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Tue, Feb. 2, 10:15 AM
- Teva Pharmaceutical Industries (TEVA -1.4%) inks a collaborative research agreement with privately held Vancouver, BC-based AbCellera to discover rare monoclonal antibodies via its high-throughput single cell antibody platform.
- Under the terms of the partnership, AbCellera will receive an upfront payment, research funding and antibody development-related milestones. Specific financial terms are not disclosed.
Tue, Feb. 2, 8:49 AM
- Based on an independent third party analysis of the results from a failed Phase 2 clinical trial assessing Trimesta (oral estradiol) and Teva's (NYSE:TEVA) COPAXONE (glatiramer acetate injection) in women with relapsing-remitting multiple sclerosis (RRMS), Synthetic Biologics (NYSEMKT:SYN) decides to terminate its license and clinical trial agreements related to the drug.
- Analyses from two clinical research organizations confirmed that Trimesta failed to demonstrate a statistically valid treatment effect over and above COPAXONE.
- CEO Jeff Riley says, "We are disappointed with the outcome of the data analyses which did not demonstrate statistically significant treatment effects in this study. We intend to focus the Company's resources on its other programs, including our two Phase 2 gut microbiome programs which have both demonstrated top-line clinical results."
- Shares are down 17% premarket on increased volume.
Thu, Jan. 28, 12:35 PM
- Teva Pharmaceutical Industries (TEVA -2.9%) announces the commercial availability of BENDEKA (bendamustine hydrochloride), a liquid, low-volume (50 mL), short-time 10-minute infusion formulation of the chemo drug bendamustine.
- BENDEKA is approved for the treatment of patients with chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab (Roche's Rituxan) or a rituximab-containing regimen. Teva intends to replace TREANDA (bendamustine HCl) Injection, which is infused over 30 minutes for CLL and 60 minutes for NHL, with BENDEKA.
- Teva owns exclusive commercial rights to BENDEKA in the U.S. under a February 2015 license agreement with Eagle Pharmaceuticals (EGRX +11.2%). The FDA approved it last month.
- Previously: FDA clears Eagle's BENDEKA for CLL and NHL (Dec. 8, 2015)
Tue, Jan. 26, 9:42 AM
- Ness Ziona, Israel-based Mapi-Pharma (MAPI) is set for its IPO of 3.125M ordinary shares at $15 - 17.
- The clinical stage firm develops improved extended-release formulations of existing drugs which it refers to as product life cycle management or LCM. Its LCM products offer advantages over currently marketed versions such as improved patient compliance and reduced side effects while allowing for extended patent and regulatory exclusivity.
- Lead product candidates include a once-monthly injection formulation (glatiramer acetate depot) of Teva Pharmaceutical Industries' (TEVA -0.3%) COPAXONE (glatiramer acetate) which is dosed 3x/week; an extended-release formulation (pregabalin ER) of Pfizer's (PFE +0.1%) LYRICA (pregabalin)(dosed 2-3 times per day) and a once-monthly depot formulation of J&J's (JNJ +1.8%) RISPERDAL CONSTA (risperidone) which is administered once every two weeks.
- 2015 Financials (9 mo.)($M): Collaboration revenue: 0.6 (+999%); Operating Expenses: 4.5 (-16.6%); Net Loss: (6.3) (-120.0%); Cash Burn: (0.6) (+86.6%).
Tue, Jan. 12, 1:00 PM
- Based on discussions between development partner Teva Pharmaceutical Industries (TEVA +1.2%) and the FDA, the size of a Phase 3 clinical trial assessing Mesoblast Limited's (MESO -0.8%) cell therapy candidate, MPC-150-IM, in patients with chronic heart failure (CHF) will be cut from 1,165 to ~600. The reduction was enabled by a change in the primary endpoint brought about by positive follow-up data in a Phase 2 study that showed the successful prevention of recurrent heart failure-related major adverse cardiovascular events (HF-MACE) for three years from a single injection of MPC-150-IM.
- In the Phase 2, no MPC-150-IM-treated patients experienced HF-MACE over 36 months compared to 11 in the control group (p<0.001), In patients with advanced heart failure, 71% of the control arm experienced at least one HF-MACE versus zero for the MPC-150-IM cohort (p<0.001).
- The revised endpoint will be a comparison of recurrent HF-MACE in patients treated with MPC-150-IM and control.
