Stemline Therapeutics, Inc. announced that the U.S. Food and Drug Administration has granted approval of ELZONRIS for the treatment of blastic plasmacytoid dendritic cell neoplasm in adult and pediatric patients two years and older, in both treatment-naive and previously-treated populations. ELZONRIS is the first treatment approved for BPDCN and the first approved CD123-targeted therapy. “Today’s approval of tagraxofusp is a major step forward for people with BPDCN, their families and the medical community,” said Naveen Pemmaraju, M.D., Associate Professor at The University of Texas MD Anderson Cancer Center, and a principal investigator on the tagraxofusp clinical trial. “CD123 is expressed in BPDCN and a number of other hematologic malignancies. The approval of tagraxofusp, a CD123-targeted therapy, represents a new standard of care for patients with BPDCN.” ELZONRIS was granted Breakthrough Therapy Designation and Orphan Drug Designation, and the ELZONRIS Biologics License Application was evaluated under Priority Review by the FDA. “We are incredibly thankful to the patients, their families and physicians who participated in our clinical trials, and proud of our exceptional team here at Stemline, all of whom played critical roles in bringing this breakthrough treatment to fruition,” said Ivan Bergstein, M.D., chief executive officer of Stemline Therapeutics. “Stemline is proud to provide the first approved treatment for BPDCN, and we are committed to making ELZONRIS available to patients.” Stemline intends to bring ELZONRIS to patients with BPDCN globally. In November 2018, the European Medicines Agency granted accelerated assessment to the upcoming ELZONRIS Marketing Authorization Application submission, which is expected in the first quarter of 2019. ELZONRIS is a CD123-directed cytotoxin for the treatment of blastic plasmacytoid dendritic cell neoplasm in adults and in pediatric patients 2 years and older. The ELZONRIS label contains a boxed warning for CLS, which may be life-threatening or fatal and can occur in patients receiving ELZONRIS. Physicians are advised to monitor for signs and symptoms of CLS and take actions as recommended in the full prescribing information.
Friday, December 21, 2018
Teva gets FDA approval for digital inhaler with Bluetooth
Teva Pharmaceuticals (TEVA -4.8%) gets U.S. FDA approval for its ProAir Digihaler (albuterol sulfate 117 mcg) inhalation powder.
The digital inhaler with built-in sensors connects to companion mobile app and provides inhaler use information to people with asthma and COPD.
The product’s sensors detect when the inhaler is used and measure inspiratory flow. The data is then sent to the mobile app using Bluetooth wireless technology so patients can review their data over time.
Previously: Teva up 1% premarket on positive fremanezumab data (Dec. 17)
Xynomic Picks up Second Cancer Drug From Boehringer in $800 Million Deal
Xynomic Pharmaceuticals, a pharma company with roots in both the U.S. and China, forged a deal worth up to $800 million to acquire a Phase II-ready cancer treatment from Germany-based Boehringer Ingelheim International GmbH.
The deal covers BI 860585, a Phase II-ready potent and selective ATP-competitive mTOR serine/threonine kinase inhibitor. BI 860585 has already gone through a Phase I trial of 90 patients with advanced solid tumors where the drug was tested as both a single agent and in combination with chemotherapy. The Phase I data, Xynomic said, showed that BI 860585 was well-tolerated and the treatment achieved disease control rates that include partial response plus stable disease of 20 percent, 28 percent and 58 percent, respectively.
This morning, Xynomic said it intends to initiate Phase II clinical trials within the next nine months. One of the trials the company is planning will combine BI 860585 with a standard-of-care treatment against breast cancer. The other trial the company is planning is a phase 1b trial combining BI 860585 with Xynomic’s XP-102 against colorectal cancer. Xynomic acquired XP-102 from Boehringer Ingelheim in October 2017 in a deal worth more than $500 million.
Citing the World Health Organization, Xynomic pointed to the wide-spread cases of breast and colorectal cancer across the globe. As of September, the WHO said breast cancer is the most commonly diagnosed cancer and the leading cause of cancer death in women. Colorectal cancer men and the third most commonly diagnosed cancer in men, the WHO noted. Xynomic pointed to the potential indications as a probable driver of revenue for the company. Citing IMS and iHealthcareanalyst, drugs treating these two malignancies are expected to generate annual revenue of approximately $25.4 billion by 2023, the company said.
Few terms of the deal with Boehringer Ingelheim were disclosed, but Xynomic said total payments associated with the agreement will total up to $800 million and include an upfront payment, regulatory milestone payments and potential royalties.
