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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
Dec. 8, 2015, 7:53 AM
- The FDA approves Eagle Pharmaceuticals' (NASDAQ:EGRX) Orphan Drug-tagged BENDEKA (bendamustine hydrochloride) for the treatment of 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 Pharmaceutical Industries (NYSE:TEVA) is responsible for commercialization in the U.S. under its February 2015 exclusive license agreement with Eagle. The launch will commence in Q1.
- Regulatory clearance triggers a $15M milestone payment from Teva. Eagle will also receive a royalty rate of 20% on BENDEKA net sales. Royalties may be stepped up based on the achievement of future sales-based milestones.
- Previously: FDA accepts Eagle Pharma's NDA for rapid infusion bendamustine (April 14)
Dec. 7, 2015, 3:07 PM
- The European Patent Office upholds the validity of Teva Pharmaceutical Industries' (TEVA +0.3%) European Patent No. 2405749 covering COPAXONE (glatiramer acetate) 40 mg/mL administered 3x per week. Generics firms Synthon, Actavis and Mylan (MYL -1%) had challenged the patent on various grounds. The ruling is subject to appeal. Teva's patent expires in 2030.
Dec. 3, 2015, 11:53 AM
- According to sources close to the matter, Teva Pharmaceutical Industries (TEVA +2.2%) is currently divesting $1B in assets in order to address antitrust concerns related to its intended $40.5B acquisition of Allergan's (AGN -0.2%) generics business, Actavis Generics. The move will help ensure that the deal goes through in Q1 as planned.
- Previously: Teva to buy Allergan Generics for $40.5B (July 27)
Dec. 3, 2015, 6:48 AM
- Teva Pharmaceutical Industries (NYSE:TEVA) prices its public offering of 54M American Depositary Shares (ADSs), each representing one ordinary share, at $62.50 per ADS. It also prices its public offering of 3.375M 7.00% Mandatory Convertible Preferred Shares at $1,000 per share, each automatically converting to between 13.3333 and 16.0000 ADSs on December 15, 2018.
- Net proceeds of ~$3.29B each will help fund the cash portion of its previously announced acquisition of Allergan's (NYSE:AGN) generics business (Actavis Generics).
- Previously: Teva initiates equity offering in connection with Actavis Generics transaction (Nov. 30)
Nov. 30, 2015, 10:10 AM
- Teva Pharmaceutical Industries (TEVA -2.2%) commences concurrent offerings of $3.375B of American Depositary Shares (ADSs), each representing on Teva ordinary share, and $3.375B of Mandatory Convertible Preferred Shares. Final amounts of the securities will be determined based on market (and other) conditions. Terms of the convertibles are not disclosed.
- Net proceeds will help fund its previously announced $40.5B acquisition of Allergan's (AGN -1.7%) generics business.
Nov. 30, 2015, 6:51 AM
- Teva Pharmaceutical Industries (NYSE:TEVA) and Takeda Pharmaceutical (OTCPK:TKPHF)(OTCPK:TKPYY) form a joint venture in Japan with the aim of building a leadership position in the fast-growing generic medicines there. The government, trying to address the medical needs of its aging population, intends to reach 80% generic penetration in its drugs market by the end of fiscal year 2020.
- The new business, expected to start operating in Q2 2016, will leverage Teva's extensive generics portfolio with Takeda's brand presence and distribution capabilities. Teva will be the majority owner with a 51% stake while Takeda will own 49%.
Nov. 27, 2015, 10:43 AM
- The FDA's Psychopharmacologic Drugs Advisory Committee will meet on Tuesday, December 1, to review privately held Fabre-Kramer Pharmaceuticals' New Drug Application (NDA) for gepirone hydrochloride extended-release tablets for the treatment of major depressive disorder (MDD).
- FDA briefing doc
- Company briefing doc
- Draft questions
- MDD-related tickers: (OTCQB:VSTA)(OTCPK:OTSKY)(OTCPK:TKPYY)(NYSE:PFE)(NASDAQ:ALKS)(NASDAQ:AVNR)(NYSE:TEVA)(NASDAQ:SHPG)(NYSE:LLY)(NYSE:GSK)
Nov. 25, 2015, 7:44 AM
- Teva Pharmaceutical Industries (NYSE:TEVA) enters into a licensing and drug discovery agreement with Sosei Group's (OTCPK:SOLTF) Heptares Therapeutics for exclusive global rights to develop, manufacture and commercialize novel, small molecule calcitonin gene-related peptide (CGRP) antagonists discovered by Heptares for the treatment of migraine.