- The size reduction will significantly shorten the time to completion. A second confirmatory study will be run in parallel using the same endpoint also in ~600 subjects.
- MPC-150-IM is an "off the shelf" cell therapy based on mesenchymal lineage adult stem cells.
Thu, Jan. 7, 4:24 PM
- In a regulatory filing, OncoGenex Pharmaceuticals (NASDAQ:OGXI) discloses that Ionis Pharmaceuticals (NASDAQ:IONS) has filed a lawsuit against its subsidiary OncoGenex Technologies seeking a portion of $23.2M it received from Teva Pharmaceutical Industries (NYSE:TEVA) for advance reimbursement of R&D expenses related to the termination of collaboration agreement.
- Ionis asserts that OncoGenex is in breach of a July 2008 license agreement that entitled it to a share of certain forms of non-royalty revenue received by OncoGenex. OncoGenex says Ionis is not entitled to a share of monies received for R&D reimbursement, however. Ionis seeks damages and a declaratory judgement.
- As expected, OncoGenex intends to vigorously defend itself in the matter.
Tue, Jan. 5, 11:31 AM
- Joining (TEVA -0.3%), Mylan (MYL +1.4%) launches its generic equivalent to Janssen's (JNJ +0.6%) contraceptive Ortho Tri-Cyclen Lo (norgestimate/ethinyl estradiol) Tablets in the U.S. The branded product generates ~$490M in annual sales.
- Previously: Teva launches generic Ortho Tri-Cyclen Lo in U.S. (Jan. 5)
Tue, Jan. 5, 9:37 AM
- Teva Pharmaceutical Industries (TEVA -0.9%) launches its generic equivalent of the oral contraceptive Ortho Tri-Cyclen Lo (norgestimate/ethinyl estradiol) tablets in the U.S. The company's offering will be sold under the brand name Tri-Lo-Sprintec (norgestimate and ethinyl estradiol tablets, USP).
- Ortho Tri-Cyclen Lo, marketed by Janssen Pharmaceuticals (JNJ +0.4%), generates ~$490M in annual sales in the U.S.
Mon, Jan. 4, 11:33 AM
- The occurrence of an inordinate number of cardiovascular (CV) events in certain multiple sclerosis (MS) patients receiving higher daily doses of laquinimod prompts the independent Data Monitoring Committee (DMC) to recommend that Teva Pharmaceutical Industries (TEVA -0.9%) discontinue the dosing regimens in two clinical studies.
- Specifically, seven patients with relapsing-remitting MS in the 2,199-subject CONCERTO trial who were receiving 1.2 mg of laquinimod per day experienced CV events compared to zero CV events in the cohorts receiving 0.6 mg per day or placebo. One CV event was observed in the 191-subject ARPEGGIO study in primary-progressive MS in a patient receiving 1.5 mg of laquinimod per day.
- Both trials will continue the low dose (0.6 mg) arms. All participants will be provided an update to confirm their consent to continued treatment. The DMC did not identify a CV signal with the 0.6 mg dose but recommended long-term monitoring. Teva has completed large studies and is conducting long-term extension trials at the 0.6 mg dose and is not concerned about the CV risk at this strength.
- Laquinimod is a CNS-active immunomodulator under development for the treatment of relapsing-remitting MS, primary-progressive MS and Huntington's disease. Teva has global rights to the product candidate via a licence agreement with Active Biotech.
Mon, Jan. 4, 9:02 AM
- Teva Pharmaceutical Industries (NYSE:TEVA) secures an additional $658M in net proceeds from its previously announced equity offering via the full exercise of the underwriters over-allotment of 5.4M ADSs and 337.5K Mandatory Convertible Preferred Shares, increasing the company's take to $7.24B.
- Net proceeds will partially fund its acquisition of Actavis Generics, its acquisition of Rimsa and the repayment of debt.
- Previously: Teva prices equity $6.75B offering (Dec. 3, 2015)
Dec. 28, 2015, 7:05 AM
- The joint venture in Japan between Teva Pharmaceutical Industries (NYSE:TEVA) and Takeda Pharmaceutical (OTCPK:TKPHF)(OTCPK:TKPYY), originally announced in November, should commence sometime around April. Teva will own 51% via Teva Takeda Pharma while Takeda will own 49% via Teva Takeda Yakuhin, both established by an absorption-type company split.
