Tue, Jan. 19, 4:51 PM
- Privately-held Eiger BioPharmaceuticals completes enrollment in a Phase 2 clinical trial assessing three (50 mg, 75 mg, 100 mg) once-daily doses of Sarasar (lonafarnib), in combination with 100 mg of ritonavir [AbbVie's (NYSE:ABBV) NORVIR] once daily, in patients with chronic hepatitis delta (HDV) infection. The study consists of 24 patients with four placed in one of six treatment groups: three dosage arms for 12 or 24 weeks. Enrollment was completed in less than four months.
- Lonafarnib inhibits an enzyme called farnesyltransferase, which plays a key role in the modification of proteins in a process called prenylation. HDV uses this host cell process inside liver cells to complete an essential step in its life cycle. Lonafarnib blocks the cycle at the assembly stage, which may present a higher bar for the virus to develop resistance to therapy. It is designated an Orphan Drug in the U.S. and Europe and tagged for Fast Track review by the FDA.
- HDV, occurring only as a co-infection with HBV, represents one of the most pernicious forms of viral hepatitis. It causes more severe liver disease than HBV alone and is associated with more rapid liver fibrosis (scarring), liver cancer and liver failure. As many as 15M people worldwide are HDV-positive. It is particularly prevalent in Mongolia and Pakistan (as many as 60% of the HBV cases).
- Hepatitis-related tickers: (NASDAQ:GILD)(NYSE:MRK)(NYSE:JNJ)(NYSE:BMY)
Fri, Jan. 8, 12:44 PM
- Momenta Pharmaceuticals (MNTA +3.3%) and Mylan (MYL -2.6%) subsidiary Mylan Ireland Ltd. enter into an exclusive global collaboration agreement to develop, manufacture and commercialize six of Momenta's biosimilar candidates, including M834, a biosimilar to Bristol-Myers Squibb's (BMY -1.6%) ORENCIA (abatacept).
- Under the terms of the deal, Momenta will receive an upfront payment of $45M. The companies will equally share costs and profits with Mylan funding part of its share of costs through six contingent early development milestone payments totaling up to $200M across all six candidates.
- Mylan will have an exclusive license to the products for all indications. In general, Momenta will be responsible for pre-clinical and early-stage clinical development, additional clinical development (Phase 3) of M834 and regulatory activities in the U.S. through approval. Mylan will be primarily responsible for late-stage development of the candidates, other than M834, regulatory activities ex-U.S. and post-approval regulatory activities in the U.S.
- Mylan will commercialize all products, but Momenta has the option to co-commercialize, in a supporting role, any U.S.-approved product.
Fri, Jan. 8, 11:35 AM
- Bristol-Myers Squibb (BMY -2%) and privately held Dual Therapeutics enter a strategic collaboration to develop small molecule compounds for the treatment of cancer and other diseases.
- Under the terms of the deal, Dual will receive an undisclosed upfront payment, milestones potentially greater than $255M and royalties on net sales. BMY will have exclusive global rights to develop and commercialize the small molecule therapeutics discovered by Dual.
- Dual, founded in 2013, develops small molecule modulators that simultaneously block multiple cancer-promoting pathways which enables a more comprehensive assault on cancer cells while avoiding toxicity to healthy cells. Its lead product candidate is an orally available activator of a tumor suppressive enzyme called PP2A (protein phosphatase 2), which has therapeutic potential across a wide range of cancers.
Tue, Jan. 5, 10:15 AM
- Bristol-Myers Squibb (BMY +1.1%) enters into a strategic collaboration with Dijon, France-based Oncodesign to discover, develop and commercialize novel cancer compounds based on the latter's Nanocyclix platform. The partnership will also leverage Oncodesign's advanced cancer pharmacology models, Predict, Chi-mice and Pharmimage.
- Under the terms of the deal, Oncodesign will be responsible for lead optimization and product candidate selection while BMY will be responsible for preclinical and clinical development and commercialization. Oncodesign will receive an upfront payment of $3M, milestones of up to $80M per target and tiered royalties on net sales.
Dec. 24, 2015, 9:45 AM
- Spark Therapeutics (ONCE) initiated with Neutral rating and $45 (1% upside) price target by Chardan Capital.
- Eyegate Pharmaceuticals (EYEG) initiated with Buy rating and $6 (115% upside) price target by Chardan Capital.
- Pfizer (PFE +0.1%), Amgen (AMGN -0.2%) and Eli Lilly (LLY -0.6%) initiated with Overweight ratings by Atlantic Equities. Price targets are $39 (20% upside), $202 (24% upside) and $100 (17% upside), respectively.
- Bristol-Myers Squibb (BMY -0.5%) initiated with Underweight rating and $57 (17% downside risk) price target by Atlantic Equities.
- Cerus (CERS +2.5%) downgraded to Neutral from Outperform by Wedbush. Price target maintained at $6.50 (6% upside).
