Teva Pharmaceutical: Bold Markets, Bold Moves
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Fri, Jun. 24, 7:28 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Teva Pharmaceutical Industries' (NYSE:TEVA) CINQAERO (reslizumab), a humanized monoclonal antibody that binds to interleukin 5 (IL-5), as add-on therapy in adult patients with severe inadequately controlled eosinophilic asthma despite high-dose inhaled corticosteroids plus another medicinal product for maintenance treatment.
- A final decision by the European Commission usually takes ~60 days.
- The FDA approved the product, branded as CINQAIR in the U.S., in March.
- Previously: FDA clears Teva's asthma med Cinqair (March 23)
Thu, Jun. 23, 9:41 AM
Tue, Jun. 21, 7:54 AM
- Impax Laboratories (NASDAQ:IPXL) acquires a group of 15 generic drugs from Teva Pharmaceutical Industries (NYSE:TEVA) and affiliates of Allergan (NYSE:AGN) for total consideration of $586M. The transaction also includes the return of the rights to the pending abbreviated New Drug Application (ANDA) for a generic version of Johnson & Johnson's (NYSE:JNJ) Concerta (methylphenidate hydrochloride) to Impax.
- The deal will be immediately accretive to Impax's earnings. The group generated ~$150M in sales and ~$100M in gross profit in 2015. Per IMS, the U.S. market for the portfolio is ~$3.1B.
- Impax will finance the acquisition with cash on hand and $400M in term loans.
- Teva divested the products to satisfy U.S. Federal Trade Commission conditions for its planned acquisition of Allergan's generics business.
Tue, Jun. 14, 8:16 AM
- Thinly traded micro cap Mesoblast Limited (NASDAQ:MESO) is down 36% premarket on light volume in response to its announcement that development partner Teva Pharmaceutical Industries (NYSE:TEVA) has returned the rights to MPC-150-IM for the treatment of chronic heart failure to Mesoblast. Some analysts had speculated that Teva would back out of the collaboration because it was outside of its core business.
- A 600-subject Phase 3 clinical trial assessing MPC-150-IM in heart failure is ongoing, with 40% of the enrollment target achieved.
- MPC-150-IM is an "off the shelf" cell therapy based on mesenchymal lineage adult stem cells.
- Update: On July 1, the company updated investors on the heart failure study saying top-line data on the primary endpoint is expected in Q1 2017. The anticipated costs to this interim analysis will be ~$13M, well below its existing cash balance of $80M. Its quick assets will be adequate to fund operations for 12-15 months and allow for the inclusion of programs in degenerative disc disease, graft-versus-host disease and biologic-refractory rheumatoid arthritis. A fully discretionary equity facility of up to $90M ($A120M) over 36 months has been established to provide additional liquidity if needed.
Mon, Jun. 13, 9:36 AM
- Citing its top priority of patient safety, Teva Pharmaceutical (TEVA -0.3%) announces that it will voluntarily suspend sales, marketing and distribution of migraine med ZECUITY (sumatriptan iontophoretic transdermal system) after receiving reports of application site reactions described as burns and scars.
- Teva is working closely with the FDA to further analyze reports of adverse skin reactions and investigate the root cause. It has also initiated a pharmacy-level recall of the product.
Mon, Jun. 13, 3:14 AM
- Looking to bolster its U.S. business, Dr. Reddy's Laboratories (NYSE:RDY) has agreed to buy eight generic medicines from Teva Pharmaceutical (NYSE:TEVA) and Allergan (NYSE:AGN) for $350M in cash.
- The sale to India's second-largest drugmaker could put Teva a step closer to winning U.S. antitrust clearance for its $40.5B acquisition of Allergan's generic drugs portfolio, and is contingent on the deal's approval.
Fri, Jun. 10, 12:47 PM
- Thinly traded small cap Eagle Pharmaceuticals (EGRX +34.6%) heads north on almost a 5x surge in volume in response to a favorable court ruling validating BENDEKA (bendamustine hydrochloride) U.S. licensee Teva Pharmaceutical Industries' (TEVA +0.4%) TREANDA (bendamustine hydrochloride) patents against would-be generic competitors. The upholding of the patents bodes well for premium pricing for BENDEKA, which Teva intends to replace TREANDA with because of its shorter infusion time.
- Teva licensed BENDEKA, approved for the treatment certain blood cancers, in February 2015.
Tue, Jun. 7, 3:52 PM
- In a joint meeting, the FDA's Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee, voted 14-3 recommending approval of Teva Pharmaceutical Industries' (TEVA -1.2%) hydrocodone bitartrate extended-release tablets for the management of chronic severe pain. The product, branded as Vantrela ER, is a long-acting formulation that has abuse-deterrent properties based on its physiochemistry.
