Thu, Aug. 18, 6:43 AM
- Portola Pharmaceuticals (NASDAQ:PTLA) plummets 18% premarket on increased volume in response to its announcement that it received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) seeking approval of anticoagulant reversal agent AndexXa (andexanet alfa).
- The company says most of the requested information relates to manufacturing although the agency also wants more data to support inclusion of edoxaban [Daiichi Sankyo's (OTCPK:DSKYF)(OTCPK:DSNKY) Savaysa] and enoxaparin [Sanofi's (NYSE:SNY) LOVENOX] in the label. It also stated that it needs more time to complete its review of the clinical amendments to Portola's post-marketing commitments that were submitted recently.
- Andexanet alfa is a modified human Factor Xa molecule that acts as a decoy to target and sequester, with high specificity, Factor Xa inhibitors in the blood. Once bound, the Factor Xa inhibitors are unable to inhibit Factor Xa and normal hemostatic processes are restored.
- Management will host a conference call this morning at 8:30 am ET to discuss the situation.
- Previously: Portola down 10% ahead of FDA action on AndexXa (Aug. 17)
Thu, Jul. 14, 6:50 AM
- Amgen (NASDAQ:AMGN) inks an exclusive deal with Tokyo-based Daiichi Sankyo (OTCPK:DSKYF)(OTCPK:DSNKY) to commercialize nine biosimilars in Japan, including adalimumab [AbbVie's (NYSE:ABBV) Humira], bevacizumab [Roche's (OTCQX:RHHBY) Avastin] and trastuzumab (Roche's Herceptin).
- Under the terms of the agreement, Amgen will be responsible for development and manufacturing and Daiichi will manage regulatory submissions and handle distribution and commercialization while Amgen will have a limited rights to co-promote the products.
- Amgen will retain all distribution and commercialization rights outside of Japan. Financial terms are not disclosed.
Wed, Jun. 1, 9:22 AM
- Nektar Therapeutics (NASDAQ:NKTR) enters into an agreement with Daiichi Sankyo Europe (OTCPK:DSKYF)(OTCPK:DSNKY) granting Daiichi European rights to ONZEALD (etirinotecan pegol) (NKTR-102), currently in Phase 3 development for advanced breast cancer.
- Under the terms of the deal, Nektar will receive an upfront payment of $20M, up to $60M in milestones and double-digit royalties on net sales in Europe. Daiichi will have exclusive rights in Europe, Switzerland and Turkey while Nektar will retain rights in the U.S. and the rest of the world.
- Nektar plans to file a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) next month seeing conditional approval of ONZEALD for the treatment of advanced breast cancer and brain metastases. The review will be under an accelerated timeline. Conditional approval, renewed annually, may be granted in cases where there is an unmet medical need in patients with a severely debilitating disease. The company will be responsible for sponsoring and funding the confirmatory trial that will support the MAA filing for ONZEALD in Europe. The data will also be used in an NDA filing in the U.S.
- ONZEALD is a long-acting topoisomerase I inhibitor which is designed to concentrate the drug in tumors. The elimination half-life of etirinotecan is 37 days compared to two days for irinotecan but with peak SN38 (active metabolite of irinotecan) levels 5 - 10 times less which improves the tolerability profile.
Tue, Apr. 26, 7:44 AM
- Aviragen Therapeutics (NASDAQ:AVIR), formerly Biota Pharmaceuticals, raises $20M in new capital via the sale of a portion of the royalty rights to Inavir to HealthCare Royalty Partners. It intends to use the proceeds to advance its pipeline of direct-acting antivirals to treat infections that have limited treatment options.
- Inavir, an inhaled neuraminidase inhibitor approved in Japan for the treatment and prevention of influenza, is the leading flu treatment there. It is marketed by Daiichi Sankyo (OTCPK:DSKYF)(OTCPK:DSNKY).
Mon, Apr. 18, 11:56 AM
- Chinese biotech BeiGene (BGNE -2.9%) reports positive data from an ongoing Phase 1 clinical trial assessing product candidate BGB-283 in patients with BRAF or KRAS/NRAS-mutated cancers who have not responded adequately to prior treatments (one to six prior lines of therapies). The data were presented at the 2016 American Association for Cancer Research Annual Meeting in New Orleans, LA.
- At the time of the data cutoff, there were 29 evaluable patients. One receiving a 40 mg starting dose had a confirmed complete response, two patients receiving a 20 mg or 30 mg starting dose had confirmed partial responses and 15 patients had stable disease (no progression), implying a disease control rate of 79% (n=23/29).
- The most frequent mild-to-moderate (grade 1 or 2) treatment-related adverse events were fatigue (52%), thrombocytopenia (low blood platelets)(39%), decreased appetite (39%), hand-foot syndrome (redness/swelling in hands and/or feet)(35%), acne (32%) and hypertension (32%). Serious treatment-related adverse events (grade 3 or 4) observed were thrombocytopenia (13%), fatigue (10%) and liver enzyme (ALT) elevation (10%).