Dec. 23, 2015, 9:55 AM
- Seattle Genetics (SGEN +1.2%) and clinical collaborator Bristol-Myers Squibb (BMY +0.3%) announce the initiation of a Phase 1/2 trial assessing the combination of ADCETRIS (brentuximab vedotin) and Opdivo (nivolumab) in patients with CD30-expressing relapsed/refractory B-cell or T-cell non-Hodgkin lymphomas, including diffuse large B-cell lymphoma, peripheral T-cell lymphoma and cutaneous T-cell lymphoma.
- The 120-subject study is the second of two trials under the companies' previously announced clinical trial collaboration. The Phase 1 portion will assess the optimal dose of the combination. The Phase 2 portion will expand enrollment to treat disease-specific cohorts at the recommended dose and treatment schedule. The primary endpoints are safety, tolerability and overall response rate at month 8 following the last dose.
- According to clinicaltrials.gov, the estimated final data collection date for the primary endpoints is November 2017. The estimated study completion date is November 2018.
- ADCETRIS is an antibody-drug conjugate (NYSE:ADC) consisting of an anti-CD30 monoclonal antibody attached to microtubule disrupting agent, monomethyl auristatin E (MMAE). The linker system it uses is designed to be stable in the bloodstream but releases MMAE when it binds to CD30-expressing cancer cells.
- Opdivo is an programmed death receptor-1 (PD-1) immune checkpoint inhibitor that activates the immune system's T cells to detect and attack cancer cells.
Dec. 18, 2015, 8:10 AM
- AbbVie (NYSE:ABBV) enters into a licensing agreement with The Medicines Patent Pool (MPP), a United Nations-sponsored public health organization, that will allow generic antiretroviral therapy (ARV) firms to manufacture and sell generic versions of Lopinavir/Ritonavir (LPV/r) across Africa.
- Once generic ARV firms obtain a sublicense from MPP, they will also be able to commercialize combinations of ritonavir with other ARVs, such as atazanavir and darunavir, as alternative second-line therapies.
- The license is royalty-free and non-exclusive. In December 2014, AbbVie extended a license to MPP for pediatric formulations of LPV/r.
- Bristol-Myers Squibb (NYSE:BMY) and Merck (NYSE:MRK) have also signed licensing deals with MPP.
- Africa accounts for ~90% of the total usage of LPV/r in donor-funded developing countries, according to MPP Executive Director Greg Perry.
Dec. 18, 2015, 4:37 AM
- GlaxoSmithKline (NYSE:GSK) has agreed to pay Bristol-Myers Squibb (NYSE:BMY) up to $1.5B to acquire the U.S. company's pipeline of HIV drugs.
- The deal will boost ViiV Healthcare, Glaxo's HIV unit in which Pfizer (NYSE:PFE) and Shionogi (OTCPK:SGIOY) are junior partners, with the hope of returning to earnings growth in 2016.
- Revenue from the HIV business increased 65% in Q3, offsetting falling sales elsewhere in the company's large pharmaceuticals unit.
- Update: Glaxo's purchase includes both late stage and preclinical/discovery stage assets. The late stage asset purchase consists of an upfront payment of $317M, milestones up to $518M and tiered royalties on net sales. The preclinical/discovery asset purchase consists of an upfront payment of $33M, milestones up to $587M and tiered royalties on net sales.
- The two independent transactions should be completed in H1 2016.
- GSK will host a conference call this morning at 9:00 am ET to discuss the deal.
Dec. 15, 2015, 10:46 AM
- Privately held Neon Therapeutics announces a clinical trial collaboration with Bristol-Myers Squibb (BMY +1.8%) that will assess Neon's lead product candidate, NEO-PV-01 and Opdivo (nivolumab) in a Phase 1b clinical trial in patients with melanoma, smoking-associated non-small cell lung cancer and bladder cancer.
- The study will evaluate neoantigen-specific immune responses in peripheral blood and tumor tissue in addition to other indicators of immune response, including PD-L1 expression. Neon will conduct the trial, expected to start in 2016 across multiple sites.
- NEO-PV-01 is a fully personalized neoantigen vaccine based on DNA mutations from the patient's individual tumors. Opdivo is a PD-1 immune checkpoint inhibitor.
- Specific financial terms of the clinical trial collaboration are not disclosed, but typically only involve supplying product.
Dec. 11, 2015, 5:35 PM
Dec. 8, 2015, 5:20 PM
- Bristol-Myers Squibb (NYSE:BMY) completes its previously announced acquisition of privately held Cardioxyl Pharmaceuticals. The deal includes the rights to Cardioxyl's lead product candidate, CXL-1427, a prodrug in Phase 2 development for the treatment of acute decompensated heart failure.
- Previously: Bristol-Myers buys Cardioxyl Pharma for up to $2.1B (Nov. 2)
Dec. 8, 2015, 4:32 PM
- Bristol-Myers Squibb Company (NYSE:BMY) declares $0.38/share quarterly dividend, 2.7% increase from prior dividend of $0.37.