- The committees also voted 14-3 backing labeling that Vantrela ER is an abuse-deterrent product by the nasal and oral routes of abuse and 16-1 backing labeling that it is abuse-deterrent by the IV route of abuse.
- FDA briefing doc
- Errata to FDA briefing doc
- Sponsor briefing doc
Fri, Jun. 3, 11:00 AM
- The trading halt in Mesoblast (NASDAQ:MESO) ADSs, instituted June 1, will remain in effect until June 10, at the company's request. Based on experience, this type of scenario almost always portends negative news.
- Analysts speculate that Teva Pharmaceutical Industries (TEVA -2.3%) could pull out of its collaboration with the company since it lies outside of its core business or the news could relate to an accounting issue, FDA warning or safety matter. In a tweet, TheStreet's Adam Feuerstein speculated that the news could be related to a criminal probe of Osiris Therapeutics (OSIR -1.9%), whose culture-expanded mesenchymal stem cell business Mesoblast acquired in 2013.
- Investors began heading for the exits more than two months before June 1. Shares had slumped 35% from the high of $10.89 on March 17 when halted.
Thu, Jun. 2, 8:44 AM
- May monthly performance was: +1.09%
- 52-week performance vs. the S&P 500 is: -6%
- No dividends were paid in May
- Top 10 Holdings as of 3/31/2016: Apple Inc (AAPL): 2.0%, Teva Pharmaceutical Industries Ltd ADR (TEVA): 1.87%, Newell Brands Inc (NWL): 1.84%, Gilead Sciences Inc (GILD): 1.74%, Sky PLC (OTCQX:BSYBF): 1.71%, CGI Group Inc Class A (GIB): 1.69%, Mattel Inc (MAT): 1.68%, Amcor Ltd (OTC:AMCRF): 1.61%, WH Group Ltd (OTC:WHGRF): 1.57%, Dollar General Corp (DG): 1.53%
Tue, May 31, 8:20 AM
- Teva Pharmaceutical Industries (NYSE:TEVA) is down 2% premarket on increased volume in response to its announcement that it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) seeking approval of SD-809 for the treatment of chorea (involuntary movements) associated with Huntington's disease, an inherited disorder characterized by the progressive breakdown of nerve cells that leads to movement, cognitive and psychiatric problems.
- The agency did not request additional clinical trials but wanted the company to re-analyze blood levels of certain metabolites. Teva intends to address the issue as soon as possible and submit its response in Q3.
- SD-809 (deutetrabenazine) 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.
Wed, May 25, 7:25 AM
- Spectrum Pharmaceuticals' (NASDAQ:SPPI) wholly owned subsidiary Allos Therapeutics settles its patent litigation with Teva Pharmaceuticals USA (NYSE:TEVA) related to lymphoma drug Folotyn (pralatrexate injection). The settlement allows Teva to market a generic version of Folotyn in the U.S. on December 1, 2022 or earlier under certain circumstances.
- Allos' litigation with other would-be generic competitors continues.
Tue, May 17, 3:02 AM
- The U.S. Supreme Court has backed out of a divisive clash involving religious groups that object to mandatory contraceptive coverage under Obamacare, issuing a compromise that said the two sides might be able to work out their differences.
- With four conservative justices and four liberals, the judges sent the case back to the lower courts, but suggested the government arrange coverage directly with health insurers rather than requiring employers to sign off on it.
- Related tickers: PFE, MRK, JNJ, TEVA, CHD, OTCPK:BAYRY
Tue, May 10, 8:30 AM
- Allergan's (NYSE:AGN) board of directors authorizes up to $10B in new share repurchases, $4B - 5B to be bought over the next four to six months subject to favorable market conditions.
- The initiative is pending the completion of the sale of the company's generics business to (NYSE:TEVA), expected to close next month.
Mon, May 9, 8:49 AM
Mon, May 9, 7:51 AM
- Teva Pharmaceutical (TEVA -6.7%) Q1 results: Revenues: $4,810M (-3.5%); R&D Expense: $389M (+17.2%); SG&A: $1143M (-7.0%); Operating Income: $1,165M (+55.5%); Net Income: $570M (+27.8%); EPS: $0.62 (+19.2%); Non-GAAP EPS: $1.20 (-11.8%); Quick Assets: $5,964M (-14.1%); CF Ops: $1,376M (1.6%).
- Q2 Guidance: Revenues: $4.7B - 4.9B; Non-GAAP EPS: $1.16 - 1.20; CF Ops: $1.2B - 1.3B.
Teva Pharmaceutical Industries Ltd. engages in the provision of pharmaceutical services. It operates through the following business divisions: Generic, Specialty Medicine, and Over-the-Counter (OTC). The Generic division involves the manufacture and sale of generic products such as tablets,... More
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