to the development program of selinexor for the treatment of patients with myelofibrosis, including primary myelofibrosis, post-essential thrombocythemia myelofibrosis, and post-polycythemia vera myelofibrosis.
"Fast Track Designation for selinexor highlights its potential to address the unmet medical need in myelofibrosis, an important acknowledgement as we continue our pivotal Phase 3 study," said Reshma Rangwala, MD, PhD, Chief Medical Officer of Karyopharm. "Selinexor's unique mechanism of action, XPO1 inhibition, is a novel and potentially fundamental mechanism in myelofibrosis. We have been highly encouraged by the efficacy and safety data observed to date [in our Phase 1 study] with selinexor in combination with ruxolitinib in patients with treatment-naïve myelofibrosis and believe selinexor has the potential to shift the treatment paradigm. We look forward to continued interaction with the FDA as we advance the development of this promising treatment for patients in need."
In June 2023, Karyopharm initiated a pivotal Phase 3 clinical trial to assess the efficacy and safety of once-weekly selinexor 60 mg in combination with ruxolitinib in JAKi-naïve patients with myelofibrosis. Updated data from the Phase 1 study were presented at the American Association for Cancer Research Annual Meeting 2023, American Society of Clinical Oncology 2023 and European Hematology Association 2023, which showed rapid, deep and sustained spleen responses and robust symptom improvement in patients treated with selinexor 60 mg in combination with ruxolitinib as of the April 10, 2023 cut-off date. Top-line data from the Phase 3 study is expected in 2025. The Company plans to expand its clinical development program in myelofibrosis by investigating selinexor in other JAKi-naïve settings, such as novel combinations, to benefit the greatest number of patients.
Fast Track Designation is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an approved product can reach the market expeditiously. Features of Fast Track Designation include frequent interactions with the FDA review team, and if relevant criteria are met, eligibility for Priority Review and Rolling Review.
About Karyopharm Therapeutics
Karyopharm Therapeutics Inc. is a commercial-stage pharmaceutical company pioneering novel cancer therapies. Since its founding, Karyopharm has been an industry leader in oral Selective Inhibitor of Nuclear Export (SINE) compound technology, which was developed to address a fundamental mechanism of oncogenesis: nuclear export dysregulation. Karyopharm's lead SINE compound and first-in-class, oral exportin 1 (XPO1) inhibitor, XPOVIO® (selinexor), is approved in the U.S. and marketed by the Company in three oncology indications and has received regulatory approvals in various indications in a growing number of ex-U.S. territories and countries, including Europe and the United Kingdom (as NEXPOVIO®) and China. Karyopharm has a focused pipeline targeting multiple high unmet need cancer indications, including in multiple myeloma, endometrial cancer, myelodysplastic neoplasms and myelofibrosis.
prnewswire | July 04, 2023
Adare Pharma Solutions, a global technology-driven CDMO focused on oral dosage forms, today announced the completion of its divestiture of its Adare Biome business unit, a pioneer in the development and manufacturing of postbiotics, to dsm-firmenich, innovators in nutrition, health, and beauty. The transaction represents an enterprise value of €275 million, an estimated 2023 EV/EBITDA multiple of 18x.
Tom Sellig, CEO of Adare Pharma Solutions, commented: "dsm-firmenich is the ideal company to take Adare Biome to the next level and realize the growth potential of postbiotics. They have the infrastructure, together with strong commercialization and science capabilities, to scale the significant scientific research that we've achieved over the years. This divestiture will provide Adare Pharma Solutions with additional resources for our core CDMO business and allow us to further grow our position as a world-class outsourcing partner to the pharmaceutical industry."
dsm-firmenich intends to extend the availability of Lactéol®, Adare Biome's over-the-counter postbiotic supplement for relieving gut upsets, through its B2C unit, i-Health. Further development of postbiotic B2B ingredients will include opportunities in dietary supplements, early-life nutrition, medical nutrition, and nutritional improvement for the under-nourished. The acquisition of Adare Biome will also position dsm-firmenich as a leader in the growing microbiome management market for pets, and expand its animal health range, where the stability of postbiotics means they can be incorporated into premix feed solutions.
