Wed, Jul. 1, 9:25 AM
- Thinly traded micro cap Xenon Pharmaceuticals (NASDAQ:XENE) drops 22% premarket on increased volume in response to its announcement that a Phase 2b trial run by development partner Teva Pharmaceutical Industries (NYSE:TEVA) evaluating TV-45070 (formerly XEN402) in patients with pain due to osteoarthritis of the knee failed to demonstrate a statistically significant difference from placebo.
- TV-45070, a small molecule inhibitor of the sodium channel Nav1.7 and other sodium channels that are expressed in the pain-sensing peripheral nervous system, is a topical cream being developed for the treatment of nociceptive (pain arising from nerve cell stimulation) pain.
- Top-line results from another Phase 2b study in post-herpetic neuralgia are expected in H2 2016.
Thu, Jun. 25, 10:03 AM
- Teva Pharmaceutical Industries (TEVA -0.1%) and co-developer Active Biotech (OTC:ATVBF) announce that patient enrollment is complete (n=2,199) in a Phase 3 study, called CONCERTO, evaluating laquinimod (0.6 mg/day or 1.2 mg/day) in patients with relapsing-remitting multiple sclerosis (RRMS) for up to 24 months. The primary endpoint is time to three-month confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS). Final data collection is projected to occur in May 2018. The study's completion date is June 2018. Regulatory filings will follow thereafter.
- The sample size of the trial will be re-assessed to confirm that the original assumptions related to completion remain valid. Per the Special Protocol Assessment (SPA) with the FDA, study completion will occur when either 260 events are reached or all patients complete 24 months of treatment. Assuming the former occurs first, then results could be available as soon as mid-2017.
- Laquinimod, a CNS-active immunomodulator, has had a rough ride on its road to approval. It has been in late-stage development for MS since late 2007. Earlier Phase 3 trials failed to demonstrate a significant reduction in relapses.
Fri, Jun. 19, 10:42 AM
- Teva Pharmaceutical Industries (TEVA +0.2%) completes its accumulation of a 4.61% stake on Mylan N.V. (MYL -0.3%) which enables Teva to commence proceedings before the Dutch Enterprise Chamber, should it become necessary.
- In addition, Teva commits to limit its stake to less than 5% if Mylan holds its shareholders meeting no later than August 31.
Thu, Jun. 18, 7:11 PM
- Sandoz (NYSE:NVS) announces the U.S. launch of Glatopa, the first generic equivalent of Teva Pharmaceutical Industries' (NYSE:TEVA) Copaxone (glatiramer acetate injection) 20 mg/ml for the treatment of patients with relapsing forms of multiple sclerosis.
- Glatopa was developed in collaboration with Momenta Pharmaceuticals (NASDAQ:MNTA). Under the terms of their agreement, the first commercial sale will trigger a $10M payment to Momenta, which is also eligible to receive up to $120M in remaining sales-based milestones.
- Copaxone is Teva's top seller by far, generating ~$4.1B in sales the past four quarters.
- TEVA is down 1% after hours on light volume. MNTA is up 3% on increased volume.
Thu, Jun. 18, 10:07 AM
- Teva Pharmaceutical Industries (TEVA -0.6%) enters into a partnership with privately-held Lexington, MA-based Microchips Biotech to explore ways to apply Microchips' implantable drug delivery device to Teva's portfolio of products with the goal of improving clinical outcomes.
- Microchips' device is comprised of microchip arrays that can store hundreds of therapeutic doses of drugs for months or years and can be programmed to release each dose at a specific time.
- Under the terms of the agreement, Teva will make a $35M upfront payment in the form of an equity investment in Microchips and a technology access fee. The partnership will focus initially on a single disease area but Teva will have the option to expand into additional areas. Microchips will be eligible for development and commercial milestones and royalties on net sales. It will also receive funding to develop products for new indications that Teva may develop. Teva will be responsible for Phase 2 and 3 development and regulatory filings.