The latest deal with Boehringer Ingelheim follows a June Series B financing round that provided the company with an undisclosed amount of funding to support eight clinical trials over the course of a year with four trials expected to be pivotal. The company initiated studies in renal cell carcinoma, breast cancer, colorectal cancer, melanoma and Lymphoma.
In addition to the financing in June, the company also launched its own R&D Innovation Center in Shanghai in May 2018 to discover and develop small molecule oncology drugs focused on kinase inhibition, immuno-oncology and epigenetic modification. The center is designed to have fully integrated in-house capabilities from lead identification to IND enabling studies. The first two molecules are XP-103, a TRK/Fra-1 inhibitor, and XP-104, a RET inhibitor.
AZ’s new COPD inhaler Bevespi Aerosphere approved in EU
AstraZeneca’s new inhaler Bevespi Aerosphere (glycopyrronium/formoterol fumarate) has been approved in Europe, as a maintenance treatment for chronic obstructive pulmonary disease (COPD).
The drug has a marketing authorisation in a pressurised metered-dose inhaler (pMDI), as a maintenance dual bronchodilator to relieve symptoms in adults with COPD.
Bevespi, which is taken twice daily, is part of a new generation of medicines that AZ hopes will revive its fortunes after it was hit hard by a series of blockbuster drugs losing patent protection over the last decade or so.
AZ acquired the product when is bought the California biotech Pearl Therapeutics for $1.15 billion in 2013, but the pressure will now be on for the pharmaceutical company to recoup this investment and the further costs of developing Bevespi.
Although gaining EU approval can be seen as another success, AZ unveiled some patchy trial results in August from Bevespi, where the drug inexplicably failed to outperform GlaxoSmithKline’s rival.
The AERISTO trial results did not affect approval but could make it harder to market the drug in a competitive market where GSK’s Anoro (umeclidinium+vilanterol) is a benchmark treatment.
AZ hopes to win over patients with its inhaler technology, and noted that Bevespi is the first drug in its class to be approved using a pMDI.
Dr Omar Usmani, consultant physician in respiratory medicine at the National Heart and Lung Institute, Imperial College London and Royal Brompton Hospital in the UK, said: “Bevespi Aerosphere is an important treatment option in COPD, particularly for patients with limited lung function and advanced age who may benefit from using a pMDI.
“The efficacy and safety profile of Bevespi Aerosphere has been well established in the phase 3 PINNACLE programme.”
The treatment combines glycopyrronium, a long-acting muscarinic antagonist (LAMA) and formoterol fumarate, a long-acting beta2-agonist (LABA).
European approval is based on the phase 3 PINNACLE trial, which evaluated the drug’s efficacy and safety and involved more than 5,000 patients with moderate to very-severe COPD.
Obalon gains on FDA approval
Obalon Therapeutics (NASDAQ:OBLN) gains 55.5% after announcing the FDA approval for its Navigation System, which removes the need for an x-ray when placing the Obalon Balloon System obesity treatment. The Navigation System instead uses magnetic resonance.
Commercial availability of the Navigation System is expected in Q1.
Pfizer: $900M termination fee if GSK shareholders don’t approve deal
In a regulatory filing, Pfizer (PFE) offered additional details regarding the stock and asset purchase agreement with GlaxoSmithKline (GSK) to sell the assets and liabilities constituting its worldwide consumer healthcare business to a consumer healthcare business joint venture in exchange for ordinary shares representing 32% of the share capital of the joint venture. GSK will retain a 68% equity interest in the joint venture. The consummation of the transaction is subject to customary closing conditions, including the approval of GSK’s shareholders pursuant to U.K. law and the receipt of required antitrust approvals. Each party is required under the purchase agreement to take all actions necessary to obtain such required antitrust approvals. The purchase agreement contains certain termination rights for both Pfizer and GSK, including the right to terminate the agreement if the transaction is not consummated by September 30, 2019, subject to extension by either party to March 31, 2020 in certain circumstances. In addition, in the event that Pfizer terminates the purchase agreement in connection with a failure to obtain GSK shareholder approval or an adverse change of recommendation of the GSK board of directors, then GSK will be required to pay Pfizer a termination fee of $900M in cash, the filing stated.
https://thefly.com/landingPageNews.php?id=2840731
Alexion says wholesale acquisition cost for Ultomiris set at $6,404 per vial
In a regulatory filing, Alexion stated that it has established a wholesale acquisition cost for Ultomiris in the United States of $6,404 per 30 mL of 10 mg/mL vial. “On an annual basis, this represents an approximate 10% discount to the cost of current labeled maintenance therapy for adult PNH patients of average weight,” Alexion stated.
https://thefly.com/landingPageNews.php?id=2840733
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