- Takeda will transfer products representing 7% of its revenue to the venture, including BLOPRESS, TAKEPRON and BASEN. As a result, Takeda's 2016 revenue will decrease by ~50B yen.
- The deal will be both EPS and cash flow accretive for Takeda in 2016 and thereafter and will be accretive to Teva's non-GAAP EPS this year and beyond.
- Previously: Teva and Takeda form JV in Japan to drive generics business (Nov. 30)
Dec. 22, 2015, 7:54 AM
- Noting significant short interest and recent selloffs, analyst Randall Stanicky makes INSY and SGNT his top "out of consensus" picks for 2016. INSY's short interest is 46% of the float and SGNT's is 4.4%.
- Though M&A will continue next year, there will be greater deal scrutiny and fewer targets, and Stanicky favors the targets vs. the accretive acquirers.
- Mylan (NASDAQ:MYL) and Impax Labs (NASDAQ:IPXL) are seen as most likely to pursue "transformative" deals, while Teva (NYSE:TEVA), Perrigo (NYSE:PRGO), Sagent, Eagle (NASDAQ:EGRX), Depomed (NASDAQ:DEPO), and Endo (NASDAQ:ENDP) are likely to pursue bolt-on purchases.
- Most likely targets: Akorn (NASDAQ:AKRX) and Flexion (NASDAQ:FLXN).
- Top large-cap picks: Endo and Teva.
- Related: 45% Upside For 2016's Top Takeover Target (Dec. 1)
Dec. 14, 2015, 8:49 AM
- Egalet (NASDAQ:EGLT) grants exclusive marketing and commercialization rights for SPRIX (ketorolac tromethamine) Nasal Spray to Teva Pharmaceutical Industries (NYSE:TEVA) for the territory of Israel, Gaza and the West Bank. Under the terms of the agreement, Egalet will receive an undisclosed upfront payment, sales-based milestones and a portion of the profits.
- SPRIX Nasal Spray is a non-steroidal anti-inflammatory drug indicated for the short term (up to five days) management of moderate-to-severe pain in adult patients.
Dec. 14, 2015, 7:57 AM
- CTI BioPharma (NASDAQ:CTIC) receives a $10M milestone payment from Teva Pharmaceutical Industries (NYSE:TEVA) for the achievement of sales milestones for TRISENOX (arsenic trioxide). It is eligible to receive up to an additional $70M in sales and development milestones pursuant to an agreement with Cephalon, which Teva acquired in October 2011.
- TRISENOX is indicated for induction of remission and consolidation in patients with a certain genetic profile of acute promyelocytic leukemia (APL) who are refractory to or have relapsed from retinoid and anthracycline chemotherapy.
Dec. 10, 2015, 7:11 AM
- The FDA's Pulmonary-Allergy Drugs Advisory Committee voted 11-3 that Teva Pharmaceutical Industries' (NYSE:TEVA) reslizumab's safety profile supports approval for the relief of symptoms of asthma and the improvement in lung function in adult patients who are inadequately controlled on inhaled corticosteroids. It voted 13-1 that Teva provided substantial evidence of clinically meaningful benefit in patients at least 18 years old.
- The committee voted 14-0 against approval in adolescents aged 12-17, however, citing the lack of substantial evidence of a clinically meaningful benefit in this age group.
- There were four reported cases of anaphylaxis (potentially life-threatening allergic reaction) in the 3 mg/kg treatment group which could potentially trip up approval or affect the approved dosing range.
- Previously: Ad Comm tomorrow for Teva's asthma candidate reslizumab (Dec. 8)
Dec. 8, 2015, 4:21 PM
- The FDA's Pulmonary-Allergy Drugs Advisory Committee meets tomorrow to discuss Teva Pharmaceutical Industries' (NYSE:TEVA) Biologics License Application (BLA) seeking clearance of reslizumab to reduce exacerbations, relieve symptoms and improve lung function in patients at least 12 years old with asthma and elevated eosinophils who are inadequately controlled on inhaled corticosteroids.
- Reslizumab is a humanized monoclonal antibody that binds to interleukin-5 (IL-5), a cytokine that plays a key role in the activation and growth of eosinophils, a type of white blood cell that is elevated in the lungs and blood in many asthmatics. High levels of eosinophils correlate with disease severity so binding to IL-5 inhibits its ability to stoke eosinophil levels.
- FDA briefing doc
- FDA errata
- Teva briefing doc
- Teva addendum
- Draft questions
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