- BGB-283 is called a RAF dimer inhibitor which has shown activity against the RAF family of kinases, including ARAF, BRAF, CRAF and BRAF V600E. It can potentially address resistance to first-generation BRAF inhibitors. For example, vemurafenib, discovered b Daiichi Sankyo (OTCPK:DSKYF)(OTCPK:DSNKY) and marketed by Roche (OTCQX:RHHBY +1.4%) under the brand name Zelboraf, achieves only a 5% response rate in BRAF V600E-positive colorectal cancer.
- BeiGene is currently conducting all clinical development for BGB-283. It retains all rights to the candidate in China while Merck KGaA (OTCPK:MKGAF)(OTCPK:MKGAY) has exclusive rights ex-China.
- Previously: BeiGene on deck for IPO (Jan. 20)
Mon, Feb. 1, 8:56 AM
- Portola Pharmaceuticals (NASDAQ:PTLA) licenses lead development and commercial rights in Japan to andexanet alfa to Bristol-Myers Squibb (NYSE:BMY) and Pfizer (NYSE:PFE) to be developed as an antidote to anti-coagulants apixaban and other Factor Xa inhibitors. In a separate deal, the company enters into a clinical collaboration agreement with Bayer HealthCare (OTCPK:BAYRY) to include its Factor Xa inhibitor rivaroxaban.
- Under the terms of the agreement with BMY and PFE, Portola will receive an upfront payment of $15M, milestones up to $90M and double-digit royalties. Under the Bayer deal, Portola will receive an upfront payment of $5M and an undisclosed milestone based on regulatory approval. BMY and PFE own exclusive commercial rights.
- Three Factor Xa inhibitors are currently available in Japan, BMY and PFE's apixaban, Bayer's rivaroxaban and Daiichi Sankyo's (OTCPK:DSKYF)(OTCPK:DSNKY) endoxaban. No antidote is approved, however.
- Oral anticoagulants are a $800M market in Japan. A antidote is needed in certain situations such as emergency surgery, trauma or episodes of uncontrolled bleeding.
Nov. 25, 2015, 9:50 AM
- As expected, the European Commission approves Roche's (OTCQX:RHHBY +1.5%) Cotellic (cobimetinib), in combination with Zelboraf (vemurafenib), for the treatment of adults with unresectable or metastatic BRAF V600 mutation-positive melanoma.
- Cobimetinib, co-developed with discoverer Exelixis (EXEL +1.1%), inhibits an enzyme called mitogen-activated protein kinase kinase (MEK), a mediator of downstream signaling of tumor growth factor receptors. Vemurafenib is a BRAF inhibitor that was discovered by Daiichi Sankyo's (OTCPK:DSKYF)(OTCPK:DSNKY) Plexxikon unit.
- Previously: European Ad Comm gives thumbs up to Roche's Cotellic/Zelboraf combo for certain type of melanoma (Sept. 25)
Nov. 3, 2015, 8:19 AM
- In a regulatory filing, ArQule (NASDAQ:ARQL) discloses that it has exercised its option with development and commercialization partner Daiichi Sankyo (OTCPK:DSKYF)(OTCPK:DSNKY) to co-commercialize lead product candidate tivantinib in the U.S. as allowed under their December 2008 Agreement (subject to FDA approval). A separate co-commercialization agreement should be inked in Q1.
- Tivantinib is currently being evaluated in a Phase 3 study, METIV-HCC, as second line treatment of liver cancer [hepatocellular carcinoma (HCC)]. The primary endpoint is overall survival. According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint is March 2017. The estimated study completion date is June 2017.
- If METIV-HCC is successful and tivantinib is cleared by the FDA, ArQule will receive $55M in milestone payments for the official acceptance of its marketing applications in the U.S. and EU. for the second line treatment of HCC. It will earn an additional $100M in combined milestones based on FDA clearance and the first commercial sale in the UK, Germany, France, Italy or Spain. The total milestone payments of $155M will partially offset the $75M - 85M that ArQule owes Daiichi for the costs of the Phase 3 trial. ArQule also expects to earn sales-based royalties of 20%.
- Tivantinib is an orally-administered selective inhibitor of MET, a receptor of tyrosine kinase.
Oct. 30, 2015, 12:23 PM
- The FDA designates Daiichi Sankyo's (OTCPK:DSKYF) (OTCPK:DSNKY) investigational pexidartinib a Breakthrough Therapy for the treatment of tenosynovial giant cell tumor (TGCT) where surgical removal is not appropriate.
- Pexidartinib is an orally available small molecule drug that selectively inhibits a primary growth driver of abnormal cells in the synovium (thin layer of tissue lining the joints and tendon sheaths) that causes TGCT called colony stimulating factor-1 receptor (CSF-1R).
- TGCT is a rare non-metastatic tumor that affects the synovium-lined joints, bursae and tendon sheaths causing swelling, pain, stiffness and reduced mobility. Its prevalence is 11 cases per million.