- Forward yield 2.19%
- Payable Feb. 1; for shareholders of record Jan 4; ex-div Dec. 30.
Dec. 4, 2015, 8:03 AM
- Horizon Pharma (NASDAQ:HZNP) resumed with Underweight rating and $23 (14% upside) price target by Morgan Stanley.
- Prima Biomed (NASDAQ:PBMD) initiated with Outperform rating and $6 (376% upside) price target by FBR Capital.
- Bluebird bio (NASDAQ:BLUE) resumed with Buy rating and $121 (54% upside) price target by Roth Capital.
- Barclays initiates coverage of six large caps: AbbVie (NYSE:ABBV) with an Equal Weight rating and $72 (28% upside) price target; Bristol-Myers Squibb (NYSE:BMY) with an Equal Weight rating and $70 (5% upside) price target; Johnson & Johnson (NYSE:JNJ) with an Overweight rating and $115 (14% upside) price target; Merck with an Overweight rating and a $66 (25% upside) price target; Eli Lilly (NYSE:LLY) with an Overweight rating and $95 (14% upside) price target and Pfizer (NYSE:PFE) with an Equal Weight rating and $34 (5% upside) price target.
- GW Pharmaceuticals (NASDAQ:GWPH) resumed with Buy rating and $130 (51% upside) price target by Roth Capital.
- ImmunoGen (NASDAQ:IMGN) resumed with Buy rating and $16 (24% upside) price target by Jefferies.
- Myokardia (NASDAQ:MYOK) initiated with an Outperform rating and $22 (75% upside) price target by Wedbush and an Outperform rating and $18 (43% upside) price target by Credit Suisse.
Nov. 30, 2015, 11:28 AM
- Under its Priority Review process, the FDA approves elotuzumab, in combination with Celgene's (CELG -1.7%) REVLIMID (lenalidomide) and dexamethasone, for the treatment of patients with multiple myeloma (MM) who have received one to three prior lines of therapy.
- In clinical studies, patients receiving elotuzumab plus REVLIMID and dexamethasone showed a longer period of progression-free survival (19.4 months) compared to those receiving REVLIMID and dexamethasone alone (14.9 months). In addition, 78.5% of patients treated with elotuzumab plus the other two experienced complete or partial shrinkage of their tumors compared to 60.1% of patients who did not receive elotuzumab.
- Orphan Drug- and Breakthrough Therapy-tagged elotuzumab was co-developed by Bristol-Myers Squibb (BMY -0.7%) and AbbVie (ABBV -2.2%). BMY has sole commercialization rights to the product, which will be marketed under the brand name Empliciti.
- Multiple myeloma, a type of blood cancer that occurs in plasma cells, strikes ~27K Americans each year resulting in over 11K deaths.
- Elotuzumab is the second monoclonal antibody cleared by the FDA for MM. It approved Janssen's (JNJ -0.7%) Darzalex (daratumumab) several weeks ago.
- Previously: FDA accepts elotuzumab BLA under Priority Review (Sept. 1)
- Previously: FDA clears J&J's Darzalex for treatment-resistant multiple myeloma (Nov. 16)
Nov. 27, 2015, 7:01 PM
- The FDA today declined to approve an expanded use for Bristol-Myers Squibb's (NYSE:BMY) Opdivo to treat another type of advanced skin cancer.
- Earlier this week, the company won approval for the immuno-oncology drug to treat advanced kidney cancer, as well as single-agent treatment of patients with BRAF V600 wild-type melanoma.
- But with a "complete response letter," the agency declined to approve the drug for treating BRAF V600 mutation positive metastatic melanoma -- a skin cancer that is both the rarest and deadliest. It indicated a need for additional data from the patient population.
- Opdivo has received approval for five other indications since its first approval last December.
- Previously: FDA clears new indication for Bristol-Myers' Opdivo (Nov. 24 2015)
- Previously: Bristol-Myers wins FDA approval for Opdivo to treat advanced kidney cancer (Nov. 23 2015)
Nov. 24, 2015, 7:50 AM
- The FDA approves Bristol-Myers Squibb's (NYSE:BMY) Opdivo (nivolumab) as a single agent for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. The data supporting clearance was generated in the Phase 3 Checkmate-066 study which compared Opdivo to chemotherapy (dacarbazine) in the target population.
- The company's supplemental BLA for Opdivo in BRAF V600+ unresectable or metastatic melanoma is still under FDA review.
Bristol-Myers Squibb Co. is engaged in the discovery, development, licensing, manufacturing, marketing, distribution and sale of biopharmaceutical products. Its pharmaceutical products include chemically-synthesized drugs or small molecules and an increasing portion of products produced from... More
Industry: Drug Manufacturers - Major
Country: United States
Other News & PR