Thu, Jun. 18, 9:31 AM
- New data from additional analyses of a Phase 2b study evaluating Teva Pharmaceutical Industries' (NYSE:TEVA) TEV-48125 for the prevention of high frequency episodic migraine (8-14 migraines per month) and chronic migraine (at least 15 per month) show that patients receiving a once-monthly injection of TEV-48125 experienced significant reductions in the number of migraines compared to placebo. The data will be presented on June 20 at the 57th Annual Scientific Meeting of the American Headache Society in Washington, DC.
- 297 patients were randomized to receive TEV-48125 (225 mg or 675 mg) or placebo. Patients were allowed to continue using other preventive migraine medications if in stable doses. Both TEV-48125 treatment arms met the primary endpoint of superiority compared to placebo as measured by the decrease in monthly migraines at month 3 versus baseline. Also, a single injection of either dose of TEV-48125 resulted in a statistically significant separation from placebo.
- The proportion of patients receiving 225 mg or 675 mg of TEV-48125 who experienced at least a 50% reduction in migraine days for the duration of the study (three months) was 53% and 59%, respectively, compared to 28% for placebo. For patients experiencing at least a 75% reduction in migraine days, the proportions were 34%, 31% and 11%, respectively.
- TEV-48125 is a monoclonal antibody that binds to calcitonin gene-related peptide (CGRP), a well-validated target in migraine. The company plans to advance the product candidate to Phase 3 development.
- Previously: Teva migraine candidate successful in Phase 2 study (March 23)
Tue, Jun. 16, 2:12 PM
- Receptos (NASDAQ:RCPT) has jumped, +4.4%, to $182.35 on chatter that Wedbush has raised its price target on the stock to $348 and says a takeover is coming.
- The company has been subject to takeover speculation, including suitors like AstraZeneca (NYSE:AZN) talking about a $200/share bid, as well as Teva (NYSE:TEVA) and Gilead (NASDAQ:GILD) discussing $280/share bids.
Tue, Jun. 16, 9:54 AM
- A 117-subject Phase 2/3 study, called ARM-TD, assessing Teva Pharmaceutical Industries' (NYSE:TEVA) SD-809 (deutetrabenazine) in patients with a movement disorder called tardive dyskinesia met its objective of demonstrating a reduction in the severity of abnormal involuntary movements. Specifically, the primary endpoint was the change in the Abnormal Involuntary Movement Scale (AIMS) from baseline to the end of 12 weeks of therapy. Patients treated with SD-809 showed an improvement of 3.0 points compared to 1.6 points for placebo (p=0.0188). The company does not specify whether the number is the average or median. Data analysis is ongoing and will be presented at future medical meetings and submitted for publication.
- Tardive dyskinesia, affecting ~500K Americans, is characterized by involuntary movements of the tongue, lips, face, trunk and extremities. It occurs most frequently in patients with neuropsychiatric disorders like schizophrenia being treated with long term dopamine-related medications. There are no approved therapies in the U.S. for the condition.
- Deutetrabenazine is an oral small molecule inhibitor of a protein called VMAT2 (vesicular monoamine 2 transporter), which plays a key role in the regulation of dopamine in the brain. The company is investigating the potential of SD-809 in various movement disorders.
Mon, Jun. 15, 11:33 AM
- The FDA accepts for review Teva Pharmaceutical Industries' (TEVA -1.4%) Biologics License Application (BLA) for reslizumab, a monoclonal antibody that inhibits interleukin-5 (IL-5), for the treatment of adolescent and adult patients with inadequately controlled eosinophilic asthma. The PDUFA date will be in March 2016.
- IL-5 plays a key role in the activation of inflammatory white blood cells called eosinophils.
Thu, Jun. 11, 6:47 AM
- Teva Pharmaceutical (NYSE:TEVA) has now raised its stake in Mylan (NASDAQ:MYL) to 3%, as part of its effort to acquire its rival, Globes reports.