- Breakthrough Therapy status provides for more intensive guidance from the FDA, the involvement of more senior agency personnel and a rolling review of the NDA.
Oct. 16, 2015, 12:09 PM
- Daiichi Sankyo (OTCPK:DSKYF) (OTCPK:DSNKY) intends to reorganize its U.S. commercial operations as it transitions its maturing primary care product portfolio to specialty offerings in cardiovascular, pain management and oncology.
- The reorganization will reduce expenses, mainly from the elimination of 1,000 to 1,200 jobs from the U.S. home office in Parsippany, NJ, field-based positions and others. The R&D group will be unaffected.
Jul. 13, 2015, 7:03 AM
- The UK's advisory group for its National Health Service (NHS), The National Institute for Health and Care Excellence (NICE), recommends Daiichi Sankyo's (OTCPK:DSNKY) (OTCPK:DSKYF) Lixiana (edoxaban) for the treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults. The committee concluded that edoxaban would be a cost effective use of NHS resources.
- Edoxaban is member of a class of blood thinners called NOACs (Non-VKA Oral Anti-Coagulants). It inhibits factor Xa, one of the key components responsible for blood clotting
Mar. 19, 2015, 12:14 PM
- AstraZeneca (AZN -0.2%) and Daiichi Sankyo (OTCPK:DSKYF) (OTCPK:DSNKY) pair up to commercialize the former's Movantik (naloxegol) in the U.S. for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain. Under the terms of the agreement, Daiichi will pay an upfront fee of $200M and subsequent sales-related payments of up to $625M. AstraZeneca will be responsible for manufacturing, will book all sales and will make sales-related commission payments to Daiichi. Both firms will sell the product. There is no change in AZN's previously announced financial guidance. The deal is emblematic of AZN's evolving business model to drive value through externalization activity. The launch in the U.S. is planned for early April.
- AZN licensed naloxegol from Nektar Therapeutics (NKTR -4.2%) in 2009. It was approved by the FDA in September. The U.S. Drug Enforcement Agency (DEA) removed it from its Schedule II list in January citing its lack of abuse and dependence potential.
- Opioids relieve pain by binding to mu-receptors in the central nervous system. Unfortunately, they can also bind to mu-receptors in the bowel which results in OIC. The incidence of OIC in patients taking prescription opioid medicines for chronic pain is believed to be as high as 81%.
- Previously: DEA removes naloxegol from Schedule II list (Jan. 26)
- Previously: FDA clears OIC drug (Sept. 16, 2014)
Jan. 8, 2015, 7:55 PM
- The FDA approves Daiichi-Sankyo's (OTCPK:DSKYF) (OTCPK:DSNKY) Savaysa (edoxaban tablets) to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.
- Edoxaban is an anticoagulant that inhibits factor Xa. It was approved in Japan in 2011 for the prevention of venous thromboembolism in patients undergoing total knee replacement surgery, total hip replacement surgery and hip fracture surgery.
- Anticoagulant-related tickers: (NASDAQ:ISIS) (NYSE:BAX) (NASDAQ:PTLA) (NASDAQ:MSLI) (NYSE:MRK) (NYSE:JNJ) (NASDAQ:MDCO) (NASDAQ:SCLN) (NYSE:PFE) (NYSE:BMY) (NYSE:AZN) (OTCPK:BAYRY)
Nov. 10, 2014, 10:19 AM
- In a 78-patient, randomized, double-blind, placebo-controlled Phase 2 trial evaluating the safety and efficacy of ArQule's (ARQL +12.3%) tivantinib for the treatment of metastatic prostate cancer, the study met its primary endpoint of improving progression-free survival (PFS) versus placebo. The trial was designed to detect an improvement in median PFS from three months to six months. The results will be presented at a future medical conference.
- Tivantinib is an orally-administered selective inhibitor of MET, a receptor of tyrosine kinase. It has yet to be approved in any market. ArQule's development and commercialization partner is Daiichi Sankyo (OTCPK:DSKYF) (OTCPK:DSNKY).
Oct. 28, 2014, 1:49 PM| Oct. 28, 2014, 1:49 PM
Apr. 7, 2014, 3:32 AM
- Sun Pharmaceutical Industries has agreed to acquire fellow Indian company Ranbaxy Laboratories (RBXLY) for $3.2B in an all-stock deal that will create the world's fifth-largest generic-drug maker. Including the debt, the transaction is worth $4B.
- The merger combines two firms that have had problems with quality issues. Ranbaxy, which is owned by Japan's Daiichi Sankyo (DSKYF), is banned from selling ingredients to the U.S., while Sun's Karkhadi facility is also not allowed to export products to the U.S. (PR)
Founded on September 28, 2005 through the merger of Daiichi Pharmaceutical and Sankyo, Daiichi Sankyo delivers innovative products that enhance the lives of millions of people around the world. Our recent successes include the antihypertensive agent olmesartan (Olmetec), launched in 2002 by... More
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