- Under the terms of the agreement, Heptares will receive an upfront payment of $10M, research funding, milestones up to $400M and royalties on commercial sales.
- Teva President of Global R&D and CSO Michael Hayden, M.D., Ph.D., says, "CGRP antagonism represents an exciting opportunity to treat migraine. We believe small molecule CGRP antagonists offer further opportunities that are highly complementary to our promising candidate, TEV-48125, an anti-CGRP antibody."
- About 36M Americans, 55M Europeans and 8M Japanese suffer from migraine.
Nov. 19, 2015, 9:42 AM
- Top-line results from three Phase 3 clinical trials assessing Teva Pharmaceutical Industries' (TEVA +0.4%) fluticasone propionate/salmeterol, a combination inhaled corticosteroid and long-acting beta agonist delivered via a multidose dry powder inhaler, and fluticasone propionate as monotherapy delivered via the same inhaler in adolescent and adult patients with asthma showed all met their primary efficacy endpoints.
- The combo product demonstrated clinically relevant and greater improvement in lung function at all doses (50/12.5, 100/12.5, 200/12.5) compared to placebo and fluticasone propionate monotherapy as measured by the change from baseline in trough Forced Expiratory Volume in one second (FEV1) at week 12.
- Fluticasone propionate monotherapy demonstrated clinically relevant and greater improvement in lung function at all doses (50 mcg, 100 mcg, 200 mcg, twice per day) compared to placebo.
- Complete results will be presented at future scientific meetings. Regulatory submissions are planned for 2016.
Nov. 9, 2015, 10:48 AM
- The FDA designates Teva Pharmaceutical Industries' (TEVA -0.3%) SD-809 (deutetrabenazine) a Breakthrough Therapy for the treatment of patients with moderate-to-severe tardive dyskinesia, a disorder affecting ~500K Americans characterized by involuntary movements of the tongue, lips, face, trunk and extremities in patients on long-term dopamine-related therapy. There are no currently approved treatments for the condition.
- Breakthrough Therapy status provides for more intensive guidance on development from the FDA, the involvement of more senior agency personnel and a rolling review of the New Drug Application (NDA).
- SD-809 is an orally available small molecule inhibitor of vesicular monoamine 2 transporter (VMAT2) that is designed to regulate the levels of the neurotransporter dopamine in the brain.
- The company's NDA for chorea associated with Huntington disease is currently under FDA review.
Nov. 2, 2015, 3:46 PM
- Melbourne, Australia-based Mesoblast (OTCPK:MEOBF)(OTCPK:MBLTY) is set for its U.S. IPO of 5,742,510 American Depositary Shares at ~$12 per ADS. Each ADS represents five ordinary shares and will trade on the Nasdaq Global Select Market under the symbol "MESO."
- The regenerative medicine firm develops products based on mesenchymal lineage adult stem cells (MLCs). According to the company, it has the most advanced regenerative medicine portfolio in world, with five MLC product candidates in Stage 3 development (ongoing or planned). Its lead programs include MPC-150-IM for chronic heart failure (partnered with (TEVA +2.9%)); MPC-06-ID for chronic low back pain caused by disc degeneration; and TEMCELL/MSC-100-IV for acute graft versus host disease.
- F2015 Financials ($M): Revenues: 19.8 (-15.5%); Operating Expenses: 131.4 (+20.5%); Net Loss: (96.2) (-27.4%); CF Ops: (101.0) (-34.9%).
Nov. 1, 2015, 10:38 PM
- Alexza Pharmaceuticals (NASDAQ:ALXA) will reacquire the U.S. rights to ADASUVE (loxapine) inhalation powder from commercial partner Teva Pharmaceuticals (NYSE:TEVA) effective January 1. Teva apparently felt the going was a bit rough considering the comment below.
- Alexza CEO Thomas Kings says, "ADASUVE is an effective product. There are considerable challenges in launching a hospital product, especially one as complex as ADASUVE. We appreciate the efforts that Teva has made to date and are looking forward to continuing to build the ADASUVE brand. We remain confident in ADASUVE's long-term commercial prospects and plant to work with Teva to effect a smooth transition. It is our intention to work diligently in 2016 to identify a new U.S. commercial partner for ADASUVE."
- ADASUVE, approved by the FDA in December 2012, is indicated for the acute treatment of adults with agitation associated with schizophrenia or bipolar I disorder.
- Previously: Alexza Pharmaceuticals (ALXA) announces an exclusive U.S. license deal for Adasuve with Teva... (May 8, 2013)
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