- Yesterday, Teva bought about 1.3M shares in Mylan for close to $100M and has now paid about $1.1B for a total of 14.9M shares.
- Previously: Reuters: Teva set to raise stake in Mylan (Jun. 03 2015)
Wed, Jun. 10, 2:20 AM
- A Pennsylvania judge has recommended Kirkland & Ellis be prevented from advising Teva Pharmaceutical (NYSE:TEVA) on its attempted takeover of Mylan (NASDAQ:MYL) after the law firm represented Mylan on other matters.
- The report is likely to shake up a bitter, three-way takeover battle. Mylan has rejected Teva's bid in unusually harsh terms and is instead plowing ahead with its own, twice-rejected offer for Perrigo (NYSE:PRGO).
Tue, Jun. 9, 11:54 AM
- Proactiveinvestors' Philip Waller says if AstraZeneca (AZN -1.1%) doesn't get serious it will miss out on an attractive acquisition candidate that would boost its pipeline, something it needs to do if it hopes to achieve its previously announced goal of $45B in revenues by 2023.
- The target is San Diego, CA-based Receptos (RCPT +0.3%), a clinical stage biopharmaceutical firm with two promising drugs in development: RPC1063 for relapsing multiple sclerosis and inflammatory bowel disorders and RPC4046 for eosinophilic esophagitis.
- The company has already approached Receptos about a $200 per share bid but it was rejected as were higher bids of ~$280 per share from (TEVA -0.3%) and Gilead Sciences (GILD +1.2%). Receptos is reportedly holding out for $350 per share which would value it at ~$11B or a 124% premium to its current valuation.
- An AZN spokesperson says, "We wouldn't comment on market rumour or speculation."
Mon, Jun. 8, 3:36 PM
- In yet another letter, Mylan (MYL -0.5%) Executive Chairman Robert Coury wants (TEVA -0.9%) to answer two simple questions: Are you going to make a formal offer for us? If so, are you willing to do whatever the U.S. Federal Trade Commission stipulates to make the deal happen?
- A response letter from Teva will, no doubt, be sent shortly.
Mon, Jun. 8, 1:15 PM
- In a letter to Mylan (MYL -0.6%) Executive Chairman Robert Coury, Teva Pharmaceutical Industries' (TEVA +0.2%) President & CEO Erez Vigodman responds to Mylan's rather negative perceptions about the latter's intent regarding a takeover bid. Teva appears committed to getting a deal done and asserts that Mylan is the one who is holding things up.
- Mylan is on the prowl for generic drug firm Perrigo (PRGO -0.9%), who keeps rejecting its offers, the latest at $34B. Teva made a $40B bid for Mylan in April that Mylan rejected.
Mon, Jun. 8, 7:15 AM
- Concert Pharmaceuticals (NASDAQ:CNCE) receives a payment of $50.2M from Auspex Pharmaceuticals pursuant to a September 2011 patent assignment agreement under which Concert assigned Auspex a U.S. patent application related to deuterium-substituted analogs of pirfenidone. Under the terms of the agreement, Concert became eligible to receive the payment due to a change in control of Auspex, which was acquired by Teva Pharmaceutical Industries (NYSE:TEVA) on May 5.
Wed, Jun. 3, 1:47 AM
- Raising additional legal concerns, Teva Pharmaceutical (NYSE:TEVA) is reportedly looking to purchase more shares in Mylan (NASDAQ:MYL), sources told Reuters.
- Teva last week disclosed a 1.8% stake in Mylan, which blasted the move as breaching U.S. antitrust laws. Companies that acquire stakes worth more than $76.3M in rivals must first obtain regulatory approval.
- The strategy is a sign of Teva's commitment to acquire Mylan, as the latter presses on with its own $34B hostile bid for Perrigo (NYSE:PRGO).
- MYL rose 1% in after-hours trading.
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