Philip Eykerman, dsm-firmenich's President Health, Nutrition & Care, said: "Adare Biome, as a global leader in the research and manufacturing of postbiotics with over a century of pioneering science in its heritage, is a perfect fit for dsm-firmenich that will complement three of our four Business Units. The Adare Biome teams bring great knowledge in this area which will greatly help in driving our 'Health from the Gut' strategy and enable us to accelerate the creation of next-generation biotics to support the health of people and animals. We are excited to welcome the Adare Biome people to the dsm-firmenich family and about the new opportunities this move will unlock. dsm-firmenich's strong global presence and reach in local markets will enable us to deliver Adare Biome products to customers in a faster, more efficient way to bring the proven benefits of postbiotics to a wider range of people around the world."
About Adare Pharma Solutions
Adare Pharma Solutions is a global, technology-driven CDMO providing product development through commercial manufacturing expertise, with a focus on oral dosage forms for the pharmaceutical industry. Adare's specialized technology platforms provide taste masking, controlled release, solubility enhancement, and patient-centric dosing solutions. With a proven history in drug delivery, Adare has developed and manufactured more than 65 products sold by customers in more than 100 countries globally. More information can be found at www.adarepharmasolutions.com.
As innovators in nutrition, health, and beauty, dsm-firmenich reinvents, manufactures, and combines vital nutrients, flavors, and fragrances for the world's growing population to thrive. With our comprehensive range of solutions, with natural and renewable ingredients and renowned science and technology capabilities, we work to create what is essential for life, desirable for consumers, and more sustainable for the planet. dsm-firmenich is a Swiss-Dutch company, listed on the Euronext Amsterdam, with operations in almost 60 countries and revenues of more than €12 billion. With a diverse, worldwide team of nearly 30,000 employees, we bring progress to life™ every day, everywhere, for billions of people.
Business Insights, PHARMACY MARKET
Businesswire | August 03, 2023
MedinCell During today’s Q2 earnings call, Richard Francis, President and CEO of Teva, and Eric Hughes, Executive Vice President, Global R&D & Chief Medical Officer, commented the US launch of UZEDY since May 2023 and the olanzapine Long-Acting Injectable (LAI).
Richard Francis said1
“We are actually right on plan or slightly ahead of our market access strategy targets and we are very happy with the launch.”
“The newest member of our innovative family is said risperidone, our long-acting treatment for schizophrenia. Now, to remind everybody, this is a $4 billion market and we've only just launched UZEDY, but we're very pleased with the feedback we're getting from healthcare professionals. And they're confirming that the product profile that we have is unique and advantageous. Now we're seeing this in the fact that our NBRX2 is 40%, so already we're getting 40% of the risperidone long-acting market. We're also seeing hospitals look to use our free samples and free trial requests, and we're having good discussions with our payers. So once again, I think excitement around UZEDY early days, but initial feedback is very positive.”
UZEDY, a long-acting injectable (LAI) risperidone for the treatment of schizophrenia in adults, is the first FDA-approved product based on MedinCell’s BEPO technology. MedinCell is eligible for up to $105m commercial milestones and for royalties on net sales.
About LAI olanzapine (mdc-TJK), initiated in January 2023
Eric Hughes said1
“Our Olanzapine Phase 3 study is actually enrolling very quickly.”
“Olanzapine as an oral agent account for 20% of the patients being treated today, but only less than 1% of patients on the long-acting form are being using that product. And that's primarily because of the safety profile3.”
Richard Francis, said1
“With olanzapine, I've already highlighted the fact that it's a $4 billion market. But if we do manage to bring this to the market with a favorable safety profile, I think we have a real opportunity to have a significant product on our hands here.”
mdc-TJK is an investigational long-acting injectable olanzapine also based on BEPO technology. If approved, it could be the first olanzapine LAI with a favorable safety profile offering a valued treatment option as a complement to UZEDY for severe schizophrenia patients. MedinCell is eligible for $12m left out of $17m of development milestones, for up to $105m commercial milestones and for royalties on net sales.
MedinCell is a commercial-stage technology pharmaceutical company developing long-acting injectable drugs in many therapeutic areas. Our innovative treatments aim to guarantee compliance with medical prescriptions, to improve the effectiveness and accessibility of medicines, and to reduce their environmental footprint. They combine already known and used active ingredients with our proprietary BEPO® technology which controls the delivery of a drug at a therapeutic level for several days, weeks or months from the subcutaneous or local injection of a simple deposit of a few millimeters, entirely bioresorbable. The first treatment based on BEPO technology, intended for the treatment of schizophrenia, was approved by the FDA in April 2023, and is now distributed in the United States by Teva under the name UZEDY™.